PMTCT Update

Update on PMTCT

Margarett Davis, MD, MPH Chief, Maternal and Child Health Branch

Division of Global HIV/AIDS Centers for Disease Control and Prevention (CDC)

African Health Profession Regulatory Collaborative for Nurses and Midwives

Johannesburg, Republic of South Africa, June 18-22, 2012

Overarching Goals

• HIV-free infant/child survival • AIDS-free maternal survival • New dynamic environment for achieving

these goals

Global Community United Around Action to End Pediatric AIDS

Global Commitment

• Global Plan towards Virtual Elimination of New HIV Infections in Children by 2015 and Keeping their Mothers Alive

• Sometimes referred to as eMTCT • Focus is on pediatric infections averted

PEPFAR Support for the Global Plan & eMTCT TUNISIA

MOROCCO

SAHARA

ALGERIA

MAURITANIA MALI

NIGER

LIBYA

CHAD

Mediterranean Sea

Sea

EGYPT

SUDAN

ETHIOPIA

DJIBOUTI

ERITREA

SOMALIA KENYA

TANZANIA

DEMOCRATIC

CENTRAL

RWANDA

GABON

EQUATORIAL

ANGOLA

CONGO

NIGERIA BENIN

DTVOIRE SIERRA

SENEGAL

GHANA

THE

GUINEA

LIBERIA CAMEROON

SOUTH AFRICA

MALAWI

ZAMBIA

MOZAMBIQUE MADAGASCAR ZIMBABWE

BOTSWANA

SWAZILAND

Indian

Ocean

LESOTHO

NAMIBIA

ANGOLA

Atlantic

Ocean

WESTERN

Red

UGANDA

OF THE CONGO

REPUBLIC

BURUNDI

GUINEA REP. OF

TOGO COTE

BURKINA GUINEA

LEONE

GAMBIA

BISSAU

Walvis Bay

SOUTH

REPUBLIC

AFRICAN

THE

AFRICA

Legend 6 Original Acceleration Countries 8 New Acceleration Countries PEPFAR PMTCT programs in 21/22 Global Plan countries*

SOUTHSUDAN

* PEPFAR supports programming in India (not pictured)

Countries in which PEPFAR supports PMTCT- broader than Global Plan

• South Africa, Lesotho, Swaziland, Angola, Mozambique, Botswana, Namibia, Zambia, Malawi, Rwanda, Burundi, DRC, Zimbabwe, Tanzania, Kenya, Uganda, Ethiopia, South Sudan

• Nigeria, Cameroon, Ghana, Cote d’Ivoire • Seychelles, Mauritius

PEPFAR Investment in PMTCT and PMTCT Acceleration

• In FY 2009 – 2011, PEPFAR’s investment in PMTCT totaled over $940 million with budgets increasing annually

• This includes PMTCT Acceleration funds allocated to high burden countries in two phases: – 2010: $100m invested in 6 countries

• Malawi, Mozambique, Nigeria, South Africa, Tanzania, Zambia

– 2011: $180m with expansion to 8 new countries • Burundi, Cameroon, Democratic Republic of Congo,

Ethiopia, Lesotho, Swaziland, Uganda, Zimbabwe

Four Pillars of PMTCT

Prevention of HIV in Women

Prevention of Unwanted Pregnancies

Prevention of Transmission from an HIV-infected Woman to her Infant

Care and Treatment for HIV-Infected Women and Families

Prong 1: Preventing New HIV Infections among Women of Childbearing Age

PEPFAR portfolio includes: • Condom distribution: 500 million/year in 2012 and

2013 • Treatment: 6 million individuals on ARVs by 2013 • Treatment of infected partner in discordant couples

New Guidelines: Couples T&C (2012) Including ARVs for Treatment and Prevention

in Serodiscordant Couples • ANC and PMTCT setting important entry for couples T&C • New evidence from HPTN 052: 96% decrease in transmission in serodiscordant couples • High rates of serodiscordance in many settings (up to 50% in couples with one infected partner)

• New Rec: Provide ART, regardless of "eligibility" for the HIV+ partner in serodiscordant couple

Prong 2: Preventing Unintended Pregnancy

• PEPFAR supports integration of FP, MNCH, SRH, and PMTCT – Priority countries for

targeted FP integration (Uganda, Malawi, Zambia)

Prong 3: Preventing MTCT PEPFAR supports • PMTCT service delivery • Technical assistance to MOH and other partners to ensure optimal implementation of PMTCT programs

• Single dose nevirapine (sd-NVP) is being phased out globally in favor of more efficacious regimens • More focus on ART which has been neglected in all PMTCT Options •New movement toward Option B+, treating all HIV+ pregnant women for life regardless of CD4 level

