Real‐life effectiveness of sofosbuvir/velpatasvir/voxilaprevir in hepatitis C patients previously treated with sofosbuvir/velpatasvir or glecaprevir/pibrentasvir

Author:

Ruiz‐Cobo Juan Carlos12ORCID,Llaneras Jordi12ORCID,Forns Xavier3456ORCID,Gallego Moya Adolfo7ORCID,Conde Amiel Isabel89ORCID,Arencibia Ana10ORCID,Diago Moises1112ORCID,García‐Samaniego Javier6131415ORCID,Castellote Jose51617ORCID,Llerena Susana1819ORCID,Rodríguez‐Seguel Elisa20212223,Mateos Beatriz242526ORCID,Rodríguez Manuel2728ORCID,Rosales Zabal Jose Miguel29ORCID,Fernández Inmaculada30,Calleja Jose Luis153132ORCID,Morillas Rosa María6333435ORCID,Montoliu Silvia3637ORCID,Andrade Raul J.6383940ORCID,Badia Aranda Ester41ORCID,Hernández‐Guerra Manuel42ORCID,Maté Carlota Jimeno43,González‐Santiago Jesús M.64445ORCID,de Cuenca Beatriz46,Bernal‐Monterde Vanesa4748ORCID,Delgado Manuel49,Turnes Juan50ORCID,Lens Sabela3456ORCID,Buti María126ORCID

Affiliation:

1. Universitat Autònoma de Barcelona (UAB) Barcelona Spain

2. Liver Unit, Hospital Universitari Vall d'Hebron Barcelona Spain

3. Liver Unit Hospital Clínic Barcelona Spain

4. Fundació de Recerca Clínic Barcelona‐Institut d'Investigacions Biomèdiques August Pi i Sunyer (FRCB‐IDIBAPS) Barcelona Spain

5. University of Barcelona (UB) Barcelona Spain

6. Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd) Instituto de Salud Carlos III Madrid Spain

7. Servicio de Patología Digestiva Hospital de la Santa Creu i Sant Pau Barcelona Spain

8. Hepatology and Liver Transplantation Unit Hospital Universitario y Politécnico La Fe Valencia Spain

9. Instituto de Investigación Sanitaria La Fe (IIS La Fe) Valencia Spain

10. Gastroenterology Department Hospital Universitario Nuestra Señora de Candelaria Santa Cruz de Tenerife Spain

11. Hospital General Universitario Valencia Valencia Spain

12. Medicine Department Universidad de Valencia Valencia Spain

13. Liver Unit Hospital Universitario La Paz Madrid Spain

14. Instituto de Investigación Hospital Universitario La Paz (IdiPAZ) Madrid Spain

15. Universidad Autónoma de Madrid Madrid Spain

16. Hepatology Unit, Gastroenterology Department Hospital Universitari de Bellvitge, L'Hospitalet de Llobregat Barcelona Spain

17. Instituto de Investigación Biomédica de Bellvitge (IDIBELL), Universitat de Barcelona Barcelona Spain

18. Gastroenterology and Hepatology Department Hospital Universitario Marqués de Valdecilla Santander Spain

19. Instituto de Investigación Sanitaria Valdecilla (IDIVAL) Santander Spain

20. Liver Diseases Instituto de Biomedicina de Sevilla (IBiS)/Hospital Universitario Virgen del Rocío/CSIC/Universidad de Sevilla Seville Spain

