Abstract
BACKGROUND: Alcohol use disorders (AUD) are common in men who have sex with men (MSM) and transgender women (TGW) in Peru and undermine antiretroviral therapy (ART) adherence. Oral naltrexone (NTX) is an evidenced-based treatment for AUD that has not been assessed in co-treating AUD in MSM/TGW with HIV.
SETTING: and Design: A two-site, randomized, double-blind, placebo-controlled trial among MSM/TGW with AUD and newly diagnosed with HIV in Lima, Peru.
METHODS: Newly diagnosed MSM/TGW with AUD were prescribed a single-treatment regimen of EFV/TDF/FTC from 2014-2015 and randomized 2:1 to oral NTX (N=103) or placebo (N=53) for 24 weeks. Primary and secondary outcomes were proportion achieving viral suppression (VS: HIV-1 RNA<400 copies/mL) or maximal viral suppression (MVS: HIV-1 RNA<40 copies/mL) at 24 weeks.
RESULTS: The were no significant differences between arms in VS (81.6% NTX vs 75.5% placebo; p=0.37) or MVS (61.2% NTX vs 66.0% placebo; p=0.48). Adherence to study medication was low (mean=34.6%) overall with only 21.4% of participants meeting recommended levels (≥80% daily doses/month). Participants allocated to NTX had significantly lower adherence compared to placebo for both 12-week study periods (44.0% vs 35.2%, p=0.04; 31.4% vs 35.2%, p=0.03).
CONCLUSIONS: Findings are inconclusive regarding use of NTX for treatment of AUD in MSM/TGW newly diagnosed with HIV. VS and MVS levels were high irrespective of allocation. Adherence to study medication was low, requiring further exploration of strategies to optimize adherence to NTX as AUD treatment.
Original language | English (US) |
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Journal | Journal of acquired immune deficiency syndromes (1999) |
DOIs | |
State | E-pub ahead of print - Dec 10 2021 |
Bibliographical note
Copyright © 2021 Wolters Kluwer Health, Inc. All rights reserved.PubMed: MeSH publication types
- Journal Article
- Randomized Controlled Trial
- Research Support, N.I.H., Extramural