New Four Drug Regimen Effective in Patients With HCV Who Inject Drugs
The rate of undetectable HCV RNA at 12 weeks post-treatment was 91%.
In patients with chronic hepatitis C virus (HCV) genotype 1 with recent injection drug use and/or current opioid substitution therapy (OST), paritaprevir/ritonavir, ombitasvir, and dasabuvir with/without ribavirin is effective, according to study results published in the International Journal of Drug Policy.
The study included participants with chronic HCV genotype 1 infection who had never received treatment and had intravenous drug use within the past 6 months and/or were receiving opioid substitution therapy. Participants received paritaprevir/ritonavir, ombitasvir, and dasabuvir twice daily for 12 weeks in a 1-week electronic blister pack that records timing of each dose; participants with HCV genotype 1a also received ribavirin twice a day at body-weight-dependent dosages. The primary end point was undetectable HCV RNA at 12 weeks post-treatment.
The study included 87 participants; median age was 48, 23% were women, 8% had cirrhosis, and 90% had HCV genotype 1a. Overall, 71% of participants were receiving opioid substitution therapy, 61% injected drugs in the previous 6 months, 45% injected drugs in the previous month, and 15% injected drugs daily.
Of 87 participants, 84 (97%) completed treatment, with 1 participant lost to follow-up, 1 lost due to non-adherence, and 1 due to incarceration. The rate of undetectable HCV RNA at 12 weeks post-treatment was 91% (n=79).
Of the participants who completed treatment, 5 did not achieve undetectable HCV RNA at 12 weeks post-treatment, with 1 loss to follow-up, 1 death, and 3 virologic relapses. The researchers found that drug use prior to and during treatment did not affect undetectable HCV RNA at 12 weeks post-treatment.
Treatment-related adverse events were reported by 53% (n=46) participants, with 6 grade 3 and no grade 4. Of these, 5 participants had ≥1 serious adverse events, with 2 possibly/probably related to treatment (nausea and myoclonus). Reinfection with HCV occurred in 2 cases: a 23-year-old woman with HCV genotype 1a prior to treatment who reported injecting Ritalin during the study and a 32-year-old man with HCV genotype 1a prior to therapy who achieved undetectable HCV RNA at 12 weeks post-treatment, but had recurrent viremia at week 36; he reported daily use of intravenous cocaine more than once a day and syringe-sharing throughout the study.
“Future research will be required to evaluate novel strategies to enhance HCV testing, linkage to care and treatment to ensure that a greater number of people who inject drugs receive HCV treatment to further efforts to eliminate HCV infection in this population,” the researchers wrote.
Grenely J, Conway B, Cunningham EB, et al. Paritaprevir, ritonavir, ombitasvir, and dasabuvir with and without ribavirin in people with HCV genotype 1 and recent injecting drug use or receiving opioid substitution therapy. Int J Drug Policy. 2018;62:94-103.