Trial Outcomes & Findings for Boceprevir/Peginterferon/Ribavirin for Chronic Hepatitis C: Erythropoietin Use Versus Ribavirin Dose Reduction for Anemia (P06086 AM2) (NCT NCT01023035)
NCT ID: NCT01023035
Last Updated: 2021-02-08
Results Overview
SVR was defined as undetectable plasma Hepatitis C Virus ribonucleic acid (HCV-RNA) at Follow-up Week 24
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
687 participants
Primary outcome timeframe
At Follow-up Week 24
Results posted on
2021-02-08
Participant Flow
687 Participants enrolled and were treated with Peginterferon/Ribavirin (PEG2b/RBV) followed by PEG2b/RBV + boceprevir. 500 participants became anemic during treatment and were randomized to either the RBV Dose Reduction Arm (n=249) or the Erythropoietin Use Arm (n=251).
Participant milestones
| Measure |
Ribavirin Dose Reduction Arm
After the initiation of treatment with 4 weeks with PEG2b/RBV followed by 24 or 44 weeks of boceprevir, participants who became anemic (serum hemoglobin = ≤10 g/dL) within the 28- or 48-week treatment period and who were randomized to the Ribavirin (RBV) Dose Reduction Arm received reduced doses of RBV for management of the anemia in combination with PEG2b and boceprevir therapies.
|
Erythropoietin Use Arm
After the initiation of treatment with 4 weeks with PEG2b/RBV followed by 24 or 44 weeks of boceprevir, participants who became anemic (serum hemoglobin = ≤10 g/dL) within the 28- or 48-week treatment period and who were randomized to the Erythropoietin Use Arm received erythropoietin for management of the anemia in addition to PEG2b/RBV and boceprevir therapies.
|
Treated/Not Randomized
Participants received 4 weeks of PEG2b/RBV followed by 24 or 44 weeks of boceprevir plus PEG2b/RBV depending on Hepatitis C Virus RNA (HCV-RNA) levels. Participants continued with this treatment if their serum hemoglobin remained \>10 g/dL throughout the 28- or 48-week treatment period.
|
|---|---|---|---|
|
Treatment Period
STARTED
|
249
|
251
|
187
|
|
Treatment Period
COMPLETED
|
177
|
166
|
69
|
|
Treatment Period
NOT COMPLETED
|
72
|
85
|
118
|
|
Follow-up Period (up to Week 72)
STARTED
|
238
|
235
|
147
|
|
Follow-up Period (up to Week 72)
COMPLETED
|
210
|
207
|
108
|
|
Follow-up Period (up to Week 72)
NOT COMPLETED
|
28
|
28
|
39
|
Reasons for withdrawal
| Measure |
Ribavirin Dose Reduction Arm
After the initiation of treatment with 4 weeks with PEG2b/RBV followed by 24 or 44 weeks of boceprevir, participants who became anemic (serum hemoglobin = ≤10 g/dL) within the 28- or 48-week treatment period and who were randomized to the Ribavirin (RBV) Dose Reduction Arm received reduced doses of RBV for management of the anemia in combination with PEG2b and boceprevir therapies.
|
Erythropoietin Use Arm
After the initiation of treatment with 4 weeks with PEG2b/RBV followed by 24 or 44 weeks of boceprevir, participants who became anemic (serum hemoglobin = ≤10 g/dL) within the 28- or 48-week treatment period and who were randomized to the Erythropoietin Use Arm received erythropoietin for management of the anemia in addition to PEG2b/RBV and boceprevir therapies.
|
Treated/Not Randomized
Participants received 4 weeks of PEG2b/RBV followed by 24 or 44 weeks of boceprevir plus PEG2b/RBV depending on Hepatitis C Virus RNA (HCV-RNA) levels. Participants continued with this treatment if their serum hemoglobin remained \>10 g/dL throughout the 28- or 48-week treatment period.
|
|---|---|---|---|
|
Treatment Period
Adverse Event
|
27
|
32
|
50
|
|
Treatment Period
Non-Medical Reasons
|
19
|
22
|
44
|
|
Treatment Period
Treatment Failure
|
26
|
31
|
24
|
|
Follow-up Period (up to Week 72)
Adverse Event
|
2
|
0
|
1
|
|
Follow-up Period (up to Week 72)
Non-medical Reason
|
26
|
28
|
38
|
Baseline Characteristics
Boceprevir/Peginterferon/Ribavirin for Chronic Hepatitis C: Erythropoietin Use Versus Ribavirin Dose Reduction for Anemia (P06086 AM2)
Baseline characteristics by cohort
| Measure |
Ribavirin Dose Reduction Arm
n=249 Participants
After the initiation of treatment with 4 weeks with PEG2b/RBV followed by 24 or 44 weeks of boceprevir, participants who became anemic (serum hemoglobin = ≤10 g/dL) within the 28- or 48-week treatment period and who were randomized to the Ribavirin (RBV) Dose Reduction Arm received reduced doses of RBV for management of the anemia in combination with PEG2b and boceprevir therapies.
