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New Oral Drugs Effective for Hepatitis C, but Cost Remains a Concern — Physician’s First Watch

Medical News |
July 28, 2014

New Oral Drugs Effective for Hepatitis C, but Cost Remains a Concern

By Amy Orciari Herman

Edited by Susan Sadoughi, MD

Two new, all-oral drug regimens are largely effective and well tolerated in patients with chronic hepatitis C (HCV) infection, according to two industry-funded studies in the Lancet. A Lancet commentator, while enthusiastic about the drugs' efficacy, says their high cost will keep them out of the hands of most patients.

In the HALLMARK-DUAL study, researchers studied 24 weeks of daily daclatasvir plus asunaprevir among some 640 patients with HCV genotype 1b infection who were treatment-naive or were nonresponders to, ineligible for, or intolerant of peginterferon plus ribavirin. Sustained virologic response 12 weeks after treatment cessation occurred in 82%-90% of patients. The drugs were well tolerated. (They have not been FDA approved.)

In the COSMOS study, roughly 170 patients with HCV genotypes 1a or 1b who were treatment-naive or had not responded to peginterferon plus ribavirin were randomized to receive simeprevir plus sofosbuvir, with or without ribavirin, for 12 or 24 weeks. Sustained virologic response 12 weeks post-treatment cessation occurred in 92% of patients overall; adding ribavirin or extending treatment to 24 weeks did not affect response rates. Treatment was well tolerated. (The FDA approved simeprevir and sofosbuvir in late 2013.)

A Lancet commentator notes that 12 weeks of simeprevir plus sofosbuvir costs roughly US$150,000. Paul Sax of NEJM Journal Watch HIV/AIDS Clinical Care says the combination "is right now the treatment of choice for interferon-ineligible patients with genotype 1 HCV, but this will likely change soon with the approval of other options later this year."

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