Clinical trial NCT02601820: The Patient-Reported Outcomes Project of HCV-TARGET
Official title: The Patient-Reported Outcomes Project of HCV-TARGET (PROP UP)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis C, Chronic
Liver Diseases
Keywords: patient-reported outcomes
observational
HCV
Hepatitis C
Liver Disease
Liver
Infectious Disease
PROs
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2015-11-10
Enrollment: 1601
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients being evaluated for Hep C treatment in 9 large academic liver centers and two private gastroenterology practices in the US.

Brief summary: The PROP UP research study is funded by The Patient Centered Outcomes Research Institute (PCORI). PROP UP is a multi-centered prospective observational study that will evaluate all-oral treatment regimens for chronic hepatitis C viral (HCV) infection regarding several patient-reported outcomes (PROs) such as HCV-associated symptoms, treatment side effects, medication adherence, out of pocket costs, comorbid conditions, and long-term benefits of cure and harms of treatment to compare PROs of different treatment regimens, treatment durations, and patient subgroups. Participants will be recruited from 9 U.S. liver centers. Approximately 1920 patients with HCV infection who are prescribed a regimen containing Sofosbuvir/Ledipasvir(SOF/LED), SOF/Velpatasvir(SOF/VEL), Grazoprevir/Elbasvir(GRZ/ELB), OBV/PTV/r + DSV (PRoD), or daclatasvir/SOF (DAC/SOF) will be recruited and approximately 1600 patients who are approved and begin HCV treatment will be enrolled in the longitudinal study. PRO surveys will be evaluated before, during and after HCV treatment.

PROP UP is a collaborative effort between behavioral and biomedical researchers, a patient engagement group and a patient advocacy organization.

Detailed description: Newer, more effective all-oral regimens for hepatitis C viral (HCV) infection are available. However the available data from industry-sponsored trials do not provide all the information that patients need, nor do these data represent the broad spectrum of patients treated in real-world practice. Trials also exclude disadvantaged subgroups, focus on short-term efficacy and clinician-rated adverse events, rarely obtain the patient's perspective, and do not investigate longer-term harms of treatment or benefits of viral cure. Given these informational gaps, patient-centered outcomes research on treatment harms and benefits that matter most to patients, is needed.

PROP UP is funded by The Patient Centered Outcomes Research Institute (PCORI). PROP UP is a multi-centered prospective observational study that will evaluate newly approved direct acting antiviral (DAA) treatment regimens for HCV regarding several patient-reported outcomes (PROs) such as HCV-associated symptoms, treatment side effects, medication adherence, out of pocket costs, comorbid conditions, and long-term benefits of cure and harms of treatment to compare PROs of different treatment regimens, treatment durations, and patient subgroups.

PROP UP is a collaborative effort between researchers, a patient engagement group, and a patient advocacy organization. Eleven U.S. liver centers will collaborate on PROP UP. Approximately 1920 patients with HCV infection who are prescribed a DAA regimen for chronic HCV will be consented and will complete baseline PRO surveys. Approximately 1600 patients who are approved and begin HCV treatment will be enrolled in the longitudinal study. Participants will complete several PRO surveys at 5 assessment periods during the study: baseline, treatment week 4, end of treatment, 3 months post-treatment, and 12 months post-treatment. PRO survey data will be collected via 3 options: patient home-based computers, tablet, smartphone; phone-administered surveys with a centralized call enter; or at regular clinic visits.

Analysis of PROs collected longitudinally before, during and after treatment for HCV will allow the investigators to answer a variety of questions important to patients and clinicians. Specifically, the investigators will evaluate: (a) prevalence of pre-existing baseline symptoms associated with HCV; (b) the development of new onset treatment side effects and exacerbation of pre-existing symptoms during HCV treatment; (c) medication adherence and out of pocket costs associated with treatment; (d) changes in HCV-associated symptoms and functional status in patients who are cured; (e) long-term patient-reported harms associated with treatments and long-term benefits associated with viral cure.

