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Epclusa Approval History

  • FDA approved: Yes (First approved June 28th, 2016)
  • Brand name: Epclusa
  • Generic name: sofosbuvir and velpatasvir
  • Dosage form: Tablets
  • Company: Gilead Sciences, Inc.
  • Treatment for: Hepatitis C

Epclusa (sofosbuvir and velpatasvir) is a nucleotide analog polymerase inhibitor and pan-genotypic NS5A inhibitor fixed-dose combination for the treatment of chronic genotype 1-6 hepatitis C virus (HCV) infection.

The safety and efficacy of Epclusa was evaluated in three Phase 3 studies (ASTRAL-1, ASTRAL-2 and ASTRAL-3) of 1,558 patients without cirrhosis or with mild cirrhosis. Of the 1,035 patients who received Epclusa for 12 weeks, 98 percent had no virus detected in their blood 12 weeks after finishing treatment. The safety and efficacy of Epclusa was also evaluated in the Phase 3 ASTRAL-4 study of 267 patients with moderate to severe cirrhosis. Of the 87 patients who received Epclusa in combination with ribavirin for 12 weeks, 94 percent had no virus detected in the blood 12 weeks after finishing treatment.

Epclusa is a tablet taken orally once daily with or without food for 12 weeks. Patients with moderate to severe cirrhosis will need to take Epclusa in combination with ribavirin. The most common side effects of Epclusa include headache and tiredness.

Development History and FDA Approval Process for Epclusa

DateArticle
Jun 28, 2016Approval FDA Approves Epclusa (sofosbuvir and velpatasvir) for Treatment of all Major Forms of Chronic Hepatitis C Virus Infection
Jan  4, 2016Gilead Announces U.S. FDA Priority Review Designation for Sofosbuvir/Velpatasvir for Treatment of All Genotypes of Chronic Hepatitis C Infection
Oct 28, 2015Gilead Submits NDA to U.S. FDA for Fixed-Dose Combination of Sofosbuvir/Velpatasvir for Treatment of All Six Genotypes of Hepatitis C

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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