Cabotegravir for HIV Prevention in Cisgender Men and Transgender Women

被引：536

作者：

Landovitz, Raphael J. ^{[1
]}

Donnell, Deborah ^{[5
]}

Clement, Meredith E. ^{[6
]}

Hanscom, Brett ^{[5
]}

Cottle, Leslie ^{[5
]}

Coelho, Lara ^{[7
]}

Cabello, Robinson ^{[11
]}

Chariyalertsak, Suwat ^{[15
]}

Dunne, Eileen F. ^{[2
,17
]}

Frank, Ian ^{[20
]}

Gallardo-Cartagena, Jorge A. ^{[12
]}

Gaur, Aditya H. ^{[22
]}

Gonzales, Pedro ^{[13
]}

Tran, Ha V. ^{[23
]}

Hinojosa, Juan C. ^{[14
]}

Kallas, Esper G. ^{[8
]}

Kelley, Colleen F. ^{[18
]}

Losso, Marcelo H. ^{[26
]}

Madruga, J. Valdez ^{[9
]}

Middelkoop, Keren ^{[28
]}

Phanuphak, Nittaya ^{[16
]}

Santos, Breno ^{[10
]}

Sued, Omar ^{[27
]}

Valencia Huamani, Javier ^{[13
]}

Overton, Edgar T. ^{[29
]}

Swaminathan, Shobha ^{[30
]}

del Rio, Carlos ^{[18
,19
]}

Gulick, Roy M. ^{[31
]}

Richardson, Paul ^{[32
]}

Sullivan, Philip ^{[32
]}

Piwowar-Manning, Estelle ^{[32
]}

Marzinke, Mark ^{[32
]}

Hendrix, Craig ^{[32
]}

Li, Maoji ^{[5
]}

Wang, Zhe ^{[5
]}

Marrazzo, Jeanne ^{[29
]}

Daar, Eric

Asmelash, Aida ^{[24
]}

Brown, Todd T. ^{[32
]}

Anderson, Peter ^{[33
]}

Eshleman, Susan H. ^{[32
]}

Bryan, Marcus ^{[24
]}

Blanchette, Cheryl ^{[24
]}

Lucas, Jonathan ^{[24
]}

Psaros, Christina ^{[34
]}

Safren, Steven ^{[35
]}

Sugarman, Jeremy ^{[32
]}

Scott, Hyman ^{[3
]}

Eron, Joseph J. ^{[23
]}

Fields, Sheldon D. ^{[21
]}

机构：

[1] Univ Calif Los Angeles, David Geffen Sch Med, Ctr Clin AIDS Res & Educ, Los Angeles, CA 90095 USA

[2] Harbor UCLA Med Ctr, Lundquist Inst, Torrance, CA 90509 USA

[3] San Francisco Dept Publ Hlth, San Francisco, CA USA

[4] Gilead Sci, Foster City, CA USA

[5] Fred Hutchinson Canc Res Ctr, 1124 Columbia St, Seattle, WA 98104 USA

[6] Louisiana State Univ, Hlth Sci Ctr, New Orleans, LA USA

[7] Inst Nacl Infectol Evandro Chagas Fiocruz, Rio De Janeiro, Brazil

[8] Univ Sao Paulo, Sao Paulo, Brazil

[9] Ctr Referencia & Treinamento DST AIDS SP, Sao Paulo, Brazil

[10] Hosp Nossa Senhora Conceicao, Porto Alegre, RS, Brazil

[11] Via Libre, Lima, Peru

[12] Univ Nacl Mayor San Marcos, Lima, Peru

[13] Asoc Civil Impacta Salud & Educ, Lima, Peru

[14] Asociac Civil Selva Amazon, Iquitos, Peru

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

[16] Inst HIV Res & Innovat, Bangkok, Thailand

[17] Emory Univ, Div HIV AIDS Prevent, Ctr Dis Control & Prevent, Atlanta, GA 30322 USA

