Applies to sofosbuvir / velpatasvir / voxilaprevir: oral tablet.
Warning
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.
Serious side effects
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
- Chest pain or discomfort
- dark-colored urine
- headache
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- lightheadedness, dizziness, or fainting
- light-colored stools
- skin rash, sometimes with blisters or hive-like swelling
- slow or irregular heartbeat
- stomach pain, continuing
- unusual tiredness or weakness
- vomiting
- yellow eyes or skin
Other side effects
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:
More common
- Diarrhea
- lack or loss of strength
- nausea
Less common
- Discouragement
- feeling sad or empty
- irritability
- lack of appetite
- loss of interest or pleasure
- tiredness
- trouble concentrating
- trouble sleeping
For Healthcare Professionals
Applies to sofosbuvir / velpatasvir / voxilaprevir: oral tablet.
General
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.[Ref]
Nervous system
Very common (10% or more): Headache (up to 27%)[Ref]
Other
Very common (10% or more): Fatigue (up to 24%)
Common (1% to 10%): Asthenia[Ref]
Gastrointestinal
Very common (10% or more): Diarrhea (up to 20%), nausea (up to 14%)
Common (1% to 10%): Elevated lipase, abdominal pain, vomiting[Ref]
Isolated, asymptomatic lipase elevations (greater than 3 times the upper limit of normal [3 x ULN]) were reported in 2% of patients.[Ref]
Hepatic
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.
Cases of hepatic decompensation/failure (including fatal outcomes) have been reported during postmarketing experience in patients treated with hepatitis C virus nonstructural protein 3/4A (NS3/4A) protease inhibitor-containing regimens (including this drug). Reported cases occurred in patients with baseline cirrhosis with and without moderate or severe liver dysfunction (Child-Pugh B or C).[Ref]
Very common (10% or more): Increased total bilirubin (up to 13%)
Postmarketing reports: Hepatic decompensation, hepatic failure[Ref]
Psychiatric
Common (1% to 10%): Insomnia
Uncommon (0.1% to 1%): Depressed mood[Ref]
Cardiovascular
Sofosbuvir-containing regimens:
-Frequency not reported: Severe bradycardia, heart block
-Postmarketing reports: Serious symptomatic bradycardia (including fatal cardiac arrest, cases requiring pacemaker intervention)[Ref]
Severe bradycardia and heart block have been reported when sofosbuvir-containing regimens were used in combination with 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.[Ref]
Dermatologic
Common (1% to 10%): Rash
Frequency not reported: Stevens-Johnson syndrome
Sofosbuvir-containing regimens:
-Postmarketing reports: Skin rashes (sometimes with blisters or angioedema-like swelling), angioedema[Ref]
Musculoskeletal
Isolated, asymptomatic creatine kinase elevations (at least 10 x ULN) were reported in up to 1% of patients.[Ref]
Common (1% to 10%): Back pain, myalgia
Uncommon (0.1% to 1%): Elevated creatine kinase, muscle spasm[Ref]
Metabolic
Common (1% to 10%): Decreased appetite
