A Randomized Clinical Trial of Pegylated Interferon for Acute Hepatitis C Virus Infection in Active Injection Drug Users

Abstract

Background: Treatment of acute HCV is more effective than treatment of chronic HCV, but physicians are often reluctant to treat people who inject drugs (PWID). Methods: HIV seronegative PWID with acute hepatitis C infection were randomized to receive 24 weeks of pegylated interferon (Peg-IFN) or to observation. Serum HCV RNA was measured every 4 weeks. After 24 weeks, control subjects with persistent viremia were offered treatment with Peg-IFN and ribavirin. The primary endpoint of the trial was likelihood of achieving a sustained virologic response (SVR).Secondary endpoints included time to viral clearance, treatment adherence and incidence of depression. Results: 24 patients were randomized to treatment vs. control; 1 was lost to follow-up before the baseline visit. Of the 9 patients who received >1 injection of Peg-IFN, 55% had an SVR; three became re-infected. Among controls, 14% cleared virus, 79% became chronically infected. Treated participants were more likely to clear HCV than controls (HR (95% CI) =15.34 (3.08-76.40), p=0.001).Additionally, for the univariate analysis, participants with more recent PWID (5.00 (1.23 – 20.00)), a baseline viremia< 5 log IU/mL (3.57 (0.94 – 14.28)), and an ALT level ≤ to 450 IU/mL (6.67 (0.83 – 50.00)) were more likely to clear virus. Sixty-seven percent of participants received at least 80% of scheduled injections and the incidence of severe depression was low. Conclusions: We found that treatment of HCV in active PWID was effective and safe, though re-infections occurred. Adherence rates in this cohort were excellent, supporting the idea that this difficult-to-treat population benefits from medically supervised injections.