CGOVIR

CGOVIR
Packing4 blister packs of 7 tablets/1 bottle of 28 tablets
Shelf life36 months
CompositionSofosbuvir 400 mg
Posology and pharmaceutical formFilm-coated tablet

Summary of product characteristic

Indications, posology and method of administration

THERAPEUTIC INDICATIONS
Sofosbuvir is indicated in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adults and adolescents aged 12 to 18 years.
For hepatitis C virus (HCV) genotype specific activity, see the pharmacology section.
POSOLOGY AND METHOD OF ADMINISTRATION
Sofosbuvir treatment should be initiated and monitored by a physician experienced in the management of patients with CHC.
Posology:
Adults:
The recommended dose of sofosbuvir is one 400 mg tablet, taken orally, once daily with food .
Sofosbuvir should be used in combination with other medicinal products. Monotherapy of sofosbuvir is not recommended. Refer also to the summary of product characteristics of the medicinal products that are used in combination with sofosbuvir. The recommended co-administered medicinal product(s) and treatment duration for sofosbuvir combination therapy are provided in Table 1.
Table 1: Recommended co-administered medicinal product(s) and treatment duration for adults treated with sofosbuvir combination therapy

Patient population*	Treatment	Duration
Patients with genotype 1, 4, 5 or 6 CHC	Sofosbuvir + ribavirin + peginterferon alfa	12 weeksa,b
Patients with genotype 1, 4, 5 or 6 CHC	Sofosbuvir + ribavirin Only for use in patients ineligible or intolerant to peginterferon alfa	24 weeks
Patients with genotype 2 CHC	Sofosbuvir + ribavirin	12 weeksb
Patients with genotype 3 CHC	Sofosbuvir + ribavirin + peginterferon alfa	12 weeksb
Patients with genotype 3 CHC	Sofosbuvir + ribavirin	24 weeks
Patients with CHC awaiting liver transplantation	Sofosbuvir + ribavirin	Until liver transplantationc

* Includes patients co-infected with human immunodeficiency virus (HIV).
a. For previously treated patients with HCV genotype 1 infection, no data exists with the combination of sofosbuvir, ribavirin and peginterferon alfa.
b. Consideration should be given to potentially extending the duration of therapy beyond 12 weeks and up to 24 weeks; especially for those subgroups who have one or more factors historically associated with lower response rates to interferon-based therapies (e.g. advanced fibrosis/cirrhosis, high baseline viral concentrations, prior null response to peginterferon alfa and ribavirin therapy).
c. See Special patient populations below.
The dose of ribavirin when used in combination with sofosbuvir depends on body weight (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) and dministered orally in two divided doses with food.
Regarding simultaneous use with other direct-acting antiviral drugs in patients with chronic hepatitis C, see the warnings and precautions section.
Dose modification in adults:
Dose reduction of sofosbuvir is not recommended.
If sofosbuvir is used in combination with peginterferon alfa, and a patient has a serious adverse reaction potentially related to this medicinal product, the peginterferon alfa dose should be reduced or discontinued. Refer to the peginterferon alfa summary of product characteristics for additional information about how to reduce and/or discontinue the peginterferon alfa dose.
If a patient has a serious adverse reaction potentially related to ribavirin, the ribavirin dose should be modified or discontinued, if appropriate, until the adverse reaction abates or decreases in severity. Table 2 provides guidelines for dose modifications and discontinuation based on the patient's haemoglobin concentration and cardiac status.
Table 2: Ribavirin dose modification guideline for co-administration with sofosbuvir in adults

Laboratory values	Reduce ribavirin dose to 600 mg/day if:	Discontinue ribavirin if:
Haemoglobin in patients with no cardiac disease	< 10 g/dL	< 8,5 g/dL
Haemoglobin in patients with history of stable cardiac disease	≥ 2 g/dL decrease in haemoglobin during any 4 week treatment period	< 12 g/dL despite 4 weeks at reduced dose

Once ribavirin has been withheld due to either a laboratory abnormality or clinical manifestation, an attempt may be made to restart ribavirin at 600 mg daily and further increase the dose to 800 mg daily. However, it is not recommended that ribavirin be increased to the original assigned dose (1,000 mg to 1,200 mg daily).
Adolescents aged 12 to 18 years:
The recommended dose of sofosbuvir is one 400 mg tablet, taken orally, once daily with food.
Sofosbuvir needs to be used in combination with other medications. Treatment with sofosbuvir alone is not recommended. The recommended regimen and treatment duration for sofosbuvir and the combination drugs are shown in Table 3 and Table 4.
Table 3: The recommended regimen and treatment duration for adolescents aged 12 to 18 years receiving sofosbuvir.

