Drug Detail:Epclusa (Sofosbuvir and velpatasvir [ soe-fos-bue-vir-and-vel-pat-as-vir ])
Generic Name: VELPATASVIR 100mg, SOFOSBUVIR 400mg
Dosage Form: tablet, film coated
Drug Class: Antiviral combinations
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.
| Patient Population | Treatment Regimen and Duration |
|---|---|
|
|
| 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)].
| Body Weight (kg) | EPCLUSA Daily Dose | Dosing of EPCLUSA Oral Pellets | Dosing of EPCLUSA 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* |
| Body Weight (kg) | Oral Ribavirin Daily Dosage* |
|---|---|
|
|
| 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.
