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Ledipasvir / sofosbuvir Side Effects

For the Consumer

Applies to ledipasvir / sofosbuvir: oral tablet

In addition to its needed effects, some unwanted effects may be caused by ledipasvir / sofosbuvir. In the event that any of these side effects do occur, they may require medical attention.

Major Side Effects

You should check with your doctor immediately if any of these side effects occur when taking ledipasvir / sofosbuvir:

Incidence not known:
  • Chest pain or discomfort
  • lightheadedness, dizziness, or fainting
  • slow or irregular heartbeat
  • trouble breathing
  • unusual tiredness

Minor Side Effects

Some of the side effects that can occur with ledipasvir / sofosbuvir may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

More common:
  • Cough
  • diarrhea
  • headache
  • irritability
  • lack or loss of strength
  • muscle pain
  • nausea
  • trouble sleeping
Less common:
  • Discouragement
  • dizziness
  • feeling sad or empty
  • lack of appetite
  • loss of interest or pleasure
  • trouble concentrating

For Healthcare Professionals

Applies to ledipasvir / sofosbuvir: oral tablet

General

The most common side effects reported with this drug were fatigue, headache, asthenia, and nausea. When this drug was studied with ribavirin, the most common side effects to this combination were consistent with known ribavirin side effects; frequency and severity of the expected side effects were not increased. Therapy was permanently discontinued due to side effects in 0%, less than 1%, and 1% of patients using this drug for 8, 12, and 24 weeks, respectively, and less than 1%, 0%, and 2% for patients using this drug with ribavirin for 8, 12, and 24 weeks, respectively.

Among 174 liver transplant recipients with compensated liver disease using this drug with ribavirin for 12 weeks, 1% permanently discontinued this drug due to a side effect.

Among 162 patients with decompensated liver disease (pretransplant or posttransplant) using this drug with ribavirin for 12 weeks, 4% died, 2% had a liver transplantation, and less than 1% had a liver transplantation and died during therapy or within 30 days after stopping therapy. Due to the advanced liver disease in these patients (who had increased risk of disease progression leading to liver failure and death), the contribution of drug effect to outcomes could not be reliably assessed. This drug was permanently discontinued due to a side effect in 2% of patients.

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

Hematologic

Decreased hemoglobin (less than 10 g/dL: up to 39%; less than 8.5 g/dL: up to 13%) has been reported in liver transplant recipients and/or patients with decompensated liver disease using this drug with ribavirin for 12 or 24 weeks. Ribavirin was permanently discontinued in up to 19% of patients. Immunosuppressive agents were modified in up to 10% of liver transplant recipients (modified dose due to improved organ function in at least 7%).

Very common (10% or more): Decreased hemoglobin (up to 39%)

Other

Very common (10% or more): Asthenia (up to 36%), fatigue (up to 18%)[Ref]

Nervous system

Very common (10% or more): Headache (up to 29%)
Common (1% to 10%): Dizziness[Ref]

Respiratory

Very common (10% or more): Cough (up to 11%)
Common (1% to 10%): Dyspnea

Gastrointestinal

Common (1% to 10%): Nausea, diarrhea, increased lipase[Ref]

Increased lipase (greater than 3 times the upper limit of normal [3 x ULN]) was reported in less than 1%, 2%, and 3% of patients using this drug for 8, 12, and 24 weeks, respectively. Increased lipase (greater than 3 x ULN) was reported in 1%, 3%, and 9% of patients with compensated cirrhosis using placebo, this drug plus ribavirin for 12 weeks, and this drug for 24 weeks, respectively. Lipase elevation was transient and asymptomatic.[Ref]

Psychiatric

Depression (especially in patients with history of psychiatric illness) was reported in patients using sofosbuvir-containing regimens. Suicidal ideation and suicide have been reported in less than 1% of patients using sofosbuvir with ribavirin or pegylated interferon/ribavirin in other clinical trials.[Ref]

Common (1% to 10%): Insomnia, irritability
Frequency not reported: Depression

Sofosbuvir:
-Frequency not reported: Depression, suicidal ideation, suicide[Ref]

Dermatologic

Common (1% to 10%): Rash
Postmarketing reports: Skin rashes (sometimes with blisters or angioedema-like swelling), angioedema

Hepatic

Increased bilirubin (greater than 1.5 x ULN) was reported in 3%, less than 1%, and 2% of patients using this drug for 8, 12, and 24 weeks, respectively. Increased bilirubin (greater than 1.5 x ULN) was reported in 3%, 11%, and 3% of patients with compensated cirrhosis using placebo, this drug plus ribavirin for 12 weeks, and this drug for 24 weeks, respectively.[Ref]

Common (1% to 10%): Increased bilirubin
Postmarketing reports: Hepatitis B reactivation[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 this drug 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 this drug.[Ref]

Musculoskeletal

Common (1% to 10%): Myalgia, elevated creatine kinase

Sofosbuvir:
-Frequency not reported: Elevated creatine kinase[Ref]

Creatine kinase was not evaluated in some phase 3 clinical trials for this drug, but was evaluated in at least 1 trial. Isolated, asymptomatic creatine kinase elevations (at least 10 x ULN) were reported in 1% of patients using this drug for 12 weeks; such elevations were previously reported in patients using sofosbuvir with ribavirin or peginterferon/ribavirin in other clinical trials.[Ref]

References

1. "Product Information. Harvoni (ledipasvir-sofosbuvir)." Gilead Sciences, Foster City, CA.

2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

3. Cerner Multum, Inc. "Australian Product Information." O 0

4. FDA. U.S. Food and Drug Administration "FDA Drug Safety Communicaation: FDA warns of serious slowing of the heart rate when antiarrhythmic drug amiodarone is used with hepatitis C treatments containing sofosbuvir (Harvoni or Sovaldi) in combination with another Direct Acting Antiviral drug. Ava" ([2015 Mar 24]):

Not all side effects for ledipasvir / sofosbuvir may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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