Epclusa Dosage

Generic name: VELPATASVIR 100mg, SOFOSBUVIR 400mg
Dosage form: tablet, film coated
Drug class: Antiviral combinations

Medically reviewed by Drugs.com. Last updated on Apr 22, 2024.

Testing Prior to the Initiation of Therapy

Test all patients for evidence of current or prior HBV infection by measuring hepatitis B surface antigen (HBsAg) and hepatitis B core antibody (anti-HBc) before initiating HCV treatment with EPCLUSA [see Warnings and Precautions (5.1)].

Recommended Treatment Regimen and Duration in Patients 3 Years of Age and Older

Table 1 shows the recommended treatment regimen and duration based on patient population.

For patients with HCV/HIV-1 coinfection follow the dosage recommendations in Table 1. For treatment-naïve and treatment-experienced liver transplant recipients without cirrhosis or with compensated cirrhosis (Child-Pugh A), the recommended regimen is EPCLUSA once daily for 12 weeks [see Clinical Studies (14.3 and 14.5)]. Refer to Drug Interactions (7) for dosage recommendations for concomitant drugs.

Table 1 Recommended Treatment Regimen and Duration in Patients 3 Years of Age and Older with Genotype 1, 2, 3, 4, 5, or 6 HCV
Patient Population	Treatment Regimen and Duration
* In clinical trials in adults, regimens contained peginterferon alfa/ribavirin with or without an HCV NS3/4A protease inhibitor (boceprevir, simeprevir, or telaprevir). † See Dosage and Administration 2.3 and 2.4 for ribavirin dosage recommendations.
Treatment-naïve and treatment-experienced*, without cirrhosis and with compensated cirrhosis (Child-Pugh A)	EPCLUSA 12 weeks
Treatment-naïve and treatment-experienced*, with decompensated cirrhosis (Child-Pugh B or C)	EPCLUSA + ribavirin† 12 weeks

Recommended Dosage in Adults

The recommended dosage of EPCLUSA in adults is one tablet (400 mg sofosbuvir and 100 mg velpatasvir) taken orally once daily with or without food [see Clinical Pharmacology (12.3)].

When administered with EPCLUSA, the recommended dosage of ribavirin is based on weight (administered with food): 1,000 mg per day for patients less than 75 kg and 1,200 mg for those weighing at least 75 kg, divided and administered twice daily. The starting dosage and on-treatment dosage of ribavirin can be decreased based on hemoglobin and creatinine clearance. For ribavirin dosage modifications refer to the ribavirin prescribing information [see Use in Specific Populations (8.6) and Clinical Studies (14.4)].

Recommended Dosage in Pediatric Patients 3 Years of Age and Older

The recommended dosage of EPCLUSA in pediatric patients 3 years of age and older is based on weight and provided in Table 2. Table 3 provides the weight-based dosage of ribavirin when used in combination with EPCLUSA for pediatric patients. Take EPCLUSA oral pellets or tablets once daily with or without food. In pediatric patients less than 6 years of age, administer the oral pellets with food to increase tolerability related to palatability [see Use in Specific Populations (8.4), Clinical Pharmacology (12.3), and Clinical Studies (14.8)].

Table 2 Dosing for Pediatric Patients 3 Years and Older with Genotype 1, 2, 3, 4, 5, or 6 HCV Using EPCLUSA Oral Pellets or Tablets
Body Weight (kg)	EPCLUSA Daily Dose	Dosing of EPCLUSA Oral Pellets	Dosing of EPCLUSA Tablet
* Two 200 mg/50 mg tablets once daily can be used for patients who cannot swallow the 400 mg/100 mg tablet.
less than 17	150 mg/37.5 mg per day	one 150 mg/37.5 mg packet of pellets once daily	N/A
17 to less than 30	200 mg/50 mg per day	one 200 mg/50 mg packet of pellets once daily	one 200 mg/50 mg tablet once daily
at least 30	400 mg/100 mg per day	two 200 mg/50 mg packets of pellets once daily	one 400 mg/100 mg tablet once daily*

Table 3 Recommended Dosing for Ribavirin in Combination Therapy with EPCLUSA for Pediatric Patients 3 Years and Older
Body Weight (kg)	Oral Ribavirin Daily Dosage*
* The daily dosage of ribavirin is weight-based and is administered orally in two divided doses with food.
less than 47	15 mg per kg per day (divided dose AM and PM)
47–49	600 mg per day (1 × 200 mg AM, 2 × 200 mg PM)
50–65	800 mg per day (2 × 200 mg AM, 2 × 200 mg PM)
66–80	1,000 mg per day (2 × 200 mg AM, 3 × 200 mg PM)
greater than 80	1,200 mg per day (3 × 200 mg AM, 3 × 200 mg PM)

Preparation and Administration of Oral Pellets

See the EPCLUSA oral pellets full Instructions for Use for details on the preparation and administration of EPCLUSA oral pellets.

Do not chew EPCLUSA oral pellets to avoid a bitter aftertaste. EPCLUSA oral pellets can be taken directly in the mouth or with food (See Instructions for Use). In pediatric patients less than 6 years of age, administer the oral pellets with food to increase tolerability related to palatability. Sprinkle the oral pellets on one or more spoonfuls of non-acidic soft food at or below room temperature. Examples of non-acidic foods include pudding, chocolate syrup, and ice cream. Take EPCLUSA oral pellets within 15 minutes of gently mixing with food and swallow the entire contents without chewing.

Renal Impairment

No dosage adjustment of EPCLUSA is recommended in patients with any degree of renal impairment, including patients requiring dialysis. Administer EPCLUSA with or without ribavirin according to the recommendations in Table 1 [see Adverse Reactions (6.1), Use in Specific Populations (8.6), and Clinical Studies (14.6)]. Refer to ribavirin tablet prescribing information for ribavirin dosage modification for patients with CrCl less than or equal to 50 mL per minute.