南非的研究表明阴道凝胶可减少HIV的感染: 根据在南非开展的一项研究显示，一种内含抗HIV药物tenofovir的阴道凝胶是一种有前途的可减少妇女HIV感染的安全有效的方法。 人们对女用HIV的预防选项有着急迫的需求，尤其是在撒哈拉沙漠以南的非洲地区，因为那里的年轻女性是HIV蔓延的最大的受害群。 Quarraisha Abdool Karim及其同事现在报告了来自CAPRISA 004 Randomized Control Trial的结果，这是一个在南非的城市和农村妇女中所开展的为期近3年的试验。该试验测试了这种凝胶的预防HIV感染的功效。 这是一个双盲的随机对照的试验。在该试验中，大约有445名女性使用了tenofovir凝胶，有44名女性用的则是一种安慰剂凝胶。 研究人员报告说，与使用安慰剂的女性相比，总的来说，该tenofovir凝胶使得HIV感染减少了39%，而在那些最能坚持使用该凝胶的女性中，HIV的感染则可减少54%。 这些女性在每月一次的随访中会接受HIV的测试。在这些随访中，他们还接受诸如妊娠测试等生殖保健服务以及HIV的预防性措施，其中包括HIV测试前后辅导、减少HIV风险的辅导、避孕套的发放以及对其它性传播疾病的治疗。 在他们的文章中，作者们指出了数个需要做进一步研究的问题，其中包括增进及客观测试这些女性在贯彻凝胶使用的指南时的认真程度，因为在该试验中，大约有40%的女性的凝胶使用坚持度低于50%。 此外，该凝胶的有效性在使用18个月之后显得有所下降，而造成这种趋势的原因包括了随着时间的推移，女性对该凝胶使用的坚持度下降，这些都需要做进一步的调查。
Article #12: "Effectiveness and Safety of Tenofovir Gel, an Antiretroviral Microbicide, for the Prevention of HIV Infection in Women," by Q. Abdool Karim; S.S. Abdool Karim; J.A. Frohlich; A.C. Grobler; C. Baxter; L.E. Mansoor; A.B.M. Kharsany; S. Sibeko; K.P. Mlisana; Z. Omar; T.N. Gengiah; S. Maarschalk; N. Arulappan; M. Mlotshwa at Centre for the AIDS Program of Research in South Africa in Durban, South Africa; Q. Abdool Karim; S.S. Abdool Karim at Columbia University in New York, NY; S.S. Abdool Karim at University of KwaZulu-Natal in Durban, South Africa; L. Morris at National Institute for Communicable Diseases in Johannesburg, South Africa; D. Taylor at FHI in Durham, North Carolina.
Published Online July 19, 2010
Science DOI: 10.1126/science.1193748
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.
