Epclusa Adverse Reactions

Summary of the safety profile: The safety profile of Epclusa has been determined in pooled Phase 3 clinical studies of patients with genotype 1, 2, 3, 4, 5 or 6 HCV infection and in the post-marketing setting. No adverse drug reactions to Epclusa were identified from clinical trials. In the post-marketing setting, cases of severe bradycardia and heart block have been observed when SOF-containing products are used in combination with amiodarone, and HBV reactivation has been observed in patients coinfected with HCV/HBV following treatment with DAAs (see Precautions).
Tabulated summary of adverse reactions: Assessment of adverse reactions for Epclusa is based on safety data from clinical studies and post-marketing experience. All adverse reactions are presented in Table 19. The adverse reactions are listed as follows by system organ class and frequency. Frequencies are defined as follows: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1000 to <1/100); rare (≥1/10,000 to <1/1000); very rare (<1/10,000). (See Table 19.)

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Description of selected adverse reactions: Cardiac arrhythmias: Cases of severe bradycardia and heart block have been observed when sofosbuvir-containing regimens are used in combination with amiodarone and/or other medicinal products that lower heart rate (see Precautions and Interactions).
Skin disorders: Frequency not known: Stevens-Johnson syndrome.
Paediatric population: The adverse reactions observed were consistent with those observed in clinical studies of Epclusa in adults. The safety assessment of Epclusa in paediatric patients aged 12 years and older is based on data from a Phase 2, open-label clinical study (Study 1143) that enrolled 102 patients who were treated with sofosbuvir/velpatasvir for 12 weeks.
Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions.