The Patient-Reported Outcomes Project of HCV-TARGET

NCT02601820 | Completed Results

• 1 other identifier: 15-1633
• Study Type: observational
• Target: 1,601
• Locations: 1 country
• Sites: 11

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.

Conditions

Hepatitis C, Chronic; Liver Diseases

Keywords

patient-reported outcomes; observational; HCV; Hepatitis C; Liver Disease; Liver; Infectious Disease; PROs

Outcome Measures

Primary Outcomes (1)

• Change in the Total Memorial Symptom Assessment Scale Mean Score (TMSAS) From Baseline to On-Treatment

  Change in "Overall Symptom Burden" was measured using the Memorial Symptom Assessment Scale (MSAS). Patients indicate the presence or absence of a symptom, and if present, rate the symptom on severity, frequency and interference. The total MSAS score (TMSAS) can range from 0 (no symptom) to 4 (symptom present and worst severity, frequency and distress). Change in TMSAS score is calculated as Baseline TMSAS mean score minus T2 TMSAS mean score or Baseline TMSAS mean score minus T3 TMSAS mean score. Change scores could range from +/- 4.0. Higher scores (+) indicate worse symptom burden. To aid in interpretation of clinically significant change, a \>5% change from baseline was set as the "minimally important change (MIC)" threshold. A 5% change in the TMSAS = 0.3 points; therefore TMSAS change scores \> +/- 0.3 were considered clinically meaningful.

  Baseline to up to 24 weeks of HCV Treatment

Secondary Outcomes (10)

• Change in Treatment-Related Symptom Mean Scores From Baseline to On-Treatment

  Baseline to up to 24 weeks of HCV Treatment

• Change in HCV-PRO Mean Scores From Baseline to On-Treatment

  Baseline to up to 24 weeks of HCV Treatment

• Cumulative Out of Pocket Costs During HCV Treatment

  Up to 24 weeks of HCV Treatment

• Percentage of Participants With Nonadherence During HCV Treatment

  Up to 24 weeks of HCV Treatment

• Change in Total Memorial Symptom Assessment Scale (TMSAS) Mean Score From Baseline to 3-months Post Treatment

  Baseline to 3-months post-treatment

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (11)

University of California at Davis

Davis, California, 95616, United States

Location

Yale University

New Haven, Connecticut, 06520, United States

Location

University of Florida

Gainesville, Florida, 32611, United States

Location

Rush University

Chicago, Illinois, 60612, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

St Louis University

St Louis, Missouri, 63104, United States

Location

Asheville Gastroenterology Associates

Asheville, North Carolina, 28801, United States

Location

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Wilmington Gastroenterology Associates

Wilmington, North Carolina, 28403, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

Related Publications (4)

• 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.

  PMID: 33387381 DERIVED

• 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.

  PMID: 31096006 DERIVED

• 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.

  PMID: 30067745 DERIVED

• 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.

  PMID: 28342989 DERIVED

Related Links

• PROP UP Patient Website

MeSH Terms

Conditions

Hepatitis C, Chronic; Liver Diseases; Hepatitis C; Communicable Diseases

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

The secondary outcome - cumulative out of pocket costs- may include less reliable data at the upper limit. Patient reporting of cumulative costs at 3 time points likely led to erroneous inflation affecting the upper limit.

Results Point of Contact

• Title: Donna Evon, PhD
• Organization: University of North Carolina at Chapel Hill

donna_evon@med.unc.edu

919-260-4062

Study Officials

• Donna M. Evon, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2015
• First Posted: November 10, 2015
• Study Start: November 1, 2015
• Primary Completion: July 1, 2018
• Study Completion: July 1, 2018
• Last Updated: September 16, 2019
• Results First Posted: September 16, 2019

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (11)