Hepatobiliary disorders and direct-acting antiviral (DAA) therapies: real-world evidence and insights from the EudraVigilance database DOI

John Scicluna,

Raffaella Di Napoli,

Daniele Pirozzi

et al.

Expert Opinion on Drug Safety, Journal Year: 2025, Volume and Issue: unknown

Published: April 17, 2025

The introduction of Direct-Acting Antivirals (DAA) brought abouts a breakthrough in the treatment HCV. This study aims to analyze hepatic safety profile Harvoni® (sofosbuvir/ledipasvir), Epclusa® (sofosbuvir/velpatasvir), and Vosevi® (sofosbuvir/velpatasvir/voxilaprevir) through review Individual Case Safety reports (ICSRs) reported EudraVigilance (EV). ICSRs with Adverse Events (AE) belonging System Organ Class (SOC) hepatobiliary disorders were retrieved from EV database. A descriptive analysis was performed. Reporting Odds Ratios (ROR) calculated assess reporting frequency among DAA combinations. Out 5,552 between Jan 2018 Dec 2023, 1,942 for Harvoni®, 3,180 430 Vosevi®. 339 1,616 PT within SOC disorders. showed statistically significant lower when compared (ROR, 0.33; 95% CI [0.26 - 0.41], ROR 0.31; [0.19 0.48], respectively). fewer drug ineffectiveness reports, suggesting it may be preferred over patients preexisting liver or biliary conditions.

Language: Английский

Hepatobiliary disorders and direct-acting antiviral (DAA) therapies: real-world evidence and insights from the EudraVigilance database DOI

John Scicluna,

Raffaella Di Napoli,

Daniele Pirozzi

et al.

Expert Opinion on Drug Safety, Journal Year: 2025, Volume and Issue: unknown

Published: April 17, 2025

The introduction of Direct-Acting Antivirals (DAA) brought abouts a breakthrough in the treatment HCV. This study aims to analyze hepatic safety profile Harvoni® (sofosbuvir/ledipasvir), Epclusa® (sofosbuvir/velpatasvir), and Vosevi® (sofosbuvir/velpatasvir/voxilaprevir) through review Individual Case Safety reports (ICSRs) reported EudraVigilance (EV). ICSRs with Adverse Events (AE) belonging System Organ Class (SOC) hepatobiliary disorders were retrieved from EV database. A descriptive analysis was performed. Reporting Odds Ratios (ROR) calculated assess reporting frequency among DAA combinations. Out 5,552 between Jan 2018 Dec 2023, 1,942 for Harvoni®, 3,180 430 Vosevi®. 339 1,616 PT within SOC disorders. showed statistically significant lower when compared (ROR, 0.33; 95% CI [0.26 - 0.41], ROR 0.31; [0.19 0.48], respectively). fewer drug ineffectiveness reports, suggesting it may be preferred over patients preexisting liver or biliary conditions.

Language: Английский

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