Sovaldi Access

SOVALDI ACCESS- sofosbuvir tablet, film coated
Gilead Sciences, Inc.

1 INDICATIONS AND USAGE

Adult Patients:

SOVALDI is indicated for the treatment of adult patients with chronic hepatitis C virus (HCV) infection as a component of a combination antiviral treatment regimen [see Dosage and Administration (2.2), and Clinical Studies (14)]

• genotype 1 or 4 infection without cirrhosis or with compensated cirrhosis for use in combination with pegylated interferon and ribavirin
• genotype 2 or 3 infection without cirrhosis or with compensated cirrhosis for use in combination with ribavirin.

Pediatric Patients:

SOVALDI is indicated for the treatment of chronic HCV genotype 2 or 3 infection in pediatric patients 12 years of age and older or weighing at least 35 kg without cirrhosis or with compensated cirrhosis for use in combination with ribavirin [see Dosage and Administration (2.3) and Clinical Studies (14.5)] .

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 SOVALDI [see Warnings and Precautions (5.1)] .

2.2 Recommended Dosage in Adults

The recommended dosage of SOVALDI is one 400 mg tablet, taken orally, once daily with or without food [see Clinical Pharmacology (12.3)] .

Administer SOVALDI in combination with ribavirin or in combination with pegylated interferon and ribavirin for the treatment of HCV. The recommended treatment regimen and duration for SOVALDI combination therapy is provided in Table 1.

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

Table 1 Recommended Treatment Regimen and Duration in Adult Patients with Genotype 1, 2, 3, or 4 HCV

	Patient Population	Treatment Regimen and Duration
* See peginterferon alfa prescribing information for dosage recommendation for patients with genotype 1 or 4 HCV. † Dosage of ribavirin is weight-based (<75 kg = 1000 mg and ≥75 kg = 1200 mg). The daily dosage of ribavirin is administered orally in two divided doses with food. Patients with renal impairment (CrCl ≤50 mL/min) require ribavirin dosage reduction; refer to ribavirin prescribing information. ‡ Treatment-experienced patients have failed an interferon based regimen with or without ribavirin.
Genotype 1 or 4	Treatment-naïve without cirrhosis or with compensated cirrhosis (Child-Pugh A)	SOVALDI + peginterferon alfa * + ribavirin † 12 weeks
Genotype 2	Treatment-naïve and treatment-experienced ‡ without cirrhosis or with compensated cirrhosis (Child-Pugh A)	SOVALDI + ribavirin † 12 weeks
Genotype 3	Treatment-naïve and treatment-experienced ‡ without cirrhosis or with compensated cirrhosis (Child-Pugh A)	SOVALDI + ribavirin † 24 weeks

Patients with Genotype 1 HCV Who are Ineligible to Receive an Interferon-Based Regimen

SOVALDI in combination with ribavirin for 24 weeks can be considered as a therapeutic option for patients with genotype 1 infection who are ineligible to receive an interferon-based regimen [see Clinical Studies (14.4)] . Treatment decision should be guided by an assessment of the potential benefits and risks for the individual patient.

Patients with Hepatocellular Carcinoma Awaiting Liver Transplantation

Administer SOVALDI in combination with ribavirin for up to 48 weeks or until the time of liver transplantation, whichever occurs first, to prevent post-transplant HCV reinfection [see Use in Specific Populations (8.8)] .

2.3 Recommended Dosage in Pediatric Patients 12 Years of Age and Older or Weighing at Least 35 kg

The recommended dosage of SOVALDI in pediatric patients 12 years of age and older or weighing at least 35 kg is one 400 mg tablet taken orally once daily with or without food in combination with ribavirin [see Clinical Pharmacology (12.3) and Clinical Studies (14.5)] .

The recommended treatment regimen and duration for SOVALDI combination therapy is provided in Table 2. Table 3 provides the weight-based dosage of ribavirin when used in combination with SOVALDI for pediatric patients. For patients with HCV/HIV-1 coinfection, follow the dosage recommendations in Table 2 and Table 3. Refer to Drug Interactions (7) for dosage recommendations for concomitant HIV-1 antiviral drugs.

Table 2 Recommended Treatment Regimen and Duration in Pediatric Patients 12 Years of Age and Older or Weighing at Least 35 kg

	Patient Population	Treatment Regimen And Duration
* Treatment-experienced patients have failed an interferon based regimen with or without ribavirin. † See Table 3 for weight-based ribavirin dosing recommendations.
Genotype 2	Treatment-naïve and treatment-experienced * without cirrhosis or with compensated cirrhosis (Child-Pugh A)	SOVALDI + ribavirin † 12 weeks
Genotype 3	Treatment-naïve and treatment-experienced * without cirrhosis or with compensated cirrhosis (Child-Pugh A)	SOVALDI + ribavirin † 24 weeks

Table 3 Recommended Dosing for Ribavirin in Combination Therapy with SOVALDI for Pediatric Patients 12 Years of Age and Older or Weighing at Least 35 kg

Body Weight kg	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/kg/day
47–49	600 mg/day
50–65	800 mg/day
66–80	1000 mg/day
greater than 80	1200 mg/day