Epclusa (sofosbuvir and velpatasvir)

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Company:

Approval Status:

Approved June 2016

Specific Treatments:

hepatitis C

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General Information

Epclusa is a fixed-dose combination of sofosbuvir, a hepatitis C virus (HCV) nucleotide analog NS5B polymerase inhibitor, and velpatasvir, an HCV NS5A inhibitor.

Epclusa is specifically indicated for the treatment of adult patients with chronic HCV genotype 1, 2, 3, 4, 5 or 6 infection:

  • without cirrhosis or with compensated cirrhosis
  • with decompensated cirrhosis for use in combination with ribavirin

Epclusa is supplied as a tablet for oral administration. The recommended dosage is one tablet (400 mg of sofosbuvir and 100 mg of velpatasvir) taken orally once daily with or without food for 12 weeks. For patients with moderate to severe cirrhosis (decompensated cirrhosis), Epclusa is approved for use in combination with the drug ribavirin.

Clinical Results

FDA Approval

The FDA approval of Epclusa was based on three Phase III clinical trials of 1,558 subjects without cirrhosis or with compensated cirrhosis (mild cirrhosis). Results demonstrated that 95 to 99 percent of patients who received Epclusa had no virus detected in the blood 12 weeks after finishing treatment, suggesting the patients' infections had been cured. The safety and efficacy of Epclusa was also evaluated in a clinical trial of 267 subjects with decompensated cirrhosis (moderate to severe cirrhosis), of whom 87 subjects received Epclusa in combination with ribavirin for 12 weeks. 94 percent of these patients had no virus detected in the blood 12 weeks after finishing treatment.

Side Effects

Adverse effects associated with the use of Epclusa may include, but are not limited to, the following:

  • headache
  • fatigue

Adverse effects associated with the use of Epclusa with ribavirin may include, but are not limited to, the following:

  • fatigue
  • anemia
  • nausea
  • headache
  • insomnia
  • diarrhea

Mechanism of Action

Epclusa is a fixed-dose combination of sofosbuvir, a hepatitis C virus (HCV) nucleotide analog NS5B polymerase inhibitor, and velpatasvir, an HCV NS5A inhibitor.

Additional Information

For additional information regarding Epclusa or hepatitis C, please visit http://www.gilead.com/