Sofosbuvir
Sofosbuvir is a nucleotide analog inhibitor of the HCV NS5B RNA-dependent RNA polymerase, which is essential for viral replication. It is a direct-acting antiviral (DAA) agent used as a core component of combination regimens for chronic Hepatitis C.
Dosage by Body Weight
Adult dose is typically 400 mg orally once daily, taken with or without food, always in combination with other antivirals. Pediatric dosing is based on body weight for patients 3 years of age and older. Treatment duration is usually 12 to 24 weeks.
- Body Weight
- Below 5 kg
- Dose
- Not established
- Frequency
- N/A
- Tracking Notes
- Safety and efficacy not established in patients under 3 years of age or weighing under 17 kg.
- Body Weight
- 5-7 kg
- Dose
- Not established
- Frequency
- N/A
- Tracking Notes
- Safety and efficacy not established in patients under 3 years of age or weighing under 17 kg.
- Body Weight
- 8-10 kg
- Dose
- Not established
- Frequency
- N/A
- Tracking Notes
- Safety and efficacy not established in patients under 3 years of age or weighing under 17 kg.
- Body Weight
- 11-15 kg
- Dose
- Not established
- Frequency
- N/A
- Tracking Notes
- Safety and efficacy not established in patients under 3 years of age or weighing under 17 kg.
- Body Weight
- 16-20 kg
- Dose
- 150 mg to 200 mg
- Frequency
- Once daily
- Tracking Notes
- For pediatric patients weighing 17 kg to less than 35 kg, the recommended daily dose is typically 200 mg (pellets or tablets) in combination with other HCV drugs.
| Body Weight | Dose | Frequency | Tracking Notes |
|---|---|---|---|
| Below 5 kg | Not established | N/A | Safety and efficacy not established in patients under 3 years of age or weighing under 17 kg. |
| 5-7 kg | Not established | N/A | Safety and efficacy not established in patients under 3 years of age or weighing under 17 kg. |
| 8-10 kg | Not established | N/A | Safety and efficacy not established in patients under 3 years of age or weighing under 17 kg. |
| 11-15 kg | Not established | N/A | Safety and efficacy not established in patients under 3 years of age or weighing under 17 kg. |
| 16-20 kg | 150 mg to 200 mg | Once daily | For pediatric patients weighing 17 kg to less than 35 kg, the recommended daily dose is typically 200 mg (pellets or tablets) in combination with other HCV drugs. |
Formulation
Purpose
Treatment of chronic hepatitis C virus (HCV) infection in adult and pediatric patients aged 3 years and older, used in combination with other antiviral medications.
Generic Name
SofosbuvirBranded Drug Names
Sofosbuvir is listed as a generic drug name. Common branded medicines that may contain the same active ingredient include:
Scheduled Drug
Yes. This medicine should be supplied or used only according to applicable prescription and regulatory requirements.