A Retrospective Study to Assess the Impact of the Use of Interferon in Patients With Chronic Hepatitis C (DECISION)

Retrospective Study to Evaluate the Impact of Using Interferon (Pegylated or Not) in the Treatment of Patients With Chronic Hepatitis C in Brazil (DECISION)

This retrospective study will assess the sustained virologic response and the safety of two different interferons (pegylated or conventional) in patients with chronic hepatitis C. Data will be collected for 24 weeks.

Study Overview

• Status: Completed
• Conditions: Hepatitis C, Chronic
• Intervention / Treatment: Drug: Conventional Interferon; Drug: Ribavirin; Drug: Peginterferon Alfa-2a; Drug: Peginterferon Alfa-2b

• Study Type: Observational
• Enrollment (Actual): 660

Contacts and Locations

Study Locations

• Brazil
  • AC
    • Rio Branco, AC, Brazil, 69908-210
  • AM
    • Manaus, AM, Brazil, 69040-000
  • BA
    • Salvador, BA, Brazil, 41110-170
  • ES
    • Vitoria, ES, Brazil, 29043-260
  • GO
    • Goiania, GO, Brazil, 74535170
  • MA
    • Sao Luis, MA, Brazil, 65020560
  • MG
    • Pouso Alegre, MG, Brazil, 37550-000
    • Uberaba, MG, Brazil, 38025-180
  • MS
    • Campo Grande - MS, MS, Brazil, 79034-000
  • PA
    • Belem, PA, Brazil, 66050-380
  • PE
    • Recife, PE, Brazil, 50100-130
    • Recife, PE, Brazil, 50670-420
  • PR
    • Curitiba, PR, Brazil, 80810-040
    • Curitiba, PR, Brazil, 80060-900
  • RJ
    • Niteroi, RJ, Brazil, 24033-900
    • Nova Iguacu, RJ, Brazil, 26030-380
    • Rio de Janeiro, RJ, Brazil, 20270-004
  • RO
    • Porto Velho, RO, Brazil, 78812-329
  • RS
    • Porto Alegre, RS, Brazil, 90035-003
    • Porto Alegre, RS, Brazil, 90610-000
    • Rio Grande, RS, Brazil, 96200-310
  • SC
    • Sao Jose Do Rio Preto, SC, Brazil, 15090-000
  • SE
    • Aracaju, SE, Brazil, 49060-100
  • SP
    • Botucatu, SP, Brazil, 18600-400
    • Campinas, SP, Brazil, 13060-803
    • Ribeirao Preto, SP, Brazil, 14049-900
    • Ribeirao Preto, SP, Brazil, 14085-410
    • Santo Andre, SP, Brazil, 09060-650
    • Santos, SP, Brazil, 11015470
    • Sao Paulo, SP, Brazil, 05403-000
    • Sao Paulo, SP, Brazil, 01246-000
    • Sao Paulo, SP, Brazil, 01323-020
    • Sao Paulo, SP, Brazil, 05403-010
    • Sao Paulo, SP, Brazil, 04040-003
    • Sao Paulo, SP, Brazil, 04039-004
    • Sao Paulo, SP, Brazil, 04040-002
    • Sorocaba, SP, Brazil, 18047-600

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Hepatitis C patients that received interferon (pegylated or conventional) during the period stipulated (from 01-Sep-2007 to 31-Aug-2008)

Description

Inclusion Criteria:

• Adult patients, >/=18 years and <70 years of age
• Diagnosis of hepatitis C
• Assessment of viral load prior to treatment (mandatory for genotype 1 only)
• Liver biopsy
• Co-morbidities data
• Use of interferon (pegylated or conventional) and ribavirin to treat hepatitis C infection genotype 2 and 3 and pegylated interferon plus ribavirin to treat hepatitis C infection genotype 1
• Above mentioned treatment started between 01-Sep-2007 and 31-Aug-2008

Exclusion Criteria:

• Co-infection with human immunodeficiency virus
• Co-infection with hepatitis B virus
• Presence of hepatocarcinoma
• Patients submitted to hemodialysis
• Organ transplant patients

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Conventional Interferon Plus Ribavirin; Eligible participants who will receive conventional interferon plus ribavirin for Chronic Hepatitis C (CHC) according to the standard of care and aligned with the local prescription instructions will be observed during treatment period (48 weeks) and follow up period (24 weeks).	Drug: Conventional Interferon; Conventional interferon according to the standard of care and aligned with the local prescription instructions; Drug: Ribavirin; Ribavirin according to the standard of care and aligned with the local prescription instructions
Peginterferon Alfa-2a Plus Ribavirin; Eligible participants who will receive peginterferon alfa-2a plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions will be observed during treatment period (48 weeks) and follow up period (24 weeks).	Drug: Ribavirin; Ribavirin according to the standard of care and aligned with the local prescription instructions; Drug: Peginterferon Alfa-2a; Peginterferon alfa-2a according to the standard of care and aligned with the local prescription instructions
Peginterferon Alfa-2b Plus Ribavirin; Eligible participants who will receive peginterferon alfa-2b plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions will be observed during treatment period (48 weeks) and follow up period (24 weeks).	Drug: Ribavirin; Ribavirin according to the standard of care and aligned with the local prescription instructions; Drug: Peginterferon Alfa-2b; Peginterferon alfa-2b according to the standard of care and aligned with the local prescription instructions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Sustained Virologic Response at 12 Weeks After End of Treatment	Sustained virological response (SVR) was defined as virological response at 12 weeks after end of treatment (EOT). Virologic response was either defined as having undetectable (that is, no hepatitis C virus Ribonucleic acid [HCV RNA] was detected in the participants' plasma samples) or less than 50 international units/milliliter (IU/mL) HCV RNA (that is, the participants' plasma samples contained traces of HCV RNA at a concentration below the limit of quantification of the viral load assay or no HCV RNA was detected in the samples). EOT= Week 48. Participants who did not have viral load assessment at Week 12 were considered treatment failures, except in the specific case where the lack of assessment was not due to treatment shortening in function of response guided therapy.	At Week 60

