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Trial Outcomes & Findings for A Study of Induction Dosing With PEGASYS (Peginterferon Alfa-2a [40KD]) Plus Copegus in Treatment-Naive Patients With Chronic Hepatitis C (NCT NCT00394277)

NCT ID: NCT00394277

Last Updated: 2010-08-03

Results Overview

SVR-24 according to the scheduled treatment period was defined as the percentage of patients with undetectable HCV RNA at 24 weeks after completion of the treatment period (a single last HCV RNA PCR \<15 IU/mL measured at or after week 68 (ie, on or after study day 477).

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

1175 participants

Primary outcome timeframe

Week 72

Results posted on

2010-08-03

Participant Flow

Participant milestones

Participant milestones
Measure
PEG-IFN 180 µg + Ribavirin 1200 mg
PEG-IFN 180 µg administered subcutaneously once weekly in abdomen or thigh. Ribavirin 600 mg administered orally twice daily (total of 1200 mg daily).
PEG-IFN 180 µg + Ribavirin 1400/1600 mg
PEG-IFN 180 µg administered subcutaneously once weekly in abdomen or thigh. Patients with a body weight of 85 kg to \<95 kg took 600 mg of ribavirin (3 tablets) in the morning and 800 mg (4 tablets) in the evening, or vice versa; total daily dose was 1400 mg. Patients with a body weight ≥ 95 kg took 800 mg of ribavirin (4 tablets) in the morning and evening; total daily dose was 1600 mg.
PEG-IFN 360/180 µg + Ribavirin 1200 mg
PEG-IFN 360 or 180 µg administered subcutaneously once weekly in abdomen or thigh. Ribavirin 600 mg administered orally twice daily (total of 1200 mg daily).
PEG-IFN 360/180 µg + Ribavirin 1400/1600 mg
PEG-IFN 360 or 180 µg administered subcutaneously once weekly in abdomen or thigh. Patients with a body weight of 85 kg to \<95 kg took 600 mg of ribavirin (3 tablets) in the morning and 800 mg (4 tablets) in the evening, or vice versa; total daily dose was 1400 mg. Patients with a body weight ≥ 95 kg took 800 mg of ribavirin (4 tablets) in the morning and evening; total daily dose was 1600 mg.
Overall Study
STARTED
195
196
393
391
Overall Study
COMPLETED
137
136
273
266
Overall Study
NOT COMPLETED
58
60
120
125

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study of Induction Dosing With PEGASYS (Peginterferon Alfa-2a [40KD]) Plus Copegus in Treatment-Naive Patients With Chronic Hepatitis C

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
PEG-IFN 180 µg + Ribavirin 1200 mg
n=195 Participants
PEG-IFN 180 µg administered subcutaneously once weekly in abdomen or thigh. Ribavirin 600 mg administered orally twice daily (total of 1200 mg daily).
PEG-IFN 180 µg + Ribavirin 1400/1600 mg
n=196 Participants
PEG-IFN 180 µg administered subcutaneously once weekly in abdomen or thigh. Patients with a body weight of 85 kg to \<95 kg took 600 mg of ribavirin (3 tablets) in the morning and 800 mg (4 tablets) in the evening, or vice versa; total daily dose was 1400 mg. Patients with a body weight ≥ 95 kg took 800 mg of ribavirin (4 tablets) in the morning and evening; total daily dose was 1600 mg.
PEG-IFN 360/180 µg + Ribavirin 1200 mg
n=393 Participants
PEG-IFN 360 or 180 µg administered subcutaneously once weekly in abdomen or thigh. Ribavirin 600 mg administered orally twice daily (total of 1200 mg daily).
PEG-IFN 360/180 µg + Ribavirin 1400/1600 mg
n=391 Participants
PEG-IFN 360 or 180 µg administered subcutaneously once weekly in abdomen or thigh. Patients with a body weight of 85 kg to \<95 kg took 600 mg of ribavirin (3 tablets) in the morning and 800 mg (4 tablets) in the evening, or vice versa; total daily dose was 1400 mg. Patients with a body weight ≥ 95 kg took 800 mg of ribavirin (4 tablets) in the morning and evening; total daily dose was 1600 mg.
Total
n=1175 Participants
Total of all reporting groups
Age Continuous
46.1 years
STANDARD_DEVIATION 9.86 • n=5 Participants
45.1 years
STANDARD_DEVIATION 9.50 • n=7 Participants
45.7 years
STANDARD_DEVIATION 9.64 • n=5 Participants
46.0 years
STANDARD_DEVIATION 10.18 • n=4 Participants
45.7 years
STANDARD_DEVIATION 9.83 • n=21 Participants
Gender
Female
37 Patients
n=5 Participants
41 Patients
n=7 Participants
90 Patients
n=5 Participants
73 Patients
n=4 Participants
241 Patients
n=21 Participants
Gender
Male
154 Patients
n=5 Participants
148 Patients
n=7 Participants
292 Patients
n=5 Participants
310 Patients
n=4 Participants
904 Patients
n=21 Participants

PRIMARY outcome

Timeframe: Week 72

Population: Intent-to-treat population (all patients treated with at least one dose of either study medication)

SVR-24 according to the scheduled treatment period was defined as the percentage of patients with undetectable HCV RNA at 24 weeks after completion of the treatment period (a single last HCV RNA PCR \<15 IU/mL measured at or after week 68 (ie, on or after study day 477).

