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Sovaldi

Generic Name: sofosbuvir (soe FOS bue vir)
Brand Names: Sovaldi
Sovaldi (sofosbuvir) is used to treat chronic hepatitis C virus (HCV) infection. Includes Sovaldi side effects, interactions and indications.
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Drug Information:
Sovaldi (sofosbuvir) is an antiviral medication that prevents hepatitis C virus (HCV) from multiplying in your body. Sovaldi is used in combination with other medications to treat chronic hepatitis C in adults and children who are at least 12 years old or who weigh at least 77 pounds (35 kilograms). Sovaldi 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. Sovaldi must be given in combination with other antiviral medications and should not be used alone. Sofosbuvir is usually given with Ribavirin, with or without peginterferon alfa. Learn more

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Sovaldi Side Effects

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

For the Consumer

Applies to sofosbuvir: 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. 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 (the active ingredient contained in Sovaldi) 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:

More common

  • Chills
  • fever
  • lower back or side pain
  • pale skin
  • ulcers, sores, or white spots in the mouth
  • unusual tiredness or weakness

Rare

  • Changes in behavior
  • discouragement
  • feeling sad or empty
  • loss of interest or pleasure
  • thoughts of killing oneself
  • trouble concentrating

Incidence not known

  • Chest pain or discomfort
  • lightheadedness, dizziness, or fainting
  • shortness of breath
  • slow or irregular heartbeat
  • unusual tiredness

Some side effects of sofosbuvir 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

  • Decreased appetite
  • diarrhea
  • difficulty with moving
  • headache
  • irritability
  • lack or loss of strength
  • muscle aching or cramping
  • muscle pains or stiffness
  • nausea
  • rash or itching skin
  • trouble sleeping

For Healthcare Professionals

Applies to sofosbuvir: oral tablet

General

When this drug is used with ribavirin or peginterferon alfa/ribavirin, the respective manufacturer product information should be consulted for associated side effects.

The most common side effects reported with sofosbuvir (the active ingredient contained in Sovaldi) and ribavirin therapy were fatigue and headache. The most common side effects reported with sofosbuvir, peginterferon alfa, and ribavirin therapy were fatigue, headache, nausea, insomnia, and anemia. Therapy was permanently discontinued due to side effects in up to 4% of subjects using placebo, up to 1% of subjects using sofosbuvir and ribavirin for 12 weeks, less than 1% of subjects using sofosbuvir and ribavirin for 24 weeks, 11% of subjects using peginterferon alfa and ribavirin for 24 weeks, and 2% of subjects using sofosbuvir, peginterferon alfa, and ribavirin for 12 weeks.

Other

Very common (10% or more): Fatigue (up to 59%), asthenia (up to 21%), pyrexia (up to 18%), chills (up to 17%), influenza-like illness (up to 16%), pain

Common (1% to 10%): Chest pain

Nervous system

Very common (10% or more): Headache (up to 36%), dizziness

Common (1% to 10%): Disturbance in attention, migraine, memory impairment

Gastrointestinal

Increased lipase (greater than 3 times the upper limit of normal [3 x ULN]) was reported in up to 2% of patients. Lipase elevation was isolated and asymptomatic.

Very common (10% or more): Nausea (up to 34%), diarrhea (up to 12%), vomiting

Common (1% to 10%): Increased lipase, abdominal discomfort, constipation, dyspepsia, dry mouth, gastroesophageal reflux

Hematologic

Very common (10% or more): Decreased hemoglobin (up to 32.5%), anemia (up to 21%), neutropenia (up to 17%), decreased neutrophils (up to 15%), decreased lymphocyte count, decreased platelet count

Uncommon (0.1% to 1%): Pancytopenia

Decreased hemoglobin (less than 10 g/dL: up to 23%; less than 8.5 g/dL: up to 2%), decreased neutrophils (0.5 to less than 0.75 x 10[9]/L: up to 15%; less than 0.5 x 10[9]/L: up to 5%), and decreased platelets (25 to less than 50 x 10[9]/L: up to 1%) have been reported.

In a study in liver transplant recipients, decreased hemoglobin was very common during therapy. Hemoglobin decreased to less than 10 g/dL in 13 of 40 patients (32.5%); hemoglobin decreased to less than 8.5 g/dL in 1 of those patients. Epoetin and/or a blood product was used in 8 patients (20%); 5 patients (12.5%) discontinued, modified, or interrupted therapy due to side effects.

Pancytopenia was reported, particularly in patients using concomitant pegylated interferon.

Dermatologic

Very common (10% or more): Pruritus (up to 27%), rash (18%)

Common (1% to 10%): Alopecia, dry skin

Frequency not reported: Stevens-Johnson syndrome

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

Psychiatric

Severe depression was reported, particularly in patients with history of psychiatric illness.

Very common (10% or more): Insomnia (up to 25%), irritability (up to 13%)

Common (1% to 10%): Depression, anxiety, agitation

Uncommon (0.1% to 1%): Severe depression (including suicidal ideation, suicide)

Cardiovascular

Severe bradycardia and heart block have been reported when sofosbuvir-containing regimens were used with 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 this drug.

Frequency not reported: Severe bradycardia, heart block

Postmarketing reports: Symptomatic bradycardia (including cases requiring pacemaker intervention)

Metabolic

Very common (10% or more): Decreased appetite (up to 18%)

Common (1% to 10%): Decreased weight

Musculoskeletal

Very common (10% or more): Myalgia (up to 14%), arthralgia

Common (1% to 10%): Increased creatine kinase, back pain, muscle spasms

Increased creatine kinase (at least 10 x ULN) was reported in up to 2% of patients. Creatine kinase elevation was isolated and asymptomatic.

Respiratory

Very common (10% or more): Dyspnea, cough

Common (1% to 10%): Nasopharyngitis, exertional dyspnea

Hepatic

Increased total bilirubin (greater than 1.5 x ULN) was reported in up to 3% of patients. Bilirubin levels peaked during the first 1 to 2 weeks of therapy then decreased and returned to baseline levels by 4 weeks after therapy. These bilirubin elevations were not associated with transaminase elevations.

Common (1% to 10%): Increased total bilirubin

Postmarketing reports: Hepatitis B reactivation

Ocular

Common (1% to 10%): Blurred vision

Editorial References and Review

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

Source: Drugs.com Sovaldi (www.drugs.com/sovaldi.html).