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

Terminated

• Conditions: Hepatitis C, Chronic
• Interventions: Drug: Boceprevir; Drug: Simeprevir; Drug: Pegylated Interferon (Peginterferon) Alfa-2a; Drug: Ribavirin

• Registration Number: NCT02118597
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-04-16
• Study First Submitted QC: 2014-04-16
• Study First Posted: 2014-04-21
• Study Start: 2014-05
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Results First Submitted: 2016-06-15
• Status Verified: 2016-10
• Results First Submitted QC: 2016-10-18
• Last Update Submitted: 2016-10-18
• Results First Posted: 2016-12-12
• Last Update Posted: 2016-12-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 19

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Triple Combination Therapy	Pegylated Interferon (Peginterferon) Alfa-2a	Participants who demonstrated genotype 1 chronic hepatitis C infection and had a history of unsuccessful treatment with pegylated interferon (peginterferon) alfa + ribavirin, and who were subjected to receive a triple combination therapy with simeprevir or boceprevir plus peginterferon alfa-2a and ribavirin were observed.
Triple Combination Therapy	Simeprevir	Participants who demonstrated genotype 1 chronic hepatitis C infection and had a history of unsuccessful treatment with pegylated interferon (peginterferon) alfa + ribavirin, and who were subjected to receive a triple combination therapy with simeprevir or boceprevir plus peginterferon alfa-2a and ribavirin were observed.
Triple Combination Therapy	Boceprevir	Participants who demonstrated genotype 1 chronic hepatitis C infection and had a history of unsuccessful treatment with pegylated interferon (peginterferon) alfa + ribavirin, and who were subjected to receive a triple combination therapy with simeprevir or boceprevir plus peginterferon alfa-2a and ribavirin were observed.
Triple Combination Therapy	Ribavirin	Participants who demonstrated genotype 1 chronic hepatitis C infection and had a history of unsuccessful treatment with pegylated interferon (peginterferon) alfa + ribavirin, and who were subjected to receive a triple combination therapy with simeprevir or boceprevir plus peginterferon alfa-2a and ribavirin were observed.

Primary Outcome Measures

Name	Time	Method
Sustained Virological Response 24 (SVR24) Rate	24 weeks after end of treatment (EOT) at Week 72	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.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Treatment Discontinuation Due to Futility	Up to Week 48	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.
Number of Participants With Adverse Events	Up to 72 weeks	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.
Percentage of Participants With Virological Response	Weeks 4, 8, 12, and 24	Virological response is defined as HCV RNA \<15 IU/mL.
Percentage of Participants With Positive Predictive Value of Liver Fibrosis	Screening (before Week 1)	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.
Number of Participants With Virological Breakthrough	Up to Week 48	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.
Percentage of Participants With Positive Predictive Value of Participant Demographics for SVR Rate	Screening (before Week 1)	Demographic characteristics recorded were age and gender. Predictive value of these characteristics for SVR rate was to be assessed.
Predictive Value of HCV Disease Characteristics	Screening (before Week 1)	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.
Number of Participants With Virological Relapse	Week 49 up to Week 72	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.
Number of Participants With Treatment Discontinuation	Up to Week 48	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.
Percentage of Participants With Positive Predictive Value of Previous Virological Response (Null-response, Partial Response, or Relapse)	Up to 72 weeks	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.