Theme: Clinical Research Year: 2025
| Background: A previously published real-world data analysis demonstrated high effectiveness of sofosbuvir/velpatasvir (SOF/VEL) in > 6,000 HCV patients from 12 clinical cohorts across Australia, Canada, Europe & USA. The aim of this large real-world analysis was to evaluate characteristics and outcomes in an expanded pool of HCV patients treated with SOF/VEL across regions globally.
Method: This analysis included patients ≥ 18 years treated with SOF/VEL without ribavirin (RBV) for 12 weeks from 13 sites across Brazil, Colombia, Hong Kong, Mexico, Singapore, Sweden, Spain, Taiwan, and the United Arab Emirates. Baseline characteristics included age (</≥50 yo), sex, being treatment experienced (TE), cirrhosis (F4, not decompensated), genotype, coinfections (HBV, HDV, HIV), time to treatment initiation (TTI) from HCV diagnosis were described, along with sustained virologic response rates (SVR). Results: Overall, 7,027 patients were included, with a median age of 55 years [IQR 46-64], with patients over 50 y.o. representing two thirds (66%) of the overall population. Patients were mainly male (65%), with 72% females vs 62% males being > = 50 yo (p < 0.001). HIV/HCV coinfection was more prevalent in males (5.8% vs 2.1%, p < 0.001), as well as GT3 (35% vs 20%, p < 0.001), these differences were seen mostly in males > = 50 yo. TTI with the HCV therapy was shorter in females, with 40% treated in the first month, as compared to 25% of males, for both above and under 50 yo (p < 0.001). SVR was achieved in 98.9% of the treated population, with SVR rates ranging from 97.1% to 100% in all sites. SVR remained higher than 98% for males and females of all ages, and for patients with mental disorders or intravenous drug use. SVR remained higher than 97% in the concomitant presence of GT3 and a cirrhotic status. Conclusion: Results on treatment effectiveness in diverse geographical regions did not differ from real world studies of patients in Western countries, reinforcing the effectiveness of pangenotypic / panfibrotic / pangeographic DAA therapies and supporting the global applicability of HCV treatment guidelines. |