Outcome measures

Outcome measures
Measure
PEG-IFN 180 µg + Ribavirin 1200 mg
n=191 Participants
PEG-IFN 180 µg administered subcutaneously once weekly in abdomen or thigh. Ribavirin 600 mg administered orally twice daily (total of 1200 mg daily).
PEG-IFN 180 µg + Ribavirin 1400/1600 mg
n=189 Participants
PEG-IFN 180 µg administered subcutaneously once weekly in abdomen or thigh. Patients with a body weight of 85 kg to \<95 kg took 600 mg of ribavirin (3 tablets) in the morning and 800 mg (4 tablets) in the evening, or vice versa; total daily dose was 1400 mg. Patients with a body weight ≥ 95 kg took 800 mg of ribavirin (4 tablets) in the morning and evening; total daily dose was 1600 mg.
PEG-IFN 360/180 µg + Ribavirin 1200 mg
n=382 Participants
PEG-IFN 360 or 180 µg administered subcutaneously once weekly in abdomen or thigh. Ribavirin 600 mg administered orally twice daily (total of 1200 mg daily).
PEG-IFN 360/180 µg + Ribavirin 1400/1600 mg
n=383 Participants
PEG-IFN 360 or 180 µg administered subcutaneously once weekly in abdomen or thigh. Patients with a body weight of 85 kg to \<95 kg took 600 mg of ribavirin (3 tablets) in the morning and 800 mg (4 tablets) in the evening, or vice versa; total daily dose was 1400 mg. Patients with a body weight ≥ 95 kg took 800 mg of ribavirin (4 tablets) in the morning and evening; total daily dose was 1600 mg.
Sustained Virological Response (SVR)-24 (Scheduled Treatment Period)
37.7 Percentage of patients
42.9 Percentage of patients
43.5 Percentage of patients
40.7 Percentage of patients

SECONDARY outcome

Timeframe: 24 weeks after end of treatment

Population: Intent-to-treat population (all patients treated with at least one dose of either study medication)

SVR-24 according to the actual treatment period was defined as the percentage of patients with undetectable HCV RNA at least 20 weeks after the last dose of study drug.

Outcome measures

Outcome measures
Measure
PEG-IFN 180 µg + Ribavirin 1200 mg
n=191 Participants
PEG-IFN 180 µg administered subcutaneously once weekly in abdomen or thigh. Ribavirin 600 mg administered orally twice daily (total of 1200 mg daily).
PEG-IFN 180 µg + Ribavirin 1400/1600 mg
n=189 Participants
PEG-IFN 180 µg administered subcutaneously once weekly in abdomen or thigh. Patients with a body weight of 85 kg to \<95 kg took 600 mg of ribavirin (3 tablets) in the morning and 800 mg (4 tablets) in the evening, or vice versa; total daily dose was 1400 mg. Patients with a body weight ≥ 95 kg took 800 mg of ribavirin (4 tablets) in the morning and evening; total daily dose was 1600 mg.
PEG-IFN 360/180 µg + Ribavirin 1200 mg
n=382 Participants
PEG-IFN 360 or 180 µg administered subcutaneously once weekly in abdomen or thigh. Ribavirin 600 mg administered orally twice daily (total of 1200 mg daily).
PEG-IFN 360/180 µg + Ribavirin 1400/1600 mg
n=383 Participants
PEG-IFN 360 or 180 µg administered subcutaneously once weekly in abdomen or thigh. Patients with a body weight of 85 kg to \<95 kg took 600 mg of ribavirin (3 tablets) in the morning and 800 mg (4 tablets) in the evening, or vice versa; total daily dose was 1400 mg. Patients with a body weight ≥ 95 kg took 800 mg of ribavirin (4 tablets) in the morning and evening; total daily dose was 1600 mg.
SVR-24 (Actual Treatment Period)
38.2 Percentage of patients
43.9 Percentage of patients
43.5 Percentage of patients
40.7 Percentage of patients

SECONDARY outcome

Timeframe: 12 weeks after end of treatment

Population: Intent-to-treat population (all patients treated with at least one dose of either study medication)

SVR-12 according to the scheduled treatment period was defined as the percentage of patients with undetectable HCV RNA at 12 weeks after the scheduled treatment period (a single last HCV RNA PCR \<15 IU/mL measured at or after week 60).

