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Harvoni
Harvoni (generic name: ledipasvir and sofosbuvir) is a prescription medication used to treat chronic hepatitis C virus (HCV) infection in adults and pediatric patients aged 12 years and older. It is a fixed-dose combination of two direct-acting antiviral agents that work together to inhibit the replication of the hepatitis C virus. Harvoni is highly effective in curing hepatitis C, often leading to sustained virologic response (SVR) with a well-tolerated treatment regimen.
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Frequently Asked Questions
How long does it take for Harvoni to work?
Most patients will see a reduction in HCV RNA levels within a few weeks, and many achieve SVR (a cure) within 12 weeks of treatment.
Can Harvoni be taken during pregnancy?
Harvoni should be used during pregnancy only if the benefits outweigh the risks. Consult your healthcare provider for personalized advice.
What should I do if I miss a dose of Harvoni?
If you miss a dose, take it as soon as you remember. If it is close to the time for your next dose, skip the missed dose and continue with your regular schedule. Do not double up on doses.
Are there any dietary restrictions while taking Harvoni?
There are no specific dietary restrictions, but maintaining a healthy diet can support overall liver health.
Is Harvoni safe for long-term use?
Harvoni is designed for short-term treatment (typically 12 weeks) of hepatitis C. Long-term safety data is available, and the medication is generally well-tolerated under medical supervision.
Comprehensive Drug Guide
How Does Harvoni Work?
- Ledipasvir: Inhibits the HCV NS5A protein, which is essential for viral replication and assembly.
- Sofosbuvir: Inhibits the NS5B polymerase enzyme, which is crucial for viral RNA synthesis. By blocking these targets, Harvoni effectively halts the replication of the hepatitis C virus.
Common Dosages
- Ledipasvir 90 mg and sofosbuvir 400 mg: Taken as one tablet once daily.
Typical Dosing
- For chronic hepatitis C: The recommended dose is one tablet (90 mg ledipasvir/400 mg sofosbuvir) taken orally once daily for 12 weeks. The treatment duration may vary based on prior treatment history and HCV genotype.
Typical Dosing
FDA Approved Indications
- Treatment of chronic hepatitis C virus infection in adults and pediatric patients aged 12 years and older who are not previously treated and without cirrhosis or with compensated cirrhosis.
Who Shouldn't Take Harvoni?
- Known hypersensitivity to ledipasvir, sofosbuvir, or any components of the formulation.
- Severe liver disease (decompensated cirrhosis).
Advice From The Pharmacist
- Take Harvoni once daily, with or without food, at the same time each day for maximum effectiveness.
- Regular monitoring of liver function and HCV viral load is essential to assess treatment response.
- Inform your healthcare provider about all medications you are taking to avoid potential drug interactions.
Side Effects of Harvoni
Common Side Effects
- Fatigue
- Headache
- Nausea
- Insomnia
- Diarrhea
Uncommon/Severe Side Effects
- Severe allergic reactions (such as rash, itching, swelling, or difficulty breathing)
- Reactivation of hepatitis B virus in patients with a history of HBV infection.
Risks and Warnings of Harvoni
- Hepatitis B Reactivation: Patients should be tested for HBV infection before starting Harvoni, as reactivation of HBV can occur during or after treatment.
- Liver Function Monitoring: Regular monitoring of liver function tests is recommended during treatment.
- Drug Interactions: Be aware of potential interactions with other medications that may affect liver enzymes.
Interactions with Harvoni
Common Drug Interactions
- Anticonvulsants: Medications like carbamazepine or phenytoin may reduce the effectiveness of Harvoni.
- Rifampin: This antibiotic can significantly decrease the levels of ledipasvir and sofosbuvir, impacting their effectiveness.
- St. John’s Wort: Use of this herbal supplement should be avoided, as it may also decrease the effectiveness of Harvoni.
Alternatives to Harvoni
- Other direct-acting antivirals: Such as Epclusa (sofosbuvir and velpatasvir) or Mavyret (glecaprevir and pibrentasvir), which may be suitable alternatives depending on the patient's specific circumstances.
- Interferon-based therapies: Older treatments for hepatitis C, although they are less commonly used now due to the effectiveness of DAAs.
