Sabela Lens1, Inmaculada Fernández2, Sergio Rodríguez-Tajes1, Vanessa Hontangas3, Mercedes Vergara4, Montserrat Forné5, Jose Luis Calleja6, Moisés Diago7, Jordi Llaneras8, Susana Llerena9,10, Xavier Torras11, Begoña Sacristán12, Merce Roget13, Conrado Manuel Fernández-Rodríguez14, Mari Carmen Navascués15, Javier Fuentes16, Juan-José Sánchez-Ruano17, Miguel-Ángel Simón18, Federico Sáez-Royuela19, Carmen Baliellas20, Rosa Morillas21, Xavier Forns1. 1. Liver Unit, Hospital Clínic, University of Barcelona, IDIBAPS, CIBERehd, Barcelona, Spain. 2. Digestive Disease Service, Hospital Universitario 12 de Octubre, Madrid, Spain. 3. Liver Unit, Hospital La Fe de Valencia, Valencia, Spain. 4. Liver Unit, Parc Tauli Sabadell, Hospital Universitari Sabadell, Universitat Autonoma Barcelona, Barcelona, Spain. 5. Digestive Department, Hospital Universitario Mutua Terrassa, Terrassa, Spain. 6. Liver Unit, Hospital Universitario Puerta de Hierro, Madrid, Spain. 7. Liver Unit, Hospital General Universitario Valencia, Valencia, Spain. 8. Liver Unit, Internal Medicine, Hospital Vall d'Hebron, Barcelona, Spain. 9. Gastroenterology and Hepatology Department, Marqués de Valdecilla University Hospital, Santander, Spain. 10. Infection, Immunity and Digestive Disease Group, Marqués de Valdecilla Research Institute (IDIVAL), Santander, Spain. 11. Liver Unit, Hospital Santa Creu i Sant Pau, CIBERehd, Barcelona, Spain. 12. Gastroenterology and Hepatology Department, Hospital San Pedro, Logroño, Spain. 13. Liver Unit, Consorci Sanitari de Terrassa, Terrassa, Spain. 14. Gastroenterology and Hepatology Department, Hospital Universitario Fundacion Alcorcon Universidad Rey Juan Carlos, Madrid, Spain. 15. Liver Unit, Gastroenterology Division, Hospital Central de Asturias, Oviedo, Spain. 16. Gastroenterology and Hepatology Department, Hospital Universitario Miguel Servet, Zaragoza, Spain. 17. Gastroenterology and Hepatology Department, Hospital Universitario de Toledo, Toledo, Spain. 18. Gastroenterology and Hepatology Department, Clinico Universitario Zaragoza, Zaragoza, Spain. 19. Gastroenterology and Hepatology Department, Hospital Universitario de Burgos, Burgos, Spain. 20. Liver Unit, Hospital Bellvitge, Barcelona, Spain. 21. Liver Unit, Hospital Germans Trias i Pujol, Badalona, Spain.
Abstract
OBJECTIVES: Interferon-free therapies have an improved safety and efficacy profile. However, data in elderly patients, who have frequently advanced liver disease, associated comorbidities, and use concomitant medications are scarce. The im of this study was to assess the effectiveness and tolerability of all-oral regimens in elderly patients in real-life clinical practice. METHODS: Retrospective analysis of hepatitis C virus (HCV) patients aged ≥65 years receiving interferon-free regimens within the Spanish National Registry (Hepa-C). RESULTS: Data of 1,252 patients were recorded. Of these, 955 (76%) were aged 65-74 years, 211 (17%) were aged 75-79 years, and 86 (7%) were aged ≥80 years at the start of antiviral therapy. HCV genotype-1b was predominant (88%) and 48% were previous non-responders. A significant proportion of patients had cirrhosis (922; 74%), of whom 11% presented decompensated liver disease. The most used regimens were SOF/LDV (33%), 3D (28%), and SOF/SMV (26%). Ribavirin was added in 49% of patients. Overall, the sustained virological response (SVR12) rate was 94% without differences among the three age categories. Albumin ≤3.5 g/dl was the only independent negative predictor of response (0.25 (0.15-0.41); P<0.01). Regarding tolerability, the rate of severe adverse events increased with age category (8.8, 13, and 14%; P=0.04). In addition, the main predictors of mortality (2.3%) were age ≥75 years (2.59 (1.16-5.83); P =0.02) and albumin ≤3.5 (17 (6.3-47); P <0.01). CONCLUSIONS: SVR rates with interferon-free regimens in elderly patients are high and comparable to the general population. Baseline low albumin levels (≤3.5 g/dl) was the only predictor of treatment failure. Importantly, the rate of severe adverse events and death increased with age. Elderly patients (≥75 years) or those with advanced liver disease (albumin ≤3.5) presented higher mortality. Thus a careful selection of patients for antiviral treatment is recommended.
OBJECTIVES: Interferon-free therapies have an improved safety and efficacy profile. However, data in elderly patients, who have frequently advanced liver disease, associated comorbidities, and use concomitant medications are scarce. The im of this study was to assess the effectiveness and tolerability of all-oral regimens in elderly patients in real-life clinical practice. METHODS: Retrospective analysis of hepatitis C virus (HCV) patients aged ≥65 years receiving interferon-free regimens within the Spanish National Registry (Hepa-C). RESULTS: Data of 1,252 patients were recorded. Of these, 955 (76%) were aged 65-74 years, 211 (17%) were aged 75-79 years, and 86 (7%) were aged ≥80 years at the start of antiviral therapy. HCV genotype-1b was predominant (88%) and 48% were previous non-responders. A significant proportion of patients had cirrhosis (922; 74%), of whom 11% presented decompensated liver disease. The most used regimens were SOF/LDV (33%), 3D (28%), and SOF/SMV (26%). Ribavirin was added in 49% of patients. Overall, the sustained virological response (SVR12) rate was 94% without differences among the three age categories. Albumin ≤3.5 g/dl was the only independent negative predictor of response (0.25 (0.15-0.41); P<0.01). Regarding tolerability, the rate of severe adverse events increased with age category (8.8, 13, and 14%; P=0.04). In addition, the main predictors of mortality (2.3%) were age ≥75 years (2.59 (1.16-5.83); P =0.02) and albumin ≤3.5 (17 (6.3-47); P <0.01). CONCLUSIONS: SVR rates with interferon-free regimens in elderly patients are high and comparable to the general population. Baseline low albumin levels (≤3.5 g/dl) was the only predictor of treatment failure. Importantly, the rate of severe adverse events and death increased with age. Elderly patients (≥75 years) or those with advanced liver disease (albumin ≤3.5) presented higher mortality. Thus a careful selection of patients for antiviral treatment is recommended.
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