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FDA approves Viekira XR for HCV genotype 1
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The FDA has approved a new drug application for Viekira XR — an extended-release, coformulation of the active ingredients in Viekira Pak — for the treatment of chronic hepatitis C virus infection genotype 1, according to a press release from the manufacturer.
Viekira XR (dasabuvir, ombitasvir, paritaprevir and ritonavir, AbbVie) is a once-daily regimen and is an extension of the active ingredients in Viekira Pak (ombitasvir, paritaprevir and ritonavir tablets with dasabuvir tablets, AbbVie) for the treatment of patients with chronic HCV genotype 1, including those with compensated cirrhosis.
Viekira XR is the first co-formulated three direct-acting antiviral (DAA) treatment for this patient population and should be taken as three oral tablets with a meal. It is recommended for use in combination with twice-daily ribavirin in patients with HCV genotype 1a patients and without ribavirin in patients with HCV genotype 1b. It is not recommended for patients with decompensated cirrhosis, according to the release.
“AbbVie’s work continues to contribute to the transformation of hepatitis C care through our focus on evolving our current therapies as part of our ongoing commitment to patients,” Rob Scott, MD, vice president of development and chief medical officer at AbbVie, said in the release. “The approval of Viekira XR provides a new treatment option for genotype 1 hepatitis C patients in the U.S. with clinical trial data using the components of Viekira XR demonstrating 100% cure rates in genotype 1b patients.”
The approval is indicative of seven phase 3 clinical trials for Viekira Pak, including data that demonstrated 100% sustained virologic response 12 weeks after treatment in patients with genotype 1b with 12 weeks of therapy without ribavirin, and 95% of patients with genotype 1a achieving SVR12 when administered the DAA regimen with ribavirin for 12 or 24 weeks of therapy.
Viekira may cause severe liver problems, particularly in patients with certain types of cirrhosis, according to the release. These severe liver problems can lead to the need for a liver transplant, or mortality.
Disclosure: Scott is employed by AbbVie.