western cape art guidelines presentation...
TRANSCRIPT
WESTERN CAPE ART GUIDELINES PRESENTATION
2013
• The WC guidelines are based on SA National ART guidelines dated 24th March 2013
• Acknowledgement goes to members of the Adult and Paediatric HAST policy advisory groups for their valuable input and comment
GOALS OF THE PROGRAMME
• Save lives and improve the quality of life of people living with HIV• Achieve best health outcomes in the most cost‐efficient manner• Implement nurse‐initiated treatment• Decentralise service delivery to PHC facilities• Integrate services for HIV, TB, MCH, SRH and wellness• Diagnose HIV earlier• Prevent HIV disease progression• Avert AIDS‐related deaths• Retain patients on lifelong therapy• Prevent new infections among children, adolescents, and adults• Mitigate the impact of HIV and AIDS
SPECIFIC OBJECTIVES
• To prioritise initiation of combination antiretroviral treatment – see detail under FDC Implementation
• To test all HIV exposed children under‐five years and treat all those found to be infected with HIV.
• To standardise first and second line therapy for children, adolescents, and adults in the public and private sector.
• To move patients currently on Stavudine‐containing regimens to Tenofovir‐based FDCs, once creatinine clearance has been checked. Stavudine (d4T) to be used only under specific circumstances.
• To strengthen capacity of nurses to initiate ARVs for treatment of pregnant women who are HIV positive for their own health and to prevent mother to child transmission.
• To strengthen PHC facilities to initiate, manage, monitor and refer patients.
Adults &Adolescents
ELIGIBILITY FOR STARTING HAART
CD4 count <350 cells/mm3 irrespective of WHO clinical stage
ORIrrespective of CD4 count
• All types of TB • HIV positive women who are pregnant or
breast feeding • WHO stage 3 or 4
Patients requiring fast tracking(i.e. ART initiation within 7 days of being eligible)
HIV positive women who are pregnant or breast feeding [where capacity exits: initiate SAME day as eligibility
established]OR
•Patients with a CD4 ≤ 200OR
Patients with WHO stage 4 disease OR
Patients with TB/HIV co morbidity with CD4 count < 50
Patients with CD4 above 350: Not yet eligible for ART
Transfer to a wellness programme for regular follow-up and repeat CD4 testing 6 monthly.Advise on how to avoid HIV transmission to sexual partners and childrenInitiate INH prophylaxis if asymptomatic for TB AND a positive mantoux testProvide counselling on nutrition and contraceptionPap smear should be doe on diagnosis and if normal every 3 years
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Standardised Western Cape ART regimensfor adults and adolescents
1st Line
All new patients needing treatment, including pregnant women
Tenofovir [TDF] +Emtricitabine [FTC] (or Lamivudine [3TC) + Efavirenz [EFV]
fixed dose combination
preferred
Adolescents - new: TDF 300mg daily if ≥15 years of age AND ≥40kg AND eGFR is ≥ 80*Adolescents – on treatment:switch to TDF 300mg daily if ≥15 years of age AND ≥40kg AND VL < 400 copies/ml IF eGFR is ≥ 80
Contra = indications to Efavirenz [EFV]
Tenofovir [TDF] +Emtricitabine[FTC] (or Lamivudine [3TC) + Nevirapinie[NVP]
Use NVP based regimen in patients with significant psychiatric co-morbidity or intolerance to EFV where the neuro-psychiatric toxicity may impair daily functioning, e.g. shift workers.Patients should not be initiated on NVP if:- Female with an initial CD4 >
