Pegylated interferon alfa-2a
DrugPegylated interferon alfa-2a will be administered according to the current standard of care and in line with current summaries of product characteristics/local labelling.
Other names: Pegasys
NCT Number: NCT01659567
This prospective observational study will investigate predictive values of virological response in pegylated interferon alfa-2a (Pegasys)/ribavirin (Copegus) treatment-naive participants with chronic hepatitis C. Participants will be treated with pegylated interferon alfa-2a and ribavirin as prescribed by the physician. Data will be collected for a maximum of 96 weeks.
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Notify Me18 year and older
All sexes
Observational
Hepatology Clinic Hepa, Tbilisi, Georgia
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Pegylated interferon alfa-2a will be administered according to the current standard of care and in line with current summaries of product characteristics/local labelling.
Other names: Pegasys
Ribavirin will be administered according to the current standard of care and in line with current summaries of product characteristics/local labelling.
Other names: Copegus
Time frame: At 24 weeks after end of treatment (EOT) (up to 96 weeks), where EOT = up to 72 weeks
SVR was defined as hepatitis C virus (HCV) ribonucleic acid (RNA) level undetectable (less than [<] 15 international units per milliliter [IU/mL]) 24 weeks after completion of the actual treatment period (measured using the COBAS AmpliPrep [CAP]/ COBAS TaqMan [CTM] test). Percentage of participants achieving SVR was reported.
Time frame: At 24 weeks after EOT (up to 96 weeks), where EOT = up to 72 weeks
RVR was defined as HCV RNA less than or equal to (<=) 25 IU/mL at Week 4 using CAP/CTM test. The percentage of participants with probability that the participant who develops RVR would achieve SVR was termed as PPV of RVR on SVR. SVR was defined as HCV RNA level undetectable (<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test).
Time frame: At 24 weeks after EOT (up to 96 weeks), where EOT = up to 72 weeks
cEVR was defined as HCV RNA <=25 IU/mL at Week 12, but not at Week 4 using CAP/CTM test. The percentage of participants with probability that the participant who develops cEVR would achieve SVR was termed as PPV of cEVR on SVR. SVR was defined as HCV RNA level undetectable (<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test).
Time frame: Baseline up to 96 weeks (assessed at Baseline, 24 weeks after EOT [up to 96 weeks], where EOT = up to 72 weeks)
The viral response development was assessed using univariate analysis with logistic regression model to calculate OR for impact of age (greater than [>] 42 years versus <=42 years) on SVR. SVR was defined as HCV RNA level undetectable (<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test).
Time frame: Baseline up to 96 weeks (assessed at Baseline, 24 weeks after EOT [up to 96 weeks], where EOT = up to 72 weeks)
The viral response development was assessed using univariate analysis with logistic regression model to calculate OR for impact of gender (male versus female) on SVR. SVR was defined as HCV RNA level undetectable (<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test).
Time frame: Baseline up to 96 weeks (assessed at Baseline, 24 weeks after EOT [up to 96 weeks], where EOT = up to 72 weeks)
The viral response development was assessed using univariate analysis with logistic regression model to calculate OR for impact of body weight on SVR. SVR was defined as HCV RNA level undetectable (<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test).
Time frame: Baseline up to 96 weeks (assessed at Baseline, 24 weeks after EOT [up to 96 weeks], where EOT = up to 72 weeks)
The viral response development was assessed using univariate analysis with logistic regression model to calculate OR for impact of baseline level of fibrosis on SVR. Level of fibrosis was measured in terms of kilopascals (kPa) using elastography. kPa score was categorized in 4 groups: 0 to 6.0; 6.1 to 9.9; 10.0 to 14.5; and 14.6 and above. SVR was defined as HCV RNA level undetectable (<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test).
Time frame: Baseline up to 96 weeks (assessed at Baseline, 24 weeks after EOT [up to 96 weeks], where EOT = up to 72 weeks)
The viral response development was assessed using univariate analysis with logistic regression model to calculate OR for impact of baseline ALT level (>40 international units per liter [IU/L] versus <=40 IU/L) on SVR. SVR was defined as HCV RNA level undetectable (<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test).
Time frame: Baseline up to 96 weeks (assessed at Baseline, 24 weeks after EOT [up to 96 weeks], where EOT = up to 72 weeks)
The viral response development was assessed using univariate analysis with logistic regression model to calculate OR for impact of baseline viral load count (>800000 IU/mL versus <=800000 IU/mL) on SVR. SVR was defined as HCV RNA level undetectable (<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test).
Time frame: Baseline up to 96 weeks (assessed at Baseline, EOT, 24 weeks after EOT [up to 96 weeks], where EOT = up to 72 weeks)
The viral response development was assessed using univariate analysis with logistic regression model to calculate OR for impact of overall duration of treatment on SVR. SVR was defined as HCV RNA level undetectable (<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test).
Time frame: Baseline up to 96 weeks (assessed at Baseline, Week 4, EOT, 24 weeks after EOT [up to 96 weeks], where EOT = up to 72 weeks)
The viral response development was assessed using univariate analysis with logistic regression model to calculate OR for impact of duration of treatment after achieving RVR (>18 weeks versus <=18 weeks) on SVR. RVR was defined as HCV RNA <=25 IU/mL at Week 4 using CAP/CTM test. SVR was defined as HCV RNA level undetectable (<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test).
Time frame: Baseline up to 96 weeks (assessed at Baseline, Weeks 4, 12, EOT, 24 weeks after EOT [up to 96 weeks], where EOT = up to 72 weeks)
The viral response development was assessed using univariate analysis with logistic regression model to calculate OR for impact of duration of treatment after achieving cEVR (>11 weeks versus <=11 weeks) on SVR. cEVR was defined as HCV RNA <=25 IU/mL at Week 12, but not at Week 4 using CAP/CTM test. SVR was defined as HCV RNA level undetectable (<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test).
Time frame: At 24 weeks after EOT (up to 96 weeks), where EOT = up to 72 weeks
The viral response development was assessed using univariate analysis with logistic regression model to calculate OR for impact of cumulative doses of pegylated interferon alfa-2a on SVR. SVR was defined as HCV RNA level undetectable (<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test).
Time frame: At 24 weeks after EOT (up to 96 weeks), where EOT = up to 72 weeks
The viral response development was assessed using univariate analysis with logistic regression model to calculate OR for impact of cumulative doses of ribavirin on SVR. SVR was defined as HCV RNA level undetectable (<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test).
Hoffmann-La Roche
Industry
Prospective, Observational Study of Predictors of the Effectiveness of Pegylated Interferon in a Cohort of Patients With Hepatitis C in Georgia
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