Sofosbuvir / Velpatasvir / Voxilaprevir Dosage
Applies to the following strengths: 400 mg-100 mg-100 mg
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Usual Adult Dose for:
Additional dosage information:
Usual Adult Dose for Chronic Hepatitis C
1 tablet orally once a day for 12 weeks
-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.
Uses: For the treatment of patients with chronic HCV infection without cirrhosis or with compensated cirrhosis (Child-Pugh A) who have:
-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 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
-Safety and efficacy not established in patients with severe renal dysfunction; dose not established due to higher exposures of the main sofosbuvir metabolite.
Liver Dose Adjustments
Mild liver dysfunction (Child-Pugh A): No adjustment recommended.
Moderate or severe liver dysfunction (Child-Pugh B or C): Not recommended.
-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.
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.
ESRD requiring hemodialysis: Data not available
-Safety and efficacy not established in ESRD patients requiring hemodialysis; dose not established due to higher exposures of the main sofosbuvir metabolite.
-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.
-Read the US FDA-approved patient labeling (Patient Information).
-Avoid missing doses and complete the entire course of therapy.
More about sofosbuvir/velpatasvir/voxilaprevir
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- During Pregnancy
- Dosage Information
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- Drug class: antiviral combinations
- Sofosbuvir, velpatasvir, and voxilaprevir
- Sofosbuvir, velpatasvir, and voxilaprevir (Advanced Reading)
Other brands: Vosevi