From TheBodyPRO.com—Vaginal Microbicides: Adherence Issues Strike Again
Following in the footsteps of other disappointing clinical trial results studying the effectiveness of vaginal microbicide gels to prevent HIV in women, a major large-scale study recently announced a failure to show that a tenofovir gel was effective in preventing HIV among women participating in the FACTS001 study in South Africa.
Read about the results of the FACTS001 study covered in the article excerpted below by TheBodyPro.com and find out what this means for future investment of vaginal gel microbicide development for women.
By Myles Helfand
Disappointing new study results have dealt a serious blow to hopes for a vaginal gel to help women protect themselves from HIV infection. In research presented at CROI 2015 in Seattle, Washington, a gel containing 1% tenofovir (Viread) failed to show any greater efficacy than a placebo gel. Poor adherence appeared to be the primary reason for the gel’s failure.
Key findings from the study, known as FACTS 001, are:
- A total of 61 HIV infections occurred in the tenofovir arm versus 60 in the placebo gel arm; both arms had an infection rate of 4.0 per 100 person-years.
- Participants in both arms only used the gel before 50 to 60% of sexual acts.
- Only 13% of participants used the gel before sex at least 80% of the time, the threshold for tenofovir gel efficacy.
- Among women who reported recently having sex and who had detectable tenofovir levels in vaginal tissue, the tenofovir gel conferred 52% protection against HIV infection….