Meeting News

Naltrexone improves HIV care in freed inmates

Photo of Sandra Springer
Sandra Springer

BOSTON — Giving HIV-positive inmates with alcohol or opiate abuse disorders long-acting naltrexone upon their release improves their likelihood of staying virally suppressed months later, according to findings presented at CROI.

In two NIH-funded studies, Sandra Springer, MD, associate professor of medicine and associate clinical professor of nursing at the Yale School of Medicine, and colleagues explored the effect of giving soon-to-be released HIV-positive inmates six monthly injections of the long-acting injectable medication, which is approved in the United States for the management of alcohol and opioid use disorders.

In both studies — one in a population of prisoners with alcohol use disorders and the other in a population of prisoners with opiate use disorders — participants who received the medication were more likely to be virally suppressed after 6 months than those who did not. There were no serious adverse events in either study.

Springer said keeping patients with HIV off drugs and alcohol — especially opioids — not only helps prevent overdoses, but it helps them stay on ART. She said relapse in former inmates can occur quickly after their release.

“In populations living with HIV, [even] just in the general community, substance use at any level interferes with the ability to stay adherent to medications and go to follow-up appointments,” she said. “If you can help them stay sober, they are more likely to take their [ART] and keep their viral loads suppressed. So, a double edge. You can get two for one.”

Participants in the two randomized, double-blind, placebo-controlled studies were screened while they were still incarcerated and asked about their history of opioid and alcohol abuse before their incarceration. Springer said the studies were designed to be maximally inclusive, meaning many patients in the alcohol (INSPIRE) and opiate (NEW HOPE) studies had concurrent substance use disorders.

Participants were randomly assigned 2-to-1 to receive six monthly injections of extended-release naltrexone or placebo starting 1 week prior to their release from incarceration. The primary outcome was the proportion of patients who maintained viral suppression — plasma HIV RNA under 50 copies/mL — at 6 months in an intention-to-treat analysis.

Among 100 participants in the INSPIRE trial, the proportion of patients in the intervention group who were virally suppressed increased from 31% at baseline to 56.7% at 6 months, whereas the proportion of virally suppressed patients in the placebo arm decreased from 42% to 30.3%. In the trial, receiving extended-release naltrexone was independently predictive of viral suppression, with an adjusted OR of 4.54 (95% CI, 1.43 to 14.43), Springer and colleagues reported. The adjusted OR of receiving three or more doses was 6.34 (95% CI, 2.08-19.29).

Among 93 participants in the NEW HOPE trial, those who received the drug were also more likely to be virally suppressed at 6 months, with the proportion increasing from 37.9% to 60.6% (P=.002) compared with the placebo arm, which saw a reduction from 55.6% to 40.7% over the study period. The intervention group was also statistically significantly more likely than those who received placebo to improve or maintain viral suppression and less likely to lose it at 6 months, according to the researchers.

Springer said HIV prevalence among inmates in the U.S. — which incarcerates more people than any other country — is three times greater than the general population. Although inmates in the U.S. can be prescribed ART while they are incarcerated and have been shown to achieve high rates of viral suppression, Springer said retention in care upon release is poor and patients can lose viral suppression quickly.

In recently freed patients with a history of substance use disorders, relapse also can occur quickly and interfere with their ability to take medication.

“If we’re trying to achieve the 90-90-90 goals in 2 years, we have to pay special attention to this population. It has significant comorbid substance use disorders, in particular opioid and alcohol use disorders,” Springer said. “We really should be using evidence-based interventions and medications that can prevent opiate and alcohol use with antiretroviral therapy for populations living with HIV that have high rates of substance-use disorders and should be considering changing or at least adding that to our guidelines.” – by Gerard Gallagher

Reference:

Springer S, et al. Abstract 96. Presented at: Conference on Retroviruses and Opportunistic Infections; March 4-7, 2018; Boston.

Disclosure: Springer reports receiving research grants from the National Institute on Drug Abuse and National Institute on Alcohol Abuse and Alcoholism.

