title: Treatment with ledipasvir and sofosbuvir improves patient-reported outcomes: Results from the ION-1, -2, and -3 clinical trials.
abstract: Treatment with interferon (IFN) and ribavirin (RBV) significantly impairs quality of life and other patient-reported outcomes (PROs). Patient experience with IFN- and RBV-free anti-HCV (hepatitis C virus) regimens has not been reported. We assessed PROs in patients treated with ledipasvir and sofosbuvir (LDV/SOF) with and without RBV. Four different PRO questionnaires were administered at baseline, during, and post-treatment in HCV genotype 1 patients treated with LDV/SOF±RBV (ION-1, -2, and -3). A total of 1,952 patients were enrolled to be treated for 8 (N = 431), 12 (N = 867), or 24 weeks (N = 654) with LDV/SOF (N = 1,080) or LDV/SOF+RBV (N = 872). Baseline demographics and psychiatric disorders were similar between treatment groups (all P > 0.05). Patients receiving LDV/SOF regimens showed significant improvement of PRO scores during treatment (up to +7.4%, +7.0%, and +6.7% on a normalized 0%-100% scale in the 8-, 12-, and 24-week-long treatment groups, respectively (all P < 0.0001). These PRO improvements coincided with early viral suppression after 2 weeks of treatment and maximized by the end of treatment. On the other hand, during treatment with LDV/SOF+RBV, PRO scores declined (up to -5.5% regardless of treatment duration; P < 0.0001). Receiving RBV was an independent predictor of PRO impairment in multivariate analysis (beta up to -5.9%; P < 0.0001). Patients who achieved sustained virological response at 12 weeks showed significant improvement of their PROs post-treatment (up to +8.3%; P < 0.0001).
  
  
  CONCLUSIONS
  IFN- and RBV-free regimens with LDV/SOF result in early HCV suppression with simultaneous improvement in PROs that continued throughout the duration of treatment and post-treatment.
authors: Center for Liver Diseases, Department of Medicine, Inova Fairfax Hospital, Falls Church, VA.|Betty and Guy Beatty Center for Integrated Research, Inova Health System, Falls Church, VA.
authors: Zobair M
authors: ZM
authors: Younossi
authors: CLDQ LLC, Washington, DC.|Betty and Guy Beatty Center for Integrated Research, Inova Health System, Falls Church, VA.
authors: Maria
authors: M
authors: Stepanova
authors: Viral Hepatitis Research Unit in Hôpital Beaujon, Clichy, France.
authors: Patrick
authors: P
authors: Marcellin
authors: Hepatology, Beth Israel Deaconess Medical Center, Boston, MA.
authors: Nezam
authors: N
authors: Afdhal
authors: Liver Care Network and Organ Care Research, Swedish Medical Center, Seattle, WA.
authors: Kris V
authors: KV
authors: Kowdley
authors: Department of Medicine, J.W. Goethe University Hospital, Frankfurt, Germany.
authors: Stefan
authors: S
authors: Zeuzem
authors: Betty and Guy Beatty Center for Integrated Research, Inova Health System, Falls Church, VA.
authors: Sharon L
authors: SL
authors: Hunt
mesh_terms: D000328:Adult; D000998:Antiviral Agents / Q000627:therapeutic use*; D001562:Benzimidazoles / Q000627:therapeutic use*; D005260:Female; D005449:Fluorenes / Q000627:therapeutic use*; D019698:Hepatitis C, Chronic / Q000188:drug therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011788:Quality of Life; D012254:Ribavirin / Q000627:therapeutic use*; D000069474:Sofosbuvir; D014542:Uridine Monophosphate / Q000031:analogs & derivatives* / Q000627:therapeutic use
chemical_list: D000998:Antiviral Agents; D001562:Benzimidazoles; D005449:Fluorenes; C000595958:ledipasvir, sofosbuvir drug combination; D012254:Ribavirin; D014542:Uridine Monophosphate; D000069474:Sofosbuvir