An observational study in Hepatitis C, Chronic, sponsored by Parc de Salut Mar. Completed at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-09-20.
Sponsored by Parc de Salut Mar · Observational
Adherence to antiviral treatment in chronic hepatitis C (CHC) is an important factor to achieve sustained virological response (SVR). The aim of our study is to evaluate the efficacy of a multidisciplinary support program (MSP) in adherence to and efficacy of pegylated interferon alfa-2a and ribavirin compared to the conventional approach. We assessed 447 patients with CHC receiving antiviral treatment distributed into 3 groups: control group (recruited 2002-2004, n= 147), MSP-pilot group (recruited 2005-2006, n=131), and MSP-validation group (recruited 2007-2009, n=169).
Adherence to antiviral treatment in chronic hepatitis C (CHC) is an important factor to achieve sustained virological response (SVR). The aim of our study is to evaluate the efficacy of a multidisciplinary support program (MSP) in adherence to and efficacy of pegylated interferon alfa-2a and ribavirin compared to the conventional approach. We assessed 447 patients with CHC receiving antiviral treatment distributed into 3 groups: control group (follow-up 2002-2004, n= 147), MSP-pilot group (follow-up 2005-2006, n=131), and MSP-validation group (follow-up 2007-2009, n=169).A cost-effectiveness analysis was performed using a Markov model.
2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.
This study's enrollment of 447 is above the median of 250 across 687 observational studies indexed under Hepatitis A.
Browse Hepatitis A studies →Parc de Salut Mar is the lead sponsor of 180 studies on the registry; 27 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Chronic hepatitis C virus infection (CHC)
Exclusion Criteria:
Retrospective control group. Usual treatment with peginterferon-2a and ribavirin. No multidisciplinary support program
Prospective group. Usual treatment with peginterferon-2a and ribavirin. Multidisciplinary support program.
Other: Multidisciplinary support program
Prospective intervention group. Usual pharmacological treatment with peginterferon-2a and ribavirin. Multidisciplinary support program.
Other: 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
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).
Time frame: 48 months
Efficacy of Treatment Measured by Sustained Virological Response
The 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.
Time frame: baseline and 72 weeks
| Milestone | Control | Validation Cohort | Pilot Cohort |
|---|---|---|---|
| Started | 147 | 169 | 131 |
| Completed | 147 | 169 | 131 |
| Not completed | 0 | 0 | 0 |
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).
| participants | Control | Validation Cohort | Pilot Cohort |
|---|---|---|---|
| Adherence to Treatment | 116 | 155 | 124 |
The 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.
Results for this outcome have not been posted.
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Control | 0/147 (0%) | 2/147 (1.4%) | 52/147 (35.4%) |
| Validation Cohort | 0/169 (0%) | 2/169 (1.2%) | 14/169 (8.3%) |
| Pilot Cohort | 0/131 (0%) | 2/131 (1.5%) | 4/131 (3.1%) |
| Event | Control | Validation Cohort | Pilot Cohort |
|---|---|---|---|
| Depression majorPsychiatric disorders | 2/147 | 2/169 | 2/131 |
| Event | Control | Validation Cohort | Pilot Cohort |
|---|---|---|---|
| AnemiaBlood and lymphatic system disorders | 52/147 | 14/169 | 4/131 |
| Age, Continuous(years) | Control | Validation Cohort | Pilot Cohort | Total |
|---|---|---|---|---|
| Mean | 43 ± 1 | 42 ± 1 | 42 ± 1 | 42 ± 1 |
| Sex: Female, Male(Participants) | Control | Validation Cohort | Pilot Cohort | Total |
|---|---|---|---|---|
| Female | 48 | 45 | 46 | 139 |
| Male | 99 | 124 | 85 | 308 |
This study is completed, as verified in May 2013. You cannot join it, but the record below documents what was studied.
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Parc de Salut Mar