What is the recommended treatment regimen for hepatitis C using Epclusa (sofosbuvir and velpatasvir)?

Epclusa (Sofosbuvir/Velpatasvir) Treatment Regimen for Hepatitis C

The recommended treatment regimen for hepatitis C using Epclusa (sofosbuvir 400 mg/velpatasvir 100 mg) is one tablet taken orally once daily for 12 weeks, with the addition of ribavirin only for patients with decompensated cirrhosis. 1

Treatment Recommendations by Patient Population

Non-Cirrhotic Patients and Compensated Cirrhosis (Child-Pugh A)

• Treatment-naïve and treatment-experienced patients with any HCV genotype (1-6):
  • Sofosbuvir/velpatasvir 400/100 mg once daily for 12 weeks without ribavirin 2, 1
  • This regimen achieves SVR12 rates of >95% across all genotypes 3

Decompensated Cirrhosis (Child-Pugh B or C)

• Treatment-naïve and treatment-experienced patients with any HCV genotype (1-6):
  • Sofosbuvir/velpatasvir 400/100 mg once daily for 12 weeks WITH weight-based ribavirin (1000 mg daily if <75 kg or 1200 mg daily if ≥75 kg) 2, 1
  • This combination is particularly important for genotype 3 patients with decompensated cirrhosis, where SVR rates increase from 50% without ribavirin to 85% with ribavirin 2

Special Populations

HCV Genotype 3 with Compensated Cirrhosis

For genotype 3 patients with compensated cirrhosis who are treatment-experienced:

• If NS5A resistance testing is available:
  • Patients with Y93H mutation: Sofosbuvir/velpatasvir plus ribavirin for 12 weeks 2
  • Patients without Y93H mutation: Sofosbuvir/velpatasvir without ribavirin for 12 weeks 2
• If resistance testing is not available:
  • Sofosbuvir/velpatasvir plus ribavirin for 12 weeks 2

HCV/HIV Co-infection

• Follow the same dosing recommendations as for HCV mono-infected patients 1
• No dose adjustments needed, but check for potential drug interactions with antiretroviral medications 1

Liver Transplant Recipients

• Treatment-naïve and treatment-experienced liver transplant recipients without cirrhosis or with compensated cirrhosis: Sofosbuvir/velpatasvir once daily for 12 weeks 1

Renal Impairment

• No dose adjustment required, even for patients with end-stage renal disease on dialysis 1

Important Clinical Considerations

Pre-Treatment Testing

• Mandatory: Test all patients for HBV infection by measuring HBsAg and anti-HBc before starting treatment 1
• HBV reactivation has been reported during or after HCV treatment, sometimes resulting in fulminant hepatitis, hepatic failure, and death 1

Drug Interactions

• Caution with amiodarone: Serious symptomatic bradycardia may occur, particularly in patients also receiving beta blockers or those with cardiac comorbidities/advanced liver disease 1
• Coadministration of amiodarone with sofosbuvir/velpatasvir is not recommended 1

Monitoring During Treatment

• Patients with decompensated cirrhosis should be treated in experienced centers with easy access to liver transplantation 2
• Close monitoring is required, with the possibility of stopping therapy if there is evidence of worsening decompensation during treatment 2

Adverse Effects

• Most common adverse reactions (≥10%): headache and fatigue 1
• In pediatric patients <6 years: vomiting and spitting up the drug 1
• Treatment is generally well-tolerated with low rates of adverse events 3

Patient Outcomes

Sofosbuvir/velpatasvir treatment not only achieves high cure rates but also improves patient-reported outcomes, particularly in those with decompensated cirrhosis who experience significant increases in quality of life scores during and after treatment 4.

Epclusa represents a valuable pangenotypic treatment option that simplifies HCV treatment as a single daily pill regimen with high efficacy across all genotypes, making it an ideal choice for most patients with chronic hepatitis C.