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 also approved for the treatment of people with chronic hepatitis C infection (HCV) as young as 6 years of age or weighing at least 17 kg, regardless of HCV genotype or liver disease severity.

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. The recommended dose for patients as young as 6 years of age or weighing at least 17 kg, regardless of HCV genotype or liver disease severity is based on weight and liver function. 

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.

The approval of Epclusa for patients as young as 6 years of age or weighing at least 17 kg, regardless of HCV genotype or liver disease severity was based on data from a Phase 2, open-label clinical trial (Study 1143) that enrolled 175 children who were treated with Epclusa for 12 weeks, of which 173 were included in the efficacy analysis. In children 12 to <18 years old, treatment with Epclusa resulted in a cure rate (SVR12) of 93 percent (71/76) in those with genotype 1 HCV infection and 100 percent in those with genotype 2 (6/6), genotype 3 (12/12), genotype 4 (2/2) and genotype 6 (6/6) HCV infection. In children 6 to <12 years old, the SVR rate was 93 percent (50/54) in those with genotype 1 HCV infection, 91 percent (10/11) in those with genotype 3 HCV infection, and 100 percent in those with genotype 2 (2/2) and genotype 4 (4/4) HCV infection.

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 Gilead's website.