e-Article
Safety, uptake, and use of a dapivirine vaginal ring for HIV-1 prevention in African women (HOPE): an open-label, extension study
Document Type
article
Author
Baeten, Jared M; Palanee-Phillips, Thesla; Mgodi, Nyaradzo M; Mayo, Ashley J; Szydlo, Daniel W; Ramjee, Gita; Mirembe, Brenda Gati; Mhlanga, Felix; Hunidzarira, Portia; Mansoor, Leila E; Siva, Samantha; Govender, Vaneshree; Makanani, Bonus; Naidoo, Logashvari; Singh, Nishanta; Nair, Gonasagrie; Chinula, Lameck; Parikh, Urvi M; Mellors, John W; Balán, Iván C; Ngure, Kenneth; van der Straten, Ariane; Scheckter, Rachel; Garcia, Morgan; Peda, Melissa; Patterson, Karen; Livant, Edward; Bunge, Katherine; Singh, Devika; Jacobson, Cindy; Jiao, Yuqing; Hendrix, Craig W; Chirenje, Zvavahera M; Nakabiito, Clemensia; Taha, Taha E; Jones, Judith; Torjesen, Kristine; Nel, Annalene; Rosenberg, Zeda; Soto-Torres, Lydia E; Hillier, Sharon L; Brown, Elizabeth R; Aanyu, Dorothy; Abima, John; Abullarade, Janne; Agarwal, Priyanka; Ahluwalia, Surabhi; Akasiima, Simon Africa; Akello, Carolyne Agwau; Albert, Samuel; Alphale, Motsamai; Alphonse, Calins; Apeduno, Lucy; Aranda, Sara; Aridor, Orly; Arnolds, Shakeera; Asiimwe, Prossy; Atujuna, Millicent; Atwebembere, Didas; Baboolall, Lakshmi; Badana, Kiran; Balamusani, David; Banda, Gabriel; Banda, Towera Whitney; Baugh, Jennifer; Baziira, James Amos; Beamer, May; Bebeza, Sivuyisiwe Asanda; Bekker, Linda-Gail; Bell, Ian; Bemer, Meagan; Berman, Richard; Berthiaume, Jennifer; Bezak, Linda; Bhagwandin, Yashveer; Bhayat, Hassen Anwar; Bhengu, Nokulunga; Bhengu, Sonto; Bhoola, Aruna; Biira, Florence Asiimwe; Bittoni, Daniel; Black, Roberta; Blose, Nombuso Jacqueline; Boks, Pearl; Bolton, Stephen Gordon; Botya, Phathiswa; Brown, Amanda; Brown, Elizabeth; Brown, Helen; Bruce, Robyn Helen; Bukenya, Luke Erismus; Bukirwa, Aidah; Bunts, Lisa; Buthelezi, Fezile; Buthelezi, Mbongeleni William; Buthelezi, Samkelisiwe Dumisile; Byogero, Rose
Source
The Lancet HIV. 8(2)
Subject
Language
Abstract
BackgroundTwo phase 3 clinical trials showed that use of a monthly vaginal ring containing 25 mg dapivirine was well tolerated and reduced HIV-1 incidence in women by approximately 30% compared with placebo. We aimed to evaluate use and safety of the dapivirine vaginal ring (DVR) in open-label settings with high background rates of HIV-1 infection, an important step for future implementation.MethodsWe did a phase 3B open-label extension trial of the DVR (MTN-025/HIV Open-label Prevention Extension [HOPE]). Women who were HIV-1-negative and had participated in the MTN-020/ASPIRE phase 3 trial were offered 12 months of access to the DVR at 14 clinical research centres in Malawi, South Africa, Uganda, and Zimbabwe. At each visit (monthly for 3 months, then once every 3 months), women chose whether or not to accept the offer of the ring. Used, returned rings were tested for residual amounts of dapivirine as a surrogate marker for adherence. HIV-1 serological testing was done at each visit. Dapivirine amounts in returned rings and HIV-1 incidence were compared with data from the ASPIRE trial, and safety was assessed. This study is registered with ClinicalTrials.gov, NCT02858037.FindingsBetween July 16, 2016, and Oct 10, 2018, of 1756 women assessed for eligibility, 1456 were enrolled and participated in the study. Median age was 31 years (IQR 27-37). At baseline, 1342 (92·2%) women chose to take the DVR; ring acceptance was more than 79% at each visit up until 12 months and 936 (73·2%) of 1279 chose to take the ring at all visits. 12 530 (89·3%) of 14 034 returned rings had residual dapivirine amounts consistent with some use during the previous month (>0·9 mg released) and the mean dapivirine amount released was greater than in the ASPIRE trial (by 0·21 mg; p