Sofosbuvir / Velpatasvir / Voxilaprevir Side Effects

Medically reviewed by Philip Thornton, DipPharm. Last updated on Oct 15, 2024.

Applies to sofosbuvir / velpatasvir / voxilaprevir: oral tablet.

Important warnings This medicine can cause some serious health issues

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.

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 side effects

• diarrhea
• lack or loss of strength
• nausea

Less common side effects

• discouragement
• feeling sad or empty
• irritability
• lack of appetite
• loss of interest or pleasure
• tiredness
• trouble concentrating
• trouble sleeping

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

For healthcare professionals

Applies to sofosbuvir / velpatasvir / voxilaprevir: oral tablet.

General adverse events

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

• Very common (10% or more): Increased total bilirubin (up to 13%)
• Postmarketing reports: Hepatic decompensation, hepatic failure^[Ref]

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]

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

• Common (1% to 10%): Back pain, myalgia
• Uncommon (0.1% to 1%): Elevated creatine kinase, muscle spasm^[Ref]

Isolated, asymptomatic creatine kinase elevations (at least 10 x ULN) were reported in up to 1% of patients.^[Ref]

Metabolic

• Common (1% to 10%): Decreased appetite

Frequently asked questions

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Further information

Sofosbuvir/velpatasvir/voxilaprevir side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer