CROI 2015 Program and Abstracts

Abstract Listing

Oral Abstracts

ratio [IRR], 1.0; 95% CI: 0.7-1.4). TFV gel effectiveness was highest in women who reported product use in 〉 72% of sex acts (IRR 0.43; 95% CI 0.09-1.61); however, this subgroup represented only 20% of participants. In the case-cohort substudy, high TFV in CVL was significantly associated with a reduction in HIV acquisition (HR: 0.52; 95% CI: 0.27-0.99; p=0.04). Conclusions: In this trial, pericoital vaginal TFV 1% gel was not effective in preventing HIV acquisition. In a stratified analysis, there was an association between adherence based on returned applicators and HIV effectiveness, and a significant association between TFV levels in CVL and reduction in HIV incidence. 27 Effect of Oral and Gel Tenofovir on Genital HSV Shedding in Immunocompetent Women Rachel A. Bender Ignacio 1 ;Tara Perti 2 ; Amalia S. Magaret 1 ; Sharanya Rajagopal 1 ; Meei-LeeW. Huang 1 ; Christine M. Johnston 1 ; Stacy Selke 1 ; Jeanne M. Marrazzo 1 ; AnnaWald 1 1 University of Washington, Seattle, WA, US; 2 US Centers for Disease Control and Prevention (CDC), Atlanta, GA, US Background: Tenofovir is a potent anti-HIV agent with efficacy in studies of pre-exposure prophylaxis when taken orally or used as intravaginal gel. Recent studies suggest that tenofovir also reduces the risk of HSV-2 acquisition. Whether oral or gel tenofovir may be useful in HSV disease management, or to decrease HIV and HSV-2 transmission from co-infected persons, is unclear. Methods: We randomized immunocompetent women with symptomatic HSV-2 infection 2:2:1 to oral tenofovir disoproxil fumarate (TDF)/placebo vaginal gel, oral placebo/ tenofovir (TFV) vaginal gel, or double placebo in a one-way cross-over clinical trial. Women collected twice daily genital swabs for HSV PCR and completed symptom diaries during a 4-week lead-in and 5 week treatment phase. The primary intent-to-treat analysis was within-arm comparison of shedding rates and genital lesions with Poisson generalized linear mixed effects models and shedding quantity with a linear mixed-effects model. Results: 73 women were enrolled and 64 completed the lead-in observation phase and were randomized: 24 women to TDF, 27 to TFV gel, and 13 to placebo. Relative to baseline, genital HSV shedding showed a small decrease from 22.9% to 19.5% (RR=0.86 p=0.09) in the TDF arm, but did not differ in the TFV gel arm (13.8% versus 12.0%; RR=0.94, p=0.54) or in the placebo arm (21.3% versus 20.4%; RR=0.90, p=0.45; Table 1). Asymptomatic shedding decreased in the TDF arm only (RR=0.74, p=0.01). There was no change in days with HSV lesions or number of shedding episodes. Shedding quantity decreased by 0.50 log 10 copies in the TFV gel arm (p=0.008), but remained consistent in the TDF (p=0.18) and placebo arms (p=0.45). The per-protocol analysis included 20 women in the TDF arm, 20 in the TFV gel arm, and 9 in the placebo armwho completed 33 days of study product with 90% adherence. Relative to baseline, the shedding frequency was reduced in the TDF arm (RR=0.74, p=0.006), and quantity was reduced in the TDF (0.41 log) and TFV gel arms (0.6 log); other findings were similar to the full cohort. The TDF and TFV products were both well tolerated, and adherence was 97% by returned product count in all arms. Conclusions: Oral TDF causes small reductions in shedding and lesion rate, and quantity of virus shed when used consistently. Vaginal TFV gel decreases shedding quantity by 60%. In contrast to evidence that oral and gel tenofovir may reduce HSV-2 acquisition, benefits in treatment of established HSV-2 infection are minimal. 