While 24 weeks of extended-release naltrexone decreased the number of heavy drinking days for patients with HIV, there were no detectable improvements in antiretroviral adherence or HIV outcomes, according to a study published in AIDS and Behavior.
This randomized, 4-site, double-blind, placebo-controlled clinical trial from April 2011 to February 2015 sought to investigate the effectiveness of extended-release naltrexone (combined with counseling) on drinking and HIV-related outcomes for 51 patients with HIV who drink heavily and have a less than 95% antiretroviral adherence. Patients self-reported heavy drinking ≥4 times in the past 4 weeks or met Diagnostic and Statistical Manual-IV criteria for alcohol abuse and dependence.
Study participants received intramuscular gluteal injections in colored syringes (to maintain blinding) of either extended-release naltrexone or placebo at 4-week intervals for 24 weeks, resulting in the receipt of 5 or more injections. Participants also received counseling that integrated medication coaching and medical management to address ART adherence, incorporate clinical advice and skills, and offer referrals to Alcoholics Anonymous.
By the end of the study, there was no detectable effect of extended-release naltrexone on antiretroviral therapy adherence (P =.38), CD4 cell count (P =.75), undetectable viral load (P =.26), or Veterans Aging Cohort Study Index score (P =.70), although naltrexone was associated with a reduction in heavy drinking days.
Study investigators conclude that despite sustained decreases in alcohol use were noted, “alternative strategies to promote ART adherence and improve HIV biomarkers among HIV-positive heavy drinkers are needed.”
This study was funded by the US National Institutes of Health, National Institute on Alcohol Abuse and Alcoholism.
Edelman EJ, Moore BA, Holt SR, et al. Efficacy of extended-release naltrexone on HIV-related and drinking outcomes among HIV-positive patients: A Randomized-controlled trial [published online August 2, 2018]. AIDS Behav. doi: 10.1007/s10461-018-2241-z