Product image of Harvoni (Ledipasvir, Sofosbuvir) supplied by GNH India

Harvoni

Active Ingredient:
Ledipasvir, Sofosbuvir
Origin:
EU

Harvoni (Ledipasvir, Sofosbuvir)

Harvoni is an oral tablet containing 90 mg ledipasvir and 400 mg sofosbuvir, approved in the EU for the treatment of chronic hepatitis C virus (HCV) genotype 1 and genotype 4 infections. It belongs to the antiviral class, combining an NS5A inhibitor (ledipasvir) with an NS5B polymerase inhibitor (sofosbuvir) to suppress viral replication. The fixed‑dose combination is administered once daily and is prescribed by healthcare professionals as part of a comprehensive HCV management plan.

Manufacturer / TM Owner

Gilead Sciences Ireland Unlimited Company

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Indications & Clinical Uses

Harvoni is indicated for the treatment of chronic hepatitis C virus infection in specific genotypes.

  • Chronic HCV genotype 1 infection in adults.
  • Chronic HCV genotype 4 infection in adults.
  • Treatment of HCV infection in patients with compensated liver disease.
  • Use in patients with resistance‑associated substitutions when guided by a specialist.
  • Option for treatment‑naïve patients or those who have previously failed interferon‑based regimens.

Side Effects

The safety profile of Harvoni includes both frequently observed and less common adverse events.

Common

  • Fatigue or tiredness.
  • Headache.
  • Nausea or upset stomach.
  • Insomnia or difficulty sleeping.

Serious

  • Severe rash or skin reactions.
  • Hepatic decompensation or worsening liver function.
  • Bradycardia when co‑administered with amiodarone.
  • Elevated bilirubin levels.

Precautions & Warnings

Clinicians should evaluate several factors before prescribing Harvoni to ensure safe and effective use.

  • Pregnancy status should be assessed; the safety in pregnancy is not established.
  • Baseline liver function tests are recommended to monitor hepatic health.
  • Renal impairment may require dosage consideration, especially in severe cases.
  • Presence of resistance‑associated substitutions may affect treatment outcome.
  • Co‑infection with HIV or HBV should be managed according to specialist guidance.
  • Adherence to the full treatment course is essential for viral eradication.

Avoid Interactions

Harvoni may interact with other medicines, affecting its efficacy or safety.

Avoid

  • Strong CYP3A4 inducers such as rifampin or St. John’s wort.
  • Certain antiretrovirals (e.g., efavirenz) that reduce drug exposure.
  • Amiodarone due to risk of serious bradycardia.
  • Anticonvulsants that induce hepatic enzymes.

Use with caution

  • Antacids containing aluminum or magnesium; separate administration by at least 4 hours.
  • Proton pump inhibitors, which may lower ledipasvir absorption.
  • Statins (e.g., simvastatin, lovastatin) because of increased plasma concentrations.
  • HIV protease inhibitors that may increase sofosbuvir levels.
  • Herbal supplements that affect liver enzymes.

Frequently Asked Questions

Harvoni combines ledipasvir, an NS5A inhibitor that blocks viral replication and assembly, with sofosbuvir, an NS5B polymerase inhibitor that terminates viral RNA synthesis, together suppressing hepatitis C virus replication.

Harvoni is approved for chronic hepatitis C virus genotype 1 and genotype 4 infections in adults.

Harvoni is taken as a single oral tablet containing 90 mg ledipasvir and 400 mg sofosbuvir, usually once daily with or without food.

Harvoni is a prescription‑only medication and must be prescribed by a qualified healthcare professional.

The safety of Harvoni in pregnancy has not been established; clinicians should weigh potential benefits against risks and consider alternative therapies when appropriate.

Common side effects include fatigue, headache, nausea, and insomnia, which are generally mild to moderate in intensity.

Serious reactions may include severe rash, hepatic decompensation, bradycardia (especially with amiodarone), and significant elevations in bilirubin.

Antacids containing aluminum or magnesium can reduce ledipasvir absorption; they should be taken at least 4 hours apart from Harvoni.

Strong CYP3A4 inducers (e.g., rifampin, St. John’s wort), certain antiretrovirals, and amiodarone should be avoided because they can lower efficacy or increase safety risks.

Baseline liver function should be assessed; patients with severe hepatic impairment may require alternative treatment strategies.

Mild to moderate renal impairment does not usually require dose adjustment, but severe renal dysfunction should be evaluated by a specialist.

Regular monitoring of liver enzymes, bilirubin, and viral load is recommended to assess treatment response and detect any hepatic adverse events.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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