Preexposure prophylaxis for HIV infection among African women

L. Van Damme; A. Corneli; K. Ahmed; K. Agot; J. Lombaard; S. Kapiga; M. Malahleha; F. Owino; R. Manongi; J. Onyango; L. Temu; M.C. Monedi; P. Mak'oketch; M. Makanda; I. Reblin; S.E. Makatu; L. Saylor; H. Kiernan; S. Kirkendale; C. Wong; R. Grant; A. Kashuba; K. Nanda; J. Mandala; K. Fransen; J. Deese; T. Crucitti; T.D. Mastro; D. Taylor

doi:10.1056/NEJMoa1202614

Preexposure prophylaxis for HIV infection among African women

L. Van Damme
, A. Corneli
, K. Ahmed
, K. Agot
, J. Lombaard
, S. Kapiga
, M. Malahleha
, F. Owino
, R. Manongi
, J. Onyango
, L. Temu
, M.C. Monedi
, P. Mak'oketch
, M. Makanda
, I. Reblin
, S.E. Makatu
, L. Saylor
, H. Kiernan
, S. Kirkendale
, C. Wong

R. Grant, A. Kashuba, K. Nanda, J. Mandala, K. Fransen, J. Deese, T. Crucitti, T.D. Mastro, D. Taylor

Research output: Contribution to journal › A1: Peer-reviewed journal articles › peer-review

Abstract

Background: Preexposure prophylaxis with antiretroviral drugs has been effective in the prevention of human immunodeficiency virus (HIV) infection in some trials but not in others. Methods: In this randomized, double-blind, placebo-controlled trial, we assigned 2120 HIV-negative women in Kenya, South Africa, and Tanzania to receive either a combination of tenofovir disoproxil fumarate and emtricitabine (TDF-FTC) or placebo once daily. The primary objective was to assess the effectiveness of TDF-FTC in preventing HIV acquisition and to evaluate safety. Results: HIV infections occurred in 33 women in the TDF-FTC group (incidence rate, 4.7 per 100 person-years) and in 35 in the placebo group (incidence rate, 5.0 per 100 person-years), for an estimated hazard ratio in the TDF-FTC group of 0.94 (95% confidence interval, 0.59 to 1.52; P=0.81). The proportions of women with nausea, vomiting, or elevated alanine aminotransferase levels were significantly higher in the TDF-FTC group (P=0.04, P

Original language	English
Journal	New England Journal of Medicine
Volume	367
Issue number	5
Pages (from-to)	411-422
Number of pages	12
ISSN	0028-4793
DOIs	https://doi.org/10.1056/NEJMoa1202614 https://doi.org/10.1056/NEJMoa1202614
Publication status	Published - 2012

Keywords

Viral diseases
HIV
AIDS
Pre-exposure
Prophylaxis
Women
Effectiveness
Assessment
Combination therapy
Tenofovir
Disoproxil
Fumarate
Emtricitabine
Transmission prevention
Safety
Evaluation
Adverse effects
Hepatic
Renal function
Randomized controlled trials
Randomized clinical trials
Kenya
Tanzania
Africa-East
South Africa
Africa-Southern

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Van Damme, L., Corneli, A., Ahmed, K., Agot, K., Lombaard, J., Kapiga, S., Malahleha, M., Owino, F., Manongi, R., Onyango, J., Temu, L., Monedi, M. C., Mak'oketch, P., Makanda, M., Reblin, I., Makatu, S. E., Saylor, L., Kiernan, H., Kirkendale, S., ... Taylor, D. (2012). Preexposure prophylaxis for HIV infection among African women. New England Journal of Medicine, 367(5), 411-422. https://doi.org/10.1056/NEJMoa1202614, https://doi.org/10.1056/NEJMoa1202614

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title = "Preexposure prophylaxis for HIV infection among African women",

abstract = "Background: Preexposure prophylaxis with antiretroviral drugs has been effective in the prevention of human immunodeficiency virus (HIV) infection in some trials but not in others. Methods: In this randomized, double-blind, placebo-controlled trial, we assigned 2120 HIV-negative women in Kenya, South Africa, and Tanzania to receive either a combination of tenofovir disoproxil fumarate and emtricitabine (TDF-FTC) or placebo once daily. The primary objective was to assess the effectiveness of TDF-FTC in preventing HIV acquisition and to evaluate safety. Results: HIV infections occurred in 33 women in the TDF-FTC group (incidence rate, 4.7 per 100 person-years) and in 35 in the placebo group (incidence rate, 5.0 per 100 person-years), for an estimated hazard ratio in the TDF-FTC group of 0.94 (95\% confidence interval, 0.59 to 1.52; P=0.81). The proportions of women with nausea, vomiting, or elevated alanine aminotransferase levels were significantly higher in the TDF-FTC group (P=0.04, P",

keywords = "Viral diseases, HIV, AIDS, Pre-exposure, Prophylaxis, Women, Effectiveness, Assessment, Combination therapy, Tenofovir, Disoproxil, Fumarate, Emtricitabine, Transmission prevention, Safety, Evaluation, Adverse effects, Hepatic, Renal function, Randomized controlled trials, Randomized clinical trials, Kenya, Tanzania, Africa-East, South Africa, Africa-Southern",

