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

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

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.