Photo of Sandra Springer
Sandra Springer

BOSTON — Giving HIV-positive inmates with alcohol or opiate abuse disorders long-acting naltrexone upon their release improves their likelihood of staying virally suppressed months later, according to findings presented at CROI.

In two NIH-funded studies, Sandra Springer, MD, associate professor of medicine and associate clinical professor of nursing at the Yale School of Medicine, and colleagues explored the effect of giving soon-to-be released HIV-positive inmates six monthly injections of the long-acting injectable medication, which is approved in the United States for the management of alcohol and opioid use disorders.

In both studies — one in a population of prisoners with alcohol use disorders and the other in a population of prisoners with opiate use disorders — participants who received the medication were more likely to be virally suppressed after 6 months than those who did not. There were no serious adverse events in either study.

Springer said keeping patients with HIV off drugs and alcohol — especially opioids — not only helps prevent overdoses, but it helps them stay on ART. She said relapse in former inmates can occur quickly after their release.

“In populations living with HIV, [even] just in the general community, substance use at any level interferes with the ability to stay adherent to medications and go to follow-up appointments,” she said. “If you can help them stay sober, they are more likely to take their [ART] and keep their viral loads suppressed. So, a double edge. You can get two for one.”

Participants in the two randomized, double-blind, placebo-controlled studies were screened while they were still incarcerated and asked about their history of opioid and alcohol abuse before their incarceration. Springer said the studies were designed to be maximally inclusive, meaning many patients in the alcohol (INSPIRE) and opiate (NEW HOPE) studies had concurrent substance use disorders.

Participants were randomly assigned 2-to-1 to receive six monthly injections of extended-release naltrexone or placebo starting 1 week prior to their release from incarceration. The primary outcome was the proportion of patients who maintained viral suppression — plasma HIV RNA under 50 copies/mL — at 6 months in an intention-to-treat analysis.

Among 100 participants in the INSPIRE trial, the proportion of patients in the intervention group who were virally suppressed increased from 31% at baseline to 56.7% at 6 months, whereas the proportion of virally suppressed patients in the placebo arm decreased from 42% to 30.3%. In the trial, receiving extended-release naltrexone was independently predictive of viral suppression, with an adjusted OR of 4.54 (95% CI, 1.43 to 14.43), Springer and colleagues reported. The adjusted OR of receiving three or more doses was 6.34 (95% CI, 2.08-19.29).

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Among 93 participants in the NEW HOPE trial, those who received the drug were also more likely to be virally suppressed at 6 months, with the proportion increasing from 37.9% to 60.6% (P=.002) compared with the placebo arm, which saw a reduction from 55.6% to 40.7% over the study period. The intervention group was also statistically significantly more likely than those who received placebo to improve or maintain viral suppression and less likely to lose it at 6 months, according to the researchers.

Springer said HIV prevalence among inmates in the U.S. — which incarcerates more people than any other country — is three times greater than the general population. Although inmates in the U.S. can be prescribed ART while they are incarcerated and have been shown to achieve high rates of viral suppression, Springer said retention in care upon release is poor and patients can lose viral suppression quickly.

In recently freed patients with a history of substance use disorders, relapse also can occur quickly and interfere with their ability to take medication.

“If we’re trying to achieve the 90-90-90 goals in 2 years, we have to pay special attention to this population. It has significant comorbid substance use disorders, in particular opioid and alcohol use disorders,” Springer said. “We really should be using evidence-based interventions and medications that can prevent opiate and alcohol use with antiretroviral therapy for populations living with HIV that have high rates of substance-use disorders and should be considering changing or at least adding that to our guidelines.” – by Gerard Gallagher

Reference:

Springer S, et al. Abstract 96. Presented at: Conference on Retroviruses and Opportunistic Infections; March 4-7, 2018; Boston.

Disclosure: Springer reports receiving research grants from the National Institute on Drug Abuse and National Institute on Alcohol Abuse and Alcoholism.

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