Extended-release Naltrexone for Treatment of Opioid and Alcohol Use Disorders in HIV Clinics

• Opioid use disorder (OUD) and alcohol use disorder (AUD) are common in HIV-infected individuals and contribute to gaps in the HIV care continuum.
• Untreated OUD and AUD are associated with decreased receipt of antiretroviral therapy (ART), decreased ART adherence, decreased HIV viral suppression, and decreased survival.
• Treatment of substance use disorders can increase engagement in HIV care, potentially narrowing gaps in the HIV care continuum by improving linkage to care, receipt of ART, retention in care, and HIV viral suppression.

Studies have found that opioid agonist therapy with methadone and buprenorphine/naloxone for the treatment of OUD improves HIV outcomes. Though pharmacotherapy for AUD is uncommon in HIV clinics, it is also associated with decreased HIV RNA levels. The CTN-0055 protocol, Comparing Treatments for HIV-Positive Opioid Users in an Integrated Care Effectiveness Study (CHOICES), aimed to inform development of a multi-site comparativeness effectiveness trial of extended-release naltrexone (XR-NTX) versus treatment as usual (TAU) in HIV clinics for improving engagement in HIV care. The non-blinded, randomized study compared XR-NTX treatment initiation, retention, and safety of XR-NTX versus treatment as usual for treating OUD and/or AUD in HIV clinics. The study was set in HIV primary care clinics in Vancouver, British Columbia, and Chicago, Illinois. Fifty-one HIV-infected patients seeking treatment for OUD (n=16), AUD (n=27), or both (n=8) were randomized. Primary outcomes were XR-NTX initiation (receipt of first injection within 4 weeks of randomization) and retention at 16 weeks. Secondary outcomes generated point estimates for change in substance use, HIV viral suppression, and safety.

Results included:

Treatment initiation and retention:

• XR-NTX group: 68% initiated treatment and 88% of these were retained on XR-NTX at 16 weeks.
• TAU group: 96% initiated treatment, but only 50% were retained on medication at 16 weeks.

  Substance use levels:
   

• XR-NTX: Mean days of opioid use in past 30 days decreased from 18 to 13. Mean heavy drinking days decreased from 13 to 6.
• TAU: Mean days of opioid use in past 30 days decreased from 19 to 10. Mean heavy drinking days decreased from 18 to 7.

  Viral suppression: Among those with OUD, HIV suppression improved from 67% to 80% for XR-NTX and 58% to 75% for TAU.

Safety: XR-NTX was well-tolerated, with no precipitated withdrawals and only 1 serious injection site reaction.

Conclusions: Extended-release naltrexone (XR-NTX) is feasible and safe for treatment of opioid use disorder and alcohol use disorder in HIV clinics. Treatment initiation appears to be lower and retention greater for XR-NTX compared with treatment as usual.  The findings underscore the need for a multi-site trial (now also being performed by the CTN, see CTN-0067 for more information) to test the potential of XR-NTX for improving engagement in the HIV care continuum. Use of long-acting addiction pharmacotherapies such as XR-NTX may improve the capacity for HIV-infected patients with substance use disorders to better engage in HIV treatment and close gaps in the HIV care continuum.

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