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Sustained Virologic Response at 24 Weeks After End of Treatment	SVR was defined as virological response at 24 weeks after EOT, EOT= Week 48. Virologic response was either defined as having undetectable (that is, no hepatitis C virus Ribonucleic acid [HCV RNA] was detected in the participants' plasma samples) or less than 50 IU/mL HCV RNA (that is, the participants' plasma samples contained traces of HCV RNA at a concentration below the limit of quantification of the viral load assay or no HCV RNA was detected in the samples). Participants who did not have viral load assessment at Week 12 were considered treatment failures, except in the specific case where the lack of assessment was not due to treatment shortening in function of response guided therapy.	At Week 72
Number of Participants With Interferon Dose Reduction Rates in Function of the Interferon Type Being Used	The number of participants with Interferon dose reduction rates in function of the interferon type being used are reported	At Week 24
Percentage of Participants With Early Virologic Response at Week 12	An early virologic response (EVR) was defined as a HCV-RNA decrease of at least two logarithmic scales (2 Log) or 100 times the pretreatment value or non-detection at Week 12 of treatment period.	At Week 12
Percentage of Participants With Sustained Virologic Response Treated at Interferon Application Centers and Treated at Home	The percentage of participants with SVR-12 and SVR-24 treated at interferon application centers (IAC) and treated at home are presented.	At Week 60 (SVR 12) and Week 72 (SVR 24)
Percentage of Participants Who Were Treated at Interferon Application Centers and at Home and Discontinued Treatment	The percentage of participants who were treated at interferon application centers and at home and who discontinued treatment is presented. Participants who did not have viral load assessment at Week 12 were considered treatment failures, except in the specific case where the lack of assessment was not due to treatment shortening in function of response guided therapy.	Up to Week 48
Mean Percentage Reduction of Hemoglobin in Treatment Responders and Treatment Non-Responders	The average percentage reduction of hemoglobin (Hb) in treatment responders and treatment non-responders between the conventional group, peginterferon alfa-2a plus and peginterferon alfa-2b is presented. Participants with undetectable HCV RNA at specified time points (Weeks 4/12/18/24/48) were considered as treatment responders. Participants with positive viral load (detectable HCV RNA) at end of treatment regardless of the treatment duration were considered as treatment non-responders.	Up to Week 72
Percentage of Participants With Rapid Virologic Response at Week 4	Rapid virologic response was defined as qualitative or quantitative HCV-RNA (viral load) undetectable (below the lower limit of detection) at Week 4 of treatment period.	At Week 4
Percentage of Participants With Virologic Response at End of Treatment	Virologic response at EOT was defined as undetectable HCV-RNA at EOT (regardless in which week treatment was concluded). EOT = Week 48.	At Week 48
Percentage of Participants With Virologic Relapse up to Week 72	Virologic relapse was defined as undetectable HCV-RNA at end of treatment and detectable HCV-RNA at the last follow-up assessment available. If the participant was a responder at end of treatment and was not submitted to any viral load assessment during the follow-up period, he was considered a relapser.	Up to Week 72
Percentage of Participants With Null Response or No Responder at End of Treatment	Null response or no responders were defined as those participants presenting positive viral load at EOT (regardless of the treatment duration). EOT= Week 48.	At Week 48
Percentage of Participants Who Discontinued Treatment Due to Adverse Events	The percentage of participants with treatment discontinuation rates due to adverse events (AE) between conventional group, peginterferon alfa-2a and peginterferon alfa-2b is presented.	Up to Week 48
Number of Participants With Any Adverse Events and Any Serious Adverse Events	An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is a significant medical event in the investigator's judgment or requires intervention to prevent one or other of these outcomes.	Up to Week 72

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Actual): November 1, 2012
• Study Completion (Actual): June 1, 2013

Study Registration Dates

• First Submitted: January 20, 2011
• First Submitted That Met QC Criteria: January 20, 2011
• First Posted (Estimate): January 21, 2011

Study Record Updates

• Last Update Posted (Estimate): November 29, 2016
• Last Update Submitted That Met QC Criteria: October 6, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Flaviviridae Infections; Hepatitis, Viral, Human; Enterovirus Infections; Picornaviridae Infections; Hepatitis, Chronic; Hepatitis; Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Antimetabolites; Antineoplastic Agents; Interferons; Ribavirin; Peginterferon alfa-2a; Peginterferon alfa-2b
• Other Study ID Numbers: ML22995