|
Erythropoietin Use Arm
n=251 Participants
After the initiation of treatment with 4 weeks with PEG2b/RBV followed by 24 or 44 weeks of boceprevir, participants who became anemic (serum hemoglobin = ≤10 g/dL) within the 28- or 48-week treatment period and who were randomized to the Erythropoietin Use Arm received erythropoietin for management of the anemia in addition to PEG2b/RBV and boceprevir therapies.
|
Treated/Not Randomized
n=187 Participants
Participants received 4 weeks of PEG2b/RBV followed by 24 or 44 weeks of boceprevir plus PEG2b/RBV depending on Hepatitis C Virus RNA (HCV-RNA) levels. Participants continued with this treatment if their serum hemoglobin remained \>10 g/dL throughout the 28- or 48-week treatment period.
|
Total
n=687 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
50.2 years
STANDARD_DEVIATION 9.9 • n=99 Participants
|
49.7 years
STANDARD_DEVIATION 9.7 • n=107 Participants
|
47.5 years
STANDARD_DEVIATION 10.1 • n=206 Participants
|
49.3 years
STANDARD_DEVIATION 10.1 • n=7 Participants
|
|
Sex: Female, Male
Female
|
171 Participants
n=99 Participants
|
164 Participants
n=107 Participants
|
99 Participants
n=206 Participants
|
434 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
78 Participants
n=99 Participants
|
87 Participants
n=107 Participants
|
88 Participants
n=206 Participants
|
253 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: At Follow-up Week 24Population: The primary efficacy analysis was performed on all participants who were randomized to either the RBV Dose Reduction Arm or the EPO Use Arm for anemia management (i.e. the Full Analysis Set of patients requiring anemia management \[FAS, n=500\]).
SVR was defined as undetectable plasma Hepatitis C Virus ribonucleic acid (HCV-RNA) at Follow-up Week 24
Outcome measures
| Measure |
Ribavirin Dose Reduction Arm
n=249 Participants
After treatment for 4 weeks with PEG2b/RBV followed by 24 or 44 weeks of boceprevir, participants who became anemic (serum hemoglobin of ≤10 g/dL) within the 28- or 48-week treatment period and who were randomized to the Ribavirin (RBV) Dose Reduction Arm received reduced doses of RBV for management of the anemia in combination with PEG2b and boceprevir therapies.
|
Erythropoietin Use Arm
n=251 Participants
After treatment for 4 weeks with PEG2b/RBV followed by 24 or 44 weeks of boceprevir, participants who became anemic (serum hemoglobin of ≤10 g/dL) within the 28- or 48-week treatment period and who were randomized to the Erythropoietin Use Arm received erythropoietin for management of the anemia in addition to PEG2b/RBV and boceprevir therapies.
|
Treated/Not Randomized
Participants received 4 weeks of PEG2b/RBV followed by 24 or 44 weeks of boceprevir plus PEG2b/RBV depending on Hepatitis C Virus RNA (HCV-RNA) levels. Participants continued with this treatment if their serum hemoglobin remained \>10 g/dL throughout the 28- or 48-week treatment period.
|
|---|---|---|---|
|
Percentage of Participants With Sustained Virologic Response (SVR)
|
71.5 percentage of participants
|
70.9 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: From Study Day 1 up to Study Treatment Week 48Population: All Treated Participants, defined as all participants who were treated with any study medication.
Cumulative discontinuation was defined as the sum of discontinuations due to adverse events, viral breakthrough/resistance, detectable HCV-RNA and futility rules (\<2-log10 decline in HCV-RNA at Treatment Week 12, ≥ Lower Limit of Quantification \[LLQ\] HCV-RNA at Treatment Week 24), and other (noncompliance, withdrawal of consent, lost to follow-up).
Outcome measures
| Measure |
Ribavirin Dose Reduction Arm
n=249 Participants
After treatment for 4 weeks with PEG2b/RBV followed by 24 or 44 weeks of boceprevir, participants who became anemic (serum hemoglobin of ≤10 g/dL) within the 28- or 48-week treatment period and who were randomized to the Ribavirin (RBV) Dose Reduction Arm received reduced doses of RBV for management of the anemia in combination with PEG2b and boceprevir therapies.
|
Erythropoietin Use Arm
n=251 Participants
After treatment for 4 weeks with PEG2b/RBV followed by 24 or 44 weeks of boceprevir, participants who became anemic (serum hemoglobin of ≤10 g/dL) within the 28- or 48-week treatment period and who were randomized to the Erythropoietin Use Arm received erythropoietin for management of the anemia in addition to PEG2b/RBV and boceprevir therapies.
|
Treated/Not Randomized
n=187 Participants
Participants received 4 weeks of PEG2b/RBV followed by 24 or 44 weeks of boceprevir plus PEG2b/RBV depending on Hepatitis C Virus RNA (HCV-RNA) levels. Participants continued with this treatment if their serum hemoglobin remained \>10 g/dL throughout the 28- or 48-week treatment period.
