What is the recommended treatment regimen for Hepatitis C (HCV) using Harvoni (ledipasvir/sofosbuvir)?

Harvoni (Ledipasvir/Sofosbuvir) Treatment Regimens for Hepatitis C

Harvoni (ledipasvir/sofosbuvir) is recommended as a first-line treatment option for chronic hepatitis C virus (HCV) infection with specific durations based on genotype, treatment history, and cirrhosis status. 1, 2

Treatment Regimens by Genotype

Genotype 1

• Treatment-naïve without cirrhosis:

  • Ledipasvir/sofosbuvir (90mg/400mg) once daily for 12 weeks 1
  • Can be shortened to 8 weeks if baseline HCV RNA <6 million IU/mL 3, 4

• Treatment-naïve with compensated cirrhosis:

  • Ledipasvir/sofosbuvir once daily for 12 weeks 1, 2

• Treatment-experienced without cirrhosis:

  • Genotype 1a: Ledipasvir/sofosbuvir with weight-based ribavirin for 12 weeks 1
  • Genotype 1b: Ledipasvir/sofosbuvir for 12 weeks 1

• Treatment-experienced with compensated cirrhosis:

  • Ledipasvir/sofosbuvir for 24 weeks OR
  • Ledipasvir/sofosbuvir with weight-based ribavirin for 12 weeks 1, 5

• Decompensated cirrhosis (Child-Pugh B or C):

  • Ledipasvir/sofosbuvir with ribavirin for 12 weeks 3, 6

Genotype 4,5, or 6

• With or without compensated cirrhosis:
  • Ledipasvir/sofosbuvir once daily for 12 weeks 1, 2

Ribavirin Dosing When Required

• Weight <75 kg: 1000 mg daily (divided into two doses)
• Weight ≥75 kg: 1200 mg daily (divided into two doses) 3
• For decompensated cirrhosis: Start at 600 mg daily and titrate as tolerated 2

Important Considerations

Monitoring

• Test all patients for HBV coinfection (HBsAg and anti-HBc) before starting treatment 3
• No routine HCV RNA monitoring is required during treatment 2
• Check HCV RNA at 12 weeks post-treatment to confirm SVR (cure) 2

Drug Interactions

• Caution with proton pump inhibitors: May reduce effectiveness of ledipasvir 2, 7
• Avoid amiodarone: Risk of serious symptomatic bradycardia when used with sofosbuvir-containing regimens 2
• Check for interactions with antiretrovirals in HIV co-infected patients 2

Special Populations

• HIV co-infection: Same regimens as HCV mono-infected patients 1
• Post-transplant: Ledipasvir/sofosbuvir with ribavirin for 12 weeks 1, 6
• Renal impairment: No dose adjustment needed for mild to moderate impairment (CrCl >30 mL/min) 2

Real-World Effectiveness

Real-world studies confirm high SVR rates (93-98%) across diverse patient populations, supporting the efficacy of these recommended regimens 7, 5.

Common Pitfalls to Avoid

• Failure to test for HBV: Can lead to HBV reactivation during treatment 3
• Underutilization of 8-week regimen: Only 44% of eligible patients receive the shorter course despite similar efficacy 7
• Not checking for drug interactions: Particularly with proton pump inhibitors, which can reduce SVR rates 2, 7
• Not considering NS5A resistance testing: For genotype 1a treatment-experienced patients 1

Harvoni represents a highly effective treatment option for HCV with cure rates exceeding 95% in most patient populations when used according to these guidelines.