An application has been filed with Japanese regulators by AbbVie for approval to market its direct-acting antiviral regimen of paritaprevir/ritonavir and ombitasvir for use in patients with hepatitis C genotype 1 infection. The filing was based on late-stage trial data that showed 95% of HCV genotype 1b patients achieved sustained virologic response after 12 weeks of therapy.
The FDA has notified Merck that the agency plans to withdraw the breakthrough-therapy designation granted to its hepatitis C drug, a combination of grazoprevir and elbasvir, because of the availability of other approved treatments for HCV genotype 1 infection. Merck said it will meet with FDA authorities to discuss the matter, but it will proceed with its plans to submit the regimen for FDA review in the next few months.
A late-stage trial showed AbbVie's all-oral hepatitis C regimen cured 96% of patients with genotype 1 virus after only 12 weeks of therapy. Results of this trial, which involved patients who didn't respond to prior treatments, resembled the outcome of another Phase III study released last month that tested the regimen in previously untreated patients. The hepatitis C regimen, which contains three investigational antiviral drugs and ribavirin, is being tested in four more Phase III trials.
A draft guidance was published by the U.K. National Institute for Health and Care Excellence endorsing a combination of ribavirin and peginterferon alfa as a treatment option for chronic forms of hepatitis C in young people and children. As a result, the National Health Service's treatment menu will now include Merck Sharp and Dohme's ViraferonPeg, or peginterferon alfa-2b, and Roche's Pegasys, or peginterferon alfa-2a, as they are the only licensed drugs in the U.K. to treat the condition. The combination treatment effectively offers the equivalent of a cure by reducing the virus to undetectable levels, NICE's independent Appraisal Committee concluded.
The FDA granted priority-review status to Janssen Research & Development and Medivir's experimental drug simeprevir as a treatment for genotype 1 chronic hepatitis C. Janssen said the FDA is likely to make a final decision this year. Simeprevir, intended to be taken with pegylated interferon and ribavirin, inhibits the protease enzyme that allows the virus to reproduce itself inside cells.