Posology : מינונים

4.2.      Posology and method of administration

Maviret treatment should be initiated and monitored by a physician experienced in the management of patients with HCV infection.

Posology

Adults and adolescents aged 12 to <18 years
The recommended dose of Maviret is 300 mg/120 mg (three 100 mg/40 mg tablets), taken orally, once daily at the same time with food (see section 5.2).


MAV API APR 22_CL                                                                            Page 1 of 25 The recommended Maviret treatment durations for HCV genotype 1, 2, 3, 4, 5, or 6 infected patients with compensated liver disease (with or without cirrhosis) are provided in Table 1 and Table 2.

Table 1: Recommended Maviret treatment duration for patients without prior HCV therapy 
Recommended treatment duration
Genotype
No cirrhosis         Cirrhosis
GT 1, 2, 3, 4, 5, 6   8 weeks              8 weeks

Table 2: Recommended Maviret treatment duration for patients who failed prior therapy with peg-IFN + ribavirin +/- sofosbuvir, or sofosbuvir + ribavirin

Genotype         Recommended treatment duration
No cirrhosis         Cirrhosis
GT 1, 2, 4-6     8 weeks              12 weeks
GT 3             16 weeks             16 weeks

For patients who failed prior therapy with an NS3/4A- and/or an NS5A inhibitor, see section 4.4.

Missed dose
In case a dose of Maviret is missed, the prescribed dose can be taken within 18 hours after the time it was supposed to be taken. If more than 18 hours have passed since Maviret is usually taken, the missed dose should not be taken and the patient should take the next dose per the usual dosing schedule. Patients should be instructed not to take a double dose.

If vomiting occurs within 3 hours of dosing, an additional dose of Maviret should be taken. If vomiting occurs more than 3 hours after dosing, an additional dose of Maviret is not needed.

Elderly
No dose adjustment of Maviret is required in elderly patients (see sections 5.1 and 5.2).

Renal impairment
No dose adjustment of Maviret is required in patients with any degree of renal impairment including patients on dialysis (see sections 5.1 and 5.2).

Hepatic impairment
No dose adjustment of Maviret is required in patients with mild hepatic impairment (Child-Pugh A).
Maviret is contraindicated in patients with moderate or severe hepatic impairment (Child-Pugh B or C) or those with any history of prior hepatic decompensation (see sections 4.3, 4.4, and 5.2).

Liver or kidney transplant patients
A 12-week treatment duration has been evaluated and is recommended in liver or kidney transplant recipients with or without cirrhosis (see section 5.1). A 16-week treatment duration should be considered in genotype 3-infected patients who are treatment-experienced with peg-IFN + ribavirin +/- sofosbuvir, or sofosbuvir + ribavirin.

Patients with HIV-1 co-infection
Follow the dosing recommendations in Tables 1 and 2. For dosing recommendations with HIV antiviral agents, refer to section 4.5.


MAV API APR 22_CL                                                                            Page 2 of 25 Paediatric population
No dose adjustment of Maviret is required in adolescents aged 12 to <18 years (see sections 5.1 and 5.2). The safety and efficacy of Maviret in children aged less than 12 years have not yet been established. No data are available.

Method of administration

For oral use.
Patients should be instructed to swallow tablets whole with food and not to chew, crush or break the tablets as it may alter the bioavailability of the agents (see section 5.2).