summary table of hiv treatment...
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SUMMARY TABLE OF HIV TREATMENT
REGIMENS
DECEMBER 2017
SUMMARY TABLE OF HIV TREATMENT
REGIMENS
This publication is made possible by the generous support of the American people through the U.S. Agency for International Development (USAID) under the terms of Cooperative Agreement AID-OAA-A-14-00046. The contents are the responsibility of AIDSFree and do not necessarily reflect the views of USAID, PEPFAR, or the U.S. Government.
AIDSFree
The Strengthening High Impact Interventions for an AIDS-free Generation (AIDSFree) Project is a five-year cooperative agreement funded by the U.S. Agency for International Development under Cooperative Agreement AID-OAA-A-14-00046. AIDSFree is implemented by JSI Research & Training Institute, Inc. with partners Abt Associates Inc., Elizabeth Glaser Pediatric AIDS Foundation, EnCompass LLC, IMA World Health, the International HIV/AIDS Alliance, Jhpiego Corporation, and PATH. AIDSFree supports and advances implementation of the U.S. President’s Emergency Plan for AIDS Relief by providing capacity development and technical support to USAID missions, host-country governments, and HIV implementers at the local, regional, and national level.
Recommended Citation
Strengthening High Impact Interventions for an AIDS-free Generation (AIDSFree) Project. 2017. Summary Table of HIV Treatment Regimens. Arlington, VA: AIDSFree Project.
JSI Research & Training Institute, Inc. 1616 Fort Myer Drive, 16th Floor Arlington, VA 22209 USA Phone: 703-528-7474 Fax: 703-528-7480
Contents ACRONYMS.................................................................................................................................. vii
INTRODUCTION............................................................................................................................. 1
National HIV Treatment Guidelines ............................................................................................ 3
Angola ............................................................................................................................................ 3
Botswana........................................................................................................................................ 5
Burundi........................................................................................................................................... 8
Cameroon....................................................................................................................................... 9
Côte d'Ivoire ................................................................................................................................ 12
Democratic Republic of Congo.................................................................................................. 13
Ethiopia ........................................................................................................................................ 14
Ghana............................................................................................................................................ 17
Haiti ..............................................................................................................................................20
Kenya ............................................................................................................................................ 23
Lesotho......................................................................................................................................... 26
Malawi .......................................................................................................................................... 28
Mozambique................................................................................................................................ 29
Myanmar (Burma)....................................................................................................................... 31
Namibia ........................................................................................................................................ 32
Nigeria.......................................................................................................................................... 34
Rwanda......................................................................................................................................... 38
South Africa ................................................................................................................................. 41
South Sudan ................................................................................................................................ 47
Swaziland ..................................................................................................................................... 49
Tanzania ....................................................................................................................................... 52
Uganda ......................................................................................................................................... 54
Zambia.......................................................................................................................................... 56
Zimbabwe .................................................................................................................................... 58
Annex: Accordance with 2015 WHO recommendations ........................................................ 61
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ACRONYMS 3TC lamivudine
ABC abacavir
AMP amprenavir
AIDSFree Strengthening High Impact Interventions for an AIDS-free Generation
ART antiretroviral therapy
ARV antiretroviral
ATV atazanavir
ATV/r atazanavir/ritonavir
AZT zidovudine
bDNA branched deoxyribonucleic acid
CCR5 cysteine-cysteine chemokine receptor 5
CD4 cluster of differentiation 4
CDC Centers for Disease Control and Prevention
d4T stavudine
ddI didanosine
DRV darunavir
DRV/r darunavir/ritonavir
EFV efavirenz
ELISA enzyme-linked immunosorbent assay
ETV etravirine
FDC fixed dose combination
FPV fosamprenavir
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FPV/r fosamprenavir/ritonavir
FTC emtricitabine
HAART highly active antiretroviral therapy
HBV hepatitis B virus
HCV hepatitis C virus
IDV indinavir
IDV/r indinavir/ritonavir
LIP lymphocytic interstitial pneumonia
LPV/r lopinavir/ritonavir
MDR TB multidrug-resistant tuberculosis
MTCT mother-to-child transmission
MVC maraviroc
NFV nelfinavir
NNRTI nonnucleoside reverse transcriptase inhibitor
NRTI nucleoside reverse transcriptase inhibitor
NVP nevirapine
OHL oral hairy leukoplakia
OI opportunistic infection
PCR polymerase chain reaction
PI protease inhibitor
PI/r protease inhibitor/ritonavir
PMTCT prevention of mother-to-child transmission
RAL raltegravir
RNA ribonucleic acid
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RT reverse transcriptase
RTV ritonavir
sdNVP single-dose nevirapine
SQV saquinavir
SQV/r saquinavir/ritonavir
T20 enfuvirtide
TB tuberculosis
TDF tenofovir
TLC total lymphocyte count
TPV tipranavir
TPV/r tipranavir/ritonavir
TWG technical working group
WHO World Health Organization
XDR TB extensively drug-resistant TB
x
1
INTRODUCTION AIDSFree has built upon the National Treatment Guidelines Database developed during AIDSTAR-One. The objective of the Database is to provide policymakers, program planners, and clinicians with the most up-to-date treatment guidelines available; create a central location to house updated national guidelines (facilitating cross-country comparisons and serving as a resource to implementers in multiple country settings); provide a Summary Table that includes an evaluation of concordance with the World Health Organization's (WHO) 2015 Consolidated Guidelines (enabling countries to determine if their treatment guidelines require updating); and provide multiple treatment guidelines per country (i.e., adult and pediatric HIV, TB, PMTCT, and PEP) all in one location, thus increasing ease of access to guidelines for global audiences.
The following tables provide summary HIV treatment guidelines for adults, adolescents, infants and children, and pregnant and lactating women that have been collected and summarized by AIDSFree. Guidelines were reviewed for 24 countries in 2017 including Angola, Botswana, Burundi, Cameroon, Côte d'Ivoire, Democratic Republic of Congo, Ethiopia, Ghana, Haiti, Kenya, Lesotho, Malawi, Mozambique, Myanmar (Burma), Namibia, Nigeria, Rwanda, South Africa, South Sudan, Swaziland, Tanzania, Uganda, Zambia, and Zimbabwe. Efforts were made to identify the most up-to-date treatment guidelines available through internet searches and contacting JSI’s and other AIDSFree partner’s country offices. In some cases there may be updated treatment guidelines that the AIDSFree team did not obtain.
The tables include information on first-, second-, and third-line treatment regimens, and indicate whether TB/HIV co-infection was addressed within the HIV guidelines. The annex at the end presents information on each country's accordance with the 2015 WHO treatment initiation guidelines (the most recent guidance available at the time of publication of most country guidelines) by population.
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Population HIV Treatment Area Criteria for Starting ARV Treatment First-Line Regimen Second-Line Regimen Third-Line Regimen
Angola - Normas de Tratamento Antirretroviral (Antiretroviral Treatment Guidelines) (2015)
TB/HIV Co-Infection addressed under HIV Guidelines: Yes
Adults and children >10 years old and ≥ 35 kg
ARV Treatment All patients with CD4 <500 cells/mm3 (prioritize patients with CD4 <350 cells/mm3)
Regardless of CD4 cell count:1. All patients with WHO stage 3 or 42. Active TB3. Co-infection with hepatitis B4. Pregnant or lactating women
Consider ART initiation regardless of CD4 cell count or clinical stage in:1. Serodiscordant couples2. Elevated cardiovascular risk3. Elevated VL (>100,000 copies/ml)4. HIV nephropathy5. More than 55 years old
TDF + 3TC/FTC + EFV****FDC approved for patients >18 years old
Alternatives:
AZT + 3TC + EFV -->ABC + 3TC + EFV -->ddI + 3TC + EFV -->TDF + 3TC + ATV/r -->TDF + 3TC + LPV/r -->TDF + 3TC + NVP -->
AZT + 3TC + LPV/r or ATV/r
TDF + 3TC + LPV/r or ATV/rAZT + 3TC + LPV/r or ATV/rAZT + 3TC + LPV/r or ATV/r2 NRTI + 1 NNRTI + LPV/r + SQV2 NRTI + 1 NNRTI + LPV/r + SQVAZT + 3TC + LPV/r or ATV/r
Adolescents <35kg Adolescents <35 kg and children 3-10 years old:ABC + 3TC + EFV
Alternatives:AZT + 3TC + EFVTDF + 3TC + EFVddI + 3TC + EFVABC + 3TC + LPV/rABC + 3TC + NVP
Children 5-10 years old ARV Treatment All patients with CD4 <500 cells/mm3 (prioritize patients with CD4 <350 cells/mm3 and/or WHO stage 3 or 4)
Initiate treatment in all patients with active TB, regardless of CD4 cell count
Children 3-4 years old ARV Treatment Initiate treatment regardless of CD4 cell count or clinical stage
Children <3 years old ARV Treatment Initiate treatment regardless of CD4 cell count or clinical stage
Children <3 years old:ABC + 3TC + LPV/rAZT + 3TC + LPV/r
Alternatives:ddI + 3TC + LPV/rAZT + 3TC + NVPABC + 3TC + NVPddI + 3TC + NVP
Children below 18 months who qualify for presumptive diagnosis
ARV Treatment Initiate treatment
Infants birth to 6 weeks PMTCT Initiate NVP in exposed infant within 48 hours of birth. Do not initiate more than 48 hours after birth.
Birth weight 2000 - 2499 g: 10 mg NVP once daily Birth weight ≥ 2500g: 15 mg NVP once dailyBirth weight <2000g: 2 mg/kg once daily.
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Population HIV Treatment Area Criteria for Starting ARV Treatment First-Line Regimen Second-Line Regimen Third-Line Regimen
Angola - Normas de Tratamento Antirretroviral (Antiretroviral Treatment Guidelines) (2015)
TB/HIV Co-Infection addressed under HIV Guidelines: Yes
Women in labor PMTCT AZT intravenous (continuous) or oral (every three hours) from start of labor until clamping of the cord
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Population HIV Treatment Area Criteria for Starting ARV Treatment First-Line Regimen Second-Line Regimen Third-Line Regimen
Botswana - Handbook of the Botswana 2016 Integrated HIV Clinical Care Guidelines (2016)
TB/HIV Co-Infection addressed under HIV Guidelines: Yes
AdultsAdolescents> 40 kgPregnant Women
ARV Treatment Treat all Initiations beginning 2016Truvada + DolutegravirTDF + FTC + DTG
Based on Resistance Testing Results & Consultation with HIV Specialist
All 2nd line failures regardless of their regimens will be resistance tested to determine 3rd line with assistance of HIV Specialist.TDF renal toxicity w/o CVD risk:
ABC/3TC/DTG
TDF renal toxicity or insufficiency with CVD risk or DTG Toxicity:Discuss with specialist
Initiations Prior to 2016TDF/FTC/EFVTDF/FTC/NVPAZT/3TC/EFVAZT/3TC/NVPABC/3TC/NVPABC/3TC/EFV
AZT/3TC/LPV/rAZT/3TC/ATA/rTDF/FTC/LPV/rTDF/FTC/ATA/r
Pregnant Women PMTCT Place all HIV positive ART naïve pregnant women on ART as soon as possible. Always prioritize HIV positive pregnant women for initiation.
Initiate ART - even late in pregnancy - unless in advanced second stage of labour, there is no stage of pregnancy that is too early or too late to begin ART.
TDF + FTC + DTG
If renal insufficiency without CVD risk use: ABC/3TC/DTG
If renal insufficiency with CVD risk: Discuss with HIV Specialist
For diabetics taking metformin, reduce dose with assistance from HIV Specialist, maximum dosage of Metformin is not to exceed 1,000 mg daily.
HIV Positive Women STABLE on ART Who Became Pregnant:Women who are clinically stable with viral loads < 400 copies µL should remain on their current ART regimen throughout pregnancy and delivery.
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Population HIV Treatment Area Criteria for Starting ARV Treatment First-Line Regimen Second-Line Regimen Third-Line Regimen
Botswana - Handbook of the Botswana 2016 Integrated HIV Clinical Care Guidelines (2016)
TB/HIV Co-Infection addressed under HIV Guidelines: Yes
Pregnant Women PMTCT Place all HIV positive ART naïve pregnant women on ART as soon as possible. Always prioritize HIV positive pregnant women for initiation.
Initiate ART - even late in pregnancy - unless in advanced second stage of labour, there is no stage of pregnancy that is too early or too late to begin ART.
HIV Positive Women Already on ART but NOT STABLE who become Pregnant:Clinically evaluate all pregnant women who are not clinically stable or not virally suppressed, to determine and correct the causes of non-suppression or illness, as a matter of urgency. Contact an HIV Specialist as needed to ensure complete virologic suppression before delivery.
During Labour: All HIV positive women - regardless of their ART regimens - should receive supplemental AZT 300 mg every three hours not to exceed 1,500 mg.
Children> 3 years old< 40 kg
ARV Treatment Treat all Initiations Beginning 2016ABC/3TC/EFV
Based on R Testing results and consultation with HIV specialist
All 2nd line failures regardless of their regimens will be resistance tested to determine 3rd line with assistance of HIV Specialist.Initiations Prior to 2016
AZT/3TC/EFVAZT/3TC/NVP
AZT/3TC/LPV/rABC/3TC/LPV/r
ChildrenInfants >1 month to 3 years old
ARV Treatment ABC/3TC/LPV/r Based on R Testing results and consultation with HIV specialist
**All pediatric patients failing 1st line regardless of their regimen will be resistance tested to determine 2nd line with assistance of HIV specialist except infants whose mothers received sd NVP - then 1st line ABC/FTC/LPV/r
Infants<1 month
ARV Treatment AZT/3TC/NVP* (switch infants to ABC/3TC/LPV/r at 1 month)
* Except infants whose mothers received sd NVP - then 1st Line ABC/FTC/LPV/r
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Population HIV Treatment Area Criteria for Starting ARV Treatment First-Line Regimen Second-Line Regimen Third-Line Regimen
Botswana - Handbook of the Botswana 2016 Integrated HIV Clinical Care Guidelines (2016)
TB/HIV Co-Infection addressed under HIV Guidelines: Yes
Infants PMTCT Administer a short-course of AZT to the infant (regardless of whether or not the mother received any ARVs during pregnancy or delivery) as soon as possible after delivery at least within 72 hours, in order to maximize PMTCT
All HIV exposed babies must complete DNA PCR testing by 6 weeks of age.
• Begin AZT 4 mg/kg PO every 12 hours for 4 weeks.• Preterm or low birth weight, give AZT dose is 2 mg/kg PO every 12 hours for the first 2 weeks, then increase to 2 mg/kg PO every 8 hours (TDS) for the final 2 weeks. • HIV-exposed infants brought in > 72 hours after birth should not receive AZT prophylaxis but rather should be referred to an HIV specialist or ARV clinic.