|
|---|---|---|---|
|
Percentage of Participants Who Discontinued Treatment
|
29 percentage of participants
Interval 23.0 to 35.0
|
34 percentage of participants
Interval 28.0 to 40.0
|
63 percentage of participants
Interval 56.0 to 70.0
|
Adverse Events
Ribavirin Dose Reduction Arm
Serious events: 39 serious events
Other events: 247 other events
Deaths: 0 deaths
Erythropoietin Use Arm
Serious events: 33 serious events
Other events: 248 other events
Deaths: 0 deaths
Treated/Not Randomized
Serious events: 15 serious events
Other events: 180 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ribavirin Dose Reduction Arm
n=249 participants at risk
After the initiation of treatment with 4 weeks with PEG2b/RBV followed by 24 or 44 weeks of boceprevir, participants who became anemic (serum hemoglobin = ≤10 g/dL) within the 28- or 48-week treatment period and who were randomized to the Ribavirin (RBV) Dose Reduction Arm received reduced doses of RBV for management of the anemia in combination with PEG2b and boceprevir therapies.
|
Erythropoietin Use Arm
n=251 participants at risk
After the initiation of treatment with 4 weeks with PEG2b/RBV followed by 24 or 44 weeks of boceprevir, participants who became anemic (serum hemoglobin = ≤10 g/dL) within the 28- or 48-week treatment period and who were randomized to the Erythropoietin Use Arm received erythropoietin for management of the anemia in addition to PEG2b/RBV and boceprevir therapies.
|
Treated/Not Randomized
n=187 participants at risk
Participants received 4 weeks of PEG2b/RBV followed by 24 or 44 weeks of boceprevir plus PEG2b/RBV depending on Hepatitis C Virus RNA (HCV-RNA) levels. Participants continued with this treatment if their serum hemoglobin remained \>10 g/dL throughout the 28- or 48-week treatment period.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.6%
4/249 • Number of events 4
|
0.80%
2/251 • Number of events 2
|
0.53%
1/187 • Number of events 1
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/249
|
0.40%
1/251 • Number of events 1
|
0.00%
0/187
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.40%
1/249 • Number of events 1
|
0.00%
0/251
|
0.00%
0/187
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.40%
1/249 • Number of events 1
|
1.2%
3/251 • Number of events 3
|
0.00%
0/187
|
|
Cardiac disorders
Acute Myocardial Infarction
|
0.00%
0/249
|
0.40%
1/251 • Number of events 1
|
0.00%
0/187
|
|
Cardiac disorders
Atrial Fibrillation
|
0.40%
1/249 • Number of events 1
|
0.00%
0/251
|
0.00%
0/187
|
|
Cardiac disorders
Pericardial Effusion
|
0.00%
0/249
|
0.40%
1/251 • Number of events 1
|
0.00%
0/187
|
|
Cardiac disorders
Sinus Bradycardia
|
0.40%
1/249 • Number of events 1
|
0.00%
0/251
|
0.00%
0/187
|
|
Cardiac disorders
Supraventricular Tachyarrhythmia
|
0.00%
0/249
|
0.40%
1/251 • Number of events 1
|
0.00%
0/187
|
|
Cardiac disorders
Tachycardia
|
0.40%
1/249 • Number of events 1
|
0.40%
1/251 • Number of events 1
|
0.00%
0/187
|
|
Ear and labyrinth disorders
Vertigo Positional
|
0.40%
1/249 • Number of events 1
|
0.00%
0/251
|
0.00%
0/187
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/249
|
0.40%
1/251 • Number of events 2
|
0.00%
0/187
|
|
Eye disorders
Retinal Detachment
|
0.00%
0/249
|
0.40%
1/251 • Number of events 1
|
0.00%
0/187
|
|
Gastrointestinal disorders
Abominal Pain
|
0.00%
0/249
|
0.40%
1/251 • Number of events 1
|
0.53%
1/187 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
0.40%
1/249 • Number of events 1
|
0.00%
0/251
|
0.00%
0/187
|
|
Gastrointestinal disorders
Anal Fissure
|
0.00%
0/249
|
0.00%
0/251
|
0.53%
1/187 • Number of events 1
|
|
Gastrointestinal disorders
Colitis
|
0.40%
1/249 • Number of events 1
|
0.00%
0/251
|
0.00%
0/187
|
|
Gastrointestinal disorders
Diarrhoea
|
0.40%
1/249 • Number of events 1
|
1.2%
3/251 • Number of events 3
|