National ARV Coverage for PMTCT, 2010

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%

BotswanaSouth Africa

NamibiaSwaziland

ARV Coverage 80%+Kenya

MozambiqueTanzania

ZambiaLesotho

MalawiZimbabwe

Cote d'IvoireUganda

ARV Coverage 50-79%Ghana

CameroonIndia

NigeriaEthiopia

AngolaBurundi

ChadDRC

ARV Coverage 0-49%

Source: Universal Access Report, 2011 % National ARV Coverage for PMTCT

Who needs ART? ~ 40% of all HIV+ pregnant and BF women

Prong 4: Ongoing Care & Support • Getting eligible women and children on

antiretroviral therapy – focus on improving linkages, adherence, & retention

• HIV-Free Child Survival through Nutrition Assessment Counseling & Support (NACS) – Mozambique – Uganda – Tanzania – Lesotho – Plus South Africa and Kenya

Women Eligible for ART Are At Highest Risk for Mother to Child HIV Transmission and Mortality

Eligible for ART

Not eligible for ART

MTCT by 6 wk 16.7% 5.0%

Proportion of MTCT by 6 wks

87.5%

12.5%

MTCT after 6 wks 17.0% 4.2%

Proportion of MTCT after 6 wks

87.5%

12.5%

Maternal mortality 24 mo post delivery

92%

8%

� Cohort 1,025 pregnant women in Zambia prior to HAART availability

� Analyzed MTCT/mortality by eligibility for ART with current WHO criteria (CD4

<350 or WHO Stage 3 or 4)

Eligible68.1%

NotEligible31.9%

Kuhn L et al. AIDS 2010;24:1374-7

Who needs ART?

CD4 >350 (50-60% of

women)

CD4 <350 (40-50% of

women)

Eligible for Treatment40-50% of pregnant women

identified as HIV+ will be eligible for treatment for their

own health (CD4 <350)

Eligible for Prophylaxis50-60% of pregnant women

identified as HIV+ will have CD4> 350 and should receive prophylaxis

under Options A or B

Prophlaxis GivenGenerally at ANC site

A) After CD4 results receivedB) After sample taken for CD4

ART GivenGenerally through referral to

treatment site

After CD4 results received:A) ART initiatedB) ART (already initiated)

continues Carter, RJ et al. JAIDS, 2010.

WHO Options A & B Who needs ART?

Transforming PMTCT: Option B+

“Recent developments suggest that substantial clinical and programmatic advantages can come from adopting a single, universal regimen both to treat HIV-infected pregnant women and to prevent mother-to-child transmission of HIV.”

-April 2012 WHO Programmatic Update on

the use of antiretroviral drugs for treating pregnant women and preventing HIV infection in infants

10 PEPFAR countries are currently implementing, transitioning to, or considering Option B+

Who needs ART?

Option B+ provides full antiretroviral treatment for life for all HIV-positive pregnant women, regardless of CD4

Major Changes in Context • The Global Plan to eliminate pediatric HIV • New evidence for ARV treatment as prevention

(TasP) • Increasing country experience with operational

and programme challenges with both Options A and B, and challenges linking PMTCT and ART

• Implementation of B+ in Malawi. Planning for B+ in Rwanda and Uganda, others. Still others considering B+; very dynamic environment

• Launch of Treatment 2.0 Initiative – to simplify and optimize ARV regimens and service delivery

• Decreasing cost of ARV drugs

PMTCT Programmatic Update April, 2012

Executive Summary: April, 2012

http://www.who.int/hiv/en

http://www.who.int/hiv/topics/mtct/en/index.html

English, French, Spanish, Portuguese

NOT formal new guidance, but interim update/ new directions

Response to • new developments

• interest by countries in B+

• strong interest in streamlining, simplifying, harmonizing PMTCT and ART regimens and programmes

http://www.who.int/hiv/pub/mtct/programmatic_update2012/en/index.html

http://www.who.int/hiv/pub/mtct/programmatic_update2012/en/index.html

WHO PMTCT Update 2012

PMTCT Progammatic Update: Key Messages

• Time to reassess PMTCT options • Option B and B+ have key advantages

– Women in need of ART receive treatment (not dependent on CD4 test)

– Simplified regimen, same ARVs throughout PMTCT and

– Harmonization with ART programmes – Benefits beyond MTCT for B+ – Potentially simpler for programmes, simpler

for health care workers, simpler for patients

WHO PMTCT Progammatic Update: Key Messages

• More countries reassessing and moving to B and B+

• Key unknowns need further research and implementation experience – Acceptability, initiation, adherence, retention, drug

resistance, safety (during pregnancy and long-term exposure during BF), impact on prevention; costing analyses, M&E, best way and place to deliver services

– Operationally simpler, many benefits but many decisions/ challenges.

