No safety concerns are associated with dapivirine rings in the third trimester of pregnancy

dapivirine rings

A woman’s chance of contracting HIV while pregnant is believed to be three times greater than other times during her life. Additionally, during the pregnancy, when a lot of women are breastfeeding, the risk is higher. A vaginal ring that contains the drug that fight HIV called dapivirine was not a safety risk when used during the third trimester of pregnancy according to the results of the very first study of the dapivirine rings during pregnancy. It is one of the very small number of studies on the HIV prevention device in pregnant females who are cisgender.

The ongoing study in phase 3b named DELIVER was created to assess the safety and efficacy of the vaginal dapivirine monthly rings, a brand new HIV prevention method that is approved in various African countries. Gather additional safety information on Truvada’s use as a daily oral pre-exposure prevention (PrEP) in pregnancy. It was also developed to be administered in a gradual way, involving groups at one given time, beginning with women at the end of pregnancy, at a time when the risks of exposure to drugs are at their most minimal. In this instance the next group is identified when the results from the study are independently evaluated. This is a safe way to conduct the study.

Data on the safety of using these HIV products to prevent HIV in the population in question is vital this is the reason we developed DELIVER in as we did. We only enrolled one group at a given time. To ensure the safety of the mothers and babies. They will be able to share their findings sooner rather instead of waiting until study has been completed,” said Kathryn Bunge, MPH, MD, University of Pittsburgh. Assistant Professor of Obstetrics and Gynecology, Reproductive Sciences, and a protocol within the School of Medicine. The director of the DELIVERY study stated in a statement.

Although animal studies of dapivirine show no issues regarding fetal or pregnancy development, prior to DELIVER, the only human study was from a group of 240 women who were pregnant when using the dapivirine band during the phase III trial (ASPIRE as well as The Ring Study) and removed the ring after finding out they were expecting. There were also none of the significant variations in the pregnancy or infant outcomes between women who were given the dapivirine-containing ring and women who received the placebo ring who were pregnant, which suggests that ring usage in early pregnancy and during conception isn’t detrimental.

DELIVER will provide details about the ring’s safety when worn for longer periods of time and at different stages of pregnancy. With today’s findings this study has already provided a greater knowledge of the safety of the ring in the third trimester pregnancy.

Cohort 1 was comprised of 150 participants who were more than 36 weeks (8-9 months) pregnant. Of these, 101 randomly selected the dapivirine ring , and 49 were randomized to use Truvada as an oral PreEP. Of the 157 women from cohort 2 who were between 30 and 35-week gestation (7-8 months pregnant) at the time participants joined in the study 106 used the ring while 51 took oral PrEP.

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