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Population HIV Treatment Area Criteria for Starting ARV Treatment First-Line Regimen Second-Line Regimen Third-Line Regimen
Burundi - Directives Nationales D'Utilisation des Antiretroviraux pour la prévention et le traitement du VIH (2016)
TB/HIV Co-Infection addressed under HIV Guidelines: Yes
Adults Adolescents(<10 years old or >35 kg)Pregnant WomenBreastfeeding women
ARV Treatment ARV treatment is initiated in anyone (child or adult) detected HIV-positive regardless of their clinical stage or CD4 counts.
Test and treat if positive result.
2 NRTI + 1 NNRTI 2 NRTI + 1 PI/r Initiation of a third line regimen will be decided by a committee of ART experts.1 NRTI + 1 PI/r + 1 INSTI
Preferred:TDF + 3TC + EFV ABC + 3TC + ATV/r DRV/r + DTG + 3TC and AZTAlternative Options:TDF + 3TC + NVP ABC + 3TC + ATV/r DRV/r + DTG + 3TC and AZTAZT + 3TC + NVP ABC + 3TC + ATV/r DRV/r + DTG + 3TC or TDF
Children < 3 years
Preferred: RAL/DTG + 2 NRTIs
DRV/r + 2 NRTIs
DRV/r + RAL/DTG + 1 NRTI
ABC + 3TC + LPV/r AZT + 3TC + RALAlternative Options:AZT + 3TC + LPV/r ABC + 3TC + RAL
Children 3 years to 10 years
Preferred:
ABC + 3TC + EFV AZT +3TC + ATV/rAlternative Options:ABC + 3TC + NVP AZT + 3TC + ATV/rAZT + 3TC + NVP ABC + 3T + ATV/r
If 1st line was ABC+3TC+LPV/rthen switch to AZT+3TC+EFVIf first line was AZT+3TC+LPV/rthen switch to ABC+3TC+EFV
PMTCT To minimize the risk of HIV transmission to the child, in addition to the treatment of the mother, ARV prophylaxis in the newborn must be established.
Provide bi-therapy (NVP + AZT) to the newborn during 12 weeks
Infant < 6 weeks old with birth weight 2000g-2500g
NVP 10 mg/d + AZT 10mgx2/d
Infant < 6 weeks old with birth weight >2500g
NVP 15 mg/d + AZT 15mg x2/d
Infant 6-12 weeks old NVP 20 mg/d + AZT 60 mg x2/d'orNVP 1/2 of 50 mg tablet/d + AZT 60 mg table x2/d
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Population HIV Treatment Area Criteria for Starting ARV Treatment First-Line Regimen Second-Line Regimen Third-Line Regimen
Cameroon - National Guideline on the Prevention and Management of HIV in Cameroon (2015)
TB/HIV Co-Infection addressed under HIV Guidelines: Yes
Adults Pregnant Women Breastfeeding women
ARV Treatment Start ARV treatment in any patient: • Stage 1 or 2 of the WHO classification or stage A and B of the CDC classification if CD4 count ≤ 500 cells/mm3. However, priority should be given to patients with CD4 ≤350• Stages 3 and 4 of the WHO classification of stage C of the CDC classification regardless of the CD4 lymphocyte count• HIV/HBV coinfection regardless of the CD4 count• In any HIV+ person in a serodiscordant couple regardless of the CD4 count• Key populations infected with HIV (SW, MSM, IDU) regardless of CD4 count• Pregnant women regardless of CD4 count• Breastfeeding women regardless of CD4 count
Preferred: Individual management of confirmed cases and the therapeutic choice in case of failure in the 2nd line will be
guided by the resistance profile (genotyping). Also the third-line
regimens should include new ARV with proven HIV activity: second
generation PI (Darunavir/ritonavir), anti integrase (Raltegravir vs dolutegravir). The choice of
treatment will take into account the level of viral load and sensitivity.
TDF + 3TC (or FTC) + EFV AZT + 3TC + (ATV/r or LPV/r)
Alternative Options:
AZT + 3TC + EFV (or NVP)TDF + FTC + (ATV/r or LPV/r)
TDF + 3TC + (ATV/r or LPV/r)
TDF + 3TC (FTC) + NVP AZT + 3TC + (ATV/r or LPV/r)
Special situations:
ABC + 3TC + EFV (or NVP)
AZT (or ABC) + 3TC + LPV/r or ATV/r
Adolescents 10 - 19 years ≥ 35 kg
ARV Treatment Preferred: In case of 2nd line treatment failure: 3rd line is possible after genotyping
RAL + DRV/r + ETV
RAL + DRV/r + TDF***
RAL + ATV/r + TDF
*** TDF will be used only in children older than 10 years.
TDF** + 3TC (or FTC) + EFV ABC + 3TC + (LPV/r or ATV/r)Alternative Options:ABC + 3TC + EFV (or NVP) TDF + 3TC + LPV/r or ATV/rAZT + 3TC + EFV (or NVP)
TDF + 3TC (or FTC) + NVP
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Population HIV Treatment Area Criteria for Starting ARV Treatment First-Line Regimen Second-Line Regimen Third-Line Regimen
Cameroon - National Guideline on the Prevention and Management of HIV in Cameroon (2015)
TB/HIV Co-Infection addressed under HIV Guidelines: Yes
Children3 - 10 years and Adolescents < 35kg
ARV Treatment Any HIV-infected child under 60 months should be put on ART regardless of CD4 count or WHO clinical stage.
HIV infected child >60 months:• Treat all the children with clinical stage III or IV• Treat all the children with CD4 <500 cells/mm3• Starting treatment should be a priority if CD4 <350 cells/mm3
Preferred: In case of 2nd line treatment failure: 3rd line is possible after genotyping
RAL + DRV/r + ETV
RAL + DRV/r + TDF***
RAL + ATV/r + TDF
*** TDF will be used only in children older than 10 years.
ABC +3TC + EFV AZT + 3TC + LPV/rAZT + 3TC + ATV/r**
** ATV/r if failure of first line treatment occurs after the age of 6
1st Alternative Lines:ABC + 3TC + NVPAZT + 3TC + EFV ABC + 3TC + LPV/r
ABC + 3TC + ATV/r**
** ATV/r if failure of first line treatment occurs after the age of 6
AZT + 3TC + NVP
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Population HIV Treatment Area Criteria for Starting ARV Treatment First-Line Regimen Second-Line Regimen Third-Line Regimen
Cameroon - National Guideline on the Prevention and Management of HIV in Cameroon (2015)
TB/HIV Co-Infection addressed under HIV Guidelines: Yes
Children<3 years
ARV Treatment Any HIV-infected child under 60 months should be put on ART regardless of CD4 count or WHO clinical stage.
Any infant under 18 months with a presumptive diagnosis of HIV infection should be put on antiretroviral treatment and diagnosis by PCR must be confirmed as soon as possible.
Preferred: In case of 2nd line treatment failure: 3rd line is possible after genotyping
RAL + DRV/r + ETV
RAL + DRV/r + TDF***
RAL + ATV/r + TDF
*** TDF will be used only in children older than 10 years.
ABC + 3TC + LPV/r AZT + 3TC + RALAZT + 3TC + LPV/r ABC + 3TC + RALABC +3TC + NVP AZT + 3TC + LPV/rAZT +3TC + NVP ABC + 3TC + LPV/r
Infant Birth to 6 weeks<2kg
PMTCT For any child born to an HIV+ mother who is breastfed or receives replacement feeding, ART should start as early as possible following the childbirth or as soon as the maternity personnel in charge of the follow-up of the mother-child pair are aware of its exposure.
Start with NVP 2 mg/kg daily until it reaches 2kg
InfantBirth to 6 weeks2 to 2.5 kg
PMTCT NVP 10 mg in a single dose once daily
InfantBirth to 6 weeks> 2.5 kg
PMTCT NVP 15 mg in a single dose once daily
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Population HIV Treatment Area Criteria for Starting ARV Treatment First-Line Regimen Second-Line Regimen Third-Line Regimen
Côte d'Ivoire - Directives 2015 de mise sous Antirétroviraux a vie des femmes enceintes infectées par le VIH/SIDA dans le cadre de la prévention de la transmission mere-enfant du VIH (PTME) en Côte d'Ivoire. (2015) Directives 2015 de Prise en charge des personnes vivant avec le VIH en Côte d'Ivoire. (2015)
TB/HIV Co-Infection addressed under HIV Guidelines: Yes
AdultsAdolescents
ARV Treatment Person infected with HIV:- WHO clinical stages 1, 2, 3, or CDC A , B with CD4 ≤ 500 cells/ml- Clinical stages WHO 4 or CDC C, regardless of the CD4 value- Co-infection (TB, severe hepatic disease)- Pregnant women regardless of CD4 count- Infected spouse in serodiscordant couple irrespective of CD4 cell count- Key populations (MSM, sex workers, Injection Drug Users (IDUs) regardless of CD4 cell count
TDF + 3TC + EFV (in fixed dose combination, 1 tablet per day)
Alternatives:AZT + 3TC + EFV ABC + 3TC + EFV
TDF + 3TC + AZT
AZT + 3TC + ATV/r or LPV/r
TDF + 3TC + ATV/rAZT + 3TC + ATV/r or TDF + 3TC +ATV/rTDF + 3TC + ATV/r
Guided by results of genotyping. If no genotyping available, the proposed regimen is:Darunavir (DRV)/r + Raltegravir (RAL) + 2INTI
Pregnant Women ARV Treatment Start treatment as soon as the diagnosis is confirmed
TDF + 3TC + EFV Treatment of pregnant women for the second and third lines are done at the reference center (SMIT Treichville).
Children< 10 years
ARV Treatment Any HIV-infected child under 10 years of age is eligible for ARV treatment regardless of CD4 and clinical stage.
Children who are ≥ 10 years start if WHO clinical stages 1-2, CDC N, A (asymptomatic patient) and CD4 ≤ 500 cell / mm3
or Clinical Stages WHO 3-4, CDC B, C regardless of CD4 value
≥ 10 years TDF + 3TC + EFV
TDF + 3TC + LPV/r
≥ 3 years and < 10 years ABC + 3TC + EFV
AZT + 3TC + EFV
ABC + 3TC + LPV/r
AZT + 3TC + LPV/r
< 3 years or weight < 10kgABC + 3TC + LPV/r
Continue same regimen. If clinical failure or adherence problems due to the taste of LPV/r, change to:ABC + 3TC + NVP
Infants PMTCT Birth (within 48-72 hours) to 4 weeks:NVP syrup 2 mg/kg once daily
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Population HIV Treatment Area Criteria for Starting ARV Treatment First-Line Regimen Second-Line Regimen Third-Line Regimen
Democratic Republic of Congo - Guide de Prise en Charge Intégrée du VIH en République Démocratique du Congo (2016)
TB/HIV Co-Infection addressed under HIV Guidelines: Yes
AdultsPregnant and breastfeeding women
ARV Treatment Start ART immediately in any person tested positive for HIV regardless of CD4 count or clinical stage.
The first-line ART will include:TDF + 3TC + EFV
Alternative:AZT + 3TC + NVP
AZT/TDF + 3TC + LPV/r DRV/r + DTG + ABC
Adolescents 10 - 19 years old
ARV Treatment TDF + 3TC + EFV
Alternative:AZT + 3TC +NVP
Children 3 - 10 years old
ARV Treatment ABC + 3TC + EFV
Alternative:AZT + 3TC + NVP
AZT + 3TC + LPV/r DRV/r+3TC+ABC/AZT
Children <3 years (< 36 months)
ARV Treatment TDF + 3TC + LPV/r
Alternative:AZT + 3TC + NVP
AZT + 3TC + RAL
Infants 3 - 36 months old
ARV prophylaxis ABC + 3TC + LPV/r (pellets)
Alternative:AZT + 3TC + LPV/r (pellets)
<3 months ARV prophylaxis AZT + 3TC + NVP,
If, after PCR, the child is infected, give:
ABC + 3TC + LPV/r (pellets)
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Population HIV Treatment Area Criteria for Starting ARV Treatment First-Line Regimen Second-Line Regimen Third-Line Regimen
Ethiopia - National Guidelines for Comprehensive HIV Prevention, Care and Treatment (2017)
TB/HIV Co-Infection addressed under HIV Guidelines: Yes
Adults > 19 years old (including adults with TB co-infection)
ARV Treatment Monitor the number and percentage of different populations (such as adults, adolescents, children and pregnant and breastfeeding women) who have initiated ART based on the new eligibility criteria: Test- and - treat
ART should be initiated in all people living with HIV, regardless of WHO clinical stage or CD4 cell count
Start ART as early as possible to all adults with a confirmed HIV diagnosis ready and willing regardless of their WHO clinical stages and CD4 count
Preferred:TDF + 3TC + EFV (FDC)
Alternatives:AZT + 3TC + EFVAZT + 3TC + NVPTDF + 3TC + NVP
Adolescents 10 - 19 years old
ARV Treatment Start ART as early as possible to all adolescent with a confirmed HIV diagnosis regardless of their WHO clinical stages and CD4 counts.
As the level of maturity varies, some younger Adolescents may need parental consent and support.
Preferred:TDF + 3TC + EFV (FDC)
Alternatives:AZT + 3TC + EFVAZT + 3TC + NVPTDF + 3TC + NVPABC + 3TC + EFV
Preferred second line:If AZT was used in first line:TDF + 3TC + LPV/r or ATV/r
If TDF was used in first line:AZT + 3TC + LPV/r or ATV/r
Pregnant and breastfeeding women
ARV Treatment Start ART as early as possible to all pregnant and breastfeeding women living with HIV regardless of their WHO clinical stages and CD4 counts.
For women identified at labor and delivery, provide ART the same hour with brief counseling and provide detailed counseling on ARVs and Adherence after delivery.
Preferred:TDF + 3TC + EFV (FDC)
Alternative:AZT + 3TC + EFVAZT + 3TC + NVPTDF + 3TC + NVP
Preferred second line:If AZT was used in first line:TDF + 3TC + LPV/r or ATV/r
If TDF was used in first line:AZT + 3TC + LPV/r or ATV/r
DRV/r a + DTG (or RAL) ± ABC
DRV/r a + DTG (or RAL) ± ABCorDRV/r a + DTG (or RAL) ± TDF
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Population HIV Treatment Area Criteria for Starting ARV Treatment First-Line Regimen Second-Line Regimen Third-Line Regimen
Ethiopia - National Guidelines for Comprehensive HIV Prevention, Care and Treatment (2017)
TB/HIV Co-Infection addressed under HIV Guidelines: Yes
Children3 - 10 years old and Adolescents <35kg
ARV Treatment Start ART as early as possible to all children living with HIV regardless of their WHO clinical stages
and CD4 counts/percentages.
