Clinical outcomes of HIV-1 infected patients switched from complex multi-tablet regimens to tenofovir alafenamide based single-tablet regimens plus a boosted protease inhibitor in a real-world setting

• Type of Material: Article
• Authors: Charlotte-Paige Rolle, Emory University Rollins School of Public Health; Vu Nguyen, University of Central Florida College of Medicine; Federico Hinestrosa, Emory University Rollins School of Public Health; Edwin DeJesus, Emory University Rollins School of Public Health
• Language: English
• Date: 2020-11-01
• Publisher: ELSEVIER
• Publication Version: Final Published Version
• Copyright Statement: © 2020 The Authors.
• License: Creative Commons Attribution-NonCommercial-NoDerivs 4.0 International
• Final Published Version (URL): http://dx.doi.org/10.1016/j.jve.2020.100021
• Title of Journal or Parent Work: Journal of Virus Eradication
• Volume: 6
• Issue: 4
• Grant/Funding Information: This work was supported by a research grant from Gilead Sciences, IN-US-292-5356 (PI: Rolle).; Dr. Charlotte-Paige Rolle has received research grants and honoraria from Gilead Sciences, ViiV Healthcare, Theratechnologies and Janssen Infectious Diseases during the conduct of this study. Dr. Federico Hinestrosa has received honoraria from Gilead Sciences, Merck, and AbbVie during the conduct of this study. Dr. Edwin DeJesus has received honoraria from Gilead Sciences, Theratechnologies, Janssen Pharmaceuticals and ViiV Healthcare during the conduct of this study.
• Keywords: Highly treatment experienced; Multi-tablet regimens; Simplification
• Research Categories: Health Sciences, Public Health; Biology, Virology; Health Sciences, Immunology

Abstract

Background Multi-tablet regimens (MTRs) are associated with increased adverse events and non-adherence. Single tablet regimens (STRs) plus boosted protease inhibitors (PIs) are a simplification option for MTR-treated patients; however, data is needed to validate this therapeutic strategy. Methods This retrospective analysis included all HIV-1 infected patients seen at a single center from March 2016 to December 2017 who were switched from twice-daily (BID) regimens or regimens containing ​≥ ​3 pills daily to elvitegravir/cobicistat/emtricitabine/tenofovir-alafenamide (E/C/F/TAF) plus darunavir (DRV) or rilpivirine/emtricitabine/tenofovir-alafenamide (RPV/F/TAF) plus DRV boosted with ritonavir or cobicistat (DRV/r-c). Eligible patients had baseline HIV-1 RNA<200 copies/mL and were followed for 48 weeks. The primary endpoint was HIV-1 RNA≥50 copies/mL at Week 48. Adherence and safety data were recorded throughout the study. Results Of 61 patients included, median age was 53 years, the median number of pills taken daily (range) was 5 (3–9), 80% were taking BID regimens, 97% had baseline HIV-1 RNA<50 copies/mL, 56 (92%) were switched to E/C/F/TAF plus DRV and 5 (8%) to RPV/F/TAF plus DRV/r-c. At Week 48, 2 patients (3%) had HIV-1 RNA≥ 50 copies/mL, both were treated with E/C/F/TAF plus DRV and neither had evidence of treatment-emergent resistance. Fifty-nine (97%) had an HIV-1 RNA<50 copies/mL. Adverse drug reactions (ADRs) occurred in 3/61 (5%) (all Grade 2) leading to 3/61 (5%) ADR-related discontinuations. Conclusion In this real-world cohort of MTR-treated patients, switching to a TAF-based STR plus boosted PI maintained virologic control in 97% and was well-tolerated, supporting potential use of this strategy for regimen simplification.