Outcome measures

Outcome measures
Measure
PEG-IFN 180 µg + Ribavirin 1200 mg
n=191 Participants
PEG-IFN 180 µg administered subcutaneously once weekly in abdomen or thigh. Ribavirin 600 mg administered orally twice daily (total of 1200 mg daily).
PEG-IFN 180 µg + Ribavirin 1400/1600 mg
n=189 Participants
PEG-IFN 180 µg administered subcutaneously once weekly in abdomen or thigh. Patients with a body weight of 85 kg to \<95 kg took 600 mg of ribavirin (3 tablets) in the morning and 800 mg (4 tablets) in the evening, or vice versa; total daily dose was 1400 mg. Patients with a body weight ≥ 95 kg took 800 mg of ribavirin (4 tablets) in the morning and evening; total daily dose was 1600 mg.
PEG-IFN 360/180 µg + Ribavirin 1200 mg
n=382 Participants
PEG-IFN 360 or 180 µg administered subcutaneously once weekly in abdomen or thigh. Ribavirin 600 mg administered orally twice daily (total of 1200 mg daily).
PEG-IFN 360/180 µg + Ribavirin 1400/1600 mg
n=383 Participants
PEG-IFN 360 or 180 µg administered subcutaneously once weekly in abdomen or thigh. Patients with a body weight of 85 kg to \<95 kg took 600 mg of ribavirin (3 tablets) in the morning and 800 mg (4 tablets) in the evening, or vice versa; total daily dose was 1400 mg. Patients with a body weight ≥ 95 kg took 800 mg of ribavirin (4 tablets) in the morning and evening; total daily dose was 1600 mg.
SVR-12 (Scheduled Treatment Period)
40.3 Percentage of patients
45.0 Percentage of patients
44.2 Percentage of patients
41.5 Percentage of patients

SECONDARY outcome

Timeframe: 12 weeks after end of treatment

Population: Intent-to-treat population (all patients treated with at least one dose of either study medication)

SVR-12 according to the actual treatment period was defined as the percentage of patients with undetectable HCV RNA at least 12 weeks after the last dose of study drug.

Outcome measures

Outcome measures
Measure
PEG-IFN 180 µg + Ribavirin 1200 mg
n=191 Participants
PEG-IFN 180 µg administered subcutaneously once weekly in abdomen or thigh. Ribavirin 600 mg administered orally twice daily (total of 1200 mg daily).
PEG-IFN 180 µg + Ribavirin 1400/1600 mg
n=189 Participants
PEG-IFN 180 µg administered subcutaneously once weekly in abdomen or thigh. Patients with a body weight of 85 kg to \<95 kg took 600 mg of ribavirin (3 tablets) in the morning and 800 mg (4 tablets) in the evening, or vice versa; total daily dose was 1400 mg. Patients with a body weight ≥ 95 kg took 800 mg of ribavirin (4 tablets) in the morning and evening; total daily dose was 1600 mg.
PEG-IFN 360/180 µg + Ribavirin 1200 mg
n=382 Participants
PEG-IFN 360 or 180 µg administered subcutaneously once weekly in abdomen or thigh. Ribavirin 600 mg administered orally twice daily (total of 1200 mg daily).
PEG-IFN 360/180 µg + Ribavirin 1400/1600 mg
n=383 Participants
PEG-IFN 360 or 180 µg administered subcutaneously once weekly in abdomen or thigh. Patients with a body weight of 85 kg to \<95 kg took 600 mg of ribavirin (3 tablets) in the morning and 800 mg (4 tablets) in the evening, or vice versa; total daily dose was 1400 mg. Patients with a body weight ≥ 95 kg took 800 mg of ribavirin (4 tablets) in the morning and evening; total daily dose was 1600 mg.
SVR-12 (Actual Treatment Period)
40.3 Percentage of patients
45.5 Percentage of patients
44.2 Percentage of patients
42.3 Percentage of patients

Adverse Events

PEG-IFN 180 µg + Ribavirin 1200 mg

Serious events: 22 serious events
Other events: 186 other events
Deaths: 0 deaths

PEG-IFN 180 µg + Ribavirin 1400/1600 mg

Serious events: 20 serious events
Other events: 179 other events
Deaths: 0 deaths

PEG-IFN 360/180 µg + Ribavirin 1200 mg

Serious events: 36 serious events
Other events: 370 other events
Deaths: 0 deaths

