Chronic Hepatitis c
Conditions
Brief summary
Objective: To coordinate active tracing of chronic hepatitis C patients lost to follow-up to inform them about there disease severity and treatment options. Study design: This is a prospective cohort study, which will start as a pilot study in the Radboudumc Population: lost to follow-up chronic hepatitis C patients in the region Nijmegen. This so-called lost population consists of all patients, that in the past have been identified at the Radboudumc but who are currently lost to or have been withdrawn from follow-up. The time-span of interest will be 2000-2015. We estimate that this project will retrace 100 lost patients through this search.
Interventions
None listed
Sponsors
Merck Sharp & Dohme LLC
Radboud University Medical Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* ever diagnosed with hepatitis C, lost to follow-up
Exclusion criteria
* none
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Liver Fibrosis Stage | Baseline | Fibrosis stage according to elastography (liver stiffness in kPa) and/or liverbiopsy (staging according to Metavir). Stage F0/1 equals minimal fibrosis, stage F2 equals significant fibrosis and stage F3/F4 equals advanced fibrosis (including cirrhosis). For elastography, F0/1 is defined as liver stiffness \<7.1 kPa, F2 as liver stiffness between 7.1 and 9.4 kPa and F3/F4 as liver stiffness \>9.4 kPa. For liver biopsy, F0/1 is defined as the presence of no fibrosis or minimal fibrosis without the presence of septa, F2 as the presence of portal fibrosis with a few septa and F3/F4 as the presence of septal fibrosis or cirrhosis. The higher the fibrosis stage, the worse the outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reasons for Loss to Follow-up | Baseline | through chart review or questioning screening event |
| Genotype Distribution | Baseline | Genotype distribution among RNA-positive patients |
| Fibrosis Progression | Baseline | Fibrosis stage comparison in patients with a previously recorded fibrosis measurement, either with Fibroscan or liver biopsy. This previous measurement will be compared to the result of the Fibroscan performed during re-evaluation. |
| Treatment Outcome | At least 12 weeks after end of treatment | Sustained virological response in treated patients, defined as non-detectable HCV RNA at least 12 weeks after end of treatment |
Countries
Netherlands
Participant flow
Recruitment details
After identification of lost to follow-up hepatitis C patients, patients who were alive and residing in the Netherlands were invited for re-evaluation at the outpatient clinic.
Pre-assignment details
After invitation, patients could not be enrolled (defined as the signing of informed consent) for multiple reasons. These reasons are described below.
Participants by arm
| Arm | Count |
|---|---|
| Re-evaluated Lost to Follow-up Patients Invited lost to follow-up patients who were seen at the outpatient clinic. | 10 |
| Total | 10 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Contact not established | 13 |
| Overall Study | In care/cured elsewhere | 15 |
| Overall Study | Moved outside study region | 50 |
| Overall Study | Refuse re-evaluation | 13 |
| Overall Study | Severe comorbidity/short life expectancy | 5 |
Baseline characteristics
| Characteristic | Re-evaluated Lost to Follow-up Patients |
|---|---|
| Age, Continuous | 62 years |
| Country of birth England | 1 Participants |
| Country of birth France | 1 Participants |
| Country of birth Netherlands | 8 Participants |
| HCV transmission route Blood transfusion | 3 Participants |
| HCV transmission route Intravenous drug use | 7 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 10 Participants |
| Region of Enrollment Netherlands | 10 participants |
| RNA-positive | 5 Participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 10 Participants |
| Treatment experienced | 5 Participants |
| Years since last hospital contact | 13.5 years |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 5 |
| other Total, other adverse events | 0 / 5 |
| serious Total, serious adverse events | 0 / 5 |
Outcome results
Primary
Liver Fibrosis Stage
Fibrosis stage according to elastography (liver stiffness in kPa) and/or liverbiopsy (staging according to Metavir). Stage F0/1 equals minimal fibrosis, stage F2 equals significant fibrosis and stage F3/F4 equals advanced fibrosis (including cirrhosis). For elastography, F0/1 is defined as liver stiffness \<7.1 kPa, F2 as liver stiffness between 7.1 and 9.4 kPa and F3/F4 as liver stiffness \>9.4 kPa. For liver biopsy, F0/1 is defined as the presence of no fibrosis or minimal fibrosis without the presence of septa, F2 as the presence of portal fibrosis with a few septa and F3/F4 as the presence of septal fibrosis or cirrhosis. The higher the fibrosis stage, the worse the outcome.
