Patient-reported symptoms during and after direct-acting antiviral therapies for chronic hepatitis C: The PROP UP study

Donna M. Evon, Souvik Sarkar, J. Amador, Anna S. Lok, Richard K. Sterling, Paul W. Stewart, Bryce B. Reeve, Marina Serper, N. Reau, K. Rajender Reddy, Adrian M. Di Bisceglie, David R. Nelson, Carol E. Golin, Joseph K. Lim, Michael W. Fried

Research output: Contribution to journalArticle

Abstract

Background & Aims: A comprehensive analysis of changes in symptoms and functioning during and after direct-acting antiviral (DAA) therapy for chronic hepatitis C virus (HCV) infection has not been conducted for patients treated in real-world clinical settings. Therefore, we evaluated patient-reported outcomes (PROs) in a diverse cohort of patients with HCV treated with commonly prescribed DAAs. Methods: PROP UP is a US multicenter observational study of 1,601 patients with HCV treated with DAAs in 2016-2017. PRO data were collected at baseline (T1), early on-treatment (T2), late on-treatment (T3) and 3-months post-treatment (T4). PRO mean change scores were calculated from baseline and a minimally important change (MIC) threshold was set at 5%. Regression analyses investigated patient and treatment characteristics independently associated with PRO changes on-treatment and post-treatment. Results: Of 1,564 patients, 55% were male, 39% non-white, 47% had cirrhosis. Sofosbuvir/ledipasvir was prescribed to 63%, sofosbuvir/velpatasvir to 21%, grazoprevir/elbasvir to 11%, and paritaprevir/ombitasvir/ritonavir + dasabuvir to 5%. During DAA therapy, mean PRO scores improved slightly in the overall cohort, but did not reach the 5% MIC threshold. Between 21–53% of patients experienced >5% improved PROs while 23–36% experienced >5% worse symptoms. Of 1,410 patients with evaluable sustained virologic response (SVR) data, 95% achieved SVR. Among those with SVR, all mean PRO scores improved, with the 5% MIC threshold met for fatigue, sleep disturbance, and functioning well-being. Regression analyses identified subgroups, defined by age 35–55, baseline mental health issues and a higher number of health comorbidities as predictors of PRO improvements. Conclusions: In real-world clinical practices, we observed heterogeneous patient experiences during and after DAA treatment. Symptom improvements were more pronounced in younger patients, those with baseline mental health issues and multiple comorbidities. Lay summary: Patients who received direct-acting antiviral medications for hepatitis C at several liver centers in the US did not generally experience significant changes in baseline symptoms during treatment. We observed a full range of patient experiences with some patients experiencing substantial symptom improvements, yet others experiencing less improvements and some even experiencing a worsening of symptoms. The 1,346 patients who were cured of hepatitis C experienced improvements in fatigue, sleep disturbance, and functional well-being, and trends for improved pain and depression; whereas the 64 who were not cured experienced minimal improvements. Clinicaltrial.gov: NCT02601820.

Original languageEnglish (US)
JournalJournal of Hepatology
DOIs
StatePublished - Jan 1 2019

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Chronic Hepatitis C
Antiviral Agents
Therapeutics
Hepacivirus
Hepatitis C
Fatigue
Comorbidity
Mental Health
Sleep
Regression Analysis
Ritonavir
Patient Reported Outcome Measures
Virus Diseases
Multicenter Studies
Observational Studies
Fibrosis
Depression

Keywords

  • Functioning
  • HCV
  • Liver
  • Pain
  • Patient-reported outcome
  • PRO
  • Quality of life
  • Sleep
  • Symptom
  • Treatment

ASJC Scopus subject areas

  • Hepatology

Cite this

Patient-reported symptoms during and after direct-acting antiviral therapies for chronic hepatitis C : The PROP UP study. / Evon, Donna M.; Sarkar, Souvik; Amador, J.; Lok, Anna S.; Sterling, Richard K.; Stewart, Paul W.; Reeve, Bryce B.; Serper, Marina; Reau, N.; Rajender Reddy, K.; Di Bisceglie, Adrian M.; Nelson, David R.; Golin, Carol E.; Lim, Joseph K.; Fried, Michael W.

In: Journal of Hepatology, 01.01.2019.

Research output: Contribution to journalArticle

Evon, DM, Sarkar, S, Amador, J, Lok, AS, Sterling, RK, Stewart, PW, Reeve, BB, Serper, M, Reau, N, Rajender Reddy, K, Di Bisceglie, AM, Nelson, DR, Golin, CE, Lim, JK & Fried, MW 2019, 'Patient-reported symptoms during and after direct-acting antiviral therapies for chronic hepatitis C: The PROP UP study', Journal of Hepatology. https://doi.org/10.1016/j.jhep.2019.04.016
Evon, Donna M. ; Sarkar, Souvik ; Amador, J. ; Lok, Anna S. ; Sterling, Richard K. ; Stewart, Paul W. ; Reeve, Bryce B. ; Serper, Marina ; Reau, N. ; Rajender Reddy, K. ; Di Bisceglie, Adrian M. ; Nelson, David R. ; Golin, Carol E. ; Lim, Joseph K. ; Fried, Michael W. / Patient-reported symptoms during and after direct-acting antiviral therapies for chronic hepatitis C : The PROP UP study. In: Journal of Hepatology. 2019.
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day = "1",
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TY - JOUR

T1 - Patient-reported symptoms during and after direct-acting antiviral therapies for chronic hepatitis C

T2 - The PROP UP study

AU - Evon, Donna M.

AU - Sarkar, Souvik

AU - Amador, J.