PEG-IFN 360/180 µg + Ribavirin 1400/1600 mg

Serious events: 39 serious events
Other events: 373 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
PEG-IFN 180 µg + Ribavirin 1200 mg
n=191 participants at risk
PEG-IFN 180 µg administered subcutaneously once weekly in abdomen or thigh. Ribavirin 600 mg administered orally twice daily (total of 1200 mg daily).
PEG-IFN 180 µg + Ribavirin 1400/1600 mg
n=189 participants at risk
PEG-IFN 180 µg administered subcutaneously once weekly in abdomen or thigh. Patients with a body weight of 85 kg to \<95 kg took 600 mg of ribavirin (3 tablets) in the morning and 800 mg (4 tablets) in the evening, or vice versa; total daily dose was 1400 mg. Patients with a body weight ≥ 95 kg took 800 mg of ribavirin (4 tablets) in the morning and evening; total daily dose was 1600 mg.
PEG-IFN 360/180 µg + Ribavirin 1200 mg
n=382 participants at risk
PEG-IFN 360 or 180 µg administered subcutaneously once weekly in abdomen or thigh. Ribavirin 600 mg administered orally twice daily (total of 1200 mg daily).
PEG-IFN 360/180 µg + Ribavirin 1400/1600 mg
n=383 participants at risk
PEG-IFN 360 or 180 µg administered subcutaneously once weekly in abdomen or thigh. Patients with a body weight of 85 kg to \<95 kg took 600 mg of ribavirin (3 tablets) in the morning and 800 mg (4 tablets) in the evening, or vice versa; total daily dose was 1400 mg. Patients with a body weight ≥ 95 kg took 800 mg of ribavirin (4 tablets) in the morning and evening; total daily dose was 1600 mg.
Infections and infestations
Pneumonia
0.52%
1/191
1.6%
3/189
0.52%
2/382
1.0%
4/383
Infections and infestations
Appendicitis
0.00%
0/191
0.00%
0/189
0.79%
3/382
0.52%
2/383
Infections and infestations
Cellulitis
0.52%
1/191
0.00%
0/189
0.52%
2/382
0.00%
0/383
Infections and infestations
Abscess Limb
0.52%
1/191
0.00%
0/189
0.26%
1/382
0.00%
0/383
Infections and infestations
Gastroenteritis
0.00%
0/191
0.53%
1/189
0.00%
0/382
0.26%
1/383
Infections and infestations
Pyelonephritis
0.00%
0/191
0.00%
0/189
0.26%
1/382
0.26%
1/383
Infections and infestations
Pyelonephritis Acute
0.00%
0/191
1.1%
2/189
0.00%
0/382
0.00%
0/383
Infections and infestations
Anal Abscess
0.00%
0/191
0.00%
0/189
0.00%
0/382
0.26%
1/383
Infections and infestations
Bronchitis
0.00%
0/191
0.53%
1/189
0.00%
0/382
0.00%
0/383
Infections and infestations
Bursitis Infective
0.52%
1/191
0.00%
0/189
0.00%
0/382
0.00%
0/383
Infections and infestations
Gastroenteritis Viral
0.52%
1/191
0.00%
0/189
0.00%
0/382
0.00%
0/383
Infections and infestations
Injection Site Abscess
0.52%
1/191
0.00%
0/189
0.00%
0/382
0.00%
0/383
Infections and infestations
Intervertebral Discitis
0.00%
0/191
0.00%
0/189
0.26%
1/382
0.00%
0/383
Infections and infestations
Lobar Pneumonia
0.00%
0/191
0.00%
0/189
0.26%
1/382
0.00%
0/383
Infections and infestations
Lung Abscess
0.00%
0/191
0.00%
0/189
0.00%
0/382
0.26%
1/383
Infections and infestations
Lung Infection
0.00%
0/191
0.00%
0/189
0.00%
0/382
0.26%
1/383
Infections and infestations
Osteomyelitis
0.00%
0/191
0.00%
0/189
0.26%
1/382
0.00%
0/383
Infections and infestations
Pelvic Abscess
0.00%
0/191
0.00%
0/189
0.00%
0/382
0.26%
1/383
Infections and infestations
Pelvic Inflammatory Disease
0.00%
0/191
0.00%
0/189
0.26%
1/382
0.00%
0/383
Infections and infestations
Rectal Abscess
0.00%
0/191
0.00%
0/189
0.00%
0/382
0.26%
1/383
Infections and infestations
Sepsis
0.00%
0/191
0.00%
0/189
0.26%
1/382
0.00%
0/383
Infections and infestations
Subcutaneous Abscess
0.00%
0/191
0.53%
1/189
0.00%
0/382
0.00%
0/383
Psychiatric disorders
Depression
0.00%
0/191
1.6%
3/189
0.26%
1/382
0.00%
0/383
Psychiatric disorders
Suicidal Ideation
0.00%
0/191
0.00%
0/189
0.52%
2/382
0.00%
0/383
Psychiatric disorders
Acute Psychosis
0.00%
0/191
0.53%
1/189
0.00%
0/382
0.00%
