Ledipasvir/Sofosbuvir: A Review in Chronic Hepatitis C.

Oral once-daily, fixed-dose, ledipasvir/sofosbuvir (Harvoni®) [± ribavirin] is approved in several countries for the treatment of chronic hepatitis C (CHC) in adults and adolescents aged 12 to < 18 years, with direct-acting antiviral (DAA) regimens resulting in a paradigm shift in the treatment of the disease. In the clinical trial and/or clinical practice setting, ledipasvir/sofosbuvir (± ribavirin) was associated with high sustained virological response rates 12 weeks post-treatment (SVR12) in treatment-naive and -experienced adults and adolescents with chronic hepatitis C virus (HCV) genotype (GT) 1 infection, including in those with compensated cirrhosis or who were co-infected with HIV. SVR12 rates in real-world studies were consistent with those in trials. In other trials, ledipasvir/sofosbuvir (± ribavirin) was associated with high SVR12 rates in various CHC populations, including patients with HCV GT2, 3, 4, 5 or 6 infection, cirrhosis, pre and/or post liver or renal transplantation, inherited blood disorders or failure after prior DAA and/or interferon therapy. Thus, ledipasvir/sofosbuvir (± ribavirin) is a valuable effective and generally well tolerated option for adolescent and adult patients with HCV GT1, 4, 5 or 6 infection, including those with HIV co-infection or cirrhosis, with evidence also supporting its use in patients with chronic HCV GT2 or 3 infection.