What Is Pharmacovigilance and Why I s I t I mportant? Margarett Davis
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Transcript of PMTCT Update - Commonwealth Nurses · Update on PMTCT Margarett Davis, MD, MPH ... •Initial costs...
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PMTCT Update
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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
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Overarching Goals
• HIV-free infant/child survival • AIDS-free maternal survival • New dynamic environment for achieving
these goals
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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
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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)
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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
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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
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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
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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
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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
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Prong 2: Preventing Unintended Pregnancy
• PEPFAR supports integration of FP, MNCH, SRH, and PMTCT – Priority countries for
targeted FP integration (Uganda, Malawi, Zambia)
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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
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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
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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
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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?
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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?
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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
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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
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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
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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
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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
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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.
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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
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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
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Transition to B+ Malawi Leads WHO Update
Each country must adopt own approach but can benefit from shared ideas and experiences
across countries
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The MCH: medical home for women and young children
Antenatal care
Maternity
Immunizations
Maternal Child Health Clinic
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Vertical transmission prevention & MCH services
Antenatal care
HIV testing
Maternity
Maternal ARV prophylaxis
Newborn Prophylaxis Immunizations
Maternal Child Health Clinic
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HIV care and antiretroviral treatment (ART) services
CD4 cell count testing
Antiretroviral therapy
Long term follow-up
HIV care & support
ART Clinic
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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
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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
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Imperative – Moving from this:
Different operational models Different organizational homes
Different specialized staff Different facilities
Different data systems and indicators
ART Program
PMTCT Program
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Imperative – Moving to this:
Shared operational models Shared organizational homes
Shared specialized staff Same facilities
Same data systems and indicators
PMTCT-ART Program
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COSTS of Treatment
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Declining PEPFAR Costs of HIV Treatment
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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
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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
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$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
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Thank you!