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HIV clinic‐based extended release naltrexone vs treatment as usual for people with HIV and opioid use disorder: A non‐blinded, randomized non‐inferiority trial

AddictionKorthuis PT, Cook RR, Lum P, et al. | February 09, 2022


This study generated supportive, but not conclusive, evidence demonstrating the non-inferiority of human immunodeficiency virus (HIV) clinic-based extended-release naltrexone, when compared with treatment as usual, for facilitating HIV viral suppression. Less opioid use was reported in patients who initiated extended-release naltrexone vs those who received treatment as usual.

  • This study included 114 participants with untreated HIV and opioid use disorder (62% male; 56% Black, 12% Hispanic; positive for fentanyl (62%), other opioids (47%), and cocaine (60%) at baseline) who received HIV clinic-based extended-release naltrexone (XR-NTX; n=55) or treatment as usual with buprenorphine or methadone (TAU; n=59).

  • Fewer patients initiated medication in the XR-NTX group vs TAU participants (47% vs 73%).

  • Primary outcome of viral suppression was noted to be comparable for XR-NTX (52.7%) and TAU (49.2%) (risk ratio [RR] 1.064) at 24 weeks.

  • Non-inferiority could not be shown, because the lower confidence limit of the RR did not exceed the prespecified margin of 0.75 in intention-to-treat (ITT) analysis.

  • ITT analysis revealed a comparable past 30-day opioid use for XR-NTX vs TAU (11.7 vs 14.8 days; mean difference -3.1; 95% CI -8.7, 1.1).

  • In cases starting on medication, XR-NTX led to fewer days of opioid use than TAU in the past 30 days (6.0 vs 13.6, mean difference -7.6; 95% CI -13.8, -0.2).