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Summary of EPCLUSA® safety profile data

In pooled Phase 3 clinical studies* of patients with genotype 1–6 HCV infection the following was observed for patients receiving 12 weeks of treatment with EPCLUSA®1

•    The proportion of patients who permanently discontinued treatment due to AEs was 0.2%

•    The proportion of patients who experienced any severe AE was 3.2% 

•    Headache, fatigue and nausea were the most common AEs (incidence ≥10%) 

•    These and other AEs were reported at a similar frequency in patients receiving placebo compared with EPCLUSA® treated patients in the Phase 3 pivotal clinical studies.

 

Real world data identified rash as the most common AE associated with EPCLUSA®1,†,‡,§

Cases of Stevens-Johnson syndrome (frequency not known), severe bradycardia and heart block (when sofosbuvir-containing regimens are used in combination with amiodarone and/or other medicinal products that lower heart rate) have been identified during surveillance of sofosbuvir-containing products.

 

Contraindications1

 •    Hypersensitivity to active substance or excipients. 

 •    Use with strong P-gp and/or strong CYP inducers (carbamazepine, phenobarbital, phenytoin, rifampicin, rifabutin, and St. John’s wort) may reduce efficacy of EPCLUSA®, refer to SmPC.

Adverse drug reactions

Assessment of adverse reactions for EPCLUSA® is based on safety data from clinical studies and postmarketing experience.1

EPC ADR

aAdverse reaction observed in paediatric patients aged 3 to <6 years

bAdverse reaction identified through post-marketing surveillance of sofosbuvir/velpatasvir-containing products

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Patients

Footnotes:

*The Phase 3 clinical studies referred to are ASTRAL-1 (n=624), ASTRAL-2 (n=134), ASTRAL-3 (n=277)1 

†Headache, fatigue and nausea (incidence ≥10%), as well as other AEs, were reported at a similar frequency in placebo-treated patients. Please refer to the EPCLUSA® Summary of Product Characteristics for further details1

‡EPCLUSA® should not be administered concurrently with other medicinal products containing sofosbuvir1 

§Most common AE reported was vomiting (≥1/10; very common) in patients aged 3 to <6 years old.1

Abbreviations:

AE = adverse event; CYP = Cytochrome P450; HCV = hepatitis C virus; P-gp = P-glycoprotein.

References:

  1. EPCLUSA® Summary of Product Characteristics.

UK-EPC-0468

Date of preparation July 2024