Studies To Determine Dapirivirine Ring’s Safety In Pregnant And Breastfeeding Women Gather Momentum

RESEARCH on the Dapivirine  or Vaginal Ring’s effectiveness and safety in pregnant and lactating women are now at advanced stage as the world prepares to rollout the ring, a tool meant to protect women against the risk of  HIV infection,  Dr Nyaradzo Mgodi, the Chairperson of Dapivirine ring study in Africa has said.

By Patricia Mashiri

The Dapivirine Vaginal Ring is a silicone made ring which is inserted into the vagina for a period of 28-35 days releasing antiretroviral drug called Dapivirine reducing the risk of HIV infections.

Speaking during a Health Communicators Forum Launch, Dr Mgodi said the Dapivirine vaginal ring is 80-90% efficient.

We are proved that this ring works. We enrolled over 3000 women and we gave them those rings. Others were on a placebo others on a ring so that we could compare if this ring works.

She added that the ring had been endorsed by the European Medicines Agency and the had been pre-qulified by the World Health Organization (WHO).

“When we do study we start with the health populations we started with women of reproductive age which is 18-45 because they do not have many other health issues non pregnant and non-breastfeeding.
“The risk of getting HIV when pregnant is higher because of social issues, cultural issues that make women to get HIV. More work is ongoing so that it can be used by all women. Zimbabwe has got only one clinic looking at pregnant women.”

She said that studies were being done in stages starting with women who would have already finished the first part of the pregnancy starting from 30weeks.

“We gave them the ring and we are following up the review is ongoing and we will get the results on the 17th and we will move to an earlier part and then another one. It’s a study design that we always employ when we are working with pregnant women.

“It’s not yet accessible because work is still ongoing. We are always working on modules for health care providers on how do we train them that the way they will dispense it just like oral contraceptives, oral PrEP, Jadelle among others,” Dr Mgodi said.

Meanwhile, Definate Nhamo of Pangea Zimbabwe Aids Trust (PZAT) said the study shows that the Dapivirine vaginal is efficient.

“The ring reduced the risk of HIV-1 infection by 35% in The Ring Study and by 27% in the ASPIRE study. No significant risk reduction was seen in participants age 18-21, who were also shown to have low adherence to the ring during the trial. Further analysis of ASPIRE study results comparing adherence and risk reduction suggest more  that than 50% protection from HIV, and up to 75-91% risk reduction as consistent use of the ring increased. Results from DREAM indicated a 62% reduction in HIV risk compared to the simulated control.

“Lastly the B-Protested study will be done in breastfeeding mothers 6-12 week old babies. Omen will use their assigned product PrEP or Dapivirine The ring must be in place for 24 hours to provide maximum protection, and should remain in place at all times to ensure the most protection from HIV.”

She added that for three months and followed by an additional two weeks, researchers will assess how much drug from Truvada and Dapivirine ring passes into breast milk and how much passes to the baby after breastfeeding and will measure the effects, if any this may have on their babies. This study will take place in South Africa, Uganda and Zimbabwe.

The ring must be in place for 24 hours to provide maximum protection, and should remain in place at all times to ensure the most protection from HIV.

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