0/383
Psychiatric disorders
Alcoholism
0.52%
1/191
0.00%
0/189
0.00%
0/382
0.00%
0/383
Psychiatric disorders
Bipolar Disorder
0.00%
0/191
0.00%
0/189
0.00%
0/382
0.26%
1/383
Psychiatric disorders
Completed Suicide
0.00%
0/191
0.00%
0/189
0.26%
1/382
0.00%
0/383
Psychiatric disorders
Dependence
0.52%
1/191
0.00%
0/189
0.00%
0/382
0.00%
0/383
Psychiatric disorders
Hostility
0.00%
0/191
0.00%
0/189
0.26%
1/382
0.00%
0/383
Psychiatric disorders
Major Depression
0.00%
0/191
0.00%
0/189
0.26%
1/382
0.00%
0/383
Psychiatric disorders
Panic Attack
0.52%
1/191
0.00%
0/189
0.00%
0/382
0.00%
0/383
Psychiatric disorders
Psychotic Disorder
0.00%
0/191
0.53%
1/189
0.00%
0/382
0.00%
0/383
Psychiatric disorders
Suicide Attempt
0.00%
0/191
0.53%
1/189
0.00%
0/382
0.00%
0/383
Blood and lymphatic system disorders
Anaemia
0.00%
0/191
1.1%
2/189
0.52%
2/382
0.78%
3/383
Blood and lymphatic system disorders
Thrombocytopenia
1.0%
2/191
0.00%
0/189
0.00%
0/382
0.00%
0/383
Blood and lymphatic system disorders
Anaemia Haemolytic Autoimmune
0.00%
0/191
0.00%
0/189
0.00%
0/382
0.26%
1/383
Blood and lymphatic system disorders
Pancytopenia
0.00%
0/191
0.00%
0/189
0.26%
1/382
0.00%
0/383
Nervous system disorders
Cerebral Haemorrhage
0.00%
0/191
0.00%
0/189
0.26%
1/382
0.26%
1/383
Nervous system disorders
Altered State of Consciousness
0.00%
0/191
0.53%
1/189
0.00%
0/382
0.00%
0/383
Nervous system disorders
Cerebrovascular Accident
0.52%
1/191
0.00%
0/189
0.00%
0/382
0.00%
0/383
Nervous system disorders
Headache
0.00%
0/191
0.00%
0/189
0.26%
1/382
0.00%
0/383
Nervous system disorders
Hepatic Encephalopathy
0.00%
0/191
0.53%
1/189
0.00%
0/382
0.00%
0/383
Nervous system disorders
Metabolic Encephalopathy
0.00%
0/191
0.00%
0/189
0.26%
1/382
0.00%
0/383
Nervous system disorders
Peripheral Motor Neuropathy
0.00%
0/191
0.00%
0/189
0.26%
1/382
0.00%
0/383
Nervous system disorders
Syncope
0.00%
0/191
0.00%
0/189
0.00%
0/382
0.26%
1/383
Nervous system disorders
Transient Ischaemic Attack
0.52%
1/191
0.00%
0/189
0.00%
0/382
0.00%
0/383
Cardiac disorders
Angina Pectoris
0.00%
0/191
0.00%
0/189
0.26%
1/382
0.52%
2/383
Cardiac disorders
Acute Coronary Syndrome
0.00%
0/191
0.53%
1/189
0.00%
0/382
0.00%
0/383
Cardiac disorders
Arrhythmia
0.00%
0/191
0.00%
0/189
0.26%
1/382
0.00%
0/383
Cardiac disorders
Atrial Fibrillation
0.00%
0/191
0.00%
0/189
0.00%
0/382
0.26%
1/383
Cardiac disorders
Cardiac Arrest
0.00%
0/191
0.53%
1/189
0.00%
0/382
0.00%
0/383
Cardiac disorders
Cardiac Failure Congestive
0.52%
1/191
0.00%
0/189
0.00%
0/382
0.00%
0/383
Cardiac disorders
Myocardial Infarction
0.52%
1/191
0.00%
0/189
0.00%
0/382
0.00%
0/383
Injury, poisoning and procedural complications
Overdose
0.00%
0/191
0.53%
1/189
0.26%
1/382
0.00%
0/383
Injury, poisoning and procedural complications
Ankle Fracture
0.00%
0/191
0.00%
0/189
0.00%
0/382
0.26%
1/383
Injury, poisoning and procedural complications
Meniscus Lesion
0.52%
1/191
0.00%
0/189
0.00%
0/382
0.00%
0/383
Injury, poisoning and procedural complications
Multiple Fractures
0.00%
0/191
0.00%
0/189
0.26%
1/382
0.00%
0/383
Injury, poisoning and procedural complications
Postoperative Fever
0.00%
0/191
0.00%
0/189
0.00%
0/382
0.26%
1/383
Injury, poisoning and procedural complications
Radius Fracture
0.00%
0/191
0.00%
0/189
0.00%
0/382
0.26%
1/383
Injury, poisoning and procedural complications
Venom Poisoning
0.00%
0/191
0.00%
0/189
0.00%
0/382
0.26%
1/383
General disorders
Non-Cardiac Chest Pain
0.52%
1/191
0.00%
0/189
0.00%
0/382
0.26%
1/383
General disorders
Asthenia
0.00%
0/191
0.00%
0/189
0.00%
0/382
0.26%
1/383
General disorders
Fatigue
0.00%
0/191
0.00%
0/189
0.26%
1/382
0.00%
0/383
General disorders
Gait Disturbance
0.00%
0/191
0.00%
0/189
0.26%
1/382
0.00%
0/383
General disorders
Hyperplasia
0.00%
0/191
0.00%
0/189
0.00%
0/382
