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Extended-release Naltrexone Improves Viral Suppression Among Incarcerated Persons Living with HIV and Alcohol use Disorders Transitioning to the Community: Results From a Double-Blind, Placebo-Controlled Trial

Springer, Sandra A., MD*,†; Di Paola, Angela, MS; Barbour, Russell, PhD; Azar, Marwan M., MD*; Altice, Frederick L., MD*,†,§,║

JAIDS Journal of Acquired Immune Deficiency Syndromes: September 1, 2018 - Volume 79 - Issue 1 - p 92–100
doi: 10.1097/QAI.0000000000001759
Clinical Science

Objective: To determine whether extended-release naltrexone (XR-NTX) would improve or maintain viral suppression (VS) among incarcerated individuals with HIV and alcohol use disorders (AUDs) transitioning to the community.

Design: A randomized, double-blind, placebo-controlled trial was conducted among incarcerated individuals with HIV and AUDs transitioning to the community from 2010 through 2016.

Methods: Eligible participants (N = 100) were randomized 2:1 to receive 6 monthly injections of XR-NTX (n = 67) or placebo (n = 33) starting at release and continued for 6 months. The primary and secondary outcomes were the proportion that maintained or improved VS at <200 and <50 copies per milliliter from baseline to 6 months, respectively, using an intention-to-treat analysis.

Results: Participants allocated to XR-NTX improved VS from baseline to 6 months for <200 copies per milliliter (48.0%–64.2%, P = 0.024) and for <50 copies per milliliter (31.0%–56.7%, P = 0.001), whereas the placebo group did not (<200 copies/mL: 64%–42.4%, P = 0.070; <50 copies/mL: 42.0%–30.3%, P = 0.292). XR-NTX participants were more likely to achieve VS than the placebo group at 6 months (<200 copies/mL: 64.2% vs. 42.4%; P = 0.041; <50 copies/mL: 56.7% vs. 30.3%; P = 0.015). XR-NTX independently predicted VS [<200 copies/mL: adjusted odds ratio (aOR) = 2.68, 95% confidence interval (CI) = 1.01 to 7.09, P = 0.047; <50 copies/mL: aOR = 4.54; 95% CI = 1.43 to 14.43, P = 0.009] as did receipt of ≥3 injections (<200 copies/mL: aOR = 3.26; 95% CI = 1.26 to 8.47, P = 0.010; <50 copies/mL: aOR = 6.34; 95% CI = 2.08 to 19.29, P = 0.001). Reductions in alcohol consumption (aOR = 1.43, 95% CI = 1.03 to 1.98, P = 0.033) and white race (aOR = 5.37, 95% CI = 1.08 to 27.72, P = 0.040) also predicted VS at <50 copies per milliliter.

Conclusions: XR-NTX improves or maintains VS after release to the community for incarcerated people living with HIV and AUDs.

*Department of Internal Medicine, Section of Infectious Diseases, AIDS Program, Yale School of Medicine, New Haven, CT;

Center for Interdisciplinary Research on AIDS, Yale University School of Public Health, New Haven, CT;

School of Public Health, The University of Texas Health Science Center at Houston (UTHealth), Houston, TX;

§Division of Epidemiology of Microbial Diseases, Yale University School of Public Health, New Haven, CT; and

Centre of Excellence in Research in AIDS (CERiA), University of Malaya, Kuala Lumpur, Malaysia.

Correspondence to: Sandra A. Springer, MD Department of Internal Medicine, Section of Infectious Disease, Yale AIDS Program, 135 College Street, Suite 323, New Haven, CT 06510 (e-mail: Sandra.springer@yale.edu).

Supported by the National Institutes on Alcohol Abuse and Alcoholism (R01 AA018944: Springer and Altice) and for career development by the National Institutes on Drug Abuse (K02 DA032322 for Springer and K24 DA017072 for Altice). The extended-release naltrexone medication and placebo for the study were provided by Alkermes, Inc., in-kind through and investigator-initiated application. The funders and Alkermes, Inc., were not involved in the research design, analysis or interpretation of the data, or the decision to publish the manuscript.

The authors have no funding or conflicts of interest to disclose.

Clinical Trial number: NCT01077310.

Received March 10, 2018

Accepted May 08, 2018

Copyright © 2018 Wolters Kluwer Health, Inc. All rights reserved.