From the Guidelines
Epclusa (Sofosbuvir/Velpatasvir) is indicated for the treatment of chronic hepatitis C virus (HCV) infection in adults and children 3 years of age and older, and is effective against all six major HCV genotypes, making it a pan-genotypic treatment option. The standard regimen is one tablet taken orally once daily for 12 weeks, with each tablet containing 400 mg of sofosbuvir and 100 mg of velpatasvir 1. Epclusa works by directly targeting the hepatitis C virus, inhibiting its replication, with sofosbuvir being a nucleotide analog that inhibits the NS5B polymerase, and velpatasvir targeting the NS5A protein, which helps prevent viral resistance and leads to high cure rates 1. Some key points to consider when using Epclusa include:
- Treatment-naïve patients without cirrhosis should be treated with the fixed-dose combination of sofosbuvir and velpatasvir for 12 weeks without ribavirin 1
- If no NS5A resistance testing is performed, treatment-experienced patients without cirrhosis, as well as treatment-naïve and treatment-experienced patients with compensated cirrhosis, should be treated with the fixed-dose combination of sofosbuvir and velpatasvir for 12 weeks with daily weight-based ribavirin 1
- Patients with contraindications to the use of ribavirin or with poor tolerance to ribavirin on treatment should receive the combination of sofosbuvir and velpatasvir for 24 weeks without ribavirin 1 It's essential to complete the full course of treatment as prescribed and to monitor liver function and viral load regularly during and after treatment to assess response and detect potential side effects 1. The most recent and highest quality study, published in 2020, supports the use of Epclusa as a simplified, genotyping/subtyping-free treatment option for HCV-monoinfected or HCV-HIV coinfected adult and adolescent patients with chronic hepatitis C without cirrhosis or with compensated cirrhosis 1.
From the FDA Drug Label
Sofosbuvir and velpatasvir is indicated for the treatment of adults and pediatric patients 3 years of age and older with chronic hepatitis C virus (HCV) genotype 1,2,3,4,5, or 6 infection [see Dosage and Administration (2.2.3,2.4) and Clinical Studies (14)]: without cirrhosis or with compensated cirrhosis with decompensated cirrhosis for use in combination with ribavirin. Sofosbuvir and velpatasvir is a fixed-dose combination of sofosbuvir, a hepatitis C virus (HCV) nucleotide analog NS5B polymerase inhibitor, and velpatasvir, an HCV NS5A inhibitor, and is indicated for the treatment of adults and pediatric patients 3 years of age and older with chronic HCV genotype 1,2,3,4,5, or 6 infection (1): without cirrhosis or with compensated cirrhosis with decompensated cirrhosis for use in combination with ribavirin.
The indication for Epclusa (Sofosbuvir/Velpatasvir) is for the treatment of chronic hepatitis C virus (HCV) genotype 1,2,3,4,5, or 6 infection in:
- Adults
- Pediatric patients 3 years of age and older without cirrhosis or with:
- Compensated cirrhosis
- Decompensated cirrhosis (for use in combination with ribavirin) 2, 2, 2.
From the Research
Indication for Epclusa (Sofosbuvir/Velpatasvir)
- Epclusa (Sofosbuvir/Velpatasvir) is indicated for the treatment of adults with chronic Hepatitis C virus (HCV) genotype 1,2,3,4,5, or 6 infection 3, 4, 5
- The treatment is effective in patients with compensated cirrhosis or HIV-1 co-infection 3, 4, 5
- In patients with decompensated cirrhosis, high cure rates were achieved with sofosbuvir/velpatasvir plus ribavirin 3, 4, 5
- The treatment has been shown to be effective in treatment-naive and treatment-experienced patients 3, 4, 5
Patient Populations
- Epclusa (Sofosbuvir/Velpatasvir) is effective in patients with chronic HCV genotype 1-6 infection, including those with: