Trial Outcomes & Findings for Patient Compliance During PegIntron and Rebetol Combination Therapy in Chronic Hepatitis C (Study P04690) (NCT NCT00725205)

Results Overview

Participants who continued treatment beyond Week 12 (i.e., 24 or 48 weeks depending on the viral genotype) were assessed for triple-80 compliance. Triple-80 compliant, or simply compliant, participants were those that received \>= 80% of the planned total doses of both pegylated interferon alfa-2b and ribavirin for \>=80% of the duration of the therapy. 3 rates were computed: Compliance with study duration, compliance with pegylated interferon dose, and compliance with ribavirin dose. A participant was defined as triple-80 compliant, if none of the 3 rates as defined above were less than 80.

Recruitment status

COMPLETED

Target enrollment

294 participants

Primary outcome timeframe

24 or 48 Weeks

Results posted on

2015-10-08

Participant Flow

A total of 294 participants were enrolled, 2 participants were not treated.

Participant milestones

Participant milestones
Measure	Peginterferon Alfa-2b and Ribavirin Previously untreated Chronic Hepatitis C (CHC) participants treated with a treatment regimen of 1.5 micgrograms (mcg)/killogram (kg) Peginterferon alfa-2b (injection pen) and weight based daily Ribavirin capsules combination therapy as their usual medical treatment administered according to the product's labeling and current practice in Hungary for 12 weeks. Those participants whose continued treatment was warranted beyond Week 12 based on response received therapy for 24 or 48 weeks depending on the viral genotype.
Overall Study STARTED	294
Overall Study COMPLETED	207
Overall Study NOT COMPLETED	87

Reasons for withdrawal

Reasons for withdrawal
Measure	Peginterferon Alfa-2b and Ribavirin Previously untreated Chronic Hepatitis C (CHC) participants treated with a treatment regimen of 1.5 micgrograms (mcg)/killogram (kg) Peginterferon alfa-2b (injection pen) and weight based daily Ribavirin capsules combination therapy as their usual medical treatment administered according to the product's labeling and current practice in Hungary for 12 weeks. Those participants whose continued treatment was warranted beyond Week 12 based on response received therapy for 24 or 48 weeks depending on the viral genotype.
Overall Study Adverse Event	22
Overall Study Investigator Discontinued	1
Overall Study Non-compliance With Protocol	14
Overall Study Other	8
Overall Study Protocol Defined Clinical Event	1
Overall Study Treatment Failure	41

Baseline Characteristics

Patient Compliance During PegIntron and Rebetol Combination Therapy in Chronic Hepatitis C (Study P04690)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Peginterferon Alfa-2b and Ribavirin n=294 Participants Previously untreated CHC participants treated with a treatment regimen of 1.5 mcg/kg Peginterferon alfa-2b (injection pen) and weight based daily Ribavirin capsules combination therapy as their usual medical treatment administered according to the product's labeling and current practice in Hungary for 12 weeks. Those participants whose continued treatment was warranted beyond Week 12 based on response received therapy for 24 or 48 weeks depending on the viral genotype.
Age, Continuous	46.7 years STANDARD_DEVIATION 10.8 • n=5 Participants
Sex: Female, Male Female	165 Participants n=5 Participants
Sex: Female, Male Male	129 Participants n=5 Participants

PRIMARY outcome

Timeframe: 24 or 48 Weeks

Population: All enrolled participants who received any dose of any medication, had a known viral genotype, and did not discontinue from the study with the status being "treatment failure". Of the 294 enrolled participants, 253 participants started treatment and continued treatment beyond Week 12.

Participants who continued treatment beyond Week 12 (i.e., 24 or 48 weeks depending on the viral genotype) were assessed for triple-80 compliance. Triple-80 compliant, or simply compliant, participants were those that received \>= 80% of the planned total doses of both pegylated interferon alfa-2b and ribavirin for \>=80% of the duration of the therapy. 3 rates were computed: Compliance with study duration, compliance with pegylated interferon dose, and compliance with ribavirin dose. A participant was defined as triple-80 compliant, if none of the 3 rates as defined above were less than 80.

Outcome measures

Outcome measures
Measure	Peginterferon Alfa-2b and Ribavirin n=253 Participants Previously untreated CHC participants treated with a treatment regimen of 1.5 mcg/kg Peginterferon alfa-2b (injection pen) and weight based daily Ribavirin capsules combination therapy as their usual medical treatment administered according to the product's labeling and current practice in Hungary for 12 weeks. Those participants whose continued treatment was warranted beyond Week 12 based on response received therapy for 24 or 48 weeks depending on the viral genotype.
Number of Participants Who Are Triple-80 Compliant	183 Participants

SECONDARY outcome

Timeframe: 24 Weeks following completion of 24 or 48 weeks of therapy

Population: Full Analyses Set: All enrolled participants who received any dose of any medication (Peginterferon or Ribavirin) and had a known viral genotype. Of the 294 enrolled participants, 2 were not treated.

Sustained virologic response (SVR) was assessed at post-treatment Follow-up Week 24. Day 1 of the Follow-up period was defined as the first day after the last dose day. A participant was considered a sustained responder if the participant had undetectable Hepatitis C virus Ribonucleic acid (HCV-RNA) level (based on qualitative test result) at Follow-up Week 24. If a participant with missing polymerase chain reaction (PCR) data at Follow-up Week 24 had undetectable HCV-RNA level at Follow-up Week 12, the participant was also considered as a sustained responder.

