Trial Outcomes & Findings for 'Fibrosis in the Lost Hepatitis C Population - Track, Trace and Treat' (NCT NCT03088917)

Last Updated: 2020-02-10

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

106 participants

Primary outcome timeframe

Baseline

Results posted on

2020-02-10

Participant Flow

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.

After invitation, patients could not be enrolled (defined as the signing of informed consent) for multiple reasons. These reasons are described below.

Participant milestones

Participant milestones
Measure	Invited Lost to Follow-up Patients Alive patients who were anti-HCV and/or HCV RNA positive in the period 2000-2015 who have not been treated and were residing in the Netherlands, were invited for re-evaluation at the outpatient clinic.
Overall Study STARTED	106
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	96

Reasons for withdrawal

Reasons for withdrawal
Measure	Invited Lost to Follow-up Patients Alive patients who were anti-HCV and/or HCV RNA positive in the period 2000-2015 who have not been treated and were residing in the Netherlands, were invited for re-evaluation at the outpatient clinic.
Overall Study In care/cured elsewhere	15
Overall Study Refuse re-evaluation	13
Overall Study Contact not established	13
Overall Study Severe comorbidity/short life expectancy	5
Overall Study Moved outside study region	50

Baseline Characteristics

'Fibrosis in the Lost Hepatitis C Population - Track, Trace and Treat'

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Re-evaluated Lost to Follow-up Patients n=10 Participants Invited lost to follow-up patients who were seen at the outpatient clinic.
Age, Continuous	62 years n=99 Participants
Sex: Female, Male Female	0 Participants n=99 Participants
Sex: Female, Male Male	10 Participants n=99 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants
Race (NIH/OMB) Black or African American	0 Participants n=99 Participants
Race (NIH/OMB) White	10 Participants n=99 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants
Region of Enrollment Netherlands	10 participants n=99 Participants
Country of birth Netherlands	8 Participants n=99 Participants
Country of birth England	1 Participants n=99 Participants
Country of birth France	1 Participants n=99 Participants
HCV transmission route Intravenous drug use	7 Participants n=99 Participants
HCV transmission route Blood transfusion	3 Participants n=99 Participants
Years since last hospital contact	13.5 years n=99 Participants
Treatment experienced	5 Participants n=99 Participants
RNA-positive	5 Participants n=99 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	RNA-positive Re-evaluated Lost to Follow-up Patients n=5 Participants LTFU patients who were still RNA-positive at the re-evaluation visit.
Liver Fibrosis Stage F0/1 (<7.1 kPa)	3 Participants
Liver Fibrosis Stage F2 (7.1 - 9.4 kPa)	1 Participants
Liver Fibrosis Stage F3/F4 (>9.4 kPa)	1 Participants

SECONDARY outcome

Timeframe: Baseline

through chart review or questioning screening event

Outcome measures

Outcome measures
Measure	RNA-positive Re-evaluated Lost to Follow-up Patients n=10 Participants LTFU patients who were still RNA-positive at the re-evaluation visit.
Reasons for Loss to Follow-up Patient: therapy refusal/contra-indication/no-show	2 Participants
Reasons for Loss to Follow-up Therapy-related: no indication or options	2 Participants
Reasons for Loss to Follow-up Care-related: no adequate follow-up planned	5 Participants
Reasons for Loss to Follow-up Unknown	1 Participants

SECONDARY outcome

Timeframe: 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.

Genotype distribution among RNA-positive patients

Outcome measures

Outcome measures
Measure	RNA-positive Re-evaluated Lost to Follow-up Patients n=5 Participants LTFU patients who were still RNA-positive at the re-evaluation visit.
Genotype Distribution 1a	2 Participants
Genotype Distribution 1b	2 Participants
Genotype Distribution 3a	1 Participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	RNA-positive Re-evaluated Lost to Follow-up Patients n=3 Participants LTFU patients who were still RNA-positive at the re-evaluation visit.
Fibrosis Progression No progression (F0/1 stayed F0/1)	2 Participants
Fibrosis Progression Progression (F0/1 became F4)	1 Participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	RNA-positive Re-evaluated Lost to Follow-up Patients n=5 Participants LTFU patients who were still RNA-positive at the re-evaluation visit.
Treatment Outcome Elbasvir/grazoprevir 12 weeks	2 Participants
Treatment Outcome Glecaprevir/pibrentasvir 8 weeks	2 Participants
Treatment Outcome Sofosbuvir/velpatasvir 12 weeks	1 Participants

Adverse Events

Treated Patients

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Prof. dr. J.P.H. Drenth

Radboudumc

Phone: 0031243613999

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place