Trial Outcomes & Findings for TMC435HPC3001 - An Efficacy, Safety and Tolerability Study for TMC435 vs Telaprevir in Combination With PegINFα-2a and Ribavirin in Chronic Hepatitis C Patients Who Were Null or Partial Responders to Prior PegINFα-2a and Ribavirin Therapy (NCT NCT01485991)
NCT ID: NCT01485991
Last Updated: 2016-04-26
Results Overview
Participants are considered to have reached SVR12 if both conditions below are met: 1) HCV RNA levels less than (\<) 25 International unit per milliliter (IU/mL) undetectable; 2) HCV RNA levels \<25 IU/mL undetectable or HCV RNA levels \<25 IU/mL detectable.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
771 participants
Primary outcome timeframe
12 Weeks After the Planned End of Treatment (EOT: Week 48)
Results posted on
2016-04-26
Participant Flow
Participant milestones
| Measure |
Simeprevir+Placebo+Peginterferon Alfa-2a+Ribavirin
Simeprevir (TMC435) 150 milligram (mg) capsule, orally, once daily for 12 weeks, along with 2 telaprevir (TVR) matched placebo tablets 3 times a day for 12 weeks, and peginterferon alfa-2a and ribavirin for 48 weeks.
|
Telaprevir+Placebo+Peginterferon Alfa-2a+Ribavirin
2 Telaprevir (TVR) tablets, orally, 3 times a day along with 150 mg TMC435 matched placebo capsule once daily for 12 weeks, in addition to peginterferon alfa-2a and ribavirin for 48 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
385
|
386
|
|
Overall Study
Treated
|
379
|
384
|
|
Overall Study
COMPLETED
|
353
|
350
|
|
Overall Study
NOT COMPLETED
|
32
|
36
|
Reasons for withdrawal
| Measure |
Simeprevir+Placebo+Peginterferon Alfa-2a+Ribavirin
Simeprevir (TMC435) 150 milligram (mg) capsule, orally, once daily for 12 weeks, along with 2 telaprevir (TVR) matched placebo tablets 3 times a day for 12 weeks, and peginterferon alfa-2a and ribavirin for 48 weeks.
|
Telaprevir+Placebo+Peginterferon Alfa-2a+Ribavirin
2 Telaprevir (TVR) tablets, orally, 3 times a day along with 150 mg TMC435 matched placebo capsule once daily for 12 weeks, in addition to peginterferon alfa-2a and ribavirin for 48 weeks.
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
4
|
|
Overall Study
Lost to Follow-up
|
13
|
10
|
|
Overall Study
Withdrawal by Subject
|
13
|
20
|
|
Overall Study
randomized but not treated
|
6
|
2
|
Baseline Characteristics
TMC435HPC3001 - An Efficacy, Safety and Tolerability Study for TMC435 vs Telaprevir in Combination With PegINFα-2a and Ribavirin in Chronic Hepatitis C Patients Who Were Null or Partial Responders to Prior PegINFα-2a and Ribavirin Therapy
Baseline characteristics by cohort
| Measure |
Simeprevir+Placebo+Peginterferon Alfa-2a+Ribavirin
n=379 Participants
Simeprevir (TMC435) 150 milligram (mg) capsule, orally, once daily for 12 weeks, along with 2 telaprevir (TVR) matched placebo tablets 3 times a day for 12 weeks, and peginterferon alfa-2a and ribavirin for 48 weeks.
|
Telaprevir+Placebo+Peginterferon Alfa-2a+Ribavirin
n=384 Participants
2 Telaprevir (TVR) tablets, orally, 3 times a day along with 150 mg TMC435 matched placebo capsule once daily for 12 weeks, in addition to peginterferon alfa-2a and ribavirin for 48 weeks.
|
Total
n=763 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
50 years
n=5 Participants
|
52 years
n=7 Participants
|
51 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
136 Participants
n=5 Participants
|
161 Participants
n=7 Participants
|
297 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
243 Participants
n=5 Participants
|
223 Participants
n=7 Participants
|
466 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 Weeks After the Planned End of Treatment (EOT: Week 48)Population: Intent-to-treat (ITT) population included all randomized participants who took at least 1 dose of study medication.
Participants are considered to have reached SVR12 if both conditions below are met: 1) HCV RNA levels less than (\<) 25 International unit per milliliter (IU/mL) undetectable; 2) HCV RNA levels \<25 IU/mL undetectable or HCV RNA levels \<25 IU/mL detectable.
