Each film-coated tablet contains 50 mg elbasvir and 100 mg grazoprevir.
Excipients with known effect
Each film-coated tablet contains 87.02 mg of lactose (as monohydrate) and 3.04 mmol (or 69.85 mg) of sodium.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet.
Beige, oval tablet of dimensions 21 mm x 10 mm debossed with “770” on one side and plain on the other.
4. Clinical particulars
4.1 Therapeutic indications
ZEPATIER is indicated for the treatment of chronic hepatitis C (CHC) in adults (see sections 4.2, 4.4 and 5.1).
For hepatitis C virus (HCV) genotype-specific activity see sections 4.4 and 5.1.
4.2 Posology and method of administration
ZEPATIER treatment should be initiated and monitored by a physician experienced in the management of patients with CHC.
Posology
The recommended dose is one tablet once daily.
Recommended regimens and treatment durations are provided in Table 1 below (see sections 4.4 and 5.1):
Table 1: Recommended ZEPATIER therapy for treatment of chronic hepatitis C infection in patients with or without compensated cirrhosis (Child-Pugh A only)
HCV genotype
Treatment and duration
1a
ZEPATIER for 12 weeks
ZEPATIER for 16 weeks plus ribavirinA should be considered in patients with baseline HCV RNA level >800,000 IU/ml and/or the presence of specific NS5A polymorphisms causing at least a 5-fold reduction in activity of elbasvir to minimise the risk of treatment failure (see section 5.1).
