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Epclusa

Generic Name: sofosbuvir and velpatasvir (soe FOS bue vir and vel PAT as vir)
Brand Names: Epclusa
Epclusa (sofosbuvir and velpatasvir) is used to treat hepatitis C. Includes: uses, side effects, interactions and indications.
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Drug Information:
Epclusa contains a combination of sofosbuvir and velpatasvir. Sofosbuvir and velpatasvir are antiviral medications that prevent hepatitis C virus (HCV) from multiplying in your body. Epclusa is used to treat chronic hepatitis C in adults. It is sometimes given in combination with another antiviral medicine called Ribavirin in people who also have advanced cirrhosis. Epclusa treats specific genotypes of hepatitis C, and only in certain people. Use only the medications prescribed for you. Do not share your medicine with other people. Learn more

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Epclusa Side Effects

Note: This document contains side effect information about sofosbuvir / velpatasvir. Some of the dosage forms listed on this page may not apply to the brand name Epclusa.

For the Consumer

Applies to sofosbuvir / velpatasvir: 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. 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 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:

Incidence not known

  • Chest pain or discomfort
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • lightheadedness, dizziness or fainting
  • skin rash, sometimes with blisters or hive-like swelling
  • slow or irregular heartbeat
  • trouble breathing
  • unconsciousness
  • unusual tiredness

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:

More common

  • Headache
  • unusual tiredness or weakness

Less common

  • Diarrhea
  • discouragement
  • feeling sad or empty
  • irritability
  • lack of appetite, nausea
  • lack or loss of strength
  • loss of interest or pleasure
  • rash
  • trouble concentrating
  • trouble sleeping

For Healthcare Professionals

Applies to sofosbuvir / velpatasvir: oral tablet

General

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.

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

Other

Very common (10% or more): Fatigue (up to 32%)

Common (1% to 10%): Asthenia, irritability

Nervous system

Very common (10% or more): Headache (up to 29%)

Hematologic

Very common (10% or more): Anemia (26%), decreased hemoglobin (up to 23%)

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.

Gastrointestinal

Very common (10% or more): Nausea (up to 15%)

Common (1% to 10%): Diarrhea, increased lipase

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

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

Cardiovascular

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)

Dermatologic

Common (1% to 10%): Rash

Postmarketing reports: Skin rashes (sometimes with blisters or angioedema-like swelling), angioedema

Musculoskeletal

Common (1% to 10%): Back pain, arthralgia, increased creatine kinase

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

Hepatic

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.

Frequency not reported: Increased indirect bilirubin

Editorial References and Review

Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/1/2020.

Source: Drugs.com Epclusa (www.drugs.com/epclusa.html).