Trial Outcomes & Findings for Multidisciplinary Support Program in Chronic Hepatitis C (NCT NCT01850745)
NCT ID: NCT01850745
Last Updated: 2021-09-20
Results Overview
Adherent patients were defined as those receiving equal or more than 80% of total dose of pegylated interferon (180 microg/week) and ribavirin (1200 mg/d) during equal o more than 80% of duration treatment (48 weeks). Non-adherent patients were defined as those receiving less than 80% of total dose of pegylated interferon (180 microg/week) and ribavirin (1200 mg/d) during less than 80% of duration treatment (48 weeks).
Recruitment status
COMPLETED
Target enrollment
447 participants
Primary outcome timeframe
48 months
Results posted on
2021-09-20
Participant Flow
Participant milestones
| Measure |
Control
Retrospective control group. Usual treatment with peginterferon-2a and ribavirin. No multidisciplinary support program
|
Validation Cohort
Prospective group. Usual treatment with peginterferon-2a and ribavirin. Multidisciplinary support program.
Multidisciplinary support program: Multidisciplinary support program that included counselling about relevance of adherence by hepatologist, nurse and pharmacist. Psychologist and psychiatrist support if needed.
|
Pilot Cohort
Prospective intervention group. Usual pharmacological treatment with peginterferon-2a and ribavirin. Multidisciplinary support program.
Multidisciplinary support program: Multidisciplinary support program that included counselling about relevance of adherence by hepatologist, nurse and pharmacist. Psychologist and psychiatrist support if needed.
|
|---|---|---|---|
|
Overall Study
STARTED
|
147
|
169
|
131
|
|
Overall Study
COMPLETED
|
147
|
169
|
131
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Multidisciplinary Support Program in Chronic Hepatitis C
Baseline characteristics by cohort
| Measure |
Control
n=147 Participants
Retrospective control group. Usual treatment with peginterferon-2a and ribavirin. No multidisciplinary support program
|
Validation Cohort
n=169 Participants
Prospective group. Usual treatment with peginterferon-2a and ribavirin. Multidisciplinary support program.
Multidisciplinary support program: Multidisciplinary support program that included counselling about relevance of adherence by hepatologist, nurse and pharmacist. Psychologist and psychiatrist support if needed.
|
Pilot Cohort
n=131 Participants
Prospective intervention group. Usual pharmacological treatment with peginterferon-2a and ribavirin. Multidisciplinary support program.
Multidisciplinary support program: Multidisciplinary support program that included counselling about relevance of adherence by hepatologist, nurse and pharmacist. Psychologist and psychiatrist support if needed.
|
Total
n=447 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
43 years
STANDARD_DEVIATION 1 • n=39 Participants
|
42 years
STANDARD_DEVIATION 1 • n=41 Participants
|
42 years
STANDARD_DEVIATION 1 • n=35 Participants
|
42 years
STANDARD_DEVIATION 1 • n=31 Participants
|
|
Sex: Female, Male
Female
|
48 Participants
n=39 Participants
|
45 Participants
n=41 Participants
|
46 Participants
n=35 Participants
|
139 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
99 Participants
n=39 Participants
|
124 Participants
n=41 Participants
|
85 Participants
n=35 Participants
|
308 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: 48 monthsAdherent patients were defined as those receiving equal or more than 80% of total dose of pegylated interferon (180 microg/week) and ribavirin (1200 mg/d) during equal o more than 80% of duration treatment (48 weeks). Non-adherent patients were defined as those receiving less than 80% of total dose of pegylated interferon (180 microg/week) and ribavirin (1200 mg/d) during less than 80% of duration treatment (48 weeks).
Outcome measures
| Measure |
Control
n=147 Participants
Retrospective control group. Usual treatment with peginterferon-2a and ribavirin. No multidisciplinary support program
|
Validation Cohort
n=169 Participants
Prospective group. Usual treatment with peginterferon-2a and ribavirin. Multidisciplinary support program.
Multidisciplinary support program: Multidisciplinary support program that included counselling about relevance of adherence by hepatologist, nurse and pharmacist. Psychologist and psychiatrist support if needed.
|
Pilot Cohort
n=131 Participants
Prospective intervention group. Usual pharmacological treatment with peginterferon-2a and ribavirin. Multidisciplinary support program.
Multidisciplinary support program: Multidisciplinary support program that included counselling about relevance of adherence by hepatologist, nurse and pharmacist. Psychologist and psychiatrist support if needed.
|
|---|---|---|---|
|
Adherence to Treatment
|
116 participants
|
155 participants
|
124 participants
|
SECONDARY outcome
Timeframe: baseline and 72 weeksThe secondary efficacy end point was to evaluate the sustained virological response (SVR) of antiviral treatment. SVR was defined as undetectable hepatitis C virus viral load (\<15 IU/ml) 24 weeks after treatment completion. Non-SVR was defined as detectable hepatitis C virus viral load (\>15 IU/ml) 24 weeks after treatment completion.
Outcome measures
Outcome data not reported
Adverse Events
Control
Serious events: 2 serious events
Other events: 52 other events
Deaths: 0 deaths
Validation Cohort
Serious events: 2 serious events
Other events: 14 other events
Deaths: 0 deaths
Pilot Cohort
Serious events: 2 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Control
n=147 participants at risk
Retrospective control group. Usual treatment with peginterferon-2a and ribavirin. No multidisciplinary support program
|
Validation Cohort
n=169 participants at risk
Prospective group. Usual treatment with peginterferon-2a and ribavirin. Multidisciplinary support program.
Multidisciplinary support program: Multidisciplinary support program that included counselling about relevance of adherence by hepatologist, nurse and pharmacist. Psychologist and psychiatrist support if needed.
|
Pilot Cohort
n=131 participants at risk
Prospective intervention group. Usual pharmacological treatment with peginterferon-2a and ribavirin. Multidisciplinary support program.
Multidisciplinary support program: Multidisciplinary support program that included counselling about relevance of adherence by hepatologist, nurse and pharmacist. Psychologist and psychiatrist support if needed.
|
|---|---|---|---|
|
Psychiatric disorders
Depression major
|
1.4%
2/147 • Number of events 2
|
1.2%
2/169 • Number of events 2
|
1.5%
2/131 • Number of events 2
|
Other adverse events
| Measure |
Control
n=147 participants at risk
Retrospective control group. Usual treatment with peginterferon-2a and ribavirin. No multidisciplinary support program
|
Validation Cohort
n=169 participants at risk
Prospective group. Usual treatment with peginterferon-2a and ribavirin. Multidisciplinary support program.
Multidisciplinary support program: Multidisciplinary support program that included counselling about relevance of adherence by hepatologist, nurse and pharmacist. Psychologist and psychiatrist support if needed.
|
Pilot Cohort
n=131 participants at risk
Prospective intervention group. Usual pharmacological treatment with peginterferon-2a and ribavirin. Multidisciplinary support program.
Multidisciplinary support program: Multidisciplinary support program that included counselling about relevance of adherence by hepatologist, nurse and pharmacist. Psychologist and psychiatrist support if needed.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
35.4%
52/147 • Number of events 52
|
8.3%
14/169 • Number of events 14
|
3.1%
4/131 • Number of events 4
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place