Time frame: Baseline
Population: Liver fibrosis was only assessed in patients who were HCV RNA-positive at baseline, i.e. in 5 out of a total of 10 re-evaluated patients.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| RNA-positive Re-evaluated Lost to Follow-up Patients | Liver Fibrosis Stage | F0/1 (<7.1 kPa) | 3 Participants |
| RNA-positive Re-evaluated Lost to Follow-up Patients | Liver Fibrosis Stage | F2 (7.1 - 9.4 kPa) | 1 Participants |
| RNA-positive Re-evaluated Lost to Follow-up Patients | Liver Fibrosis Stage | F3/F4 (>9.4 kPa) | 1 Participants |
Secondary
Fibrosis Progression
Fibrosis stage comparison in patients with a previously recorded fibrosis measurement, either with Fibroscan or liver biopsy. This previous measurement will be compared to the result of the Fibroscan performed during re-evaluation.
Time frame: Baseline
Population: Fibrosis progression could only be measured if patients had a previous fibrosis measurement, either by liver biopsy or liver stiffness measurement. This was the case in 3 out of 5 HCV RNA-positive patients, or 3 out of 10 re-evaluated patients.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| RNA-positive Re-evaluated Lost to Follow-up Patients | Fibrosis Progression | No progression (F0/1 stayed F0/1) | 2 Participants |
| RNA-positive Re-evaluated Lost to Follow-up Patients | Fibrosis Progression | Progression (F0/1 became F4) | 1 Participants |
Secondary
Genotype Distribution
Genotype distribution among RNA-positive patients
Time frame: Baseline
Population: HCV genotype was only determined in patients who were HCV RNA-positive at baseline, i.e. 5 out of a total of 10 re-evaluated patients.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| RNA-positive Re-evaluated Lost to Follow-up Patients | Genotype Distribution | 1a | 2 Participants |
| RNA-positive Re-evaluated Lost to Follow-up Patients | Genotype Distribution | 1b | 2 Participants |
| RNA-positive Re-evaluated Lost to Follow-up Patients | Genotype Distribution | 3a | 1 Participants |
Secondary
Reasons for Loss to Follow-up
through chart review or questioning screening event
Time frame: Baseline
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| RNA-positive Re-evaluated Lost to Follow-up Patients | Reasons for Loss to Follow-up | Patient: therapy refusal/contra-indication/no-show | 2 Participants |
| RNA-positive Re-evaluated Lost to Follow-up Patients | Reasons for Loss to Follow-up | Therapy-related: no indication or options | 2 Participants |
| RNA-positive Re-evaluated Lost to Follow-up Patients | Reasons for Loss to Follow-up | Care-related: no adequate follow-up planned | 5 Participants |
| RNA-positive Re-evaluated Lost to Follow-up Patients | Reasons for Loss to Follow-up | Unknown | 1 Participants |
Secondary
Treatment Outcome
Sustained virological response in treated patients, defined as non-detectable HCV RNA at least 12 weeks after end of treatment
Time frame: At least 12 weeks after end of treatment
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| RNA-positive Re-evaluated Lost to Follow-up Patients | Treatment Outcome | Elbasvir/grazoprevir 12 weeks | 2 Participants |
| RNA-positive Re-evaluated Lost to Follow-up Patients | Treatment Outcome | Glecaprevir/pibrentasvir 8 weeks | 2 Participants |
| RNA-positive Re-evaluated Lost to Follow-up Patients | Treatment Outcome | Sofosbuvir/velpatasvir 12 weeks | 1 Participants |