Viral eradication is required for sustained improvement of patient-reported outcomes in patients with hepatitis C.
Aged
Aminoisobutyric Acids
Antiviral Agents
/ administration & dosage
Carbamates
/ administration & dosage
Cyclopropanes
Drug Therapy, Combination
Female
Hepacivirus
/ genetics
Hepatitis C, Chronic
/ complications
Heterocyclic Compounds, 4 or More Rings
/ administration & dosage
Humans
Lactams, Macrocyclic
Leucine
/ analogs & derivatives
Linear Models
Liver Cirrhosis
/ epidemiology
Macrocyclic Compounds
/ administration & dosage
Male
Middle Aged
Multivariate Analysis
Patient Reported Outcome Measures
Proline
/ analogs & derivatives
Quality of Life
Quinoxalines
Sofosbuvir
/ administration & dosage
Sulfonamides
/ administration & dosage
Sustained Virologic Response
emotional health
fatigue
health-related quality of life
vitality
work productivity
Journal
Liver international : official journal of the International Association for the Study of the Liver
ISSN: 1478-3231
Titre abrégé: Liver Int
Pays: United States
ID NLM: 101160857
Informations de publication
Date de publication:
01 2019
01 2019
Historique:
received:
05
03
2018
accepted:
05
06
2018
pubmed:
13
6
2018
medline:
9
1
2020
entrez:
13
6
2018
Statut:
ppublish
Résumé
Clearance of chronic HCV infection improves quality of life and other patient-reported outcomes (PROs). Lack of placebo-controlled data led to concerns about the extent of contribution of viral eradication to PRO improvement. To assess PRO changes in HCV patients initially randomized to placebo treatment who received SOF/VEL/VOX in a deferred treatment substudy. HCV-infected direct-acting antivirals-experienced patients who received placebo treatment in POLARIS-1 subsequently received SOF/VEL/VOX (400/100/100 mg) daily for 12 weeks. PROs were prospectively collected using SF-36v2, CLDQ-HCV, FACIT-F, WPAI:SHP. Of 147 patients treated, most were male (79%), white (82%), 33% had cirrhosis, 99% had HCV genotype 1 with SVR-12 of 97%. During treatment with placebo, there were no significant changes in any PROs from patients' own baseline (all P > .05) except for the Worry domain of CLDQ-HCV. However, soon after initiation of treatment with SOF/VEL/VOX, significant PRO improvements were noted: +2.4% to +8.1% of a PRO range size, P < .05 for 6 of the 26 studied PROs, by treatment week 4; +2.0% to +8.3%, P < .05 for 14/26 PROs by treatment week 12. Achieving SVR was associated with similar or greater PRO improvement: +2.5% to +11.9%, P < .05 for 24/26 PROs, by SVR-12; +3.2% to +14.9%, P < .05 for 23/26 PROs, by SVR-24. In multivariate regression analysis, being viraemic was associated with PRO impairment: beta from -2.4% to -8.5%, P < .05 for all but one PRO. Treatment with SOF/VEL/VOX for 12 weeks led to significant and sustainable improvement in patient-reported outcomes in patients who had previously failed another direct-acting antiviral regimen.
Sections du résumé
BACKGROUND
Clearance of chronic HCV infection improves quality of life and other patient-reported outcomes (PROs). Lack of placebo-controlled data led to concerns about the extent of contribution of viral eradication to PRO improvement.
AIM
To assess PRO changes in HCV patients initially randomized to placebo treatment who received SOF/VEL/VOX in a deferred treatment substudy.
METHODS
HCV-infected direct-acting antivirals-experienced patients who received placebo treatment in POLARIS-1 subsequently received SOF/VEL/VOX (400/100/100 mg) daily for 12 weeks. PROs were prospectively collected using SF-36v2, CLDQ-HCV, FACIT-F, WPAI:SHP.
RESULTS
Of 147 patients treated, most were male (79%), white (82%), 33% had cirrhosis, 99% had HCV genotype 1 with SVR-12 of 97%. During treatment with placebo, there were no significant changes in any PROs from patients' own baseline (all P > .05) except for the Worry domain of CLDQ-HCV. However, soon after initiation of treatment with SOF/VEL/VOX, significant PRO improvements were noted: +2.4% to +8.1% of a PRO range size, P < .05 for 6 of the 26 studied PROs, by treatment week 4; +2.0% to +8.3%, P < .05 for 14/26 PROs by treatment week 12. Achieving SVR was associated with similar or greater PRO improvement: +2.5% to +11.9%, P < .05 for 24/26 PROs, by SVR-12; +3.2% to +14.9%, P < .05 for 23/26 PROs, by SVR-24. In multivariate regression analysis, being viraemic was associated with PRO impairment: beta from -2.4% to -8.5%, P < .05 for all but one PRO.
CONCLUSION
Treatment with SOF/VEL/VOX for 12 weeks led to significant and sustainable improvement in patient-reported outcomes in patients who had previously failed another direct-acting antiviral regimen.
Substances chimiques
Aminoisobutyric Acids
0
Antiviral Agents
0
Carbamates
0
Cyclopropanes
0
Heterocyclic Compounds, 4 or More Rings
0
Lactams, Macrocyclic
0
Macrocyclic Compounds
0
Quinoxalines
0
Sulfonamides
0
voxilaprevir
0570F37359
Proline
9DLQ4CIU6V
Leucine
GMW67QNF9C
velpatasvir
KCU0C7RS7Z
Sofosbuvir
WJ6CA3ZU8B
Types de publication
Clinical Trial, Phase III
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
54-59Informations de copyright
© 2018 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.