author = "\{Van Damme\}, L. and A. Corneli and K. Ahmed and K. Agot and J. Lombaard and S. Kapiga and M. Malahleha and F. Owino and R. Manongi and J. Onyango and L. Temu and M.C. Monedi and P. Mak'oketch and M. Makanda and I. Reblin and S.E. Makatu and L. Saylor and H. Kiernan and S. Kirkendale and C. Wong and R. Grant and A. Kashuba and K. Nanda and J. Mandala and K. Fransen and J. Deese and T. Crucitti and T.D. Mastro and D. Taylor",

note = "NPP; ITG-C25A; ITG-C27A; DCS; U-ARLAB; JIF; DOI; PDF; Abstract; DSPACE",

year = "2012",

doi = "10.1056/NEJMoa1202614",

language = "English",

volume = "367",

pages = "411--422",

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Van Damme, L, Corneli, A, Ahmed, K, Agot, K, Lombaard, J, Kapiga, S, Malahleha, M, Owino, F, Manongi, R, Onyango, J, Temu, L, Monedi, MC, Mak'oketch, P, Makanda, M, Reblin, I, Makatu, SE, Saylor, L, Kiernan, H, Kirkendale, S, Wong, C, Grant, R, Kashuba, A, Nanda, K, Mandala, J, Fransen, K, Deese, J, Crucitti, T, Mastro, TD & Taylor, D 2012, 'Preexposure prophylaxis for HIV infection among African women', New England Journal of Medicine, vol. 367, no. 5, pp. 411-422. https://doi.org/10.1056/NEJMoa1202614, https://doi.org/10.1056/NEJMoa1202614

TY - JOUR

T1 - Preexposure prophylaxis for HIV infection among African women

AU - Van Damme, L.

AU - Corneli, A.

AU - Ahmed, K.

AU - Agot, K.

AU - Lombaard, J.

AU - Kapiga, S.

AU - Malahleha, M.

AU - Owino, F.

AU - Manongi, R.

AU - Onyango, J.

AU - Temu, L.

AU - Monedi, M.C.

AU - Mak'oketch, P.

AU - Makanda, M.

AU - Reblin, I.

AU - Makatu, S.E.

AU - Saylor, L.

AU - Kiernan, H.

AU - Kirkendale, S.

AU - Wong, C.

AU - Grant, R.

AU - Kashuba, A.

AU - Nanda, K.

AU - Mandala, J.

AU - Fransen, K.

AU - Deese, J.

AU - Crucitti, T.

AU - Mastro, T.D.

AU - Taylor, D.

N1 - NPP; ITG-C25A; ITG-C27A; DCS; U-ARLAB; JIF; DOI; PDF; Abstract; DSPACE

PY - 2012

Y1 - 2012

N2 - Background: Preexposure prophylaxis with antiretroviral drugs has been effective in the prevention of human immunodeficiency virus (HIV) infection in some trials but not in others. Methods: In this randomized, double-blind, placebo-controlled trial, we assigned 2120 HIV-negative women in Kenya, South Africa, and Tanzania to receive either a combination of tenofovir disoproxil fumarate and emtricitabine (TDF-FTC) or placebo once daily. The primary objective was to assess the effectiveness of TDF-FTC in preventing HIV acquisition and to evaluate safety. Results: HIV infections occurred in 33 women in the TDF-FTC group (incidence rate, 4.7 per 100 person-years) and in 35 in the placebo group (incidence rate, 5.0 per 100 person-years), for an estimated hazard ratio in the TDF-FTC group of 0.94 (95% confidence interval, 0.59 to 1.52; P=0.81). The proportions of women with nausea, vomiting, or elevated alanine aminotransferase levels were significantly higher in the TDF-FTC group (P=0.04, P

AB - Background: Preexposure prophylaxis with antiretroviral drugs has been effective in the prevention of human immunodeficiency virus (HIV) infection in some trials but not in others. Methods: In this randomized, double-blind, placebo-controlled trial, we assigned 2120 HIV-negative women in Kenya, South Africa, and Tanzania to receive either a combination of tenofovir disoproxil fumarate and emtricitabine (TDF-FTC) or placebo once daily. The primary objective was to assess the effectiveness of TDF-FTC in preventing HIV acquisition and to evaluate safety. Results: HIV infections occurred in 33 women in the TDF-FTC group (incidence rate, 4.7 per 100 person-years) and in 35 in the placebo group (incidence rate, 5.0 per 100 person-years), for an estimated hazard ratio in the TDF-FTC group of 0.94 (95% confidence interval, 0.59 to 1.52; P=0.81). The proportions of women with nausea, vomiting, or elevated alanine aminotransferase levels were significantly higher in the TDF-FTC group (P=0.04, P

KW - Viral diseases

KW - HIV

KW - AIDS

KW - Pre-exposure

KW - Prophylaxis

KW - Women

KW - Effectiveness

KW - Assessment

KW - Combination therapy

KW - Tenofovir

KW - Disoproxil

KW - Fumarate

KW - Emtricitabine

KW - Transmission prevention

KW - Safety

KW - Evaluation

KW - Adverse effects

KW - Hepatic

KW - Renal function

KW - Randomized controlled trials

KW - Randomized clinical trials

KW - Kenya

KW - Tanzania

KW - Africa-East

KW - South Africa

KW - Africa-Southern

U2 - 10.1056/NEJMoa1202614

DO - 10.1056/NEJMoa1202614

M3 - A1: Peer-reviewed journal articles

C2 - 22784040

SN - 0028-4793

VL - 367

SP - 411

EP - 422

JO - New England Journal of Medicine

JF - New England Journal of Medicine

IS - 5

ER -

Preexposure prophylaxis for HIV infection among African women

Abstract

Keywords

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