CROI 2015 Program and Abstracts

Abstract Listing

Oral Abstracts

Conclusions: Rate of viral decline following ART was significantly slower among women with AHI than CHI, perhaps because HIV-specific immune responses that work synergistically with ART to decrease PVL have not yet developed in AHI. Strategies to accelerate viral decline, such as ART-intensification among AHI during pregnancy and postpartum, may be useful to reduce MTCT risk. 959 Tenofovir/Emtricitabine Plus LPV/r vs MVC or Raltegravir for PEP: 2 Randomized Trials Lorna Leal ; Agathe Leon; BertaTorres; Alexy Inciarte; Constanza Lucero; Josep Mallolas; Maria Martinez-Rebollar; Ana González-Cordón; Jose M. Gatell; Felipe Garcia Hospital Clínic Barcelona, Barcelona, Spain Background: PEP is recommended after a potential exposure to HIV. In animal models, PEP has to be maintained 4 weeks to be effective. However, with the recommended regimens in humans, side effects are frequent and are the main reason for poor adherence and a high rate of discontinuation. The objective of these 2 trials was to assess the rate of discontinuation of PEP at 28 days comparing the standard of care Lopinavir/r (LPV/r) vs Maraviroc (MVC) or Raltegravir (RAL) both with Tenofovir/Emtricitabine ( TVD). Methods: Individuals coming to the emergency room (ER) for potential sexual exposure to HIV were randomized to: TVD 200/245 QD plus LPV/r 400/100 BID (n=117) or plus MVC 300 BID (n=120) in one trial (n=237) and TVD plus LPV/r (n=121) or plus RAL 400 BID (n=122) in the second trial (n=243). After randomization, 4 follow-up visits were scheduled: day 0, 28, 90 and 180. The primary end-point was rate of discontinuation at day 28. Secondary end-points were adherence to PEP, side effects and rate of seroconversions. Results: In MVC and RAL trials, median age was 35 and 33 years and 92% and 90%were males respectively. The median interval between exposure and presentation at ER was 15h and 13.5h. Type of exposition was male homosexual sex in 83% and 81%. The level of risk was high in only 13% and 9% of individuals. The source patient was known to be HIV infected in 30.8% and 31%. In MVC trial, only 187/237 (79%) who were randomized and started PEP attended the first scheduled visit (day 0) and differences between arms were not observed (p=0.92). Similar results were found in RAL trial [198/243 (81.5%) attended the day 0 (p=0.62)]. The rate of discontinuation of PEP before day 28 of follow-up was significantly higher in LPV/r (31.5%) vs MVC (11.6%) arm (p=0.001) and in LPV/r (36.6%) vs RAL (23.7%) arm (p=0.04). The proportion of patients with low adherence to PEP was similar in LPV/r vs MVC arms (54% vs 46%, respectively, p=0.56), but was higher in LPV/r vs RAL arms (49.2% vs 30.8%, respectively, p=0.03). Adverse effects were reported in 122 out of 187 (50.8%) patients in MVC study attending at least the day 0 visit [70/92 (76.1%) in LPV/r and 52/95 (54.7%) in MVC arm, p=0.002] and in in 134 out of 198 (67.7%) patients in RAL study [75/101 (74.3%) in LPV/r and 59/97 (60.8%) in RAL arm, p=0.04]. No seroconversions were observed. Conclusions: The rate of discontinuation of PEP and side effects were higher in patients allocated to TVD plus LPV/r as compared with those with TVD plus MVC or TVD plus RAL. 958 Rilpivirine-Emtricitabine-Tenofovir for HIV Nonoccupational Postexposure Prophylaxis Rosalind Foster 1 ; John McAllister 2 ;Tim R. Read 3 ; Anna Pierce 4 ; Robyn Richardson 2 ; Anna McNulty 1 ; Andrew Carr 2 On behalf of the EPEP Study Researchers 1 Sydney Sexual Health Centre, Sydney, Australia; 2 St Vincent’s Centre for Applied Medical Research, Sydney, Australia; 3 Melbourne Sexual Health Centre, Melbourne, Australia; 4 The Alfred Hospital, Melbourne, Australia Background: CDC recommends 3-drug post-exposure prophylaxis (PEP) with emtricitabine-tenofovir disoproxil fumarate (FTC-TDF) plus raltegravir (RAL) for 28 days. But in one non-occupational (N)PEP study, FTC-TDF-RAL adherence was imperfect (only 52% took all 3 pills/day) and RAL was associated with acute muscle adverse effects (9%). FTC-TDF coformulated with rilpivirine (RPV) as a single-tablet regimen (STR) is a well-tolerated, once-daily NPEP candidate. A plasma tenofovir (TFV) level >40ng/mL is thought to reflect recent full adherence, whereas a level <10ng/mL suggests no dose for ≥ 7 days. NPEP studies to date have neither evaluated STRs nor measured TFV levels. We hypothesized FTC/ RPV/TDF as an STR NPEP would be safe, well-tolerated, and result in high adherence. Methods: We evaluated NPEP with STR FTC/RPV/TDF for 28 days in gay men after high-risk, sexual exposure, in an open-label, single-arm study. We assessed adherence (pill count; patient report; and plasma TFV levels at Week 4 in a subset by HPLC), adverse events (AEs) and HIV status through Week 12. Final intention-to-treat (ITT) analyses are reported. Results: 100 men (mean age 31 years [SD 9]) presented a mean 30 hours (SD 21) after anal sex (88% receptive). NPEP commenced 2 hours (SD 2.3) post-presentation. No participant was HIV+ at enrolment or through Week 12, or ceased NPEP because their ‘source’ was found to be HIV-negative. NPEP completion was 92% (95%CI 85 to 96); failures occurred at median 14 days for loss to follow-up (6%), adverse event (1%) or study burden (1%). NPEP adherence was 98.6% (SD 2.7) by self-report. In the 78 participants with pill-count data, adherence was 98.7% (SD 2.4). 86% reported taking all doses with food. Of 78 paired assessments available for percent adherence by pill count and self-report, agreement was 100% (kappa=1.0; P<0.0001). From the final 50 participants, plasma TFV was measured within 48 hours of the last dose in 41 (88%) participants who reached Day 28 (mean 16 hrs [SD 10]): 36 (88%) participants had levels >40ng/mL and only 1 (2%) was <10ng/mL. One participant developed pancreatitis 1 day post-NPEP. 5 other participants

Oral Abstracts

191

CROI 2015