0.00%
0/187
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
0.40%
1/249 • Number of events 1
|
0.00%
0/251
|
0.00%
0/187
|
|
Gastrointestinal disorders
Inguinal Hernia
|
0.40%
1/249 • Number of events 1
|
0.00%
0/251
|
0.00%
0/187
|
|
Gastrointestinal disorders
Lower Gastrointestinal Haemorrhage
|
0.40%
1/249 • Number of events 1
|
0.00%
0/251
|
0.00%
0/187
|
|
Gastrointestinal disorders
Megacolon
|
0.40%
1/249 • Number of events 1
|
0.00%
0/251
|
0.00%
0/187
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/249
|
1.2%
3/251 • Number of events 3
|
0.00%
0/187
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/249
|
0.40%
1/251 • Number of events 1
|
0.00%
0/187
|
|
Gastrointestinal disorders
Rectal Haemorrhage
|
0.00%
0/249
|
0.40%
1/251 • Number of events 1
|
0.00%
0/187
|
|
Gastrointestinal disorders
Upper Gastrointestinal Haemorrhage
|
0.40%
1/249 • Number of events 1
|
0.00%
0/251
|
0.00%
0/187
|
|
Gastrointestinal disorders
Vomiting
|
0.40%
1/249 • Number of events 2
|
2.8%
7/251 • Number of events 7
|
0.53%
1/187 • Number of events 1
|
|
General disorders
Asthenia
|
0.00%
0/249
|
0.40%
1/251 • Number of events 1
|
0.00%
0/187
|
|
General disorders
Chest Pain
|
0.40%
1/249 • Number of events 1
|
0.80%
2/251 • Number of events 2
|
0.53%
1/187 • Number of events 1
|
|
General disorders
Fatigue
|
0.40%
1/249 • Number of events 1
|
0.00%
0/251
|
0.00%
0/187
|
|
General disorders
Irritability
|
0.40%
1/249 • Number of events 1
|
0.00%
0/251
|
0.00%
0/187
|
|
General disorders
Pain
|
0.00%
0/249
|
0.40%
1/251 • Number of events 1
|
0.00%
0/187
|
|
General disorders
Pyrexia
|
0.40%
1/249 • Number of events 1
|
0.00%
0/251
|
0.00%
0/187
|
|
General disorders
Sudden Cardiac Death
|
0.40%
1/249 • Number of events 1
|
0.00%
0/251
|
0.00%
0/187
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.40%
1/249 • Number of events 1
|
0.00%
0/251
|
0.00%
0/187
|
|
Hepatobiliary disorders
Cholelithiasis Obstructive
|
0.40%
1/249 • Number of events 1
|
0.00%
0/251
|
0.00%
0/187
|
|
Infections and infestations
Abscess Soft Tissue
|
0.40%
1/249 • Number of events 1
|
0.00%
0/251
|
0.00%
0/187
|
|
Infections and infestations
Appendicitis
|
0.00%
0/249
|
0.00%
0/251
|
0.53%
1/187 • Number of events 1
|
|
Infections and infestations
Bronchitis
|
0.00%
0/249
|
0.40%
1/251 • Number of events 1
|
0.00%
0/187
|
|
Infections and infestations
Cellulitis
|
0.40%
1/249 • Number of events 1
|
0.40%
1/251 • Number of events 1
|
0.00%
0/187
|
|
Infections and infestations
Clostridium Difficile Colitis
|
0.40%
1/249 • Number of events 1
|
0.00%
0/251
|
0.00%
0/187
|
|
Infections and infestations
Corneal Abscess
|
0.40%
1/249 • Number of events 1
|
0.00%
0/251
|
0.00%
0/187
|
|
Infections and infestations
Endocarditis
|
0.00%
0/249
|
0.00%
0/251
|
0.53%
1/187 • Number of events 1
|
|
Infections and infestations
Gastroenteritis
|
0.40%
1/249 • Number of events 1
|
0.40%
1/251 • Number of events 2
|
0.00%
0/187
|
|
Infections and infestations
Infected Skin Ulcer
|
0.40%
1/249 • Number of events 1
|
0.00%
0/251
|
0.00%
0/187
|
|
Infections and infestations
Kidney Infection
|
0.40%
1/249 • Number of events 1
|
0.00%
0/251
|
0.00%
0/187
|
|
Infections and infestations
Pneumonia
|
0.80%
2/249 • Number of events 2
|
0.80%
2/251 • Number of events 2
|
0.00%
0/187
|
|
Infections and infestations
Tubo-ovarian Abscess
|
0.00%
0/249
|
0.40%
1/251 • Number of events 1
|
0.00%
0/187
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.40%
1/249 • Number of events 1
|
0.00%
0/251
|
0.00%
0/187
|
|
Infections and infestations
Urinary Tract Infection
|
0.40%
1/249 • Number of events 1
|
0.00%
0/251
|
0.00%
0/187
|
|
Injury, poisoning and procedural complications
Accidental Overdose
|
0.40%
1/249 • Number of events 1
|
0.00%
0/251
|
0.00%
0/187
|
|
Injury, poisoning and procedural complications
