Directly Observed Treatment for Hepatitis C Virus Infection among People with Active Drug Use
This study appears to be the first randomized controlled trial (RCT) of treatment for HCV with directly observed interferon (peg-IFN) alpha-2a plus self-administered ribavirin (RBV) conducted exclusively among adults with active* injection drug or crack cocaine use. Subjects were randomized to either immediate treatment with peg-IFN/RBV or delayed treatment (after 24–48 weeks). The original primary outcome was loss to follow-up and adverse events. The authors here report on sustained virologic response (SVR)—defined as undetectable HCV RNA—24 weeks after completion of treatment.
- 377 participants were screened and only 66 (18%) were enrolled. The leading reasons for exclusion were cessation of drug use (82), loss to follow-up (72), and HCV RNA-negative status (61). The study was terminated early as the desired sample size (100) could not be achieved.
- In intention-to-treat analysis, SVR was 65% in the immediate group and 39% in the delayed group.
- Recent drug use in the past month did not impact treatment completion or SVR.
* Defined as use at least once in a month and within 3 months of the date of randomization.
Comments:
The results of this study suggest a benefit for immediate treatment over delayed treatment, although the authors encourage readers to interpret the findings with caution as they are observed in a small number of patents and the study was not originally designed to answer a question regarding efficacy via SVR. The inability of the investigators to recruit their targeted sample size informs translation into real-world settings. As newer therapies for HCV with fewer side effects and shorter duration of treatment become available, it may become easier to treat people with illicit drug use and HCV.
Judith Tsui, MD, MPH
Reference:
Hilsden RJ, Macphail G, Grebely J, et al. Directly observed pegylated interferon plus self-administered ribavirin for the treatment of hepatitis C virus infection in people actively using drugs: a randomized controlled trial. Clin Infect Dis. 2013;57 Suppl 2:S90–96.