Vosevi Dosage/Direction for Use

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 Pharmacology: Pharmacokinetics under Actions).
The recommended durations of treatment applicable to all HCV genotypes are shown in Table 13. (See Table 13.)

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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 dose of Vosevi should be taken. If vomiting occurs more than 4 hours after dosing, no further dose of Vosevi is needed (see Pharmacology: Pharmacodynamics under Actions).
Elderly: No dose adjustment is warranted for elderly patients (see Pharmacology: Pharmacokinetics under Actions).
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 Pharmacology: Pharmacodynamics and Pharmacokinetics under Actions, Precautions, and Adverse Reactions).
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 Pharmacology: Pharmacokinetics under Actions). Postmarketing cases of hepatic decompensation/failure have been reported in these patients (see Precautions).
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 Pharmacology: Pharmacokinetics under Actions). Due to the bitter taste, it is recommended that the film-coated tablet is not chewed or crushed.