Sofosbuvir

Mechanism :

It is a direct-acting antiviral agent against the hepatitis C virus, is a prodrug converted to its pharmacologically active form (GS-461203) via intracellular metabolism. It inhibits HCV NS5B RNA-dependent RNA polymerase and acts as a chain terminator.

Indication :

Treatment of genotype 1, 2, 3, or 4 chronic hepatitis C virus (HCV) infection in adults and genotype 2 or 3 chronic HCV infection in pediatric patients ≥12 years or weighing ≥35 kg, without cirrhosis or with compensated cirrhosis.

Contraindications :

Hypersensitivity to sofosbuvir or any component of the formulation; males whose female partners may become pregnant.

Dosing :

Children and Adolescents ≥12 years or ≥35 kg:

Oral Genotype 2:

400 mg once daily with concomitant ribavirin for 12 weeks.

Oral Genotype 3:

400 mg once daily with concomitant ribavirin for 24 weeks.

Adverse Effect :

Fatigue, headache, insomnia, chills, irritability, pruritus, skin rash, nausea, decreased appetite, diarrhea, anemia, neutropenia, thrombocytopenia, weakness, myalgia, flu like symptoms, fever, increased serum lipase, bilirubin and creatine kinase.

Interaction :

Amiodarone: Sofosbuvir may enhance the bradycardic effect of Amiodarone.
Oxcarbazepine, phenobarbital, primidone: May decrease the serum concentration of Sofosbuvir.
P-glycoprotein/ABCB1 Inducers: May decrease the serum concentration of Sofosbuvir.
P-glycoprotein/ABCB1 Inhibitors: May increase the serum concentration of P-glycoprotein/ABCB1 Substrates.
Rifabutin: May decrease the serum concentration of Sofosbuvir.

Hepatic Dose :

No dose adjustment recommended.