0.26%
1/383
General disorders
Malaise
0.00%
0/191
0.00%
0/189
0.26%
1/382
0.00%
0/383
General disorders
Multi-Organ Failure
0.00%
0/191
0.53%
1/189
0.00%
0/382
0.00%
0/383
General disorders
Pain
0.00%
0/191
0.00%
0/189
0.00%
0/382
0.26%
1/383
Gastrointestinal disorders
Abdominal Pain
0.00%
0/191
0.00%
0/189
0.26%
1/382
0.52%
2/383
Gastrointestinal disorders
Intestinal Obstruction
0.00%
0/191
0.00%
0/189
0.00%
0/382
0.26%
1/383
Gastrointestinal disorders
Pancreatitis Acute
0.00%
0/191
0.00%
0/189
0.00%
0/382
0.26%
1/383
Gastrointestinal disorders
Small Intestinal Obstruction
0.00%
0/191
0.00%
0/189
0.26%
1/382
0.00%
0/383
Gastrointestinal disorders
Vomiting
0.52%
1/191
0.00%
0/189
0.00%
0/382
0.00%
0/383
Hepatobiliary disorders
Cholelithiasis
0.00%
0/191
0.53%
1/189
0.00%
0/382
0.26%
1/383
Hepatobiliary disorders
Hepatic Failure
0.00%
0/191
0.00%
0/189
0.26%
1/382
0.26%
1/383
Hepatobiliary disorders
Cholecystitis
0.00%
0/191
0.00%
0/189
0.00%
0/382
0.26%
1/383
Hepatobiliary disorders
Cholecystitis Acute
0.00%
0/191
0.00%
0/189
0.00%
0/382
0.26%
1/383
Hepatobiliary disorders
Hepatorenal Syndrome
0.00%
0/191
0.53%
1/189
0.00%
0/382
0.00%
0/383
Eye disorders
Retinal Haemorrhage
0.52%
1/191
0.53%
1/189
0.26%
1/382
0.00%
0/383
Eye disorders
Retinal Detachment
0.00%
0/191
0.53%
1/189
0.26%
1/382
0.00%
0/383
Eye disorders
Glaucoma
0.00%
0/191
0.00%
0/189
0.26%
1/382
0.00%
0/383
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma
0.00%
0/191
0.00%
0/189
0.00%
0/382
0.26%
1/383
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic Neoplasm Malignant
0.52%
1/191
0.00%
0/189
0.00%
0/382
0.00%
0/383
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic Carcinoma
0.00%
0/191
0.00%
0/189
0.00%
0/382
0.26%
1/383
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic Neoplasm
0.00%
0/191
0.00%
0/189
0.26%
1/382
0.00%
0/383
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tonsil Cancer
0.00%
0/191
0.00%
0/189
0.00%
0/382
0.26%
1/383
Respiratory, thoracic and mediastinal disorders
Alveolitis Fibrosing
0.52%
1/191
0.00%
0/189
0.00%
0/382
0.26%
1/383
Respiratory, thoracic and mediastinal disorders
Haemoptysis
0.00%
0/191
0.00%
0/189
0.00%
0/382
0.52%
2/383
Respiratory, thoracic and mediastinal disorders
Pneumothorax
0.00%
0/191
0.53%
1/189
0.00%
0/382
0.00%
0/383
Metabolism and nutrition disorders
Dehydration
0.00%
0/191
0.00%
0/189
0.52%
2/382
0.26%
1/383
Metabolism and nutrition disorders
Diabetic Ketoacidosis
0.00%
0/191
0.00%
0/189
0.00%
0/382
0.26%
1/383
Musculoskeletal and connective tissue disorders
Back Pain
0.52%
1/191
0.00%
0/189
0.00%
0/382
0.00%
0/383
Musculoskeletal and connective tissue disorders
Fracture Nonunion
0.52%
1/191
0.00%
0/189
0.00%
0/382
0.00%
0/383
Musculoskeletal and connective tissue disorders
Intervertebral Disc Protrusion
0.52%
1/191
0.00%
0/189
0.00%
0/382
0.00%
0/383
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
0.52%
1/191
0.00%
0/189
0.00%
0/382
0.00%
0/383
Renal and urinary disorders
Calculus Ureteric
0.00%
0/191
0.00%
0/189
0.52%
2/382
0.00%
0/383
Renal and urinary disorders
Renal Failure Acute
0.00%
0/191
0.00%
0/189
0.00%
0/382
0.26%
1/383
Renal and urinary disorders
Tubulointerstitial Nephritis
0.00%
0/191
0.00%
0/189
0.00%
0/382
0.26%
1/383
Skin and subcutaneous tissue disorders
Dermatitis
0.00%
0/191
0.00%
0/189
0.26%
1/382
0.00%
0/383
Skin and subcutaneous tissue disorders
Psoriasis
0.00%
0/191
0.00%
0/189
0.26%
1/382
0.00%
0/383
Skin and subcutaneous tissue disorders
Skin Ulcer
0.00%
0/191
0.00%
0/189
0.00%
0/382
0.26%
1/383
Vascular disorders
Hypertension
0.00%
0/191
0.00%
0/189
0.00%
0/382
0.26%
1/383
Vascular disorders
Vena Cava Thrombosis
0.00%
0/191
0.53%
1/189
0.00%
0/382
0.00%
0/383
Endocrine disorders
Hyperthyroidism
0.00%
0/191
0.00%
0/189
0.00%
0/382
0.26%
1/383

