N/A
N=1,601
The Patient-Reported Outcomes Project of HCV-TARGET
Hepatitis C, Chronic · Liver Diseases
Bottom Line
View on ClinicalTrials.gov: NCT02601820 ↗Enrolled (actual)
1,601
Serious AEs
—
Results posted
Sep 2019
Primary outcome: Primary: Change in the Total Memorial Symptom Assessment Scale Mean Score (TMSAS) From Baseline to On-Treatment — -0.10; -0.1 units on a scale
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- University of North Carolina, Chapel Hill
- Primary completion
- Jul 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in the Total Memorial Symptom Assessment Scale Mean Score (TMSAS) From Baseline to On-Treatment |
-0.10; -0.1 | — |
| SECONDARY Change in Treatment-Related Symptom Mean Scores From Baseline to On-Treatment |
-1.1; -1.6; 0.8; 0.8; -1.2; -1.5 | — |
| SECONDARY Change in HCV-PRO Mean Scores From Baseline to On-Treatment |
3.2; 3.8 | — |
| SECONDARY Cumulative Out of Pocket Costs During HCV Treatment |
582.50 | — |
| SECONDARY Percentage of Participants With Nonadherence During HCV Treatment |
4.5; 4.2; 5.9; 4; 5.5; 4.3 | — |
| SECONDARY Change in Total Memorial Symptom Assessment Scale (TMSAS) Mean Score From Baseline to 3-months Post Treatment |
-0.2; -0.1 | — |
| SECONDARY Change in HCV Symptom Mean Scores From Baseline to 3-months Post Treatment |
-2.3; 0.2; -2.1; 0.7; -1.7; -0.7 | — |
| SECONDARY Change in HCV-PRO Mean Score From Baseline to 3-months Post Treatment |
6.5; 2.0 | — |
| SECONDARY Change in Total Memorial Symptom Assessment Scale (TMSAS) Mean Score From Baseline to 1 Year Post-Treatment |
-0.2; 0 | — |
| SECONDARY Changes in HCV Symptom Mean Scores From Baseline to 1 Year Post-Treatment |
-2.2; -0.9; -2.2; -0.3; -2.0; -0.4 | — |
| SECONDARY Change in HCV-PRO Mean Score From Baseline to 1 Year Post-treatment |
7.0; 0.6 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT02601820). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.