Trial Outcomes & Findings for A Study of Ribavirin in Combination With PEGASYS (Peginterferon Alfa-2a (40KD))in Patients With Chronic Hepatitis C (NCT NCT00922779)

Last Updated: 2016-01-20

Results Overview

An AE was any untoward medical occurrence in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Number of participants with non-serious AEs were exclusive of serious AEs.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

6661 participants

Primary outcome timeframe

From signing of informed consent up to end of study (up to Week 72)

Results posted on

2016-01-20

Participant Flow

A total of 7799 participants were screened, of which 6661 participants were included in the study.

Participant milestones

Participant milestones
Measure	Ribavirin + Peginterferon Alfa-2a Participants with genotype 1 received ribavirin oral tablets daily depending on the body weight. Participants with body weight of less than 75 kilograms (kg) received dose of 400 milligrams (mg) (2 tablets of 200 mg) in morning and 600 mg (3 tablets of 200 mg) in evening, and participants with body weight of 75 kg or more, received dose of 600 mg (3 tablets of 200 mg) in the morning and evening along with Peginterferon (PEG-INF) Alfa-2a 180 micrograms per milliliter (µg/mL) subcutaneous (SC) injection once weekly for 12 to 48 weeks. Participants with other genotypes received ribavirin dose of 400 mg (2 tablets of 200 mg) in morning and evening along with PEG-INF Alfa-2a 180 µg/mL SC injection once weekly for 12 to 24 weeks.
Overall Study STARTED	6661
Overall Study COMPLETED	4334
Overall Study NOT COMPLETED	2327

Reasons for withdrawal

Reasons for withdrawal
Measure	Ribavirin + Peginterferon Alfa-2a Participants with genotype 1 received ribavirin oral tablets daily depending on the body weight. Participants with body weight of less than 75 kilograms (kg) received dose of 400 milligrams (mg) (2 tablets of 200 mg) in morning and 600 mg (3 tablets of 200 mg) in evening, and participants with body weight of 75 kg or more, received dose of 600 mg (3 tablets of 200 mg) in the morning and evening along with Peginterferon (PEG-INF) Alfa-2a 180 micrograms per milliliter (µg/mL) subcutaneous (SC) injection once weekly for 12 to 48 weeks. Participants with other genotypes received ribavirin dose of 400 mg (2 tablets of 200 mg) in morning and evening along with PEG-INF Alfa-2a 180 µg/mL SC injection once weekly for 12 to 24 weeks.
Overall Study Adverse Event	67
Overall Study Pregnancy	7
Overall Study Withdrawal by Subject	308
Overall Study Lost to Follow-up	44
Overall Study Other	27
Overall Study Missing	1874

Baseline Characteristics

A Study of Ribavirin in Combination With PEGASYS (Peginterferon Alfa-2a (40KD))in Patients With Chronic Hepatitis C

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ribavirin + Peginterferon Alfa-2a n=6661 Participants Participants with genotype 1 received ribavirin oral tablets daily depending on the body weight. Participants with body weight of less than 75 kg received dose of 400 mg (2 tablets of 200 mg) in morning and 600 mg (3 tablets of 200 mg) in evening, and participants with body weight of 75 kg or more, received dose of 600 mg (3 tablets of 200 mg) in the morning and evening along with PEG-INF Alfa-2a 180 µg/mL SC injection once weekly for 12 to 48 weeks. Participants with other genotypes received ribavirin dose of 400 mg (2 tablets of 200 mg) in morning and evening along with PEG-INF Alfa-2a 180 µg/mL SC injection once weekly for 12 to 24 weeks.
Age, Continuous	34.21 Years STANDARD_DEVIATION 9.81 • n=5 Participants
Sex/Gender, Customized Male	4396 Participants n=5 Participants
Sex/Gender, Customized Female	2250 Participants n=5 Participants
Sex/Gender, Customized Missing	15 Participants n=5 Participants

PRIMARY outcome

Timeframe: From signing of informed consent up to end of study (up to Week 72)

Population: Safety analysis population included all participants who received at least one therapeutic dose of ribavirin.

