Dr Mike Chirenje, co-chairperson for the microbicides study and principal investigator UZ-UCSF, said the results released last week revealed that the majority of young women in the study, who were expected to use the microbicides in order for researchers to assess their acceptability and effectiveness as an HIV preventive tool, did not use it as expected and failed to meet the envisaged protection levels.
“Since the results failed to confirm the 39 percent level of protection for HIV infection seen in CAPRISA 004 in 2010, we will not proceed with the demonstration projects that had been planned. Our focus is now on the results of the ongoing ASPIRE ring study expected by early 2016,” said Chirenje.
Recent studies among young women in South Africa have shown that microbicides could protect 60 percent of adults living with HIV from further infection. Microbicide for HIV is a gel or cream both women and men can use to protect themselves against HIV infection. It kills or neutralise viruses and bacteria.
A joint statement by International Partnership (IPM) for Microbicides Trials Network (MTN), conducting one of the two ongoing phase three studies of the Dapivirine ring, noted that though the FACTS 001 results were disappointing, the research was a well-run trial that would inform and help advance efforts to develop new preventive methods that women will use.
“The high HIV incidence rate seen in FACTS 001 underscores the urgency of this research for women, who have largely been left behind by global progress against HIV/AIDS,” reads part of the statement.
While it appeared that most of the participants used the product at some point, there was not enough correct and consistent use in the trial to provide significant levels of protection. There was a trend of modest protection among the small proportion of women in the trial who appeared to have used the product consistently.
Researchers noted that the findings underscored the need to find products that can fit into the realities of young women’s lives.
“The results add to a powerful body of evidence that ARV-based prevention works when it is used correctly and consistently. But they’re also a reminder that with nearly every prevention option available today, from condoms to PrEP to HIV treatment, correct and consistent use is both critically important and a real challenge,” said Mitchell Warren, executive director AVAC.Post published in: Health