HIV infected infants shall be started on ART and counseling on dosage and administration will be
provided for parents.
Preferred:AZT/ABC + 3TC + EFV
Alternatives:ABC + 3TC + NVP**AZT + 3TC + NVPTDF + 3TC + EFVTDF + 3TC + NVP
**Caution: co-administration of ABC with NVP in pediatric patients will increase the risk of hypersensitivity reaction and requires extreme precaution.
ABC or TDF + 3TC + LPV/rAZT + 3TC + LPV/r
AZT + 3TC + LPV/rABC or TDF + 3TC + LPV/rAZT + 3TC + LPV/rAZT + 3TC + LPV/r
DTG/RAL/DRV/r + AZT+3TC
< 3 years old Preferred:ABC or AZT + 3TC + LPV/r
Alternatives:ABC + 3TC + NVPAZT + 3TC + NVP
No change
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Population HIV Treatment Area Criteria for Starting ARV Treatment First-Line Regimen Second-Line Regimen Third-Line Regimen
Ethiopia - National Guidelines for Comprehensive HIV Prevention, Care and Treatment (2017)
TB/HIV Co-Infection addressed under HIV Guidelines: Yes
Infants ARV prophylaxis Infant prophylaxis duration is based on the total duration of material ART coverage.
Infant prophylaxis should begin within 1 hour at birth or when HIV exposure is recognized postpartum.
Infants born to HIV infected women who took ART for more than 4 weeks at time of delivery:
NVP prophylaxis for 6 weeks Infants born to mothers covered with ART for less than 4 weeks or for who was diagnosed at birth or postpartum, give:
Extended NVP prophylaxis for the infant for 12 weeks.
16
Population HIV Treatment Area Criteria for Starting ARV Treatment First-Line Regimen Second-Line Regimen Third-Line Regimen
Ghana - Guidelines for Antiretroviral Therapy in Ghana (2016)
TB/HIV Co-Infection addressed under HIV Guidelines: Yes
Adults ARV Treatment ART should be given to all confirmed HIV positive clients regardless of WHO clinical stage and at any CD4 cell count. As a priority, ART should be initiated in all adults with severe or advanced HIV clinical disease (WHO clinical stage 3 or 4) and adults with CD4 count ≤ 350 cells/mm3
Preferred Regimen:TDF + 3TC (or FTC) + EFV
Alternative Regimen:TDF + 3TC (or FTC) + NVPor AZT + 3TC (or FTC) + NVPorAZT + 3TC (or FTC) + EFV
First alternative: If Tenofovir-based first line:AZT + 3TC (or FTC) + LPV/r (or ATV/r*)* If LPV/r was used for HIV-2 in first line, use ATV/r
Second alternative: If Zidovudine-based first line:TDF + 3TC (or FTC) + LPV/r (or ATV/r**)** Consider ABC if client has used both TDF and AZT.
First Alternative:DRV/r + DTG (or RAL) ± 1 or 2 NRTI
Second Alternative: DRV/r* + 2 NRTI ± NNRTI
* In PI-experienced patients DRV/r should be given BID.
Adolescents 10 - 19 years old
Children < 10 years old
ARV Treatment All children who have been confirmed HIV positive are eligible for ART initiation provided all critical issues listed below have been addressed. A child with an acute opportunistic infection must be stabilized in accordance with good medical practice before the initiation of ART.
Critical issues to address prior to initiation:1. Opportunistic infections identified and treated2. Parental or guardian motivation3. Treatment sustainable4. Caregiver completed pre-treatment adherence counseling5. Reliable caregiver6. No end-stage hepatic or renal insufficiency
Adolescents (10 - 18 years)Preferred Regimen:TDF + 3TC (or FTC) + EFV
TDF + FTC + EFV Fixed-dose combination
Alternative Regimens:AZT + 3TC (or FTC) + EFVorAZT + 3TC (or FTC) + NVPor TDF + 3TC (or FTC) + NVPorABC + 3TC (or FTC) + EFV
AZT + 3TC (or FTC) + ATV/r (or LPV/r)
Ideally based on genotyping
The following regimen is recommended if patient failed a second line regimen:DRV/r + 3TC + TDF
17
Population HIV Treatment Area Criteria for Starting ARV Treatment First-Line Regimen Second-Line Regimen Third-Line Regimen
Ghana - Guidelines for Antiretroviral Therapy in Ghana (2016)
TB/HIV Co-Infection addressed under HIV Guidelines: Yes
Adolescents 10 - 19 years old
Children < 10 years old
ARV Treatment < 18 months:If HIV antibody test seropositive and DNA PCR not available: Treat if WHO Paediatric Presumptive Stage 4 disease and repeat HIV antibody test at 18 months or request a virologic test as soon as it becomes available to confirm infection.
If positive HIV DNA PCR: Treat
18 months to 18 years:Treat if HIV antibody test seropositive
Children (3 - <10 years)Preferred Regimen:TDF + 3TC (or FTC) + EFV
Alternative Regimens:ABC + 3TC (or FTC) + EFVorABC + 3TC (or FTC) + NVPor AZT + 3TC (or FTC) + EFVorAZT + 3TC (or FTC) + NVP
AZT + 3TC (or FTC) + LPV/r
AZT + 3TC (or FTC) + ATV/r
AZT + 3TC (or FTC) + ATV/r
ABC + 3TC (or FTC) + LPV/r
ABC + 3TC (or FTC) + LPV/r
Ideally based on genotyping
The following regimen is recommended if patient failed a second line regimen:DRV/r + 3TC + TDF
Children (< 3 years)Preferred Regimen: AZT + 3TC (or FTC) + NVP
Alternative Regimen:ABC + 3TC (or FTC) + NVP
ABC + 3TC (or FTC) + LPV/r
AZT + 3TC (or FTC) + LPV/r
Ideally based on genotyping
The following regimen is recommended if patient failed a second line regimen:AZT (or ABC) + 3TC (or FTC) + RAL
18
Population HIV Treatment Area Criteria for Starting ARV Treatment First-Line Regimen Second-Line Regimen Third-Line Regimen
Ghana - Guidelines for Antiretroviral Therapy in Ghana (2016)
TB/HIV Co-Infection addressed under HIV Guidelines: Yes
Infants Prophylaxis All HIV-exposed infants irrespective of feeding option are to be provided with prophylaxis within 48 hours.
AZT 12 hourly for six weeks
Where AZT is contraindicated (e.g. anaemia or bleeding disorder), NVP daily for six weeks should be given.
Exposed infants who are at high risk of acquiring HIV should receive dual prophylaxis.
High-risk infants are defined as those:- born to women with established HIV infection who have received less than four weeks of ART at the time of delivery, OR - born to women with established HIV infection with VL > 1000 copies/mL in the four weeks before delivery, if VL available, OR - born to women with incident HIV infection during pregnancy or breastfeeding, OR - identified for the first time during the postpartum period, with or without a negative HIV test prenatally.
If formula fed: Dual prophylaxis with daily AZT and NVP for the first 6 weeks of life
If breastfed: Dual prophylaxis with daily AZT and NVP for the first 12 weeks of life
19
Population HIV Treatment Area Criteria for Starting ARV Treatment First-Line Regimen Second-Line Regimen Third-Line Regimen
Haiti - Normes Nationales pour la Prise en Charge des Personnes Vivant avec le VIH Resume Executif (2016)
TB/HIV Co-Infection addressed under HIV Guidelines: Yes
Adults> 19 years old
ARV Treatment ARV therapy should be initiated in all adults (> 19 years of age) with a confirmed HIV + diagnosis.
Recommended:
TDF + 3TC + EFV AZT + 3TC + ATV/r or LPV/r
Patients with virological failure under 2nd line regimen despite adherence support:
DRV + RAL + ETVAlternatives:AZT or ABC + 3TC + EFV TDF + 3TC + ATV/r or LPV/rTDF or AZT + 3TC + ABC (if TB and intolerance to EFV)TDF + 3TC + ATV/r or LPV/r AZT + 3TC + ATV/r or LPV/rAZT or ABC + 3TC + ATV/r or LPV/r
TDF + 3TC + ATV/r or LPV/r
Pregnant WomenBreastfeeding Women
ARV Treatment ARV therapy should be initiated in all pregnant and breastfeeding women living with HIV.
Recommended:
TDF + 3TC + EFV AZT + 3TC + ATV/r or LPV/r
Alternatives:AZT + 3TC + EFV TDF + 3TC + ATV/r or LPV/rTDF + 3TC + ATV/r or LPV/r AZT + 3TC + ATV/r or LPV/rABC + 3TC +EFV
Adolescents 10 - 19 years old
ARV Treatment ARV therapy should be initiated in all adolescents (10 - 19 years) living with HIV.
Recommended:
TDF + 3TC + EFV
AZT + 3TC + ATV/r or LPV/r
Alternatives:ABC + 3TC + EFVAZT + 3TC + EFV TDF + 3TC + ATV/r or LPV/rTDF + 3TC + ATV/r or LPV/r AZT + 3TC + ATV/r or LPV/rABC + 3TC + ATV/r or LPV/rAZT + 3TC + ATV/r or LPV/r TDF + 3TC + ATV/r or LPV/r
20
Population HIV Treatment Area Criteria for Starting ARV Treatment First-Line Regimen Second-Line Regimen Third-Line Regimen
Haiti - Normes Nationales pour la Prise en Charge des Personnes Vivant avec le VIH Resume Executif (2016)
TB/HIV Co-Infection addressed under HIV Guidelines: Yes
Children 3 - 10 years old
ARV Treatment ARV therapy should be initiated in all children <10 years of age living with HIV.
Recommended:
ABC + 3TC + EFV
If failure under LPV/r: RAL
If failure under NVP:LPV/r or ATV/r
If failure under ABC + 3TC or TDF + 3TC:AZT + 3TC
If failure under AZT + 3TC:TDF +3TC or ABC + 3TC
Patients with virological failure under 2nd line regimen despite adherence support:
DRV + RAL + ETV
Alternatives:ABC + 3TC + NVP AZT + 3TC + LPV/r or ATV/rTDF + 3TC + NVP AZT + 3TC + LPV/r or ATV/rAZT + 3TC + EFVTDF + 3TC + EFV
21
Population HIV Treatment Area Criteria for Starting ARV Treatment First-Line Regimen Second-Line Regimen Third-Line Regimen
Haiti - Normes Nationales pour la Prise en Charge des Personnes Vivant avec le VIH Resume Executif (2016)
TB/HIV Co-Infection addressed under HIV Guidelines: Yes
< 3 years old ARV Treatment ARV therapy should be initiated in all children <10 years of age living with HIV.
Recommended:
ABC + 3TC + LPV/r
For children with undetectable viral load, EFV can be given instead of LPV/r from 3 years of age if the mother was not on EFV during pregnancy.
AZT + 3TC + RAL
Patients with virological failure under 2nd line regimen despite adherence support:
DRV + RAL + ETV
Alternatives:AZT + 3TC + LPV/r TDF + 3TC + RAL
ABC + 3TC + RALABC + 3TC + NVP AZT + 3TC + LPV/r or ATV/r
Exposed Infants PMTCT Children of mothers on ARV during pregnancy and lactation
If the child is breastfed:
NVP 1x/day for 6 weeks
If the child is not breastfed:AZT 2x/day for 4-6 weeks or NVP 1x/day for 4-6 weeks
Exposed children born to HIV + mothers who presented late in pregnancy or during labor
If the child is breastfed:
Triple therapy from birth up to 24 weeks of life, if viral suppression in the mother.
If no viral suppression in the mother, continue triple therapy up to 12 months.
If positive PCR: Triple therapy for life.
If the child is not breastfed:AZT 2x/day for 4-6 weeks or NVP 1x/day for 4-6 weeks
22
Population HIV Treatment Area Criteria for Starting ARV Treatment First-Line Regimen Second-Line Regimen Third-Line Regimen
Kenya - Guidelines on Use of Antiretroviral Drugs for Treating and Preventing HIV Infection in Kenya (2016)
TB/HIV Co-Infection addressed under HIV Guidelines: Yes
Adults> 15 years old
ARV Treatment All individuals with confirmed HIV infection are eligible for ART, irrespective of CD4 count/, WHO clinical stage, age, pregnancy or breastfeeding status, co-infection status, risk group, or any other criteria, PROVIDED that the individual is willing and ready to take ART and adhere to follow-up recommendations
ART should be started in all patients as soon as possible (preferably within 2 weeks of confirmation of HIV status)
TDF + 3TC + EFV AZT + 3TC + ATV/r Patients failing second-line ART require thorough assessment for barriers to adherence and ongoing enhanced adherence support including:- Assignment to a case manager- More frequent adherence counselling by a trained counsellor- Assessment and treatment of mental health and substance use disorders- Provision of adherence support such as modified directly observed therapy, a treatment supporter, home visits, etc.
RAL (or DTG) + 3TC + DRV + RTV
AZT + RAL (or DTG) + 3TC + DRV + RTV
TDF + RAL (or DTG) + 3TC + DRV + RTV
ETV +3TC + DRV/r
Pregnant WomenBreastfeeding Women
PMTCT ART should be initiated in all pregnant and breastfeeding women living with HIV, regardless of gestational age, WHO clinical stage and at any CD4 count, and continued lifelong.
TDF + 3TC + EFV
as FDC, 1 tab once daily
For women exposed to single dose NVP (without AZT + 3TC as part of PMTCT) within the past 2 years: use ATV/r instead of EFV
For patients already on ART, continue ART unless the regimen or part of the regimen is contraindicated because of the pregnancy.