Outcome measures

Outcome measures
Measure	Ribavirin + Peginterferon Alfa-2a n=6661 Participants Participants with genotype 1 received ribavirin oral tablets daily depending on the body weight. Participants with body weight of less than 75 kg received dose of 400 mg (2 tablets of 200 mg) in morning and 600 mg (3 tablets of 200 mg) in evening, and participants with body weight of 75 kg or more, received dose of 600 mg (3 tablets of 200 mg) in the morning and evening along with PEG-INF Alfa-2a 180 µg/mL SC injection once weekly for 12 to 48 weeks. Participants with other genotypes received ribavirin dose of 400 mg (2 tablets of 200 mg) in morning and evening along with PEG-INF Alfa-2a 180 µg/mL SC injection once weekly for 12 to 24 weeks.
Number of Participants With Non-Serious Adverse Events (AEs) And Serious Adverse Events (SAEs) Non Serious AEs	2058 Participants
Number of Participants With Non-Serious Adverse Events (AEs) And Serious Adverse Events (SAEs) SAEs	67 Participants

SECONDARY outcome

Timeframe: 24 weeks after end of therapy (Week 72)

Population: Intent-to-treat (ITT) population included all participants who received at least one therapeutic dose of ribavirin.

SVR at 24 weeks after end of therapy was defined as a negative result of HCV Ribonucleic Acid (HCV RNA) qualitative assay 24 weeks after end of therapy. Percentage of participants with SVR was calculated as \[number of participants with negative results of HCV RNA qualitative assay 24 weeks after end of therapy divided by the total number of participants analyzed\] multiplied by 100. The participants who failed to undergo tests at 24 weeks after completion of therapy were considered not amenable to therapy.

Outcome measures

Outcome measures
Measure	Ribavirin + Peginterferon Alfa-2a n=6661 Participants Participants with genotype 1 received ribavirin oral tablets daily depending on the body weight. Participants with body weight of less than 75 kg received dose of 400 mg (2 tablets of 200 mg) in morning and 600 mg (3 tablets of 200 mg) in evening, and participants with body weight of 75 kg or more, received dose of 600 mg (3 tablets of 200 mg) in the morning and evening along with PEG-INF Alfa-2a 180 µg/mL SC injection once weekly for 12 to 48 weeks. Participants with other genotypes received ribavirin dose of 400 mg (2 tablets of 200 mg) in morning and evening along with PEG-INF Alfa-2a 180 µg/mL SC injection once weekly for 12 to 24 weeks.
Percentage of Participants With Sustained Virological Response (SVR) at 24 Weeks After End of Therapy	50.9 Percentage of Participants

SECONDARY outcome

Timeframe: Weeks 12,24 and 48 After Therapy Initiation

Population: ITT Population.

HCV RNA levels of \< 50 International Units per milliliter (IU/mL) were defined as undetectable HCV RNA. The percentage of participants with undetectable HCV RNA was calculated as \[number of participants with undetectable HCV RNA divided by the total number of participants analyzed\] multiplied by 100 for Weeks 12, 24 and 48.

Outcome measures

Outcome measures
Measure	Ribavirin + Peginterferon Alfa-2a n=6661 Participants Participants with genotype 1 received ribavirin oral tablets daily depending on the body weight. Participants with body weight of less than 75 kg received dose of 400 mg (2 tablets of 200 mg) in morning and 600 mg (3 tablets of 200 mg) in evening, and participants with body weight of 75 kg or more, received dose of 600 mg (3 tablets of 200 mg) in the morning and evening along with PEG-INF Alfa-2a 180 µg/mL SC injection once weekly for 12 to 48 weeks. Participants with other genotypes received ribavirin dose of 400 mg (2 tablets of 200 mg) in morning and evening along with PEG-INF Alfa-2a 180 µg/mL SC injection once weekly for 12 to 24 weeks.
Percentage of Participants With Undetectable HCV RNA at Weeks 12, 24 and 48 After Therapy Initiation Week 12	58.8 Percentage of Participants
Percentage of Participants With Undetectable HCV RNA at Weeks 12, 24 and 48 After Therapy Initiation Week 24	69.7 Percentage of Participants
Percentage of Participants With Undetectable HCV RNA at Weeks 12, 24 and 48 After Therapy Initiation Week 48	24.8 Percentage of Participants

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 8, 12, 24, 36, 48 and follow-up Weeks 4 (Week 52), 12 (Week 60), and 24 (Week 72)

Population: ITT Population.

Change in hemoglobin level (compared to baseline) was reported as "significant decrease", "Normal" (no change), "Increase", "Decrease", and "Missing". Significant decrease was defined as per Investigator's discretion.

