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Indications

Sofovir-C 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.

Sofovir-C 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 Sofovir-C:
  • Monotherapy of Sofovir-C 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.

Pharmacology

Sofosbuvir is nucleotide analog inhibitor, which specifically inhibits HCV NS5B (non-structural protein 5B) RNA-dependent RNA polymerase. Following intracellular metabolism to form the pharmacologically active uridine analog triphosphate (GS-461203), sofosbuvir incorporates into HCV RNA by the NS5B polymerase and acts as a chain terminator. More specifically, Sofosbuvir prevents HCV viral replication by binding to the two Mg2+ ions present in HCV NS5B polymerase's GDD active site motif and preventing further replication of HCV genetic material

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
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Interaction

Reduced therapeutic effect with drugs that are potent P-gp inducers in the intestine (eg rifampicin, St. John's wort, carbamazepine & phenytoin), modafinil, phenobarb/ oxcarbazepine, rifabutin/ rifapentine. P-gp &/or BCRP inhibitors. May result in serious symptomatic bradycardia when co-administered with amiodarone in combination with another direct acting antiviral.

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.

Side Effects

The most common adverse events (incidence greater than or equal to 20%, all grades) observed with Sofovir-C in combination with Ribavirin were fatigue and headache. The most common adverse events observed with Sofovir-C 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.

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.

Precautions & Warnings

Bradycardia with amiodarone co-administration: Serious symptomatic bradycardia may occur in patients taking amiodarone and Sofovir-C 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. Co-administration of amiodarone with Sofovir-C in combination with another DAA is not recommended. In patients without alternative, viable treatment options, cardiac monitoring is recommended.

Use in Special Populations

Pediatric Use: Safety and effectiveness of Sofovir-C in children less than 18 years of age have not been established.

Geriatric Use: Sofovir-C was administered to 90 subjects aged 65 and over. The response rates observed for subjects over 65 years of age were similar to that of younger subjects across treatment groups. No dose adjustment of Sofovir-C is warranted in geriatric patients.

Overdose Effects

The highest dose of Sofovir-C is a single dose of Sofovir-C 1200 mg. No specific antidote is available for overdose treatment. Treatment of overdose with Sofovir-C consists of general supportive measures including monitoring of vital signs as well as observation of the clinical status of the patient.

Therapeutic Class

Hepatic viral infections (Hepatitis C)

Storage Conditions

Keep out of the reach of children. Keep in a cool & dry place. Protect from light.
Pack Image of Sofovir-C 400 mg Tablet Pack Image: Sofovir-C 400 mg Tablet