New Drug Combo Clears HepC Virus in 92% of Patients

Two new interferon-free oral drug regimens—detailed in the HALLMARK-DUAL and COSMOS studies—were effective and well-tolerated treatments for patients with hepatitis C infection, according to researchers.

Both studies hoped to assess the efficacy and safety of interferon-free oral drug therapy options for hepatitis C that have been unavailable up until now.

In the HALLMARK-DUAL study,¹ researchers tested a combination of daclatasvir and asunaprevir, (a NS5A replication complex inhibitor and NS3 protease inhibitor, respectively) in patients with hepatitis C and high unmet needs, cirrhosis, or both.
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Patients were randomly assigned either 60 mg daily of daclatasvir and 100 mg twice daily of asunaprevir, or placebo.

Of the 640 participants with hepatitis C who were treatment-naïve or did not respond to, or were ineligible for, treatment with ribavirin, 82% to 90% experienced sustained virologic response up to 12 weeks after treatment cessation. Ten patients experienced increases in alanine or aspartate aminotransferase, leading to discontinuation of treatment.

In the COSMOS study,² researchers followed 167 patients who had not responded to pegylated interferon and ribavirin or were treatment naïve. Patients were randomly assigned to 400 mg sofosbuvir and 150 mg simeprevir for 24 weeks with or without ribavirin or 12 weeks with or without ribavirin and split into 2 cohorts: those with METAVIR scores F0-F2 and those with METAIR scores F3-F4.

Overall, 92% of participants experienced sustained virologic response 12 weeks after treatment cessation. Increasing treatment from 12 weeks to 24 weeks, or adding ribavirin, did not affect results.

While the combination found in COSMOS of simeprevir and sofosbuvir was FDA approved in late 2013, the HALLMARK-DUAL study combination of daclatasvir and asunaprevir has not yet been approved.

—Michael Potts

1. Manns M, Pol S, Jacobson IM, Marcellin P, Gordon SC, et al. All-oral daclastasvir plus asunaprevir for hepatitis C virus genotype 1b: a multinational, phase 3, multicohort study. Lancet. 2014 July 28 [epub ahead or print]. doi:10.1016/S0140-6736(14)61059-X

2. Lawitz E, Sulkowski MS, Ghalib R, Torres M, Younossi ZM, et al. Simeprevir plus sofosbuvir, with or without ribavirin, to treat chronic infection with hepatitis C virus genotype 1 in non-responders to pegylated interferon and ribavirin and treatment-naive patients: the COSMOS randomised study. Lancet. 2014 July 28, 2014 [epub ahead of print]. doi:10.1016/S0140-6736(14)61036-9