Hepatitis C, Chronic
Conditions
Keywords
Chronic hepatitis C virus infection (CHC)
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).
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.
Interventions
Multidisciplinary support program that included counselling about relevance of adherence by hepatologist, nurse and pharmacist. Psychologist and psychiatrist support if needed.
Sponsors
Parc de Salut Mar
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Spain
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control Retrospective control group. Usual treatment with peginterferon-2a and ribavirin. No multidisciplinary support program | 147 |
| 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. | 169 |
| 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. | 131 |
| Total | 447 |
Baseline characteristics
| Characteristic | Control | Validation Cohort | Pilot Cohort | Total |
|---|---|---|---|---|
| Age, Continuous | 43 years STANDARD_DEVIATION 1 | 42 years STANDARD_DEVIATION 1 | 42 years STANDARD_DEVIATION 1 | 42 years STANDARD_DEVIATION 1 |
| Sex: Female, Male Female | 48 Participants | 45 Participants | 46 Participants | 139 Participants |
| Sex: Female, Male Male | 99 Participants | 124 Participants | 85 Participants | 308 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 147 | 0 / 169 | 0 / 131 |
| other Total, other adverse events | 52 / 147 | 14 / 169 | 4 / 131 |
| serious Total, serious adverse events | 2 / 147 | 2 / 169 | 2 / 131 |
Outcome results
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).
Time frame: 48 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control | Adherence to Treatment | 116 participants |
| Validation Cohort | Adherence to Treatment | 155 participants |
| Pilot Cohort | Adherence to Treatment | 124 participants |
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.
Time frame: baseline and 72 weeks