Outcome measures

Outcome measures
Measure	Ribavirin + Peginterferon Alfa-2a n=6661 Participants Participants with genotype 1 received ribavirin oral tablets daily depending on the body weight. Participants with body weight of less than 75 kg received dose of 400 mg (2 tablets of 200 mg) in morning and 600 mg (3 tablets of 200 mg) in evening, and participants with body weight of 75 kg or more, received dose of 600 mg (3 tablets of 200 mg) in the morning and evening along with PEG-INF Alfa-2a 180 µg/mL SC injection once weekly for 12 to 48 weeks. Participants with other genotypes received ribavirin dose of 400 mg (2 tablets of 200 mg) in morning and evening along with PEG-INF Alfa-2a 180 µg/mL SC injection once weekly for 12 to 24 weeks.
Percentage of Participants With Change in Hemoglobin Level Week 2, Significant decrease	13.5 Percentage of Participants
Percentage of Participants With Change in Hemoglobin Level Week 2, Normal	32.4 Percentage of Participants
Percentage of Participants With Change in Hemoglobin Level Week 2, Increase	11.7 Percentage of Participants
Percentage of Participants With Change in Hemoglobin Level Week 2, Decrease	32.3 Percentage of Participants
Percentage of Participants With Change in Hemoglobin Level Week 2, Missing	10.0 Percentage of Participants
Percentage of Participants With Change in Hemoglobin Level Week 4, Significant decrease	27.9 Percentage of Participants
Percentage of Participants With Change in Hemoglobin Level Week 4, Normal	21.0 Percentage of Participants
Percentage of Participants With Change in Hemoglobin Level Week 4, Increase	6.9 Percentage of Participants
Percentage of Participants With Change in Hemoglobin Level Week 4, Decrease	35.1 Percentage of Participants
Percentage of Participants With Change in Hemoglobin Level Week 4, Missing	9.1 Percentage of Participants
Percentage of Participants With Change in Hemoglobin Level Week 8, Significant decrease	35.4 Percentage of Participants
Percentage of Participants With Change in Hemoglobin Level Week 8, Normal	15.3 Percentage of Participants
Percentage of Participants With Change in Hemoglobin Level Week 8, Increase	5.1 Percentage of Participants
Percentage of Participants With Change in Hemoglobin Level Week 8, Decrease	31.5 Percentage of Participants
Percentage of Participants With Change in Hemoglobin Level Week 8, Missing	12.8 Percentage of Participants
Percentage of Participants With Change in Hemoglobin Level Week 12, Significant decrease	38.9 Percentage of Participants
Percentage of Participants With Change in Hemoglobin Level Week 12, Normal	15.2 Percentage of Participants
Percentage of Participants With Change in Hemoglobin Level Week 12, Increase	4.7 Percentage of Participants
Percentage of Participants With Change in Hemoglobin Level Week 12, Decrease	30.1 Percentage of Participants
Percentage of Participants With Change in Hemoglobin Level Week 12, Missing	11.1 Percentage of Participants
Percentage of Participants With Change in Hemoglobin Level Week 24, Significant decrease	34.9 Percentage of Participants
Percentage of Participants With Change in Hemoglobin Level Week 24, Normal	13.6 Percentage of Participants
Percentage of Participants With Change in Hemoglobin Level Week 24, Increase	4.6 Percentage of Participants
Percentage of Participants With Change in Hemoglobin Level Week 24, Decrease	25.4 Percentage of Participants
Percentage of Participants With Change in Hemoglobin Level Week 24, Missing	21.5 Percentage of Participants
Percentage of Participants With Change in Hemoglobin Level Week 36, Significant decrease	16.2 Percentage of Participants
Percentage of Participants With Change in Hemoglobin Level Week 36, Normal	4.1 Percentage of Participants
Percentage of Participants With Change in Hemoglobin Level Week 36, Increase	1.7 Percentage of Participants
Percentage of Participants With Change in Hemoglobin Level Week 36, Decrease	9.1 Percentage of Participants
Percentage of Participants With Change in Hemoglobin Level Week 36, Missing	69.0 Percentage of Participants
Percentage of Participants With Change in Hemoglobin Level Week 48, Significant decrease	13.7 Percentage of Participants
Percentage of Participants With Change in Hemoglobin Level Week 48, Normal	3.8 Percentage of Participants
Percentage of Participants With Change in Hemoglobin Level Week 48, Increase	1.7 Percentage of Participants
Percentage of Participants With Change in Hemoglobin Level Week 48, Decrease	7.7 Percentage of Participants
Percentage of Participants With Change in Hemoglobin Level Week 48, Missing	73.1 Percentage of Participants
Percentage of Participants With Change in Hemoglobin Level Follow-up Week 4, Significant decrease	11.5 Percentage of Participants
Percentage of Participants With Change in Hemoglobin Level Follow-up Week 4, Normal	18.5 Percentage of Participants
Percentage of Participants With Change in Hemoglobin Level Follow-up Week 4, Increase	6.8 Percentage of Participants
Percentage of Participants With Change in Hemoglobin Level Follow-up Week 4, Decrease	19.6 Percentage of Participants
Percentage of Participants With Change in Hemoglobin Level Follow-up Week 4, Missing	43.7 Percentage of Participants
Percentage of Participants With Change in Hemoglobin Level Follow-up Week 12, Significant decrease	5.8 Percentage of Participants
Percentage of Participants With Change in Hemoglobin Level Follow-up Week 12, Normal	23.0 Percentage of Participants
Percentage of Participants With Change in Hemoglobin Level Follow-up Week 12, Increase	10.2 Percentage of Participants
Percentage of Participants With Change in Hemoglobin Level Follow-up Week 12, Decrease	16.1 Percentage of Participants
Percentage of Participants With Change in Hemoglobin Level Follow-up Week 12, Missing	44.8 Percentage of Participants
Percentage of Participants With Change in Hemoglobin Level Follow-up Week 24, Significant decrease	4.7 Percentage of Participants
Percentage of Participants With Change in Hemoglobin Level Follow-up Week 24, Normal	27.5 Percentage of Participants
Percentage of Participants With Change in Hemoglobin Level Follow-up Week 24, Increase	12.2 Percentage of Participants
Percentage of Participants With Change in Hemoglobin Level Follow-up Week 24, Decrease	15.5 Percentage of Participants
Percentage of Participants With Change in Hemoglobin Level Follow-up Week 24, Missing	40.2 Percentage of Participants

