Zobair M Younossi1, Maria Stepanova2, Linda Henry3, Edward Gane4, Ira M Jacobson5, Eric Lawitz6, David Nelson7, Lynn Gerber2, Fatema Nader8, Sharon Hunt2. 1. Center for Liver Diseases, Department of Medicine, Inova Fairfax Hospital, Falls Church, Virginia; Betty and Guy Beatty Center for Integrated Research, Inova Health System, Falls Church, Virginia. Electronic address: zobair.younossi@inova.org. 2. Center for Liver Diseases, Department of Medicine, Inova Fairfax Hospital, Falls Church, Virginia; Betty and Guy Beatty Center for Integrated Research, Inova Health System, Falls Church, Virginia. 3. Betty and Guy Beatty Center for Integrated Research, Inova Health System, Falls Church, Virginia. 4. Auckland City Hospital, Auckland, New Zealand. 5. Weill Cornell Medical College, New York, New York. 6. Texas Liver Institute, University of Texas Health Science Center, San Antonio, Texas. 7. University of Florida, Gainesville, Florida. 8. Center for Liver Diseases, Department of Medicine, Inova Fairfax Hospital, Falls Church, Virginia.
Abstract
BACKGROUND & AIMS: Interferon-based treatment of chronic hepatitis C virus (HCV) infection can negatively affect patient-reported outcomes (PROs) and work productivity (WP). We assessed these factors in patients with chronic hepatitis C treated with sofosbuvir and ribavirin, with or without pegylated interferon. METHODS: The HCV-specific Quality of Life (Chronic Liver Disease Questionnaire-HCV version [CLDQ-HCV]), Functional Assessment of Chronic Illness Therapy-Fatigue, and Work Productivity and Activity Index: Specific Health Problem questionnaires were completed before, during, and after treatment of patients infected with HCV genotypes 2 or 3 who received sofosbuvir and ribavirin for 16 or 12 weeks (the FUSION study, n = 201) or patients infected with HCV genotype 1 who received pegylated interferon, sofosbuvir, and ribavirin for 12 weeks (the NEUTRINO study, n = 327). RESULTS: Patients in each group of the FUSION study had similar PRO and WP scores at each time point (all comparisons, P > .05). Compared with baseline, patients had modest reductions in fatigue, HCV-specific quality of life, and WP and Activity Index scores during treatment (P = .02 to <.0001). However, by 4 weeks after treatment, all scores returned to baseline levels or higher. Subjects in the NEUTRINO study had greater reductions in these scores during treatment; most remained significant through 4 weeks after treatment (P < .05). Significant improvements in PROs were observed among patients with sustained virologic responses 12 weeks after treatment in the FUSION and NEUTRINO studies (all P < .05). In multivariate analyses after adjustment for confounders, interferon therapy was independently associated with worse PROs after 12 weeks of treatment. CONCLUSIONS: On the basis of an analysis of 2 large clinical trials (FUSION and NEUTRINO), patient outcome and productivity are more negatively affected by the inclusion of pegylated interferon in treatment than by interferon-free regimens. Patients with sustained virologic responses 12 weeks after treatment had significant improvements in PROs in both studies.
BACKGROUND & AIMS: Interferon-based treatment of chronic hepatitis C virus (HCV) infection can negatively affect patient-reported outcomes (PROs) and work productivity (WP). We assessed these factors in patients with chronic hepatitis C treated with sofosbuvir and ribavirin, with or without pegylated interferon. METHODS: The HCV-specific Quality of Life (Chronic Liver Disease Questionnaire-HCV version [CLDQ-HCV]), Functional Assessment of Chronic Illness Therapy-Fatigue, and Work Productivity and Activity Index: Specific Health Problem questionnaires were completed before, during, and after treatment of patients infected with HCV genotypes 2 or 3 who received sofosbuvir and ribavirin for 16 or 12 weeks (the FUSION study, n = 201) or patients infected with HCV genotype 1 who received pegylated interferon, sofosbuvir, and ribavirin for 12 weeks (the NEUTRINO study, n = 327). RESULTS:Patients in each group of the FUSION study had similar PRO and WP scores at each time point (all comparisons, P > .05). Compared with baseline, patients had modest reductions in fatigue, HCV-specific quality of life, and WP and Activity Index scores during treatment (P = .02 to <.0001). However, by 4 weeks after treatment, all scores returned to baseline levels or higher. Subjects in the NEUTRINO study had greater reductions in these scores during treatment; most remained significant through 4 weeks after treatment (P < .05). Significant improvements in PROs were observed among patients with sustained virologic responses 12 weeks after treatment in the FUSION and NEUTRINO studies (all P < .05). In multivariate analyses after adjustment for confounders, interferon therapy was independently associated with worse PROs after 12 weeks of treatment. CONCLUSIONS: On the basis of an analysis of 2 large clinical trials (FUSION and NEUTRINO), patient outcome and productivity are more negatively affected by the inclusion of pegylated interferon in treatment than by interferon-free regimens. Patients with sustained virologic responses 12 weeks after treatment had significant improvements in PROs in both studies.
Authors: Donna M Evon; Carol E Golin; Paul Stewart; Michael W Fried; Shani Alston; Bryce Reeve; Anna S Lok; Richard K Sterling; Joseph K Lim; Nancy Reau; Souvik Sarkar; David R Nelson; K R Reddy; Adrian M Di Bisceglie Journal: Contemp Clin Trials Date: 2017-03-22 Impact factor: 2.226
Authors: David A Goodkin; Brian Bieber; Michel Jadoul; Paul Martin; Eiichiro Kanda; Ronald L Pisoni Journal: Clin J Am Soc Nephrol Date: 2016-12-01 Impact factor: 8.237
Authors: Zobair M Younossi; Maria Stepanova; Mark Sulkowski; Graham R Foster; Nancy Reau; Alessandra Mangia; Keyur Patel; Norbert Bräu; Stuart K Roberts; Nezam Afdhal; Fatema Nader; Linda Henry; Sharon Hunt Journal: Clin Infect Dis Date: 2016-07-20 Impact factor: 9.079
Authors: D M Evon; J Amador; P Stewart; B B Reeve; A S Lok; R K Sterling; A M Di Bisceglie; N Reau; M Serper; S Sarkar; J K Lim; C E Golin; M W Fried Journal: Aliment Pharmacol Ther Date: 2018-01-29 Impact factor: 8.171