Usual Adult Dose for Chronic Hepatitis C

1 tablet orally once a day for 12 weeks

Comments:

• This drug showed no additional benefit over sofosbuvir-velpatasvir in patients with genotype 1b, 2, 4, 5, or 6 infection previously treated with sofosbuvir without a nonstructural protein 5A (NS5A) inhibitor.

• Genotype 1, 2, 3, 4, 5, or 6 infection and were previously treated with an NS5A inhibitor-containing HCV regimen; in clinical trials, prior NS5A inhibitor experience included daclatasvir, elbasvir, ledipasvir, ombitasvir, or velpatasvir
• Genotype 1a or 3 infection and were previously treated with an HCV regimen containing sofosbuvir without an NS5A inhibitor; in clinical trials, prior treatment experience included sofosbuvir with or without any of the following: peginterferon alfa/ribavirin, ribavirin, HCV NS3/4A protease inhibitor (boceprevir, simeprevir, or telaprevir)

Renal Dose Adjustments

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

Liver Dose Adjustments

Mild liver dysfunction (Child-Pugh A): No adjustment recommended.
Moderate or severe liver dysfunction (Child-Pugh B or C): Not recommended.

Comments:

• Safety and efficacy have not been established in HCV-infected patients with moderate or severe liver dysfunction; higher voxilaprevir exposures observed in non-HCV-infected subjects.

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.

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 food.
• Administer this drug at least 4 hours before or 4 hours after aluminum- or magnesium-containing antacids.

• Store below 30C (86F) in the original container.

• Each fixed-dose combination tablet contains sofosbuvir 400 mg, velpatasvir 100 mg, and voxilaprevir 100 mg.

• General: For clinical and laboratory signs of hepatitis flare or HBV reactivation in patients with serological proof of HBV infection (during HCV therapy with this drug and during posttreatment follow-up)
• Hepatic: Hepatic laboratory testing in patients with compensated cirrhosis or proof of advanced liver disease (as clinically indicated); for signs/symptoms of hepatic decompensation

• Read the US FDA-approved patient labeling (Patient Information).
• Seek medical evaluation at once for symptoms of worsening liver problems (e.g., tiredness, yellowing of the skin/white part of the eyes, bleeding/bruising more easily than normal, confusion, loss of appetite, diarrhea, dark/brown urine, dark/bloody stool, swelling of the stomach area [abdomen]/pain in the upper right side of the stomach area, sleepiness, vomiting of blood).
• Avoid missing doses and complete the entire course of therapy.

Frequently asked questions

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