REPORTING FROM CROI

BOSTON (FRONTLINE MEDICAL NEWS) – Prisoners living with HIV who have drug- or alcohol-abuse disorders and are given extended-release naltrexone prior to release are significantly more likely to have improved viral suppression at 6 months, compared with fellow HIV+ prisoners who do not, investigators in two parallel clinical trials reported.

“A medication that can be used for reduction of alcohol and opiate use could also help stabilize patients coming out of prison and jail, and help maintain or achieve viral suppression,” said Sandra Springer, MD, from Yale University, New Haven, Conn.

Giving naltrexone XR (XR-NTX) to HIV-positive prisoners who are returning to the community can help health authorities achieve the Joint United Nations Program on HIV/AIDS (UNAIDS) “ 90-90-90 by 2020 ” goals of 90% of people who are HIV-positive knowing their HIV status, 90% receiving antiretroviral therapy, and 90% achieving viral suppression, she said at the annual Conference on Retroviruses and Opportunistic Infections.

“The United States incarcerates more individuals than any other country in the world, and our prevalence rates in prison of HIV are three times greater, and if we’re trying to achieve the 90-90-90 goals in 2 years, we have to pay special attention to this population that has significant substance-use disorders, in particular opiate- and alcohol-use disorders,” she said at a briefing following her presentation of the data in an oral abstract session.

Dr. Springer and her colleagues had shown in a previous study that, although 59% of HIV-positive prisoners treated with ART while incarcerated attained viral suppression, the percentage who retained suppression dropped to 18% just 3 months after they were released. The investigators also found that relapse to drug and alcohol use occurs quickly after release, and that relapses are associated with loss of viral suppression.

In the studies reported at CROI 2018, Dr. Springer and her colleagues evaluated the effects of treatment with XR-NTX on HIV viral suppression among HIV-positive prisoners and jail detainees with either opioid-use disorders ( NEW HOPE study ) or alcohol-use disorders ( INSPIRE study ) after they are released to the community.

Both studies were double-blind, placebo-controlled, randomized trials. Detainees were recruited, enrolled, and randomized while imprisoned to receive either placebo or XR-NTX in six monthly injections, with the first performed in prison, and the subsequent five injections performed in the community.

The participants were all HIV-seropositive prisoners aged 18 years or older returning to communities in Connecticut and western Massachusetts who met DSM-IV criteria for either alcohol- or opioid-use disorder.

The investigators found that among opioid users in NEW HOPE, viral suppression levels (fewer than 50 copies/mL) improved from 37.9% at baseline to 60.6% at 6 months among 66 individuals who received XR-NTX (P = .002). In contrast, viral suppression among 27 placebo users dropped from 55.6% at baseline to 40.7%, although this decline was not statistically significant.

In multivariate analysis controlling for treatment arm, cocaine-use disorder, homelessness, or number of injections received, the only significant predictor for viral suppression at 6 months was XR-NTX vs. placebo (odds ratio, 2.90; P = .043). There were no serious adverse events in this study.

Among those with alcohol-use disorders in the INSPIRE study, the changes in viral suppression were similar to those in the NEW HOPE study, improving from 31% at baseline to 56.7% at 6 months among 67 participants in the XR-NTX arm (P = .001), compared with a decline from 42% to 30.3% among 33 participants in the placebo arm, although again this difference was not significant.

In the INSPIRE study, significant predictors of viral suppression at 6 months included naltrexone XR (OR, 4.54; P = .009), three or more injections (OR, 6.34; P = .001), white vs. black or Hispanic (OR, 5.37; P = .040), and alcohol improvement score, a composite measure of drinking parameters (OR, 1.43; P =.033).

Dr. Springer said in the briefing that inclusion criteria in the studies were broad enough to allow overlap between alcohol-use and drug-use disorders,

She emphasized that persons living with HIV who have drug- or alcohol-use disorders and are being released from incarcerations should be strongly considered for antiopioid and/or antialcohol pharmacotherapy in addition to ART.

The study was supported by National Institutes of Health grants, and by Alkermes, which supplied XR-NTX and placebo to investigators. Dr. Springer disclosed research grants from the National Institute on Drug Abuse.

SOURCE: Springer S et al. CROI Abstract 96

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