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Effectiveness and Safety of Tenofovir Gel, an Antiretroviral Microbicide, for the Prevention of HIV

Effectiveness and Safety of Tenofovir Gel, an Antiretroviral Microbicide, for the Prevention of HIV

  1. YIPMAN
    ATTENTION: Despite a promising pilot study, the chemical substance has now proven to be ineffective.

    See News Article - in german
    Wirkungslos gegen HIV - US-Behörde bricht Vaginalgel-Studie ab
    http://www.drugs-forum.com/forum/showthread.php?p=1056851#post1056851

    ...

    Effectiveness and Safety of Tenofovir Gel, an Antiretroviral Microbicide, for the Prevention of HIV Infection in Women

    Quarraisha Abdool Karim, et al.
    Science 329, 1168 (2010);
    DOI: 10.1126/science.1193748

    Quarraisha Abdool Karim1,2,*†, Salim S. Abdool Karim1,2,3,*, Janet A. Frohlich1, Anneke C. Grobler1, Cheryl Baxter1, Leila E. Mansoor1, Ayesha B. M. Kharsany1, Sengeziwe Sibeko1, Koleka P. Mlisana1, Zaheen Omar1, Tanuja N. Gengiah1, Silvia Maarschalk1, Natasha Arulappan1, Mukelisiwe Mlotshwa1, Lynn Morris4, Douglas Taylor5 and on behalf of the CAPRISA 004 Trial Group

    ABSTRACT

    The Centre for the AIDS Program of Research in South Africa (CAPRISA) 004 trial assessed the effectiveness and safety of a 1% vaginal gel formulation of tenofovir, a nucleotide reverse transcriptase inhibitor, for the prevention of HIV acquisition in women. A double-blind, randomized controlled trial was conducted comparing tenofovir gel (n = 445 women) with placebo gel (n = 444 women) in sexually active, HIV-uninfected 18- to 40-year-old women in urban and rural KwaZulu-Natal, South Africa. HIV serostatus, safety, sexual behavior, and gel and condom use were assessed at monthly follow-up visits for 30 months. HIV incidence in the tenofovir gel arm was 5.6 per 100 women-years (person time of study observation) (38 out of 680.6 women-years) compared with 9.1 per 100 women-years (60 out of 660.7 women-years) in the placebo gel arm (incidence rate ratio = 0.61; P = 0.017). In high adherers (gel adherence > 80%), HIV incidence was 54% lower (P = 0.025) in the tenofovir gel arm. In intermediate adherers (gel adherence 50 to 80%) and low adherers (gel adherence < 50%), the HIV incidence reduction was 38 and 28%, respectively. Tenofovir gel reduced HIV acquisition by an estimated 39% overall, and by 54% in women with high gel adherence. No increase in the overall adverse event rates was observed. There were no changes in viral load and no tenofovir resistance in HIV seroconverters. Tenofovir gel could potentially fill an important HIV prevention gap, especially for women unable to successfully negotiate mutual monogamy or condom use.