AU - Lok, Anna S.

AU - Sterling, Richard K.

AU - Stewart, Paul W.

AU - Reeve, Bryce B.

AU - Serper, Marina

AU - Reau, N.

AU - Rajender Reddy, K.

AU - Di Bisceglie, Adrian M.

AU - Nelson, David R.

AU - Golin, Carol E.

AU - Lim, Joseph K.

AU - Fried, Michael W.

PY - 2019/1/1

Y1 - 2019/1/1

N2 - Background & Aims: A comprehensive analysis of changes in symptoms and functioning during and after direct-acting antiviral (DAA) therapy for chronic hepatitis C virus (HCV) infection has not been conducted for patients treated in real-world clinical settings. Therefore, we evaluated patient-reported outcomes (PROs) in a diverse cohort of patients with HCV treated with commonly prescribed DAAs. Methods: PROP UP is a US multicenter observational study of 1,601 patients with HCV treated with DAAs in 2016-2017. PRO data were collected at baseline (T1), early on-treatment (T2), late on-treatment (T3) and 3-months post-treatment (T4). PRO mean change scores were calculated from baseline and a minimally important change (MIC) threshold was set at 5%. Regression analyses investigated patient and treatment characteristics independently associated with PRO changes on-treatment and post-treatment. Results: Of 1,564 patients, 55% were male, 39% non-white, 47% had cirrhosis. Sofosbuvir/ledipasvir was prescribed to 63%, sofosbuvir/velpatasvir to 21%, grazoprevir/elbasvir to 11%, and paritaprevir/ombitasvir/ritonavir + dasabuvir to 5%. During DAA therapy, mean PRO scores improved slightly in the overall cohort, but did not reach the 5% MIC threshold. Between 21–53% of patients experienced >5% improved PROs while 23–36% experienced >5% worse symptoms. Of 1,410 patients with evaluable sustained virologic response (SVR) data, 95% achieved SVR. Among those with SVR, all mean PRO scores improved, with the 5% MIC threshold met for fatigue, sleep disturbance, and functioning well-being. Regression analyses identified subgroups, defined by age 35–55, baseline mental health issues and a higher number of health comorbidities as predictors of PRO improvements. Conclusions: In real-world clinical practices, we observed heterogeneous patient experiences during and after DAA treatment. Symptom improvements were more pronounced in younger patients, those with baseline mental health issues and multiple comorbidities. Lay summary: Patients who received direct-acting antiviral medications for hepatitis C at several liver centers in the US did not generally experience significant changes in baseline symptoms during treatment. We observed a full range of patient experiences with some patients experiencing substantial symptom improvements, yet others experiencing less improvements and some even experiencing a worsening of symptoms. The 1,346 patients who were cured of hepatitis C experienced improvements in fatigue, sleep disturbance, and functional well-being, and trends for improved pain and depression; whereas the 64 who were not cured experienced minimal improvements. Clinicaltrial.gov: NCT02601820.

AB - Background & Aims: A comprehensive analysis of changes in symptoms and functioning during and after direct-acting antiviral (DAA) therapy for chronic hepatitis C virus (HCV) infection has not been conducted for patients treated in real-world clinical settings. Therefore, we evaluated patient-reported outcomes (PROs) in a diverse cohort of patients with HCV treated with commonly prescribed DAAs. Methods: PROP UP is a US multicenter observational study of 1,601 patients with HCV treated with DAAs in 2016-2017. PRO data were collected at baseline (T1), early on-treatment (T2), late on-treatment (T3) and 3-months post-treatment (T4). PRO mean change scores were calculated from baseline and a minimally important change (MIC) threshold was set at 5%. Regression analyses investigated patient and treatment characteristics independently associated with PRO changes on-treatment and post-treatment. Results: Of 1,564 patients, 55% were male, 39% non-white, 47% had cirrhosis. Sofosbuvir/ledipasvir was prescribed to 63%, sofosbuvir/velpatasvir to 21%, grazoprevir/elbasvir to 11%, and paritaprevir/ombitasvir/ritonavir + dasabuvir to 5%. During DAA therapy, mean PRO scores improved slightly in the overall cohort, but did not reach the 5% MIC threshold. Between 21–53% of patients experienced >5% improved PROs while 23–36% experienced >5% worse symptoms. Of 1,410 patients with evaluable sustained virologic response (SVR) data, 95% achieved SVR. Among those with SVR, all mean PRO scores improved, with the 5% MIC threshold met for fatigue, sleep disturbance, and functioning well-being. Regression analyses identified subgroups, defined by age 35–55, baseline mental health issues and a higher number of health comorbidities as predictors of PRO improvements. Conclusions: In real-world clinical practices, we observed heterogeneous patient experiences during and after DAA treatment. Symptom improvements were more pronounced in younger patients, those with baseline mental health issues and multiple comorbidities. Lay summary: Patients who received direct-acting antiviral medications for hepatitis C at several liver centers in the US did not generally experience significant changes in baseline symptoms during treatment. We observed a full range of patient experiences with some patients experiencing substantial symptom improvements, yet others experiencing less improvements and some even experiencing a worsening of symptoms. The 1,346 patients who were cured of hepatitis C experienced improvements in fatigue, sleep disturbance, and functional well-being, and trends for improved pain and depression; whereas the 64 who were not cured experienced minimal improvements. Clinicaltrial.gov: NCT02601820.

KW - Functioning

KW - HCV

KW - Liver

KW - Pain

KW - Patient-reported outcome

KW - PRO

KW - Quality of life

KW - Sleep

KW - Symptom

KW - Treatment

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