ChildrenAdolescents3 - 15 years old ≥ 35 kg
ARV Treatment All individuals with confirmed HIV infection are eligible for ART, irrespective of CD4 count/%, WHO clinical stage, age, pregnancy or breastfeeding status, co-infection status, risk group, or any other criteria, PROVIDED that the individual is willing and ready to take ART and adhere to follow-up recommendations
ART should be started in all patients as soon as possible (preferably within 2 weeks of confirmation of HIV status)
TDF + 3TC + EFV AZT + 3TC + ATV/r or LPV/r RAL (or DTG) + 3TC + DRV + RTV
AZT + RAL (or DTG) + 3TC + DRV + RTV
ABC/TDF + RAL (or DTG) + 3TC + DRV + RTV
ETV + 3TC + DRV + RTV
In children weighing 30 kg and aged 6-12 years, DTG can be substituted for RAL
3 - 15 years old< 35 kg
ABC + 3TC + EFV AZT + 3TC + LPV/r
23
Population HIV Treatment Area Criteria for Starting ARV Treatment First-Line Regimen Second-Line Regimen Third-Line Regimen
Kenya - Guidelines on Use of Antiretroviral Drugs for Treating and Preventing HIV Infection in Kenya (2016)
TB/HIV Co-Infection addressed under HIV Guidelines: Yes
4 weeks - < 3 years old ARV Treatment All individuals with confirmed HIV infection are eligible for ART, irrespective of CD4 count/%, WHO clinical stage, age, pregnancy or breastfeeding status, co-infection status, risk group, or any other criteria, PROVIDED that the individual is willing and ready to take ART and adhere to follow-up recommendations
ART should be started in all patients as soon as possible (preferably within 2 weeks of confirmation of HIV status)
ABC + 3TC + LPV/r Drug Resistance Test-based 2nd line*Patients failing PI-based first-line regimens should have a Drug Resistance Test (DRT) ordered as soon as treatment failure is confirmed. The patient summary and DRT results should be sent to the Regional or National Clinical HIV TWG to determine the most suitable second-line regimen for the patient ([email protected]). The DRT results will be used to determine if a PI will still be effective in 2nd line.
RAL (or DTG) + 3TC + DRV + RTV
AZT + RAL (or DTG) + 3TC + DRV + RTV
ABC/TDF + RAL (or DTG) + 3TC + DRV + RTV
ETV + 3TC + DRV + RTV
In children weighing 30 kg and aged 6-12 years, DTG can be substituted for RAL
Infants2 weeks - < 4 weeks old
AZT + 3TC + LPV/r
<2 weeks AZT + 3TC + NVP ABC + 3TC + LPV/r
24
Population HIV Treatment Area Criteria for Starting ARV Treatment First-Line Regimen Second-Line Regimen Third-Line Regimen
Kenya - Guidelines on Use of Antiretroviral Drugs for Treating and Preventing HIV Infection in Kenya (2016)
TB/HIV Co-Infection addressed under HIV Guidelines: Yes
PMTCT 12 weeks of infant prophylaxis:AZT+NVP for 6 weeks,followed by NVP for 6 weeks
Infants Birth to 6 weeksBirth weight < 2,000 g
2 mg/kg per dose of NVP ODand 4 mg/kg per dose of AZT BD
Birth weight 2,000 - 2,499 g
10 mg of NVP ODand10 mg of AZT BD
Birth weight ≥2,500 g 15 mg of NVP ODand15 mg of AZT BD
> 6 - 12 weeks of ageAny weight
20 mg of NVP ODand 60 mg of AZT BD
25
Population HIV Treatment Area Criteria for Starting ARV Treatment First-Line Regimen Second-Line Regimen Third-Line Regimen
Lesotho - National Guidelines on the Use of Antiretroviral Therapy for HIV Prevention and Treatment (2016)
TB/HIV Co-Infection addressed under HIV Guidelines: Yes
AdultsAdolescents10 - 19 years old and ≥ 35 kgPregnant WomenBreastfeeding Women
ARV Treatment Every person living with HIV should be started on ART regardless of their CD4 count or HIV
clinical stage
TDF + 3TC + EFV AZT + 3TC + LPV/r or ATV/r All patients failing second-line ART should receive a genotypic resistance test to determine the best third-line regimen and should be reviewed by an expert HIV clinician/committee.
Alternative 1st line:AZT + 3TC + EFVABC + 3TC + EFVTDF + 3TC + DTG
TDF-3TC-LPV/r or ATV/rAZT + 3TC + LPV/r or ATV/rAZT + 3TC + LPV/r or ATV/r
If severe EFV adverse effect or EFV contraindication:TDF + 3TC + LPV/r or ATV/r AZT + 3TC + LPV/r or ATV/r
Based on resistance testPreferred:
AZT-3TC-RAL or DTGTDF-3TC-RAL or DTG
Adolescents < 35 kg
Children3 - 9 years old
ARV Treatment ABC + 3TC + EFV AZT + 3TC + LPV/r or ATV/r*
*ATV/r can be used in children ≥ 6 years and is the preferred PI in adolescents due to once daily
dosing.
Alternative 1st line:AZT + 3TC + EFV ABC + 3TC + LPV/r or ATV/rIf severe EFV adverse effect or EFV contraindication:ABC + 3TC + LPV/r or ATV/rAZT + 3TC + LPV/r or ATV/r
Based on resistance testPreferred:
AZT + 3TC + DRV/rABC + 3TC + DRV/r
Children<3 years old< 10 kg
ARV Treatment
ABC + 3TC + LVP/r
Alternative 1st line:AZT + 3TC + LPV/r
Based on resistance test:
AZT + 3TC + RALif LPV/r resistance identified
ABC + 3TC + RALif LPV/r resistance identified
Other alternatives:AZT - 3TC - DRV/r
DRV/r - RAL or DTGAZT - 3TC - NVP
26
Population HIV Treatment Area Criteria for Starting ARV Treatment First-Line Regimen Second-Line Regimen Third-Line Regimen
Lesotho - National Guidelines on the Use of Antiretroviral Therapy for HIV Prevention and Treatment (2016)
TB/HIV Co-Infection addressed under HIV Guidelines: Yes
Infants≥ 2.5 kg
PMTCT All HIV-exposed infants (infants born to HIV-infected mothers, of infants with positive or indeterminate rapid tests) should receive ARV prophylaxis.
If the mother was on ART for ≥4 weeks prior to delivery or last viral load before delivery was <1000 copies/ml, give NVP prophylaxis from birth until 6 weeks of life
� If the mother was started on ART <4 weeks before delivery or last viral load before delivery was ≥1000 copies/ml, give NVP prophylaxis from birth until 14 weeks
� If the mother refuses to start or has defaulted ART, continue NVP prophylaxis until the mother has initiated/restarted ART and been taking ARVs for 12 weeks or 1 week after breastfeeding is stopped
15 mg NVP daily dose birth to 6 weeks
2 - 2.49 kg 10 mg NVP daily dose birth to 6 weeks
<2 kg See table 4.13, pg 37
27
Population HIV Treatment Area Criteria for Starting ARV Treatment First-Line Regimen Second-Line Regimen Third-Line Regimen
Malawi - 3rd Edition of the Malawi Guidelines for Clinical Management of HIV in Children and Adults (2016)
TB/HIV Co-Infection addressed under HIV Guidelines: Yes
Adults ARV Treatment Start ART as soon as possible for all HIV children and adults, regardless of clinical stage, CD4 count and/or pregnancy status.
ABC 600 / 3TC 300 + NVP 200 TDF 300 / 3TC 300 + ATV/r 300/100
TDF 300 / 3TC 300 + LPV/r 200/50
AZT 300 / 3TC 150 + ATV/r 300/100
ABC 600 / 3TC 300 + LPV/r 200/50
AZT 300 / 3TC 150 + LPV/r 200/50
Treatment failure on 2nd line ART needs confirmation of resistance mutations by genotyping before 3rd line ART can be considered. 3rd line can only be initiated by a specialised ARV clinician upon authorization of review committee
DRV 600 + r 100 + ETV 100 + RAL 400
AZT 300 / 3TC 150 / NVP 200*Standard for children and adults under 35kg
AZT 300 / 3TC 150 + EFV 600TDF 300 / 3TC 300 / EFV 600*Standard for children and adults 35 kg or more
TDF 300 / 3TC 300 + NVP 200Pregnant WomenBreastfeeding Women
PMTCT Mothers already on ART: continue the same ART regimen at regular prescribed intervals. Pregnancy / breastfeeding are no indication to change women from any previous ART regimen.
HIV positive but not yet on ART / someone who interrupted/stopped ART:Emergency ART initiation
Start lifelong TDF/3TC/EFV as soon as possible, during labour or after delivery
Children ARV Treatment All children under 24 months who start ART need a confirmatory DNA-PCR. This can be collected on the day of starting ART. No follow-up testing using rapid antibody tests.
ABC 60 / 3TC 30 + NVP 50 AZT 60 / 3TC 30 + LPV/r 100/25*ABC 60 / 3TC 30 + LPV/r 200/50* Preferred start regimen for children under 3 years at sites with extra support.
AZT 60 / 3TC 30 / NVP 50AZT 60 / 3TC 30 + EFV 200
Infants PMTCT As the mother is known to be HIV-infected
Start giving NVP syrup as soon as possible after birth. The earlier the start, the more effective. NVP syrup can be started anytime between birth and 4 weeks of age if the mother presents late. Starting NVP prophylaxis later is less effective and may cause drug-resistant HIV if the baby is already infected (and needs to start ART). Stop giving NVP syrup when the infant is 6 weeks old. The infant will receive less than 6 weeks of prophylaxis if NVP syrup has been started late.
The dose of NVP syrup remains the same for the whole 6 week period - do not change the dose according to age or body weight, etc.
Use the standard dose (1.5ml) if birth weight is unknown (home birth/ no scale).
Birth weight 2500g or less 1.0 ml NVP (10mg per ml) 24-hourly
Birth weight over 2500g or unknown
1.5 ml NVP (10 mg per ml) 24-hourly
28
Population HIV Treatment Area Criteria for Starting ARV Treatment First-Line Regimen Second-Line Regimen Third-Line Regimen
Mozambique - "Tratamento Antiretroviral e Infecções Oportunistas do Adulto, Adolescente, Grávida e Criança" Antiretroviral treatment and opportunistic infections in adults, adolescents, pregnant women, and children (2016)
TB/HIV Co-Infection addressed under HIV Guidelines: Yes
Adults ARV Treatment WHO stage 1 or 2:Initiate ART if CD4 ≤500 cells/mm3If no CD4 available, do not initiate ART
WHO stage 3 or 4:Initiate ART regardless of CD4 countIf no CD4 available, initiate ART
The following patients should initiate ART regardless of CD4 count or clinical stage:● HIV/TB co-infection● HIV/HBV co-infection● Any invasive malignancy● HIV positive partners of HIV negative pregnant or breastfeeding women
Preferred first line regimens:TDF + 3TC + EFV
AZT + 3TC + NVP
AZT + 3TC + LPV/rABC + 3TC + LPVr
TDF + 3TC + LPV/rABC + 3TC + LPV/r
TDF/AZT + 3TC + RAL + DRV + RITONAVIR
Pregnant or breastfeeding women
ARV Treatment All HIV positive pregnant and breastfeeding women should initiate lifelong ART regardless of their CD4 count or WHO clinical stage.
TDF+3TC+EFV
Alternative regimens:AZT+3TC + EFVTDF+3TC + LPV/r
Children 5-14 years old ARV Treatment CD4 <500 cells/mm3: initiate ART regardless of clinical stageWHO stage 3 or 4: initiate ART regardless of CD4 count
Preferred first line regimens:AZT+3TC+NVP/EFVTDF+3TC+EFV (if ≥ 35Kg)
Alternative regimens:ABC+3TC+NVP/EFVTDF+ 3TC + LPVrAZT+3TC+LPVr
TDF+3TC+LPVr
TDF+3TC+EFV
Children <5 years old ARV Treatment All HIV positive children <5 years old should initiate lifelong ART regardless of their CD4 count or WHO clinical stage.
Preferred first line regimens:AZT+3TC+NVPAZT+ 3TC + LPV/r
Alternative regimens:ABC+3TC+NVPABC+3TC+LPV/r
ABC+3TC+LPV/r<3 years old: ABC + 3TC+NVP≥3 years old and ≥10 kg: ABC+3TC+EFV
AZT+3TC+LPV/r
29
Population HIV Treatment Area Criteria for Starting ARV Treatment First-Line Regimen Second-Line Regimen Third-Line Regimen
Mozambique - "Tratamento Antiretroviral e Infecções Oportunistas do Adulto, Adolescente, Grávida e Criança" Antiretroviral treatment and opportunistic infections in adults, adolescents, pregnant women, and children (2016)
TB/HIV Co-Infection addressed under HIV Guidelines: Yes
Pregnant or breastfeeding women
PMTCT Option A:CD4 ≥500 cells/mm3: ● Start AZT at 14 weeks gestation● Provide single dose NVP tobe taken at start of labor● Give AZT +3TC from labor until 7 days postpartum
CD4 <500 cells/mm3: Initiate lifelong ART TDF+3TC+EFV
Alternative regimens:AZT+3TC + EFVTDF+3TC + LPV/r
Option B+:Initiate lifelong ART
HIV exposed infants PMTCT Option A:● Breastfed infant: NVP once daily until one week after stopping breastfeeding● Non breastfed infant: NVP once daily from birth until age 6 weeks
Option B+:NVP once daily from birth until age 6 weeks
Dosing of NVP:Birth weight 2000 - 2499 g:10 mg once dailyBirth weight ≥ 2500g:15 mg once dailyAge 1-6 months: 20 mg dailyAge 6-9 months: 30 mg dailyAge >9 months: 40 mg daily
30
Population HIV Treatment Area Criteria for Starting ARV Treatment First-Line Regimen Second-Line Regimen Third-Line Regimen
Myanmar - Guidelines for the Clinical Management of HIV in Myanmar (2017)
TB/HIV Co-Infection addressed under HIV Guidelines: Yes
Adults and adolescents ARV treatment Initiate ART regardless of WHO clinical stage and at any CD4 count. As a priority, initiate those with:• severe HIV clinical disease (WHO clinical stage
3 or 4)• CD4 count ≤350 cells/mm³
TDF + 3TC (or FTC) + EFV AZT + 3TC + ATV/r or LPV/r DRV/r + DTG (or RAL) ± 1–2 NRTIs
Alternatives:AZT + 3TC + EFV
TDF + 3TC + ATV/r or LPV/r DRV/r + DTG (or RAL) ± 1–2 NRTIs
TDF + 3TC (or FTC) + DTG AZT + 3TC + ATV/r or LPV/r DRV/r + 2 NRTIs ± NNRTI
ABC + 3TC + EFV AZT + 3TC + ATV/r or LPV/r DRV/r + DTG (or RAL) ± 1–2 NRTIsPregnant and breastfeeding women
ARV treatment and PMTCT
Initiate ART in all pregnant and breastfeeding women living with HIV regardless of WHO clinical stage and at any CD4 count and continue lifelong.
TDF + 3TC (or FTC) + EFV AZT + 3TC + ATV/r or LPV/r DRV/r + DTG (or RAL) ± 1–2 NRTIs
Alternatives:AZT + 3TC + EFV
TDF + 3TC + ATV/r or LPV/r DRV/r + DTG (or RAL) ± 1–2 NRTIs
TDF + 3TC (or FTC) + NVP AZT + 3TC + ATV/r or LPV/r DRV/r + DTG (or RAL) ± 1–2 NRTIsABC + 3TC + EFV (ABC based regimen may be considered for pregnant women under special circumstances)
AZT + 3TC + ATV/r or LPV/r DRV/r + DTG (or RAL) ± 1–2 NRTIs
Children <3 years ARV treatment Initiate ART regardless of WHO clinical stage or at any CD4 count. As a priority, initiate:• All children under 2 years of age• Children younger than 5 years of age with
WHO clinical stage 3 or 4 or CD4 count ≤ 750/mm³ or CD4 percentage <25%• Children 5 years of age and older with WHO
clinical stage 3 or 4 or CD4 count ≤350/mm³.