Other adverse events

Other adverse events
Measure
PEG-IFN 180 µg + Ribavirin 1200 mg
n=191 participants at risk
PEG-IFN 180 µg administered subcutaneously once weekly in abdomen or thigh. Ribavirin 600 mg administered orally twice daily (total of 1200 mg daily).
PEG-IFN 180 µg + Ribavirin 1400/1600 mg
n=189 participants at risk
PEG-IFN 180 µg administered subcutaneously once weekly in abdomen or thigh. Patients with a body weight of 85 kg to \<95 kg took 600 mg of ribavirin (3 tablets) in the morning and 800 mg (4 tablets) in the evening, or vice versa; total daily dose was 1400 mg. Patients with a body weight ≥ 95 kg took 800 mg of ribavirin (4 tablets) in the morning and evening; total daily dose was 1600 mg.
PEG-IFN 360/180 µg + Ribavirin 1200 mg
n=382 participants at risk
PEG-IFN 360 or 180 µg administered subcutaneously once weekly in abdomen or thigh. Ribavirin 600 mg administered orally twice daily (total of 1200 mg daily).
PEG-IFN 360/180 µg + Ribavirin 1400/1600 mg
n=383 participants at risk
PEG-IFN 360 or 180 µg administered subcutaneously once weekly in abdomen or thigh. Patients with a body weight of 85 kg to \<95 kg took 600 mg of ribavirin (3 tablets) in the morning and 800 mg (4 tablets) in the evening, or vice versa; total daily dose was 1400 mg. Patients with a body weight ≥ 95 kg took 800 mg of ribavirin (4 tablets) in the morning and evening; total daily dose was 1600 mg.
General disorders
Pyrexia
43.5%
83/191
41.3%
78/189
46.1%
176/382
53.5%
205/383
General disorders
Fatigue
34.6%
66/191
54.0%
102/189
48.2%
184/382
47.5%
182/383
General disorders
Chills
22.0%
42/191
29.1%
55/189
31.9%
122/382
34.5%
132/383
General disorders
Asthenia
14.7%
28/191
18.5%
35/189
22.0%
84/382
20.9%
80/383
General disorders
Irritability
17.8%
34/191
15.3%
29/189
16.8%
64/382
17.2%
66/383
General disorders
Pain
5.2%
10/191
9.5%
18/189
6.3%
24/382
8.1%
31/383
General disorders
Injection Site Erythema
8.4%
16/191
7.4%
14/189
7.3%
28/382
6.3%
24/383
General disorders
Injection Site Reaction
6.3%
12/191
6.9%
13/189
5.2%
20/382
3.7%
14/383
General disorders
Malaise
5.2%
10/191
5.3%
10/189
3.7%
14/382
4.7%
18/383
Gastrointestinal disorders
Nausea
21.5%
41/191
22.2%
42/189
29.3%
112/382
27.2%
104/383
Gastrointestinal disorders
Diarrhoea
13.1%
25/191
14.3%
27/189
16.2%
62/382
16.2%
62/383
Gastrointestinal disorders
Vomiting
6.3%
12/191
10.1%
19/189
11.0%
42/382
8.1%
31/383
Gastrointestinal disorders
Abdominal Pain Upper
5.8%
11/191
9.5%
18/189
7.3%
28/382
6.0%
23/383
Gastrointestinal disorders
Dyspepsia
4.7%
9/191
6.3%
12/189
6.5%
25/382
6.0%
23/383
Gastrointestinal disorders
Dry Mouth
2.6%
5/191
7.4%
14/189
6.0%
23/382
6.0%
23/383
Gastrointestinal disorders
Abdominal Pain
3.1%
6/191
5.3%
10/189
3.9%
15/382
3.4%
13/383
