As an oral, pan-genotypic direct-acting antiviral (DAA) medication for hepatitis C virus (HCV) infection, Epclusa (Sofosbuvir and Velpatasvir Tablets) features a standard treatment regimen characterized by excellent efficacy and a simple administration schedule. The recommended dosage and administration of this medication are individualized based on the patient population, severity of liver disease, and presence of specific comorbid conditions. Specific usage must strictly follow the doctor's instructions.
Pre-Treatment Testing
Before initiating treatment, all patients must undergo testing for hepatitis B virus (HBV) infection. This involves measuring hepatitis B surface antigen (HBsAg) and hepatitis B core antibody (anti-HBc) to confirm the presence of current or past HBV infection.
Recommended Treatment Regimens and Durations
(Applicable to patients aged 3 years and older with genotype 1, 2, 3, 4, 5, or 6 HCV infection)
Patients with No Cirrhosis or Compensated Cirrhosis (Child-Pugh Class A)
Including treatment-naive patients and treatment-experienced patients (treatment-experienced patients refer to those who received treatment in clinical trials with regimens containing pegylated interferon alfa/ribavirin, with or without HCV NS3/4A protease inhibitors such as boceprevir, simeprevir, or telaprevir).
Recommended regimen: Epclusa administered alone.
Treatment duration: 12 weeks.
Patients with Decompensated Cirrhosis (Child-Pugh Class B or C)
Including treatment-naive and treatment-experienced patients (definition of treatment-experienced same as above).
Recommended regimen: Epclusa in combination with ribavirin.
Treatment duration: 12 weeks.
Patients with HCV/HIV-1 Coinfection
The treatment regimen and duration follow the recommendations for patients with the corresponding cirrhosis status mentioned above:
Patients with no cirrhosis or compensated cirrhosis: Epclusa alone for 12 weeks.
Patients with decompensated cirrhosis: Epclusa combined with ribavirin for 12 weeks.
Post-Liver Transplant Patients
For treatment-naive and treatment-experienced liver transplant recipients with no cirrhosis or compensated cirrhosis (Child-Pugh Class A):
Recommended regimen: Epclusa administered once daily.
Treatment duration: 12 weeks.
Dosage for Adults
Epclusa Dosage
Recommended dose: 1 tablet taken orally once daily. Each tablet contains 400 mg sofosbuvir and 100 mg velpatasvir.
Administration: May be taken with or without food.
Ribavirin Dosage (When Used in Combination with Epclusa)
Ribavirin dosage is calculated based on body weight and must be taken with food.
Patients with body weight < 75 kg: Daily dose of 1000 mg, administered in two divided oral doses.
Patients with body weight ≥ 75 kg: Daily dose of 1200 mg, administered in two divided oral doses.
The initial dose and dose during treatment may be adjusted based on the patient’s hemoglobin level and creatinine clearance. For specific adjustment methods, refer to the prescribing information for ribavirin.
Dosage for Children Aged 3 Years and Older
(I) Epclusa Dosage
Body weight < 17 kg: Daily dose of 150 mg sofosbuvir / 37.5 mg velpatasvir. Administer one packet of 150 mg/37.5 mg oral granules; tablets are not allowed.
Body weight 17 kg to < 30 kg: Daily dose of 200 mg sofosbuvir / 50 mg velpatasvir. Option: Either one packet of 200 mg/50 mg oral granules or one 200 mg/50 mg tablet.
Body weight ≥ 30 kg: Daily dose of 400 mg sofosbuvir / 100 mg velpatasvir. Options:
Two packets of 200 mg/50 mg oral granules;
One 400 mg/100 mg tablet;
For patients unable to swallow a 400 mg/100 mg tablet: Two 200 mg/50 mg tablets.
(II) Ribavirin Dosage (When Used in Combination with Epclusa)
Body weight < 47 kg: Daily dose of 15 mg/kg, administered in two divided doses (morning and evening).
Body weight 47–49 kg: Daily dose of 600 mg (200 mg in the morning [1 tablet of 200 mg strength] and 400 mg in the evening [2 tablets of 200 mg strength]).
Body weight 50–65 kg: Daily dose of 800 mg (400 mg in the morning and 400 mg in the evening; 2 tablets of 200 mg strength each time).
Body weight 66–80 kg: Daily dose of 1000 mg (400 mg in the morning [2 tablets of 200 mg strength] and 600 mg in the evening [3 tablets of 200 mg strength]).
Body weight > 80 kg: Daily dose of 1200 mg (600 mg in the morning and 600 mg in the evening; 3 tablets of 200 mg strength each time).
Preparation and Administration of Oral Granules
The preparation and administration of Epclusa oral granules must strictly follow the Instructions for Use.
Do not chew the oral granules, as this may cause a bitter taste.
Granules may be taken directly by mouth or mixed with food (children under 6 years of age must take granules mixed with food).
If mixed with food: Sprinkle the granules on 1 teaspoon or more of non-acidic soft food (e.g., pudding, chocolate syrup, ice cream) at room temperature or cooler. The mixture must be consumed within 15 minutes of preparation, and chewing is not allowed during administration.
Dosage Adjustment for Special Populations
(I) Patients with Renal Impairment
Including patients with end-stage renal disease (ESRD) requiring dialysis: No dosage adjustment of Epclusa is needed. The treatment regimen and duration still follow the recommendations for patients with the corresponding cirrhosis status. If ribavirin is used in combination, refer to the prescribing information for ribavirin for dosage adjustment (for patients with creatinine clearance ≤ 50 mL/min).
(II) Other Special Populations
Dosage adjustments for post-liver transplant patients and patients with HCV/HIV-1 coinfection have been specified in the "Recommended Treatment Regimens and Durations" section; no additional dosage adjustments are required.
Currently, there is no safety data available for children under 3 years of age or children with severe renal impairment, and the relevant dosage regimens remain unclear.
