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 Type
OBSERVATIONAL
Enrollment
660
Conventional interferon according to the standard of care and aligned with the local prescription instructions
Peginterferon alfa-2a according to the standard of care and aligned with the local prescription instructions
Peginterferon alfa-2b according to the standard of care and aligned with the local prescription instructions
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
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
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
Percentage of Participants With Early Virologic Response at Week 12
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Ribavirin according to the standard of care and aligned with the local prescription instructions
Unnamed facility
Rio Branco, Acre, Brazil
Unnamed facility
Manaus, Amazonas, Brazil
Unnamed facility
Vitória, Espírito Santo, Brazil
Unnamed facility
Salvador, Estado de Bahia, Brazil
Unnamed facility
Goiânia, Goiás, Brazil
Unnamed facility
São Luís, Maranhão, Brazil
Unnamed facility
Campo Grande - MS, Mato Grosso do Sul, Brazil
Unnamed facility
Pouso Alegre, Minas Gerais, Brazil
Unnamed facility
Uberaba, Minas Gerais, Brazil
Unnamed facility
Curitiba, Paraná, Brazil
...and 27 more locations
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
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)
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
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
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
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
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
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
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
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