July 25, 2016 – The U.S. FDA approved Viekira XR™, an extended-release formulation of dasabuvir/ombitasvir/paritaprevir/ritonavir tablets, manufactured by AbbVie. Viekira XR is indicated to treat adults who have chronic genotype 1 hepatitis C virus (HCV) infection. Approximately 3.2 million Americans have HCV infection, with genotype 1 accounting for nearly 75% of cases in the United States. Viekira XR is three tablets taken once a day in addition to ribavirin, along with a meal. Each available dose possesses extended-release tablets containing 200mg of dasabuvir, 8.33mg of ombitasvir, 50mg of paritaprevir and 33.33mg of ritonavir.
For genotype 1a patients with compensated cirrhosis (Child-Pugh A) the recommended length of therapy is 24 weeks; for genotype 1a patients without cirrhosis, the recommended duration of treatment is 12 weeks. For patients with genotype 1b HCV infection without cirrhosis or compensated cirrhosis, Viekira XR is recommended for 12 weeks and ribavirin is not needed. Patients with decompensated cirrhosis or severe liver conditions (Child-Pugh B or C) should not take it. It will be dispensed in 28-day cartons, which will include four boxes that contain a one-week supply of daily dose packs. AbbVie expects Viekira XR to be in pharmacies by the end of this week.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Actual drug patent expiration dates and a availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.