Use of a Vaginal Ring Containing Dapivirine for HIV-1 Prevention in Women

被引：609

作者：

Baeten, J. M. ^{[1
,2
,3
]}

Palanee-Phillips, T. ^{[6
]}

Brown, E. R. ^{[4
,5
]}

Schwartz, K. ^{[10
]}

Soto-Torres, L. E. ^{[11
]}

Govender, V. ^{[7
]}

Mgodi, N. M. ^{[17
]}

Kiweewa, F. Matovu ^{[18
]}

Nair, G. ^{[8
]}

Mhlanga, F. ^{[17
]}

Siva, S. ^{[7
]}

Bekker, L. -G. ^{[9
]}

Jeenarain, N. ^{[7
]}

Gaffoor, Z. ^{[7
]}

Martinson, F. ^{[19
]}

Makanani, B. ^{[20
]}

Pather, A. ^{[7
]}

Naidoo, L. ^{[7
]}

Husnik, M. ^{[3
,5
]}

Richardson, B. A. ^{[1
,4
,5
]}

Parikh, U. M. ^{[21
]}

Mellors, J. W. ^{[21
]}

Marzinke, M. A. ^{[14
]}

Hendrix, C. W. ^{[14
]}

van der Straten, A. ^{[24
,25
]}

Ramjee, G. ^{[7
]}

Chirenje, Z. M. ^{[17
]}

Nakabiito, C. ^{[18
]}

Taha, T. E. ^{[15
,20
]}

Jones, J. ^{[23
]}

Mayo, A. ^{[10
]}

Scheckter, R. ^{[10
]}

Berthiaume, J. ^{[5
]}

Livant, E. ^{[23
]}

Jacobson, C. ^{[23
]}

Ndase, P. ^{[1
]}

White, R. ^{[10
]}

Patterson, K. ^{[5
]}

Germuga, D. ^{[11
]}

Galaska, B. ^{[23
]}

Bunge, K. ^{[22
]}

Singh, D. ^{[23
]}

Szydlo, D. W. ^{[5
]}

Montgomery, E. T. ^{[24
]}

Mensch, B. S. ^{[26
]}

Torjesen, K. ^{[10
]}

Grossman, C. I. ^{[12
]}

Chakhtoura, N. ^{[13
]}

Nel, A. ^{[16
]}

Rosenberg, Z. ^{[16
]}

机构：

[1] Univ Washington, Dept Global Hlth, 325 Ninth Ave,Box 359927, Seattle, WA 98104 USA

[2] Univ Washington, Dept Med, 325 Ninth Ave,Box 359927, Seattle, WA 98104 USA

[3] Univ Washington, Dept Epidemiol, 325 Ninth Ave,Box 359927, Seattle, WA 98104 USA

[4] Univ Washington, Dept Biostat, 325 Ninth Ave,Box 359927, Seattle, WA 98104 USA

[5] Fred Hutchinson Canc Res Ctr, Stat Ctr HIV AIDS Res & Prevent, 1124 Columbia St, Seattle, WA 98104 USA

[6] Univ Witwatersrand, Wits Reprod Hlth & HIV Inst, Johannesburg, South Africa

[7] South African Med Res Council, HIV Prevent Res Unit, Durban, South Africa

[8] Ctr AIDS Programme Res South Africa, Durban, South Africa

[9] Univ Cape Town, Desmond Tutu HIV Ctr, Cape Town, South Africa

[10] FHI 360, Durham, NC USA

[11] NIAID, NIH, 9000 Rockville Pike, Bethesda, MD 20892 USA

[12] NIMH, NIH, Bethesda, MD 20892 USA

[13] Eunice Kennedy Shiver Natl Inst Child Hlth & Huma, NIH, Bethesda, MD USA

[14] Johns Hopkins Univ, Dept Med, Baltimore, MD USA

[15] Johns Hopkins Univ, Dept Epidemiol, Baltimore, MD USA

[16] Int Partnership Microbicides, Silver Spring, MD USA

[17] Univ Zimbabwe Univ Calif San Francisco Collaborat, Harare, Zimbabwe

[18] Makerere Univ Johns Hopkins Univ Res Collaborat, Kampala, Uganda

[19] Univ North Carolina Project, Lilongwe, Malawi

[20] Queen Elizabeth Cent Hosp, Malawi Coll Med Johns Hopkins Univ Res Project, Blantyre, Malawi

[21] Univ Pittsburgh, Dept Med, Pittsburgh, PA USA

[22] Univ Pittsburgh, Dept Obstet Gynecol & Reprod Sci, Pittsburgh, PA USA

[23] Magee Womens Res Inst, Pittsburgh, PA USA

[24] RTI Int, Womens Global Hlth Imperat, San Francisco, CA USA

[25] Univ Calif San Francisco, Dept Med, San Francisco, CA USA

[26] Populat Council, 1230 York Ave, New York, NY 10021 USA

来源：

NEW ENGLAND JOURNAL OF MEDICINE | 2016年 / 375卷 / 22期

关键词：

PREEXPOSURE PROPHYLAXIS; ANTIRETROVIRAL PROPHYLAXIS; CLINICAL-TRIALS; AFRICAN WOMEN; DOUBLE-BLIND; INFECTION; TENOFOVIR; THAILAND; SAFETY; MEN;

D O I：

10.1056/NEJMoa1506110

中图分类号：

R5 [内科学];

学科分类号：

100201 [内科学];

摘要：

BACKGROUND Antiretroviral medications that are used as prophylaxis can prevent acquisition of human immunodeficiency virus type 1 (HIV-1) infection. However, in clinical trials among African women, the incidence of HIV-1 infection was not reduced, probably because of low adherence. Longer-acting methods of drug delivery, such as vaginal rings, may simplify use of antiretroviral medications and provide HIV-1 protection. METHODS We conducted a phase 3, randomized, double-blind, placebo-controlled trial of a monthly vaginal ring containing dapivirine, a non-nucleoside HIV-1 reverse-transcriptase inhibitor, involving women between the ages of 18 and 45 years in Malawi, South Africa, Uganda, and Zimbabwe. RESULTS Among the 2629 women who were enrolled, 168 HIV-1 infections occurred: 71 in the dapivirine group and 97 in the placebo group (incidence, 3.3 and 4.5 per 100 personyears, respectively). The incidence of HIV-1 infection in the dapivirine group was lower by 27% (95% confidence interval [ CI], 1 to 46; P = 0.046) than that in the placebo group. In an analysis that excluded data from two sites that had reduced rates of retention and adherence, the incidence of HIV-1 infection in the dapivirine group was lower by 37% (95% CI, 12 to 56; P = 0.007) than that in the placebo group. In a post hoc analysis, higher rates of HIV-1 protection were observed among women over the age of 21 years (56%; 95% CI, 31 to 71; P < 0.001) but not among those 21 years of age or younger (-27%; 95% CI, -133 to 31; P = 0.45), a difference that was correlated with reduced adherence. The rates of adverse medical events and antiretroviral resistance among women who acquired HIV-1 infection were similar in the two groups. CONCLUSIONS A monthly vaginal ring containing dapivirine reduced the risk of HIV-1 infection among African women, with increased efficacy in subgroups with evidence of increased adherence. (Funded by the National Institutes of Health; ClinicalTrials.gov number, NCT01617096.)

引用

页码：2121 / 2132

页数：12

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