Hepatobiliary disorders and Direct-Acting Antiviral (DAA) therapies: real-world evidence and insights from the EudraVigilance database

Expert Opin Drug Saf. 2025 Apr 18:1-8. doi: 10.1080/14740338.2025.2495180. Online ahead of print.

ABSTRACT

BACKGROUND: The introduction of Direct-Acting Antivirals (DAA) brought about a breakthrough in the treatment of HCV. This study aims to analyze the hepatic safety profile of Harvoni® (sofosbuvir/ledipasvir), Epclusa® (sofosbuvir/velpatasvir), and Vosevi® (sofosbuvir/velpatasvir/voxilaprevir) through a review of the Individual Case Safety Reports (ICSRs) reported in EudraVigilance (EV).

RESEARCH DESIGN AND METHODS: ICSRs with adverse events (AE) belonging to the system organ class (SOC) hepatobiliary disorders were retrieved from the EV database. A descriptive analysis was performed. Reporting odds ratios (ROR) were calculated to assess the reporting frequency of hepatobiliary disorders among the DAA combinations.

RESULTS: Out of 5,552 ICSRs reported between January 2018 and December 2023, 1,942 were for Harvoni®, 3,180 for Epclusa® and 430 for Vosevi®. Three hundred and thirty-nine ICSRs reported 1,616 PT within the SOC hepatobiliary disorders. Harvoni® showed a statistically significant lower frequency of reporting for the hepatobiliary disorders SOC when compared to Epclusa® and Vosevi® (ROR, 0.33; 95% CI [0.26-0.41] and ROR 0.31; 95% CI [0.19-0.48], respectively).

CONCLUSION: Harvoni® showed a lower reporting frequency of hepatobiliary disorders and fewer drug ineffectiveness reports, suggesting it may be preferred over Epclusa® and Vosevi® in patients with preexisting liver or biliary conditions.

PMID:40243008 | DOI:10.1080/14740338.2025.2495180