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Pregnancy and Infant Outcomes Among Women Using the Dapivirine Vaginal Ring in Early Pregnancy

Makanani, Bonus, MBBS, FCOG*; Balkus, Jennifer E., PhD, MPH†,‡,§; Jiao, Yuqing, MS§; Noguchi, Lisa M., CNM, PhD; Palanee-Phillips, Thesla, PhD; Mbilizi, Yamikani, MBBS*; Moodley, Jothi, BS#; Kintu, Kenneth, MBChB**; Reddy, Krishnaveni, MBChB; Kabwigu, Samuel, MBChB**; Jeenariain, Nitesha, MBChB#; Harkoo, Ishana, MBChB††; Mgodi, Nyaradzo, MBChC, Mmed‡‡; Piper, Jeanna, MD§§; Rees, Helen, MD, MS; Scheckter, Rachel, MPH║║; Beigi, Richard, MD¶¶; Baeten, Jared M., MD, PhD†,‡,##

JAIDS Journal of Acquired Immune Deficiency Syndromes: December 15, 2018 - Volume 79 - Issue 5 - p 566–572
doi: 10.1097/QAI.0000000000001861
Epidemiology
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Background: Monthly use of the dapivirine vaginal ring has been shown to be safe and effective for HIV-1 prevention in nonpregnant reproductive-aged women. The impact of dapivirine on pregnancy outcomes and infant is not known. We compared pregnancy incidence and outcomes by study arm among HIV-1–uninfected women who became pregnant while participating in MTN-020/ASPIRE.

Methods: ASPIRE was a randomized, double-blind, placebo-controlled phase III safety and effectiveness study of the dapivirine ring for HIV-1 prevention. Sexually active women aged 18–45 years from Malawi, South Africa, Uganda, and Zimbabwe were enrolled. Urine pregnancy tests were performed monthly, and, if positive, study product was withheld during pregnancy and breastfeeding. Pregnancy-related outcomes included the following: pregnancy incidence, pregnancy outcomes (live birth, preterm birth, pregnancy loss, and congenital anomalies), and infant growth.

Results: Of 2629 women enrolled in ASPIRE, 169 became pregnant during follow-up, resulting in 179 incident pregnancies and 181 pregnancy outcomes. No difference in pregnancy incidence by study arm was observed (hazard ratio = 0.93; 95% confidence interval: 0.68 to 1.26). The distribution of pregnancy outcomes was similar by study arm, and no difference was noted in the frequency or pattern of congenital anomalies or infant growth parameters by study arm.

Conclusions: Dapivirine use in the periconception period does not seem to be associated with adverse effects on pregnancy or infant outcomes. Our findings provide support for additional safety studies of the dapivirine ring throughout pregnancy.

*Johns Hopkins University Research Project, Blantyre, Malawi;

Departments of Epidemiology; and

Global Health, University of Washington, Seattle, WA;

§Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA;

Department of Epidemiology, Johns Hopkins University, Baltimore, MD;

Wits Reproductive Health and HIV Institute, University of the Witwatersrand, Johannesburg, South Africa;

#South African Medical Research Council, Durban, South Africa;

**Makerere University-Johns Hopkins University Research Collaboration, Kampala, Uganda;

††CAPRISA, Durban, South Africa;

‡‡University of Zimbabwe, Harare, Zimbabwe;

§§US National Institutes of Health, Bethesda, MD;

║║FHI 360, Durham, NC;

¶¶Magee-Womens Hospital of UPMC, Pittsburgh, PA; and

##Department of Medicine, University of Washington, Seattle, WA.

Correspondence to: Jennifer E. Balkus, PhD, MPH, University of Washington, 1959 NE Pacific Street, Box 357236, Seattle, WA 98195 (e-mail: jbalkus@uw.edu).

The Microbicide Trials Network (MTN) is funded by National Institutes of Allergy and Infectious Disease (NIAID) (UM1AI068633, UM1AI068615, UM1AI106707), with cofunding from Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) and National Institute of Mental Health (NIMH), all components of the US National Institutes of Health (NIH).

Presented in part at the Conference on Retroviruses and Opportunistic Infections; February 13–17, 2017; Seattle, WA.

J.E.B. has received honoraria from Lupin, Inc. and is a scientific advisor to uBiome. The remaining authors have no funding or conflicts of interest to disclose.

B.M. and J.E.B. contributed equally to this article.

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The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH.

Received May 30, 2018

Accepted August 27, 2018

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