Outcome measures
| Measure |
Simeprevir+Placebo+Peginterferon Alfa-2a+Ribavirin
n=379 Participants
Simeprevir (TMC435) 150 milligram (mg) capsule, orally, once daily for 12 weeks, along with 2 telaprevir (TVR) matched placebo tablets 3 times a day for 12 weeks, and peginterferon alfa-2a and ribavirin for 48 weeks.
|
Telaprevir+Placebo+Peginterferon Alfa-2a+Ribavirin
n=384 Participants
2 Telaprevir (TVR) tablets, orally, 3 times a day along with 150 mg TMC435 matched placebo capsule once daily for 12 weeks, in addition to peginterferon alfa-2a and ribavirin for 48 weeks.
|
|---|---|---|
|
Percentage of Participants With Sustained Virologic Response 12 Weeks After the Planned End of Treatment (SVR12)
|
53.6 percentage of participants
|
54.7 percentage of participants
|
SECONDARY outcome
Timeframe: 24 Weeks After the Planned EOT (Week 48)Population: ITT population included all randomized participants who took at least 1 dose of study medication.
Participants are considered to have reached SVR24 if both conditions below are met: 1) HCV RNA levels less than \<25 International unit per milliliter (IU/mL) undetectable (at the actual end of treatment);2) HCV RNA levels \<25 IU/mL undetectable or HCV RNA levels \<25 IU/mL detectable (24 weeks after the planned EOT).
Outcome measures
| Measure |
Simeprevir+Placebo+Peginterferon Alfa-2a+Ribavirin
n=379 Participants
Simeprevir (TMC435) 150 milligram (mg) capsule, orally, once daily for 12 weeks, along with 2 telaprevir (TVR) matched placebo tablets 3 times a day for 12 weeks, and peginterferon alfa-2a and ribavirin for 48 weeks.
|
Telaprevir+Placebo+Peginterferon Alfa-2a+Ribavirin
n=384 Participants
2 Telaprevir (TVR) tablets, orally, 3 times a day along with 150 mg TMC435 matched placebo capsule once daily for 12 weeks, in addition to peginterferon alfa-2a and ribavirin for 48 weeks.
|
|---|---|---|
|
Percentage of Participants With Sustained Virologic Response 24 Weeks After the Planned End of Treatment (SVR24)
|
53.3 percentage of participants
|
55.2 percentage of participants
|
SECONDARY outcome
Timeframe: End of Treatment (Week 48) up to Follow-up Period (until Week 72)Population: ITT population included all randomized participants who took at least 1 dose of study drug. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
Participants are considered to have a viral relapse if both conditions as specified are met: 1) \<25 IU/mL undetectable HCV RNA at the actual end of study drug treatment; 2) confirmed HCV RNA greater than or equal to (\>=) 25 IU/mL during follow-up.
Outcome measures
| Measure |
Simeprevir+Placebo+Peginterferon Alfa-2a+Ribavirin
n=246 Participants
Simeprevir (TMC435) 150 milligram (mg) capsule, orally, once daily for 12 weeks, along with 2 telaprevir (TVR) matched placebo tablets 3 times a day for 12 weeks, and peginterferon alfa-2a and ribavirin for 48 weeks.
|
Telaprevir+Placebo+Peginterferon Alfa-2a+Ribavirin
n=256 Participants
2 Telaprevir (TVR) tablets, orally, 3 times a day along with 150 mg TMC435 matched placebo capsule once daily for 12 weeks, in addition to peginterferon alfa-2a and ribavirin for 48 weeks.
|
|---|---|---|
|
Percentage of Participants With Viral Relapse
|
17.9 percentage of participants
|
16.4 percentage of participants
|
Adverse Events
Simeprevir+Placebo+Peginterferon Alfa-2a+Ribavirin
Serious events: 22 serious events
Other events: 349 other events
Deaths: 0 deaths
Telaprevir+Placebo+Peginterferon Alfa-2a+Ribavirin
Serious events: 54 serious events
Other events: 369 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Simeprevir+Placebo+Peginterferon Alfa-2a+Ribavirin
n=379 participants at risk
Simeprevir (TMC435) 150 milligram (mg) capsule, orally, once daily for 12 weeks, along with 2 telaprevir (TVR) matched placebo tablets 3 times a day for 12 weeks, and peginterferon alfa-2a and ribavirin for 48 weeks.
