The Liver Meeting
The Liver Meeting
November 05, 2013
2 min read
Save

Interferon/ribavirin-free triple therapy highly effective for chronic HCV genotype 1

You've successfully added to your alerts. You will receive an email when new content is published.

Click Here to Manage Email Alerts

We were unable to process your request. Please try again later. If you continue to have this issue please contact customerservice@slackinc.com.

WASHINGTON — Patients with chronic hepatitis C genotype 1, including those with cirrhosis, experienced high rates of sustained virologic response at 12 weeks post-treatment with a safe, well-tolerated, interferon- and ribavirin-free regimen of three direct-acting antivirals in a study presented at The Liver Meeting.

In a phase 2b, open-label study, researchers randomly assigned 166 patients to triple therapy with NS5A inhibitor daclatasvir, NS3 inhibitor asunaprevir and 75 mg (n=80) or 150 mg (n=86) non-nucleoside NS5B inhibitor BMS-791325 for 12 weeks. All patients were treatment naive, had HCV genotype 1, and 9% of the cohort had biopsy-confirmed cirrhosis. Eighty-two percent of patients had genotype 1a, 67% had a non-CC IL28B genotype and 38% had a METAVIR fibrosis stage of F3 or F4. SVR at 12 weeks post-treatment was the primary endpoint.

End-of-treatment response occurred in 97.5% of the 75-mg group and 94.2% of the 150-mg group. SVR at 12 weeks was approximately 92% across the cohort, with no significant impact observed as a result of BMS-791325 dosage. Among cirrhotic patients, overall rates of SVR12 were more than 90%, regardless of genotype 1 subtype or IL28B status.

Gregory T. Everson, MD 

Gregory T. Everson

Virologic breakthrough occurred in two patients in the 75-mg group and three in the 150-mg group. Relapse occurred in four 75-mg patients and in two 150-mg recipients, all within 4 weeks of treatment initiation. All patients who experienced virologic failure had genotype 1a; no other characteristics at baseline were associated with breakthrough.

Treatment was well tolerated in both groups. No patients discontinued treatment because of treatment-related serious adverse events, and symptoms while on treatment were mild or moderate in all but one patient who developed an AST elevation of grade 3-4 that later normalized, and one cirrhotic patient who experienced an elevation in bilirubin.

“This looks like a fairly good regimen: It’s a 12-week course of therapy, interferon-free, ribavirin-free, all-oral, three DAAs, and achieves an SVR12 in over 90% of treated patients,” presenter Gregory T. Everson, MD, University of Colorado, Denver, said. “And, in this study, this was achieved despite a high prevalence of genotype 1a subtype, advanced fibrosis, cirrhosis and a predominance of non-CC IL28B genotype. … These results support phase 3 trials with a twice-daily, fixed-dose combination of this regimen at the 75-mg dose of [BMS-791325].”

Disclosure: The researchers report numerous financial disclosures.

For more information:

Everson GT. LB-1: Late-Breaking Abstract Session: Phase 2b Study of the Interferon-free and Ribavirin-free Combination of Daclatasvir, Asunaprevir, and BMS-791325 for 12 Weeks in Treatment-Naive Patients with Chronic HCV Genotype 1 Infection. Presented at: The Liver Meeting 2013; Nov. 1-5, Washington.