Ledipasvir/Sofosbuvir: A Review in Chronic Hepatitis C.

Area of Science:

• Hepatology
• Virology
• Pharmacology

Background:

• Chronic hepatitis C (CHC) treatment has been revolutionized by direct-acting antiviral (DAA) regimens.
• Ledipasvir/sofosbuvir (Harvoni®) is an approved, fixed-dose, once-daily oral treatment for CHC in adults and adolescents.

Purpose of the Study:

• To evaluate the efficacy and tolerability of ledipasvir/sofosbuvir (± ribavirin) in diverse CHC patient populations.
• To assess sustained virological response rates (SVR12) in treatment-naive and -experienced individuals.

Main Methods:

• Analysis of clinical trial and real-world data for ledipasvir/sofosbuvir (± ribavirin) treatment.
• Inclusion of patients with various hepatitis C virus (HCV) genotypes (GT1-6), cirrhosis, HIV co-infection, and post-transplant status.

Main Results:

• High SVR12 rates were observed in adults and adolescents with HCV GT1 infection, including those with compensated cirrhosis or HIV co-infection.
• Consistent SVR12 rates were reported in real-world studies compared to clinical trials.
• High SVR12 rates were also achieved in patients with HCV GT2, 3, 4, 5, or 6 infection, cirrhosis, post-transplant status, and prior DAA/interferon treatment failure.

Conclusions:

• Ledipasvir/sofosbuvir (± ribavirin) is an effective and well-tolerated option for adults and adolescents with HCV GT1, 4, 5, or 6 infection, including those with HIV co-infection or cirrhosis.
• Evidence supports its use in patients with chronic HCV GT2 or 3 infection as well.