Sofosbuvir and velpatasvir
Dosing in kidney impairment
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 , Use in Specific Populations , and Clinical Studies ]. Refer to ribavirin tablet prescribing information for ribavirin dosage modification for patients with CrCl less than or equal to 50 mL per minute.
Dosing in liver impairment
Hepatic Impairment No dosage adjustment of EPCLUSA is recommended for patients with mild, moderate, or severe hepatic impairment (Child-Pugh Class A, B, or C) [see Adverse Reactions , Clinical Pharmacology , and Clinical Studies ]. Clinical and hepatic laboratory monitoring (including direct bilirubin), as clinically indicated, is recommended for patients with decompensated cirrhosis receiving treatment with EPCLUSA and ribavirin [see Adverse Reactions ].
| Patient Population | Regimen and Duration |
|---|---|
| Treatment-naïve and treatment-experiencedIn clinical trials, regimens contained peginterferon alfa/ribavirin with or without an HCV NS3/4A protease inhibitor (boceprevir, simeprevir, or telaprevir)., without cirrhosis and with compensated cirrhosis (Child-Pugh A) | EPCLUSA 12 weeks |
| Treatment-naïve and treatment-experienced, with decompensated cirrhosis (Child-Pugh B and C) | EPCLUSA + ribavirin 12 weeks |
| Patient Population | Treatment Regimen and Duration |
|---|---|
| Treatment-naïve and treatment-experiencedIn clinical trials in adults, regimens contained peginterferon alfa/ribavirin with or without an HCV NS3/4A protease inhibitor (boceprevir, simeprevir, or telaprevir)., 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 + ribavirinSee Dosage and Administration 2.3 and 2.4 for ribavirin dosage recommendations. 12 weeks |
Preparation and administration
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.