A Retrospective Study to Assess the Impact of the Use of Interferon in Patients With Chronic Hepatitis C (DECISION)
- Conditions
- Hepatitis C, Chronic
- Interventions
- Registration Number
- NCT01280656
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 660
- 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
- Co-infection with human immunodeficiency virus
- Co-infection with hepatitis B virus
- Presence of hepatocarcinoma
- Patients submitted to hemodialysis
- Organ transplant patients
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Conventional Interferon Plus Ribavirin Conventional Interferon 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). Conventional Interferon Plus Ribavirin 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). Peginterferon Alfa-2a Plus Ribavirin Peginterferon Alfa-2a 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). Peginterferon Alfa-2a Plus Ribavirin 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). Peginterferon Alfa-2b Plus Ribavirin 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). Peginterferon Alfa-2b Plus Ribavirin Peginterferon Alfa-2b 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).
- Primary Outcome Measures
Name Time Method Percentage of Participants With Sustained Virologic Response at 12 Weeks After End of Treatment At Week 60 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.
- Secondary Outcome Measures
Name Time Method Percentage of Participants With Early Virologic Response at Week 12 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.
Percentage of Participants With Null Response or No Responder at End of Treatment At Week 48 Null response or no responders were defined as those participants presenting positive viral load at EOT (regardless of the treatment duration). EOT= Week 48.
Percentage of Participants With Sustained Virologic Response at 24 Weeks After End of Treatment At Week 72 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.
Percentage of Participants Who Discontinued Treatment Due to Adverse Events Up to Week 48 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.
Number of Participants With Interferon Dose Reduction Rates in Function of the Interferon Type Being Used At Week 24 The number of participants with Interferon dose reduction rates in function of the interferon type being used are reported
Percentage of Participants With Sustained Virologic Response Treated at Interferon Application Centers and Treated at Home At Week 60 (SVR 12) and Week 72 (SVR 24) The percentage of participants with SVR-12 and SVR-24 treated at interferon application centers (IAC) and treated at home are presented.
Mean Percentage Reduction of Hemoglobin in Treatment Responders and Treatment Non-Responders Up to Week 72 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.
Percentage of Participants With Virologic Response at End of Treatment At Week 48 Virologic response at EOT was defined as undetectable HCV-RNA at EOT (regardless in which week treatment was concluded). EOT = Week 48.
Percentage of Participants Who Were Treated at Interferon Application Centers and at Home and Discontinued Treatment Up to Week 48 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.
Percentage of Participants With Rapid Virologic Response at Week 4 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.
Percentage of Participants With Virologic Relapse up to Week 72 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.
Number of Participants With Any Adverse Events and Any Serious Adverse Events Up to Week 72 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.