Posology : מינונים

4.2     Posology and method of administration

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

Posology

The recommended dose of Vosevi is one tablet, taken orally, once daily with food (see section 5.2).
The recommended durations of treatment applicable to all HCV genotypes are shown in Table 1.

Table 1: Recommended treatment durations for Vosevi for all HCV genotypes Patient population                                   Treatment duration 
DAA naïve patients without cirrhosis                                 8 weeks 
12 weeks
DAA naïve patients with compensated cirrhosis
8 weeks may be considered in genotype 3 infected patients (see section 5.1)
DAA experienced patients* without cirrhosis or with
12 weeks compensated cirrhosis
DAA: direct-acting antiviral agent

* In clinical studies the DAA experienced patients had been exposed to combination regimens containing any of the following: daclatasvir, dasabuvir, elbasvir, grazoprevir, ledipasvir, ombitasvir, paritaprevir, sofosbuvir, velpatasvir, voxilaprevir (administered with sofosbuvir and velpatasvir for less than 12 weeks) 
Missed dose
If a dose of Vosevi is missed and it is within 18 hours of the normal time, patients should be instructed to take the tablet as soon as possible and then patients should take the next dose at the usual time. If it is after 18 hours then patients should be instructed to wait and take the next dose of Vosevi at the usual time. Patients should be instructed not to take a double dose of Vosevi.

Patients should be instructed that if vomiting occurs within 4 hours of dosing an additional tablet of Vosevi should be taken. If vomiting occurs more than 4 hours after dosing, no further dose of Vosevi is needed (see section 5.1).

Elderly
No dose adjustment is warranted for elderly patients (see section 5.2).

Renal impairment
No dose adjustment of Vosevi is required for patients with mild or moderate renal impairment.
Safety data are limited in patients with severe renal impairment (estimated Glomerular Filtration Rate [eGFR] < 30 mL/min/1.73 m2) and end stage renal disease (ESRD) requiring haemodialysis. Vosevi has not been studied in patients with ESRD requiring dialysis. Vosevi can be used in these patients with no dose adjustment when no other relevant treatment options are available (see section 4.4, 4.8, 5.1 and 5.2).

Vosevi has not been studied in patients with severe renal impairment not requiring dialysis.

Hepatic impairment
No dose adjustment of Vosevi is required for patients with mild hepatic impairment (Child-Pugh- Turcotte [CPT] Class A). Vosevi is not recommended in patients with moderate or severe hepatic impairment (CPT Class B or C) (see section 5.2).

Paediatric population
The safety and efficacy of Vosevi in children and adolescents aged less than 18 years have not yet been established. No data are available.

Method of administration

For oral use.
Patients should be instructed to swallow the tablet whole with food (see section 5.2). Due to the bitter taste, it is recommended that the film-coated tablet is not chewed or crushed.