Giuseppe
Emeritus
Effectiveness and Safety of Tenofovir Gel, an Antiretroviral Microbicide, for the Prevention of HIV Infection in Women (Science, abstract, edited)
[Source: Science, original abstract and free full text, <cite cite="http://www.sciencemag.org/cgi/content/abstract/science.1193748">Effectiveness and Safety of Tenofovir Gel, an Antiretroviral Microbicide, for the Prevention of HIV Infection in Women -- Karim et al., 10.1126/science.1193748 -- Science</cite>. Abstract, edited.]
Published Online July 19, 2010
Science
DOI: 10.1126/science.1193748
Research Articles
Effectiveness and Safety of Tenofovir Gel, an Antiretroviral Microbicide, for the Prevention of HIV Infection in Women
Quarraisha Abdool Karim,1,2,*, Salim S. Abdool Karim,1,2,3,* Janet A. Frohlich,1 Anneke C. Grobler,1 Cheryl Baxter,1 Leila E. Mansoor,1 Ayesha B. M. Kharsany,1 Sengeziwe Sibeko,1 Koleka P. Mlisana,1 Zaheen Omar,1 Tanuja N. Gengiah,1 Silvia Maarschalk,1 Natasha Arulappan,1 Mukelisiwe Mlotshwa,1 Lynn Morris,4 Douglas Taylor,5 on behalf of the CAPRISA 004 Trial Group
The CAPRISA 004 trial assessed 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) with placebo gel (n = 444) 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, i.e., person time of study observation (38/680.6 women-years), compared to 9.1 per 100 women-years (60/660.7 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.
1 Centre for the AIDS Program of Research in South Africa (CAPRISA), Durban, South Africa.
2 Department of Epidemiology, Mailman School of Public Health, Columbia University, New York, NY, USA.
3 University of KwaZulu-Natal, Durban, South Africa.
4 National Institute for Communicable Diseases, Johannesburg, South Africa.
5 FHI, North Carolina, USA.
* These authors contributed equally to this work.
To whom correspondence should be addressed. E-mail: caprisa@ukzn.ac.za
Received for publication 14 June 2010. Accepted for publication 13 July 2010.
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[Source: Science, original abstract and free full text, <cite cite="http://www.sciencemag.org/cgi/content/abstract/science.1193748">Effectiveness and Safety of Tenofovir Gel, an Antiretroviral Microbicide, for the Prevention of HIV Infection in Women -- Karim et al., 10.1126/science.1193748 -- Science</cite>. Abstract, edited.]
Published Online July 19, 2010
Science
DOI: 10.1126/science.1193748
Research Articles
Effectiveness and Safety of Tenofovir Gel, an Antiretroviral Microbicide, for the Prevention of HIV Infection in Women
Quarraisha Abdool Karim,1,2,*, Salim S. Abdool Karim,1,2,3,* Janet A. Frohlich,1 Anneke C. Grobler,1 Cheryl Baxter,1 Leila E. Mansoor,1 Ayesha B. M. Kharsany,1 Sengeziwe Sibeko,1 Koleka P. Mlisana,1 Zaheen Omar,1 Tanuja N. Gengiah,1 Silvia Maarschalk,1 Natasha Arulappan,1 Mukelisiwe Mlotshwa,1 Lynn Morris,4 Douglas Taylor,5 on behalf of the CAPRISA 004 Trial Group
The CAPRISA 004 trial assessed 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) with placebo gel (n = 444) 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, i.e., person time of study observation (38/680.6 women-years), compared to 9.1 per 100 women-years (60/660.7 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.
1 Centre for the AIDS Program of Research in South Africa (CAPRISA), Durban, South Africa.
2 Department of Epidemiology, Mailman School of Public Health, Columbia University, New York, NY, USA.
3 University of KwaZulu-Natal, Durban, South Africa.
4 National Institute for Communicable Diseases, Johannesburg, South Africa.
5 FHI, North Carolina, USA.
* These authors contributed equally to this work.
To whom correspondence should be addressed. E-mail: caprisa@ukzn.ac.za
Received for publication 14 June 2010. Accepted for publication 13 July 2010.
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