ABC (or AZT) + 3TC + LPV/r AZT (or ABC) + 3TC + RAL RAL (or DTG) + 2 NRTIs DRV/r + 2 NRTIs DRV/r + RAL (or DTG) ± 1–2 NRTIsAlternative:
ABC (or AZT) + 3TC + NVPAZT (or ABC) + 3TC + LPV/r
Children 3 years - <10 years
ARV treatment ABC + 3TC + EFV AZT + 3TC + LPV/r
Alternatives:
ABC + 3TC + NVP AZT + 3TC + LPV/r
AZT + 3TC + EFV (or NVP) TDF (or ABC) + 3TC + LPV/r
TDF + 3TC (or FTC) + EFV (or NVP)
AZT + 3TC + LPV/r
If LPV/r based regimen was used as first line: switch to EFV or RAL
Exposed infants PMTCT AZT (twice daily) and NVP (once daily) for 6 weeks regardless of breast-fed or formula-fed
31
Population HIV Treatment Area Criteria for Starting ARV Treatment First-Line Regimen Second-Line Regimen Third-Line Regimen
Namibia - National Guidelines for Antiretroviral Therapy (2016)
TB/HIV Co-Infection addressed under HIV Guidelines: Yes
Adults Adolescents ≥ 10 years old, and weigh at least 35 kgPregnant WomenBreastfeeding Women
ARV Treatment All HIV positive adults irrespective of CD4 counts or WHO stage are eligible to start ART (Treat All). Patients should be initiated on ART immediately when they are ready, either on the same day or as soon as possible within one week.
Preferred Regimen:TDF + FTC (or 3TC) + EFV (once daily FDC)
Alternative Regimens:ABC + 3TC + EFV (or NVP)
AZT + 3TC + EFV
AZT + 3TC + NVP
TDF + FTC (or 3TC) + NVP
Preferred Regimen (Where standard first line regimens were used): AZT/TDF/3TC/ATV-r
Alternative Regimen:AZT/TDF/3TC/LPV-r
All patients failing second line regimens should undergo HIV resistance testing following consultation with an HIV specialist in order to select the most effective regimen.
Children ARV Treatment ALL children and Adolescents are eligible for ART and should be initiated on ART irrespective of CD4 count and clinical stage.
3 years to <10 years or <35 kg:ABC/3TC/EFV
If had NVP eMTCT/PMTCT, give:ABC/3TC/LPV/r
AZT/ABC/3TC/LPV/r if <6 years old or <15 kgAZT/ABC/3TC/ATV+r if ≥ 6 years old >15 kg
ABC/AZT/3TC/EFV
3 months to 2 years old or <10 kg:ABC/3TC/LPV/r [ABC/3TC as a once daily dose, LPV/r given twice daily]
ABC/AZT/3TC/NVP(if never had eMTCT/PMTCT NVP)
If had eMTCT/PMTCT NVP, do genotype.
2 weeks to <3 months old:AZT/3TC/LPV/r
Until the child is 3 months old at which time AZT should be changed to ABC
Birth to <2 weeks:AZT/3TC/NVP
Given until the infant is 2 weeks old at which time NVP should be changed to LPV/r
AZT/ABC/3TC/LPV/r
32
Population HIV Treatment Area Criteria for Starting ARV Treatment First-Line Regimen Second-Line Regimen Third-Line Regimen
Namibia - National Guidelines for Antiretroviral Therapy (2016)
TB/HIV Co-Infection addressed under HIV Guidelines: Yes
Infants Prophylaxis High risk infants:- born to women with HIV infection who have received less than 4 weeks of ART at the time of delivery; or- born to women with HIV infection with viral load >40 copies/ml in the 3 months prior to delivery or VL unknown or- born to women with HIV infection diagnosed during labour and delivery, post-partum or in the breastfeeding period
First 6 weeks: NVP + AZT
After 6 weeks:If breastfeeding AND mother’s VL ≥ 40 or unknown, continue with NVP daily.If NOT breastfeeding sincebirth or in last 4 weeks, OR mother’s VL < 40, discontinue infant prophylaxis
Average risk infants:- Infants born to HIV infected pregnant or breastfeeding women who do not fit into the above high risk category
First 6 weeks: NVP
After 6 weeks:If breastfeeding AND mother’s VL ≥ 40 or unknown, continue with NVP daily.If NOT breastfeeding sincebirth or in last 4 weeks, OR mother’s VL < 40, discontinue infant prophylaxis
Infants who present to care more than 72 hours after birth:
If breastfeeding: provide the same prophylaxis according to the above risk assessment
If not breastfeeding: do not give prophylaxis
33
Population HIV Treatment Area Criteria for Starting ARV Treatment First-Line Regimen Second-Line Regimen Third-Line Regimen
Nigeria - National Guidelines for HIV Prevention Treatment and Care (2016)
TB/HIV Co-Infection addressed under HIV Guidelines: Yes
Adults ARV Treatment ART should be initiated in all adults living with HIV, regardless of WHO clinical stage and at any CD4+ cell count.
As a priority, ART should be initiated in all adults with severe or advanced HIV clinical disease (WHO clinical stage 3 or 4) and adults with a CD4+ cell count of ≤350 cells/mm3.
Preferred fixed dose combinations:
TDF + 3TC + EFV or
TDF + FTC + EFV
If TDF (tenofovir) is used in first-line therapy:AZT + 3TC + LPV/ror AZT + 3TC + ATV/r
If AZT (zidovudine) is used in first-line therapy:TDF + 3TC + ATV/r or TDF + 3TC + LPV/r
The recommendation is that the switch to third line therapy be left in the hands of highly qualified HIV specialists with requisite experience and expertise in the management of advanced and complicated HIV disease.
Alternatives:- TDF + 3TC (or FTC) + DTG- AZT + 3TC + EFV- TDF + 3TC (or FTC) + EFV400 - AZT + 3TC + NVP- TDF + 3TC (or FTC) + NVP- ABC + 3TC + EFV
Considerations for third line: Adults:
DRV/r + DTG (or RAL) ± 1 - 2 NRTIsorDRV/r + 2 NRTIs ± NNRTI
Optimize regimen using genotype profile.
Pregnant WomenBreastfeeding Women
Pregnancy is an absolute indication for ART. ART should be initiated in all HIV pregnant and breastfeeding women regardless of WHO clinical stage, CD4+ cell count, or gestational age and continued for life.
Preferred fixed dose combinations: TDF + 3TC + EFV or TDF + FTC + EFV
Pregnant or breastfeeding women:DRV/r + DTG (or RAL) ± 1 - 2 NRTIs
Alternatives:AZT + 3TC + EFV (or NVP) TDF + 3TC (or FTC) + NVP
Adolescents 10 - 19 years old
ARV Treatment ART should be initiated in all adolescents living with HIV, regardless of WHO clinical stage and at any CD4+ cell count.
As a priority, ART should be initiated in all Adolescents with severe or advanced HIV clinical disease (WHO clinical stage 3 or 4) and a CD4+ cell count of ≤350 cells/mm3.
Preferred once daily fixed dose combination:TDF + 3TC + EFV or
TDF + FTC+ EFV
Adolescents (>10 years):
DRV/r + DTG (or RAL) ± 1 - 2 NRTIsorDRV/r + 2 NRTIs ± NNRTI
Optimize regimen using genotype profile.
Alternatives:- TDF + 3TC (or FTC) + DTG- AZT + 3TC + NVP- TDF + 3TC (or FTC) + EFV400 - ABC + 3TC + EFV- AZT + 3TC + EFV- TDF + 3TC (or FTC) + NVP
34
Population HIV Treatment Area Criteria for Starting ARV Treatment First-Line Regimen Second-Line Regimen Third-Line Regimen
Nigeria - National Guidelines for HIV Prevention Treatment and Care (2016)
TB/HIV Co-Infection addressed under HIV Guidelines: Yes
Children 3 - < 10 years old
ARV Treatment ART should be initiated in all children with HIV, regardless of WHO clinical stage, or at any CD4+ cell count.
As a priority, ART should be initiated in the following situations- All children < 2 years of age- All children younger than 5 years of age with WHO clinical stage 3 or 4 disease or CD4+ cell count ≤ 750 cells/mm3 or CD4+ percentage < 25%- All children 5 years and older with WHO HIV clinical stage 3 or 4 disease or CD4+ cell count < 350 cells/mm3
Preferred:ABC + 3TC + EFV AZT + 3TC + LPV/r
Children (0-10 years):RAL (or DTG) + 2 NRTIsorDRV/r + 2 NRTIsorDRV/r + RAL (or DTG) ± 1-2 NRTIs
Alternatives:- ABC + 3TC + NVP- AZT + 3TC + EFV- AZT + 3TC + NVP- TDF + 3TC (or FTC) + EFV- TDF + 3TC (or FTC) + NVP
If first regimen AZT + 3TC + EFV,then use: ABC or TDF*+3TC + LPV/r*** TDF may be given only to children older than 2 years.** ATV/r can be used as an alternative to LPV/r in children older than 3 months. However, the limited availability of suitable formulations for children younger than 6 years, the lack of an FDC and the need for separate administration of the RTV booster should be considered when choosing this regimen.
< 3 years old Preferred:ABC + 3TC + LPV/r orAZT + 3TC + LPV/r
AZT or ABC + 3TC + RALa
a) If RAL is not available, no change is recommended unless in the case of advanced clinical disease progression or lack of adherence specifically due to poor palatability of LPV/r. In this case, switching to a second-line NVP-based regimen should be considered. Based on approval of the use of EFV in children less than 3 years, an EFV-based regimen could be considered as an alternative. However, more data are needed to inform how best to use EFV in this population.
Alternatives:- ABC + 3TC + NVP- AZT + 3TC + NVP
In special circumstances where preferred and alternative regimes are not available or suitable the following regimen can be used:- ABC + 3TC + RAL*- AZT + 3TC + RAL *
35
Population HIV Treatment Area Criteria for Starting ARV Treatment First-Line Regimen Second-Line Regimen Third-Line Regimen
Nigeria - National Guidelines for HIV Prevention Treatment and Care (2016)
TB/HIV Co-Infection addressed under HIV Guidelines: Yes
< 3 years old ART Treatment *RAL is approved for use in infants and children from the age of 4 weeks, but there is very limited evidence to inform the use of RAL as a first-line drug in infants and young children. The use of this INSTI could be considered where available in instances of poor tolerability or administration challenges with LPV/r, particularly in settings where as a result of rapid expansion of maternal treatment, infants and children are at very high risk of carrying an NNRTI resistant virus.
Infants Prophylaxis All HIV exposed infants should receive ARV prophylaxis.
Birth to 6 weeks:Birth weight < 2,500 g10 mg (1ml) of NVP once daily
Birth weight ≥ 2,500 g15 mg (1.5ml) of NVP once daily
Infants born to mothers with HIV who are at high risk* of acquiring HIV should receive dual prophylaxis with AZT (twice daily) and NVP (once daily) for the first 6 weeks of life, whether they are breastfed or formula fed.*High-risk infants are defined as those:• Born to women with established HIV infection who have received less than four weeks of ART at the time of delivery; or• Born to women with established HIV infection with viral load >1000 copies/mL in the four weeks before delivery; or• Born to women with incident HIV infection during pregnancy or breastfeeding; or• Identified for the first time during the postpartum period, with or without a negative HIV test prenatally.
Birth to 6 weeks:Birth weight < 2,500 g10 mg (1ml) of NVP once dailyplus10 mg (1ml) of AZT twice daily
Birth weight ≥ 2,500 g15 mg (1.5ml) of NVP once daily, plus15 mg (1.5ml) of AZT twice daily
36
Population HIV Treatment Area Criteria for Starting ARV Treatment First-Line Regimen Second-Line Regimen Third-Line Regimen
Nigeria - National Guidelines for HIV Prevention Treatment and Care (2016)
TB/HIV Co-Infection addressed under HIV Guidelines: Yes
Infants Prophylaxis Breastfed infants who are at high risk of acquiring HIV should continue infant prophylaxis for an additional 6 weeks (total of 12 weeks of infant prophylaxis) using AZT (twice daily) and NVP (once daily).
6 weeks to 12 weeks:20 mg (2ml) of NVP once daily, plus20 mg (2ml) of AZT twice daily
37
Population HIV Treatment Area Criteria for Starting ARV Treatment First-Line Regimen Second-Line Regimen Third-Line Regimen
Rwanda - National Guidelines for Prevention and Management of HIV and STIs (2016)
TB/HIV Co-Infection addressed under HIV Guidelines: Yes
Adults> 19 years old
ARV Treatment These guidelines call upon and recommend the commencement of the ART for everyone living with HIV – regardless of their CD4 count.
TDF + 3TC + EFV
ABC + 3TC + EFV
ABC + 3TC + NVP
TDF + 3TC + NVP
AZT + 3TC + ATV/r or LPV/r
AZT + 3TC + ATV/r or LPVr
AZT + 3TC + ATV/r or LPVr
AZT + 3TC + ATV/r or LPVr
If first line was AZT based(AZT+ 3TC+EFV/NVP), useTDF + 3TC + ATV/r or LPV/ras second line.
The 3rd line regimen combination is:
RAL/ETV/DRV/rThe 3rd line regimen must only be given upon expert consultation and usually with the assistance of genotyping test.
Before prescribing third-line therapy, the patient MUST undergo extensive additional adherence counselling and should have a treatment partner involved with assisting in adherence. Pregnant Women
Breastfeeding WomenARV Treatment TDF + 3TC + EFV
*If a woman has already started ART for her own health, there is no need to change the regimen except in cases of side effects. The woman should continue the same regimen.
Adolescents10 - 19 years old
ARV Treatment Adolescents > 35kg
Preferred Regimen:TDF + 3TC + EFV
Alternatives:TDF + 3TC + NVP
AZT + 3TC + ATV/r
If first line AZT based: TDF + 3TC + ATV/r
RAL + ETV + DRV/r
Third line is given by Expert only, genotyping and VL are required before switching to third line.
