The Patient-Reported Outcomes Project of HCV-TARGET

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 (PCOR) 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 5 newly approved 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. Nine U.S. liver centers will collaborate on PROP UP.
Approximately 1920 patients with HCV infection who are prescribed a regimen containing
Harvoni®, Viekera Pak®, Zepatier®, DAC/SOF or SOF/VEL 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.

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 (Harvoni®) with or without ribavirin

- ombitasvir/paritaprevir/ritonavir with dasabuvir (Viekera Pak®), VPK) with or
without ribavirin

- elbasvir/grazoprevir (Zepatier®) 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