Harvoni Application Scope

Harvoni is approved for use in adults and children aged 3 years and older with HCV genotypes 1, 4, 5, or 6.

Treatment duration typically ranges from 8 to 24 weeks, depending on factors such as the patient’s HCV genotype, prior treatment history, and presence of cirrhosis.

harvoni

Characteristics

Ingredients: Ledipasvir and Sofosbuvir

Properties:
- Ledipasvir inhibits the HCV NS5A protein, preventing viral replication.
- Sofosbuvir inhibits the HCV NS5B RNA polymerase, leading to chain termination of viral RNA synthesis .
Packaging Specification: Available as tablets and oral pellets, typically supplied in bottles containing 28 units

Storage: Store at temperatures below 30°C (86°F) in the original container to protect from moisture and light
Expiry Date: Refer to the expiration date printed on the product packaging.
Executive Standard: Approved by the U.S. Food and Drug Administration (FDA) in 2014 for the treatment of HCV
Approval Number: Refer to the FDA approval documentation for specific numbers
Date of Revision: For the most recent updates, consult the latest prescribing information or the manufacturer’s website.
Manufacturer: Gilead Sciences, Inc.

Guidelines for the Use of Harvoni

Dosage and Administration:
- Adults: One tablet (90 mg ledipasvir/400 mg sofosbuvir) taken orally once daily, with or without food.
- Treatment Duration:
  - 8 weeks: Treatment-naïve patients without cirrhosis and HCV RNA <6 million IU/mL.
  - 12 weeks: Most patients, including those with compensated cirrhosis.
  - 24 weeks: Patients with decompensated cirrhosis or prior treatment failure .

Adverse Reactions:
- Common side effects (≥10%): Fatigue, headache, asthenia.
- Less common: Nausea, diarrhea, insomnia
Contraindications:
- Co-administration with other products containing sofosbuvir.
- When used with ribavirin, all contraindications to ribavirin apply, including pregnancy avoidance.
Precautions:
- Risk of serious symptomatic bradycardia when co-administered with amiodarone
- Cardiac monitoring is recommended if no alternatives are available.
- Potential reactivation of hepatitis B virus (HBV); screen for HBV before initiating therapy.
- Use with caution in patients with advanced liver disease .

Harvoni Interactions

Drug Interactions:

Avoid concomitant use with:
- Amiodarone (risk of bradycardia).
- P-gp inducers (e.g., rifampin, St. John’s wort) which may decrease Harvoni plasma concentrations.
- Certain anticonvulsants (e.g., carbamazepine, phenytoin) and antimycobacterials (e.g., rifabutin, rifapentine).
- HIV antiretrovirals (e.g., tipranavir/ritonavir) and HCV protease inhibitors (e.g., simeprevir).
- Rosuvastatin (risk of increased statin levels leading to myopathy) .

Note:

If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
It is only for internal discussion among medical staff and does not serve as a basis for medication. For specific medication guidelines, please consult the attending physician.