Antiretroviral Therapy for the Prevention of HIV-1 Transmission

被引：1103

作者：

Cohen, M. S. ^{[1
]}

Chen, Y. Q. ^{[2
,3
]}

McCauley, M. ^{[6
]}

Gamble, T. ^{[7
]}

Hosseinipour, M. C. ^{[1
]}

Kumarasamy, N. ^{[8
]}

Hakim, J. G. ^{[10
]}

Kumwenda, J. ^{[11
]}

Grinsztejn, B. ^{[12
]}

Pilotto, J. H. S. ^{[13
,14
]}

Godbole, S. V. ^{[9
]}

Chariyalertsak, S. ^{[16
]}

Santos, B. R. ^{[15
]}

Mayer, K. H. ^{[17
]}

Hoffman, I. F. ^{[1
]}

Eshleman, S. H. ^{[19
]}

Piwowar-Manning, E. ^{[19
]}

Cottle, L. ^{[4
]}

Zhang, X. C. ^{[2
]}

Makhema, J. ^{[25
]}

Mills, L. A. ^{[26
]}

Panchia, R. ^{[27
]}

Faesen, S. ^{[28
]}

Eron, J. ^{[1
]}

Gallant, J. ^{[29
]}

Havlir, D. ^{[30
]}

Swindells, S. ^{[31
]}

Elharrar, V. ^{[23
]}

Burns, D. ^{[23
]}

Taha, T. E. ^{[21
]}

Nielsen-Saines, K. ^{[32
]}

Celentano, D. D. ^{[22
]}

Essex, M. ^{[18
]}

Hudelson, S. E. ^{[19
]}

Redd, A. D. ^{[20
,24
]}

Fleming, T. R. ^{[5
]}

机构：

[1] Univ North Carolina Chapel Hill, Dept Med, Chapel Hill, NC USA

[2] Fred Hutchinson Canc Res Ctr, Div Vaccine & Infect Dis, 1124 Columbia St, Seattle, WA 98104 USA

[3] Fred Hutchinson Canc Res Ctr, Div Publ Hlth Sci, 1124 Columbia St, Seattle, WA 98104 USA

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

[5] Univ Washington, Dept Biostat, Seattle, WA 98195 USA

[6] FHI 360, Washington, DC USA

[7] FHI 360, Durham, NC USA

[8] YR Gaitonde Ctr AIDS Res & Educ, Madras, Tamil Nadu, India

[9] Natl AIDS Res Inst, Pune, Maharashtra, India

[10] Univ Zimbabwe, Harare, Zimbabwe

[11] Johns Hopkins Project, Coll Med, Blantyre, Malawi

[12] Inst Pesquisa Clin Evandro Chagas, Rio De Janeiro, Brazil

[13] Hosp Geral Nova Iguacu, Rio De Janeiro, Brazil

[14] Fiocruz MS, IOC, Lab AIDS & Imunol Mol, Rio De Janeiro, Brazil

[15] Hosp Nossa Senhora Conceicao GHC, Serv Infectol, Porto Alegre, RS, Brazil

[16] Chiang Mai Univ, Res Inst Hlth Sci, Chiang Mai, Thailand

[17] Fenway Inst, Boston, MA USA

[18] Harvard Sch Publ Hlth, Boston, MA USA

[19] Johns Hopkins Univ, Sch Med, Dept Pathol, Baltimore, MD 21205 USA

[20] Johns Hopkins Univ, Sch Med, Dept Med, Baltimore, MD 21205 USA

[21] Bloomberg Sch Publ Hlth, Dept Epidemiol, Baltimore, MD USA

[22] Johns Hopkins Bloomberg Sch Publ Hlth, Baltimore, MD USA

[23] NIAID, Div Aids, NIH, 9000 Rockville Pike, Bethesda, MD 20892 USA

[24] NIAID, Immunoregulat Lab, NIH, 9000 Rockville Pike, Bethesda, MD 20892 USA

[25] Botswana Harvard AIDS Inst, Gaborone, Botswana

[26] Ctr Dis Control & Prevent CDC, Div HIV AIDS Prevent, KEMRI CDC Res & Publ Hlth Collaborat HIV Res Bran, Kisumu, Kenya

[27] Univ Witwatersrand, Perinatal HIV Res Unit, Johannesburg, South Africa

[28] Univ Witwatersrand, Clin HIV Res Unit, Dept Med, Fac Hlth Sci, Johannesburg, South Africa

[29] Southwest CARE Ctr, Santa Fe, NM USA

[30] Univ Calif San Francisco, San Francisco, CA 94143 USA

[31] Univ Nebraska Med Ctr, Omaha, NE USA

[32] David Geffen UCLA Sch Med, Div Infect Dis, Los Angeles, CA USA

来源：

NEW ENGLAND JOURNAL OF MEDICINE | 2016年 / 375卷 / 09期

关键词：

RANDOMIZED-TRIAL; VIRAL LOAD; HPTN; 052; INFECTION;

D O I：

10.1056/NEJMoa1600693

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

BACKGROUND An interim analysis of data from the HIV Prevention Trials Network (HPTN) 052 trial showed that antiretroviral therapy (ART) prevented more than 96% of genetically linked infections caused by human immunodeficiency virus type 1 (HIV-1) in serodiscordant couples. ART was then offered to all patients with HIV-1 infection (index participants). The study included more than 5 years of follow-up to assess the durability of such therapy for the prevention of HIV-1 transmission. METHODS We randomly assigned 1763 index participants to receive either early or delayed ART. In the early-ART group, 886 participants started therapy at enrollment (CD4+ count, 350 to 550 cells per cubic millimeter). In the delayed-ART group, 877 participants started therapy after two consecutive CD4+ counts fell below 250 cells per cubic millimeter or if an illness indicative of the acquired immunodeficiency syndrome (i.e., an AIDS-defining illness) developed. The primary study end point was the diagnosis of genetically linked HIV-1 infection in the previously HIV-1-negative partner in an intention-to-treat analysis. RESULTS Index participants were followed for 10,031 person-years; partners were followed for 8509 person-years. Among partners, 78 HIV-1 infections were observed during the trial (annual incidence, 0.9%; 95% confidence interval [CI], 0.7 to 1.1). Viral-linkage status was determined for 72 (92%) of the partner infections. Of these infections, 46 were linked (3 in the early-ART group and 43 in the delayed-ART group; incidence, 0.5%; 95% CI, 0.4 to 0.7) and 26 were unlinked (14 in the early-ART group and 12 in the delayed-ART group; incidence, 0.3%; 95% CI, 0.2 to 0.4). Early ART was associated with a 93% lower risk of linked partner infection than was delayed ART (hazard ratio, 0.07; 95% CI, 0.02 to 0.22). No linked infections were observed when HIV-1 infection was stably suppressed by ART in the index participant. CONCLUSIONS The early initiation of ART led to a sustained decrease in genetically linked HIV-1 infections in sexual partners. (Funded by the National Institute of Allergy and Infectious Diseases; HPTN 052 ClinicalTrials.gov number, NCT00074581.)

引用

页码：830 / 839

页数：10

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