Adverse Events

Ribavirin + Peginterferon Alfa-2a

Serious events: 67 serious events

Other events: 1674 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Ribavirin + Peginterferon Alfa-2a n=6661 participants at risk Participants with genotype 1 received ribavirin oral tablets daily depending on the body weight. Participants with body weight of less than 75 kg received dose of 400 mg (2 tablets of 200 mg) in morning and 600 mg (3 tablets of 200 mg) in evening, and participants with body weight of 75 kg or more, received dose of 600 mg (3 tablets of 200 mg) in the morning and evening along with PEG-INF Alfa-2a 180 µg/mL SC injection once weekly for 12 to 48 weeks. Participants with other genotypes received ribavirin dose of 400 mg (2 tablets of 200 mg) in morning and evening along with PEG-INF Alfa-2a 180 µg/mL SC injection once weekly for 12 to 24 weeks.
Infections and infestations Pyelonephritis acute	0.03% 2/6661 • From signing of informed consent up to end of study (up to Week 72)
Infections and infestations Acute tonsillitis	0.02% 1/6661 • From signing of informed consent up to end of study (up to Week 72)
Infections and infestations Appendicitis	0.02% 1/6661 • From signing of informed consent up to end of study (up to Week 72)
Infections and infestations Chronic hepatitis C	0.02% 1/6661 • From signing of informed consent up to end of study (up to Week 72)
Infections and infestations Enteritis infectious	0.02% 1/6661 • From signing of informed consent up to end of study (up to Week 72)
Infections and infestations Furuncle	0.02% 1/6661 • From signing of informed consent up to end of study (up to Week 72)
Infections and infestations Hepatitis G	0.02% 1/6661 • From signing of informed consent up to end of study (up to Week 72)
Infections and infestations Pneumonia	0.02% 1/6661 • From signing of informed consent up to end of study (up to Week 72)
Infections and infestations Urinary tract infection	0.02% 1/6661 • From signing of informed consent up to end of study (up to Week 72)
Hepatobiliary disorders Cholecystitis	0.03% 2/6661 • From signing of informed consent up to end of study (up to Week 72)
Hepatobiliary disorders Cholelithiasis	0.03% 2/6661 • From signing of informed consent up to end of study (up to Week 72)
Hepatobiliary disorders Hepatic cirrhosis	0.03% 2/6661 • From signing of informed consent up to end of study (up to Week 72)
Hepatobiliary disorders Hepatic failure	0.03% 2/6661 • From signing of informed consent up to end of study (up to Week 72)
Hepatobiliary disorders Cholecystitis acute	0.02% 1/6661 • From signing of informed consent up to end of study (up to Week 72)
Hepatobiliary disorders Hyperbilirubinaemia	0.02% 1/6661 • From signing of informed consent up to end of study (up to Week 72)
Cardiac disorders Myocardial infarction	0.03% 2/6661 • From signing of informed consent up to end of study (up to Week 72)
Cardiac disorders Cardiovascular insufficiency	0.02% 1/6661 • From signing of informed consent up to end of study (up to Week 72)
Cardiac disorders Coronary artery disease	0.02% 1/6661 • From signing of informed consent up to end of study (up to Week 72)
Cardiac disorders Tachycardia	0.02% 1/6661 • From signing of informed consent up to end of study (up to Week 72)
Cardiac disorders Ventricular extrasystoles	0.02% 1/6661 • From signing of informed consent up to end of study (up to Week 72)
Psychiatric disorders Completed suicide	0.03% 2/6661 • From signing of informed consent up to end of study (up to Week 72)
Psychiatric disorders Depression	0.03% 2/6661 • From signing of informed consent up to end of study (up to Week 72)
Psychiatric disorders Delusional disorder, persecutory type	0.02% 1/6661 • From signing of informed consent up to end of study (up to Week 72)
Psychiatric disorders Schizophrenia	0.02% 1/6661 • From signing of informed consent up to end of study (up to Week 72)
Gastrointestinal disorders Food poisoning	0.02% 1/6661 • From signing of informed consent up to end of study (up to Week 72)
Gastrointestinal disorders Gastric ulcer haemorrhage	0.02% 1/6661 • From signing of informed consent up to end of study (up to Week 72)
Gastrointestinal disorders Gastrointestinal haemorrhage	0.02% 1/6661 • From signing of informed consent up to end of study (up to Week 72)
Gastrointestinal disorders Pancreatitis acute	0.02% 1/6661 • From signing of informed consent up to end of study (up to Week 72)
General disorders Asthenia	0.03% 2/6661 • From signing of informed consent up to end of study (up to Week 72)
General disorders Death	0.02% 1/6661 • From signing of informed consent up to end of study (up to Week 72)
