Ascletavir (Ravidasvir) | Chronic Hepatitis C Virus

Ravidasvir Application Scope

• Used in combination with Sofosbuvir for the treatment of chronic hepatitis C virus (HCV) infection in adult patients, across genotypes 1, 3, 4, 6—including those with compensated cirrhosis and HCV/HIV co-infection

• Recognized by WHO’s Model List of Essential Medicines for chronic HCV

 

Ravidasvir Characteristics

• Ingredients: Ravidasvir hydrochloride, 219 mg tablet equivalent to 200 mg ravidasvir; excipients include ~152.8 mg isomalt

• Properties: NS5A inhibitor, pangenotypic antiviral activity; does not significantly interact with CYP enzymes; is P-gp substrate; contraindicated with strong P-gp inducers

• Packaging Specification: 200 mg per film-coated tablet (with isomalt excipient)

• Storage: Unknown

• Expiry Date: Unknown

• Executive Standard: Unknown

• Approval Number: Unknown

• Date of Revision: Unknown

• Manufacturer: Pharco Pharmaceuticals (Egypt) and licensing via DNDi; locally produced in Malaysia

Guidelines for the Use of Ravidasvir

• Dosage and Administration:

  • Regimen:

    • 12 weeks of Ravidasvir (200 mg QD) + Sofosbuvir (400 mg QD) in non-cirrhotic adults.

    • 24 weeks for adults with compensated cirrhosis

  • Special populations: Includes HCV/HIV co-infected individuals with no dose adjustment necessary

• Adverse Reactions:

  • Common (≥10%):

    • Headache, fatigue, nausea; pyrexia, cough, upper respiratory infection

  • Others:

    • Dizziness, rash, itching, gastrointestinal discomfort, insomnia

  • Serious adverse events:

    • Rare: transient bradycardia, hearing impairment, liver enzyme elevations; overall SAE incidence ~2–6%

• Contraindications:

  • Concurrent use with strong P-gp inducers (e.g., rifampin, St John’s wort, carbamazepine) is contraindicated

  • Likely contraindicated during pregnancy or breastfeeding (not recommended without effective contraception)

• Precautions:

  • Monitor liver function: potential hepatic enzyme elevations.

  • Avoid in pregnancy and breastfeeding—use effective contraception for women of reproductive potential

  • Caution in patients with severe hepatic impairment outside of compensated cirrhosis studies.

  • Observe for and manage any bradycardia when co-administered with Sofosbuvir

Interactions

• Drug Interactions:​

• No significant CYP-mediated interactions.

• Strong P-gp inducers reduce levels—contraindicated.

• Co-administration is safe with most antiretrovirals; no clinically significant interactions reported in HCV/HIV co-infection

• Monitor when used with Sofosbuvir for rare bradycardia events

 

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.