Two HCV treatment models effective in people who inject drugs

In a comparison of two treatment models for HCV, researchers found that both were effective among people who injected drugs,

Alain Litwin, MD, professor of medicine and psychiatry at Albert Einstein College of Medicine, said people who inject drugs (PWID) with HCV can be effectively treated with direct-acting antivirals, but the best models for care have not been fully studied. Researchers compared the effectiveness of two treatment models, patient navigation (PN) and modified directly observed therapy (mDOT), delivered in opioid treatment programs (OTPs) and community-based clinics (CBCs) in the HERO study.

“Definitions of active PWID in large, prospective trials have varied from having ever injected drugs to injecting within the last 6 months,” he said in his presentation at The Liver Meeting Digital Experience. “HERO is a national study, which enrolled at 25 sites and eight states across the U.S.; only active PWID who injected drugs within 12 weeks of study entry were eligible.”

Researchers randomly assigned 755 PWID to either mDOT or PN, and patients were treated with 12 weeks of Epclusa (sofosbuvir/velpatasvir, Gilead). Investigators also explored associations of sustained virologic response with baseline factors, adherence and completion.

Alain Litwin

Overall, 623 patients initiated treatment with no differences between the two study arms. Among patients who initiated treatment, 82.7% completed treatment and SVR was 72.2%. Rates were similar across both groups. In the study’s per-protocol analysis (n = 502), SVR was 89.6%, with similar rates in both groups.

Litwin and colleagues found that treatment completion was associated with SVR (adjusted OR = 9.5, P < .001), as was each 10% increase in adherence (aOR = 1.5, P < .001).

Overall adherence was higher in the mDOT group (78%) than in the PN group (73.4%, P = .001). The mDOT group had significantly higher adherence in the OTP setting but not in CBCs.

Researchers also determined that a high SVR was associated with age of at least 40 years (aOR = 1.8), Hispanic ethnicity (aOR = 2.1), stable housing (aOR = 2.6) taking methadone vs. buprenorphine (aOR = 2.2). A low SVR was associated with injecting more than twice a day (aOR = 0.5), at least 30 days injecting over the last 3 months (aOR = 0.7) and positive baseline urine toxicity for methamphetamine (aOR = 0.5), cocaine (aOR = 0.6) and opiate (aOR = 0.6).

“SVR rates were similar with mDOT and patient navigation models, with approximately 90% achieving SVR in the pro-protocol analysis,” Litwin said. “In the ongoing phase 2 of the HERO study, we will examine rates of reinfection over a 3-year period.”