250 cells/mm3
- Males with an initial CD4 > 400 cells/mm3
Contra = indication to Tenofovir [TDF]
Zidovudine [AZT] +Lamivudine [3TC] + Efavirenz [EFV] OR Nevirapine [NVP]
Renal disease [Cr Cl ≤ 50 ml/min] or the concurrent use of other nephrotoxic drugs e.g. aminoglycosides [kanamycin]Pregnant women: Cr < 85µmol/l
Contra = indication to Tenofovir [TDF] and Zidovudine [AZT]
Stavudine [d4T] + Lamivudine [3TC] + Efavirenz [EFV] OR Nevirapine [NVP]
Renal disease [Cr Cl ≤ 50 ml/min] or the concurrent use of other nephrotoxic drugs e.g. aminoglycosides [kanamycin] and anaemia [Hb ≤ 8g/dl: use Zidovudine 200mg bd; Hb ≤ 6.5 g/dl: change medicine]
Contra = indication to Tenofovir [TDF]; Zidovudine [AZT] and Stavudine [d4T]
Abacavir [ABC] +Lamivudine [3TC] +Efavirenz [EFV] OR Nevirapine [NVP]
Renal disease [Cr Cl ≤ 50 ml/min] or the concurrent use of other nephrotoxic drugs e.g. aminoglycosides [kanamycin]; anaemia [Hb ≤ 8g/dl: use Zidovudine 200mg bd; Hb ≤ 6.5 g/dl: change medicine]; peripheral neuropathy; hyperlactataemia; lypoatrophy [circular H34 2012: submit motivation]
Currently on d4T-based regimen
Tenofovir [TDF] + Emtricitabine[FTC] (or Lamivudine [3TC) + Efavirenz [EFV]
If patients experience, or are at high risk of toxicity (high BMI or pregnant). Switch to TDF if virologicallysuppressed and the patient’s creatinineclearance is normal
2ND LINE
Management of virological failure
If plasma HIV RNA > 1 000 copies/ml:
- Check adherence, compliance, tolerability, drug-drug interactions and assess any psychological issues.
- Repeat VL test within 3 months.
If plasma VL confirmed > 1 000 copies/ml change to second line therapy
Patients on Tenofovir and Emtricitabine [or Lamivudine]:- Check Hepatitis B status prior to changing
regimen- If HepB sAg positive: maintain patients on
Tenofovir and Emtricitabine [or Lamivudine]Suggested regimen would be: TDF + AZT + FTC [or 3TC] + LPV/r
Failing on a Tenofovir [TDF] -based 1st line regimen
Zidovudine [AZT] + Lamivudine [3TC] + Lopinavir / ritonavir [LPV/r]
Failing on a Stavudine [d4T] or Zidovudine [AZT] based 1st line regimen
Tenofovir [TDF] + Lamivudine [3TC] + Lopinavir / ritonavir [LPV/r]
LPV/r may increase the levels of TDF: monitor for TDF side effects
Contraindication to Tenofovir [TDF]; Zidovudine [AZT] and Stavudine [d4T]
Abacavir [ABC] + Lamivudine [3TC] + Lopinavir / ritonavir [LPV/r]
Renal disease [Cr Cl ≤ 50 ml/min] or the concurrent use of other nephrotoxic drugs e.g. aminoglycosides [kanamycin]; anaemia [Hb ≤ 8g/dl: use Zidovudine 200mg bd; Hb ≤ 6.5 g/dl: change medicine]; peripheral neuropathy; hyperlactataemia; lypoatrophy [circular H34 2012: submit motivation]v
Lopinavir / ritonavir [LPV/r] related adverse effects:Hypertriglyceridaemia: fasting triglycerides > 5mmol/lCardiovascular event risk > 20%Severe hypercholesterolaemia: Total Cholesterol > 7.5mmol/lEstablished clinical cardiovascular diseaseSevere GIT side effects: > 6 weeks
Switch Lopinavir / ritonavir [LPV/r] to Atazanavir / ritonavir [ATV/r]
No motivation requiredRefer to Circular H148 2011
Third line
Failing any 2nd
line regimen: A provincial policy will be forthcoming
Specialist referral: Should be managed by an infectious disease specialist on the basis of genotype resistance testing. Most likely regimen may include one or more of the following: Raltegravir, Darunavir or Etravirine.
