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 WESTERN SAHARA THE GAMBIA GUINEA BISSAU SENEGAL SIERRA LEONE MAURITANIA GUINEA LIBERIA COTE DTVOIRE MOROCCO MALI BURKINA GHANA ALGERIA BENIN TOGO NIGER NIGERIA CAMEROON TUNISIA LIBYA CHAD Mediterranean Sea CENTRAL AFRICAN REPUBLIC EGYPT SUDAN SOUTH SUDAN Red Sea ERITREA DJIBOUTI ETHIOPIA Legend 6 Original Acceleration Countries 8 New Acceleration Countries PEPFAR PMTCT programs in 21/22 Global Plan countries* * PEPFAR supports programming in India (not pictured) EQUATORIAL GUINEA GABON ANGOLA REP. OF THE CONGO DEMOCRATIC REPUBLIC OF THE CONGO RWANDA BURUNDI UGANDA TANZANIA KENYA SOMALIA Indian Ocean Atlantic Ocean ANGOLA MALAWI ZAMBIA NAMIBIA ZIMBABWE MOZAMBIQUE MADAGASCAR SOUTH AFRICA Walvis Bay BOTSWANA LESOTHO SOUTH AFRICA SWAZILAND
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
Who needs ART? ~ 40% of all HIV+ pregnant and BF women National ARV Coverage for PMTCT, 2010 ARV Coverage 0-49% DRC Chad Burundi Angola Ethiopia Nigeria India Cameroon Ghana ARV Coverage 50-79% Uganda Cote d'ivoire Zimbabwe Malawi Lesotho Zambia Tanzania Mozambique Kenya ARV Coverage 80%+ Swaziland Namibia South Africa Botswana 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% Source: Universal Access Report, 2011 % National ARV Coverage for PMTCT
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
Who needs ART? Women Eligible for ART Are At Highest Risk for Mother to Child HIV Transmission and Mortality Not Eligible 31.9% Eligible for ART Not eligible for ART MTCT by 6 wk 16.7% 5.0% Eligible 68.1% 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% 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) Maternal mortality 24 mo post delivery 92% 8% Kuhn L et al. AIDS 2010;24:1374-7
Who needs ART? WHO Options A & B Eligible for Treatment 40-50% of pregnant women identified as HIV+ will be eligible for treatment for their own health (CD4 <350) CD4 <350 (40-50% of women) CD4 >350 (50-60% of women) Eligible for Prophylaxis 50-60% of pregnant women identified as HIV+ will have CD4> 350 and should receive prophylaxis under Options A or B ART Given Generally through referral to treatment site After CD4 results received: A) ART initiated B) ART (already initiated) Prophlaxis Given Generally at ANC site A) After CD4 results received B) After sample taken for CD4 continues Carter, RJ et al. JAIDS, 2010.
Who needs ART? Transforming PMTCT: Option B+ Option B+ provides full antiretroviral treatment for life for all HIV-positive pregnant women, regardless of CD4 10 PEPFAR countries are currently implementing, transitioning to, or considering 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
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/i ndex.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
WHO PMTCT Update 2012 http://www.who.int/hiv/pub/mtct/programmatic_update2012/en/index.h
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 HIVuninfected, 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 Maternal Child Health Clinic Antenatal care Maternity Immunizations
Vertical transmission prevention & MCH services Maternal Child Health Clinic Antenatal care HIV testing Maternal ARV prophylaxis Maternity Newborn Prophylaxis Immunizations
HIV care and antiretroviral treatment (ART) services ART Clinic HIV care & support CD4 cell count testing Antiretroviral therapy Long term follow-up
Maternal Child Health Clinic Antenatal care HIV testing Maternal ARV prophylaxis Maternity Newborn prophylaxis Immunizations ART Clinic HIV care & support CD4 cell count testing Antiretroviral therapy Long term follow-up
Comprehensive services for prevention of vertical transmission and HIV care & treatment Integrated Care Antenatal care HIV testing Maternal ARV prophylaxis Maternity Newborn Prophylaxis Immunizations Maternal Child Health HIV care & support CD4 cell count testing Antiretroviral therapy Long term follow-up ART Care & Treatment
Imperative Moving from this: PMTCT Program ART Program Different operational models Different organizational homes Different specialized staff Different facilities Different data systems and indicators
Imperative Moving to this: PMTCT-ART Program Shared operational models Shared organizational homes Shared specialized staff Same facilities Same data systems and indicators
COSTS of Treatment
Declining PEPFAR Costs of HIV Treatment
Significant Predictors of Per-Patient Treatment Costs 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 Source: Nicolas A. Menzies, Andres A. Berruti, John M. Blandford. The determinants of HIV treatment costs in resource-limited settings. In review.
Broad Societal Benefits of ART For every 1000 patientyears 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
Broad Societal Benefits of ART $M574.2 Costs Savings Attributable to ART $M180.4 $M280.6 $M614.9 Averted non-art treatment costs Averted orphan care costs Averted sexual transmissions Averted vertical transmissions 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
Thank you!