Cabotegravir for the prevention of HIV-1 in women: results from HPTN 084, a phase 3, randomised clinical trial

作者：Sinéad Delany‐Moretlwe, James P. Hughes, Peter Bock, Samuel Gurrion Ouma, Portia Hunidzarira, Dishiki Kalonji, Noel Kayange, Joseph Makhema, Patricia Mandima, Carrie Mathew, Elizabeth Spooner, Juliet Mpendo, Pamela Mukwekwerere, Nyaradzo Mgodi, Patricia Nahirya Ntege, Gonasagrie Nair, Clemensia Nakabiito, Harriet Nuwagaba‐Biribonwoha, Ravindre Panchia, Nishanta Singh, Bekezela Siziba, Jennifer Farrior, Scott Rose, Peter L. Anderson, Susan H. Eshleman, Mark A. Marzinke, Craig W. Hendrix, Stephanie Beigel-Orme, Sybil Hosek, Elizabeth E. Tolley, Nirupama Sista, Adeola Adeyeye, James F. Rooney, Alex R. Rinehart, William Spreen, Kimberly Y. Smith, Brett Hanscom, Myron S. Cohen, Mina C. Hosseinipour, Aida Asmelash, Alice Sehurutshi, Allan Baguma, Anita Marais, Barbarah Kawoozo, Bongiwe Prudence Malinga, Brenda Gati Mirembe, Brenda Okech, Bryan Esterhuizen, Caroline Murombedzi, Daphne Gadama, Eldinah Hwengwere, Elizabeth Roos, Elizabeth S Magada, Emily Shava, Estelle Piwowar-Manning, Eunice Tahuringana, Felix GS Muhlanga, Francesca Conradie, Frank Angira, Gertrude Nanyonjo, Girisha Kistnasami, Hazzie Mvula, Ishana Naidoo, Jaco Horak, Jane Jere, Jeeva Moodley, Katie Shin, Kerry Nel, Kevin Bokoch, Lilian Birungi, Lynda Emel, Maletsatsi Monametsi, Marvelous Sibanda, Mercy Mutambanengwe, Miria Chitukuta, Moleen Matimbira, Muchaneta Bhondai-Mhuri, Ncamsile Sibisi, Neetha Morar, Netsai Mudzonga, Paul Natureeba, Paul Richardson, Petina Musara, Pippa Macdonald, Rejoice Nkambule, Repelang Mosime, Rhonda White, Ribka Berhanu, Ritha Ncube-Sihlongonyane, Rogers Sekabira, Samantha Siva, Saresha Pillay, Shamelle Govender, Sheiala Bamweyana, Siyabonga Nzimande, Steve Innes, Sufia Dadabhai, Taraz Samandari, Tchangani Tembo, Thandie Lungu Mabedi, Thandiwe Chirenda, Tinashe Chidemo, Victor Mudhune, Vikesh Naidoo, Wadzanai Samaneka, Yaw Agyei, Yeukai Musodza, Yolandie Fourie, Zakir Gaffoor · 发表于：The Lancet · 年份：2022 · DOI：10.1016/s0140-6736(22)00538-4 · 被引用次数：567 · 研究领域：HIV/AIDS Research and Interventions、Reproductive tract infections research、HIV, Drug Use, Sexual Risk

BACKGROUND: Oral pre-exposure prophylaxis has been introduced in more than 70 countries, including many in sub-Saharan Africa, but women experience considerable barriers to daily pill-taking, such as stigma, judgement, and the fear of violence. Safe and effective long-acting agents for HIV prevention are needed for women. We aimed to evaluate the safety and efficacy of injectable cabotegravir compared with daily oral tenofovir diphosphate plus emtricitabine (TDF-FTC) for HIV prevention in HIV-uninfected women. METHODS: HPTN 084 was a phase 3, randomised, double-blind, double-dummy, active-controlled, superiority trial in 20 clinical research sites in seven countries in sub-Saharan Africa. Participants were eligible for enrolment if they were assigned female sex at birth, were aged 18-45 years, reported at least two episodes of vaginal intercourse in the previous 30 days, were at risk of HIV infection based on an HIV risk score, and agreed to use a long-acting reversible contraceptive method. Participants were randomly assigned (1:1) to either active cabotegravir with TDF-FTC placebo (cabotegravir group) or active TDF-FTC with cabotegravir placebo (TDF-FTC group). Study staff and participants were masked to study group allocation, with the exception of the site pharmacist who was responsible for study product preparation. Participants were prescribed 5 weeks of daily oral product followed by intramuscular injections every 8 weeks after an initial 4-week interval load, alongsid...