Monitoring of Adult and Adolescents with HIV
At initial Diagnosis of HIV PurposeConfirm HIV status Ensure that Western Cape testing
algorithm has been followedDo CD4 count and WHO clinical staging if HIV positive
To assess eligibility for ART To assess eligibility for fast-tracking
Screen for pregnancy or ask if planning to conceive
To identify women who need ART
Screen for TB symptoms To identify TB/HIV co-infection [refer to WC TB screening tool]
Mantoux test [TST] Identify need for IPTCLAT: All HIV + patients with an initial CD4 < 100 cells/mm3
Identify patients who required cryptococcal meningitis prophylaxis with fluconazole
At Routine Follow-Up Visits for those not yet eligible for
ART
Purpose
Repeat CD4 count 6 monthly
To determine if patient has become eligible for ART
WHO clinical staging at every visit
To determine if patient has become eligible for ART
Screen for TB symptoms to identify TB suspectsOffer IPT if no TB symptoms AND mantoux positivei
To identify TB/HIV co-infection
To prevent TB activation
Prior to initiation of ART (Baseline)
Purpose
Hb and differential WCC: for patients initiating on Zidovudine [AZT]
To detect anaemia; neutropenia
ALT: for patients initiating on Nevirapine [NVP]
To assess for liver dysfunction
Serum creatinine and creatinine clearance: for patients initiating on Tenofovir [TDF]
If pregnant: serum creatinine level
To detect renal insufficiency: if CrCl ≤ 50: DO NOT use Tenofovir. Zidovudine and Lamivudine may be used: doses should be adjusted for renal impairment. [Appendix 1: Adult dosages in renal impairment]Should be ≤ 85 µmol/l
On ART PurposeCD4 at 1 year on ART. If CD4 < 200 cells/mm3 repeat 6 monthly until two consecutive CD4’s > 200 cells/mm3
To monitor immune response to ARTStop prophylactic cotrimoxazole and fluconazole after two consecutive CD4’s > 200 cells/mm3
VL at month 4, month 12 and then annually If on DR TB treatment: VL 6 monthly until DR TB treatment completedIf pregnant or breastfeeding: VL 6 monthlyvii. Do a VL at 36 weeks if no VL has been done in the last 4 months
To monitor response to treatment and identify treatment failures
To ensure optimal viral suppression prior to delivery
ALT: if on Nevirapine [NVP] or Efavirenz [EFV] and develops rash or symptoms of hepatitis
To identify Nevirapine [NVP] or Efavirenz [EFV] toxicity
HB and diff WCC at month 1, 2, 3 and 6 if on Zidovudine [AZT]
To identify Zidovudine [AZT] toxicity
Creatinine clearance at month 1; 4; 12 and then every 12 months if on Tenfovoir [TDF]
To identify Tenofovir [TDF] toxicity. *If < 16 years: the following formula should be used:
GFR = height [cm] x 40creatinine [µmol/l]
If > 16 years: use adult weight-based formula for GFRFasting cholesterol and triglycerides: baseline on initiating Lopinavir / ritonavir [LPV/r].Then at month 4, month 12 and then annually
To identify Lopinavir / ritonavir [LPV/r] toxicity
Hep B sAg Patients on Tenofovir [TDF] and Emtricitabine [FTC] or Lamivudine [3TC] changing to second line treatment
INFANTS & CHILDREN
Eligibility criteria for initiating ARTin infants and children
Eligibility for starting ART
All children less than 5 years of age: irrespective of CD4Children 5 years to 15 years:
WHO clinical stage 3 or 4 ORCD4 <350 cells/ mm3
Patients requiring fast tracking (i.e. start ART within 7 days of being eligible)
Children less than 1 year of ageWHO clinical Stage 4MDR or XDR-TBCD4 count < 200 cells/mm3 or < 15%
ART regimens for infants and children
First Line RegimenAll infants and children under 3 years (or < 10kg)
Abacavir [ABC] + Lamivudine [3TC] + Lopinavir / Ritonavir [LPV/r]
Children ≥ 3 years (or ≥ 10kg): •NOT exposed to Nevirapine during PMTCT•EXPOSED to Nevirapine during PMTCT for 6 weeks or longer
Abacavir [ABC] + Lamivudine [3TC] + Efavirenz [EFV]
Abacavir [ABC] + Lamivudine [3TC] + Lopinavir / Ritonavir [LPV/r]
Currently on Stavudine [d4T] -based regimen
Change Stavidine [d4T] to Abacavir [ABC] if viral load is undetectable If viral load >1000 copies/ml manage as treatment failureIf viral load between 50 – 1000 copies/ml –consult with expert for advice
Second Line Regimen
Failed first line Protease Inhibitor (PI) based regimen
ABC + 3TC + LPV/r
Consult with Paediatric Infectious Disease Specialist for advice*
D4T + 3TC + LPV/r
Unboosted PI-based regimenRifampicin while on LPV/r
Failed First line NNRTI based regimen (discuss with expert before changing)
First line NNRTI-based regimen
Recommended second line regimen
ABC +3TC + EFV (or NVP)
AZT + 3TC +LPV/r
d4T +3TC + EFV (or NVP AZT + ABC + LPV/r
Third line regimens
Failing any 2nd line regimen
Should be managed by a Paediatric Infectious Disease Specialist on the basis of genotype resistance testing.