General disorders Pyrexia	0.02% 1/6661 • From signing of informed consent up to end of study (up to Week 72)
Nervous system disorders Autonomic nervous system imbalance	0.02% 1/6661 • From signing of informed consent up to end of study (up to Week 72)
Nervous system disorders Cranial nerve disorder	0.02% 1/6661 • From signing of informed consent up to end of study (up to Week 72)
Nervous system disorders IIIrd nerve disorder	0.02% 1/6661 • From signing of informed consent up to end of study (up to Week 72)
Nervous system disorders Intracranial pressure increased	0.02% 1/6661 • From signing of informed consent up to end of study (up to Week 72)
Nervous system disorders Vascular encephalopathy	0.02% 1/6661 • From signing of informed consent up to end of study (up to Week 72)
Skin and subcutaneous tissue disorders Toxic skin eruption	0.03% 2/6661 • From signing of informed consent up to end of study (up to Week 72)
Skin and subcutaneous tissue disorders Angioedema	0.02% 1/6661 • From signing of informed consent up to end of study (up to Week 72)
Skin and subcutaneous tissue disorders Dermatitis allergic	0.02% 1/6661 • From signing of informed consent up to end of study (up to Week 72)
Vascular disorders Deep vein thrombosis	0.02% 1/6661 • From signing of informed consent up to end of study (up to Week 72)
Vascular disorders Thrombophlebitis	0.02% 1/6661 • From signing of informed consent up to end of study (up to Week 72)
Vascular disorders Vasculitis	0.02% 1/6661 • From signing of informed consent up to end of study (up to Week 72)
Blood and lymphatic system disorders Pancytopenia	0.02% 1/6661 • From signing of informed consent up to end of study (up to Week 72)
Blood and lymphatic system disorders Thrombocytopenia	0.02% 1/6661 • From signing of informed consent up to end of study (up to Week 72)
Endocrine disorders Autoimmune thyroiditis	0.02% 1/6661 • From signing of informed consent up to end of study (up to Week 72)
Endocrine disorders Hyperthyroidism	0.02% 1/6661 • From signing of informed consent up to end of study (up to Week 72)
Endocrine disorders Hypothyroidism	0.02% 1/6661 • From signing of informed consent up to end of study (up to Week 72)
Injury, poisoning and procedural complications Injury	0.02% 1/6661 • From signing of informed consent up to end of study (up to Week 72)
Injury, poisoning and procedural complications Spinal compression fracture	0.02% 1/6661 • From signing of informed consent up to end of study (up to Week 72)
Metabolism and nutrition disorders Diabetes mellitus	0.02% 1/6661 • From signing of informed consent up to end of study (up to Week 72)
Metabolism and nutrition disorders Hyperglycaemia	0.02% 1/6661 • From signing of informed consent up to end of study (up to Week 72)
Metabolism and nutrition disorders Type 1 diabetes mellitus	0.02% 1/6661 • From signing of informed consent up to end of study (up to Week 72)
Musculoskeletal and connective tissue disorders Mixed connective tissue disease	0.02% 1/6661 • From signing of informed consent up to end of study (up to Week 72)
Musculoskeletal and connective tissue disorders Rheumatoid arthritis	0.02% 1/6661 • From signing of informed consent up to end of study (up to Week 72)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Brain neoplasm	0.02% 1/6661 • From signing of informed consent up to end of study (up to Week 72)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.02% 1/6661 • From signing of informed consent up to end of study (up to Week 72)
Respiratory, thoracic and mediastinal disorders Asthma	0.02% 1/6661 • From signing of informed consent up to end of study (up to Week 72)
Respiratory, thoracic and mediastinal disorders Bronchial obstruction	0.02% 1/6661 • From signing of informed consent up to end of study (up to Week 72)
Congenital, familial and genetic disorders Von Willebrand's disease	0.02% 1/6661 • From signing of informed consent up to end of study (up to Week 72)
Ear and labyrinth disorders Sudden hearing loss	0.02% 1/6661 • From signing of informed consent up to end of study (up to Week 72)
Eye disorders Macular oedema	0.02% 1/6661 • From signing of informed consent up to end of study (up to Week 72)
Immune system disorders Sarcoidosis	0.02% 1/6661 • From signing of informed consent up to end of study (up to Week 72)
Renal and urinary disorders Renal impairment	0.02% 1/6661 • From signing of informed consent up to end of study (up to Week 72)
Reproductive system and breast disorders Metrorrhagia	0.02% 1/6661 • From signing of informed consent up to end of study (up to Week 72)
Infections and infestations Chronic tonsillitis	0.02% 1/6661 • From signing of informed consent up to end of study (up to Week 72)

