Sofosbuvir / Velpatasvir / Voxilaprevir Side Effects

Medically reviewed by Philip Thornton, DipPharm. Last updated on Jun 22, 2024.

Applies to sofosbuvir / velpatasvir / voxilaprevir: oral tablet.

Precautions

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Do not take this medicine together with products containing rifampin (eg, Rifadin®, Rifamate®, Rifater®, Rimactane®). Using these medicines together may cause serious side effects.

If you have ever had a hepatitis B infection, the virus could become active again during treatment with sofosbuvir, velpatasvir, and voxilaprevir combination. You should be tested for hepatitis B infection before starting treatment with this medicine. Talk with your doctor if you have concerns.

This medicine may cause worsening of liver problems. Tell your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin while using this medicine.

Amiodarone can cause serious side effects (including cardiac arrest, slow heartbeat, or conditions that need a pacemaker) if used together with this medicine or other medicines containing sofosbuvir, or if you have used it recently. This is more likely to occur in patients with heart disease or advanced liver disease. Tell your doctor if you are taking amiodarone before using this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St. John's wort) or vitamin supplements.

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:

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:

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

See also:

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