Patients should strictly adhere to the recommended dosage of Epclusa under the guidance of their physician, avoiding missed doses or arbitrary changes in dosage timing. It is also important to be aware of potential drug interactions and the specific requirements for use in certain populations.
I. Pre-treatment Testing
Before initiating hepatitis C (HCV) treatment with Epclusa, all patients must be tested to confirm current or past hepatitis B virus (HBV) infection. Testing methods include detecting hepatitis B surface antigen (HBsAg) and hepatitis B core antibody (anti-HBc).
II. Recommended Treatment Regimen and Duration for Patients
Aged 3 Years and Older Based on different patient populations, the recommended treatment regimen and duration are as follows:
For patients who are "treatment-naïve" or "treated (experienced), without cirrhosis but with compensated cirrhosis (Child-Pugh A)": The recommended regimen is Epclusa for 12 weeks.
For patients who are treatment-naïve or have received treatment and have decompensated cirrhosis (Child-Pugh B or C): The recommended regimen is Epclusa combined with ribavirin for 12 weeks.
Special Note: For patients co-infected with hepatitis C/HIV-1, the above patient-based dosage recommendations should be followed.
For treatment-naïve or treated liver transplant recipients without cirrhosis or with compensated cirrhosis (Child-Pugh A), the recommended regimen is once-daily Epclusa for 12 weeks.
III. Recommended Adult Dosage:
The recommended adult dose of Epclusa is one tablet daily, each containing 400 mg sofosbuvir and 100 mg velpatasvir, which can be taken with or without food.
Ribavirin Dosage in Combination of Epclusa and Ribavirin: The recommended ribavirin dose is based on patient weight (to be taken with food):
Patients weighing less than 75 kg: 1000 mg daily;
Patients weighing ≥75 kg: 1200 mg daily;
Ribavirin should be taken in two divided doses. The starting dose and the dose during treatment can be adjusted according to the patient's hemoglobin level and creatinine clearance. If an adjustment to the ribavirin dose is required, please refer to the ribavirin prescribing information.
IV. Recommended Dosage for Children Aged 3 Years and Older
The recommended dose of Epclusa for children aged 3 years and older is based on weight. The ribavirin dose in combination with Epclusa is also based on weight, as follows:
(I) Epclusa Dosage
Note: Patients unable to swallow 400 mg/100 mg Epclusa tablets may use two 200 mg/50 mg tablets once daily. Epclusa tablets are taken orally once daily, with or without food.
Children weighing less than 17 kg: Daily dose is 150 mg/37.5 mg, tablets are not applicable.
Children weighing 17 kg (inclusive) to less than 30 kg: Daily dose is 200 mg/50 mg, tablets are taken once daily, one 200 mg/50 mg tablet.
Children weighing ≥30 kg: Daily dose is 400 mg/100 mg, tablets are taken once daily, one 400 mg/100 mg tablet (or, as per the above notes, two 200 mg/50 mg tablets instead).
(II) Ribavirin Dosage in Combination with Epclusa
Note: The daily ribavirin dose is based on the patient's weight, orally, divided into two doses, taken with meals.
Children weighing less than 47 kg: Daily dose is 15 mg/(kg・d), divided into two doses, morning and evening.
Children weighing 47kg to 49kg: The daily dose is 600mg, taken as one 200mg tablet in the morning and two 200mg tablets in the evening.
Children weighing 50kg to 65kg: The daily dose is 800mg, taken as two 200mg tablets in the morning and two 200mg tablets in the evening.
Children weighing 66kg to 80kg: The daily dose is 1000mg, taken as two 200mg tablets in the morning and three 200mg tablets in the evening.
Children weighing over 80kg: The daily dose is 1200mg, taken as three 200mg tablets in the morning and three 200mg tablets in the evening.
V. Use in Patients with Renal Impairment
No dose adjustment is required for patients with any degree of renal impairment (including those requiring dialysis).
The decision to combine Epclusa with ribavirin should be based on the recommendations in the "Recommended Treatment Plan and Course of Treatment for Patients Aged 3 Years and Above" section above.
For patients with a creatinine clearance (CrCl) ≤ 50 mL/min, ribavirin dosage adjustments should refer to the ribavirin tablet prescription information.
