DECLINE IN POSITIVITY RATES AMONG HIV-EXPOSED INFANTS WITH CHANGES IN PMTCT ARV REGIMENS IN NIGERIA: EVIDENCE FROM 7 YEARS OF FIELD IMPLEMENTATION

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Abst#_O_01 DECLINE IN POSITIVITY RATES AMONG HIV-EXPOSED INFANTS WITH CHANGES IN PMTCT ARV REGIMENS IN NIGERIA: EVIDENCE FROM 7 YEARS OF FIELD IMPLEMENTATION Hadiza Khamofu, 1 Edward Oladele, 1 Uche Ralph-Opara, 1 Titi Badru, 1 Oluwasanmi Adedokun, 1 Mariya Saleh, 1 McPaul Okoye, 2 Olufunsho Adebayo, 3 Kwasi Torpey 1 1 FHI 360, Abuja, Nigeria, 2 USAID Nigeria, 3 FHI 360, South Africa Strengthening Integrated Delivery of HIV/AIDS Services

BACKGROUND Africa s most populous country: 178.5 million 42 million women of child bearing age and TFR 5.5 children per woman CPR (modern methods) 10% Unmet need for FP 15% High MMR 545/100,000 High IMR 75/1,000 Second highest number of PLHIV: 3.2% prevalence = 3.2 million; F>M; young 220,394 new infections in 2013 including 53,000 among children 240,000 AIDS-related deaths each year

BACKGROUND Nigeria accounts for about 30% of global Pediatric HIV burden. Only 30% HIV-positive pregnant women receive ART for PMTCT Nigeria s PMTCT program has evolved over the years with each new WHO guideline review Cut-off for art eligibility Transition from monotherapy (single dose nevirapine) to the use of more efficacious triple ARVs for PMTCT This report set out to examine the trend of HIV-infection among HIV-exposed infants over a 7-year period with the introduction of more efficacious ARV combinations for PMTCT in a PEPFAR funded program in Nigeria between 2008 and 2014.

METHOD The setting cuts across two projects funded by the U.S. President s Emergency Plan for AIDS Relief through the U.S. Agency for International Development (USAID) and implemented by an FHI 360-led consortium. o Global HIV/AIDS Initiative in Nigeria (GHAIN) project: from 2004 to 2011 o Strengthening Integrated Delivery of HIV/AIDS services (SIDHAS): from 2011 till date Over 10 million individuals counselled and tested (4.5m pregnant women) About 400,000 adults and children newly enrolled on ART About 120,000 pregnant women received ARVs for PMTCT Retrospective review Routinely collected PMTCT service data (DHIS) 2008 to 2014 682 secondary and tertiary health facilities across Nigeria Proportions of different ARV regimens received by HIV-positive pregnant women each year Rate of HIV-positive PCR tests among HIV exposed infants each year

MAJOR CHANGES TO NIGERIA NATIONAL PMTCT GUIDELINES PMTCT Service ANTENATAL HAART Eligibility Assessment Provision of Antenatal ARV Prophylaxis as Eligible Provision of Antenatal HAART as Eligible Stage IV disease regardless of CD4 Stage III disease with CD4 <350 Stage I or II with CD4 <200 Stage II with TLC <1200 ZDV from 28weeks, OR ZDV+ 3TC from week 34-36 Guideline 2005 2007 2010 2014 Delay ARV use in first trimester. Triple regimen (NVP + 2NRTIs if CD4<250 or EFV+ 2NRTIs if CD4>250); ZDV preferred NRTI <200 CD4 <350 irrespective of clinical stage Stages III and IV disease irrespective of CD4 count ZDV from 28wks OR ZDV+ 3TC from week 34-36 Triple regimen (after the 1 st trimester). ZDV preferred NRTI Option A: ZDV from 14 wks. Option B: Triple ARV Triple regimen (after the 1 st trimester). <500 irrespective of clinical stage Stages III and IV disease irrespective of CD4 count Option B: Triple ARV Triple (irrespective of GA). TDF preferred NRTI and EFV preferred NNRTI

MAJOR CHANGES TO NATIONAL PMTCT GUIDELINES II PMTCT Service INTRAPARTUM (LABOR AND DELIVERY) Intrapartum ARV Prophylaxis or Continue ZDV during labor, Continuation of HAART as Eligible plus single-dose NVP at onset of labor POSTPARTUM/POSTNATAL Maternal Postpartum ARV Prophylaxis or Continuation of HAART as Eligible Infant ARV Early Infant Diagnosis (EID) Guideline 2005 2007 2010 2014 Continuation of HAART as eligible NVP+ 2NRTIs (ZDV preferred) Single-dose NVP as soon as possible after birth, plus ZDV for 6 weeks DNA PCR done 6-8weeks after birth sdnvp +ZDV+3TC at onset of labor Continuation of HAART as eligible ZDV+3TC for 7 days postpartum Single dose NVP as soon as possible after birth plus ZDV for 6 weeks DNA PCR done 6-8weeks after birth ZDV+3TC 12hourly during labor, plus single-dose NVP at onset of labor and ZDV+3TC 12hourly for 7 days postpartum Continuation of HAART as eligible Triple regimen (ZDV/TDF-based) NVP suspension recommended from birth to 6 weeks Recommended from 4-6 weeks of birth (for 1 st DNA PCR) Continuation of triple ARV prophylaxis or HAART as eligible Triple regimen TDF based preferred) NVP suspension recommended from birth to 6 weeks Recommended from 4-6 weeks of birth (for 1 st DNA PCR)

RESULTS The total number of pregnant women who tested positive for HIV and received different ARV regimen for PMTCT during the period (2008-2014) was 63,774; ranging from 7,506 in 2008 to 10,388 in 2014 Maternal HIV positivity rates varied from 4.1% in 2008, 2.9% in 2011, 3.2% in 2012, then declined steadily to 1.9% in 2014 Women who received sdnvp were 34.4%, 41.6% and 45.9% of all pregnant women in 2008, 2009 and 2010 respectively HIV positive pregnant women on triple ARVs (prophylaxis or treatment) increased from 22% in 2008 to 99% in 2014 Infant HIV positivity rates showed a steady decline over the years, from 38% in 2008 to 6% in 2014 (p<0.001)

DECLINE IN INFANT HIV POSITIVITY RATE WITH CHANGES IN ARV REGIMEN OVER TIME 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% 36% 21% 14% 10% 10% 8% 4% 4% 3% 3% 3% 3% 6% 2% 2008 2009 2010 2011 2012 2013 2014 ART Option B Option A AZT+3TC+SDNVP AZT+SDNVP sdnvp Infant positivity rate Maternal positivity rate

CONCLUSION HIV-infection among HIV-exposed infant in Nigerian PEPFAR funded programs have declined steadily as more and more efficacious ARV regimens were introduced for PMTCT There is an urgent need for innovative ideas to take these program achievements recorded to scale We conclude that if current efforts were sustained and coverage widened, an alignment of the country s PMTCT program with the best available scientific evidence could lead to elimination of mother to child transmission The GON at all levels must embrace and own the fight to end MTCT through adequate investment to ensure success.

ACKNOWLEDGEMENTS The U.S. President s Emergency Plan for AIDS Relief (PEPFAR)/the American people through the U.S. Agency for International Development (USAID) for funding the GHAIN and SIDHAS projects in Nigeria The hardworking staff of the supported facilities The brave men, women and children living with HIV Thank you!