Harvoni

Active Ingredient:: Ledipasvir, Sofosbuvir
Origin:: EU

Harvoni (Ledipasvir, Sofosbuvir)

Q: What is the mechanism of action of Harvoni?

Harvoni combines ledipasvir, an NS5A inhibitor that blocks viral replication and assembly, with sofosbuvir, an NS5B polymerase inhibitor that causes chain termination of viral RNA synthesis.

Q: Which hepatitis C genotypes can be treated with Harvoni?

Harvoni is approved for chronic HCV genotype 1, 4, 5, and 6 infections.

Q: How is Harvoni administered?

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

Q: Is Harvoni safe to use during pregnancy?

Harvoni is classified as pregnancy category B, indicating no evidence of risk in animal studies, but it should be used during pregnancy only if clearly needed and after consulting a healthcare professional.

Q: What are the most common side effects of Harvoni?

The most frequently reported adverse events include fatigue, headache, and nausea.

Q: What serious adverse reactions require medical attention while taking Harvoni?

Serious reactions may include hepatic decompensation, severe rash or allergic response, and significant elevations in liver enzymes; patients should seek medical care promptly if these occur.

Q: Can Harvoni be taken with other antiviral medications?

Co‑administration with certain antivirals, especially strong enzyme inducers, is not recommended. Always discuss any additional antiviral therapy with a healthcare provider.

Q: Are there any dietary restrictions while on Harvoni?

Harvoni can be taken with or without food; no specific dietary restrictions are required, but patients should follow any guidance from their prescriber.

Q: How should liver function be monitored during Harvoni therapy?

Baseline liver function tests should be obtained before starting treatment, and periodic monitoring is advised throughout the course to detect any changes.

Q: What should patients do if they miss a dose of Harvoni?

If a dose is missed, patients should take it as soon as they remember on the same day and then continue with the regular dosing schedule; they should not double‑dose.

Harvoni is a prescription oral tablet that combines 90 mg ledipasvir and 400 mg sofosbuvir in a single fixed‑dose tablet. It belongs to the antiviral class and is marketed in the European Union for the treatment of chronic hepatitis C virus (HCV) infection. The medication works by targeting two viral proteins essential for HCV replication. Both components act synergistically to inhibit viral replication and assembly, providing a high barrier to resistance.

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 adults.

Chronic HCV genotype 1 infection
Chronic HCV genotype 4 infection
Chronic HCV genotype 5 infection
Chronic HCV genotype 6 infection
Patients with compensated cirrhosis caused by HCV

Side Effects

The safety profile of Harvoni includes both common and less frequent serious adverse events.

Common

Fatigue
Headache
Nausea

Serious

Hepatic decompensation
Severe rash or allergic reaction
Elevated liver enzymes

Precautions & Warnings

Before starting Harvoni, several safety considerations should be reviewed.

Use only under medical supervision; it is a prescription‑only medication.
Pregnancy category B: discuss potential risks with a healthcare provider.
Not recommended for patients with severe renal impairment (eGFR <30 mL/min).
Monitor liver function tests regularly during therapy.
Assess for potential drug resistance, especially in previously treated patients.
Counsel patients on the importance of adherence to the full treatment course.

Avoid Interactions

Harvoni may interact with other medicines; some combinations should be avoided while others require caution.

Avoid

Strong CYP3A4 inducers such as rifampin, carbamazepine, or phenytoin.
Amiodarone, due to risk of serious bradycardia.
Certain antiretroviral protease inhibitors that may increase exposure.

Use with caution

Statins (e.g., simvastatin, lovastatin) because of increased statin levels.
Other anticonvulsants that are moderate enzyme inducers.
Herbal supplements such as St. John's wort, which can lower Harvoni concentrations.

Frequently Asked Questions

Harvoni combines ledipasvir, an NS5A inhibitor that blocks viral replication and assembly, with sofosbuvir, an NS5B polymerase inhibitor that causes chain termination of viral RNA synthesis.

Harvoni is approved for chronic HCV genotype 1, 4, 5, and 6 infections.

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

Harvoni is classified as pregnancy category B, indicating no evidence of risk in animal studies, but it should be used during pregnancy only if clearly needed and after consulting a healthcare professional.

The most frequently reported adverse events include fatigue, headache, and nausea.

Serious reactions may include hepatic decompensation, severe rash or allergic response, and significant elevations in liver enzymes; patients should seek medical care promptly if these occur.

Co‑administration with certain antivirals, especially strong enzyme inducers, is not recommended. Always discuss any additional antiviral therapy with a healthcare provider.

Harvoni can be taken with or without food; no specific dietary restrictions are required, but patients should follow any guidance from their prescriber.

Baseline liver function tests should be obtained before starting treatment, and periodic monitoring is advised throughout the course to detect any changes.

If a dose is missed, patients should take it as soon as they remember on the same day and then continue with the regular dosing schedule; they should not double‑dose.

Harvoni is not recommended for patients with severe renal impairment (eGFR <30 mL/min) because safety and efficacy have not been established in this population.

Yes, Harvoni is approved for use in patients with compensated cirrhosis caused by HCV infection.

Published by GNH India Pharmaceuticals Limited

Last updated: 12 Jul 2026

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