Eligibility criteria: Inclusion Criteria:

* Diagnosed with HCV genotype 1-6
* English-speaking
* Age 21 or older
* Medically cleared and being prescribed one of the following DAA regimens:

  * sofosbuvir/ledipasvir (SOF/LED) with or without ribavirin
  * ombitasvir/paritaprevir/ritonavir with dasabuvir (PRoD), with or without ribavirin
  * elbasvir/grazoprevir (ELB/GRZ) with or without ribavirin
  * daclatasvir/sofosbuvir, with or without ribavirin (DAC/SOF)
  * sofosbuvir/velpatasvir (SOF/VEL)

Exclusion Criteria:

* Inability to provide written informed consent
* Currently participating in a pharmaceutical-sponsored drug trial of hepatitis C treatment
* Major cognitive or mental impairment
* Unable to read or speak English
* Unwilling or unable to complete survey questionnaires

Primary outcomes:
measure: Change in the Total Memorial Symptom Assessment Scale Mean Score (TMSAS) From Baseline to On-Treatment
timeFrame: Baseline to up to 24 weeks of HCV Treatment
Secondary outcomes:
measure: Change in Treatment-Related Symptom Mean Scores From Baseline to On-Treatment
timeFrame: Baseline to up to 24 weeks of HCV Treatment
measure: Change in HCV-PRO Mean Scores From Baseline to On-Treatment
timeFrame: Baseline to up to 24 weeks of HCV Treatment
measure: Cumulative Out of Pocket Costs During HCV Treatment
timeFrame: Up to 24 weeks of HCV Treatment
measure: Percentage of Participants With Nonadherence During HCV Treatment
timeFrame: Up to 24 weeks of HCV Treatment
measure: Change in Total Memorial Symptom Assessment Scale (TMSAS) Mean Score From Baseline to 3-months Post Treatment
timeFrame: Baseline to 3-months post-treatment
measure: Change in HCV Symptom Mean Scores From Baseline to 3-months Post Treatment
timeFrame: Baseline to 3-months post-treatment
measure: Change in HCV-PRO Mean Score From Baseline to 3-months Post Treatment
timeFrame: Baseline to 3-months post-treatment
measure: Change in Total Memorial Symptom Assessment Scale (TMSAS) Mean Score From Baseline to 1 Year Post-Treatment
timeFrame: Baseline to 1 year post-treatment
measure: Changes in HCV Symptom Mean Scores From Baseline to 1 Year Post-Treatment
timeFrame: Baseline to 1 year post-treatment
measure: Change in HCV-PRO Mean Score From Baseline to 1 Year Post-treatment
timeFrame: Baseline to 1 year post-treatment
Other outcomes:
Locations:
city: Davis
country: United States
facility: University of California at Davis
state: California
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Chicago
country: United States
facility: Rush University
state: Illinois
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Saint Louis
country: United States
facility: St Louis University
state: Missouri
city: Asheville
country: United States
facility: Asheville Gastroenterology Associates
state: North Carolina
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
city: Wilmington
country: United States
facility: Wilmington Gastroenterology Associates
state: North Carolina
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Donna M. Evon, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Serper M, Evon DM, Amador J, Stewart PW, Sarkar S, Lok AS, Sterling RK, Reeve BB, Golin CE, Rajender Reddy K, Lim JK, Reau N, Nelson DR, Di Bisceglie AM, Fried MW. Patient-reported outcomes 12 months after hepatitis C treatment with direct-acting antivirals: Results from the PROP UP study. Liver Int. 2021 Apr;41(4):692-704. doi: 10.1111/liv.14781. Epub 2021 Jan 22.
citation: 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. Patient-reported symptoms during and after direct-acting antiviral therapies for chronic hepatitis C: The PROP UP study. J Hepatol. 2019 Sep;71(3):486-497. doi: 10.1016/j.jhep.2019.04.016. Epub 2019 May 13.
citation: Evon DM, Stewart PW, Amador J, Serper M, Lok AS, Sterling RK, Sarkar S, Golin CE, Reeve BB, Nelson DR, Reau N, Lim JK, Reddy KR, Di Bisceglie AM, Fried MW. A comprehensive assessment of patient reported symptom burden, medical comorbidities, and functional well being in patients initiating direct acting antiviral therapy for chronic hepatitis C: Results from a large US multi-center observational study. PLoS One. 2018 Aug 1;13(8):e0196908. doi: 10.1371/journal.pone.0196908. eCollection 2018.
citation: Evon DM, Golin CE, Stewart P, Fried MW, Alston S, Reeve B, Lok AS, Sterling RK, Lim JK, Reau N, Sarkar S, Nelson DR, Reddy KR, Di Bisceglie AM. Patient engagement and study design of PROP UP: A multi-site patient-centered prospective observational study of patients undergoing hepatitis C treatment. Contemp Clin Trials. 2017 Jun;57:58-68. doi: 10.1016/j.cct.2017.03.013. Epub 2017 Mar 22.