Naltrexone Improves Virologic Suppression
April 11, 2018
Release from correctional settings is a high-stakes time for persons with HIV, as it is for those with other health issues. People with substance use disorders often relapse, and those with HIV often stop ART and do not engage in HIV care, increasing the risk of declines in personal health as well as transmission of HIV to others.
A presentation at CROI examined whether giving extended-release (XR) intramuscular naltrexone to inmates with HIV and opiate or alcohol use disorders starting just before release from the correctional setting would result in improved rates of viral suppression 6 months later. Two randomized (2:1) double blind placebo-controlled studies were conducted, one for inmates with opioid use disorder (OUD), the other for alcohol use disorder (AUD). Subjects were randomized within 7 days of discharge from jail or prison, received their first injection of naltrexone XR (or placebo) before release, and then continued with 5 more monthly injections after release.
The two studies required that subjects meet DSM criteria for OUD or AUD, respectively, but otherwise had few restrictions. More than 77% of persons in the studies were men, >80% were black or Hispanic, >60% were homeless or unstably housed, and a high proportion had other concurrent substance use disorders (in the OUD group, 80% had concurrent cocaine use disorder and 27% had AUD; in the AUD group, 59% had cocaine use disorder, 16% had OUD). At baseline, 87-89% of persons in both studies were on ART.
After 6 months, increases in rates of viral suppression were seen in both studies in the groups that received naltrexone XR, while decreases were seen in those who received placebo.
Proportion with VL <50 copies/mL at 6 months:
|OUD Study||Increased from 38% to 60%|
(p = .002)
|Decreased from 56% to 41% (difference not significant)|
|AUD Study||Increased from 31% to 57%|
(p = .001)
|Decreased from 42% to 30% (difference not significant)|
In multivariate analysis, naltrexone was the only predictor of viral suppression in the OUD study (odds ratio: 2.9). In the AUD study, naltrexone, receipt of 3 or more injections of naltrexone, reduction in alcohol use, and white ethnicity were associated with viral suppression. No significant adverse effects were reported in either study.
Clinical Bottom Line
In a difficult-to-engage population of HIV-infected persons with opiate or alcohol use disorder who are transitioning from correctional settings to the community, use of naltrexone XR resulted in significantly higher rates of HIV suppression at 6 months postrelease. More studies are needed on this and other strategies to improve engagement in care and viral suppression after release from correctional settings, including evaluations of naltrexone in populations in which use of methamphetamines is high, but this is a promising approach and should be considered in transition planning.
Springer S, Azar M DiPaola A, et al. Extended-release naltrexone improves viral suppression in HIV+ prisoners. In: Program and abstracts of the 2018 Conference on Retroviruses and Opportunistic Infections; March 4-7, 2018; Boston. Abstract 96.
Susa Coffey is medical editor of the NCRC. She is a Professor of Medicine at UCSF in the Division of HIV, Infectious Diseases and Global Medicine and a longtime clinician and educator in the HIV at San Francisco General Hospital clinic (“Ward 86”). She also is medical editor of HIV InSite. Dr. Coffey is Co-Lead of the RAPID clinical program at Ward 86, San Francisco General Hospital and the Chair of the RAPID Committee of San Francisco's Getting to Zero campaign.