SoviHep V 28Tabs

Velpatasvir + Sofosbuvir

Recommended Retail Price $345

Each tablet contains:

  • Velpatasvir 100 mg
  • Sofosbuvir 400 mg

Manufacturer: Hetero Inc., India

Distributor: Zydus Heptiza, India

 

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Description

Dosage Forms & Strengths

Sofosbuvir/Velpatasvir

Tablet

  • 400mg/100mg

Chronic Hepatitis C

Indicated for adults with chronic hepatitis C virus (HCV) infection genotypes 1, 2, 3, 4, 5, and 6.

1 tablet (400 mg Sofosbuvir/ 100 mg Velpatasvir) PO qDay.

Treatment duration

  • Patients without cirrhosis or with compensated cirrhosis (Child-Pugh A): SoviHep V for 12 weeks.
  • Patients with decompensated cirrhosis (Child-Pugh B or C): SoviHep V plus weight-based ribavirin with food for 12 weeks.
  • The above regimens also apply to patients coinfected with HIV-1
  • Weight-based ribavirin dose
    • <75 kg: 1000 mg/day PO divided BID
    • ≥75 kg: 1200 mg/day PO divided BID
    • Ribavirin starting dose and on-treatment dosage should be modified based on hemoglobin and creatinine clearance

Dosage Modifications

Renal impairment

  • Severe renal impairment (eGFR <30mL/min/1.73 m²) or ESRD: No dosage recommendation can be give owing to higher exposures (up to 20-fold) of the predominant Sofosbuvir metabolite

Hepatic impairment

  • Mild, moderate, or severe (Child-Pugh A, B, or C): No dosage adjustment required

Dosing Considerations

Test all patients for evidence of current or prior hepatitis B virus (HBV) infection before initiating treatment with HCV direct acting antivirals (DDAs).

Coinfected with HIV-1 without cirrhosis or with compensated cirrhosis: HCV outcomes (SVR12) were ≥92% for all genotypes.

Contraindications

SoviHep V plus ribavirin combination regimen is contraindicated in patients for whom ribavirin is contraindicated

Cautions

Hepatitis B virus (HBV) reactivation has been reported in HCV/HBV coinfected patients who were undergoing or had completed treatment with HCV DDAs, and who were not receiving HBV antiviral therapy; HBV reactivation is characterized as an abrupt increase in HBV replication manifesting as a rapid increase in serum HBV DNA level.

If administered with ribavirin, warnings and precautions for ribavirin apply to this combination; see ribavirin prescribing information.

Bradycardia

  • Coadministration with amiodarone is not recommended
  • Serious symptomatic bradycardia may occur if Sofosbuvir is coadministered with amiodarone in combination with another direct-acting antiviral (eg, daclatasvir, simeprevir).
  • Bradycardia has generally occurred within hours to days, but reports have been observed up to 2 weeks after initiating HCV treatment.
  • Patients also taking beta blockers, or those with underlying cardiac comorbidities, and/or advanced liver disease may be at increased risk for symptomatic bradycardia with coadministration of amiodarone.
  • If no alternative exists for amiodarone, inpatient cardiac monitoring is recommended for the first 48 hr and then daily home monitoring for at least the first 2 weeks.
  • Because of amiodarone’s long half-life, patients discontinuing amiodarone just prior to starting therapy should also undergo similar cardiac monitoring.

Drug interaction overview

  • Drugs affecting SoviHep V.
    • SoviHep V is substrates of drug transporters P-gp and BCRP while GS-331007 (the predominant circulating metabolite of Sofosbuvir) is not.
    • In vitro, slow metabolic turnover of velpatasvir by CYP2B6, CYP2C8, and CYP3A4 was observed.
    • Drugs that are potent P-gp inducers and/or moderate-to-potent inducers of CYP2B6, CYP2C8, or CYP3A4 (eg, rifampin, carbamazepine, St. John’s wort) may significantly decrease Sofosbuvir and/or velpatasvir plasma concentrations, leading to potentially reduced therapeutic effect; avoid coadministration.
  • Drugs that increase gastric pH.
    • Coadministration with drugs that increase gastric pH are expected to decrease velpatasvir serum concentration.
    • See the Administration section for how long is needed between SoviHep V doses and drugs that increase gastric pH.
  • SoviHep V effect on other drugs.
    • Velpatasvir inhibits drug transporters P-gp, BCRP, OATP1B1, OATP1B3, and OATP2B1.
    • Coadministration with drugs that are substrates of these transporters may increase the exposure of such drugs.

Pregnancy

Contraindicated if administered with ribavirin in pregnant women and in men whose female partners are pregnant.

There are no adequate data available to establish pregnancy risk for SoviHep V.

Lactation

Unknown if SoviHep V or their metabolites are distributed in human breast milk.

Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for the drug, and any potential adverse effects on the breastfed infant from the drug or from the underlying maternal condition.

If regimen includes ribavirin, refer to ribavirin prescribing information.

Pregnancy Categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

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