May 18, 2024
Healthcare CMO Market

Dapivirine Vaginal Ring Deemed Safe for Use During Pregnancy

A recent study, DELIVER (MTN-042), revealed no safety concerns with the use of the dapivirine vaginal ring during the second and third trimesters of pregnancy. The findings were presented at the Conference on Retroviruses and Opportunistic Infections (CROI 2024) in Denver. This study, conducted by the Microbicide Trials Network (MTN) in Malawi, South Africa, Uganda, and Zimbabwe, aimed to assess the safety and acceptability of the monthly dapivirine vaginal ring for HIV prevention during pregnancy.

Researchers noted that the dapivirine ring, a novel HIV prevention method approved in several African countries and endorsed by the World Health Organization (WHO), is now considered safe for use throughout pregnancy. The study included a total of 558 participants across three cohorts, with 409 women using the dapivirine ring.

The DELIVER study was conducted in a phased approach, with participants enrolled in groups starting from late pregnancy and progressing to earlier stages of pregnancy. The results from Cohort 3, which included 251 participants between 3 and 6 months pregnant, showed outcomes and complications similar to those expected in the local communities. Moreover, the study provided valuable safety data on the use of the dapivirine ring during all stages of pregnancy, offering reassurance about its safety for both mothers and babies.

During the study, participants were randomly assigned to use either the dapivirine ring or Truvada as daily oral pre-exposure prophylaxis (PrEP). The findings revealed that the dapivirine ring was well-tolerated and did not pose any significant risks or complications for pregnant women or their infants. Additionally, the incidence of adverse events related to the dapivirine ring was comparable to local background rates.

One of the key concerns addressed by the study was the risk of infections or preterm delivery associated with the use of the ring during pregnancy. However, no such complications were observed, indicating the safety of the dapivirine ring in this population. Furthermore, there were no maternal deaths or instances of HIV acquisition among the participants.

The study also highlighted the importance of ongoing data analysis to further assess the product’s safety during pregnancy. Follow-up of the infants for one year post-birth will provide additional insights into the long-term effects of the dapivirine ring exposure.

Overall, the DELIVER study offers crucial evidence supporting the safety and efficacy of the dapivirine vaginal ring for HIV prevention during pregnancy. The results of this study will be instrumental in informing regulatory decisions and expanding access to this innovative prevention method for pregnant and breastfeeding individuals in the future.

1. Source: Coherent Market Insights, Public sources, Desk research
2. We have leveraged AI tools to mine information and compile it