Outcome measures

Outcome measures
Measure	Peginterferon Alfa-2b and Ribavirin n=292 Participants Previously untreated CHC participants treated with a treatment regimen of 1.5 mcg/kg Peginterferon alfa-2b (injection pen) and weight based daily Ribavirin capsules combination therapy as their usual medical treatment administered according to the product's labeling and current practice in Hungary for 12 weeks. Those participants whose continued treatment was warranted beyond Week 12 based on response received therapy for 24 or 48 weeks depending on the viral genotype.
Number of Participants Who Achieved Sustained Virological Response as Assessed at 24-week Post-treatment Follow-up	66 Participants

SECONDARY outcome

Timeframe: Up to 48 Weeks

Population: All Participants enrolled.

Number of participants self-administering Pegylated interferon alfa-2b injection pen. If a participant changed the way he or she administered the injection pen during the course of the study (from self-administering to clinic-administering or the other way around), that participant was also considered as self-administering.

Outcome measures

Outcome measures
Measure	Peginterferon Alfa-2b and Ribavirin n=294 Participants Previously untreated CHC participants treated with a treatment regimen of 1.5 mcg/kg Peginterferon alfa-2b (injection pen) and weight based daily Ribavirin capsules combination therapy as their usual medical treatment administered according to the product's labeling and current practice in Hungary for 12 weeks. Those participants whose continued treatment was warranted beyond Week 12 based on response received therapy for 24 or 48 weeks depending on the viral genotype.
Number Of Participants Self-Administering Pegylated Interferon Alfa-2b	291 Participants

Adverse Events

Peginterferon Alfa-2b and Ribavirin

Serious events: 9 serious events

Other events: 109 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Peginterferon Alfa-2b and Ribavirin n=292 participants at risk Previously untreated CHC participants treated with a treatment regimen of 1.5 mcg/kg Peginterferon alfa-2b (injection pen) and weight based daily Ribavirin capsules combination therapy as their usual medical treatment administered according to the product's labeling and current practice in Hungary for 12 weeks. Those participants whose continued treatment was warranted beyond Week 12 based on response received therapy for 24 or 48 weeks depending on the viral genotype.
Blood and lymphatic system disorders Anaemia	0.68% 2/292 • Number of events 2 The All Patients as Treated (APAT) population included all enrolled participants who took at least one dose of Peginterferon alfa-2b or Ribavirin.
Blood and lymphatic system disorders Eosinophilia	0.34% 1/292 • Number of events 1 The All Patients as Treated (APAT) population included all enrolled participants who took at least one dose of Peginterferon alfa-2b or Ribavirin.
Blood and lymphatic system disorders Thrombocytopenia	0.34% 1/292 • Number of events 1 The All Patients as Treated (APAT) population included all enrolled participants who took at least one dose of Peginterferon alfa-2b or Ribavirin.
Infections and infestations Pneumonia	0.34% 1/292 • Number of events 1 The All Patients as Treated (APAT) population included all enrolled participants who took at least one dose of Peginterferon alfa-2b or Ribavirin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic Neoplasm Malignant	0.68% 2/292 • Number of events 2 The All Patients as Treated (APAT) population included all enrolled participants who took at least one dose of Peginterferon alfa-2b or Ribavirin.
Psychiatric disorders Depression	0.34% 1/292 • Number of events 1 The All Patients as Treated (APAT) population included all enrolled participants who took at least one dose of Peginterferon alfa-2b or Ribavirin.
Respiratory, thoracic and mediastinal disorders Asphyxia	0.34% 1/292 • Number of events 1 The All Patients as Treated (APAT) population included all enrolled participants who took at least one dose of Peginterferon alfa-2b or Ribavirin.
Skin and subcutaneous tissue disorders Toxic Skin Eruption	0.34% 1/292 • Number of events 1 The All Patients as Treated (APAT) population included all enrolled participants who took at least one dose of Peginterferon alfa-2b or Ribavirin.

Other adverse events

Other adverse events
Measure	Peginterferon Alfa-2b and Ribavirin n=292 participants at risk Previously untreated CHC participants treated with a treatment regimen of 1.5 mcg/kg Peginterferon alfa-2b (injection pen) and weight based daily Ribavirin capsules combination therapy as their usual medical treatment administered according to the product's labeling and current practice in Hungary for 12 weeks. Those participants whose continued treatment was warranted beyond Week 12 based on response received therapy for 24 or 48 weeks depending on the viral genotype.
Blood and lymphatic system disorders Anaemia	25.3% 74/292 • Number of events 87 The All Patients as Treated (APAT) population included all enrolled participants who took at least one dose of Peginterferon alfa-2b or Ribavirin.
Blood and lymphatic system disorders Thrombocytopenia	5.1% 15/292 • Number of events 17 The All Patients as Treated (APAT) population included all enrolled participants who took at least one dose of Peginterferon alfa-2b or Ribavirin.
General disorders Pyrexia	7.9% 23/292 • Number of events 26 The All Patients as Treated (APAT) population included all enrolled participants who took at least one dose of Peginterferon alfa-2b or Ribavirin.
Investigations Weight Decreased	6.5% 19/292 • Number of events 19 The All Patients as Treated (APAT) population included all enrolled participants who took at least one dose of Peginterferon alfa-2b or Ribavirin.

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Investigators require the SPONSOR'S written permission to publish any information pertaining to the study during and five years after closure of the study.
Publication restrictions are in place

Restriction type: OTHER