Sofosbuvir is indicated for the treatment of Chronic Hepatitis C (CHC) infection as a component of a combination antiviral treatment regimen. The efficacy of Sofosbuvir has been established in subjects with HCV genotype 1, 2, 3, or 4 infections, including those with hepatocellular carcinoma meeting Milan criteria (awaiting liver transplantation) and those with HCV/HIV-1 co-infection.
The recommended dose of Sofosbuvir is one 400 mg tablet, taken orally, once daily, with or without food.
Sofosbuvir should be used in combination with Ribavirin or in combination with Pegylated Interferon alfa and Ribavirin for the treatment of CHC in adults.
The recommended regimen and treatment duration for Sofosbuvir combination therapy are provided in the following table:
Recommended Regimens and Treatment Duration for Sofosbuvir Combination Therapy in HCV Mono-infected and HCV/HIV-1 Co-infected Patients
Genotype Treatment Duration
Patients with genotype 1 or 4 CHC Sofosbuvir + Peginterferon alfa + Ribavirin 12 weeks
Patients with genotype 2 CHC Sofosbuvir + Ribavirin 12 weeks
Patients with genotype 3 CHC Sofosbuvir + Ribavirin 24 weeks
Sofosbuvir in combination with Ribavirin for 24 weeks can be considered for CHC patients with genotype 1 infection who are interferon-ineligible.
It should be used in combination with Ribavirin for the treatment of CHC in patients with hepatocellular carcinoma awaiting liver transplantation for up to 48 weeks or until liver transplantation, whichever occurs first.
A dose recommendation cannot be made for patients with severe renal impairment or end-stage renal disease.
The most common adverse events observed with Sofosbuvir in combination with Ribavirin were fatigue and headache. The most common adverse events observed with Sofosbuvir in combination with Peginterferon alfa and Ribavirin were fatigue, headache, nausea, insomnia, and anemia.
Pregnancy: Ribavirin may cause birth defects and fetal death, and animal studies have shown that Interferons & Ribavirin have abortifacient effects. Avoid pregnancy in female patients and female partners of male patients.
Bradycardia with Amiodarone co-administration: Symptomatic bradycardia may occur in patients taking Amiodarone and Sofosbuvir in combination with another direct-acting antiviral (DAA), particularly in patients also receiving beta blockers, or those with underlying cardiac comorbidities and/or advanced liver disease.
Because Ribavirin may cause birth defects and fetal death, Sofosbuvir in combination with Peginterferon alfa/Ribavirin or Ribavirin is contraindicated in pregnant women and in men whose female partners are pregnant.
Pregnancy Category X: Use with Ribavirin or Peginterferon alfa/Ribavirin requires extreme caution. Female patients and female partners of male patients must avoid pregnancy while taking this combination. Women of childbearing potential and their male partners should use two forms of effective contraception during treatment with Ribavirin and for six months after treatment has concluded.
Pregnancy Category B: There are no adequate and well-controlled studies with Sofosbuvir in pregnant women.
It is not known whether Sofosbuvir and its metabolites are present in human breast milk. Because of the potential for adverse reactions in nursing infants, a decision must be made whether to discontinue nursing or discontinue treatment with Ribavirin-containing regimens, taking into account the importance of the therapy to the mother.
The safety and effectiveness of Sofosbuvir in children under 18 years of age have not been established.
Co-administration of Amiodarone with Sofosbuvir in combination with another DAA may result in symptomatic bradycardia.
Store at a temperature not exceeding 30°C in a dry place. Protect from light and moisture.
Medicine: Keep out of reach of children.
