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Study of tenofovir vaginal gel shows daily dosing ineffective due to lack of adherence
Date:3/4/2013

ion, however, was not statistically significant.

Some of the previous studies using the same antiretrovirals in tablet or gel form for HIV prevention showed effectiveness. In particular, CAPRISA 004, a study completed in 2010 using the same tenofovir vaginal gel used in the VOICE trial, showed an average of a 39% reduction in HIV infections and a 54% reduction in women who used it at least 80% of the time. Additionally, tenofovir gel reduced the risk of herpes genital infections by 51%. The dosing regimen was different than the daily dosing used in the VOICE study women in CAPRISA 004 were required to insert 1 dose before sex and 1 dose after sex, not to exceed 2 doses in 24 hours (a regimen dubbed BAT24). CAPRISA 004 was the first trial to show that a topical product containing tenofovir could reduce HIV infection and suggests that a dosing method that requires women to use the product around the time of sex, versus daily dosing, may be preferable to women.

To that end, FACTS 001, a study sponsored by CONRAD, funded by USAID, the Bill & Melinda Gates Foundation and the South African government, and co-chaired by the South African scientists, Drs. Helen Rees and Glenda Gray, is currently being conducted at 9 sites in South Africa. The trial replicates the dosing regimen used in CAPRISA 004 (i.e., BAT 24). FACTS 001 is using a variety of methods to collect information about gel use, condom use, and sexual behavior in order to measure adherence. The study has enrolled close to 1,900 participants and is expected to be complete at the end of 2014. FACTS 001 is an important study as it is designed to confirm the results obtained in CAPRISA 004 and contribute to the approval of tenofovir gel as a pericoital method for prevention of HIV infection in women.

The VOICE study also found that single women under 25 were the least likely to use the product and the most likely to acquire HIV. "The VOICE results highlight the gravity of th
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Contact: Annette Larkin
alarkin@conrad.org
703-772-6427
CONRAD
Source:Eurekalert

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