(i) Indications Sofosbuvir is a hepatitis C virus (HCV) nucleotide analogue NS5B polymerase inhibitor used as a combination component in combination antiviral regimens for the treatment of chronic hepatitis C (CHC) infection. Sofosbuvir has been shown in trials to be effective in the treatment of subjects with genotype 1, 2, 3 or 4 hepatitis C, including subjects with hepatocellular carcinoma who meet the Milan criteria and are awaiting liver transplantation, and subjects with HCV/HIV-1 co-infection. The recommended combination regimens are listed below: (ii) Contraindications Sofosbuvir alone or in combination with ribavirin is contraindicated in women who are pregnant, women who are planning to become pregnant and men whose partners are planning to become pregnant. (iii) Warnings and Precautions: Combination with amiodarone causes bradycardia: Severe symptomatic bradycardia may occur in patients with chronic hepatitis C treated with sofibuvir in combination with antivirals (DAA) who are also taking amiodarone, particularly in patients on concomitant beta-blockers or with underlying cardiac complications and/or advanced liver disease. Pregnancy: Ribavirin has the potential to cause congenital malformations or stillbirths in the fetus. Therefore, pregnancy should be avoided in female patients taking this drug and in the spouses of male patients. Prior to starting treatment, patients must have a negative pregnancy test, use at least two non-hormonal methods of contraception, and receive monthly pregnancy tests. (iv) Adverse reactions The most common known adverse reactions (incidence equal to or greater than 20%, all grades) caused by sofibuvir in combination with ribavirin are headache and fatigue. (v) Drug interactions Severe symptomatic bradycardia may occur with the combination of amiodarone and sofibuvir and antivirals (DAA). Potent intestinal P-gp-inducing drugs (e.g., rifampin, St. John’s wort) may alter sofosbuvir concentrations. (vi) Special Population Use Patients with HCV/HIV-1 co-infection: The safety and efficacy of this drug have been confirmed by studies. Patients with hepatocellular carcinoma awaiting liver transplantation: the safety and efficacy of this drug have been confirmed in studies.