Other adverse events

Other adverse events
Measure	Ribavirin + Peginterferon Alfa-2a n=6661 participants at risk Participants with genotype 1 received ribavirin oral tablets daily depending on the body weight. Participants with body weight of less than 75 kg received dose of 400 mg (2 tablets of 200 mg) in morning and 600 mg (3 tablets of 200 mg) in evening, and participants with body weight of 75 kg or more, received dose of 600 mg (3 tablets of 200 mg) in the morning and evening along with PEG-INF Alfa-2a 180 µg/mL SC injection once weekly for 12 to 48 weeks. Participants with other genotypes received ribavirin dose of 400 mg (2 tablets of 200 mg) in morning and evening along with PEG-INF Alfa-2a 180 µg/mL SC injection once weekly for 12 to 24 weeks.
General disorders Asthenia	13.6% 905/6661 • From signing of informed consent up to end of study (up to Week 72)
General disorders Influenza like illness	12.5% 833/6661 • From signing of informed consent up to end of study (up to Week 72)
General disorders Pyrexia	5.6% 371/6661 • From signing of informed consent up to end of study (up to Week 72)
Blood and lymphatic system disorders Anaemia	6.9% 459/6661 • From signing of informed consent up to end of study (up to Week 72)
Metabolism and nutrition disorders Weight loss poor	5.1% 343/6661 • From signing of informed consent up to end of study (up to Week 72)

Additional Information

Medical Communications

Hoffmann-LaRoche

Phone: 800-821-8590

Email: [email protected]

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