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FDA Approves Once-Daily Viekira XR for Treatment of Genotype-1 Chronic Hepatitis C
The FDA has approved the new drug application for Viekira XR extended-release tablets (dasabuvir, ombitasvir, paritaprevir, and ritonavir, AbbVie). Viekira XR is a once-daily, extended-release co-formulation of the active ingredients in Viekira Pak (ombitasvir, paritaprevir, and ritonavir tablets; dasabuvir tablets, AbbVie) and is indicated for the treatment of patients with chronic genotype-1 (GT1) hepatitis C virus (HCV) infection, including those with compensated cirrhosis (Child–Pugh A). It is not for patients with decompensated cirrhosis. Viekira XR is the first co-formulated three direct-acting antiviral (DAA) treatment for adults with GT1 HCV infection.
Viekira XR consists of 200 mg of dasabuvir, 8.33 mg of ombitasvir, 50 mg of paritaprevir, and 33.33 mg of ritonavir per tablet. The treatment is administered once daily as three oral tablets and must be taken with a meal. It is used without ribavirin (RBV) in GT1b patients and in combination with twice-daily RBV in GT1a patients.
The FDA’s approval was based on the results from phase 3 clinical studies of Viekira Pak, which included data demonstrating a 100% sustained virologic response 12 weeks after treatment (SVR12) in GT1b patients who received 12 weeks of therapy without RBV and a 95% SVR12 in GT1a patients when used with RBV for 12 or 24 weeks of therapy.
The components of Viekira XR have been studied in an array of GT1 patients with HCV infection, ranging from treatment-naïve to difficult-to-treat patients, such as those with compensated (mild, Child–Pugh A) cirrhosis of the liver; HCV/human immunodeficiency-1 co-infection; liver transplant recipients with normal hepatic function and mild fibrosis; and those who have failed previous treatment with pegylated interferon (pegIFN) and RBV.
Viekira XR is contraindicated in patients with moderate-to-severe hepatic impairment (Child–Pugh B and C) because of the risk of toxicity. Viekira XR is taken for 12 weeks, except in GT1a patients with cirrhosis and all liver transplant recipients with normal hepatic function and mild fibrosis, who should take the product for 24 weeks. RBV should be coadministered in GT1a patients and in all patients who have received a liver transplant.
Paritaprevir was discovered during the ongoing collaboration between AbbVie and Enanta Pharmaceuticals for HCV protease inhibitors and regimens that include protease inhibitors. Paritaprevir is used in combination with AbbVie’s ombitasvir with or without dasabuvir for the treatment of hepatitis C.
Source: AbbVie; July 25, 2016.