Suvirus 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.
Suvirus 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.
The following points should be considered when initiating treatment with Suvirus:
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.
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.
When Sofosbivur is used in combination with Ribavirin or Peginterferon alfa/ Ribavirin, the contraindications applicable to those agents are applicable to combination therapies.
The most common adverse events (incidence greater than or equal to 20%, all grades) observed with Suvirus in combination with Ribavirin were fatigue and headache.
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.
Bradycardia with amiodarone co-administration: Serious symptomatic bradycardia may occur in patients taking amiodarone and Suvirus 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.
Pediatric Use: Safety and effectiveness of Suvirus in children less than 18 years of age have not been established.
Geriatric Use: Suvirus 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 Suvirus is warranted in geriatric patients.
The highest dose of Suvirus is a single dose of Suvirus 1200 mg. No specific antidote is available for overdose treatment. Treatment of overdose with Suvirus consists of general supportive measures including monitoring of vital signs as well as observation of the clinical status of the patient.
Hepatic viral infections (Hepatitis C)
Keep out of the reach of children. Keep in a cool & dry place. Protect from light.
