Ombitasvir, Paritaprevir, and Ritonavir (Viekira™ Pak)
This supplement was written by William T. Elliott, MD, FACP, Chair, Formulary Committee, Kaiser Permanente, California Division; Assistant Clinical Professor of Medicine, University of California-San Francisco. In order to reveal any potential bias in this publication, we disclose that Dr. Elliott reports no consultant, stockholder, speaker’s bureau, research, or other financial relationships with companies having ties to this field of study. For questions and comments, please e-mail: leslie.hamlin @ahcmedia.com.
The hepatitis C wars have escalated with the approval of a new four-drug oral combination to treat hepatitis C virus (HCV) genotype 1 infection. The combination contains three new drugs — ombitasvir, paritaprevir and dasabuvir — as well as the previously approved ritonavir, a CYP3A inhibitor, to boost the levels of paritaprevir. The drug is approved for use in patients with HCV infections, including those with cirrhosis. It can be used with or without ribavirin, but it is not recommended in those with decompensated cirrhosis. The combination was evaluated in six clinical trials of more than 2300 patients with HCV infection with and without cirrhosis, showing 91-100% sustained viral response (SVR) rate after 12 weeks of treatment. The new combination is marketed by AbbVie Inc as Viekira Pak. The approval comes 2 months after the approval of Gilead’s combination HCV drug, Harvoni, which boasts similar SVR rates. Harvoni is also an all-oral regimen for 12 weeks, and like VIekira Pak, is an interferon-free regimen. It appears that AbbVie and Gilead may be locked in a price war, with both drugs costing from $85,000 to $95,000 per treatment course. Health plans and PBMs are already maneuvering for best pricing. In late December, Express Scripts announced an exclusive contract with AbbVie to make Viekira Pak, their drug of choice, for HCV genotype 1 patients.
Evidence-based updates in clinical pharmacology
In this issue: Tramadol: Increased Risk for Hypoglycemia?; Clarithromycin: Proceed with Caution; and FDA Actions.
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