Ankle Fracture
|
0.00%
0/249
|
0.40%
1/251 • Number of events 1
|
0.00%
0/187
|
|
Injury, poisoning and procedural complications
Fibula Fracture
|
0.00%
0/249
|
0.40%
1/251 • Number of events 1
|
0.00%
0/187
|
|
Injury, poisoning and procedural complications
Multiple Drug Overdose
|
0.00%
0/249
|
0.40%
1/251 • Number of events 1
|
0.00%
0/187
|
|
Injury, poisoning and procedural complications
Operative Haemorrhage
|
0.00%
0/249
|
0.00%
0/251
|
0.53%
1/187 • Number of events 1
|
|
Injury, poisoning and procedural complications
Overdose
|
0.40%
1/249 • Number of events 1
|
1.2%
3/251 • Number of events 3
|
0.00%
0/187
|
|
Injury, poisoning and procedural complications
Post Procedural Haemorrhage
|
0.00%
0/249
|
0.40%
1/251 • Number of events 1
|
0.00%
0/187
|
|
Injury, poisoning and procedural complications
Snake Bite
|
0.00%
0/249
|
0.00%
0/251
|
0.53%
1/187 • Number of events 1
|
|
Injury, poisoning and procedural complications
Traumatic Liver Injury
|
0.40%
1/249 • Number of events 1
|
0.00%
0/251
|
0.00%
0/187
|
|
Investigations
Blood Potassium Decreased
|
0.40%
1/249 • Number of events 1
|
0.00%
0/251
|
0.00%
0/187
|
|
Investigations
Neutrophil Count Decreased
|
0.00%
0/249
|
0.00%
0/251
|
0.53%
1/187 • Number of events 1
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
0.00%
0/249
|
0.40%
1/251 • Number of events 1
|
0.00%
0/187
|
|
Metabolism and nutrition disorders
Dehydration
|
1.2%
3/249 • Number of events 3
|
1.2%
3/251 • Number of events 4
|
0.00%
0/187
|
|
Metabolism and nutrition disorders
Diabetes Melllitus
|
0.40%
1/249 • Number of events 1
|
0.00%
0/251
|
0.00%
0/187
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.40%
1/249 • Number of events 1
|
0.00%
0/251
|
0.00%
0/187
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.80%
2/249 • Number of events 2
|
0.40%
1/251 • Number of events 1
|
0.00%
0/187
|
|
Musculoskeletal and connective tissue disorders
Arthraliga
|
0.00%
0/249
|
0.00%
0/251
|
0.53%
1/187 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/249
|
0.40%
1/251 • Number of events 1
|
0.00%
0/187
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
0.40%
1/249 • Number of events 1
|
0.00%
0/251
|
0.00%
0/187
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anal Cancer
|
0.00%
0/249
|
0.00%
0/251
|
0.53%
1/187 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal Cell Carcinoma
|
0.40%
1/249 • Number of events 1
|
0.00%
0/251
|
0.00%
0/187
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal Neoplasm
|
0.40%
1/249 • Number of events 1
|
0.00%
0/251
|
0.00%
0/187
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to Lymph Nodes
|
0.00%
0/249
|
0.40%
1/251 • Number of events 1
|
0.00%
0/187
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic Carcinoma
|
0.00%
0/249
|
0.40%
1/251 • Number of events 1
|
0.00%
0/187
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic Neoplasm
|
0.00%
0/249
|
0.00%
0/251
|
0.53%
1/187 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate Cancer
|
0.40%
1/249 • Number of events 1
|
0.00%
0/251
|
0.00%
0/187
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal Cell Carcinoma
|
0.40%
1/249 • Number of events 1
|
0.00%
0/251
|
0.00%
0/187
|
|
Nervous system disorders
Cerebrovascular Accident
|
0.00%
0/249
|
0.40%
1/251 • Number of events 1
|
0.00%
0/187
|
|
Nervous system disorders
Dizziness
|
0.00%
0/249
|
0.00%
0/251
|
0.53%
1/187 • Number of events 1
|
|
Nervous system disorders
Headache
|
0.00%
0/249
|
0.40%
1/251 • Number of events 1
|
0.00%
0/187
|
|
Nervous system disorders
Ischaemic Stroke
|
0.40%
1/249 • Number of events 1
|
0.00%
0/251
|
0.00%
0/187
|
|
Nervous system disorders
Migraine
|
0.00%
0/249
|
0.40%
1/251 • Number of events 1
|
0.00%
0/187
|
|
Nervous system disorders
Presyncope
|
0.00%
0/249
|
0.40%
1/251 • Number of events 1
|
0.53%
1/187 • Number of events 1
