Zobair M Younossi1, Maria Stepanova2, Nezam Afdhal3, Kris V Kowdley4, Stefan Zeuzem5, Linda Henry6, Sharon L Hunt7, Patrick Marcellin8. 1. Center for Liver Diseases, Department of Medicine, Inova Fairfax Hospital, Falls Church, VA, United States; Betty and Guy Beatty Center for Integrated Research, Inova Health System, Falls Church, VA, United States. Electronic address: zobair.younossi@inova.org. 2. Betty and Guy Beatty Center for Integrated Research, Inova Health System, Falls Church, VA, United States; Center for Outcomes Research in Liver Diseases, Washington, DC, United States. 3. Hepatology, Beth Israel Deaconess Medical Center, Boston, MA, United States. 4. Digestive Diseases Institute, Virginia Mason Clinic, Seattle, WA, United States. 5. Department of Medicine, J.W. Goethe University Hospital, Frankfurt, Germany. 6. Center for Outcomes Research in Liver Diseases, Washington, DC, United States. 7. Betty and Guy Beatty Center for Integrated Research, Inova Health System, Falls Church, VA, United States. 8. Viral Hepatitis Research Unit in Hôpital Beaujon, Clichy, France.
Abstract
BACKGROUND & AIMS: New interferon-free anti-HCV regimens are highly efficacious with a favorable safety profile. We assessed health-related quality of life (HRQL) and work productivity in patients with different stages of hepatic fibrosis treated with sofosbuvir+ledipasvir. METHODS: Four questionnaires [Chronic Liver Disease Questionnaire-HCV (CLDQ-HCV), Short Form-36 (SF-36), Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), Work Productivity and Activity Index:Specific Health Problem (WPAI:SHP)] were administered at baseline, during, and after treatment with sofosbuvir+ledipasvir+ribavirin or sofosbuvir+ledipasvir (ION-1,2,3 clinical trials). Metavir fibrosis stage was determined from pre-treatment liver biopsies. RESULTS: There were 1005 patients included (stage F0: n=94; F1: n=311; F2: n=301; F3: n=197; F4: n=102). At baseline, patients with more advanced fibrosis had more HRQL impairments, predominantly related to physical functioning (stage 0 vs. stage 4 by up to 0.126 on a normalized 0-1 scale p<0.0001). During and post-treatment, HRQL remained lower in patients with advanced fibrosis. After achieving sustained virologic response, significant improvements from baseline in most HRQL domains were observed regardless of fibrosis stage (by 0.024-0.103 on a 0-1 scale; all p>0.05 across fibrosis stages). In multivariate analysis, advanced fibrosis was independently associated with impairment of HRQL and work productivity (beta up to -0.056 in comparison with none-to-mild fibrosis, p<0.05). However, improvement of HRQL and work productivity after viral clearance was not related to the stage of fibrosis (all p>0.05). CONCLUSIONS: Although advanced hepatic fibrosis is associated with HRQL and work productivity impairment, viral eradication with sofosbuvir+ledipasvir leads to HRQL improvement regardless of fibrosis stage. HCV patients with early fibrosis experience similar improvement of patient reported outcomes as those with advanced fibrosis.
BACKGROUND & AIMS: New interferon-free anti-HCV regimens are highly efficacious with a favorable safety profile. We assessed health-related quality of life (HRQL) and work productivity in patients with different stages of hepatic fibrosis treated with sofosbuvir+ledipasvir. METHODS: Four questionnaires [Chronic Liver Disease Questionnaire-HCV (CLDQ-HCV), Short Form-36 (SF-36), Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), Work Productivity and Activity Index:Specific Health Problem (WPAI:SHP)] were administered at baseline, during, and after treatment with sofosbuvir+ledipasvir+ribavirin or sofosbuvir+ledipasvir (ION-1,2,3 clinical trials). Metavir fibrosis stage was determined from pre-treatment liver biopsies. RESULTS: There were 1005 patients included (stage F0: n=94; F1: n=311; F2: n=301; F3: n=197; F4: n=102). At baseline, patients with more advanced fibrosis had more HRQL impairments, predominantly related to physical functioning (stage 0 vs. stage 4 by up to 0.126 on a normalized 0-1 scale p<0.0001). During and post-treatment, HRQL remained lower in patients with advanced fibrosis. After achieving sustained virologic response, significant improvements from baseline in most HRQL domains were observed regardless of fibrosis stage (by 0.024-0.103 on a 0-1 scale; all p>0.05 across fibrosis stages). In multivariate analysis, advanced fibrosis was independently associated with impairment of HRQL and work productivity (beta up to -0.056 in comparison with none-to-mild fibrosis, p<0.05). However, improvement of HRQL and work productivity after viral clearance was not related to the stage of fibrosis (all p>0.05). CONCLUSIONS: Although advanced hepatic fibrosis is associated with HRQL and work productivity impairment, viral eradication with sofosbuvir+ledipasvir leads to HRQL improvement regardless of fibrosis stage. HCV patients with early fibrosis experience similar improvement of patient reported outcomes as those with advanced fibrosis.
Authors: Shari S Rogal; Rory McCarthy; Andrea Reid; Keri L Rodriguez; Linda Calgaro; Krupa Patel; Molly Daley; Naudia L Jonassaint; Susan L Zickmund Journal: Dig Dis Sci Date: 2017-05-18 Impact factor: 3.199
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