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

• 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.

• 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

• 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

• 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.

• 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.

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.

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

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

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

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

• 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.

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