Multidisciplinary Support Program in Chronic Hepatitis C

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Parc de Salut Mar
ClinicalTrials.gov Identifier:
NCT01850745
First received: May 7, 2013
Last updated: NA
Last verified: May 2013
History: No changes posted
  Purpose

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 Intervention
Hepatitis C, Chronic
Other: Multidisciplinary support program

Study Type: Observational
Study Design: Observational Model: Cohort
Official Title: Evaluation of a multidìsciplinary Support Program in the Adherence and Efficacy of Peginterferon Alfa-2a and Ribavirin Therapy in Chronic Hepatitis C.

Resource links provided by NLM:


Further study details as provided by Parc de Salut Mar:

Primary Outcome Measures:
  • Adherence to treatment [ Time Frame: 48 months ] [ Designated as safety issue: No ]

    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 [ Time Frame: baseline and 72 weeks ] [ Designated as safety issue: No ]

    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.



Enrollment: 447
Study Start Date: January 2003
Study Completion Date: January 2010
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Chronic hepatitis C virus infection (CHC)

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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01850745

Locations
Spain
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
  More Information

No publications provided

Responsible Party: Parc de Salut Mar
ClinicalTrials.gov Identifier: NCT01850745     History of Changes
Other Study ID Numbers: HMAR-MSP-CHC
Study First Received: May 7, 2013
Last Updated: May 7, 2013
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Parc de Salut Mar:
Chronic hepatitis C virus infection (CHC)

Additional relevant MeSH terms:
Hepatitis C, Chronic
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Peginterferon alfa-2a
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 21, 2014