To determine whether extended-release naltrexone (XR-NTX) would improve or maintain viral suppression (VS) among prisoners or jail detainees with HIV and opioid use disorder (OUD) transitioning to the community.
A 4-site, prospective randomized double-blind, placebo-controlled trial was conducted among prison and jail inmates with HIV and OUD transitioning to the community from September 2010 through March 2016.
Eligible participants (N = 93) were randomized 2:1 to receive 6 monthly injections of XR-NTX (n = 66) or placebo (n = 27) starting at release and observed for 6 months. The primary outcome was the proportion that maintained or improved VS (<50 copies/mL) from baseline to 6 months.
Participants allocated to XR-NTX significantly improved to VS (<50 copies/mL) from baseline (37.9%) to 6 months (60.6%) (P = 0.002), whereas the placebo group did not (55.6% at baseline to 40.7% at 6 months P = 0.294). There was, however, no statistical significant difference in VS levels at 6 months between XR-NTX (60.6%) vs. placebo (40.7%) (P = 0.087). After controlling for other factors, only allocation to XR-NTX (adjusted odds ratio = 2.90; 95% confidence interval = 1.04 to 8.14, P = 0.043) was associated with the primary outcome. Trajectories in VS from baseline to 6 months differed significantly (P = 0.017) between treatment groups, and the differences in the discordant values were significantly different as well (P = 0.041): the XR-NTX group was more likely than the placebo group to improve VS (30.3% vs. 18.5%), maintain VS (30.3% vs. 27.3), and less likely to lose VS (7.6% vs. 33.3%) by 6 months.
XR-NTX improves or maintains VS after release to the community for incarcerated people living with HIV with OUD.
*AIDS Program, Section of Infectious Diseases, Department of Internal Medicine, Yale School of Medicine, New Haven, CT;
†Faculty of Medicine, Infectious Diseases, Center for Interdisciplinary Research on AIDS, Yale University School of Public Health, New Haven, CT;
‡Faculty of Medicine, Infectious Diseases, School of Public Health, The University of Texas Health Science Center at Houston (UTHealth), Houston, TX;
§Department of Medicine, Baystate Medical Center, Springfield, MA;
║Division of Epidemiology of Microbial Diseases, Yale University School of Public Health, New Haven, CT; and
¶Faculty of Medicine, Infectious Diseases, Centre of Excellence in Research in AIDS (CERiA), University of Malaya, Kuala Lumpur, Malaysia.
Correspondence to: Sandra A. Springer, MD, Yale AIDS Program, Section of Infectious Diseases, Yale School of Medicine 135 College Street, Suite 323, New Haven, CT 06510 (e-mail: Sandra.email@example.com).
Supported by the National Institutes on Drug Abuse (R01DA030762, Springer) and for career development by the National Institutes on Drug Abuse (K02 DA032322 for Springer and K24 DA017072 for Altice). Both study medication and placebo were provided in-kind from an investigator-initiated application from Alkermes, Inc., Waltham, MA. The funders were not involved in the research design, analysis, or interpretation of the data or the decision to publish the manuscript.
F.L.A. receives funding from Gilead Sciences and Merck Pharmaceuticals. The remaining authors have no funding or conflicts of interest to disclose.
Clinical Trial number: NCT01246401.
Received November 03, 2017
Accepted January 08, 2018