An Observational Study Examining the Use of Triple Combination Therapy With Boceprevir, Peginterferon Alfa-2a and Ribavirin in the Re-Treatment of Chronic Hepatitis C Patients

Hoffmann-La Roche19 enrolled

Overview

This prospective, national, multicenter, non-interventional study examined the use of triple combination therapy with boceprevir, pegylated interferon (peginterferon) alfa-2a and ribavirin in re-treating participants with genotype 1 chronic hepatitis C (CHC) infection. Dosing and treatment duration were at the discretion of the investigator in accordance with local clinical practice and local labeling. Participants were to be observed for the duration of their triple combination therapy and for up to 24 weeks thereafter.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Hepatitis C, Chronic

Interventions

BoceprevirDRUG

Boceprevir administered according to corresponding summary of product characteristics (SmPC).

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 18 years of age or over * Genotype 1 CHC infection * Prior unsuccessful treatment with peginterferon alfa plus ribavirin (null-response, partial response and relapsed participants) * Receiving triple combination therapy with boceprevir, peginterferon alfa-2a and ribavirin according to standard of care and in line with local labeling * Enrollment in the study no later than 4 weeks after start of triple combination therapy (including peginterferon alfa-2a and ribavirin lead-in phase) Exclusion Criteria: * Naïve participants not responding to peginterferon alfa plus ribavirin at week 4 (HCV RNA drop \< 1 log10) or at week 12 (HCV RNA \>/= 15 international units/milliliter \[IU/mL\]) and switching to triple combination therapy with boceprevir

Locations (7)

Unnamed facility

Békéscsaba, Hungary

Unnamed facility

Budapest, Hungary

Unnamed facility

Budapest, Hungary

Unnamed facility

Debrecen, Hungary

Unnamed facility

Eger, Hungary

Unnamed facility

Kaposvár, Hungary

Unnamed facility

Szombathely, Hungary

Outcomes

Primary Outcomes

Sustained Virological Response 24 (SVR24) Rate

The SVR 24 rate is defined as percentage of participants with Hepatitis C virus (HCV) Ribonucleic Acid (RNA) less than 15 international unit/milliliter (IU/mL) after the 24-weeks follow-up.

Time frame: 24 weeks after end of treatment (EOT) at Week 72

Secondary Outcomes

Percentage of Participants With Virological Response

Virological response is defined as HCV RNA \<15 IU/mL.

Time frame: Weeks 4, 8, 12, and 24

Number of Participants With Virological Breakthrough

Virological breakthrough is defined as either HCV RNA \>=15 IU/mL in participants with prior virological response or as an increase in HCV RNA \>/=1 log10 above nadir.

Time frame: Up to Week 48

Number of Participants With Virological Relapse

Virological response is defined as HCV RNA \>/=15 IU/mL during the treatment free follow-up period in participants with virological response at the end of treatment.

Time frame: Week 49 up to Week 72

Number of Participants With Treatment Discontinuation Due to Futility

Treatment discontinuation due to futility is defined as HCV RNA drop \<3 log10 at Week 8, HCV RNA \>/=100 IU/mL at Week 12, or HCV RNA \>/=15 IU/mL at Week 24.

Time frame: Up to Week 48

Number of Participants With Treatment Discontinuation

Treatment discontinuation is reported by sub-categories of reasons for treatment discontinuation. Futility rule is defined as HCV RNA drop \<3 log10 at Week 8, HCV RNA \>/=100 IU/mL at Week 12, or HCV RNA \>/=15 IU/mL at Week 24.

Time frame: Up to Week 48

Number of Participants With Adverse Events

An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.

Time frame: Up to 72 weeks

Percentage of Participants With Positive Predictive Value of Participant Demographics for SVR Rate

Demographic characteristics recorded were age and gender. Predictive value of these characteristics for SVR rate was to be assessed.

Time frame: Screening (before Week 1)

Percentage of Participants With Positive Predictive Value of Liver Fibrosis

The following sub-categories of liver fibrosis were determined in this study: 1) no cirrhosis, 2) bridging fibrosis and 3) cirrhosis. Predictive value of these sub-categories of liver fibrosis for SVR rate was to be assessed.

Time frame: Screening (before Week 1)

Predictive Value of HCV Disease Characteristics

HCV disease characteristics evaluated were HCV genotype (subtype), including HCV 1(a) and HCV 1(b). Predictive value of these disease characteristics for SVR rate were to be assessed.

Time frame: Screening (before Week 1)

Percentage of Participants With Positive Predictive Value of Previous Virological Response (Null-response, Partial Response, or Relapse)

Previous virological response was sub-categorized into the following categories: null-response, partial response, or relapse. Predictive value of these sub-categories for SVR rate were to be assessed.

Time frame: Up to 72 weeks