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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| Pilot cohort | Prospective intervention group. Usual pharmacological treatment with peginterferon-2a and ribavirin. Multidisciplinary support program. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multidisciplinary support program | Other | Multidisciplinary support program that included counselling about relevance of adherence by hepatologist, nurse and pharmacist. Psychologist and psychiatrist support if needed. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 48 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Chronic hepatitis C virus infection (CHC)
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| Name | Affiliation | Role |
|---|---|---|
| Ricard Sola, MD | Hsopital del Mar, Parc de Salut MAR | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital del Mar | Barcelona | 08003 | Spain |
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| ID | Title | Description |
|---|---|---|
| FG000 | Control | Retrospective control group. Usual treatment with peginterferon-2a and ribavirin. No multidisciplinary support program |
| FG001 | 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. |
| FG002 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Control | Retrospective control group. Usual treatment with peginterferon-2a and ribavirin. No multidisciplinary support program |
| BG001 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Posted | Number | participants | 48 months |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control | Retrospective control group. Usual treatment with peginterferon-2a and ribavirin. No multidisciplinary support program |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Depression major | Psychiatric disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Professor Ricard Sola | Liver Section. Hospital del Mar | 0034932483200 | 35783@parcdesalutmar.cat |
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| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| baseline and 72 weeks |
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG002 | 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. |
|
|
| Secondary | 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. | Not Posted | baseline and 72 weeks | Participants |
| 0 |
| 147 |
| 2 |
| 147 |
| 52 |
| 147 |
| EG001 | 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. | 0 | 169 | 2 | 169 | 14 | 169 |
| EG002 | 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. | 0 | 131 | 2 | 131 | 4 | 131 |
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| D006525 |
| Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |