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Extended-release naltrexone improves viral suppression levels in prisoners with HIV and alcohol use disorders who are transitioning to the community: Results from a double-blind, placebo-controlled trial

Springer, Sandra A., MD1,2; Di Paola, Angela, MS3; Barbour, Russell, PhD2; Azar, Marwan M., MD1; Altice, Frederick L., MD1,2,4,5

JAIDS Journal of Acquired Immune Deficiency Syndromes: May 16, 2018 - Volume Publish Ahead of Print - Issue - p
doi: 10.1097/QAI.0000000000001759
Original Article: PDF Only

Objective: To determine if 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 copies/mL and <50 copies/ml from baseline to 6 months respectively using an intention to treat analysis.

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

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

1Department of Internal Medicine, Section of Infectious Diseases, AIDS Program, Yale School of Medicine, 135 College Street, Suite 323, New Haven, CT 06510-2283

2Yale University School of Public Health, Center for Interdisciplinary Research on AIDS, 135 College Street, 2nd Floor, New Haven CT 06510-2283

3The University of Texas Health Science Center at Houston (UTHealth), School of Public Health, 7000 Fannin St. 2610C, Houston TX 77030

4Yale University School of Public Health, Division of Epidemiology of Microbial Diseases, New Haven, CT

5Centre of Excellence in Research in AIDS (CERiA), University of Malaya, Kuala Lumpur, Malaysia.

Contact: Sandra A. Springer, MD Email: Sandra.springer@yale.edu Phone: 203-687-6680 Fax: 203-737-4051

The authors report no conflicts of interest related to this work.

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