Sofosbuvir / Velpatasvir Side Effects

Medically reviewed by Philip Thornton, DipPharm. Last updated on Aug 19, 2024.

Applies to sofosbuvir / velpatasvir: oral packet, 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 and to check for unwanted effects.

Do not take this medicine together with other products containing sofosbuvir (eg, Sovaldi®).

Ribavirin may cause birth defects if either partner is using it together with this medicine during conception or pregnancy. Females who take this medicine with ribavirin should avoid becoming pregnant during treatment and for at least 6 months after the last dose. Tell your doctor right away if you or your partner becomes pregnant. Follow all directions about birth control.

If you have ever had a hepatitis B infection or if you have been coinfected with a hepatitis B or C virus and have or have not received treatment, the virus could become active again during treatment with sofosbuvir and velpatasvir combination. You should be tested for hepatitis B infection before starting treatment with this medicine. Talk with your doctor if you have concerns.

Amiodarone can cause serious side effects (eg, cardiac arrest, slow heartbeat, conditions that need pacemaker) if used together with medicines containing sofosbuvir (including ledipasvir and sofosbuvir combination, Harvoni®), 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 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 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:

For healthcare professionals

Applies to sofosbuvir / velpatasvir: oral pellet, oral tablet.

General adverse events

The most common side effects reported with this drug were fatigue, headache, nausea, and nasopharyngitis. When this drug was studied with ribavirin, the most common side effects were fatigue, anemia, nausea, headache, insomnia, and diarrhea.

The most common side effects in liver transplant recipients (without cirrhosis or with compensated cirrhosis) were headache, fatigue, nausea, diarrhea, and asthenia.

The most common side effect in patients with hepatitis C virus (HCV) with compensated liver disease (with or without cirrhosis) and end-stage renal disease requiring dialysis was nausea.

If this drug is used with ribavirin, the manufacturer product information for ribavirin should be consulted for associated side effects.^[Ref]

Other

• Very common (10% or more): Fatigue (up to 32%)
• Common (1% to 10%): Asthenia, irritability^[Ref]

Nervous system

• Very common (10% or more): Headache (up to 29%)^[Ref]

Hematologic

• Very common (10% or more): Anemia (26%), decreased hemoglobin (up to 23%)^[Ref]

Decreases in hemoglobin to less than 10 g/dL and 8.5 g/dL during combination therapy were reported in 23% and 7% of subjects, respectively.^[Ref]

Gastrointestinal

• Very common (10% or more): Nausea (up to 15%)
• Common (1% to 10%): Diarrhea, increased lipase
• Frequency not reported: Vomiting, spitting up the drug^[Ref]

Isolated, asymptomatic lipase elevations (greater than 3 times the upper limit of normal [3 x ULN]) were reported in up to 6% of subjects.

Vomiting and spitting up the drug was reported in 15% and 10% of pediatric patients younger than 6 years (n=41), respectively.^[Ref]

Respiratory

• Very common (10% or more): Nasopharyngitis (up to 12%)
• Common (1% to 10%): Cough

Psychiatric

• Very common (10% or more): Insomnia (up to 11%)
• Uncommon (0.1% to 1%): Depressed mood^[Ref]

Cardiovascular

• 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
• Postmarketing reports: Skin rashes (sometimes with blisters or angioedema-like swelling), angioedema^[Ref]

Musculoskeletal

• Common (1% to 10%): Back pain, arthralgia, increased creatine kinase^[Ref]

Isolated, asymptomatic creatine kinase elevations (at least 10 x ULN) were reported in up to 2% of subjects.^[Ref]

Hepatic

• Frequency not reported: Increased indirect bilirubin^[Ref]

Increased indirect bilirubin (up to 3 mg/dL above baseline) was reported in HIV-1/HCV-coinfected patients using this drug and an atazanavir/ritonavir-based antiretroviral regimen.^[Ref]

See also:

Frequently asked questions

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Further information

Sofosbuvir/velpatasvir 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