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Viekira XR Approval History

  • FDA approved: Yes (First approved July 22nd, 2016)
  • Brand name: Viekira XR
  • Generic name: dasabuvir, ombitasvir, paritaprevir and ritonavir
  • Dosage form: Extended-Release Tablets
  • Company: AbbVie Inc.
  • Treatment for: Hepatitis C

Viekira XR (dasabuvir, ombitasvir, paritaprevir and ritonavir) is a hepatitis C virus non-nucleoside NS5B palm polymerase inhibitor, NS5A inhibitor, NS3/4A protease inhibitor, and CYP3A inhibitor fixed-dose combination indicated for the once-daily treatment of adult patients with chronic hepatitis C virus (HCV) genotype 1 infection.

Viekira XR is a single tablet co-formulation of the ingredients in Viekira Pak (ombitasvir/paritaprevir/ritonavir tablets co-packaged with dasabuvir tablets) approved December 2014. Viekira XR is taken in combination with twice daily ribavirin in patients with genotype 1a infection, and without ribavirin in patients with the genotype 1b infection.

The recommended dose of Viekira XR is three tablets taken orally as a single dose, once-daily with a meal. Tablets must be swallowed whole, and alcohol should not be consumed within four hours of each dose.

The most common side effects reported in genotype 1a patients taking Viekira XR with ribavirin include fatigue, nausea, pruritus, other skin reactions, insomnia and asthenia. In genotype 1b patients taking Viekira XR without ribavirin, the most common side effects reported include nausea, pruritus and insomnia.

Development History and FDA Approval Process for Viekira XR

Jul 25, 2016Approval AbbVie Receives U.S. FDA Approval of Once-Daily Viekira XR (dasabuvir, ombitasvir, paritaprevir and ritonavir) for the Treatment of Genotype 1 Chronic Hepatitis C

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