Gastrointestinal disorders
Constipation
2.6%
5/191
6.9%
13/189
2.4%
9/382
3.7%
14/383
Musculoskeletal and connective tissue disorders
Myalgia
24.1%
46/191
23.3%
44/189
29.1%
111/382
30.8%
118/383
Musculoskeletal and connective tissue disorders
Arthralgia
26.2%
50/191
25.9%
49/189
23.0%
88/382
23.2%
89/383
Musculoskeletal and connective tissue disorders
Back Pain
11.0%
21/191
11.6%
22/189
7.3%
28/382
6.0%
23/383
Musculoskeletal and connective tissue disorders
Muscle Spasms
4.2%
8/191
6.3%
12/189
3.4%
13/382
3.9%
15/383
Skin and subcutaneous tissue disorders
Rash
19.9%
38/191
21.2%
40/189
17.0%
65/382
20.4%
78/383
Skin and subcutaneous tissue disorders
Pruritus
17.8%
34/191
14.3%
27/189
19.9%
76/382
15.4%
59/383
Skin and subcutaneous tissue disorders
Alopecia
12.0%
23/191
10.6%
20/189
18.6%
71/382
18.5%
71/383
Skin and subcutaneous tissue disorders
Dry Skin
12.0%
23/191
11.6%
22/189
9.9%
38/382
9.7%
37/383
Nervous system disorders
Headache
39.3%
75/191
40.2%
76/189
39.5%
151/382
43.9%
168/383
Nervous system disorders
Dizziness
7.3%
14/191
14.3%
27/189
11.5%
44/382
15.4%
59/383
Nervous system disorders
Disturbance in Attention
2.6%
5/191
3.2%
6/189
5.2%
20/382
7.0%
27/383
Psychiatric disorders
Insomnia
24.1%
46/191
23.8%
45/189
25.7%
98/382
29.5%
113/383
Psychiatric disorders
Depression
16.2%
31/191
17.5%
33/189
17.0%
65/382
14.6%
56/383
Psychiatric disorders
Anxiety
5.8%
11/191
9.5%
18/189
8.1%
31/382
6.0%
23/383
Respiratory, thoracic and mediastinal disorders
Cough
14.1%
27/191
18.5%
35/189
15.4%
59/382
18.0%
69/383
Respiratory, thoracic and mediastinal disorders
Dyspnoea
7.9%
15/191
7.9%
15/189
10.2%
39/382
8.4%
32/383
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
6.3%
12/191
5.8%
11/189
4.2%
16/382
5.7%
22/383
Respiratory, thoracic and mediastinal disorders
Dyspnoea Exertional
3.1%
6/191
6.9%
13/189
4.5%
17/382
4.2%
16/383
Respiratory, thoracic and mediastinal disorders
Epistaxis
5.2%
10/191
5.3%
10/189
2.4%
9/382
3.7%
14/383
Blood and lymphatic system disorders
Anaemia
12.0%
23/191
11.6%
22/189
9.9%
38/382
14.1%
54/383
Blood and lymphatic system disorders
Neutropenia
4.7%
9/191
8.5%
16/189
7.6%
29/382
7.3%
28/383
Metabolism and nutrition disorders
Decreased Appetite
15.7%
30/191
16.4%
31/189
19.1%
73/382
22.2%
85/383
Investigations
Weight Decreased
16.2%
31/191
16.4%
31/189
14.1%
54/382
17.5%
67/383
Vascular disorders
Hypertension
3.7%
7/191
5.8%
11/189
4.2%
16/382
5.2%
20/383
Infections and infestations
Upper Respiratory Tract Infection
5.8%
11/191
3.7%
7/189
2.9%
11/382
4.2%
16/383

Additional Information

Medical Communications

Hoffmann-La Roche

Phone: 800-821-8590

Results disclosure agreements

  • Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
  • Publication restrictions are in place

Restriction type: OTHER