Sovel Tablet

Sofosbuvir 400mg + Velpatasvir 100mg

Description
Sovel® is the preparation of Sofosbuvir and Velpatasvir which are direct acting antiviral agents against the hepatitis C virus. Sofosbuvir is an inhibitor of the HCV NS5B RNA-dependent RNA polymerase and Velpatasvir is an inhibitor of the HCV NS5A protein. Both NS5B RNA-dependent RNA polymerase and NS5A protein is required for viral replication.


Indications
Sovel® is indicated for the treatment of adult patients with chronic HCV genotype 1, 2, 3, 4, 5, or 6 infection:

  • Without cirrhosis or with compensated cirrhosis
  • With decompensated cirrhosis for use in combination with ribavirin.


Dosage and administration
Adult: The recommended dosage of Sovel® is one tablet taken orally once daily with or without food.Recommended treatment regimen:

  • Patients without cirrhosis and with compensated cirrhosis (Child-Pugh A) - one Sovel® tablet for 12 weeks.
  • Patients with decompensated cirrhosis (Child-Pugh B or C) - one Sovel® tablet plus ribavirin for 12 weeks.


When administered with Sovel® the recommended dosage of ribavirin is based on weight (administered with food): 1000 mg per day for patients less than 75 kg and 1200 mg for those weighing at least 75 kg, divided and administered twice daily. The starting dosage and on treatment dosage of ribavirin can be decreased based on hemoglobin and creatinine clearance.


Children: Safety and effectiveness of this combination have not been established in pediatric patients.
Patients with hepatic impairment: No dosage adjustment of this combination is required for patients with mild, moderate or severe hepatic impairment.
Patients with renal impairment: No dosage adjustment of this combination is required for patients with mild or moderate renal impairment. The safety and
efficacy of this combination have not been established in patients with severe renal impairment (eGFR less than 30 ml/min/1.73 m²) or end stage renal
diseases requiring hemodialysis.


Use in pregnancy and lactation
Pregnancy: No adequate human data are available to establish whether or not this combination poses a risk to pregnancy outcomes. If this combination is administered with ribavirin, this combination is contraindicated in pregnant women and in men whose female partners are pregnant.
Lactation: It is not known whether the components of this combination and its metabolites are present in human breast milk, affect human milk production or have effects on the breastfed infant. The development and health benefits of breastfeeding should be considered along with the mother’s clinical need for this combination and any potential adverse effects on the breastfed child from this combination or from the underlying maternal condition. If this combination is administered with ribavirin, the nursing mother’s information for ribavirin also applies to this combination regimen.


Side effects The most common side effects of this combination are headache and fatigue. And the most common side effects observed with treatment with this combination and ribavirin for are fatigue, anemia, nausea, headache, insomnia and diarrhea.


Contraindications: This combination and ribavirin combination regimen is contraindicated in patients for whom ribavirin is contraindicated.

Warnings and precautions
Risk of hepatitis B virus reactivation: Test all patients for evidence of current or prior HBV infection before initiation of HCV treatment. Monitor HCV or HBV co-infected patients for HBV reactivation and hepatitis flare during HCV treatment and post treatment follow up. Initiate appropriate patient management for HBV infection as clinically indicated.

Bradycardia with amiodarone co-administration: Serious symptomatic bradycardia may occur in patients taking amiodarone, particularly in patients also receiving beta blockers, or those with underlying cardiac comorbidities and/or advanced liver disease. Co-administration of amiodarone with this combination is not recommended. In patients without alternative viable treatment options, cardiac monitoring is recommended. 

Drug interactions
Drugs may decrease the concentrations of this combination are antacids, H2-receptor antagonists and proton pump inhibitors. Co-administration is not recommended with topotecan, carbamazepine, phenytoin, phenobarbital, oxcarbazepine, rifabutin, rifampin, rifapentine, efavirenz, tipranavir, ritonavir and hypericum perforatum. Co-administration of this combination with rosuvastatin and atorvastatin may significantly increase the concentration of rosuvastatin and atorvastatin.

Overdose: No specific antidote is available for overdose with this combination. If overdose occurs the patient must be monitored for evidence of toxicity. Treatment of overdose with this combination consists of general supportive measures including monitoring of vital signs as well as observation of the clinical status of the
patient.

Pharmaceutical precautions: Store in a cool (below 30°C) and dry place protected from light. Keep away from the reach of children.

Presentation: Sovel® tablet: Each coated tablet contains Sofosbuvir INN 400 mg and Velpatasvir INN 100 mg.

Package quantities
Sovel® tablet: Carton of 7 tablets in blister pack.