Adolescents < 35kg
Preferred Regimen:ABC + 3TC + EFV
Alternatives:ABC + 3TC + NVP
AZT + 3TC + ATV/rif > 6 years oldAZT + 3TC + LPV/rif < 6 years old
If first line AZT based: ABC + 3TC + ATV/rif >6 years old
38
Population HIV Treatment Area Criteria for Starting ARV Treatment First-Line Regimen Second-Line Regimen Third-Line Regimen
Rwanda - National Guidelines for Prevention and Management of HIV and STIs (2016)
TB/HIV Co-Infection addressed under HIV Guidelines: Yes
Children ARV Treatment These guidelines call upon and recommend the commencement of the ART for everyone living with HIV – regardless of their CD4 count.
3 - 10 years of age < 35kgPreferred:ABC + 3TC + EFV
Alternatives:ABC + 3TC + NVPAZT + 3TC + EFV or NVP
AZT + 3TC + ATV/rif > 6 years oldAZT + 3TC + LPV/rif < 6 years old
ABC + 3TC + ATV/rif > 6 years oldABC + 3TC + LPV/rif < 6 years old
Third line is given by Expert only
Genotyping & VL are required before switching to third line
Regimens include:RAL + ETV + DRV/rSometimes associated with TDF and 3TC
<3 years of agePreferred:ABC + 3TC + LPV/r
Alternatives:a) ABC + 3TC + NVPb) AZT + 3TC + LPV/rc) AZT + 3TC + NVP
At 3 years of age, switch from LPV/r to EFV based regimen if the VL is suppressed
ABC + 3TC + RAL
AZT + 3TC + LPV/rABC + 3TC + RALABC + 3TC +LPV/r
39
Population HIV Treatment Area Criteria for Starting ARV Treatment First-Line Regimen Second-Line Regimen Third-Line Regimen
Rwanda - National Guidelines for Prevention and Management of HIV and STIs (2016)
TB/HIV Co-Infection addressed under HIV Guidelines: Yes
Infants Prophylaxis All children born to HIV-positive mothers, whether the mothers breastfeed or not
All children born to HIV-positive mothers, whether the mothers breastfeed or not, will receive Nevirapine (NVP) syrup from birth for the first six weeks of life. The baby will start Cotrimoxazole syrup at the age of 6 weeks and will be discontinued after final confirmation of HIV negative status at 24 months and at least three months after the end of breastfeeding.
Prophylaxis in children born to a serodiscordant couple where the mother is newly diagnosed HIV infected
If the mother is shown to be HIV-positive at the time of breastfeeding, the child should start combined AZT and NVP until six weeks after initiation of the mother's ART.
40
Population HIV Treatment Area Criteria for Starting ARV Treatment First-Line Regimen Second-Line Regimen Third-Line Regimen
South Africa - National Consolidated Guidelines for the Prevention of Mother-to-Child Transmission of HIV (PMTCT) and the Management of HIV in Children, Adolescents and Adults (2015)
TB/HIV Co-Infection addressed under HIV Guidelines: Yes
Adults (Older than 19 years)
Late Adolescents (Age 15-19 inclusive) > 40kg
ARV Treatment CD4 count ≤ 500 cells/μl irrespective of clinical stage (Prioritise those with CD4≤350 cells/μl)
or
severe or advanced HIV disease (WHO clinical stage 3 or 4) , regardless of CD4 count
or
Irrespective of CD4 count or clinical stage:• Active TB disease• Pregnant and breastfeeding women who are
HIV-positive• Known hepatitis B virus (HBV) co-infection• Prioritise those CD4 ≤ 350 cells/μl or advanced
HIV disease
Fast tracking (within 7 days)• Patients with CD4 ≤ 200 cells/μl• HIV stage 4, even if CD4 is not yet available
Adolescents >15 years and weighing >40kg Adults
TDF + 3TC (or FTC) + EFV
provide as fixed dose combination (FDC)
AZT + 3TC + LPV/r
Failing on a AZT-based first line regimen:TDF + 3TC (or FTC) + LPV/r
Failing any second-line regimen
Decision should be based on expert consultation and genotype resistance and supervised care.
Most likely regimens may contain: Raltegravir, Darunavir/Retravirine adjusted according to genotype interpretation and patient history.
An expert panel will manage patients failing on second-line therapy. The drugs for third-line will be managed centrally. Should take into account prior exposure and predictable mutations.
AZT + TDF + 3TC + LPV/r
(If HBV co-infected)
Adults and Adolescents on d4T
Change d4T to TDF
(No patient must be on d4T)
Failing on a d4T-based first line regimen:TDF + 3TC (or FTC) + LPV/r
Adolescents <15 years or weight < 40kg
ABC + 3TC + EFV
Contraindication to EFV: Significant psychiatric co-morbidity Intolerance to EFV Impairment of daily function (shift workers)
Substitute Drug TDF + FTC (or 3TC) + NVP or LPV/r
TDF contraindication:
Creatinine clearance of <50 mL/min
ABC + 3TC + EFV (or NVP)
41
Population HIV Treatment Area Criteria for Starting ARV Treatment First-Line Regimen Second-Line Regimen Third-Line Regimen
South Africa - National Consolidated Guidelines for the Prevention of Mother-to-Child Transmission of HIV (PMTCT) and the Management of HIV in Children, Adolescents and Adults (2015)
TB/HIV Co-Infection addressed under HIV Guidelines: Yes
Pregnant WomenBreastfeeding Women
ARV Treatment Initiate lifelong ART in all pregnant or breastfeeding women on the same day of diagnosis regardless of CD4 count or gestational age.
All pregnant women who first test positive during labour should be given prophylactic ART during labour and initiated on lifelong ART before being discharged.
1st ANC visit:All pregnant women not on ART (any gestational age) and all breastfeeding women not on ARTTDF + 3TC (or FTC) + EFVProvide as fixed-dose combination (FDC)
Failing on a TDF-based 1st line regimen
AZT + 3TC +LPV/r
AZT + TDF + 3TC +LPV/r (4 drugs if HBV co-infected)
Failing on a d4T or AZT-based 1st line regimen
TDF + 3TC (or FTC) + LPV/r
Dyslipidemia or diarrhoea associated with LPV/r
Switch to ATV/r
Not specified.
Pregnant women currently on ART:Continue current ART regimenChange to FDC if on individual first-line drugs and virally suppressed and no contraindications to FDC
2nd ANC visit (1 week later) Pregnant women Creatinine ≤ 85μmol/l and any CD4 cell count) Continue FDC
Creatinine > 85 μmol/l TDF contraindicatedStop FDC, initiate AZT if Hb ≥7g/dl
Contraindication to EFV (active psychiatric illness)TDF+3TC+NVP (if CD4 <250 cells/μl) or TDF+3TC+LPV/r (CD4 ≥250 cells/μl)
42
Population HIV Treatment Area Criteria for Starting ARV Treatment First-Line Regimen Second-Line Regimen Third-Line Regimen
South Africa - National Consolidated Guidelines for the Prevention of Mother-to-Child Transmission of HIV (PMTCT) and the Management of HIV in Children, Adolescents and Adults (2015)
TB/HIV Co-Infection addressed under HIV Guidelines: Yes
Pregnant WomenBreastfeeding Women
ARV Treatment Initiate lifelong ART in all pregnant or breastfeeding women on the same day of diagnosis regardless of CD4 count or gestational age.
All pregnant women who first test positive during labour should be given prophylactic ART during labour and initiated on lifelong ART before being discharged.
Labour Unbooked and presents in labour and tests HIV positive: sdNVP + sd TDF/FTC and AZT 3-hourly in labour
Emergency caesarean section in an unbooked woman with no ART:sdNVP + sd TDF/FTC
Start FDC of TDF + 3TC (or FTC) + EFV next day regardless of CD4 cell count
Postpartum Mother diagnosed with HIV within 1 year postpartum or still breastfeeding beyond 1 year
Lifelong FDC of TDF + 3TC (or FTC) + EFV initiated immediately
43
Population HIV Treatment Area Criteria for Starting ARV Treatment First-Line Regimen Second-Line Regimen Third-Line Regimen
South Africa - National Consolidated Guidelines for the Prevention of Mother-to-Child Transmission of HIV (PMTCT) and the Management of HIV in Children, Adolescents and Adults (2015)
TB/HIV Co-Infection addressed under HIV Guidelines: Yes
Early Adolescents10 - 15 years old
ARV Treatment WHO stage 3 or 4 CD4 count ≤500 cells/μl
Fast-tracking (initiating ART within 7 days of being eligible) • CD4 count ≤ 200 cells/μl• WHO stage 4 disease• MDR/XDR-TB
Weight < 40 kg or age < 15 years ABC + 3TC + EFV
If failed on ABC/TDF + 3TC/FTC + EFV then switch to AZT +3TC + LPV/r
If failed on d4T + 3TC + EFV then switch to AZT + ABC + LPV/r
Refer for specialist opinion - Regimen based on genotype resistance testing, expert opinion and supervised care
Access to third-line ART will be managed centrally by the National Department of Health
Weight ≥ 40 kg and age ≥ 15 years TDF + 3TC/FTC + EFV (Use FDC)
Children 10 years or younger
ARV Treatment 5-10 years: Symptomatic (Stage 3 or 4) Irrespective of CD4 count OR CD4 ≤ 500 cells/μl irrespective of WHO stage Criteria for fast-tracking (i.e. start ART within 7 days of being eligible) • Children less than 1 year of age • CD4 count ≤ 200 cells/μl or < 15% • WHO clinical stage 4 • MDR or XDR-TB
Children 3 - 10 years and > 10 kg ABC + 3TC + EFV (or NVP) *Children who started on ABC/3TC/LPV/r before 3 years must remain on same regimen at 3yr
AZT +3TC + LPV/r Children who fail second-line treatment should be referred to an expert so that the treatment with third-line agents can be considered.
Children on d4T: Change all d4T to ABC Children on ddl: Change all ddl to ABC
If failed on d4T + 3TC + EFV (or NVP) then switch to AZT + ABC + LPV/r (discuss with expert before changing)
Child < 5: All children should be started on ART
Children < 3 years or older children weighing < 10 kg ABC + 3TC + LPV/r*Doses are based on child's weight and need to be adjusted as the child grows
Consult with expert for advice
Infants PMTCT Mother on lifelong ART (Mother has been on ART for >4 weeks prior to delivery)
Infant post-exposure prophylaxis should be used for 6-12 weeks after delivery, dependent on when maternal ART was initiated.
NVP at birth and then daily for 6 weeks
Not Specified
<2.0kg Birth to 2 weeks: NVP 2 mg/kg 2 to 6 weeks: NVP 4mg/kg
2.0 - 2.5kg: Birth to 6 weeks: NVP 10mg> 2.5kg: Birth - 6 weeks: NVP 15mg
44
Population HIV Treatment Area Criteria for Starting ARV Treatment First-Line Regimen Second-Line Regimen Third-Line Regimen
South Africa - National Consolidated Guidelines for the Prevention of Mother-to-Child Transmission of HIV (PMTCT) and the Management of HIV in Children, Adolescents and Adults (2015)
TB/HIV Co-Infection addressed under HIV Guidelines: Yes
Infants PMTCT Mother on lifelong ART (Mother has been on ART for >4 weeks prior to delivery)
Infant post-exposure prophylaxis should be used for 6-12 weeks after delivery, dependent on when maternal ART was initiated.
Any weight:6 - 12 weeks: NVP 20 mg6 weeks - 12 months: NVP 20 mg6 - 9 months: NVP 30 mg/day>9 months: NVP 40 mg/day
Not Specified
Mother did not get any ART before or during delivery and tests HIV-positive > 72 hours post-deliveryor Mother newly diagnosed HIV-positive within 72 hours of delivery or Mother started ART less than 4 weeks prior to delivery
NVP as soon as possible and daily for 12 weeks (if infant is breastfed)
Breastfeeding mother diagnosed with HIV(Start mother on FDC of TDF + 3TC (or FTC) + EFV immediately)
NVP and AZT immediatelyIf infant tests HIV PCR negative: stop AZTand continue NVP for 12 weeksIf mother has received 12 weeks of ART then infant NVP can be stoppedIf infant tests HIV PCR+, initiate ART immediately
Unknown maternal status for any reason including orphans and abandoned infants
Give NVP immediately*Test infant with rapid HIV test*If positive continue NVP for 6 weeksIf negative discontinue NVP
*If rapid HIV test can be done within 2 hours, then wait for HIV result before commencing NVP.
If rapid test is positive, do an HIV PCR. If negative, repeat HIV PCR at 10 weeks. If HIV PCR is positive, initiate baby on triple ART immediately and send confirmatory HIV PCR.
45
Population HIV Treatment Area Criteria for Starting ARV Treatment First-Line Regimen Second-Line Regimen Third-Line Regimen
South Africa - National Consolidated Guidelines for the Prevention of Mother-to-Child Transmission of HIV (PMTCT) and the Management of HIV in Children, Adolescents and Adults (2015)
TB/HIV Co-Infection addressed under HIV Guidelines: Yes
Infants PMTCT Mother with latest viral load > 1000 copies/ml Dual ARV for 6 weeks (NVP and AZT).Perform an HIV PCR at or shortly after birth
Non-breastfeeding mother diagnosed with HIV If more than 72 hours since delivery, no infant NVPPerform an HIV PCR, if positive initiate ART
46
Population HIV Treatment Area Criteria for Starting ARV Treatment First-Line Regimen Second-Line Regimen Third-Line Regimen
South Sudan - Consolidated Clincal Guidelines on Use of Antiretrovirla Drugs for HIV Treatment and Prevention (2017)
TB/HIV Co-Infection addressed under HIV Guidelines: Yes
Adults Adolescents
ART Treatment All HIV positive adults and adolescents irrespective of CD4 counts of WHO stage are eligible to start ART (Treat All). Patients should be initiated on ART as soon as the patient is ready and preferably within one week. In circumstances where prioritisation is required, ART should be initiated in all individuals with severe or advanced HIV clinical disease (WHO clinical stage 3 or 4) and or individuals with CD4 count <350 cells/mm^3
In adults and adolescents, the preferred 1st line regimen is tenofovir + lamivudine (or emtricitabine) + efavirenz (TDF + 3TC + EFV) as a once daily Fixed Dose Combination (FDC) and should be prescribed for all population groups including adults, pregnant women, clients co-infected with HIV and TB or HBV
Failing on TDF-based 1st line:
AZT+3TC+ LPV/r or ATV/r
Adolescents >12 years and adults failing any 2nd line regimen:
DTG+DRV/r
Dolutergavir 50mg plus Darunavir (600mg)/Ritonavir (100mg) twice daily (for patients that have taken a PI before) Clients failing on second line therapy will be referred to Specialists at tertiary referral centers and the drugs for third line managed centrally
If DTG is not available:Raltegravir 400 mg BD can be used
**NB. DTG cannot be used in adolescents under 12 years of age and among pregnant women as its safety and efficacy data are not yet available. Consult a Paediatrician for 3rd line options for children under 12 years of age.
