What is the treatment regimen for Hepatitis C using Epclusa (Sofosbuvir/Velpatasvir)?

From the Guidelines

Epclusa is a highly effective treatment for hepatitis C virus (HCV) infection and should be administered for 12 weeks to achieve cure rates exceeding 95% in most patient populations. This regimen combines two antiviral medications, sofosbuvir (400 mg) and velpatasvir (100 mg), in a single daily tablet, making it a pangenotypic treatment option for adults with all six major HCV genotypes 1. Epclusa works by directly targeting the virus's ability to replicate, with sofosbuvir inhibiting the viral RNA polymerase and velpatasvir blocking the NS5A protein essential for viral replication.

Some key points to consider when treating patients with Epclusa include:

• Patients should take Epclusa with food once daily for the full 12-week course, even if they feel better before completing treatment.
• Common side effects include headache, fatigue, and nausea, which are typically mild.
• For patients with decompensated cirrhosis, Epclusa is usually combined with ribavirin.
• Regular monitoring during treatment includes blood tests to assess liver function and viral response.
• Patients should avoid taking antacids within 4 hours of Epclusa and should inform their healthcare provider about all medications they're taking, as certain drugs like amiodarone or certain seizure medications may interact with Epclusa 1.

It's also important to note that the treatment regimen may vary depending on the patient's HCV genotype, presence of liver cirrhosis, and treatment history. For example, patients with HCV genotype 3 infection may be treated with Epclusa for 12 weeks, with or without ribavirin, depending on the presence of NS5A resistance-associated substitutions (RASs) 1. Similarly, patients with HCV genotype 1b infection may be treated with Epclusa for 12 weeks, with or without ribavirin, depending on the presence of liver cirrhosis and treatment history 1.

Overall, Epclusa is a highly effective treatment for HCV infection and should be considered as a first-line treatment option for patients with all six major HCV genotypes, in accordance with the most recent guidelines and evidence-based recommendations 1.

From the FDA Drug Label

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 Recommended treatment regimen and duration in patients 3 years of age and older with genotypes 1,2,3,4,5, or 6 HCV in table below: Patient Population | Regimen and Duration

• In clinical trials, regimens contained peginterferon alfa/ribavirin with or without an HCV NS3/4A protease inhibitor (boceprevir, simeprevir, or telaprevir) Treatment-naïve and treatment-experienced*, without cirrhosis and with compensated cirrhosis (Child-Pugh A) | Sofosbuvir and velpatasvir 12 weeks Treatment-naïve and treatment-experienced*, with decompensated cirrhosis (Child-Pugh B and C) | Sofosbuvir and velpatasvir + ribavirin 12 weeks

The Epclusa (sofosbuvir and velpatasvir) treatment for hepatitis C is indicated for adults and pediatric patients 3 years of age and older with chronic HCV genotype 1,2,3,4,5, or 6 infection. The recommended treatment regimen and duration are as follows:

• Treatment-naïve and treatment-experienced patients without cirrhosis and with compensated cirrhosis (Child-Pugh A): Sofosbuvir and velpatasvir for 12 weeks
• Treatment-naïve and treatment-experienced patients with decompensated cirrhosis (Child-Pugh B and C): Sofosbuvir and velpatasvir + ribavirin for 12 weeks 2

From the Research

Epclusa Treatment for Hepatitis C

• Epclusa, a single-tablet combination of sofosbuvir and velpatasvir, is a direct-acting antiviral (DAA) medication for the treatment of chronic hepatitis C infection of all genotypes 3, 4.
• The treatment has shown excellent activity against the 6 most prevalent HCV genotypes in the United States, with reported rates of sustained virological response at 12 weeks after treatment completion ranging from 95% to 100% in various HCV-infected populations 3.
• In patients with decompensated cirrhosis or HIV coinfection, reported cure rates are 85-100% and 92-100%, respectively 3.
• The duration of treatment with sofosbuvir-velpatasvir is 12 weeks regardless of the HCV genotype involved, previous treatment, and the presence of cirrhosis or baseline resistance-associated NS5A mutations 3, 4.

Efficacy and Safety

• Sofosbuvir-velpatasvir was well tolerated in clinical trials, with adverse effects reported at a rate of ≥10% being fatigue, headache, nausea, and nasopharyngitis 3.
• A systematic review and meta-analysis of six randomized trials showed that velpatasvir plus sofosbuvir achieved sustained virological response (SVR12) rates of 98.2% in genotype-1,99.4% in genotype-2,94.7% in genotype-3,99.6% in genotype-4,97.1% in genotype-5, and 98.8% in genotype-6 patients 5.
• The addition of ribavirin did not significantly increase the SVR12 or decrease relapse rates in HCV genotype-1 patients, but it did significantly increase SVR12 in genotype-3 patients 5.

Treatment Options

• Sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) and glecaprevir/pibrentasvir (G/P) are pangenotypic regimens that received approval from the U.S. Food and Drug Administration in 2017 6.
• SOF/VEL/VOX is positioned as a salvage regimen for patients previously treated with NS5A inhibitors and for genotype 1a- and 3-infected patients who had failed other sofosbuvir-containing regimens 6.
• G/P is the first pangenotypic regimen with an 8-week duration for treatment-naïve, non-cirrhotic patients, and it is indicated for patients with any genotype who have advanced kidney disease, including those on dialysis 6.
• SOF/VEL/VOX is an effective regimen for virologic failures to G/P, with 94% of subjects achieving sustained virologic response with re-treatment 7.