作者
Jeanne M Marrazzo, Gita Ramjee, Barbra A Richardson, Kailazarid Gomez, Nyaradzo Mgodi, Gonasagrie Nair, Thesla Palanee, Clemensia Nakabiito, Ariane Van Der Straten, Lisa Noguchi, Craig W Hendrix, James Y Dai, Shayhana Ganesh, Baningi Mkhize, Marthinette Taljaard, Urvi M Parikh, Jeanna Piper, Benoît Mâsse, Cynthia Grossman, James Rooney, Jill L Schwartz, Heather Watts, Mark A Marzinke, Sharon L Hillier, Ian M McGowan, Z Mike Chirenje
发表日期
2015/2/5
期刊
New England Journal of Medicine
卷号
372
期号
6
页码范围
509-518
出版商
Massachusetts Medical Society
简介
Background
Reproductive-age women need effective interventions to prevent the acquisition of human immunodeficiency virus type 1 (HIV-1) infection.
Methods
We conducted a randomized, placebo-controlled trial to assess daily treatment with oral tenofovir disoproxil fumarate (TDF), oral tenofovir–emtricitabine (TDF-FTC), or 1% tenofovir (TFV) vaginal gel as preexposure prophylaxis against HIV-1 infection in women in South Africa, Uganda, and Zimbabwe. HIV-1 testing was performed monthly, and plasma TFV levels were assessed quarterly.
Results
Of 12,320 women who were screened, 5029 were enrolled in the study. The rate of retention in the study was 91% during 5509 person-years of follow-up. A total of 312 HIV-1 infections occurred; the incidence of HIV-1 infection was 5.7 per 100 person-years. In the modified intention-to-treat analysis, the effectiveness was −49.0% with TDF (hazard ratio for infection …
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JM Marrazzo, G Ramjee, BA Richardson, K Gomez… - New England Journal of Medicine, 2015