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Dosage of Epclusa

Pretreatment Testing

Before initiating Sofosbuvir/Velpatasvir treatment, all patients should be screened for current or past HBV infection by testing for HBsAg and anti-HBc.

Recommended Treatment Regimens and Durations

For treatment-naive and treatment-experienced patients without cirrhosis or with compensated cirrhosis (Child-Pugh Class A), Sofosbuvir/Velpatasvir is recommended for a 12-week treatment course.

For treatment-naive and treatment-experienced patients with decompensated cirrhosis (Child-Pugh Class B and C), Sofosbuvir/Velpatasvir in combination with ribavirin is recommended for a 12-week treatment course.

For patients with HCV/HIV-1 coinfection, follow the same dosage recommendations as above.

For treatment-naive and treatment-experienced liver transplant recipients without cirrhosis or with compensated cirrhosis (Child-Pugh Class A), the recommended regimen is Sofosbuvir/Velpatasvir once daily for a 12-week treatment course.

For patients with renal impairment of any severity (including end-stage renal disease requiring dialysis), follow the treatment regimen recommendations above.

Recommended Dosage for Adults

Take one tablet (containing 400 mg sofosbuvir and 100 mg velpatasvir) orally once daily, with or without food. If used in combination with ribavirin, follow the dosage recommendations and adjustment instructions for ribavirin.

Recommended Dosage for Pediatric Patients (Aged 3 Years and Older)

The dosage is based on body weight. For specific dosage guidelines, refer to the table in the full prescribing information. For pediatric patients under 6 years of age, Sofosbuvir/Velpatasvir oral granules should be taken with food to improve taste tolerance.

Preparation and Administration of Oral Granules

Follow the full instructions for use of Sofosbuvir/Velpatasvir oral granules. Do not chew the granules to avoid a bitter taste. The granules can be taken orally directly or mixed with food (non-acidic, soft food at or below room temperature, such as pudding, chocolate sauce, ice cream) and swallowed within 15 minutes; chewing is not allowed.

Renal Impairment

No dosage adjustment of Sofosbuvir/Velpatasvir is required for patients with renal impairment of any severity (including those requiring dialysis). Administer according to the recommended regimen (used alone or in combination with ribavirin) based on the patient population.

FDA,2022.04

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