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Indications - Sofosbuvir is a hepatitis C virus (HCV) nucleotide analog NS5B polymerase inhibitor indicated for the treatment of chronic hepatitis C (CHC) infection as a component of a combination antiviral treatment regimen. Sofosbuvir efficacy has been established in subjects with HCV genotype 1, 2, 3 or 4 infection, including those with hepatocellular carcinoma meeting Milan criteria (awaiting liver transplantation) and those with HCV/HIV-1 co-infection. The following points should be considered when initiating treatment with Sofosbuvir: Monotherapy of Sofosbuvir is not recommended for treatment of CHC. Treatment regimen and duration are dependent on both viral genotype and patient population. Treatment response varies based on baseline host and viral factor.

Dosage & Administration - One 400 mg tablet taken once daily with or without food. Should be used in combination with Ribavirin or in combination with Pegylated Interferon and Ribavirin for the treatment of CHC. Recommended combination therapy: (HCV Mono-infected and HCV/HIV-1 Co-infected)- Genotype 1 or 4: Sofosbuvir + Peginterferon alfa + Ribavirin for 12 weeks Genotype 2: Sofosbuvir + Ribavirin for 12 weeks Genotype 3: Sofosbuvir + Ribavirin for 24 weeks Sofosbuvir in combination with Ribavirin for 24 weeks can be considered for CHC patients with genotype 1 infection who are Interferon ineligible Should be used in combination with Ribavirin for 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

Side Effects - The most common adverse events (incidence greater than or equal to 20%, all grades) 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, anemia, pruritus, asthenia, rash, decreased appetite, chills, influenza like illness, pyrexia, diarrhea, neutropenia, myalgia, irritability.

Contraindications - When Sofosbivur is used in combination with Ribavirin or Peginterferon alfa/ Ribavirin, the contraindications applicable to those agents are applicable to combination therapies. Sofosbuvir combination treatment with Ribavirin or Peginterferon alfa/Ribavirin is contraindicated in women who are pregnant or may become pregnant and men whose female partners are pregnant, because of the risks for birth defects and fetal death associated with Ribavirin.

Others - Pregnancy & Lactation Pregnancy Category B: Sofosbuvir There are no adequate and well-controlled studies with Sofosbuvir in pregnant women. Nursing Mothers: It is not known whether Sofosbuvir and its metabolites are present in human breast milk.