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

Browse trials for

• Hepatitis A 2,710
• Hepatitis C 2,321
• Hepatitis C, Chronic 1,073
• Hepatitis 3,381

Hepatitis A

2,710 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.

This study's enrollment of 660 is above the median of 250 across 687 observational studies indexed under Hepatitis A.

Lead sponsor

Hoffmann-La Roche is the lead sponsor of 2,061 studies on the registry; 85 are open to participants now.

Of its 319 completed or terminated interventional studies of FDA-regulated products, 239 (75%) have results posted.

Study population

Groups and cohorts

• 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 · Drug: Ribavirin

• 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: Peginterferon Alfa-2a · Drug: Ribavirin

• 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: Peginterferon Alfa-2b · Drug: Ribavirin

Interventions

• DrugConventional Interferon

  Conventional interferon according to the standard of care and aligned with the local prescription instructions

• DrugPeginterferon Alfa-2a

  Peginterferon alfa-2a according to the standard of care and aligned with the local prescription instructions

• DrugPeginterferon Alfa-2b

  Peginterferon alfa-2b according to the standard of care and aligned with the local prescription instructions

• DrugRibavirin

  Ribavirin according to the standard of care and aligned with the local prescription instructions

Primary outcomes

1. 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.

   Time frame: At Week 60

Secondary outcomes

1. 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.

   Time frame: At Week 72

2. 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

   Time frame: At Week 24

3. 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.

   Time frame: At Week 12

4. 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.

   Time frame: At Week 60 (SVR 12) and Week 72 (SVR 24)

5. 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.

   Time frame: Up to Week 48

6. 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.

   Time frame: Up to Week 72

7. 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.

   Time frame: At Week 4

8. 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.

   Time frame: At Week 48

9. 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.

   Time frame: Up to Week 72

10. 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.

    Time frame: At Week 48

11. 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.

    Time frame: Up to Week 48

12. 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.

    Time frame: Up to Week 72

Baseline characteristics