Skip to main content
Journal cover image

Sustainable and equivalent improvements in symptoms and functional well-being following viral cure from ledipasvir/sofosbuvir versus elbasvir/grazoprevir for chronic hepatitis C infection: Findings from the randomized PRIORITIZE trial.

Publication ,  Journal Article
Evon, DM; Dong, M; Reeve, BB; Peter, J; Michael, L; Lok, AS; Nelson, DR; Stewart, PW
Published in: J Viral Hepat
September 2022

The PRIORITIZE trial (clinicaltrials.gov: NCT02786537) was the first comparative effectiveness study to directly compare ledipasvir/sofosbuvir (LDV/SOF) and elbasvir/grazoprevir (EBR/GZR) for the treatment of chronic hepatitis C virus (HCV). A secondary aim of this study was to compare LDV/SOF and EBR/GZR on sustainable changes in several HCV-associated symptoms and functional well-being in patients who achieved sustained virological response (SVR). PRIORITIZE, a randomized controlled trial conducted between 2016 and 2020, evaluated change in six PROMIS® symptom scores (fatigue, sleep disturbance, cognitive disturbance, nausea, diarrhoea, abdominal pain) and functional well-being using the disease-specific HCV-PRO instrument. Survey assessments were administered at baseline, early post-treatment (median = 6 months) and late post-treatment (median = 21 months). Constrained longitudinal linear mixed-effects models were used to evaluate within-treatment change and between-treatment differences. Data from 793 participants (average 55 years old, 57% male, 44% black, 17% with cirrhosis) were analysed. From baseline to early post-treatment, 5 out of 6 symptoms and functional well-being significantly improved (all p's < .05). In the LDV/SOF arm, mean changes ranged from -3.73 for nausea to -6.41 for fatigue and in the EBR/GZR, mean changes ranged from -2.19 for cognitive impairment to -4.67 for fatigue. Change of >3 points was consider clinically meaningful. Improvements in most symptoms slightly favoured LDV/SOF, although the magnitude of differences between the regimens were small. Both regimens demonstrated significant improvements in symptoms and functional well-being that were sustained during the late post-treatment phase. EBR/GZR and LDV/SOF regimens had clinically equivalent and durable improvements in HCV symptoms and functional well-being up to two years after SVR.

Duke Scholars

Altmetric Attention Stats
Dimensions Citation Stats

Published In

J Viral Hepat

DOI

EISSN

1365-2893

Publication Date

September 2022

Volume

29

Issue

9

Start / End Page

795 / 806

Location

England

Related Subject Headings

  • Sulfonamides
  • Sofosbuvir
  • Quinoxalines
  • Nausea
  • Middle Aged
  • Male
  • Imidazoles
  • Humans
  • Hepatitis C, Chronic
  • Hepatitis C
 

Citation

APA
Chicago
ICMJE
MLA
NLM
Evon, D. M., Dong, M., Reeve, B. B., Peter, J., Michael, L., Lok, A. S., … Stewart, P. W. (2022). Sustainable and equivalent improvements in symptoms and functional well-being following viral cure from ledipasvir/sofosbuvir versus elbasvir/grazoprevir for chronic hepatitis C infection: Findings from the randomized PRIORITIZE trial. J Viral Hepat, 29(9), 795–806. https://doi.org/10.1111/jvh.13716
Evon, Donna M., Meichen Dong, Bryce B. Reeve, Joy Peter, Larry Michael, Anna S. Lok, David R. Nelson, and Paul W. Stewart. “Sustainable and equivalent improvements in symptoms and functional well-being following viral cure from ledipasvir/sofosbuvir versus elbasvir/grazoprevir for chronic hepatitis C infection: Findings from the randomized PRIORITIZE trial.J Viral Hepat 29, no. 9 (September 2022): 795–806. https://doi.org/10.1111/jvh.13716.
Journal cover image

Published In

J Viral Hepat

DOI

EISSN

1365-2893

Publication Date

September 2022

Volume

29

Issue

9

Start / End Page

795 / 806

Location

England

Related Subject Headings

  • Sulfonamides
  • Sofosbuvir
  • Quinoxalines
  • Nausea
  • Middle Aged
  • Male
  • Imidazoles
  • Humans
  • Hepatitis C, Chronic
  • Hepatitis C