Please use this identifier to cite or link to this item:
Type
ArticleCopyright
Open access
Collections
- INI - Artigos de Periódicos [3645]
Metadata
Show full item record
PREEXPOSURE CHEMOPROPHYLAXIS FOR HIV PREVENTION IN MEN WHO HAVE SEX WITH MEN
Deoxycytidine
Emtricitabine
Kaplan-Meier Estimate
Organophosphonates
Patient Compliance
Tenofovir
Preexposure
The authors’ affiliations are as follows: the Gladstone Institute of Virology and Immunology (R.M.G., V.M., P.G., R.J.H., J.J.M., P.D., J.L.), the University of California, San Francisco (R.M.G., A.Y.L., S.P.B., K.M., F.W., D.V.G.), and the HIV Research Section, San Francisco Department of Public Health (A.Y.L., S.P.B.) — all in San Francisco; Investigaciones Medicas en Salud, Lima (J.R.L., L.V.), Asociación Civil Impacta Salud y Educación, Lima (J.R.L., J.V.G.-C., M.E.R.-C., C.G.), and Asociación Civil Selva Amazónica, Iquitos (M.C.) — all in Peru; the University of Colorado, Denver (P.L.A., L.R.B., J.-H.Z.).; Fundación Ecuatoriana Equidad, Guayaquil, Ecuador (O.M.- H., T.F.); Fundação Oswaldo Cruz, Instituto Nacional de Infectologia Evandro Chagas, Laboratório de Pesquisa Clínica em DST/AIDS (V.G.V.), and Projeto Praça Onze, Hospital Escola São Francisco de Assis, Universidade Federal do Rio de Janeiro (M.S.) — both in Rio de Janeiro; Brown University, Providence, RI (K.H.M.); the Fenway Institute, Fenway Health, Boston (K.H.M.); the Division of Clinical Immunology and Allergy, School of Medicine, University of São Paulo, and Instituto de Investigação em Imunologia — both in São Paulo (E.G.K.); Research Institute for Health Sciences, Chiang Mai University, Chiang Mai, Thailand (S.C.); Desmond Tutu HIV Centre and Department of Medicine, University of Cape Town, Cape Town, South Africa (L.-G.B.); Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD (A.I.M., D.N.B.); Gilead Sciences, Foster City, CA ( J.F.R., H.S.J.); DF/Net Research, Seattle (B.P.); Applied Health Research, Brighton, MI (K.R.A.); and the Center for Health, Intervention, and Prevention, University of Connecticut, Storrs (K.R.A.).
Author
Affilliation
Abstract
Background: Antiretroviral chemoprophylaxis before exposure is a promising approach for the prevention of human immunodeficiency virus (HIV) acquisition. Methods: We randomly assigned 2499 HIV-seronegative men or transgender women who have sex with men to receive a combination of two oral antiretroviral drugs, emtricitabine and tenofovir disoproxil fumarate (FTC-TDF), or placebo once daily. All subjects received HIV testing, risk-reduction counseling, condoms, and management of sexually transmitted infections. Results: The study subjects were followed for 3324 person-years (median, 1.2 years; maximum, 2.8 years). Of these subjects, 10 were found to have been infected with HIV at enrollment, and 100 became infected during follow-up (36 in the FTC-TDF group and 64 in the placebo group), indicating a 44% reduction in the incidence of HIV (95% confidence interval, 15 to 63; P=0.005). In the FTC-TDF group, the study drug was detected in 22 of 43 of seronegative subjects (51%) and in 3 of 34 HIV-infected subjects (9%) (P<0.001). Nausea was reported more frequently during the first 4 weeks in the FTC-TDF group than in the placebo group (P<0.001). The two groups had similar rates of serious adverse events (P=0.57). Conclusions: Oral FTC-TDF provided protection against the acquisition of HIV infection among the subjects. Detectable blood levels strongly correlated with the prophylactic effect.
Keywords
HIVDeoxycytidine
Emtricitabine
Kaplan-Meier Estimate
Organophosphonates
Patient Compliance
Tenofovir
Preexposure
Citation
GRANT, R. M. et al. Preexposure chemoprophylaxis for HIV prevention in men who have sex with men. New England Journal of Medicine, v. 363, n. 27, p. 2587-2599, Dec. 2010.DOI
10.1056/NEJMoa1011205ISSN
0028-4793Notes
Beatriz Grinsztejn - Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Rio de Janeiro, RJ, Brasil - Documento produzido em parceria ou por autor vinculado à Fiocruz, mas não consta à informação no documento.The authors’ affiliations are as follows: the Gladstone Institute of Virology and Immunology (R.M.G., V.M., P.G., R.J.H., J.J.M., P.D., J.L.), the University of California, San Francisco (R.M.G., A.Y.L., S.P.B., K.M., F.W., D.V.G.), and the HIV Research Section, San Francisco Department of Public Health (A.Y.L., S.P.B.) — all in San Francisco; Investigaciones Medicas en Salud, Lima (J.R.L., L.V.), Asociación Civil Impacta Salud y Educación, Lima (J.R.L., J.V.G.-C., M.E.R.-C., C.G.), and Asociación Civil Selva Amazónica, Iquitos (M.C.) — all in Peru; the University of Colorado, Denver (P.L.A., L.R.B., J.-H.Z.).; Fundación Ecuatoriana Equidad, Guayaquil, Ecuador (O.M.- H., T.F.); Fundação Oswaldo Cruz, Instituto Nacional de Infectologia Evandro Chagas, Laboratório de Pesquisa Clínica em DST/AIDS (V.G.V.), and Projeto Praça Onze, Hospital Escola São Francisco de Assis, Universidade Federal do Rio de Janeiro (M.S.) — both in Rio de Janeiro; Brown University, Providence, RI (K.H.M.); the Fenway Institute, Fenway Health, Boston (K.H.M.); the Division of Clinical Immunology and Allergy, School of Medicine, University of São Paulo, and Instituto de Investigação em Imunologia — both in São Paulo (E.G.K.); Research Institute for Health Sciences, Chiang Mai University, Chiang Mai, Thailand (S.C.); Desmond Tutu HIV Centre and Department of Medicine, University of Cape Town, Cape Town, South Africa (L.-G.B.); Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD (A.I.M., D.N.B.); Gilead Sciences, Foster City, CA ( J.F.R., H.S.J.); DF/Net Research, Seattle (B.P.); Applied Health Research, Brighton, MI (K.R.A.); and the Center for Health, Intervention, and Prevention, University of Connecticut, Storrs (K.R.A.).
Share