Zobair M Younossi1,2, Maria Stepanova3, Ira Jacobson4, Andrew J Muir5, Stanislas Pol6, Stefan Zeuzem7, Ziad Younes8, Robert Herring9, Eric Lawitz10, Issah Younossi3, Andrei Racila3. 1. Center for Liver Diseases, Department of Medicine. 2. Betty and Guy Beatty Center for Integrated Research, Inova Health System, Falls Church, Virginia. 3. Center for Outcomes Research Liver Diseases, Washington, DC. 4. New York University Langone Health. 5. Duke Clinical Research Institute, Durham, North Carolina. 6. Hopital Cochin, Universite Paris Descartes, France. 7. Universitatsklinikum, Frankfurt, Germany. 8. Gastro One, Germantown. 9. Quality Medical Research, Nashville, Tennessee. 10. Texas Liver Institute, University of Texas Health, San Antonio.
Abstract
BACKGROUND: The causative relationship between the clearance of infections and long-term, health-related quality-of-life (HRQL) improvements in patients with hepatitis C virus (HCV) has been generally accepted. The aim of this study was to assess long-term HRQL trends in HCV patients who did not achieve sustained virologic responses (SVRs) after treatment with direct-acting antivirals. METHODS: HCV patients who completed treatment in clinical trials and did not achieve SVRs were enrolled in a long-term registry (#NCT01457768). HRQL scores were prospectively collected using the short form-36 instrument (8 HRQL domains and 2 summary scores). RESULTS: There were 242 patients included: they had a median age of 54 years (standard deviation ± 8 years), 85% were male, and 38% had cirrhosis. Before treatment, patients' HRQL scores were similar to the general population norms (all 1-sided P > 0.05), but were followed by significant decreases by the end of treatment (-3.4 to -6.2 points; P < .05 for 5/8 HRQL domains and mental summary). By the time subjects entered the registry, all but 1 of the mean HRQL scores had returned to their pretreatment levels (P > .05). During subsequent periods in the registry, patients experienced further HRQL decrements: up to -9.2 points (P < .05 for all HRQL domains) at Week 24 and up to -8.3 points (P < .05 for 5/8 HRQL domains) at Week 48. Although these HRQL decrements were observed regardless of cirrhosis status, they were more pronounced in patients with cirrhosis (P < .05 for 3/8 HRQL domains). CONCLUSIONS: Patients who did not achieve an SVR after treatment experienced worsening HRQL scores in long-term follow-ups. Retreatment of these patients will be important not only to improve their clinical outcomes, but also their quality of life.
BACKGROUND: The causative relationship between the clearance of infections and long-term, health-related quality-of-life (HRQL) improvements in patients with hepatitis C virus (HCV) has been generally accepted. The aim of this study was to assess long-term HRQL trends in HCVpatients who did not achieve sustained virologic responses (SVRs) after treatment with direct-acting antivirals. METHODS:HCVpatients who completed treatment in clinical trials and did not achieve SVRs were enrolled in a long-term registry (#NCT01457768). HRQL scores were prospectively collected using the short form-36 instrument (8 HRQL domains and 2 summary scores). RESULTS: There were 242 patients included: they had a median age of 54 years (standard deviation ± 8 years), 85% were male, and 38% had cirrhosis. Before treatment, patients' HRQL scores were similar to the general population norms (all 1-sided P > 0.05), but were followed by significant decreases by the end of treatment (-3.4 to -6.2 points; P < .05 for 5/8 HRQL domains and mental summary). By the time subjects entered the registry, all but 1 of the mean HRQL scores had returned to their pretreatment levels (P > .05). During subsequent periods in the registry, patients experienced further HRQL decrements: up to -9.2 points (P < .05 for all HRQL domains) at Week 24 and up to -8.3 points (P < .05 for 5/8 HRQL domains) at Week 48. Although these HRQL decrements were observed regardless of cirrhosis status, they were more pronounced in patients with cirrhosis (P < .05 for 3/8 HRQL domains). CONCLUSIONS:Patients who did not achieve an SVR after treatment experienced worsening HRQL scores in long-term follow-ups. Retreatment of these patients will be important not only to improve their clinical outcomes, but also their quality of life.
Authors: Elliot B Tapper; Neehar D Parikh; Pamela K Green; Kristin Berry; Akbar K Waljee; Andrew M Moon; George N Ioannou Journal: Clin Gastroenterol Hepatol Date: 2019-10-04 Impact factor: 11.382