CROI 2015 Program and Abstracts

Abstract Listing

Oral Abstracts

Session O-2 Oral Abstracts

Room 613

10:00 am– 12:00 pm Prevention, Diagnosis, and Treatment of Pediatric HIV Infection 31LB PROMISE: Efficacy and Safety of 2 Strategies to Prevent Perinatal HIV Transmission Mary Glenn Fowler 1 ; Min Qin 2 ; Susan A. Fiscus 3 ; Judith S. Currier 4 ; Bonus Makanani 5 ; Francis Martinson 6 ;Tsungai Chipato 7 ; Renee Browning 8 ; David Shapiro 2 ; Lynne Mofenson 9 On Behalf of the IMPAACT PROMISETeam

1 Johns Hopkins University School of Medicine/Makerere University–Johns Hopkins University Research Collaboration, Baltimore, MD, US; 2 Harvard School of Public Health, Center for Biostatistics in AIDS Research, Boston, MA, US; 3 University of North Carolina at Chapel Hill, Chapel Hill, NC, US; 4 University of California Los Angeles, Los Angeles, CA, US; 5 Univ of Malawi, Blantyre, Malawi; 6 University of North Carolina Project– Malawi, Lilongwe, Malawi; 7 Univ of Zimbabwe, Harare, Zimbabwe; 8 NIAID/NIH, Bethesda, MD, US; 9 National Institute of Child Health and Human Development, Bethesda, MD, US Background: There are limited c linical trial data comparing the efficacy and safety of antepartum (AP) antiretroviral (ARV) regimens for prevention of mother-to-child transmission (PMTCT) in women with high CD4 counts. Methods: PROMISE 1077BF/1077FF is an ongoing, prospective, open-label randomized trial being conducted in 14 sites in Africa and India among HIV+ pregnant and postpartum women with high CD4 counts. The trial has 3 randomized components, assessing the maternal and infant efficacy and safety of ARV PMTCT strategies during 3 periods: pregnancy through 14 days postpartum; breastfeeding; and after MTCT risk is over. The AP component compared a zidovudine (ZDV)-based regimen ( Arm A: AP ZDV + single-dose nevirapine (NVP) at delivery + tenofovir (TDF)/emtricitabine (FTC) tail) and two triple ARV regimens ( Arm B: ZDV-lamivudine (3TC) + lopinavir/ritonavir (LPV-r); Arm C: TDF/FTC + LPV-r) . Efficacy analyses using infant Roche 1.5 PCR, compared MTCT in Arm A to the pooled triple ARV arms. Safety analyses compared all 3 arms. Since Arm C was only open to all women in protocol Version 3 (V3), comparisons of Arms A and B included all women, but comparisons with Arm C only included those randomized under V3. Results: On 11/4/14, the Data Safety Monitoring Board recommended release of interim AP data through 14 days post delivery. As of 9/10/14, 3529 pregnant women had enrolled, including 1230 women in V3, and 3234 live births had occurred. Baseline median maternal age was 26 years; 97%were black African; median enrollment gestational age was 26 weeks; 97%were WHO Clinical Stage I; median CD4 was 530 cells/uL and 58% had CD4 ≥ 500 cells/uL. The Table shows significantly reduced MTCT with triple ARVs during pregnancy compared to Arm A. There were no maternal deaths. We found significantly higher rates of Grade >2 maternal chemistry events and moderate adverse pregnancy outcomes with either triple ARV arm compared to Arm A; but no significant differences in very preterm delivery (VPTD) <34 weeks, very low birth weight (VLBW) < 1500 g, or early neonatal death between Arm A and either triple ARV arm. However, among 1229 enrollees in V3, ZDV/3TC+ LPV-r was associated with significantly lower risk of neonatal death or VPTD than TDF/FTC + LPV-r.

Oral Abstracts

Conclusions: These results provide the first clinical trial evidence to support the current WHO PMTCT recommendations for use of triple ARVs during pregnancy. The safety findings require further study. 32 Most BreastfeedingWomenWith High Viral Load Are Still Undiagnosed in Sub-Saharan Africa David Maman 1 ; Helena Huerga 1 ; Irene Mukui 4 ; Benson Chilima 2 ; Beatrice Kirubi 5 ; GillesVan Cutsem 6 ; Charles Masiku 7 ; Elisabeth Szumilin 8 ;Thomas Ellman 3 ; Jean-François Etard 1 1 Epicentre/Médecins Sans Frontières, Paris, France; 2 3. Ministry of Health, Lilongwe, Malawi; 3 Medecins Sans Frontières, Cape Town, South Africa; 4 National AIDS and STDs Control Program, Nairobi, Kenya; 5 Médecins Sans Frontières, Nairobi, Kenya; 6 Médecins Sans Frontières, Cape Town, South Africa; 7 Médecins Sans Frontières, Lilongwe, Malawi; 8 Médecins Sans Frontières, Paris, France Background: No study has assessed the proportion of HIV-positive pregnant or breastfeeding (PBF) women virally suppressed at population level. Furthermore, critical data assessing the cascade of care among PBF women are needed to inform program policy. We used data from three population surveys to assess these key indicators.

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CROI 2015