Alternative ARV regimens: Contraindications to EFV:TDF + or 3TC + NVPContraindication to TDF:AZT+ 3TC +EFV or (NVP)
Failing on AZT based 1st line:TDF +3TC (or FTC) + LPV/r or ATV/r
Contraindication to TDF and AZT:ABC + 3TC + EFV (or NVP)Currently on d4T-based regimen:TDF + 3TC + EFVFDC preferred
Failing on TDF-based 1st line:AZT+3TC+ LPV/r or ATV/r
Adolescents ≤ 35 kg ABC + 3TC + EFVChildren Infants
ART Treatment All infants and children should be initiated on ART regardless of WHO clinical stage or CD4 cell count (Treat All approach)• All infants under 18 months of age with apresumptive diagnosis of HIV
Children ≥ 3 years-10 years and adolescents ≤ 35kg
ABC + 3TC + EFV
AlternativeABC+3TC+NVPAZT+ 3TC+EFVAZT+ 3TC+NVPTDF+3TC+EFV (or NVP)
All Ages: Failed NNRTI-based first lineFailed: ABC+3TC+EFV (NVP)orFailed TDF+3TC+EFV (NVP)AZT+3TC+ATV/r or LPV/r
Failed AZT+3TC+EFV (NVP)ABC or TDF +3TC+ ATV/r or LPV/r
3 years and olderFailed 1st Line:ABC+3TC+LPV/rAZT+3TC+EFV or RALFailed 1st line: AZT +3TC+ LPV/rABC+3TC+EFV or RAL
Refer for specialist opinion
Infants and Children under 3 years who develop TB while on ARTABC+3TC+AZT
47
Population HIV Treatment Area Criteria for Starting ARV Treatment First-Line Regimen Second-Line Regimen Third-Line Regimen
South Sudan - Consolidated Clincal Guidelines on Use of Antiretrovirla Drugs for HIV Treatment and Prevention (2017)
TB/HIV Co-Infection addressed under HIV Guidelines: Yes
Children Infants
ART Treatment All infants and children should be initiated on ART regardless of WHO clinical stage or CD4 cell count (Treat All approach)• All infants under 18 months of age with apresumptive diagnosis of HIV
All infants and children between 2 weeks and under 3 years :
Preferred 1st lineABC+3TC+LPV/r
Alternative AZT+3TC+LPV/rABC+3TC+NVPAZT+3TC+NVP
Younger than 3 yearsFailed 1st Line: ABC (or TDF) +3TC + LPV/rAZT+3TC+RAL
Failed 1st Line:AZT+3TC+ LPV/rABC+3TC+RAL
Infants PMTCT ARV prophylaxis for HIV exposed infants is administered based on the level of risk of HIV for the infant.
A high risk infant is defined as follows:1. High maternal viral load >1000copies/ml during the last 4 weeks before delivery or2. An infant born to HIV infected woman who has received less than 4 weeks of ART at the time of delivery or3. An infant born to a newly diagnosed HIV infected woman during labor, delivery and postpartum (Incident HIV infection)
All infants who do not meet the criteria for ‘high-risk’ infants are classified as ‘low-risk’ infants. The table below shows infant prophylactic ARV regimens by risk stratification.
Health workers should offer high-risk infants dual ARV prophylaxis of AZT and NVP for 12 weeks post- delivery.
Birth weight 2000−2499 gmDosing NVP:10 mg once daily(1 ml of syrup once daily)Dosing AZT:10 mg twice daily(1 ml of syrup twice daily)
Birth weight ≥2500 gDosing NVP: 15 mg once daily(1.5 ml of syrup once daily)Dosing AZT: 15 mg once daily(1.5 ml of syrup once daily)
>6 weeks to 12 weeksDosing NVP:20 mg once daily(2 ml of syrup once daily or half a 50 mg tablet once daily)Dosing AZT:No dose established for prophylaxis; use treatment dose 60 mg twice daily 6 ml of syrup twice daily or a 60 mg tablet twice daily)
48
Population HIV Treatment Area Criteria for Starting ARV Treatment First-Line Regimen Second-Line Regimen Third-Line Regimen
Swaziland - Swaziland Integrated HIV Management Guidelines (2015) Memorandum: Re: Scale Up of Test and Start Strategy in all ART Providing Facilities (2016)
TB/HIV Co-Infection addressed under HIV Guidelines: Yes
Adults ARV Treatment Using the Test and Start strategy, initiate all people living with HIV on antiretroviral therapy (ART) as soon as possible (preferably within 2-8 weeks) after the diagnosis of HIV infection irrespective of CD4 count.
Recommended:TDF + 3TC + EFV AZT + 3TC + LPV/r or ATV/r*
*Preferred when available
Initiate third-line regimen treatment after reviewing results to resistance tests and after satisfactory stepped-
up adherence counselling.
DRV/r 600 mg/100 mg 12 hourly+
ETV 200 mg 12 hourly+
RAL 400 mg 12 hourly
Alternatives:When EFV cannot be used:TDF + 3TC + NVPor AZT + 3TC + NVP
TDF + 3TC (or FTC) + LPV/r or ATV/r**Preferred when available
When TDF cannot be used:AZT + 3TC + EFVorABC + 3TC + EFV
When AZT cannot be used:ABC + 3TC + EFV ord4T + 3TC + EFV
Pregnant WomenLactating Women
ARV Treatment All pregnant and lactating HIV-positive women should be initiated on lifelong ART regardless of CD4 and WHO clinical stage, preferably on the day of HIV diagnosis.
ART initiation should be done at any gestational age (while waiting for the CD4 result and other baselines).
A once-daily fixed-dose combination of
TDF + 3TC + EFV
is recommended as first-line ART in pregnant and breastfeeding women, including pregnant women in the first trimester of pregnancy and women of childbearing age.
AZT + 3TC + LPV/r or ATV/r*
*Preferred when available
Alternative is TDF contra-indicated:AZT + 3TC + EFV
If during the last 12 months woman was exposed to sdNVP (+/- antepartum AZT) with no tail:TDF + 3TC + LPV/rorTDF + 3TC + ABC
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Population HIV Treatment Area Criteria for Starting ARV Treatment First-Line Regimen Second-Line Regimen Third-Line Regimen
Swaziland - Swaziland Integrated HIV Management Guidelines (2015) Memorandum: Re: Scale Up of Test and Start Strategy in all ART Providing Facilities (2016)
TB/HIV Co-Infection addressed under HIV Guidelines: Yes
Children ARV Treatment Children ≥ 5 years: Initiate on ART, if CD4 <500 cells/mm3, or WHO stage 3 or 4
>5 to 12 years and older> 40kg:Preferred:TDF + 3TC + EFV (adult FDC)
Children < 12 Years:AZT + 3TC + LPV/r>12 Years AZT + 3TC + LPV/r OR ATV/r
DRV/r + ETV + RAL
Management of these children is complex. Evaluation for third-line ART needs to be done by paediatric specialists and the recommendation is to contact the Baylor Clinicians in Mbabane, Manzini or Hlathikhulu. It is highly recommended to call the paediatric hotline to consult on each individual case.
Alternative:AZT + 3TC + NVP
< 12 Years:ABC + 3TC + LPV/r>12 Years:TDF + 3TC + LPV/r (if >40kg) orABC + 3TC + LPV/r (if <40kg)
<40 kg: Preferred:ABC + 3TC + EFV
Children < 12 Years:AZT + 3TC + LPV/r>12 Years AZT + 3TC + LPV/r OR ATV/r
Alternative: AZT + 3TC + NVP
< 12 Years:ABC + 3TC + LPV/r>12 Years:TDF + 3TC + LPV/r (if >40kg) orABC + 3TC + LPV/r (if <40kg)
Children < 5 years: Initiate on ART regardless of WHO clinical stage or CD4 count
3 to <5 years NVP-exposed:Preferred:ABC + 3TC + LPV/r
If child < 3 years: keep current regimen, reinforce adherence,
reassess after 6 months
If child > 3 years consult MDT or call Baylor hotline for second line failure
assessment
Alternative:AZT + 3TC + LPV/rNot NVP-exposed:Preferred:ABC + 3TC + EFV
Children < 12 Years:AZT + 3TC + LPV/r
Alternative:AZT + 3TC + NVP
ABC +3TC + LPV/r
< 3 years oldPreferred:ABC + 3TC + LPV/r
If child < 3 years: keep current regimen, reinforce adherence,
reassess after 6 months
If child > 3 years consult MDT or call Baylor hotline for second line failure
assessment
Alternative: AZT + 3TC + LPV/r
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Population HIV Treatment Area Criteria for Starting ARV Treatment First-Line Regimen Second-Line Regimen Third-Line Regimen
Swaziland - Swaziland Integrated HIV Management Guidelines (2015) Memorandum: Re: Scale Up of Test and Start Strategy in all ART Providing Facilities (2016)
TB/HIV Co-Infection addressed under HIV Guidelines: Yes
Infants PMTCT All HIV-exposed infants should be offered NVP prophylaxis for six weeks postpartum
Give CTX to all HIV-exposed infants, starting from six weeks of age - Continue treatment until HIV infection has been definitely ruled out AND the infant is no longer breastfeeding
Birth weight < 2,500 grams: Give NVP 1.0 ml daily
Birth weight > 2,500 grams:Give NVP 1.5 ml daily
Special Considerations for Infant NVP prophylaxis:Mother diagnosed HIV-positive during breastfeeding and is initiated on ART:
Infant initiates NVP for at least 6 weeksChild defaulted NVP prophylaxis before they are 6 weeks old:
Counsel on importance of on-going prophylaxis and restart NVP for 6 weeks
Mother diagnosed HIV-positive during breastfeeding and refuses to be initiated on ART:
Give child NVP for 6 weeks and continue counselling mother for ART
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Population HIV Treatment Area Criteria for Starting ARV Treatment First-Line Regimen Second-Line Regimen Third-Line Regimen
Tanzania - National Guidelines for the Management of HIV and AIDS (2015)
TB/HIV Co-Infection addressed under HIV Guidelines: Yes
AdultsAdolescents<15 years old
ARV Treatment All patients in WHO stage 3 and 4 clinical criteria, regardless of CD4 cell count
All Adolescents and adults with CD4 count <500 cells / mm3, regardless of WHO clinical stage
ART should be initiated in all individuals with HIV regardless of WHO clinical stage or CD4 cell count in the following situations:- Individuals with TB-HIV co-infection- Individuals co-infected with HIV and HBV with evidence of severe chronic liver disease- The following key populations: people who inject drugs (PWIDs), men who have sex with men (MSM), sex workers, prisoners- Partners with HIV in serodiscordant couples should be offered ART to reduce HIV transmission to uninfected partners.
Tenofovir (TDF) 300 mg / Lamivudine (3TC) 300 mg / Efavirenz (EFV) 600 mg once daily at night
Adolescents > 35 kgTDF + 3TC + EFV
Alternatives:TDF + FTC + EFVTDF + XTC + NVPAZT + 3TC + EFVAZT + 3TC + NVP
AZT + XTC + ATV/r or LPV/r
If first line regimen AZT-based:TDF + XTC + ATV/r or LPV/r
For patients who were initiated on TDF in first line because of intolerance to AZT:ABC + 3TC + LPV/r or ATV/r
Note:
For Adolescents, the dose of TDF is 200 mg once daily for a body weight of between 20- 35 kgs.
For patients <40kg, the dose of EFV should be <600mg.
Pregnant WomenBreastfeeding Women
ARV Treatment Pregnant or breastfeeding women with HIV should be started with lifelong ART, regardless of their CD4 count, WHO clinical stage, or gestational age.
TDF + 3TC + EFV ATV/r or LPV/r + AZT/3TCAlternative:AZT + 3TC + NVP
*This regimen is recommended to pregnant women in the first trimester and women of childbearing age.
ATV/r or LPV/r + TDF/FTCAlternative for either first line regimen:ATV/r or LPV/r + ABC + 3TC
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Population HIV Treatment Area Criteria for Starting ARV Treatment First-Line Regimen Second-Line Regimen Third-Line Regimen
Tanzania - National Guidelines for the Management of HIV and AIDS (2015)
TB/HIV Co-Infection addressed under HIV Guidelines: Yes
Children0 - 15 years old
ARV Treatment Treat all regardless of WHO clinical stage or CD4 cell count
Children 3 years to Adolescents < 35 kgABC + 3TC + EFV
AZT + 3TC + LPV/r
Alternative:AZT + 3TC + EFV
ABC or TDF + 3TC + LPV/r
Children younger than 3 years old"
ABC + 3TC + LPV/r
Alternatives:AZT + 3TC + LPV/rAZT + 3TC + NVP
No change; measures to improve adherence should be undertakenChildren below 18 months
who qualify for presumptive diagnosis
ARV Treatment Start ART while awaiting virologic confirmation
InfantsBirth to 6 weeks
PMTCT HIV exposed infant
Administer NVP syrup immediately after birth and continue at appropriate dose until six weeks of age. Do not initiate after the age of four weeks. Stop at age six weeks, regardless of when it was started.
Birth weight 2000 - 2499g10 mg NVP once daily Birth weight ≥ 2500g15 mg NVP once dailyLow birth weight infants should receive mg/kg dosing, suggested starting dose is 2 mg/kg once daily.
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Population HIV Treatment Area Criteria for Starting ARV Treatment First-Line Regimen Second-Line Regimen Third-Line Regimen
Uganda - Consolidated Guidelines for Prevention and Treatment of HIV in Uganda (2016)
TB/HIV Co-Infection addressed under HIV Guidelines: Yes
AdultsAdolescents (≥ 35kg)≥ 10 years old Pregnant WomenBreastfeeding Women
ARV Treatment ART should be initiated at the earliest opportunity in all people with confirmed HIV infection, regardless of clinical stage or CD4 cell count.
TDF + 3TC + EFV
All HIV-infected adults and Adolescents aged 10 years and above should be initiated on TDF + 3TC + EFV600mg as a once-daily fixed dose combination.
Alternative first line:TDF + 3TC + DTG only if EFV is contraindicated (Adolescents should be ≥ 12 years)ABC + 3TC + DTG only if TDF is contraindicated
AZT + 3TC + ATV/r
If patient was on AZT + 3TC first line, switch to TDF + 3TC + ATV/r
In adults, Adolescents, and pregnant women who weigh less than 40kg, use LPV/r
All 3rd line regimens to be guided by Resistance Testing
If patient is not exposed to INSTI's DRV/r + DTG with an option of adding 2 NRTIs based on resistance profiling
If patient is exposed to INSTI's DRV/r + ETV with an option of adding 2 NRTIs based on resistance profiling
Pregnant WomenBreastfeeding Women
ARV Treatment All HIV-infected pregnant, and breastfeeding women should be initiated on TDF+3TC+EFV600mg
Alternative first line:AZT+3TC+ATV/r only when TDF or EFV are contraindicated
Pregnant WomenBreastfeeding Women
eMTCT Give ART: for mothers on treatment, continue the same ART regimen.