Patient population*	Treatment and duration
Patients with genotype 2 CHC	Sofosbuvir + ribavirina for 12 weeksb
Patients with genotype 3 CHC	Sofosbuvir + ribavirina for 24 weeks

* Includes patients co-infected with human immunodeficiency virus (HIV).
a. See Table 4 for weight-based ribavirin dosing recommendations.
b. Consideration should be given to potentially extending the duration of therapy beyond 12 weeks and up to 24 weeks; especially for those subgroups who have one or more factors historically associated with lower response rates to interferon-based therapies (e.g. advanced fibrosis/cirrhosis, high baseline viral concentrations, prior null response to peginterferon alfa and ribavirin therapy).
Table 4: The recommended dose of ribavirin in combination treatment with sofosbuvir in adolescents aged 12 to 18 years

Body weight (kg)	Ribavirin daily dose*
<47	15 mg/kg/day
47-49	600 mg/day
50-65	800 mg/day
66-74	1000 mg/day
≥ 75	1200 mg/day

* Ribavirin is administered orally in two divided doses with food.
Dose modification in adolescents aged 12 to 18 years
Dose reduction of sofosbuvir is not recommended.
If a patient has a serious adverse reaction potentially related to ribavirin, the ribavirin dose should be modified or discontinued, if appropriate, until the adverse reaction abates or decreases in severity. Refer to the ribavirin prescribing information for guidance on dose modification or discontinuation.
Discontinuation of dosing:
If the other medicinal products used in combination with sofosbuvir are permanently discontinued, sofosbuvir should also be discontinued.
Special patient populations:
Elderly
No dose adjustment is warranted for elderly patients.
Renal impairment
No dose adjustment of sofosbuvir 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.
Hepatic impairment
No dose adjustment of sofosbuvir is required for patients with mild, moderate or severe hepatic impairment (Child-Pugh-Turcotte [CPT] class A, B or C). The safety and efficacy of sofosbuvir have not been established in patients with decompensated cirrhosis.
Patients awaiting liver transplantation
The duration of administration of sofosbuvir in patients awaiting liver transplantation should be guided by an assessment of the potential benefits and risks for the individual patient.
Adult liver transplant recipients
Sofosbuvir in combination with ribavirin is recommended for 24 weeks in liver transplant recipients. In adults a starting ribavirin dose of 400 mg administered orally in two divided doses with food is recommended. If the starting dose of ribavirin is well-tolerated, the dose can be titrated up to a maximum of 1,000 – 1,200 mg daily (1,000 mg for patients weighing <75 kg and 1,200 mg for patients weighing ≥ 75 kg). If the starting dose of ribavirin is not well-tolerated, the dose should be reduced as clinically indicated based on haemoglobin levels.
Paediatric population
The safety and efficacy of sofosbuvir in children and adolescents aged < 12 years have not yet been established. No data are available.
Method of administration:
Oral use. Patients should be instructed to swallow the tablet(s) whole and should not be chewed or crushed. The tablet(s) should be taken with food.
Patients should be instructed that if vomiting occurs within 2 hours of dosing an additional dose should be taken. If vomiting occurs more than 2 hours after dosing, no further dose is needed. These recommendations are based on the absorption kinetics of sofosbuvir and GS-331007 suggesting that the majority of the dose is absorbed within 2 hours after dosing.
If a dose is missed and it is within 18 hours of the normal time, patients should be instructed to take the dose 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 at the usual time. Patients should be instructed not to take a double dose.
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients.
Use with strong P-gp inducers:
Medicinal products that are strong P-glycoprotein (P-gp) inducers in the intestine (Rifampicin, St. John's wort [Hypericum perforatum], carbamazepine và phenytoin). Co-administration will significantly decrease sofosbuvir plasma concentration and could result in loss of efficacy of sofosbuvir.

This information is for reference only. Please read the leaflet inside.

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