CROI 2016 Abstract eBook

Abstract Listing

Oral Abstracts

110LB Safety and Efficacy of Dapivirine Vaginal Ring for HIV-1 Prevention in AfricanWomen Annalene Nel 1 ; Saidi Kapiga 2 ; Linda-Gail Bekker 3 ; Brid Devlin 4 ; Maarten Borremans 5 ; Zeda Rosenberg 4 ; for the IPM 027/Ring Study Research CenterTeams 1 Intl Partnership for Microbicides, Paarl, South Africa; 2 London Sch of Hygiene & Trop Med, London, UK; 3 Desmond Tutu HIV Cntr, Cape Town, South Africa; 4 International Partnership for Microbicides, Silver Spring, MD, USA; 5 SGS Life Science Services, Mechelen, Belgium Background: A monthly vaginal ring (Ring-004), containing 25 mg dapivirine, was evaluated for safety and efficacy against HIV-1 infection in two large Phase III clinical trials, IPM 027 and MTN-020. Higher than anticipated HIV-1 incidence was observed and final safety and efficacy analyses were performed for IPM 027 prior to the planned completion of this time-driven trial based on an independent DSMB recommendation. The final results of IPM 027 at the data cut-off point of 16 October 2015 are reported. Methods: IPM 027 is a Phase III, multi-centre, double-blind, randomized, placebo-controlled trial, conducted at six research centers in South Africa, and one center in Uganda to assess the safety and efficacy of dapivirine vaginal ring, inserted once every 4 weeks over 24 months, in healthy, sexually active HIV-negative women, 18 to 45 years of age. The primary efficacy endpoint was the rate of HIV-1 seroconversion and the primary safety endpoint was incidence of adverse events (AEs). Results: 1959 women (1762 in South Africa and 197 in Uganda) were randomized in a 2:1 ratio to receive either a dapivirine ring or a placebo ring. The median age at enrolment was 25 years, and 91%were unmarried. At the data cut-off point, the total number of person years of follow-up was 2805 and 761 women had completed the two year follow-up period. A total of 133 post-randomization HIV-1 infections occurred: 77 among women assigned to dapivirine ring (incidence 4.08 per 100 person-years) and 56 among women assigned to placebo (incidence 6.10 per 100 person-years). Dapivirine vaginal ring reduced the risk of HIV-1 infection by 30.7% (95% CI: 0.90-51.5%; p=0.0401) relative to placebo. A 37.5% (95% CI: 3.5-59.5%) reduction in HIV-1 infection was observed in a subgroup analysis of women older than 21 years. Product-related AEs included metrorrhagia, menometrorrhagia, pelvic discomfort/pain, suprapubic pain and application site pain. The rate of AEs, including product-related AEs, urogenital AEs, serious AEs and deaths, was similar between treatment arms. Additional analyses of adherence to product use as measured by dapivirine levels in plasma and residual dapivirine levels in used rings will be presented. Conclusions: Dapivirine Vaginal Ring-004 was safe and effective in preventing HIV-1 infection via vaginal intercourse in women in sub-Saharan Africa and may be an important HIV prevention option for women at risk of HIV infection. 111 Botswana Is Close to Meeting UNAIDS 2020 Goals of 90-90-90 Coverage Tendani Gaolathe 1 ; KathleenWirth 2 ; Molly Pretorius Holme 2 ; Joseph Makhema 1 ; Sikhulile Moyo 3 ; EricTchetgenTchetgen 2 ; Refeletswe Lebelonyane 4 ; Lisa A. Mills 5 ; M. Essex 2 ; Shahin Lockman 6 1 Botswana Harvard AIDS Inst Partnership, Gaborone, Botswana; 2 Harvard Sch of PH, Boston, MA, USA; 3 Botswana Harvard AIDS Inst Partnership, Gaborone, Botswana; 4 Ministry of Hlth, Gaborone, Botswana; 5 CDC, Gaborone, Botswana; 6 Brigham and Women’s Hosp, Harvard Med Sch, Boston, MA, USA Background: Many countries have experienced challenges with achieving high rates of HIV testing and treatment. Botswana may serve as a useful “demonstration case” in assessing the feasibility of approaching the new UNAIDS 2020 targets for 90% of HIV-infected persons knowing their status, 90% of these individuals receiving sustained ART, and 90% of those starting ART having undetectable HIV-1 RNA. Methods: A population-based random sample of individuals was recruited and interviewed in 24 communities in Botswana from October 2013 to July 2015 as part of a large, ongoing PEPFAR funded pair-matched community-randomized trial designed to evaluate the impact of a combination prevention package on HIV incidence (the “BCPP” study). A random sample of 20% of households in each of these 24 communities was selected from a list of all households created using Google Maps. Consenting household residents age 16-64 years who were Botswana citizens were asked to participate in an individual questionnaire, and to have blood drawn for HIV testing in absence of written documentation of positive HIV status (and for HIV-RNA testing if HIV-infected, regardless of ART status). Results: Seventy-nine percent of enumerated eligible household members took part in the survey (11% refused participation and 10%were absent). Among 9,780 participants, 2,727 (28%) were HIV-infected; 2,226 (82%) of the HIV-infected residents already knew their HIV status. Among those who knew their HIV status, 1,915 (86%) were receiving ART (this represented 95% of those eligible for ART by national guidelines). Overall, 70% of all HIV-infected persons were on ART. We obtained an HIV-1 RNA result in greater than 99% of HIV-infected. Of the 1,932 individuals who had already started ART (including 17 defaulters), 1,837 (95%) had HIV-1 RNA <400 copies/mL and 1,764 (91%) had HIV-1 RNA <40 copies/mL. Conclusions: Botswana, a resource-constrained setting with high HIV prevalence, has achieved very high rates of HIV testing and treatment coverage. Rates of knowledge of HIV status, ART initiation, and virologic suppression are close to the UNADS 90-90-90 targets, at 82%, 86%, and 95%, respectively. Overall, 67% of HIV-infected persons had HIV-1 RNA<400 copies/mL, approaching the UNAIDS target of 73%.

Oral Abstracts

112 Streamlining Antiretroviral Therapy Uptake: A Stepped-Wedge Cluster Randomized Trial Gideon Amanyire 1 ; Fred Collins Semitala 1 ; Jennifer Namusobya 1 ; Richard Katuramu 2 ; Leatitia Kampiire 2 ; JeannaWallenta 3 ; DavidV. Glidden 3 ; Moses R. Kamya; DianeV. Havlir 3 ; Elvin H. Geng 3 1 Makerere Univ Coll of Hlth Scis, Kampala, Uganda; 2 Infectious Diseases Rsr Collab, Kampala, Uganda; 3 Univ of California San Francisco, San Francisco, CA, USA Background: In Africa, uptake of antiretroviral therapy (ART), even among clinically-eligible patients presenting for care, is often sub-optimal. Common reasons include sluggish diffusion of contemporary evidence about risks of delay (especially among symptomatic patients); overnight CD4 processing and therefore inefficient determination of treatment eligibility; and multiple pre-treatment adherence counseling norms.

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CROI 2016