GNH USA

Europe — EMA

Harvoni

Harvoni (ledipasvir/sofosbuvir) oral tablet for chronic hepatitis C genotype 1‑6 – indications, side effects, precautions, and drug interactions.

Ledipasvir, Sofosbuvir

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What is Ledipasvir, Sofosbuvir?

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.

What is Ledipasvir, Sofosbuvir used for?

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

What are the side effects of Ledipasvir, Sofosbuvir?

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

What precautions apply to Ledipasvir, Sofosbuvir?

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.

What does Ledipasvir, Sofosbuvir interact with?

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

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.
Which hepatitis C genotypes can be treated with Harvoni?+
Harvoni is approved for chronic HCV genotype 1, 4, 5, and 6 infections.
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.
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.
What are the most common side effects of Harvoni?+
The most frequently reported adverse events include fatigue, headache, and nausea.
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.
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.
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.
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.
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.
Is dose adjustment needed for patients with renal impairment?+
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.
Can Harvoni be used in patients with compensated cirrhosis?+
Yes, Harvoni is approved for use in patients with compensated cirrhosis caused by HCV infection.
Information provided on this page is for educational use by procurement and clinical professionals. Always consult a licensed healthcare provider for medical advice and prescribing decisions. GNH USA supplies this product subject to applicable regulatory and licensing requirements.
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Product details

Drug
Ledipasvir, Sofosbuvir
Route
Oral Use
Manufacturer
Gilead Sciences Ireland Unlimited Company
Origin
EU

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