|
|
Nervous system disorders
Syncope
|
1.6%
4/249 • Number of events 4
|
0.00%
0/251
|
0.00%
0/187
|
|
Nervous system disorders
Toxic Encephalopathy
|
0.00%
0/249
|
0.40%
1/251 • Number of events 1
|
0.00%
0/187
|
|
Nervous system disorders
Transient Ischemic Attack
|
0.00%
0/249
|
0.40%
1/251 • Number of events 1
|
0.00%
0/187
|
|
Nervous system disorders
VIIth Nerve Paralysis
|
0.40%
1/249 • Number of events 1
|
0.00%
0/251
|
0.00%
0/187
|
|
Psychiatric disorders
Depression
|
0.40%
1/249 • Number of events 1
|
0.00%
0/251
|
1.6%
3/187 • Number of events 3
|
|
Psychiatric disorders
Psychotic Disorder
|
0.00%
0/249
|
0.00%
0/251
|
0.53%
1/187 • Number of events 1
|
|
Psychiatric disorders
Suicidal Behaviour
|
0.00%
0/249
|
0.00%
0/251
|
0.53%
1/187 • Number of events 1
|
|
Psychiatric disorders
Suicidal Ideation
|
0.40%
1/249 • Number of events 1
|
0.00%
0/251
|
1.1%
2/187 • Number of events 2
|
|
Psychiatric disorders
Suicide Attempt
|
0.40%
1/249 • Number of events 1
|
0.00%
0/251
|
0.00%
0/187
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/249
|
0.40%
1/251 • Number of events 1
|
0.00%
0/187
|
|
Renal and urinary disorders
Renal Colic
|
0.00%
0/249
|
0.40%
1/251 • Number of events 1
|
0.00%
0/187
|
|
Reproductive system and breast disorders
Adnexa Uteri Mass
|
0.00%
0/249
|
0.40%
1/251 • Number of events 1
|
0.00%
0/187
|
|
Reproductive system and breast disorders
Prostatitis
|
0.40%
1/249 • Number of events 1
|
0.00%
0/251
|
0.00%
0/187
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.40%
1/249 • Number of events 1
|
0.00%
0/251
|
0.00%
0/187
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/249
|
0.40%
1/251 • Number of events 1
|
0.00%
0/187
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.00%
0/249
|
0.40%
1/251 • Number of events 1
|
0.00%
0/187
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.40%
1/249 • Number of events 1
|
0.00%
0/251
|
0.53%
1/187 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.40%
1/249 • Number of events 1
|
0.00%
0/251
|
0.00%
0/187
|
|
Skin and subcutaneous tissue disorders
Skin Lesion
|
0.00%
0/249
|
0.40%
1/251 • Number of events 1
|
0.00%
0/187
|
|
Vascular disorders
Arterial Occlusive Disease
|
0.40%
1/249 • Number of events 1
|
0.00%
0/251
|
0.00%
0/187
|
|
Vascular disorders
Arteriosclerosis
|
0.40%
1/249 • Number of events 1
|
0.00%
0/251
|
0.00%
0/187
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.00%
0/249
|
0.40%
1/251 • Number of events 1
|
0.00%
0/187
|
|
Vascular disorders
Hypotension
|
0.80%
2/249 • Number of events 2
|
0.00%
0/251
|
0.00%
0/187
|
|
Vascular disorders
Orthostatic Hypotension
|
0.40%
1/249 • Number of events 1
|
0.40%
1/251 • Number of events 1
|
0.00%
0/187
|
|
Vascular disorders
Thrombophlebitis Superficial
|
0.00%
0/249
|
0.40%
1/251 • Number of events 1
|
0.00%
0/187
|
|
Vascular disorders
Thrombosed Varicose Vein
|
0.00%
0/249
|
0.40%
1/251 • Number of events 1
|
0.00%
0/187
|
Other adverse events
| Measure |
Ribavirin Dose Reduction Arm
n=249 participants at risk
After the initiation of treatment with 4 weeks with PEG2b/RBV followed by 24 or 44 weeks of boceprevir, participants who became anemic (serum hemoglobin = ≤10 g/dL) within the 28- or 48-week treatment period and who were randomized to the Ribavirin (RBV) Dose Reduction Arm received reduced doses of RBV for management of the anemia in combination with PEG2b and boceprevir therapies.
|
Erythropoietin Use Arm
n=251 participants at risk
After the initiation of treatment with 4 weeks with PEG2b/RBV followed by 24 or 44 weeks of boceprevir, participants who became anemic (serum hemoglobin = ≤10 g/dL) within the 28- or 48-week treatment period and who were randomized to the Erythropoietin Use Arm received erythropoietin for management of the anemia in addition to PEG2b/RBV and boceprevir therapies.
