SOFOSBUVIR AND VELPATASVIR- velpatasvir and sofosbuvir tablet, film coated
Asegua Therapeutics LLC
Test all patients for evidence of current or prior hepatitis B virus (HBV) infection before initiating treatment with sofosbuvir and velpatasvir. HBV reactivation has been reported in HCV/HBV coinfected patients who were undergoing or had completed treatment with HCV direct acting antivirals and were not receiving HBV antiviral therapy. Some cases have resulted in fulminant hepatitis, hepatic failure, and death. Monitor HCV/HBV coinfected patients for hepatitis flare or HBV reactivation during HCV treatment and post-treatment follow-up. Initiate appropriate patient management for HBV infection as clinically indicated [see Warnings and Precautions (5.1)].
Sofosbuvir and velpatasvir is indicated for the treatment of adults and pediatric patients 3 years of age and older with chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6 infection [see Dosage and Administration (2.2, 2.3, 2.4) and Clinical Studies (14)]:
- without cirrhosis or with compensated cirrhosis
- with decompensated cirrhosis for use in combination with ribavirin.
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 sofosbuvir and velpatasvir [see Warnings and Precautions (5.1)].
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 sofosbuvir and velpatasvir 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)||Sofosbuvir and velpatasvir12 weeks|
|Treatment-naïve and treatment-experienced *, with decompensated cirrhosis (Child-Pugh B or C)||Sofosbuvir and velpatasvir + ribavirin †12 weeks|
The recommended dosage of sofosbuvir and velpatasvir 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 sofosbuvir and velpatasvir, 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)].
The recommended dosage of sofosbuvir and velpatasvir 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 sofosbuvir and velpatasvir for pediatric patients. Take sofosbuvir and velpatasvir once daily with or without food. In pediatric patients less than 6 years of age, administer the sofosbuvir and velpatasvir (EPCLUSA) oral pellets with food to increase tolerability related to palatability [see Use in Specific Populations (8.4), Clinical Pharmacology (12.3), and Clinical Studies (14.7)].
| Body Weight (kg)||Sofosbuvir and Velpatasvir Daily Dose||Dosing of Sofosbuvir and Velpatasvir (EPCLUSA) Oral Pellets||Dosing of Sofosbuvir and Velpatasvir Tablets|
| less than 17||150 mg/37.5 mg per day||one 150 mg/37.5 mg packet of Sofosbuvir and Velpatasvir (EPCLUSA) oral pellets once daily||N/A|
| 17 to less than 30||200 mg/50 mg per day||one 200 mg/50 mg packet of Sofosbuvir and Velpatasvir (EPCLUSA) oral pellets once daily||one Sofosbuvir and Velpatasvir (EPCLUSA) 200 mg/50 mg tablet once daily|
| at least 30||400 mg/100 mg per day||two 200 mg/50 mg packets of Sofosbuvir and Velpatasvir (EPCLUSA) oral pellets once daily||one Sofosbuvir and Velpatasvir 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)|
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