Drug Detail:Sovaldi (Sofosbuvir [ soe-fos-bue-vir ])
Generic Name: SOFOSBUVIR 400mg
Dosage Form: tablet, film coated
Drug Class: Miscellaneous antivirals
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)].
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.
| Patient Population | Treatment Regimen and Duration | |
|---|---|---|
|
||
| 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.
Recommended Dosage in Pediatric Patients 3 Years of Age and Older with Genotype 2 or 3 HCV
The recommended treatment regimen, duration, and recommended dosage for SOVALDI combination therapy is provided in Table 2 and Table 3. Table 4 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 3 and Table 4. Refer to Drug Interactions (7) for dosage recommendations for concomitant HIV-1 antiviral drugs. In pediatric 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)].
| | Patient Population | Treatment Regimen and Duration |
|---|---|---|
|
||
| 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 |
The recommended dosage of SOVALDI in pediatric patients 3 years and older with genotype 2 or 3 HCV using SOVALDI tablets or oral pellets (with or without food) is based on weight (Table 3), and is to be taken orally once daily in combination with ribavirin [see Dosage and Administration (2.4), Use in Specific Populations (8.4), Clinical Pharmacology (12.3), and Clinical Studies (14.5)]. SOVALDI pellets can be taken by pediatric patients who cannot swallow the tablet formulation [see Dosage and Administration (2.4)].
| Body Weight (kg) | Dosing of SOVALDI Tablets or Oral Pellets | SOVALDI Daily Dose |
|---|---|---|
| at least 35 | one 400 mg tablet once daily or two 200 mg tablets once daily or two 200 mg packets of pellets once daily |
400 mg per day |
| 17 to less than 35 | one 200 mg tablet once daily or one 200 mg packet of pellets once daily |
200 mg per day |
| less than 17 | one 150 mg packet of pellets once daily | 150 mg per day |
| 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 | 1000 mg per day (2 × 200 mg AM, 3 × 200 mg PM) |
| greater than 80 | 1200 mg per day (3 × 200 mg AM, 3 × 200 mg PM) |
Preparation and Administration of Oral Pellets
See the SOVALDI oral pellets full Instructions for Use for details on the preparation and administration of SOVALDI pellets.
Do not chew SOVALDI pellets. If SOVALDI pellets are administered with food, sprinkle the 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, mashed potato, and ice cream. Take SOVALDI pellets within 30 minutes of gently mixing with food and swallow the entire contents without chewing to avoid a bitter aftertaste.
Dosage Modification
Dosage reduction of SOVALDI is not recommended.
If a patient has a serious adverse reaction potentially related to peginterferon alfa and/or ribavirin, the peginterferon alfa and/or ribavirin dosage should be reduced or discontinued, if appropriate, until the adverse reaction abates or decreases in severity. Refer to the peginterferon alfa and ribavirin prescribing information for additional information about how to reduce and/or discontinue the peginterferon alfa and/or ribavirin dosage.
Discontinuation of Dosing
If the other agents used in combination with SOVALDI are permanently discontinued, SOVALDI should also be discontinued.
Severe Renal Impairment and End Stage Renal Disease
No dosage recommendation can be given for patients with severe renal impairment (estimated Glomerular Filtration Rate [eGFR] less than 30 mL/min/1.73m2) or with end stage renal disease (ESRD) due to higher exposures (up to 20-fold) of the predominant sofosbuvir metabolite [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].
