CROI 2018 Abstract eBook
Abstract eBook
Poster Abstracts
VL ≥50 c/mL or premature discontinuation with last VL ≥50 c/mL) cumulative through Week 48. Secondary endpoints included virologic response and VF by FDA snapshot (50 c/mL threshold). Results were evaluated by prior VF and number of ARVs previously used. Results: In total, 1141 patients were randomized and treated; 14.8% (N=169) had prior VF, including 7.0% (N=80) of all patients with PI VF, 11.4% (N=130) with NRTI VF, and 6.5% (N=74) with NNRTI VF, and 27.3% (N=312) had used >7 ARVs. Overall rebound rates were 2.5% for D/C/F/TAF and 2.1% for control. Response rates were 94.9% and 93.7%, respectively. No resistance associated with any study drug was observed post-baseline. In patients with ≥1 prior VF, rebound rates were 2.6% for D/C/F/TAF and 0% for control (Table); response rates were 95.7% (D/C/F/TAF) and 92.5% (control), and VF rates were 1.7% and 0%, respectively. Overall, patients in the D/C/F/TAF and control arms had low and similar rates of discontinuation due to an adverse event (AE; 1.4% vs 1.3%), grade 3-4 AEs (6.8% vs 8.2%), and serious AEs (4.6% vs 4.8%). Virologic response rates were high and safety results were consistent across subgroups by ARV treatment experience. Conclusion: Virologically suppressed, HIV-1–infected adults, including those with prior VF and experience with numerous ARVs, who switched to D/C/F/TAF had low cumulative virologic rebound and high virologic response rates over 48 weeks.
treatment history and antiretroviral preference information from 263 treatment experienced patients. Methods: Between February and August 2017, a convenience sample of 263 HIV-infected patients from Infectious Diseases clinics at Duke University and the University of South Carolina were surveyed about HIV treatment experiences and attitudes. Participants were asked about characteristics of their current regimen as well as their interest, on 5-point scales (1=not at all interested; 5=very interested), in switching to either a single pill once a week, two shots in clinic every other month, or implanting and removing two small plastic rods about the size of matchsticks in each forearm every six months. Multivariate linear regression methods identified correlates of patients’ interest in switching to these alternatives from their current regimen. Results: Survey participants were highly experienced (mean 14.3 years on therapy), predominantly minority (80.5%), with a mean age of 46.7 years, and 41.4% had received more than high-school education. In multivariate analysis, clinic, gender, race/ethnicity, time on treatment, taking more than 1 pill a day, and administration restrictions, were not associated with interest in switching to novel regimens. Those who had previously switched regimens expressed greater interest in switching to a single pill once a week (p=.03); higher education was associated with greater interest in switching to injection and implants (p<.01), and younger age was associated with greater interest in switching to injection (p=.02). Conclusion: Across a highly treatment-experienced cohort of HIV-infected patients, we describe greatest interest in switching to an oral regimen taken once weekly, followed by injections taken every other month. Those with higher education expressed greater interest in novel drug delivery systems and younger patients were more interested in injections. Having taken more prior regimens was associated with greater interest in a weekly oral pill. Understanding drivers of preference heterogeneity for new treatment modalities may help to inform their development and predict uptake.
Poster Abstracts
504 SWITCHING TO RPV/FTC/TAF FROM RPV/FTC/TDF OR EFV/FTC/TDF: WEEK 96 RESULTS Anthony Mills 1 , Cynthia Brinson 2 , Claudia Martorell 3 , Gordon Crofoot 4 , Eric Daar 5 , Olayemi Osiyemi 6 , Bruce Rashbaum 7 , David Shamblaw 8 , Hans-Jurgen Stellbrink 9 , Daniel Podzamczer 10 , Hui Liu 11 , Ya-Pei Liu 11 , Danielle Porter 11 , Sean Collins 11 , Devi SenGupta 11 1 Southern California Men’s Medical Group, Los Angeles, CA, USA, 2 Central Texas Clinical Research, Austin, TX, USA, 3 Infectious Disease and The Research Institute, Springfield, MA, USA, 4 Crofoot Research Center, Houston, TX, USA, 5 Harbor–UCLA Medical Center, Torrance, CA, USA, 6 Triple O Research Institute, West Palm Beach, FL, USA, 7 Capital Medical Associates, Washington, DC, USA, 8 La Playa Medical Group, San Diego, CA, USA, 9 ICH Study Center, Hamburg, Germany, 10 Bellvitge University Hospital, Barcelona, Spain, 11 Gilead Sciences, Inc, Foster City, CA, USA Background: Tenofovir alafenamide (TAF) is a novel tenofovir prodrug with reduced risk of bone and renal toxicities compared to tenofovir disoproxil fumarate (TDF). TAF (25 mg) is coformulated with emtricitabine (FTC, 200 mg) and rilpivirine (RPV, 25 mg). The impact of switching to RPV/FTC/TAF single tablet regimen (STR) from other NNRTI-containing STRs RPV/FTC/TDF or efavirenz (EFV)/FTC/TDF was evaluated in two Phase 3 clinical trials. Final efficacy and safety results fromWeek 96 are presented. Methods: We conducted two randomized, double-blind, active controlled, 96 week, Phase 3 clinical studies in virologically suppressed (HIV-1 RNA <50 c/ mL), HIV-1-infected adults with estimated glomerular filtration rate > 50 mL/ min, taking either RPV/FTC/TDF (Study 1216) or EFV/FTC/TDF (Study 1160) for at least 6 months. The secondary virologic efficacy (HIV-1 RNA <50 c/mL) endpoint
503 WHO WANTS TO SWITCH? GAUGING INTEREST IN POTENTIAL NEW ANTIRETROVIRAL THERAPIES Jan Ostermann 1 , Caroline Derrick 1 , Amy Hobbie 2 , AndrewWeinhold 2 , Noor Al-Shareef 1 , Valerie Yelverton 3 , Sharon Weissman 1 , Helmut Albrecht 1 , Nathan Thielman 2 1 University of South Carolina at Columbia, Columbia, SC, USA, 2 Duke University, Durham, NC, USA, 3 Hochschule Neubrandenburg University of Applied Sciences, Neubrandenburg, Germany Background: Despite increased numbers of easily tolerated and highly effective antiretroviral regimens, adherence rates for many populations remain suboptimal. Novel drug delivery systems and drugs with extended half-lives may allow for dramatically reduced dosing frequency of specific antiretroviral regimens. To explore initial interest in such regimens, we gathered detailed
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