28 Injectable Hormonal Contraception Use andWomen’s Risk for HSV-2 Acquisition Mary K. Grabowski 1 ; Ronald H. Gray 1 ; Fred Makumbi 2 ; Joseph Kagaayi 2 ; Andrew D. Redd 3 ; Fred Nalugoda 2 ; Maria J.Wawer 1 ; David Serwadda 4 ;Thomas C. Quinn 3 ; Aaron A.Tobian 5 1 Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, US; 2 Rakai Health Sciences Program, Kalisizo, Uganda; 3 National Institute of Allergy and Infectious Diseases (NIAID), Bethesda, MD, US; 4 Makerere University College of Health Sciences, Kampala, Uganda; 5 Johns Hopkins University, Baltimore, MD, US Background: Injectable hormonal contraception (HC) use has been associated with increased risk of HIV acquisition in women, but findings are inconsistent. The pathophysiology of how injectable HC use might increase HIV risk is unclear. Heightened risk for other sexually transmitted infections (STI) has been postulated as a possible mechanism, but it is unknown if injectable HC increases risk for other viral STIs. We assessed the association between oral and injectable HC use and incident herpes simplex virus type 2 (HSV-2), which is a risk factor for HIV acquisition. Methods: Risk of incident HSV-2 associated with HC use was assessed among 682 HIV and HSV-2-negative women whose HIV-negative male partners were enrolled in a trial of medical male circumcision in Rakai, Uganda. Women were followed annually over two years. HSV-2 incidence was compared among women using injectable HC stratified into consistent, newly initiated, or discontinued use between visits, women using oral HC, pregnant women, and women who were neither pregnant nor using HC (referent group). Hazard ratios (HR) were estimated using discrete-time Cox proportional hazards models with adjustment for demographics, sexual behaviors, and condom use. Results: We identified 70 incident HSV-2 events. Incidence was 13.1/100 person-years (py) among women consistently using injectable HC, and 3.9 and 5.2/100 py among women initiating and discontinuing injectable HC, respectively. Incidence was 2.8/100 py among oral HC users, while among non-HC users, incidence was 4.3/100 py in pregnant women and 6.6/100 py in non-pregnant non-HC using women. Compared to women who were neither pregnant nor using HC, the adjusted hazard ratio of HSV-2 acquisition among women consistently using injectable HC was 2.26 (95%CI: 1.09-4.69, p=0.029). Among 132 women with HSV-2 positive partners, incidence was 36.4/100 py in consistent injectable HC users and 10.6/100 py in women who were neither pregnant nor using HC (adjHR: 6.23; 1.49-26.3, p=0.012). There was no increased risk for HSV-2 among women who recently initiated or discontinued injectable HC, oral HC users, or pregnant women. Conclusions: Our data suggest consistent use of injectable HC is associated with increased risk of HSV-2 acquisition. The findings may be relevant to the associations between HIV risk and use of injectable HC in some prior studies, and might indicate that injectable methods broadly affect the risk of viral sexually transmitted infections in women. 29 Effect of Financial Incentives on Linkage to Care and Viral Suppression: HPTN 065 Wafaa M. El-Sadr 1 ; Bernard M. Branson 2 ; Gheetha Beauchamp 3 ; H. Irene Hall 2 ; LuciaV.Torian 4 ; Barry S. Zingman 5 ; Garret Lum 6 ; Rick Elion 7 ;Theresa Gamble 8 ; Deborah Donnell 3 1 ICAP at Columbia University, New York, NY, US; 2 US Centers for Disease Control and Prevention (CDC), Atlanta, GA, US; 3 SCHARP, Fred Hutchinson Cancer Research Center, Seattle, WA, US; 4 New York City Department of Health and Mental Hygiene, New York, NY, US; 5 Montefiore Medical Center, University Hospital for Albert Einstein College of Medicine, New York, NY, US; 6 District of Columbia Department of Health, Washington, DC, US; 7 Whitman-Walker Health, Washington, DC, US; 8 FHI360, Durham, NC, US Background: Enhancing the HIV continuum is critical. HPTN 065 evaluated the effect of financial incentives (FI) on linkage to care (L2C) and viral suppression (VS) in Bronx, NY (BNY) and Washington, DC (DC).

Oral Abstracts

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CROI 2015