Long-term Benefits of Sustained Virologic Response for Patient-Reported Outcomes in Patients With Chronic Hepatitis C Virus Infection

Zobair M. Younossi, Maria Stepanova, Andrei Racila, Arian Afendy, Eric J. Lawitz, Christian Schwabe, Peter J. Ruane, Jay Lalezari, K. Rajender Reddy, Ira M. Jacobson, Andrew J. Muir, Anuj Gaggar, Robert P. Myers, Issah Younossi, Fatema Nader

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Abstract

Background & Aims: Patients with hepatitis C virus (HCV) infections who achieve a sustained virologic response (SVR) to treatment have improved patient-reported outcomes (PROs). We compared post-treatment PRO scores between patients with chronic HCV infection who did and did not achieve an SVR to treatment. Methods: Patients who completed treatment in clinical trials were enrolled in 2 registries, depending on the treatment outcome (NCT01457755, NCT01457768), from 2016 to 2017 in 17 countries in North America, Europe, and the Asia–Pacific region. PRO scores (scale, 0–100) were collected at pretreatment (baseline); the last day of treatment; the post-treatment week 12 follow-up visit (in patients with SVR only); the registry baseline; and on registry weeks 12, 24, 36, 48, and 96 (the non-SVR registry) or every 24 weeks until week 96 (SVR registry), using the Short Form-36 (SF-36) instrument. Results: Our analysis included 4234 patients with an SVR and 242 without an SVR from whom pretreatment PRO data were available (mean age, 54 ± 10 y; 63% male; 65% enrolled in the United States; 17% with cirrhosis; 12% with human immunodeficiency virus co-infection). Upon registry enrollment, patients with an SVR had significant increases in all PRO scores compared with pretreatment baseline levels (all P < .05). Patients without an SVR had mean reductions of 9.2 points or less in PRO scores while followed up on the registry (P < .05 for 4–8 of 8 PRO domains measured by the SF-36). In contrast, patients with an SVR had sustained increases in PRO scores (mean increase, ≤7.0 points) while on the registry. In multivariate analysis, achieving an SVR was associated independently with superior scores in all SF-36 domains at all registry time points (β, +4.8 to +15.9 points, all P ≤ .01). Conclusions: In a follow-up analysis of participants in clinical trials, we found that those with an SVR to treatment for HCV infection had significant increases in well-being, based on PRO scores. Patients without an SVR had decreasing PRO scores over the follow-up period.

Original languageEnglish (US)
Pages (from-to)468-476.e11
JournalClinical Gastroenterology and Hepatology
Volume18
Issue number2
DOIs
StatePublished - Feb 2020

Keywords

  • HRQoL
  • Mental Health
  • Physical Function
  • Vitality

ASJC Scopus subject areas

  • Hepatology
  • Gastroenterology

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    Younossi, Z. M., Stepanova, M., Racila, A., Afendy, A., Lawitz, E. J., Schwabe, C., Ruane, P. J., Lalezari, J., Reddy, K. R., Jacobson, I. M., Muir, A. J., Gaggar, A., Myers, R. P., Younossi, I., & Nader, F. (2020). Long-term Benefits of Sustained Virologic Response for Patient-Reported Outcomes in Patients With Chronic Hepatitis C Virus Infection. Clinical Gastroenterology and Hepatology, 18(2), 468-476.e11. https://doi.org/10.1016/j.cgh.2019.07.047