For mothers not yet on treatment, initiateTDF + 3TC+ EFV600mg
Adolescents <35kg
ARV Treatment ABC + 3TC + DTG
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Population HIV Treatment Area Criteria for Starting ARV Treatment First-Line Regimen Second-Line Regimen Third-Line Regimen
Uganda - Consolidated Guidelines for Prevention and Treatment of HIV in Uganda (2016)
TB/HIV Co-Infection addressed under HIV Guidelines: Yes
Children3 - 9.9 years old
ARV Treatment ART should be initiated at the earliest opportunity in all people with confirmed HIV infection, regardless of clinical stage or CD4 cell count.
ABC + 3TC + EFV
Alternative first line:ABC+3TC+NVP only if EFV is contraindicated
AZT + 3TC + LPV/r
If patient was on AZT + 3TC first line, switch to ABC + 3TC + LPV/r
If patient was on LPV/r first line, switch to RAL
For children below 6 years:DRV/r+ RAL+ 2 NRTIs
For children above 6 years, ETV or RAL may be used.
For children above 6 years and prior exposure to INSTI's:DRV/r ± 1-2 NRTIs
Children<3 years old
ARV Treatment ABC + 3TC + LPV/r
Alternative first line:AZT+3TC+ LPV/r only in children who experience a hypersensitivity reaction to ABC
AZT +3TC + RAL
If patient was on AZT + 3TC first line, switch to ABC + 3TC + RAL
If patient was on NVP first line, switch to LPV/r
Optimize regimen using genotype profile.
Infants eMTCT Exposure to HIV Initiate NVP prophylaxis for the infant at birth.
Low risk:counsel mother and provide NVP syrup to HIV exposed infant from birth until 6 weeks of age
High risk: Counsel mother and provide NVP syrup from birth until 12 weeks of age.
High risk babies are breastfeeding infants whose mothers:- Have received ART for four weeks or less before delivery; or -Have VL > 1000 copies in 4 weeks before delivery; or - Diagnosed with HIV during 3rd trimester or breastfeeding period (postnatal)
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Population HIV Treatment Area Criteria for Starting ARV Treatment First-Line Regimen Second-Line Regimen Third-Line Regimen
Zambia - Zambia Consolidated Guidelines for Treatment & Prevention of HIV Infection (2016)
TB/HIV Co-Infection addressed under HIV Guidelines: Yes
Adults ARV Treatment Treat ALL regardless of WHO clinical stage or CD4 count
TDF +XTC + EFV 400Alternative regimen:TDF + XTC + NVPABC + 3TC + EFV
AZT + XTC + ATV/r or LPV/r
If AZT was used in first line:TDF + 3TC + LPV/r or ATV/r
Failure is two consecutive viral load measurements within a three-month interval, with adherence support between measurements after at least six months of using triple combination ARV drugs.
Based on genotype testing
The most likely ARVs to be successful in patients who have followed National Guidelines are:RAL + TDF + XTCRAL + AZT + 3TCDRV/r + TDF + XTCDRV/r + AZT + 3TC
Pregnant WomenBreastfeeding Women
ARV Treatment TDF + XTC + EFV(note: 400mg)Alternative regimen:TDF + XTC + NVPABC + 3TC + EFV
Previous sd-NVP exposure; or NVP monotherapy exposure (NVP without 7 days of AZT + 3TC cover); or: Unsure of tail coverage
TDF + XTC + LPV/rAlternative regimen:TDF + XTC + ATV/r
PMTCT HIV-positive mothers should immediately start cART
Adolescents 10 - 19 years old<35kg)
ARV Treatment Treat ALL regardless of WHO clinical stage or CD4 count
TDF + XTC + EFV (weight-based dosing)Alternative regimen:TDF + XTC + NVPABC + 3TC + EFV
AZT + XTC + ATV/r or LPV/r
If AZT was used in first line:TDF + 3TC + LPV/r or ATV/r
Children 5 - <10 years old
ARV Treatment ABC + 3TC + EFV
Alternative regimen:AZT + 3TC + EFV orABC + 3TC + NVP
AZT + 3TC + LPV/r or ATV/r
If AZT was used in first line:TDF + 3TC + LPV/r or ATV/r
For children, viral load may still be detectable at 6-9 months after initiation and does not necessarily mean treatment failure.
Based on genotype testingChildren2 weeks - 5 years old
ABC + 3TC + LPV/r AZT + 3TC + RAL
Children0 - 2 weeks
AZT + 3TC + NVPAlternative regimen:AZT + 3TC + LPV/r
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Population HIV Treatment Area Criteria for Starting ARV Treatment First-Line Regimen Second-Line Regimen Third-Line Regimen
Zambia - Zambia Consolidated Guidelines for Treatment & Prevention of HIV Infection (2016)
TB/HIV Co-Infection addressed under HIV Guidelines: Yes
Infants> 6 weeks to 12 weeks
PMTCT Both high and low risk infants should be provided with prophylaxis.
Low risk HIV exposed infant:Known HIV-positive mother who has been on ART for more than 12 weeks--> Provide AZT/NVP for 6 weeks
High risk HIV exposed infant:1. Born to woman with established HIV infection not on ART; or:2. Born to woman with established HIV infection and having received less than 12 weeks of ART at the time of delivery; or:3. Born to woman with established HIV infection with viral load >1000 copies/mL within the four weeks before delivery.--> Provide AZT/NVP for 12 weeks
High risk HIV exposed infant born to known HIV positive woman who refuses ART--> Provide Prophylactic AZT/NVPuntil confirmed final outcome HIV negative after complete cessation of breastfeeding
NVP 20 mg once dailyandAZT: use treatment dose 60 mg twice daily.
Birth to <6 weeks oldBirth weight ≥ 2500g
NVP 15 mg once dailyandAZT 15mg twice daily
Birth to <6 weeks oldBirth weight2000g - 2499g **
NVP 10mg once dailyandAZT 10 mg twice daily
** For infants weight <2000g and older than 35 weeks of gestational age, the suggested doses are: NVP 2 mg/kg per dose once daily and AZT 4 mg/kg per dose twice daily. Premature infants younger than 35 weeks of gestation age should be dosed using expert guidance.
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Population HIV Treatment Area Criteria for Starting ARV Treatment First-Line Regimen Second-Line Regimen Third-Line Regimen
Zimbabwe - Guidelines for Antiretroviral Therapy for the Prevention and Treatment of HIV in Zimbabwe (2016)
TB/HIV Co-Infection addressed under HIV Guidelines: Yes
AdultsPregnant WomenBreastfeeding WomenAdolescents(10 - 19 years) ≥ 35kg
ARV Treatment All individuals with a confirmed HIV diagnosis are eligible for antiretroviral therapy (ART) irrespective of WHO clinical stage and CD4 count level, i.e. TREAT ALL.
As a priority, initiate ART in all individuals with severe or advanced HIV clinical disease (WHO clinical stage 3 or 4) or CD4 count less than or equal to 350 cells/mm3.
It is also recommended to initiate ART, as a priority, in the following categories of patients regardless of CD4 cell count:- Active TB disease- Pregnant and breastfeeding women with HIV- Individuals with HIV in serodiscordant relationshipsHBV co-infection with severe chronic liver disease
Preferred first line regimen:TDF + 3TC + EFV
Alternative Regimens:TDF + 3TC + NVPAZT + 3TC + EFVAZT + 3TC + NVP
If TDF was used in first line ART:AZT + 3TC + ATV/r or LPV/r
If AZT was used in first line ART:TDF + 3TC + ATV/r or LPV/r
Those failing second-line therapy will need to be referred for Specialist assessment which includes viral load and may be genotype testing prior to recommending the third-line medicines.
In adolescents > 12 years and adults, the preferred 3rd line ART regimen is Dolutegravir (50mg) and Darunavir (600 mg)/Ritonavir (100 mg) twice daily (for PI-experienced patients). Raltegravir (400 mg) twice a day can be used when DTG is not available. (Safety and efficacy data on the use of DTG in adolescents younger than 12 years and pregnant women are not yet available.)
Pregnant WomenBreastfeeding Women
PMTCT All HIV positive pregnant and breastfeeding women should initiate lifelong ART as soon possible after their HIV positive status is confirmed irrespective of their CD4 count or WHO clinical stage; and continue ART throughout the breastfeeding period and beyond.
TDF + 3TC + EFV600
Alternative options:AZT + 3TC + EFV600AZT + 3TC + NVPTDF + 3TC + NVP
Children< 10 years
ARV Treatment ART should be initiated in ALL children living with HIV, regardless of WHO clinical stage and at any CD4 count. Children less than 5 years old or with WHO clinical stage III/IV or CD4 < 25% (< 5 years) or ≤ 350 (>5 years) should be a priority.
Early ART initiation in infants as soon as birth PCR results are available. ALWAYS retest and confirm results with repeat PCR but retesting should not delay ART initiation.
Babies who test negative at birth (birth PCR) or were not tested MUST be tested at 6 weeks.
3 years to < 10 years:Preferred:ABC + 3TC + EFV
Alternatives:AZT + 3TC + EFVAZT + 3TC+ NVPTDF + 3TC + EFV (or NVP)2 weeks to < 3 years
AZT + 3TC + LPV/r or RAL
ABC + 3TC + LPV/rABC + 3TC + ATV/r
Children 0 - 10 years
RAL + 2NRTIsDRV/r + 2 NRTIsDRV/r + RAL +/- 1 - 2
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Population HIV Treatment Area Criteria for Starting ARV Treatment First-Line Regimen Second-Line Regimen Third-Line Regimen
Zimbabwe - Guidelines for Antiretroviral Therapy for the Prevention and Treatment of HIV in Zimbabwe (2016)
TB/HIV Co-Infection addressed under HIV Guidelines: Yes
Children < 10 years
ARV Treatment ART should be initiated in ALL children living with HIV, regardless of WHO clinical stage and at any CD4 count. Children less than 5 years old or with WHO clinical stage III/IV or CD4 < 25% (< 5 years) or ≤ 350 (>5 years) should be a priority.
Early ART initiation in infants as soon as birth PCR results are available. ALWAYS retest and confirm results with repeat PCR but retesting should not delay ART initiation.
Babies who test negative at birth (birth PCR) or were not tested MUST be tested at 6 weeks.
2 weeks to <3 years:Preferred:ABC + 3TC + LPV/r
Alternatives:AZT + 3TC + LPV/rABC + 3TC + NVP
AZT + 3TC + RAL
ABC + 3TC + RAL
0 - 2 weeks:AZT + 3TC + NVP
InfantsBirth to 6 weeks
PMTCT Infants at high risk of transmission will receive dual ARVs (AZT and NVP) for 12 weeks as prophylaxis if breastfed and for 6 weeks if formula fed.
Infants at low risk of transmission (either breastfed or formula fed) will receive daily NVP for 6 weeks.
A high risk infant is defined as follows:1. High maternal viral load >1000 copies/mlduring the last 4 weeks before delivery2. An infant born to HIV infected woman whohas received less than 4 weeks of ART at the time of delivery3. An infant born to a newly diagnosed HIVinfected woman during labor, delivery andpostpartum (Incident HIV infection)
Cotrimoxazole must be started from 6 weeks of age even in babies on longer CD4>200 copies/ml and be at least 6 months on ART.
For infants weighing <2000 g and older than 35 weeks of gestational age, the suggested doses are: NVP 2 mg/kg per dose once daily and AZT 4 mg/kg per dose twice daily. Premature infants younger than 35 weeks of gestational age should be dosed using expert guidance.
59
Population HIV Treatment Area Criteria for Starting ARV Treatment First-Line Regimen Second-Line Regimen Third-Line Regimen
Zimbabwe - Guidelines for Antiretroviral Therapy for the Prevention and Treatment of HIV in Zimbabwe (2016)
TB/HIV Co-Infection addressed under HIV Guidelines: Yes
InfantsBirth to 6 weeks
PMTCT Infants at high risk of transmission will receive dual ARVs (AZT and NVP) for 12 weeks as prophylaxis if breastfed and for 6 weeks if formula fed.
Infants at low risk of transmission (either breastfed or formula fed) will receive daily NVP for 6 weeks.
A high risk infant is defined as follows:1. High maternal viral load >1000 copies/mlduring the last 4 weeks before delivery2. An infant born to HIV infected woman whohas received less than 4 weeks of ART at the time of delivery3. An infant born to a newly diagnosed HIVinfected woman during labor, delivery andpostpartum (Incident HIV infection)
Cotrimoxazole must be started from 6 weeks of age even in babies on longer CD4>200 copies/ml and be at least 6 months on ART.
Birth weight: 2000 - 2499g
Dosing NVP:10 mg once daily(1 ml of syrup once daily)
Dosing AZT:10 mg twice daily(1 ml of syrup twice daily)
Birth weight:≥ 2500g
Dosing of NVP:15 mg once daily(1.5 ml of syrup once daily)
Dosing of AZT:15 mg twice daily(1.5 ml of syrup twice daily)
> 6 weeks to 12 weeks Dosing of NVP:20 mg once daily(2 ml of syrup once daily or half a 50 mg tablet once daily)
Dosing of AZT:No dose established for prophylaxis; use treatment dose 60 mg twice daily(6 ml of syrup twice daily or a 60 mg tablet twice daily)
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Accordance with 2015 WHO recommendations on criteria for starting ART
Country Adults(>19)
Pregnant and breastfeeding women
Adolescents (10-19)
Children (<10)
Angola No Yes No NoBotswana Yes Yes Yes YesBurundi Yes Yes Yes YesCameroon No Yes No NoCote d'Ivoire No Yes No YesDemocratic Republic of Congo
Yes Yes Yes Yes
Ethiopia No Yes No YesGhana Yes Yes Yes YesHaiti Yes Yes Yes YesKenya Yes Yes Yes YesLesotho Yes Yes Yes YesMalawi Yes Yes Yes YesMozambique No Yes No NoMyanmar (Burma) Yes Yes Yes YesNamibia Yes Yes Yes YesNigeria Yes Yes Yes YesRwanda Yes Yes Yes YesSouth Africa No Yes No NoSouth Sudan Yes Yes Yes YesSwaziland No Yes No NoTanzania No Yes No YesUganda Yes Yes Yes YesZambia Yes Yes Yes YesZimbabwe Yes Yes Yes Yes
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