Individuals with chronic hepatitis C virus (HCV) had high rates of sustained virological response 12 weeks after completion of treatment, regardless of injection drug use before or during therapy, according to data published in the Lancet.
Jason Grebely, PhD, from the Kirby Institute in Sydney, Australia, and colleagues conducted the phase 4 SIMPLIFY trial to evaluate the efficacy of sofosbuvir and velpatasvir therapy in individuals with HCV who had recently used injection drugs (ClinicalTrials.gov identifier: NCT02336139). The trial included 103 participants (28% female) with chronic HCV genotype 1-6 infection. Participants received oral sofosbuvir 400 mg and velpatasvir 100 mg once daily for 12 weeks.
The investigators found that 59% of participants were receiving opioid substitution therapy during the study, 74% had injected drugs 1 month before the study, and 26% injected at least daily in the month before the study. Results showed that 94% of individuals achieved sustained virologic response 12 weeks (SVR12) after completion of treatment, defined as HCV RNA less than 12 IU/mL.
Overall, drug use before and during treatment did not affect SVR12. Treatment-related adverse events were seen in 47% of participants, and 7% had at least 1 serious adverse event, but only 1 resolved event of rhabdomyolysis could have been related to the therapy. In addition, investigators observed 1 case of HCV reinfection.
The researchers note several limitations, including that HIV-positive individuals were excluded from the study and that information on drug use risk behaviors was self-reported. They add that the study population may not be generalizable to all populations of people with recent injection drug use.
“These data provide evidence to inform international guidelines on the management of HCV infection in people with recent injection drug use and support the removal of restrictions for the reimbursement of DAA therapy among people with HCV infection and recent injection drug use that are in place in several countries,” the investigators wrote.
Disclosure: This study was funded by Gilead Sciences.
Grebely J, Dalgard O, Conway B, et al. Sofosbuvir and velpatasvir for hepatitis C virus infection in people with recent injection drug use (SIMPLIFY): an open-label, single-arm, phase 4, multicentre trial [published online January 5, 2018]. Lancet. doi: 10.1016/S2468-1253(17)30404-1