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Note: This document contains side effect information about sofosbuvir / velpatasvir / voxilaprevir. Some of the dosage forms listed on this page may not apply to the brand name Vosevi.
Applies to sofosbuvir/velpatasvir/voxilaprevir: oral tablet
Oral route (Tablet)
Test all patients for evidence of current or prior hepatitis B virus (HBV) infection before initiating treatment with sofosbuvir / velpatasvir / voxilaprevir. HBV reactivation has been reported in HCV/HBV coinfected patients who were undergoing or had completed treatment with HCV direct-acting antivirals and were not receiving HBV antiviral therapy. Some cases have resulted in fulminant hepatitis, hepatic failure, and death. Monitor HCV/HBV coinfected patients for hepatitis flare or HBV reactivation during HCV treatment and post-treatment follow-up. Initiate appropriate patient management for HBV infection as clinically indicated.
Along with its needed effects, sofosbuvir / velpatasvir / voxilaprevir may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking sofosbuvir / velpatasvir / voxilaprevir:
Incidence not known
Some side effects of sofosbuvir / velpatasvir / voxilaprevir may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Applies to sofosbuvir / velpatasvir / voxilaprevir: oral tablet
The most common side effects reported with this drug were headache, fatigue, diarrhea, and nausea. This drug was permanently discontinued due to side effects in up to 0.2% of patients.
Very common (10% or more): Headache (up to 27%)
Very common (10% or more): Fatigue (up to 24%)
Common (1% to 10%): Asthenia
Very common (10% or more): Diarrhea (up to 20%), nausea (up to 14%)
Common (1% to 10%): Elevated lipase, abdominal pain, vomiting
Isolated, asymptomatic lipase elevations (greater than 3 times the upper limit of normal [3 x ULN]) were reported in 2% of patients.
Very common (10% or more): Increased total bilirubin (up to 13%)
Due to inhibition of OATP1B1 and OATP1B3 by voxilaprevir, increased total bilirubin (up to 1.5 x ULN) occurred with this drug. No jaundice was observed and total bilirubin levels decreased after completion of therapy.
Common (1% to 10%): Insomnia
Uncommon (0.1% to 1%): Depressed mood
Severe bradycardia and heart block have been reported when sofosbuvir plus another direct-acting antiviral was used with concomitant amiodarone and/or other agents that lower heart rate.
Serious symptomatic bradycardia has been reported in patients taking amiodarone who started therapy with a regimen containing sofosbuvir.
-Frequency not reported: Severe bradycardia, heart block
-Postmarketing reports: Serious symptomatic bradycardia (including fatal cardiac arrest, cases requiring pacemaker intervention)
Common (1% to 10%): Rash
-Postmarketing reports: Skin rashes (sometimes with blisters or angioedema-like swelling), angioedema
Common (1% to 10%): Back pain, myalgia
Uncommon (0.1% to 1%): Elevated creatine kinase, muscle spasm
Isolated, asymptomatic creatine kinase elevations (at least 10 x ULN) were reported in up to 1% of patients.
Common (1% to 10%): Decreased appetite