Epclusa Access

EPCLUSA ACCESS- velpatasvir and sofosbuvir tablet, film coated
Gilead Sciences, Inc.

WARNING: RISK OF HEPATITIS B VIRUS REACTIVATION IN PATIENTS COINFECTED WITH HCV AND HBV

Test all patients for evidence of current or prior hepatitis B virus (HBV) infection before initiating treatment with EPCLUSA. 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)] .

1 INDICATIONS AND USAGE

EPCLUSA™ is indicated for the treatment of adults and pediatric patients 6 years of age and older or weighing at least 17 kg 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.

2 DOSAGE AND ADMINISTRATION

2.1 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)] .

2.2 Recommended Treatment Regimen and Duration in Patients 6 Years of Age and Older or Weighing at Least 17 kg

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 Refer to for dosage recommendations for concomitant HIV-1 antiviral drugs. For patients with HCV/HIV-1 coinfection, follow the dosage recommendations in Table 1 [see Clinical Studies (14.3)]. Refer to Drug Interactions (7) for dosage recommendations for concomitant HIV-1 antiviral drugs.

Table 1 Recommended Treatment Regimen and Duration in Patients 6 Years of Age and Older or Weighing at Least 17 kg 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

2.3 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 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)].

2.4 Recommended Dosage in Pediatric Patients 6 Years of Age and Older or Weighing at Least 17 kg

The recommended dosage of EPCLUSA in pediatric patients 6 years of age and older or weighing at least 17 kg 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 once daily with or without food [see Use in Specific Populations (8.4), Clinical Pharmacology (12.3), and Clinical Studies (14.6)] .

Table 2 Dosing for Pediatric Patients 6 Years and Older or Weighing at Least 17 kg with Genotype 1, 2, 3, 4, 5, or 6 HCV
Body Weight (kg) Dosing of EPCLUSA EPCLUSA Daily Dose
at least 30 one 400 mg/100 mg tablet once daily or two 200 mg/50 mg tablets once daily 400 mg/100 mg per day
17 to less than 30 one 200 mg/50 mg tablet once daily 200 mg/50 mg per day
Table 3 Recommended Dosing for Ribavirin in Combination Therapy with EPCLUSA for Pediatric Patients 6 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)

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