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Recent injection drug users achieve high adherence, SVR during HCV therapy
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Most patients with hepatitis C who were recent injection drug users achieved sustained virologic response after treatment with direct-acting antiviral Epclusa, according to recently published study results.
“In the USA and Europe, some jurisdictions have restrictions for the reimbursement of DAA therapy for people with recent illicit drug or alcohol use or those receiving opioid substitution therapy, irrespective of disease stage. The scarcity of data on DAA treatment outcomes in these populations has been used as a rationale for such restrictions,” Jason Grebely, PhD, from the Kirby Institute, University of New South Wales, Sydney, and colleagues wrote. “Data from this phase 4 SIMPLIFY study show high adherence and SVR among people who have injected drugs in the past 6 months.”
Grebely and colleagues enrolled 103 adult patients with HCV from 19 international sites between Mar. 29, and Oct. 31, 2016. Patients were naive to NS5A-based therapy, had injected drugs within 6 months of enrollment, and received Epclusa (sofosbuvir/velpatasvir, Gilead Sciences) during therapy.
At 12 weeks, 100 patients completed treatment. Of the three who did not complete treatment, one died of a drug overdose at week 3 and two were lost to follow-up.
Median adherence was 94% (range, 88%-98%) and 68 patients were at least 90% adherent to therapy. At end of treatment, 99 of 103 patients had an end-of-treatment response and 97 patients achieved SVR12. Of the three who did not achieve SVR, one was reinfected with HCV and two were lost to follow-up. Otherwise, the researchers observed no cases of virologic failure or relapse.
The rate of SVR did not differ between those with and without injection drug use within 1 month prior to baseline, between those with fewer than daily and those with at least daily injection drug use, between those with and without ongoing injection drug use during therapy, or those who were at least 90% adherent to therapy and those with less than 90% adherence.
Seven patients had at least one serious adverse event (n = 9). The researchers deemed one case of resolved rhabdomyolysis as possibly related to treatment.
“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 researchers concluded. – by Talitha Bennett
Disclosure: Grebely reports he received grants and personal fees from AbbVie, Cepheid, Gilead Sciences and Merck. Please see the full study for the other authors’ relevant financial disclosures.