Twice-Yearly Lenacapavir or Daily F/TAF for HIV Prevention in Cisgender Women

被引：159

作者：

Bekker, Linda-Gail ^{[1
]}

Das, Moupali ^{[21
]}

Karim, Quarraisha Abdool ^{[3
,22
]}

Ahmed, Khatija ^{[8
,9
]}

Batting, Joanne ^{[11
]}

Brumskine, William ^{[13
,23
]}

Gill, Katherine ^{[1
]}

Harkoo, Ishana ^{[4
]}

Jaggernath, Manjeetha ^{[5
]}

Kigozi, Godfrey ^{[24
]}

Kiwanuka, Noah ^{[25
]}

Kotze, Philip ^{[14
,15
]}

Lebina, Limakatso ^{[6
]}

Louw, Cheryl E. ^{[16
]}

Malahleha, Moelo ^{[12
]}

Manentsa, Mmatsie ^{[17
]}

Mansoor, Leila E. ^{[4
]}

Moodley, Dhayendre ^{[4
]}

Naicker, Vimla ^{[7
]}

Naidoo, Logashvari ^{[7
]}

Naidoo, Megeshinee ^{[4
]}

Nair, Gonasagrie ^{[1
]}

Ndlovu, Nkosiphile ^{[18
]}

Palanee-Phillips, Thesla ^{[18
,27
]}

Panchia, Ravindre ^{[19
]}

Pillay, Saresha ^{[7
]}

Potloane, Disebo ^{[4
]}

Selepe, Pearl ^{[20
]}

Singh, Nishanta ^{[7
]}

Singh, Yashna ^{[1
]}

Spooner, Elizabeth ^{[7
]}

Ward, Amy M. ^{[2
]}

Zwane, Zwelethu ^{[10
]}

Ebrahimi, Ramin ^{[21
]}

Zhao, Yang ^{[21
]}

Kintu, Alexander ^{[21
]}

Deaton, Chris ^{[28
]}

Carter, Christoph C. ^{[21
]}

Baeten, Jared M. ^{[21
]}

Kiweewa, Flavia Matovu ^{[25
,26
]}

机构：

[1] Univ Cape Town, Desmond Tutu Hiv Ctr, Cape Town, South Africa

[2] Univ Cape Town, Dept Med, Vuka Res Clin, Cape Town, South Africa

[3] Univ KwaZulu Natal, Dept Epidemiol & Prevent, Ctr AIDS Programme Res South Africa, Durban, South Africa

[4] Univ KwaZulu Natal, Ctr AIDS Programme Res South Africa, Durban, South Africa

[5] Univ Witwatersrand, Dept Obstet & Gynaecol, Wits Maternal Adolescent & Child Hlth Res Unit, Durban, South Africa

[6] South African Med Res Council, Africa Hlth Res Inst, Durban, South Africa

[7] South African Med Res Council, Hiv & Other Infect Dis Res Unit, Durban, South Africa

[8] Setshaba Res Ctr, Tshwane City, South Africa

[9] Univ Pretoria, Fac Hlth Sci, Sch Med, Dept Med Microbiol, Pretoria, South Africa

[10] Aurum Inst, Pretoria Clin Res Site, Pretoria, South Africa

[11] Ndevana Community Res Site, Fdn Profess Dev, East London, South Africa

[12] Synergy Biomed Res Inst, East London, South Africa

[13] Aurum Inst, Clin Res Div, Rustenburg, South Africa

[14] Qhakaza Mbokodo Res Clin, Ladysmith, South Africa

[15] La Verna Hosp, Ladysmith, South Africa

[16] Madibeng Ctr Res, Brits, South Africa

[17] Univ Witwatersrand, Aurum Inst, Johannesburg, South Africa

[18] Univ Witwatersrand, Wits Reprod Hlth & Hiv Inst, Fac Hlth Sci, Sch Publ Hlth, Johannesburg, South Africa

