Generic name: ELBASVIR 50mg, GRAZOPREVIR 100mg
Dosage form: tablet, film coated
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Testing Prior to the Initiation of Therapy
NS5A Resistance Testing in HCV Genotype 1a-Infected Patients
Testing patients with HCV genotype 1a infection for the presence of virus with NS5A resistance-associated polymorphisms is recommended prior to initiation of treatment with ZEPATIER to determine dosage regimen and duration [see Dosage and Administration (2.2)], Table 1. In subjects receiving ZEPATIER for 12 weeks, sustained virologic response (SVR12) rates were lower in genotype 1a-infected patients with one or more baseline NS5A resistance-associated polymorphisms at amino acid positions 28, 30, 31, or 93 [see Microbiology (12.4)], Table 11.
Hepatic Laboratory Testing
Obtain hepatic laboratory testing prior to and during treatment with ZEPATIER [see Warnings and Precautions (5.1)].
Recommended Dosage in Adults
ZEPATIER is a two-drug, fixed-dose combination product containing 50 mg of elbasvir and 100 mg of grazoprevir in a single tablet. The recommended dosage of ZEPATIER is one tablet taken orally once daily with or without food [see Clinical Pharmacology (12.3)]. ZEPATIER is used in combination with ribavirin in certain patient populations (see Table 1). When administered with ZEPATIER, the recommended dosage of ribavirin in patients without renal impairment is weight-based administered in two divided doses with food. For further information on ribavirin dosing and dosage modifications, refer to the ribavirin prescribing information.
Treatment Regimen and Duration of Therapy
Relapse rates are affected by baseline host and viral factors and differ between treatment regimens and durations for certain subgroups [see Clinical Studies (14)].
Table 1 below provides the recommended ZEPATIER treatment regimen and duration based on the patient population and genotype in HCV mono-infected and HCV/HIV-1 co-infected patients with or without cirrhosis and with or without renal impairment including patients receiving hemodialysis.
|Genotype 1a: Treatment-naïve or PegIFN/RBV-experienced* without baseline NS5A polymorphisms†||ZEPATIER||12 weeks|
|Genotype 1a: Treatment-naïve or PegIFN/RBV-experienced* with baseline NS5A polymorphisms†||ZEPATIER + RBV‡||16 weeks|
|Genotype 1b: Treatment-naïve or PegIFN/RBV-experienced*||ZEPATIER||12 weeks|
|Genotype 1a§ or 1b: PegIFN/RBV/PI-experienced¶||ZEPATIER + RBV‡||12 weeks|
|Genotype 4: Treatment-Naïve||ZEPATIER||12 weeks|
|Genotype 4: PegIFN/RBV-experienced*||ZEPATIER + RBV‡||16 weeks|
No dosage adjustment of ZEPATIER is recommended in patients with any degree of renal impairment including patients on hemodialysis. Administer ZEPATIER with or without ribavirin according to the recommendations in Table 1[see Use in Specific Populations (8.8) and Clinical Studies (14.4)]. Refer to the ribavirin tablet prescribing information for the correct ribavirin dosage for patients with CrCl less than or equal to 50 mL per minute.
No dosage adjustment of ZEPATIER is recommended in patients with mild hepatic impairment (Child-Pugh A). ZEPATIER is contraindicated in patients with moderate or severe hepatic impairment (Child-Pugh B or C) [see Contraindications (4), Use in Specific Populations (8.9), and Clinical Pharmacology (12.3)].
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