The fixed-dose combination of ledipasvir-sofosbuvir provides an effective and well-tolerated one-pill once-a-day option for treatment of genotypes 1, 4, 5, and 6 chronic hepatitis C (HCV) infection.
Medicince introduction including background, function, caution, etc.
Indication The fixed dose combination ledipasvir-sofosbuvir (90 mg/400 mg) is indicated for treatment, with or without ribavirin, for the treatment of patients with chronic hepatitis C genotypes 1, 4, 5, and 6. The detailed indications are listed below. When treating patients coinfected with HCV and HIV, the recommendations are the same as listed below. Genotype 1
Treatment-naïve without cirrhosis or with compensated cirrhosis (Child-Pugh A) : ledipasvir-sofosbuvir x 12 weeks* Treatment-experienced** without cirrhosis: ledipasvir-sofosbuvir x 12 weeks Treatment experienced** with compensated cirrhosis (Child-Pugh A): ledipasvir-sofosbuvir x 24 weeks† Treatment naïve and treatment experienced** with decompensated cirrhosis (Child-Pugh B or C): ledipasvir-sofosbuvir plus ribavirin‡ x 12 weeks Genotype 1 or 4
Treatment-naïve and treatment-experienced ** liver transplant recipients without cirrhosis, or with compensated cirrhosis (Child-Pugh A): ledipasvir-sofosbuvir plus ribavirin§ x 12 weeks Genotype 4, 5, or 6
Treatment-naïve and treatment-experienced ** without cirrhosis or with compensated cirrhosis (Child-Pugh A): ledipasvir-sofosbuvir plus ribavirin x 12 weeks
Side Effects Nausea, severe dizziness, trouble breathing. Mechanism Of Action Ledipasvir is a potent inhibitor of HCV NS5A, a viral phosphoprotein that plays an important role in viral replication, assembly, and secretion. Sofosbuvir is a nucleotide analog inhibitor of hepatitis C virus NS5B polymerase—the key enzyme mediating HCV RNA replication. The triphosphate form of sofosbuvir (GS-461203) mimics the natural cellular uridine nucleotide and is incorporated by the HCV RNA polymerase into the elongating RNA primer strand, resulting in viral chain termination