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Sofosbuvir / Velpatasvir Dosage

Medically reviewed by Drugs.com. Last updated on May 18, 2022.

Applies to the following strengths: 400 mg-100 mg; 200 mg-50 mg; 150 mg-37.5 mg

Usual Adult Dose for:

Usual Pediatric Dose for:

Additional dosage information:

Usual Adult Dose for Chronic Hepatitis C

Sofosbuvir 400 mg-velpatasvir 100 mg orally once a day

Recommended Regimen and Duration of Therapy:

  • Therapy-naive and therapy-experienced patients (including those coinfected with HIV-1), without cirrhosis and with compensated cirrhosis (Child-Pugh A): Sofosbuvir-velpatasvir for 12 weeks
  • Therapy-naive and therapy-experienced patients (including those coinfected with HIV-1), with decompensated cirrhosis (Child-Pugh B or C): Sofosbuvir-velpatasvir plus ribavirin for 12 weeks
  • Therapy-naive and therapy-experienced liver transplant recipients, without cirrhosis or with compensated cirrhosis (Child-Pugh A): Sofosbuvir-velpatasvir for 12 weeks

Comments:
  • In clinical trials, therapy-experienced patients received a peginterferon alfa/ribavirin-based regimen with or without an HCV nonstructural protein 3/4A (NS3/4A) protease inhibitor (boceprevir, simeprevir, or telaprevir).
  • If applicable, the manufacturer product information should be consulted for ribavirin dose recommendations; the manufacturer product information for ribavirin should be consulted for further information regarding dosing and dose adjustments.

Uses: For the treatment of chronic HCV genotype 1, 2, 3, 4, 5, or 6 infection
  • In patients without cirrhosis or with compensated cirrhosis
  • In combination with ribavirin: In patients with decompensated cirrhosis

Usual Pediatric Dose for Chronic Hepatitis C

3 years or older:

  • Weight less than 17 kg: Sofosbuvir 150 mg-velpatasvir 37.5 mg orally once a day
  • Weight 17 to less than 30 kg: Sofosbuvir 200 mg-velpatasvir 50 mg orally once a day
  • Weight at least 30 kg: Sofosbuvir 400 mg-velpatasvir 100 mg orally once a day

Recommended Regimen and Duration of Therapy:
  • Therapy-naive and therapy-experienced patients (including those coinfected with HIV-1), without cirrhosis and with compensated cirrhosis (Child-Pugh A): Sofosbuvir-velpatasvir for 12 weeks
  • Therapy-naive and therapy-experienced patients (including those coinfected with HIV-1), with decompensated cirrhosis (Child-Pugh B or C): Sofosbuvir-velpatasvir plus ribavirin for 12 weeks
  • Therapy-naive and therapy-experienced liver transplant recipients, without cirrhosis or with compensated cirrhosis (Child-Pugh A): Sofosbuvir-velpatasvir for 12 weeks

Comments:
  • Patients younger than 6 years should be given the oral pellets with food to increase tolerability related to palatability.
  • In clinical trials, therapy-experienced adults received a peginterferon alfa/ribavirin-based regimen with or without an HCV NS3/4A protease inhibitor (boceprevir, simeprevir, or telaprevir).
  • If applicable, the manufacturer product information should be consulted for ribavirin dose recommendations; the manufacturer product information for ribavirin should be consulted for further information regarding dosing and dose adjustments.

Uses: For the treatment of chronic HCV genotype 1, 2, 3, 4, 5, or 6 infection
  • In patients without cirrhosis or with compensated cirrhosis
  • In combination with ribavirin: In patients with decompensated cirrhosis

Renal Dose Adjustments

Mild, moderate, or severe renal dysfunction: No adjustment recommended.

Comments:

  • No safety data available in patients with both decompensated cirrhosis and severe renal dysfunction.
  • No safety data available in pediatric patients with renal dysfunction.
  • The manufacturer product information for ribavirin tablets should be consulted for ribavirin dose adjustment in patients with CrCl up to 50 mL/min (if applicable).

Liver Dose Adjustments

Mild, moderate, or severe liver dysfunction (Child-Pugh A, B, or C): No adjustment recommended.

Comments:

  • Clinical and hepatic laboratory monitoring (including direct bilirubin), as clinically indicated, recommended for patients with decompensated cirrhosis using this drug plus ribavirin.

Precautions

US BOXED WARNING:

  • RISK OF HBV REACTIVATION IN PATIENTS COINFECTED WITH HCV AND HBV: All patients should be tested for evidence of current/prior HBV infection before starting this drug. HBV reactivation has been reported during or after completion of HCV direct-acting antiviral therapy in HCV/HBV-coinfected patients who were not receiving HBV antiviral therapy; some cases resulted in fulminant hepatitis, hepatic failure, and death. HCV/HBV-coinfected patients should be monitored for hepatitis flare or HBV reactivation during HCV therapy and posttherapy follow-up; appropriate patient management for HBV infection should be started as clinically indicated.

CONTRAINDICATIONS:
Combination Therapy: Contraindications to ribavirin

Safety and efficacy have not been established in patients younger than 3 years.

Consult WARNINGS section for additional precautions.

Dialysis

ESRD requiring dialysis: No adjustment recommended.

Comments:

  • No safety data available in dialysis patients with decompensated cirrhosis.

Other Comments

Administration advice:

  • Before starting this drug, test all patients for evidence of current/prior HBV infection; measure hepatitis B surface antigen (HBsAg) and hepatitis B core antibody (anti-HBc).
  • Administer with or without food.
  • Use the oral pellets in pediatric patients who cannot swallow the tablet formulation; consult the manufacturer product information (Instructions for Use) for details regarding administration.
  • Do not chew the oral pellets.
  • If administered with food, sprinkle the oral pellets on at least 1 spoonful of nonacidic soft food (e.g., pudding, chocolate syrup, ice cream) at or below room temperature; administer oral pellets within 15 minutes of gently mixing with food and swallow the entire contents without chewing (to avoid bitter aftertaste).
  • Consult the manufacturer product information regarding missed doses.

Storage requirements:
  • Store below 30C (86F).
  • Tablets: Dispense only in original container.

Reconstitution/preparation techniques:
  • Oral pellets: The manufacturer product information (Instructions for Use) should be consulted.

General:
  • The manufacturer product information for ribavirin should be consulted for additional information (if applicable).

Monitoring:
  • General: Clinical monitoring in decompensated cirrhosis patients (as clinically indicated)
  • Hepatic: Hepatic laboratory values, including direct bilirubin, in decompensated cirrhosis patients (as clinically indicated)

Patient advice:
  • Read the US FDA-approved patient labeling (Patient Information and Instructions for Use).
  • Avoid missing doses and complete the entire course of therapy.
  • Oral pellets: Read and follow the Instructions for Use for preparing the correct dose.

Frequently asked questions

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.