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Sofosbuvir / Velpatasvir Dosage

Medically reviewed on December 26, 2017.

Applies to the following strengths: 400 mg-100 mg

Usual Adult Dose for Chronic Hepatitis C

1 tablet orally once a day

Recommended Regimen and Duration of Therapy:
-Therapy-naive and therapy-experienced, without cirrhosis and with compensated cirrhosis (Child-Pugh A): Sofosbuvir-velpatasvir for 12 weeks
-Therapy-naive and therapy-experienced, with decompensated cirrhosis (Child-Pugh B or C): Sofosbuvir-velpatasvir plus ribavirin for 12 weeks

Comments:
-Dose recommendations also apply to HCV/HIV-1-coinfected patients.
-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).
-The manufacturer product information for ribavirin should be consulted regarding dosing and dose adjustments (if applicable).

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 or moderate renal dysfunction: No adjustment recommended.
Severe renal dysfunction (estimated glomerular filtration rate less than 30 mL/min/1.73 m2): Data not available

Comments:
-Safety and efficacy not established in patients with severe renal dysfunction; dose not established due to higher exposures of the main sofosbuvir metabolite.
-The manufacturer product information for ribavirin should be consulted regarding use in renal dysfunction patients (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.

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

ESRD requiring hemodialysis: Data not available

Comments:
-Safety and efficacy not established in ESRD patients requiring hemodialysis; dose not established due to higher exposures of the main sofosbuvir metabolite.

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).
-May administer without regard to food
-Consult the manufacturer product information regarding missed doses.

Storage requirements:
-Store below 30C (86F) in the original container

General:
-Each fixed-dose combination tablet contains sofosbuvir 400 mg and velpatasvir 100 mg.
-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).
-Avoid missing doses and complete the entire course of therapy.

Further information

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

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