Advantages of B+ • Benefit to the mother's health of early ART • Protection against MTCT in future pregnancies • Avoiding stopping and starting ARV drugs • Simplification of regimen and service delivery and

harmonization with ART programmes – One FDC pill once a day: TDF + 3TC + EFV – Same ARV regimen as first line treatment – CD4 testing not required before starting treatment

• Prevention against sexual transmission to HIV-uninfected, including sero-discordant partners

• Models and calculations show long term cost savings and cost effectiveness

Challenges and Risks of B+ • Initial costs for drugs, training, supervision,

mentoring, etc • Where to deliver ART to pregnant / BF women?

– All MNCH/PMTCT sites now become ART sites – Task-sharing for MNCH nurse-initiation of ART and f/u – Relationship with treatment programmes. When if ever

do women transfer? • Initiation, retention, adherence

– Continuation of ART through pregnancy, BF, and beyond – Women’s health; transmission; HIV Drug resistance

• Pharmacovigilance – Safety, especially with EFV, but also TDF – Very limited data: concern about EFV and birth defects

Transition to B+ Malawi Leads WHO Update

Each country must adopt own approach but can benefit from shared ideas and experiences

across countries

The MCH: medical home for women and young children

Antenatal care

Maternity

Immunizations

Maternal Child Health Clinic

Vertical transmission prevention & MCH services

Antenatal care

HIV testing

Maternity

Maternal ARV prophylaxis

Newborn Prophylaxis Immunizations

Maternal Child Health Clinic

HIV care and antiretroviral treatment (ART) services

CD4 cell count testing

Antiretroviral therapy

Long term follow-up

HIV care & support

ART Clinic

CD4 cell count testing

Antiretroviral therapy

Long term follow-up

HIV care & support

ART Clinic

Antenatal care HIV testing

Maternity

Maternal ARV prophylaxis

Newborn prophylaxis

Immunizations

Maternal Chi ld Health Cl inic

Comprehensive services for prevention of vertical

transmission and HIV care & treatment

CD4 cell count testing

Antiretroviral therapy

Long term follow-up

HIV care & support

Integrated Care

Antenatal care

HIV testing

Maternity

Maternal ARV prophylaxis

Newborn Prophylaxis

Immunizations Maternal Child Health ART Care & Treatment

Imperative – Moving from this:

Different operational models Different organizational homes

Different specialized staff Different facilities

Different data systems and indicators

ART Program

PMTCT Program

Imperative – Moving to this:

Shared operational models Shared organizational homes

Shared specialized staff Same facilities

Same data systems and indicators

PMTCT-ART Program

COSTS of Treatment

Declining PEPFAR Costs of HIV Treatment

Significant Predictors of Per-Patient Treatment Costs

Source: Nicolas A. Menzies, Andres A. Berruti, John M. Blandford. The determinants of HIV treatment costs in resource-limited settings. In review.

� Site maturity � 43% drop over first year � 25% drop in subsequent years

� Patient load � 43% drop as patients increase from 500 to 5,000 � 28% drop as patients increase from 5,000 to 10,000

� Price level � Unit costs increase 22% for each doubling of GDP per capita

� Also significant independent predictors � Frequency of clinical follow-up, frequency of laboratory

monitoring, clinician-patient ratios

Broad Societal Benefits of ART For every 1000 patient-years of treatment: • 228 patient deaths averted • 449 children not orphaned • 61 sexual transmissions of

HIV averted • 26 vertical (mother-to-child)

infections averted • 9 TB cases averted among

HIV patients • 2.2 life-years gained

Global Impact of PEPFAR-Supported Treatment in 2011 • Averted more than 800,000

deaths of HIV patients • Prevented nearly 1.6 million

children from being orphaned

• Prevented nearly 220,000 sexual infections with HIV

• Prevented more than 93,000 mother-to-child HIV infections

• Saved more than 7.7 million life-years

$M280.6

$M614.9

$M574.2

$M180.4

Costs Savings Attributable to ART

Averted non-ARTtreatment costsAverted orphancare costsAverted sexualtransmissionsAverted verticaltransmissions

• Averted more than 800,000 deaths of HIV patients

• Prevented nearly 1.6 million children from being orphaned

• Prevented nearly 220,000 sexual infections with HIV

• Prevented more than 93,000 mother-to-child HIV infections

• Saved more than 7.7 million life-years

Global Impact of PEPFAR-Supported Treatment in 2011

Broad Societal Benefits of ART

Thank you!