Patient engagement and study design of PROP UP: A multi-site patient-centered prospective observational study of patients undergoing hepatitis C treatment.
New highly efficacious direct-acting antiviral (DAA) therapies are available to treat chronic hepatitis C viral (HCV) infection. Real-world, patient-centered data on harms and benefits associated with these therapies are needed.



PROP UP is a multi-center prospective observational study that plans to enroll 1600 patients starting treatment with recently-approved DAA regimens. Informed by extensive input from a HCV patient engagement group who prioritized outcomes most important to them, patient-reported outcomes will be characterized using surveys at five time points: Baseline (T1), treatment week 4 (T2), end of treatment (T3), 12weeks post-treatment (T4), 12months post-treatment (T5).



(1) Changes in side effects, functioning, pre-existing conditions, and out-of-pocket costs during therapy (T1 vs T2/T3); (2) Medication adherence in relation to a history of mental health/substance abuse, treatment regimens, pill burden, reasons for missed doses, and cure rates; (3) Short term impact of cure on functioning and amelioration of symptoms (T1 vs T4); (4) Long-term treatment harms or benefits of cure on symptoms, side effects, pre-existing conditions, and functioning (T1 vs T5). Similarities between regimens will be examined where comparisons are appropriate and meaningful.



PROP UP complements previous clinical trials by focusing on patient-reported outcomes in a representative sample of patients treated in clinical practice, by collaborating with a patient engagement group, by characterizing the experiences of vulnerable subgroups, and by investigating long-term harms and benefits of treatments. PROP UP is designed to provide novel and detailed information to support informed decision-making for patients and providers contemplating HCV treatment (PCORI CER-1408-20,660; NCT02601820).
Division of Gastroenterology and Hepatology, University of North Carolina, United States. Electronic address: Donna_evon@med.unc.edu.
Donna M
DM
Evon
Division of General Medicine and Clinical Epidemiology, University of North Carolina, United States; Department of Health Behavior, University of North Carolina, United States.
Carol E
CE
Golin
Department of Biostatistics, University of North Carolina, United States.
Paul
P
Stewart
Division of Gastroenterology and Hepatology, University of North Carolina, United States.
Michael W
MW
Fried
Division of Gastroenterology and Hepatology, University of North Carolina, United States.
Shani
S
Alston
Department of Health Policy and Management, University of North Carolina, United States.
Bryce
B
Reeve
Division of Gastroenterology and Hepatology, University of Michigan, United States.
Anna S
AS
Lok
Department of Internal Medicine, Virginia Commonwealth University, United States.
Richard K
RK
Sterling
Department of Internal Medicine, Yale University, United States.
Joseph K
JK
Lim
Department of Internal Medicine, Rush Medical College, United States.
Nancy
N
Reau
Department of Internal Medicine, University of California, Davis, United States.
Souvik
S
Sarkar
Department of Medicine, University of Florida, United States.
David R
DR
Nelson
Department of Medicine, the University of Pennsylvania, United States.
K R
KR
Reddy
Department of Internal Medicine, Saint Louis University, United States.
Adrian M
AM
Di Bisceglie
D000328:Adult; D000998:Antiviral Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001562:Benzimidazoles / Q000009:adverse effects / Q000627:therapeutic use; D001572:Benzofurans / Q000009:adverse effects / Q000627:therapeutic use; D002219:Carbamates / Q000009:adverse effects / Q000627:therapeutic use; D004338:Drug Combinations; D005260:Female; D005449:Fluorenes / Q000009:adverse effects / Q000627:therapeutic use; D019698:Hepatitis C, Chronic / Q000188:drug therapy*; D006576:Heterocyclic Compounds, 4 or More Rings / Q000009:adverse effects / Q000627:therapeutic use; D006801:Humans; D007093:Imidazoles / Q000009:adverse effects / Q000627:therapeutic use; D047028:Macrocyclic Compounds / Q000009:adverse effects / Q000627:therapeutic use; D008297:Male; D010358:Patient Participation; D018802:Patient-Centered Care / Q000379:methods; D011446:Prospective Studies; D011759:Pyrrolidines; D011810:Quinoxalines / Q000009:adverse effects / Q000627:therapeutic use; D019438:Ritonavir / Q000009:adverse effects / Q000627:therapeutic use; D000069474:Sofosbuvir / Q000009:adverse effects / Q000627:therapeutic use; D013449:Sulfonamides / Q000009:adverse effects / Q000627:therapeutic use; D016896:Treatment Outcome; D014498:Uracil / Q000009:adverse effects / Q000031:analogs & derivatives / Q000627:therapeutic use; D014542:Uridine Monophosphate / Q000009:adverse effects / Q000031:analogs & derivatives / Q000627:therapeutic use; D014633:Valine / Q000031:analogs & derivatives
D000998:Antiviral Agents; D001562:Benzimidazoles; D001572:Benzofurans; D002219:Carbamates; D004338:Drug Combinations; D005449:Fluorenes; D006576:Heterocyclic Compounds, 4 or More Rings; D007093:Imidazoles; D047028:Macrocyclic Compounds; D011759:Pyrrolidines; D011810:Quinoxalines; D013449:Sulfonamides; C000607373:Viekira Pak; C000611265:elbasvir-grazoprevir drug combination; C000595958:ledipasvir, sofosbuvir drug combination; C000611331:sofosbuvir-velpatasvir drug combination; D014498:Uracil; D014542:Uridine Monophosphate; D014633:Valine; C549273:daclatasvir; D019438:Ritonavir; D000069474:Sofosbuvir
Direct acting antiviral (DAA); Hepatitis; Liver; Patient-centered outcomes research (PCOR); Patient-reported outcomes