|
Treated/Not Randomized
n=187 participants at risk
Participants received 4 weeks of PEG2b/RBV followed by 24 or 44 weeks of boceprevir plus PEG2b/RBV depending on Hepatitis C Virus RNA (HCV-RNA) levels. Participants continued with this treatment if their serum hemoglobin remained \>10 g/dL throughout the 28- or 48-week treatment period.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
69.1%
172/249 • Number of events 239
|
60.6%
152/251 • Number of events 215
|
4.3%
8/187 • Number of events 10
|
|
Blood and lymphatic system disorders
Leukopenia
|
7.2%
18/249 • Number of events 29
|
8.4%
21/251 • Number of events 54
|
4.3%
8/187 • Number of events 10
|
|
Blood and lymphatic system disorders
Neutropenia
|
28.5%
71/249 • Number of events 154
|
32.3%
81/251 • Number of events 162
|
16.0%
30/187 • Number of events 49
|
|
Endocrine disorders
Hypothyroidism
|
6.0%
15/249 • Number of events 16
|
4.4%
11/251 • Number of events 11
|
2.7%
5/187 • Number of events 5
|
|
Eye disorders
Vision Blurred
|
7.2%
18/249 • Number of events 19
|
5.6%
14/251 • Number of events 14
|
6.4%
12/187 • Number of events 12
|
|
Gastrointestinal disorders
Abdominal Pain
|
8.0%
20/249 • Number of events 23
|
6.4%
16/251 • Number of events 18
|
5.3%
10/187 • Number of events 15
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
6.4%
16/249 • Number of events 18
|
4.8%
12/251 • Number of events 13
|
3.7%
7/187 • Number of events 7
|
|
Gastrointestinal disorders
Constipation
|
6.4%
16/249 • Number of events 16
|
8.8%
22/251 • Number of events 23
|
7.5%
14/187 • Number of events 15
|
|
Gastrointestinal disorders
Diarrhoea
|
30.9%
77/249 • Number of events 102
|
34.7%
87/251 • Number of events 107
|
27.8%
52/187 • Number of events 70
|
|
Gastrointestinal disorders
Dry Mouth
|
6.4%
16/249 • Number of events 17
|
12.0%
30/251 • Number of events 30
|
9.1%
17/187 • Number of events 17
|
|
Gastrointestinal disorders
Dysguesia
|
34.1%
85/249 • Number of events 94
|
39.8%
100/251 • Number of events 104
|
32.6%
61/187 • Number of events 67
|
|
Gastrointestinal disorders
Dyspepsia
|
6.4%
16/249 • Number of events 16
|
9.6%
24/251 • Number of events 33
|
4.8%
9/187 • Number of events 11
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
8.0%
20/249 • Number of events 21
|
5.2%
13/251 • Number of events 13
|
7.5%
14/187 • Number of events 16
|
|
Gastrointestinal disorders
Mouth Ulceration
|
1.2%
3/249 • Number of events 3
|
5.6%
14/251 • Number of events 14
|
2.1%
4/187 • Number of events 4
|
|
Gastrointestinal disorders
Nausea
|
51.0%
127/249 • Number of events 171
|
61.0%
153/251 • Number of events 211
|
50.3%
94/187 • Number of events 118
|
|
Gastrointestinal disorders
Stomatitis
|
7.6%
19/249 • Number of events 20
|
8.0%
20/251 • Number of events 22
|
5.3%
10/187 • Number of events 11
|
|
Gastrointestinal disorders
Vomiting
|
19.7%
49/249 • Number of events 66
|
24.7%
62/251 • Number of events 103
|
20.3%
38/187 • Number of events 48
|
|
General disorders
Asthenia
|
8.4%
21/249 • Number of events 32
|
7.6%
19/251 • Number of events 29
|
8.6%
16/187 • Number of events 22
|
|
General disorders
Chills
|
28.9%
72/249 • Number of events 78
|
31.5%
79/251 • Number of events 86
|
26.2%
49/187 • Number of events 54
|
|
General disorders
Fatigue
|
69.9%
174/249 • Number of events 237
|
70.9%
178/251 • Number of events 248
|
57.8%
108/187 • Number of events 138
|
|
General disorders
Influenza Like Illness
|
27.3%
68/249 • Number of events 74
|
26.7%
67/251 • Number of events 75
|
23.5%
44/187 • Number of events 47
|
|
General disorders
Injection Site Erythema
|
10.8%
27/249 • Number of events 28
|
13.1%
33/251 • Number of events 37
|
11.2%
21/187 • Number of events 21
|
|
General disorders
Injection Site Reaction
|
9.2%
23/249 • Number of events 25
|
14.3%
36/251 • Number of events 36
|
11.2%
21/187 • Number of events 25
|
|
General disorders
Irritability
|
20.5%
51/249 • Number of events 62
|
25.5%
64/251 • Number of events 74
|
21.9%
41/187 • Number of events 44
|
|
General disorders
Oedema Peripheral
|
6.8%
17/249 • Number of events 19
|
2.4%
6/251 • Number of events 6
|
2.7%
5/187 • Number of events 7
|
|
General disorders
Pain
|
7.6%
19/249 • Number of events 21
|
14.7%
37/251 • Number of events 43
|
11.2%
21/187 • Number of events 22
|
|
General disorders
Pyrexia
|
22.1%
55/249 • Number of events 63
|
27.9%
70/251 • Number of events 114
|
24.1%
45/187 • Number of events 52
|
|
Infections and infestations
Bronchitis
|
3.6%
9/249 • Number of events 9
|
5.2%
13/251 • Number of events 14
|
3.2%
6/187 • Number of events 6
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
5.2%
13/249 • Number of events 13
|
4.8%
12/251 • Number of events 14
|
5.3%
10/187 • Number of events 10
|
|
Infections and infestations
Urinary Tract Infection
|
5.6%
