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IDDF2024-ABS-0194 Real-world data with pangenotypic direct-acting antivirals: preliminary results of the SVR10K study
  1. Grace Lai-Hung Wong1,
  2. Ming Lung Yu2,
  3. Maria Fátima Higuera3,
  4. Mohamed Alzaabi4,
  5. Javier Garcia-Samaniego5,
  6. Marta Casado6,
  7. Habiba Kamal Khodir7,
  8. Karin Lindahl7,
  9. Aastha Chandak8,
  10. Marta Martínez8,
  11. Artak Khachatryan8,
  12. Linda Chen9,
  13. Candido Hernandez9,
  14. Soo Aleman7
  1. 1Department of Medicine and Therapeutics, The Chinese University of Hong Kong, Hong Kong, China
  2. 2Department of Internal Medicine and Hepatitis Center, Kaohsiung Medical University Hospital, Taiwan
  3. 3Department of Gastroenterology and Hepatology, Hospital General de México
  4. 4College of Pharmacy and Health Sciences, Zayed Military Hospital, United Arab Emirates
  5. 5Unidad de Hepatología, Hospital Universitario La Paz, Madrid, Spain
  6. 6Department of Digestive Diseases, Hospital de Torrecárdenas, Almeria, Spain
  7. 7Department of Medicine Huddinge, Karolinska University Hospital, Stockholm, Sweden
  8. 8Certara, USA
  9. 9Global Medical Affairs, Gilead Sciences, USA

Abstract

Background A previous real-world data analysis demonstrated the high effectiveness of sofosbuvir/velpatasvir (SOF/VEL) in > 6,000 HCV patients from 12 clinical cohorts across Australia, Canada, Europe & USA. Expanding this research initiative to include even more patients from additional geographical areas will allow us to show SOF/VEL effectiveness across multiple diverse populations & the evaluation of HCV patient characteristics across Western countries, Asia, Middle Eastern, and Latin-American regions.

Methods This real-world analysis includes patients ≥ 18 years treated with SOF/VEL without RBV for 12 weeks, as decided by the treating HCP, from 7 sites across Hong Kong, Mexico, Sweden, Spain, Taiwan, and the United Arab Emirates. Age, sex, treatment-experienced (TE), cirrhosis stage (no decompensated included), genotype, coinfections, time to treatment initiation (TTI) from HCV diagnosis, and SVR (4/12/24) were analyzed.

Results Overall, 4,679 patients were included, 51% of them from Asian countries. Median age was 56.9 [IQR 46-66], where males were 59%, and age > 50 years in 68%. Genotype 3 was present in 25%, F4 21%, TE 5%, while HIV, HBV and HDV coinfection was reported in 4.7%, 4.3%, and 0.1%, respectively. The TTI was available in 74%, with 17% having ≤30 days. In terms of effectiveness, SVR was achieved in 98.4% of the treated population and 99% of Asian countries.

Conclusions Results on treatment effectiveness in these new geographies did not differ from real-world studies of patients in Western countries, reinforcing that HCV treatment guidelines are globally applicable and supporting the efficacy of pDAA therapy.

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