Effectiveness and safety of tenofovir gel, an antiretroviral microbicide, for the prevention of HIV infection in women

Abdool Karim, Quarraisha, Abdool Karim, Salim S, Frohlich, Janet A, Grobler, Anneke C, Baxter, Cheryl, Mansoor, Leila E, Kharsany, Ayesha B M, Sibeko, Sengeziwe, Mlisana, Koleka P, Omar, Zaheen, Gengiah, Tanuja N, Maarschalk, Silvia, Arulappan, Natasha, Mlotshwa, Mukelisiwe, Morris, Lynn, Taylor, Douglas, The CAPRISA 004 Trial Group, and Fisher, Martin (2010) Effectiveness and safety of tenofovir gel, an antiretroviral microbicide, for the prevention of HIV infection in women. Science, 329 (5996). pp. 1168-1174. ISSN 0036-8075

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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.

Item Type: Article
Additional Information: Martin Fisher is not a named author of this article but is a member of the CAPRISA 004 Trial Group.
Schools and Departments: Brighton and Sussex Medical School > Brighton and Sussex Medical School
Subjects: R Medicine > RA Public aspects of medicine > RA0421 Public health. Hygiene. Preventive Medicine > RA0643 Communicable diseases and public health > RA0644 Individual diseases or groups of diseases, A-Z > RA0644.A25 AIDS. HIV infections
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Depositing User: Ellen Thomas
Date Deposited: 07 Apr 2014 14:01
Last Modified: 07 Apr 2014 14:01
URI: http://sro.sussex.ac.uk/id/eprint/47552
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