WEAC0101 - Oral Abstract Session
Pregnancy incidence and birth outcomes among African women in a clinical trial of pre-exposure prophylaxis: the Partners PrEP Study
Presented by Elizabeth Bukusi (Kenya).
N. Mugo1,2, T. Hong2, C. Celum2, D. Donnell3, E. Bukusi4, E. Were5, G. John-Stewart6, J. Baeten2, Partners PrEP Study
1Kenya Medical Research Center, Center for Clinical Research, Nairobi, Kenya, 2University of Washington, Global Health, International Center for Clinical Research, Seattle, United States, 3Fred Hutchinson Cancer Research Center, Seattle, United States, 4Kenya Medical Research Institute, Nairobi, Kenya, 5Moi University, Obstetrics and Gynaecology, Eldoret, Kenya, 6University of Washington, Global Health, Seattle, United States
Background: Antiretroviral pre-exposure prophylaxis (PrEP), using daily oral tenofovir disoproxyl fumarate (TDF) and combination emtricitabine (FTC)/TDF, is highly efficacious for prevention of HIV acquisition. Implementation of PrEP for HIV prevention will require data on its safety in women who become pregnant.
Methods: We conducted a randomized, three-arm trial of oral PrEP among HIV serodiscordant heterosexual couples from Kenya and Uganda (the Partners PrEP Study), including 1785 couples with HIV uninfected female partners. Seronegative partners were randomized to TDF, FTC/TDF, or placebo and followed monthly for 24-36 months, including monthly HIV and pregnancy testing. HIV uninfected women were not pregnant at the time of study enrollment; if they became pregnant, the study medication was discontinued for the duration of pregnancy and lactation. Infants born to HIV uninfected women were followed at quarterly visits for 12 months after birth. In July 2011, the study placebo arm was discontinued, due to demonstration of PrEP efficacy for HIV prevention. We present updated data on pregnancies conceived as of July 2011.
Results: A total of 288 pregnancies occurred among 267 women, with similar incidence rates across the trial randomization study arms: TDF 11.9 per 100 person-years (p=0.19 vs. placebo), FTC/TDF 8.8 (p=0.40 vs. placebo), placebo 10.0. Of the 288 pregnancies, 192 (66.7%) ended in live births and 96 (33.3%) ended in pregnancy losses, most (91.7%) occurred at < 20 weeks of gestation; pregnancy outcomes did not differ statistically across the study arms. Median birth weight was similar across the study arms: TDF 3368 gm (p=0.54 vs. placebo), FTC/TDF 3352 gm (p=0.68 vs. placebo), placebo 3290 gm. Infants born to women randomized to PrEP versus placebo had similar WHO gestational age-adjusted Z-scores for head circumference, length, and weight throughout the first year of life.
Conclusion: In this randomized, placebo-controlled trial of PrEP, pregnancy incidence, losses, outcomes, and infant growth were similar for women receiving PrEP and placebo at the time of conception. PrEP may offer a method for HIV uninfected women with HIV infected partners to reduce risk of infection during conception.
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