Vosevi 400 mg/100 mg/100 mg film coated tablets
Gilead Sciences Ltd
contact details
Active ingredient
sofosbuvir
velpatasvir
voxilaprevir
Legal Category
POM: Prescription only medicine
Vosevi 400 mg/100 mg/100 mg film-coated tablets
Each film-coated tablet contains 400 mg sofosbuvir, 100 mg velpatasvir and 100 mg voxilaprevir.
Excipients with known effect
Each film-coated tablet contains 111 mg of lactose (as lactose monohydrate).
For the full list of excipients, see section 6.1.
Film-coated tablet.
Beige, capsule-shaped, film-coated tablet of dimensions 10 mm x 20 mm, debossed with “GSI” on one side and “” on the other side.
Vosevi is indicated for the treatment of chronic hepatitis C virus (HCV) infection in adults (see sections 4.2, 4.4 and 5.1).
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
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Treatment duration
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DAA naïve patients without cirrhosis
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8 weeks
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DAA naïve patients with compensated cirrhosis
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12 weeks
8 weeks may be considered in genotype 3 infected patients (see section 5.1)
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DAA experienced patients* without cirrhosis or with compensated cirrhosis
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12 weeks
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DAA: direct-acting antiviral agent
* In clinical trials 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. The safety and efficacy of Vosevi has not been assessed in patients with severe renal impairment (estimated Glomerular Filtration Rate [eGFR] < 30 mL/min/1.73 m2) or end stage renal disease (ESRD) requiring haemodialysis (see section 4.4 and 5.2).
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.
Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.
Concomitant use with medicinal products that are strong P-glycoprotein (P-gp) and/or strong cytochrome P450 (CYP) inducers (e.g. rifampicin, rifabutin, St. John's wort [Hypericum perforatum], carbamazepine, phenobarbital and phenytoin) (see section 4.5).
Concomitant use with rosuvastatin or dabigatran etexilate (see section 4.5).
Concomitant use with ethinylestradiol-containing medicinal products such as combined oral contraceptives or contraceptive vaginal rings (see section 4.5).
Severe bradycardia and heart block
Cases of severe bradycardia and heart block have been observed when sofosbuvir used in combination with another DAA, is used with concomitant amiodarone with or without other medicinal products that lower heart rate. The mechanism is not established.
The concomitant use of amiodarone was limited through the clinical development of sofosbuvir plus DAAs. Cases are potentially life threatening, therefore amiodarone should only be used in patients on Vosevi when other alternative anti-arrhythmic treatments are not tolerated or are contraindicated.
Should concomitant use of amiodarone be considered necessary, it is recommended that patients are closely monitored when initiating Vosevi. Patients who are identified as being at high risk of bradyarrhythmia should be continuously monitored for 48 hours in an appropriate clinical setting.
Due to the long half-life of amiodarone, appropriate monitoring should also be carried out for patients who have discontinued amiodarone within the past few months and are to be initiated on Vosevi.
All patients receiving Vosevi in combination with amiodarone with or without other medicinal products that lower heart rate should also be warned of the symptoms of bradycardia and heart block and should be advised to seek medical advice urgently should they experience them.
HCV/HBV co-infection
There are no data on the use of Vosevi in patients with HCV/hepatitis B virus (HBV) co-infection. Cases of HBV reactivation, some of them fatal, have been reported during or after treatment with DAAs. HBV screening should be performed in all patients before initiation of treatment. HCV/HBV co-infected patients are at