The SVR10K Hepatitis C study: final results show 98.9% SVR in 7,000 patients treated with SOF/VEL in Asia, Latin America, Middle East, Nordics, and Southern Europe

Background and Aims: 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. Irrespective of age, male patients were more likely to have advanced fibrosis and infection with HCV GT 3, and median time to treatment initiation was numerically shorter in male patients across the age spectrum. 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 includes patients≥18 years treated with SOF/VEL without ribavirin (RBV) for 12 weeks, as decided by the treating HCP, from 13 sites across Brazil, Colombia, Hong Kong, Mexico, Singapore, Spain, Sweden, Taiwan, and the United Arab Emirates. Baseline characteristics included age (in categories</≥50 yo), sex, being treatment experienced, presence of cirrhosis (F4, not decompensated), genotype, coinfections (HBV, HDV, HIV), time to treatment initiation (TTI) from HCV diagnosis, along with sustained virologic response rates (SVR). Final results of this study are presented.

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 therapy such as SOF/VEL and supporting the global applicability of HCV treatment guidelines.

 

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Artikel online veröffentlicht:
04. September 2025