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

Hoffmann-La Roche991 enrolled

Overview

This multi-center, observational study will evaluate the efficacy and safety of dual and triple therapies based on Pegasys (peginterferon alfa-2a) in patients with chronic hepatitis C. Patients receiving treatment with either Pegasys plus ribavirin or Pegasys plus ribavirin plus telaprevir/boceprevir will be observed for the duration of their treatment and for up to 24 weeks of follow-up.

Study Type

OBSERVATIONAL

Enrollment

991

Conditions

Hepatitis C, Chronic

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Adult patients, \>/= 18 years of age * Chronic hepatitis C (all genotypes, naïve or treatment experienced, HCV mono-infected or HCV-HIV co-infected) * Receiving either dual therapy (Pegasys plus ribavirin) or triple therapy (Pegasys plus ribavirin plus telaprevir/boceprevir) * No contra-indications to Pegasys and ribavirin therapy or to treatment regimen containing protease inhibitor (telaprevir or boceprevir) as detailed in local Prescribing Information * Quantitative serum HCV RNA by PCR test before initiation of treatment Exclusion Criteria: * Hepatitis A/B co-infection * Evidence of severe illness, active malignancy, or any other conditions which would make the patient, in the opinion of the investigator, unsuitable for the study * Pregnant or breast-feeding women

Locations (21)

Haemek Hospital; Gastroenterology

Afula, Israel

Barzilai MC; Gastroenterology

Ashkelon, Israel

Outcomes

Primary Outcomes

Percentage of Participants With Sustained Viral Response (SVR) at Week 24

Time frame: Week 24

Secondary Outcomes

Comparison of SVR at Week 24

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

Time frame: Week 24

Number of Participants With SVR at Week 24 According to the Demographic Characteristics

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

Percentage of Participants With Rapid Virologic Response (RVR) at Week 4

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

Time frame: Week 4

Percentage of Participants With Extended RVR

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

Data from ClinicalTrials.gov

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Soroka Medical Center; Gastroenterology

Beersheba, Israel

Hillel Yaffe Hospital; Gastroenterology

Hadera, Israel

Rambam Medical Center; Gastroenterology - Liver Unit

Haifa, Israel

Bnei-Zion Medical Center; Gastroenterology

Haifa, Israel

Carmel Hospital; Liver Unit

Haifa, Israel

Wolfson Hospital; Gastroenterology Unit

Holon, Israel

Shaare Zedek Hospital Liver Unit; Liver Unit

Jerusalem, Israel

Hadassah Hospital; Liver Unit

Jerusalem, Israel

...and 11 more locations

Percentage of Participants With Complete Early Virologic Response (cEVR)

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

Time frame: Week 12

Percentage of Participants With End of Treatment Response (EoT)

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

Time frame: Week 24

Percentage of Participants With Virologic Relapse

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

Treatment Duration

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

Time frame: Week 48

Time to First Dose Modification of Peginterferon Alfa-2a

Time frame: Week 48

Time to First Dose Modification of Ribavirin

Time frame: Week 48

Time to First Dose Modification of Telaprevir/Boceprevir

Time frame: Week 48

Percentage of Participants With Adverse Events (AEs)

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

Mean Value of Hemoglobin in Participants With Treatment-Induced Anemia

Time frame: Week 48

Percentage of Participants With Treatment Regimen for HCV Treatment Induced Anemia

Time frame: Week 48

Percentage of Participants Who Had SVR at Week 24 With Dose Modifications

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