Utilization of the monthly dapivirine vaginal ring and daily oral pre-exposure prophylaxis (PrEP) with tenofovir disoproxil fumarate and emtricitabine are both safe among pregnant cisgender women for HIV prevention, according to recent data presented at the 2024 Conference on Retroviruses and Opportunistic Infections.
Takeaways
- Both the monthly dapivirine vaginal ring and daily oral PrEP are safe for preventing HIV in pregnant women, according to recent research.
- Pregnant women face a significantly higher risk of HIV, emphasizing the importance of safe prevention methods during pregnancy.
- Previous trials lacked data on the safety of the dapivirine ring for pregnant individuals.
- A large study funded by the National Institute of Allergy and Infectious Diseases assessed the safety of these prevention methods in pregnant women aged 18 to 40 in South Africa and Uganda.
- Reassuringly, no HIV cases were reported among participants, and adverse effects related to the prevention methods were minimal.
The risk of HIV is increased 3-fold among pregnant women compared to similarly aged nonpregnant individuals. The World Health Organization recommends the dapivirine ring, a flexible silicone that vaginally administers an antiretroviral drug, to prevent HIV.
Previously, participants in clinical trials evaluating the dapivirine ring discontinued use following pregnancy onset, leading to a lack of data about its use in the pregnant population. The safety of the dapivirine ring for use during pregnancy was evaluated in a large clinical study.
The study was funded by the National Institute of Allergy and Infectious Diseases and conducted in South Africa, Uganda. Participants included women aged 18 to 40 years receiving either the monthly dapivirine vaginal ring or daily oral PrEP.
Oral PrEP with tenofovir disoproxil fumarate and emtricitabine had an established safety profile in pregnant women with HIV prior to the analysis. Participants were randomized to receive treatment, which occurred until delivery or 41 weeks and 6 days.
There were 248 pregnancies included in the final analysis. Stillbirth or miscarriage was reported in 1% of pregnancies. Of deliveries, 95% were at term and 4% were preterm.
Congenital anomalies were reported in 4% of live births, but none were linked to the dapivirine ring or PrEP use. When comparing these outcomes to a reference dataset including more than 10,000 deliveries at the same hospital, similar trends were observed.
No cases of HIV were reported among study participants. Investigators concluded the dapivirine ring and PrEP are both safe to use for preventing HIV in pregnant women.
Reference
Vaginal ring and oral pre-exposure prophylaxis found safe for HIV prevention throughout pregnancy. National Institutes of Health. March 5, 2024. Accessed March 6, 2024. https://www.nih.gov/news-events/news-releases/vaginal-ring-oral-pre-exposure-prophylaxis-found-safe-hiv-prevention-throughout-pregnancy
