Viekira Pak Approved for Hepatitis C.

The FDA on Friday approved a new, all-oral, interferon-free treatment for patients with hepatitis C genotype 1, including those with cirrhosis. Viekira Pak includes a combination ombitasvir/paritaprevir/ritonavir tablet (two tablets taken once daily) plus a dasabuvir tablet (taken twice daily).

Ombitasvir is an NS5A inhibitor, paritaprevir a protease inhibitor, and dasabuvir a non-nucleoside polymerase inhibitor. (Ritonavir is a previously approved HIV-1 protease inhibitor used to boost levels of paritaprevir.) Viekira Pak may be used with or without ribavirin.

In clinical trials of patients with chronic HCV infection with or without cirrhosis, 91% to 100% of Viekira Pak recipients achieved a sustained virologic response.

The New York Times reports that the wholesale price of Viekira Pak will be roughly $83,000 for 12 weeks of therapy — “less than the $94,500 for 12 weeks of [the recently approved] Harvoni, but probably not enough of a discount to allay complaints about high prices.”

Infectious disease expert Paul Sax told Physician’s First Watch: “The key factor whether people will choose this regimen is going to be price/payer coverage. It’s definitely more complex than what’s been approved already.

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