[19] Univ Witwatersrand, Kliptown Aeroton Clin Res Site, Perinatal Hiv Res Unit, Soweto, South Africa

[20] Aurum Inst, Klerksdorp Clin Res Site, Klerksdorp, South Africa

[21] Gilead Sci, 333 Lakeside Dr, Foster City, CA 94404 USA

[22] Columbia Univ, Dept Epidemiol, Mailman Sch Publ Hlth, New York, NY USA

[23] Vanderbilt Univ, Dept Med, Nashville, TN USA

[24] Africa Med & Behav Sci Org, Kalisizo, South Africa

[25] Makerere Univ, Dept Epidemiol & Biostat, Sch Publ Hlth, Kampala, Uganda

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

[27] Univ Washington, Sch Publ Hlth, Dept Epidemiol, Seattle, WA USA

[28] Gilead Sci, Cambridge, England

来源：

NEW ENGLAND JOURNAL OF MEDICINE | 2024年 / 391卷 / 13期

关键词：

TENOFOVIR DISOPROXIL FUMARATE; PREEXPOSURE PROPHYLAXIS; DOUBLE-BLIND; PHASE-3; EMTRICITABINE; CABOTEGRAVIR; ALAFENAMIDE;

D O I：

10.1056/NEJMoa2407001

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

BACKGROUND There are gaps in uptake of, adherence to, and persistence in the use of preexposure prophylaxis for human immunodeficiency virus (HIV) prevention among cisgender women. METHODS We conducted a phase 3, double-blind, randomized, controlled trial involving adolescent girls and young women in South Africa and Uganda. Participants were assigned in a 2:2:1 ratio to receive subcutaneous lenacapavir every 26 weeks, daily oral emtricitabine-tenofovir alafenamide (F/TAF), or daily oral emtricitabine-tenofovir disoproxil fumarate (F/TDF; active control); all participants also received the alternate subcutaneous or oral placebo. We assessed the efficacy of lenacapavir and F/TAF by comparing the incidence of HIV infection with the estimated background incidence in the screened population and evaluated relative efficacy as compared with F/TDF. RESULTS Among 5338 participants who were initially HIV-negative, 55 incident HIV infections were observed: 0 infections among 2134 participants in the lenacapavir group (0 per 100 person-years; 95% confidence interval [CI], 0.00 to 0.19), 39 infections among 2136 participants in the F/TAF group (2.02 per 100 person-years; 95% CI, 1.44 to 2.76), and 16 infections among 1068 participants in the F/TDF group (1.69 per 100 person-years; 95% CI, 0.96 to 2.74). Background HIV incidence in the screened population (8094 participants) was 2.41 per 100 person-years (95% CI, 1.82 to 3.19). HIV incidence with lenacapavir was significantly lower than background HIV incidence (incidence rate ratio, 0.00; 95% CI, 0.00 to 0.04; P<0.001) and than HIV incidence with F/TDF (incidence rate ratio, 0.00; 95% CI, 0.00 to 0.10; P<0.001). HIV incidence with F/TAF did not differ significantly from background HIV incidence (incidence rate ratio, 0.84; 95% CI, 0.55 to 1.28; P=0.21), and no evidence of a meaningful difference in HIV incidence was observed between F/TAF and F/TDF (incidence rate ratio, 1.20; 95% CI, 0.67 to 2.14). Adherence to F/TAF and F/TDF was low. No safety concerns were found. Injection-site reactions were more common in the lenacapavir group (68.8%) than in the placebo injection group (F/TAF and F/TDF combined) (34.9%); 4 participants in the lenacapavir group (0.2%) discontinued the trial regimen owing to injection-site reactions. CONCLUSIONS No participants receiving twice-yearly lenacapavir acquired HIV infection. HIV incidence with lenacapavir was significantly lower than background HIV incidence and HIV incidence with F/TDF.

引用

页码：1179 / 1192

页数：14

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