14/249 • Number of events 22
|
3.2%
8/251 • Number of events 9
|
4.8%
9/187 • Number of events 9
|
|
Investigations
Weight Decreased
|
7.6%
19/249 • Number of events 20
|
15.5%
39/251 • Number of events 53
|
11.8%
22/187 • Number of events 26
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
24.5%
61/249 • Number of events 65
|
25.9%
65/251 • Number of events 71
|
27.3%
51/187 • Number of events 56
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
19.7%
49/249 • Number of events 55
|
23.1%
58/251 • Number of events 68
|
18.2%
34/187 • Number of events 41
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
12.4%
31/249 • Number of events 33
|
7.6%
19/251 • Number of events 20
|
8.0%
15/187 • Number of events 19
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
4.0%
10/249 • Number of events 11
|
4.8%
12/251 • Number of events 16
|
5.9%
11/187 • Number of events 13
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
22.5%
56/249 • Number of events 64
|
23.9%
60/251 • Number of events 66
|
15.0%
28/187 • Number of events 36
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
3.2%
8/249 • Number of events 10
|
5.2%
13/251 • Number of events 15
|
4.3%
8/187 • Number of events 10
|
|
Nervous system disorders
Disturbance in Attention
|
8.4%
21/249 • Number of events 23
|
16.7%
42/251 • Number of events 46
|
10.7%
20/187 • Number of events 24
|
|
Nervous system disorders
Dizziness
|
23.3%
58/249 • Number of events 70
|
26.7%
67/251 • Number of events 85
|
19.8%
37/187 • Number of events 38
|
|
Nervous system disorders
Headache
|
47.8%
119/249 • Number of events 151
|
54.2%
136/251 • Number of events 168
|
41.2%
77/187 • Number of events 92
|
|
Nervous system disorders
Hypoaesthesia
|
5.6%
14/249 • Number of events 20
|
4.4%
11/251 • Number of events 14
|
2.1%
4/187 • Number of events 4
|
|
Nervous system disorders
Paraesthesia
|
6.4%
16/249 • Number of events 17
|
5.6%
14/251 • Number of events 17
|
5.9%
11/187 • Number of events 15
|
|
Psychiatric disorders
Affect Lability
|
4.0%
10/249 • Number of events 11
|
5.6%
14/251 • Number of events 14
|
4.8%
9/187 • Number of events 11
|
|
Psychiatric disorders
Anxiety
|
11.6%
29/249 • Number of events 33
|
12.0%
30/251 • Number of events 36
|
15.0%
28/187 • Number of events 31
|
|
Psychiatric disorders
Depression
|
20.1%
50/249 • Number of events 60
|
20.7%
52/251 • Number of events 65
|
20.3%
38/187 • Number of events 41
|
|
Psychiatric disorders
Insomnia
|
28.9%
72/249 • Number of events 81
|
29.9%
75/251 • Number of events 89
|
32.1%
60/187 • Number of events 63
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
22.9%
57/249 • Number of events 65
|
24.3%
61/251 • Number of events 71
|
17.1%
32/187 • Number of events 42
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
19.3%
48/249 • Number of events 55
|
20.7%
52/251 • Number of events 60
|
13.9%
26/187 • Number of events 30
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea Exertional
|
10.4%
26/249 • Number of events 32
|
11.6%
29/251 • Number of events 35
|
8.6%
16/187 • Number of events 20
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
6.4%
16/249 • Number of events 21
|
10.4%
26/251 • Number of events 31
|
4.8%
9/187 • Number of events 9
|
|
Respiratory, thoracic and mediastinal disorders
Productive Cough
|
2.4%
6/249 • Number of events 6
|
6.8%
17/251 • Number of events 21
|
0.53%
1/187 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
38.2%
95/249 • Number of events 102
|
39.4%
99/251 • Number of events 108
|
29.4%
55/187 • Number of events 57
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
18.1%
45/249 • Number of events 47
|
17.5%
44/251 • Number of events 45
|
11.2%
21/187 • Number of events 22
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
17.7%
44/249 • Number of events 56
|
22.7%
57/251 • Number of events 68
|
11.2%
21/187 • Number of events 31
|
|
Skin and subcutaneous tissue disorders
Rash
|
28.1%
70/249 • Number of events 94
|
24.3%
61/251 • Number of events 100
|
18.2%
34/187 • Number of events 40
|
|
Skin and subcutaneous tissue disorders
Rash Generalised
|
1.6%
4/249 • Number of events 4
|
5.2%
13/251 • Number of events 13
|
3.2%
6/187 • Number of events 6
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The investigator agrees not to publish or publicly present any interim results of the trial without the prior written consent of the sponsor. The investigator further agrees to provide to the sponsor 45 days prior to submission for publication or presentation, review copies of abstracts or manuscripts for publication that report any results of the trial. The sponsor shall have the right to review and comment with respect to publications, abstracts, slides, and manuscripts.
- Publication restrictions are in place
Restriction type: OTHER