21. Hospital Universitario Virgen del Rocío Seville Spain

22. Digestive Diseases Research Unit Virgen Del Rocío University Hospital Seville Spain

23. Cell Biology Department, Faculty of Biology University of Seville Seville Spain

24. Gastroenterology Department, Hospital Universitario Ramón y Cajal Madrid Spain

25. Instituto Ramón y Cajal de Investigación Sanitaria (IRYCIS) Madrid Spain

26. University of Alcala Madrid Spain

27. Liver Unit, Gastroenterology and Hepatology Division Hospital Universitario Central de Asturias Oviedo Spain

28. University of Oviedo Oviedo Spain

29. Gastroenterology Department Hospital Universitario Costa del Sol Marbella Spain

30. Gastroenterology Department Hospital Universitario 12 de Octubre Madrid Spain

31. Servicio de Gastroenterología y Hepatología Hospital Universitario Puerta de Hierro Madrid Spain

32. Instituto de Investigación Sanitaria Puerta de Hierro (IDIPHIM) Madrid Spain

33. Hepatology Unit Hospital Universitari Germans Trias i Pujol Badalona Spain

34. Institute for Health Science Research Germans Trias i Pujol (IGTP) Badalona Spain

35. Department of Medicine Barcelona Autonomous University (UAB) Barcelona Spain

36. Gastroenterology Department Hospital Universitari Joan XXIII Tarragona Spain

37. Institut d'Investigació Sanitària Pere Virgili (IISPV) Tarragona Spain

38. Hospital Universitario Virgen de la Victoria Málaga Spain

39. University Hospital‐IBIMA Platform BIONAND Málaga Spain

40. University of Malaga Málaga Spain

41. Gastroenterology Department Hospital Universitario de Burgos Burgos Spain

42. Hospital Universitario de Canarias Santa Cruz de Tenerife Spain

43. Gastroenterology Department Hospital Universitario Virgen de Valme Sevilla Spain

44. Gastroenterology and Hepatology Department University Hospital of Salamanca Salamanca Spain

45. Instituto de Investigación Biomédica de Salamanca (IBSAL) Salamanca Spain

46. Hospital Universitario de Getafe Getafe Spain

47. Servicio de Aparato Digestivo Hospital Universitario Miguel Servet Zaragoza Spain

48. Instituto de Investigación Sanitaria de Aragón (IISA) Zaragoza Spain

49. Hospital Universitario La Coruña La Coruña Spain

50. Department of Gastroenterology and Hepatology Complejo Hospitalario Universitario Pontevedra & IIS Galicia Sur Pontevedra Spain

Abstract

SummaryBackgroundSofosbuvir, velpatasvir and voxilaprevir (SOF/VEL/VOX) is the recommended rescue therapy for patients with chronic hepatitis C infection who fail direct‐acting antivirals (DAAs). Data are limited on the effectiveness of this treatment after the current first‐line therapies. Our aim was to analyse the effectiveness and safety of SOF/VEL/VOX among patients failing sofosbuvir/velpatasvir (SOF/VEL) or glecaprevir/pibrentasvir (GLE/PIB).MethodsRetrospective multicentre study (26 Spanish hospitals), including chronic hepatitis C patients unsuccessfully treated with SOF/VEL or GLE/PIB, and retreated with SOF/VEL/VOX ± ribavirin for 12 weeks between December 2017 and December 2022.ResultsIn total, 142 patients included: 100 (70.4%) had failed SOF/VEL and 42 (29.6%) GLE/PIB. Patients were mainly men (84.5%), White (93.9%), with hepatitis C virus genotype (GT) 3 (49.6%) and 47.2% had liver cirrhosis. Sustained virological response (SVR) was evaluated in 132 patients who completed SOF/VEL/VOX and were followed 12 weeks after end of treatment; 117 (88.6%) achieved SVR. There were no significant differences in SVR rates according to initial DAA treatment (SOF/VEL 87.9% vs. GLE/PIB 90.2%, p = 0.8), cirrhosis (no cirrhosis 90% vs. cirrhosis 87.1%, p = 0.6) or GT3 infection (non‐GT3 91.9% vs. GT3 85.5%, p = 0.3). However, when considering the concurrent presence of SOF/VEL treatment, cirrhosis and GT3 infection, SVR rates dropped to 82.8%. Ribavirin was added in 8 (6%) patients, all achieved SVR.ConclusionSOF/VEL/VOX is an effective rescue therapy for failures to SOF/VEL or GLE/PIB, with an SVR of 88.6%. Factors previously linked to lower SVR rates, such as GT3 infection, cirrhosis and first‐line therapy with SOF/VEL were not associated with lower SVRs.

Publisher

Wiley

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