Multidisciplinary Support Program in Chronic Hepatitis C
Study Details
Study Description
Brief Summary
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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. |
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.
|
| Pilot cohort 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.
|
Outcome Measures
Primary Outcome Measures
- Adherence to Treatment [48 months]
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).
Secondary Outcome Measures
- Efficacy of Treatment Measured by Sustained Virological Response [baseline and 72 weeks]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
- Patients with chronic hepatitis C eligible to receive antiviral treatment.
Exclusion Criteria:
- Patients who had undergone previous antiviral treatment, those with human immunodeficiency virus (HIV) or hepatitis B virus (HBV) co-infection, and individuals included in other treatment protocols.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hospital del Mar | Barcelona | Spain | 08003 |
Sponsors and Collaborators
- Parc de Salut Mar
Investigators
- Principal Investigator: Ricard Sola, MD, Hsopital del Mar, Parc de Salut MAR
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HMAR-MSP-CHC
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Control | Validation Cohort | Pilot Cohort |
|---|---|---|---|
| Arm/Group Description | 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. Multidisciplinary support program: Multidisciplinary support program that included counselling about relevance of adherence by hepatologist, nurse and pharmacist. Psychologist and psychiatrist support if needed. | 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. |
| Period Title: Overall Study | |||
| STARTED | 147 | 169 | 131 |
| COMPLETED | 147 | 169 | 131 |
| NOT COMPLETED | 0 | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | Control | Validation Cohort | Pilot Cohort | Total |
|---|---|---|---|---|
| Arm/Group Description | 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. Multidisciplinary support program: Multidisciplinary support program that included counselling about relevance of adherence by hepatologist, nurse and pharmacist. Psychologist and psychiatrist support if needed. | 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 of all reporting groups |
| Overall Participants | 147 | 169 | 131 | 447 |
| Age (years) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [years] |
43
(1)
|
42
(1)
|
42
(1)
|
42
(1)
|
| Sex: Female, Male (Count of Participants) | ||||
| Female |
48
32.7%
|
45
26.6%
|
46
35.1%
|
139
31.1%
|
| Male |
99
67.3%
|
124
73.4%
|
85
64.9%
|
308
68.9%
|
Outcome Measures
| Title | Adherence to Treatment |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Control | Validation Cohort | Pilot Cohort |
|---|---|---|---|
| Arm/Group Description | 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. Multidisciplinary support program: Multidisciplinary support program that included counselling about relevance of adherence by hepatologist, nurse and pharmacist. Psychologist and psychiatrist support if needed. | 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. |
| Measure Participants | 147 | 169 | 131 |
| Number [participants] |
116
78.9%
|
155
91.7%
|
124
94.7%
|
| Title | Efficacy of Treatment Measured by Sustained Virological Response |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title |
|---|
| Arm/Group Description |
Adverse Events
| Time Frame | ||||||
|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||
| Arm/Group Title | Control | Validation Cohort | Pilot Cohort | |||
| Arm/Group Description | 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. Multidisciplinary support program: Multidisciplinary support program that included counselling about relevance of adherence by hepatologist, nurse and pharmacist. Psychologist and psychiatrist support if needed. | 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. | |||
All Cause Mortality |
||||||
| Control | Validation Cohort | Pilot Cohort | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/147 (0%) | 0/169 (0%) | 0/131 (0%) | |||
Serious Adverse Events |
||||||
| Control | Validation Cohort | Pilot Cohort | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 2/147 (1.4%) | 2/169 (1.2%) | 2/131 (1.5%) | |||
| Psychiatric disorders | ||||||
| Depression major | 2/147 (1.4%) | 2 | 2/169 (1.2%) | 2 | 2/131 (1.5%) | 2 |
Other (Not Including Serious) Adverse Events |
||||||
| Control | Validation Cohort | Pilot Cohort | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 52/147 (35.4%) | 14/169 (8.3%) | 4/131 (3.1%) | |||
| Blood and lymphatic system disorders | ||||||
| Anemia | 52/147 (35.4%) | 52 | 14/169 (8.3%) | 14 | 4/131 (3.1%) | 4 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Professor Ricard Sola |
|---|---|
| Organization | Liver Section. Hospital del Mar |
| Phone | 0034932483200 |
| 35783@parcdesalutmar.cat |
- HMAR-MSP-CHC