CROI 2017 Abstract e-Book

Abstract eBook

Poster and Themed Discussion Abstracts

Poster and Themed Discussion Abstracts

934 PREP USED IN PREGNANCY DOES NOT INCREASE POOR BIRTH OUTCOMES Renee Heffron 1 , Nelly Mugo 2 , Ting Hong 1 , Elizabeth A. Bukusi 2 , Elly T. Katabira 3 , Stephen Asiimwe 4 , Mark A. Marzinke 5 , Connie L. Celum 1 , Jared Baeten 1 , for the Partners Demonstration Project and Partners PrEP StudyTeams 1 Univ of Washington, Seattle, WA, USA, 2 Kenya Med Rsr Inst, Nairobi, Kenya, 3 Makerere Univ, Kampala, Uganda, 4 Kabwohe Clinical Rsr Cntr, Kabwohe, Uganda, 5 The Johns Hopkins Univ, Baltimore, MD, USA Background: Current recommendations for women using PrEP who become pregnant include counseling with the choice to continue or discontinue PrEP. However, safety data fromwomen using PrEP throughout pregnancy are very limited. Methods: In an open-label delivery study of PrEP integrated with ART for high risk HIV serodiscordant couples in Kenya and Uganda (the Partners Demonstration Project), women who became pregnant while using PrEP were counseled and offered the opportunity to continue using PrEP throughout pregnancy. Using age-adjusted generalized estimating equations with a logistic link, we compared birth outcomes from babies with exposure to FTC/TDF PrEP throughout pregnancy to those without any exposure, using data from the placebo arm of the Partners PrEP Study clinical trial, which was conducted in the same setting. Results: Women in the open-label study who became pregnant were a median of 25.8 years (interquartile range [IQR]: 21.0-28.8) and had 2 (IQR: 1-2) children prior to study engagement. Of 34 who became pregnant while using PrEP, 30 (88%) elected to continue PrEP use. Objective adherence measures indicated at least two-thirds of expected doses were taken: a median of 71% of days (IQR: 28%-93%) had a pill bottle opening recorded via MEMS caps and 74% (116/156) of plasma samples collected fromwomen during pregnancy had tenofovir detected, including 35% (54/156) with >40ng/ml detected. Birth outcomes from these pregnancies were compared with 96 pregnancies occurring among 88 women in the Partners PrEP Study clinical trial (median age=28 (IQR: 24.5-33.0), children=3 (IQR: 2-5)). There was no increase in the frequency of pregnancy loss (16.7% PrEP-exposed versus 32.3% PrEP-unexposed, adjusted odds ratio [aOR]=0.29, 95% CI 0.17-1.52) or preterm delivery (0 versus 7.7%, [aOR]=0.4 (0-2.32), exact p=0.4). No congenital anomalies occurred among PrEP-exposed babies. Conclusion: To our knowledge, these are the first data to report birth outcomes from a study where women used PrEP throughout pregnancy and compare to a similar cohort without PrEP exposure. PrEP-exposed pregnancies had similar rates of pregnancy loss and preterm delivery to PrEP-unexposed women. These data provide some reassurance that PrEP use can safely continue during pregnancy. 935 PREGNANCY INCIDENCE AND OUTCOMES AMONG WOMEN USING THE DAPIVIRINE VAGINAL RING Bonus Makanani 1 , Jennifer Balkus 2 , Thesla Palanee-Phillips 3 , Yamikani Mbilizi 1 , Jeanna Piper 4 , Kenneth Kintu 5 , Tchangani Tembo 6 , Lisa Noguchi 7 , Helen Rees 3 , Jared Baeten 8 1 Malawi Coll of Med–Johns Hopkins Univ Rsr Proj, Blantyre, Malawi, 2 Fred Hutchinson Cancer Rsr Cntr, Seattle, WA, USA, 3 Wits Reproductive Hlth and HIV Inst, Johannesburg, South Africa, 4 NIH, Bethesda, MD, USA, 5 Makerere Univ–Johns Hopkins Univ Rsr Collab, Kampala, Uganda, 6 Univ of North Carolina Proj–Malawi, Lilongwe, Malawi, 7 The Johns Hopkins Univ, Baltimore, MD, USA, 8 Univ of Washington, Seattle, WA, USA Background: The dapivirine vaginal ring has been shown to be safe and effective for HIV prevention. Understanding the safety of exposure during pregnancy is important for the potential roll-out of the dapivirine ring among reproductive aged women. In the MTN-020/ASPIRE trial, use of a highly effective contraceptive method was a criterion for study participation and a range of methods were offered to study participants. However, pregnancies did occur, resulting in short-term exposure to study product during the periconception period. This analysis assessed pregnancy incidence and outcomes among women randomized to receive the dapivirine ring versus matching placebo. Methods: ASPIRE was a randomized, double-blind, placebo-controlled phase III safety and effectiveness study of the dapivirine vaginal ring for HIV-1 prevention. Sexually active women aged 18-45 fromMalawi, South Africa, Uganda, and Zimbabwe were enrolled. Pregnancy tests were performed monthly and, if positive, study product was withheld during pregnancy and breastfeeding. Pregnancy incidence by armwas calculated and compared using an Andersen-Gill proportional hazards model with censoring at HIV infection. Pregnancy outcomes and infant congenital anomalies were determined by participant report and medical record review. Results: Of 2629 women enrolled, 78 reported prior history of tubal ligation, leaving 2551 women for analysis. A total of 179 pregnancies were detected in 169 women, resulting in 180 pregnancy outcomes (86 in the dapivirine arm and 94 in the placebo arm). Pregnancy incidence in the dapivirine armwas 4.0 per 100 person-years (95% CI 3.1-5.1) versus 4.3 per 100 person-years (95% CI 3.4-5.5) in the placebo arm (HR=0.93, 95% CI 0.68-1.26). Pregnancy outcomes were similar by arm (see Table). Among 114 pregnancies that resulted in live births, data on potential congenital anomalies were available for 107, with any anomaly seen in 4 (8%) in the dapivirine arm versus 4 (7%) in the placebo arm and no pattern of anomalies for those assigned dapivirine. Conclusion: Pregnancy rates did not differ between women randomized to dapivirine ring versus placebo in the ASPIRE trial. Pregnancy outcomes and the frequency of site-identified congenital anomalies were also similar by arm, suggesting that dapivirine use in the periconception period is not associated with adverse effects on pregnancy. Additional studies are needed to further assess the safety of the dapivirine ring use throughout pregnancy.

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