|
Telaprevir+Placebo+Peginterferon Alfa-2a+Ribavirin
n=384 participants at risk
2 Telaprevir (TVR) tablets, orally, 3 times a day along with 150 mg TMC435 matched placebo capsule once daily for 12 weeks, in addition to peginterferon alfa-2a and ribavirin for 48 weeks.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.53%
2/379 • Baseline up to Follow-up (Week 72)
|
4.2%
16/384 • Baseline up to Follow-up (Week 72)
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.53%
2/379 • Baseline up to Follow-up (Week 72)
|
0.78%
3/384 • Baseline up to Follow-up (Week 72)
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.26%
1/379 • Baseline up to Follow-up (Week 72)
|
0.26%
1/384 • Baseline up to Follow-up (Week 72)
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.26%
1/379 • Baseline up to Follow-up (Week 72)
|
0.26%
1/384 • Baseline up to Follow-up (Week 72)
|
|
Blood and lymphatic system disorders
Haemorrhagic diathesis
|
0.26%
1/379 • Baseline up to Follow-up (Week 72)
|
0.00%
0/384 • Baseline up to Follow-up (Week 72)
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.26%
1/379 • Baseline up to Follow-up (Week 72)
|
0.00%
0/384 • Baseline up to Follow-up (Week 72)
|
|
Blood and lymphatic system disorders
Splenic vein thrombosis
|
0.00%
0/379 • Baseline up to Follow-up (Week 72)
|
0.26%
1/384 • Baseline up to Follow-up (Week 72)
|
|
Infections and infestations
Pneumonia
|
0.00%
0/379 • Baseline up to Follow-up (Week 72)
|
1.0%
4/384 • Baseline up to Follow-up (Week 72)
|
|
Infections and infestations
Appendicitis
|
0.53%
2/379 • Baseline up to Follow-up (Week 72)
|
0.26%
1/384 • Baseline up to Follow-up (Week 72)
|
|
Infections and infestations
Acute sinusitis
|
0.26%
1/379 • Baseline up to Follow-up (Week 72)
|
0.00%
0/384 • Baseline up to Follow-up (Week 72)
|
|
Infections and infestations
Bronchitis
|
0.26%
1/379 • Baseline up to Follow-up (Week 72)
|
0.00%
0/384 • Baseline up to Follow-up (Week 72)
|
|
Infections and infestations
Cellulitis
|
0.26%
1/379 • Baseline up to Follow-up (Week 72)
|
0.00%
0/384 • Baseline up to Follow-up (Week 72)
|
|
Infections and infestations
Cholecystitis infective
|
0.26%
1/379 • Baseline up to Follow-up (Week 72)
|
0.00%
0/384 • Baseline up to Follow-up (Week 72)
|
|
Infections and infestations
Gastroenteritis viral
|
0.26%
1/379 • Baseline up to Follow-up (Week 72)
|
0.00%
0/384 • Baseline up to Follow-up (Week 72)
|
|
Infections and infestations
Superinfection
|
0.26%
1/379 • Baseline up to Follow-up (Week 72)
|
0.00%
0/384 • Baseline up to Follow-up (Week 72)
|
|
Infections and infestations
Candidiasis
|
0.00%
0/379 • Baseline up to Follow-up (Week 72)
|
0.26%
1/384 • Baseline up to Follow-up (Week 72)
|
|
Infections and infestations
Impetigo
|
0.00%
0/379 • Baseline up to Follow-up (Week 72)
|
0.26%
1/384 • Baseline up to Follow-up (Week 72)
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/379 • Baseline up to Follow-up (Week 72)
|
0.26%
1/384 • Baseline up to Follow-up (Week 72)
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/379 • Baseline up to Follow-up (Week 72)
|
0.26%
1/384 • Baseline up to Follow-up (Week 72)
|
|
Infections and infestations
Pneumonia legionella
|
0.00%
0/379 • Baseline up to Follow-up (Week 72)
|
0.26%
1/384 • Baseline up to Follow-up (Week 72)
|
|
Infections and infestations
Pneumonia pneumococcal
|
0.00%
0/379 • Baseline up to Follow-up (Week 72)
|
0.26%
1/384 • Baseline up to Follow-up (Week 72)
|
|
Infections and infestations
Sepsis
|
0.00%
0/379 • Baseline up to Follow-up (Week 72)
|
0.26%
1/384 • Baseline up to Follow-up (Week 72)
|
|
Infections and infestations
Septic shock
|
0.00%
0/379 • Baseline up to Follow-up (Week 72)
|
0.26%
1/384 • Baseline up to Follow-up (Week 72)
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/379 • Baseline up to Follow-up (Week 72)