[18] Emory Univ, Sch Med, Atlanta, GA USA

[19] Emory Univ, Rollins Sch Publ Hlth, Atlanta, GA 30322 USA

[20] Univ Penn, Perelman Sch Med, Philadelphia, PA 19104 USA

[21] Penn State Univ, State Coll, University Pk, PA 16802 USA

[22] St Jude Childrens Res Hosp, 332 N Lauderdale St, Memphis, TN 38105 USA

[23] Univ N Carolina, Chapel Hill, NC 27515 USA

[24] FHI 360, Durham, NC USA

[25] ViiV Healthcare, Res Triangle Pk, NC USA

[26] Hosp Gen Agudos Jose Maria Ramos Mejia, Buenos Aires, DF, Argentina

[27] Fdn Huesped, Buenos Aires, DF, Argentina

[28] Univ Cape Town, Inst Infect Dis & Mol Med, Cape Town, South Africa

[29] Univ Alabama Birmingham, Birmingham, AL USA

[30] Rutgers New Jersey Med Sch, Newark, NJ USA

[31] Weill Cornell Med, New York, NY USA

[32] Johns Hopkins Univ, Baltimore, MD USA

[33] Univ Colorado Anschutz Med Campus, Aurora, CO USA

[34] Massachusetts Gen Hosp, Boston, MA 02114 USA

[35] Univ Miami, Coral Gables, FL 33124 USA

[36] Off AIDS Res, Rockville, MD USA

[37] NIAID, Div AIDS, NIH, Rockville, MD USA

来源：

NEW ENGLAND JOURNAL OF MEDICINE | 2021年 / 385卷 / 07期

基金：

美国国家卫生研究院;

关键词：

PREEXPOSURE PROPHYLAXIS; PROTECTS MACAQUES; ANTIRETROVIRAL PROPHYLAXIS; DOUBLE-BLIND; HIGH-RISK; TENOFOVIR; SEX; EMTRICITABINE; INFECTION; PHASE-3;

D O I：

10.1056/NEJMoa2101016

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

Injectable Cabotegravir for Prevention of HIV Infection Antiviral medication has emerged as an important tool in the prevention of HIV infection. In this randomized, controlled trial, an injectable long-acting agent, cabotegravir, was found to be superior to daily oral tenofovir disoproxil fumarate-emtricitabine in preventing incident HIV infection in cisgender men and transgender women who have sex with men. Background Safe and effective long-acting injectable agents for preexposure prophylaxis (PrEP) for human immunodeficiency virus (HIV) infection are needed to increase the options for preventing HIV infection. Methods We conducted a randomized, double-blind, double-dummy, noninferiority trial to compare long-acting injectable cabotegravir (CAB-LA, an integrase strand-transfer inhibitor [INSTI]) at a dose of 600 mg, given intramuscularly every 8 weeks, with daily oral tenofovir disoproxil fumarate-emtricitabine (TDF-FTC) for the prevention of HIV infection in at-risk cisgender men who have sex with men (MSM) and in at-risk transgender women who have sex with men. Participants were randomly assigned (1:1) to receive one of the two regimens and were followed for 153 weeks. HIV testing and safety evaluations were performed. The primary end point was incident HIV infection. Results The intention-to-treat population included 4566 participants who underwent randomization; 570 (12.5%) identified as transgender women, and the median age was 26 years (interquartile range, 22 to 32). The trial was stopped early for efficacy on review of the results of the first preplanned interim end-point analysis. Among 1698 participants from the United States, 845 (49.8%) identified as Black. Incident HIV infection occurred in 52 participants: 13 in the cabotegravir group (incidence, 0.41 per 100 person-years) and 39 in the TDF-FTC group (incidence, 1.22 per 100 person-years) (hazard ratio, 0.34; 95% confidence interval, 0.18 to 0.62). The effect was consistent across prespecified subgroups. Injection-site reactions were reported in 81.4% of the participants in the cabotegravir group and in 31.3% of those in the TDF-FTC group. In the participants in whom HIV infection was diagnosed after exposure to CAB-LA, INSTI resistance and delays in the detection of HIV infection were noted. No safety concerns were identified. Conclusions CAB-LA was superior to daily oral TDF-FTC in preventing HIV infection among MSM and transgender women. Strategies are needed to prevent INSTI resistance in cases of CAB-LA PrEP failure. (Funded by the National Institute of Allergy and Infectious Diseases and others; HPTN 083 ClinicalTrials.gov number, .)

引用

页码：595 / 608

页数：14

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