Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: Gilead Sciences Ireland UC, Carrigtohill, County Cork, T45 DP77, Ireland
Epclusa is indicated for the treatment of chronic hepatitis C virus (HCV) infection in patients 3 years of age and older (see sections 4.2, 4.4 and 5.1).
Epclusa treatment should be initiated and monitored by a physician experienced in the management of patients with HCV infection.
The recommended dose of Epclusa in adults is one 400 mg/100 mg tablet, taken orally, once daily with or without food (see section 5.2).
The recommended dose of Epclusa in paediatric patients aged 3 years and above is based on weight as detailed in Table 3.
A granule formulation of Epclusa is available for the treatment of chronic HCV infection in paediatric patients aged 3 years and above having difficulty swallowing film-coated tablets. For patients weighing <17 kg, please refer to the Summary of Product Characteristics for Epclusa 200 mg/50 mg or 150 mg/37.5 mg granules.
Table 1. Recommended treatment and duration for adults regardless of HCV genotypes:
| Adult patient populationa | Treatment and duration |
|---|---|
| Patients without cirrhosis and patients with compensated cirrhosis | Epclusa for 12 weeks Addition of ribavirin may be considered for genotype 3 infected patients with compensated cirrhosis (see section 5.1) |
| Patients with decompensated cirrhosis | Epclusa + ribavirin for 12 weeks |
a Includes patients co-infected with human immunodeficiency virus (HIV) and patients with recurrent HCV post-liver transplant (see section 4.4).
When used in combination with ribavirin, refer also to the Summary of Product Characteristics of the medicinal product containing ribavirin.
The following dosing is recommended for adults where ribavirin is divided in two daily doses and given with food:
Table 2. Guidance for ribavirin dosing when administered with Epclusa to adults with decompensated cirrhosis:
| Adult 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 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 ribavirin is used in genotype 3 infected adult patients with compensated cirrhosis (pre- or posttransplant) the recommended dose of ribavirin is 1,000/1,200 mg (1,000 mg for adult patients weighing <75 kg and 1,200 mg for adult patients weighing ≥75 kg).
For ribavirin dose modifications, refer to the Summary of Product Characteristics of the medicinal product containing ribavirin.
Table 3. Recommended treatment and duration for paediatric patients aged 3 to <18 Years regardless of HCV genotype using Epclusa Tablets*:
| Body Weight (kg) | Dosing of Epclusa Tablets | Sofosbuvir/Velpatasvir Daily Dose | Recommended Treatment Regimen |
|---|---|---|---|
| ≥30 | one 400 mg/100 mg tablet once daily or two 200 mg/50 mg tablets once daily | 400 mg/100 mg per day | Epclusa for 12 weeks |
| 17 to <30 | one 200 mg/50 mg tablet once daily | 200 mg/50 mg per day |
* Epclusa is also available as granules for paediatric patients with chronic HCV infection aged 3 years and above. For patients weighing <17 kg, please refer to the Summary of Product Characteristics for Epclusa 200 mg/50 mg or 150 mg/37.5 mg granules.
Patients should be instructed that if vomiting occurs within 3 hours of dosing an additional tablet of Epclusa should be taken. If vomiting occurs more than 3 hours after dosing, no further dose of Epclusa is needed (see section 5.1).
If a dose of Epclusa 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 Epclusa at the usual time. Patients should be instructed not to take a double dose of Epclusa.
Epclusa + ribavirin for 24 weeks may be considered (see section 4.4).
No dose adjustment is warranted for elderly patients (see section 5.2).
No dose adjustment of Epclusa 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. Epclusa can be used in these patients with no dose adjustment when no other relevant treatment options are available (see sections 4.4, 5.1 and 5.2).
No dose adjustment of Epclusa is required for patients with mild, moderate, or severe hepatic impairment (CPT Class A, B, or C) (see section 5.2). Safety and efficacy of Epclusa have been assessed in patients with CPT Class B cirrhosis, but not in patients with CPT Class C cirrhosis (see sections 4.4 and 5.1).
The safety and efficacy of Epclusa in children aged less than 3 years have not been established. No data are available.
For oral use.
Patients should be instructed to swallow the tablet(s) whole with or without food (see section 5.2). Due to the bitter taste, it is recommended that the film-coated tablet is not chewed or crushed.
The highest documented doses of sofosbuvir and velpatasvir were a single dose of 1,200 mg and a single dose of 500 mg, respectively. In these healthy adult volunteer studies, there were no untoward effects observed at these dose levels, and adverse events were similar in frequency and severity to those reported in the placebo groups. The effects of higher doses/exposures are not known.
No specific antidote is available for overdose with Epclusa. If overdose occurs the patient must be monitored for evidence of toxicity. Treatment of overdose with Epclusa consists of general supportive measures including monitoring of vital signs, as well as observation of the clinical status of the patient. Haemodialysis can efficiently remove the predominant circulating metabolite of sofosbuvir, GS-331007, with an extraction ratio of 53%. Haemodialysis is unlikely to result in significant removal of velpatasvir, since velpatasvir is highly bound to plasma protein.
4 years.
This medicinal product does not require any special storage conditions.
High density polyethylene (HDPE) bottle with a polypropylene child-resistant closure containing 28 film-coated tablets with polyester coil.
Pack size of 1 bottle containing 28 film-coated tablets.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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