An Observational Study of Dual and Triple Therapies Based on Pegasys (Peginterferon Alfa-2a) in Patients With Chronic Hepatitis C

The overall SVR-24 rate was defined as percentage of participants with Hepatitis C Virus Ribonucleic Acid (HCV-RNA) levels \< 50 International Units per MilliLiter (IU/mL) (as measured by Polymerase Chain Reaction (PCR)) at 24 weeks post treatment completion.

Time frame: Week 24

Population: Modified All Treated (mTRT) Population: includes all participants who had an HCV-RNA result ≥50 IU/mL at their last measurement prior to commencing CHC therapy; had received one of the study's combination therapies; the participants' treatment documentation was sufficient for assignment to treatment groups.

SVR at Week 24 is compared by treatment group, type of infection, prior treatments and genotype.

Time frame: Week 24

Population: Modified All Treated (mTRT) Population: includes all participants who had an HCV-RNA result ≥50 IU/mL at their last measurement prior to commencing CHC therapy; had received one of the study's combination therapies; the participants' treatment documentation was sufficient for assignment to treatment groups.

Time frame: Week 48

Population: Safety Population. Included only participants who had received at least one dose of peginterferon alfa-2a plus ribavirin or peginterferon alfa-2a plus ribavirin plus telaprevir/boceprevir and had at least one post-baseline safety assessment.

The overall SVR-24 rate was defined as percentage of participants with Hepatitis C Virus Ribonucleic Acid (HCV-RNA) levels \< 50 International Units per MilliLiter (IU/mL) (as measured by Polymerase Chain Reaction (PCR)) at 24 weeks post treatment completion. Number of participants analysed signifies participants who were evaluated for outcome measure. Data for this outcome measure was not summarized for each arm. Hence, data is reported for all participants.

Time frame: Week 24

Population: Participants who treated for chronic hepatitis C(CHC)with either dual therapy (peginterferon alfa-2a and ribavirin)or triple therapy(peginterferon alfa-2a and ribavirin and telaprevir/boceprevir)for up to 24 weeks thereafter in line with local prescribing information at time of study and for whom demographic baseline characteristics were available.

Participants with dose modifications who had achieved SVR at Week 24 were reported. Data was collected for all participants who had dose modification of Peginterferon alfa-2a, Ribavirin or Telaprevir/boceprevir in any of the treatment regimen during the study.

Time frame: Week 24

Population: mTRT population: includes all participants who had an HCV-RNA result ≥50 IU/mL at their last measurement prior to commencing CHC therapy; had received one of the study's combination therapies; the participants' treatment documentation was sufficient for assignment to treatment groups.

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. Safety analysis included 2 additional participants in arm 'Peginterferon Alfa-2a + Ribavirin + Telaprevir'. The safety parameters were analyzed by the treatment actually received by the participants.

Time frame: Week 48

Population: Safety Population. Included only participants who had received at least one dose of peginterferon alfa-2a plus ribavirin or peginterferon alfa-2a plus ribavirin plus telaprevir/boceprevir and had at least one post-baseline safety assessment.

Complete early virologic response (cEVR) was defined as HCV-RNA \<50 IU/mL by Week 12

Time frame: Week 12

Population: mTRT population: participants who had an HCV-RNA result ≥50 IU/mL at their last measurement prior to commencing CHC therapy; had received one of the study's combination therapies; participants' treatment documentation was sufficient for assignment to treatment groups. Number of participants analyzed: participants evaluated for this outcome measure.

End-of-Treatment (EoT) response was defined as HCV-RNA \<50 IU/mL by the end of treatment.

Time frame: Week 24

Population: mTRT population: participants who had an HCV-RNA result ≥50 IU/mL at their last measurement prior to commencing CHC therapy; had received one of the study's combination therapies; participants' treatment documentation was sufficient for assignment to treatment groups. Number of participants analyzed: participants evaluated for this outcome measure.

Extended RVR was defined as HCV-RNA \<50 IU/mL at weeks 4 and 12 for participants treated with telaprevir; or at weeks 8 & 24 for participants treated with boceprevir. The assessment was performed in participants who received triple therapy in treatment arms 'Peginterferon Alfa-2a + Ribavirin +Telaprevir' and 'Peginterferon Alfa-2a + Ribavirin + Boceprevir'.

Time frame: Week 4 and 12 for telaprevir group; Week 8 and 24 for boceprevir group

Population: mTRT population:participants who had an HCV-RNA result ≥50 IU/mL at their last measurement prior to commencing CHC therapy;had received one of study's triple combination therapies;participants' treatment documentation was sufficient for assignment to treatment groups.Number of participants analyzed:participants evaluated for this outcome measure.

RVR was defined as HCV-RNA \<50 IU/mL by Week 4

Time frame: Week 4

Population: mTRT population: participants who had an HCV-RNA result ≥50 IU/mL at their last measurement prior to commencing CHC therapy; had received one of the study's combination therapies; participants' treatment documentation was sufficient for assignment to treatment groups. Number of participants analyzed: participants evaluated for this outcome measure.

Time frame: Week 48

Population: Safety Population. Included only participants who had received at least one dose of peginterferon alfa-2a plus ribavirin or peginterferon alfa-2a plus ribavirin plus telaprevir/boceprevir and had at least one post-baseline safety assessment.

Virologic relapse was defined as detectable HCV-RNA during the treatment-free follow-up period in participants with HCV-RNA \<50 IU/mL at EoT.

Time frame: Week 72

Population: mTRT population: participants who had an HCV-RNA result ≥50 IU/mL at their last measurement prior to commencing CHC therapy; had received one of the study's combination therapies; participants' treatment documentation was sufficient for assignment to treatment groups. Number of participants analyzed: participants evaluated for this outcome measure.

Time frame: Week 48

Population: mTRT population: participants who had an HCV-RNA result ≥50 IU/mL at their last measurement prior to commencing CHC therapy; had received one of the study's combination therapies; participants' treatment documentation was sufficient for assignment to treatment groups. Number of participants analyzed: participants evaluated for this outcome measure.

Time frame: Week 48

Population: mTRT population: participants who had an HCV-RNA result ≥50 IU/mL at their last measurement prior to commencing CHC therapy; had received one of the study's combination therapies; participants' treatment documentation was sufficient for assignment to treatment groups. Number of participants analyzed: participants evaluated for this outcome measure.

Time frame: Week 48

Population: mTRT population:participants who had an HCV-RNA result ≥50 IU/mL at their last measurement prior to commencing CHC therapy;had received 1 of study's triple combination therapies;participants' treatment documentation was sufficient for assignment to treatment groups.Number of participants analyzed:participants evaluated for this outcome measure.

The average amount of time a treatment was prescribed to participants.

Time frame: Week 48

Population: All Enrolled Participants