Monitoring for infants and children with HIV
At initial Diagnosis of HIV PurposeConfirm HIV status Ensure that Western Cape testing
algorithm has been followedDocument weight, height, head circumference (<2yrs) and development
To monitor growth and development and identify eligibility for ART
Screen for TB symptoms To identify TB/HIV co-infectionWHO Clinical Staging [≥ 5 years] To determine if patient is eligible
for ARTCD4 count Children < 5 years: DO NOT wait
for CD4 count to start ART Children ≥ 5 years: to determine eligibility for ART and start cotrimoxazole prophylaxis as per Western Cape guideline
FBC + diff To detect anaemia; neutropenia; thrombocytopaenia
Neurocognitive developmental assessments
With appropriate available tool
At Routine Follow-Up Visits for those not yet
eligible for ART
Purpose
Document weight, height, head circumference (<2 years) and development
To monitor growth and development
Repeat CD4 count 6 monthly
To determine if patient has become eligible for ART
WHO clinical staging at every visit
To determine if patient has become eligible for ART
Screen for TB symptoms
To identify TB/HIV co-infection
Neurocognitive developmental assessments
With appropriate available tool
Prior to initiation of ART (Baseline)
Purpose
FBC If less than 8g/dl start ART and discuss with specialist
CD4 count (if not performed in last 6 months)
Baseline assessment
HIV Viral Load (VL) Baseline assessment. DO NOT wait for viral load result before starting ART in infants
Cholesterol + Triglyceride if on PI-based regimen
Baseline assessment
Creatinine if on TDF regimen
If abnormal refer for specialist opinion
ALT (if jaundiced or on TB treatment)
To assess for liver dysfunction
Neurocognitive developmental assessments
With appropriate available tool
Urine dipsticks dispsticks
Baseline assessment
Serum phosphate [if on TDF]:
Baseline assessment
On ART PurposeHeight, weight, head circumference (<2yrs) and development
To monitor growth and developmental stages
Clinical assessment To monitor response to ART and exclude adverse effects
CD4: ALL at month 4 and month 12. Then1-5 years: 6 monthly5 years: If CD4 < 200 cells/mm3 repeat 6 monthly until two consecutive CD4’s > 200 cells/mm3
To monitor response to ART.When to stop prophylactic cotrimoxazole: • All children to take prophylaxis until 12 months of
age• 1 – 5 years: CD4 count > 500 cells/mm3 for two
consecutive occasions 3 to 6 months apart• >5 years: CD4 count > 200 cells/mm3 for two
consecutive occasions 3 to 6 months apart• If previous PCP: stop at 5 years of age
When to stop secondary fluconazole prophylaxis:• All children to take prophylaxis until 24 months of
age• 2-5 years: if completed 1 year of prophylaxis AND
CD4 > 750 cells/mm3 on at least two occasions• > 5 years: if completed 1 year of prophylaxis AND
CD4 > 200 cells/mm3 on at least two occasions
VL: All: at month 4 and 12, then
- children <5 years: 6 monthly
- children 5 years to 15 years: 12 monthly
To monitor viral suppression response to ARTTo identify treatment failure and to identify
problems with adherence
Hb and diff WCC at month 1, 2, 3 and 6 months if on AZT
To identify AZT-related anaemia
Creatinine clearance at month 1; 4; 12 and then every 12 months if on TDF
To identify TDF toxicity. *If < 16 years: the following formula should be used:
GFR = height [cm] x 40Creatinine [µmol/l]
If > 16 years: use adult weight-based formula for GFR
Cholesterol + Triglyceride at 4 months; 1 year and then every 12 months if on PI-based regimen
To monitor for PI-related metabolic side-effects
Clinical assessment with awareness of drug-related adverse events
To monitor response to ARTTo identify drug-related adverse events. If develops jaundice or rash on EFV or NVP do liver function test and refer to specialist
Neurocognitive developmental assessments
With appropriate available tool
Urine dipsticks [on TDF]: 6 monthly
Monitor possible adverse effects of tenofovir: particularly if also on Lopinavir / Ritonavir
Serum phosphate [on TDF]: annually
Monitor possible adverse effects of tenofovir
SPECIAL CONSIDERATIONS
TB Patients (adults and adolescents):
HIV positive TB patients qualify for lifelong ART regardless of CD4 cell count.
Suspect TB if 2 or more of the following symptoms are present:
1. Cough any duration 2. Sputum production which may occasionally be blood stained 3. Fever 4. Drenching night sweats 5. Unexplained weight loss 6. Loss of appetite, malaise, tiredness 7. Shortness of breath, chest pains 8. New palpable lymphadenopathy
The patient that presents with TB before commencing ART:
I. All TB patients with CD4< 50, as well as those with WHO stage IV disease[excluding TB meningitis [TBM] or Cryptococcal meningitis [CM)], should bestarted on ARV’s AT 2 weeks post diagnosis.
II. All TB patients with CD4 >50 who are ‘well’, have no stage 4 illness or markersof severity (low BMI or Hb) should start ART between 2 - 10 weeks of initiationof TB treatment .
III. Patients with TBM or CM should be started on ARV’s within 4 to 6 weeks.
Summary: Antiretroviral Treatment for Adults with concomitant TBTB develops while on ART TB diagnosed before starting ART
Continue ARV therapy throughout TB treatment.
First-line regimen.
Patient can remain on their regimen
Second-line regimen:
The lopinavir/ ritonavir dose should be doubled (from 2 tablets 12 hourly to 4 tablets 12 hourly) while the patient is on rifampicin-based TB treatment.
Monitor ALT monthly.
Reduce lopinavir/ ritonavir to standard dose 2 weeks after TB treatment is completed.
CD4 count >350/mm3:
Delay ART for two months (until intensive phase of TB therapy is complete).
CD4< 50 Introduce ART AT two weeksCD4 >50 Introduce ART between 2 and 10 weeks
Cryptococcal and TBM: start between 4 and 6 weeks
INH PROPHYLAXIS
a. All people living with HIV should be screened for active TB and eligibility forART.
b. Those who are eligible should be started on ART. c. TB preventive therapy is an effective intervention for HIV infected individuals. d. All people living with HIV with a positive Mantoux, in whom active TB has been
reasonably excluded, should be started on IPT (as soon as practically possibleafter initiation of ART in those who are eligible for ART).
e. Alcohol abuse, adherence challenges and side-effects should be assessedprior to initiating IPT.
f. Dose: 5mg/kg to a maximum dose of 300mg daily, with pyridoxine 25mg/day.Pregnancy is not a contraindication to INH prophylaxis.
Summary Recommendations
Pre-ART(CD4>350)
On ART
TST negative No IPT NO IPT
TST positive IPT for at least 36 months
IPT for at least 36 months
Thank you