Extended-release naltrexone is associated with sustained virologic suppression among HIV+ prisoners with alcohol use disorders after release to the community

Background: For people living with HIV (PLH), alcohol use disorders (AUDs) are associated with poor immunologic and virologic outcomes. Prisoners with HIV lose HIV VL suppression they gained while incarcerated within 3 months post-release. We aimed to see if the use of extended-release naltrexone (XR-NTX), an effective treatment for AUDs, could maintain and/ or improve rates of VLS for PLH with AUDs after they are released from prison.
Methods: This is a double-blind placebo-controlled randomized trial of XR-NTX (randomized 2:1, XR-NTX: placebo) conducted among HIV+ prisoners with AUDs who were released to the community in Connecticut, U.S.A. Participants were administered 6 monthly injections given 1-2 weeks prior to release and monthly thereafter for 5 months post-release. The primary outcome was sustained virologic suppression at 6 months at < 400 copies/mL with additional secondary outcomes of proportion with VLS at < 200 and < 50.
Results: A total of 100 participants were randomized 2:1 (N=67 XR-NTX; N=33 Placebo). Baseline demographics were: 21% women, 37% homeless, 65% Black/African American, mean incarceration time period of 13 months, 50% with chronic HCV, 86% prescribed ART, and 90% with a CD4 >200. There was a statistically significant greater mean proportion of persons who had a VL UD at baseline who maintained a VL UD at 6 months in the XR-NTX group as compared to the placebo group at < 50 copies/ ML and < 200 copies/mL value, but not at the < 400 copies/mL value (see Table 1).


Viral Load (Copies/ml) by Treatment ArmBaseline (%) (XR-NTX, PLC)6 months (%) (XR-NTX, PLC)Mean of the Differences95% Confidence IntervalP value
<50 XR-NTX, Placebo36,4850, 340.2120.740, 0.3490.003*
<200 XR-NTX, Placebo53, 7255, 340.1760.043,0.310.013*
<400 XR-NTX, Placebo70, 7263, 410.11-0.027, 0.2390.118
[Table 1: Comparisons of Percentages of VL suppression from baseline to 6 months by treatment arm based on Results of T Test analyses.]


Conclusions: Preliminary results from this RCT show that XR-NTX may help maintain VL suppression and/ or improve to achieve VL suppression as HIV+ prisoners transition to the community, thus a potential intervention to improve the HIV continuum of care for PLH with AUDs involved in the CJS.

S. Springer1, M. Azar2, R. Barbour3, F. Altice2, A. Di Paola1
1Yale School of Medicine, Infectious Disease, New Haven, United States, 2Yale School of Medicine, Section of Infectious Disease/ Yale AIDS Program, New Haven, United States, 3Yale University School of Medicine, Center for Interdisciplinary Research on AIDS, New Haven, United States