Providing direct-acting antivirals to people with hepatitis C virus (HCV) who inject drugs cured almost all participants in a recent industry-funded trial.
The open-label, single-arm phase 4 trial included patients who had used injection drugs within six months and had chronic HCV, recruited at 19 sites in seven countries (one site in the U.S.). All received oral sofosbuvir (400 mg) and velpatasvir (100 mg) once daily for 12 weeks. Therapy was given in one-week electronic blister packs with an integrated sensor grid that recorded the time and date that each daily dose was punched out of the pack. Patients were given the equivalent of AUS$10 (about $8 U.S.) as an incentive to return each blister pack. The trial was funded by Gilead Sciences.
Between March 29 and Oct. 31, 2016, 103 patients were enrolled in the study: 28% female, 9% with cirrhosis, 59% on opioid substitution therapy, and the majority with HCV genotype 3 or 1. About three-quarters had injected drugs in the past month, and a quarter had injected drugs at least daily in the past month. All but three patients completed treatment (97%): Two were lost to follow-up, and one died of an overdose. There were no virological failures, and 97 of the patients (94%; 95% CI, 88% to 98%) had sustained virological response 12 weeks after completion of treatment, the primary endpoint of the study. Two patients were lost to follow-up before 12 weeks and one had reinfection. Treatment-related adverse events occurred in 48 (47%) patients, and only one serious adverse event possibly related to the therapy was observed (rhabdomyolysis).
“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 [direct-acting antiviral] therapy among people with HCV infection and recent injection drug use that are in place in several countries,” the authors said. “Recent injection drug use should not be used as a reason to withhold reimbursement of HCV therapy.”
They noted that the single case of reinfection was consistent with previous research in this area. The study was limited by its study population, which excluded 10% of assessed participants and all HIV-positive patients and might be more engaged in health services than the general population of people who use injection drugs, the authors said. The study was published by The Lancet Gastroenterology & Hepatology on Jan. 5.
An accompanying editorial comment also noted that participating patients “received more monitoring, support, and incentives than might be feasible in the real world, including weekly appointments for medication dispensation, monetary incentives for the return of blister packs, and clinic visits.” Still, the editorialists said that the study provided “exciting new data,” and they called for repeal of insurance restrictions and sobriety requirements on the use of HCV drugs in patients who inject drugs, which they described as “unwarranted and unsupported by data.”