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Sofoveravir

Anti-infective
Product

Sofoveravir

Active

Sofosbuvir 400 mg / Ledipasvir 90 mg

Category
Anti-infective
Indication

Sofoveravir is indicated for the treatment of chronic hepatitis C (CHC) in adults and in adolescents aged 12 to < 18 years.

For hepatitis C virus (HCV) genotype-specific activity see special warnings and precautions and pharmacodynamics properties.

Dose

Sofoveravir treatment should be initiated and monitored by a physician experienced in the management of patients with CHC.

Posology

Adults and adolescents aged 12 to < 18 years

The recommended dose sofoveravir is one tablet once daily with or without food

Table 1: Recommended treatment duration for sofoveravir and the recommended use of co-administered ribavirin for certain subgroups

Table 1: Recommended treatment duration for sofoveravir and the recommended use of co-administered ribavirin for certain subgroups

Patient population

(including HIV co-infected patients)

Treatment and duration
Adult and Adolescent patients 12 years of age or older with genotype 1, 4, 5 or 6 CHC
Patients without cirrhosis Sofoveravir for 12 weeks.

sofoveravir for 8 weeks may be considered in previously untreated genotype 1-infected patients

Patients with compensated cirrhosis Sofoveravir + ribavirinA for 12 weeks

Or sofoveravir (without ribavirin) for 24 weeks.

sofoveravir (without ribavirin) for 12 weeks may be considered for patients deemed at low risk for clinical disease progression and who have subsequent retreatment options

Patients who are post-liver transplant without cirrhosis or with compensated cirrhosis Sofoveravir + ribavirinA for 12 weeks

– sofoveravir (without ribavirin) for 12 weeks (in patients without cirrhosis) or 24 weeks (in patients with cirrhosis) may be considered for patients who are ineligible for or intolerant to ribavirin.

Patients with decompensated cirrhosis irrespective of transplant status Sofoveravir + ribavirinB for 12 weeks

sofoveravir (without ribavirin) for 24 weeks may be considered in patients who are ineligible for or intolerant to ribavirin.

Adult and Adolescent patients 12 years of age or older with genotype 3 CHC
Patients with compensated cirrhosis and/or prior treatment failure Sofoveravir + ribavirinA for 24 weeks

Adults: weight based ribavirin (< 75 kg = 1,000 mg and ≥ 75 kg = 1,200 mg), administered orally in two divided doses with food. Adolescents: for ribavirin dosing recommendations see table 3 below.

For ribavirin dosing recommendations in patients with decompensated cirrhosis, see table 2 below

Table 2: Guidance for ribavirin dosing when administered with sofoveravir to patients with decompensated cirrhosis

Patient Ribavirin Dose*
Child-Pugh-Turcotte (CPT) Class B cirrhosis pre-transplant 1,000 mg per day for patients < 75 kg and 1,200 mg for those weighing ≥ 75 kg
CPT Class C cirrhosis pre-transplant

CPT Class B or C cirrhosis post-transplant

Starting dose of 600 mg, which can be titrated up to a maximum of 1,000/1,200 mg (1,000 mg for patients weighing < 75 kg and 1,200 mg for patients weighing ≥ 75 kg) if well tolerated. If the starting dose is not well tolerated, the dose should be reduced as clinically indicated based on haemoglobin levels

* – If a more normalized dose of ribavirin (by weight and renal function) cannot be reached for reasons of tolerability, 24 weeks of sofoveravir + ribavirin should be considered in order to minimize the risk for relapse.

When ribavirin is added to sofoveravir, refer also to the Summary of Product Characteristics of ribavirin.

In adolescent patients aged 12 to <18 years the following ribavirin dosing is recommended where ribavirin is divided into two daily doses and given with food:

Table 3. Guidance for ribavirin dosing when administered with sofoveravir to adolescents aged 12 to < 18 years.

Body weight kg Ribavirin Dose*
<47 15 mg/kg/day
47-49 600 mg/day
50-65 800 mg/day
66-74 1000 mg/day
> or = 75

1200 mg/day

* Ribavirin administered orally in two divided doses with food.

Dose modification of ribavirin in adults taking 1,000-1,200 mg daily

If sofoveravir is used in combination with ribavirin and 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 4 provides guidelines for dose modifications and discontinuation based on the patient’s haemoglobin concentration and cardiac status

Table 4: Ribavirin dose modification guideline for co-administration with sofoveravir 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 originally assigned dose (1,000 mg to 1,200 mg daily).

Paediatric Population aged <12 years

The safety and effectiveness of sofosbuvir / ledipasvir in paediatric patients aged < 12 years have not been established. No data on paediatric patients aged < 12 years are available.

Missed dose

Patients should be instructed that if vomiting occurs within 5 hours of dosing an additional tablet should be taken. If vomiting occurs more than 5 hours after dosing, no further dose is needed

If a dose 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 at the usual time. Patients should be instructed not to take a double dose.

Elderly

No dose adjustment is warranted for elderly patients

Renal impairment

No dose adjustment of sofoveravir is required for patients with mild or moderate renal impairment. The safety of ledipasvir/sofosbuvir 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

Hepatic impairment

No dose adjustment of sofoveravir is required for patients with mild, moderate or severe hepatic impairment (Child-Pugh-Turcotte [CPT] class A, B or C). Safety and efficacy of ledipasvir/sofosbuvir have been established in patients with decompensated cirrhosis