|
0.26%
1/384 • Baseline up to Follow-up (Week 72)
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.26%
1/379 • Baseline up to Follow-up (Week 72)
|
0.00%
0/384 • Baseline up to Follow-up (Week 72)
|
|
Gastrointestinal disorders
Nausea
|
0.26%
1/379 • Baseline up to Follow-up (Week 72)
|
0.00%
0/384 • Baseline up to Follow-up (Week 72)
|
|
Gastrointestinal disorders
Oesophageal varices haemorrhage
|
0.26%
1/379 • Baseline up to Follow-up (Week 72)
|
0.00%
0/384 • Baseline up to Follow-up (Week 72)
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/379 • Baseline up to Follow-up (Week 72)
|
0.26%
1/384 • Baseline up to Follow-up (Week 72)
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/379 • Baseline up to Follow-up (Week 72)
|
0.26%
1/384 • Baseline up to Follow-up (Week 72)
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.00%
0/379 • Baseline up to Follow-up (Week 72)
|
0.26%
1/384 • Baseline up to Follow-up (Week 72)
|
|
Gastrointestinal disorders
Mesenteric vein thrombosis
|
0.00%
0/379 • Baseline up to Follow-up (Week 72)
|
0.26%
1/384 • Baseline up to Follow-up (Week 72)
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/379 • Baseline up to Follow-up (Week 72)
|
0.26%
1/384 • Baseline up to Follow-up (Week 72)
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/379 • Baseline up to Follow-up (Week 72)
|
0.26%
1/384 • Baseline up to Follow-up (Week 72)
|
|
Nervous system disorders
Syncope
|
0.53%
2/379 • Baseline up to Follow-up (Week 72)
|
0.00%
0/384 • Baseline up to Follow-up (Week 72)
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.26%
1/379 • Baseline up to Follow-up (Week 72)
|
0.00%
0/384 • Baseline up to Follow-up (Week 72)
|
|
Nervous system disorders
Transient ischaemic attack
|
0.26%
1/379 • Baseline up to Follow-up (Week 72)
|
0.00%
0/384 • Baseline up to Follow-up (Week 72)
|
|
Nervous system disorders
Convulsion
|
0.00%
0/379 • Baseline up to Follow-up (Week 72)
|
0.26%
1/384 • Baseline up to Follow-up (Week 72)
|
|
Nervous system disorders
Critical illness polyneuropathy
|
0.00%
0/379 • Baseline up to Follow-up (Week 72)
|
0.26%
1/384 • Baseline up to Follow-up (Week 72)
|
|
Nervous system disorders
Headache
|
0.00%
0/379 • Baseline up to Follow-up (Week 72)
|
0.26%
1/384 • Baseline up to Follow-up (Week 72)
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/379 • Baseline up to Follow-up (Week 72)
|
0.26%
1/384 • Baseline up to Follow-up (Week 72)
|
|
Nervous system disorders
Mononeuropathy
|
0.00%
0/379 • Baseline up to Follow-up (Week 72)
|
0.26%
1/384 • Baseline up to Follow-up (Week 72)
|
|
Psychiatric disorders
Depression
|
0.26%
1/379 • Baseline up to Follow-up (Week 72)
|
0.26%
1/384 • Baseline up to Follow-up (Week 72)
|
|
Psychiatric disorders
Suicide attempt
|
0.26%
1/379 • Baseline up to Follow-up (Week 72)
|
0.00%
0/384 • Baseline up to Follow-up (Week 72)
|
|
Psychiatric disorders
Panic attack
|
0.00%
0/379 • Baseline up to Follow-up (Week 72)
|
0.26%
1/384 • Baseline up to Follow-up (Week 72)
|
|
Psychiatric disorders
Substance-induced psychotic disorder
|
0.00%
0/379 • Baseline up to Follow-up (Week 72)
|
0.26%
1/384 • Baseline up to Follow-up (Week 72)
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
0.26%
1/379 • Baseline up to Follow-up (Week 72)
|
0.00%
0/384 • Baseline up to Follow-up (Week 72)
|
|
Skin and subcutaneous tissue disorders
Drug rash with eosinophilia and systemic symptoms
|
0.00%
0/379 • Baseline up to Follow-up (Week 72)
|
0.26%
1/384 • Baseline up to Follow-up (Week 72)
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/379 • Baseline up to Follow-up (Week 72)
|
0.26%
1/384 • Baseline up to Follow-up (Week 72)
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
0.00%
0/379 • Baseline up to Follow-up (Week 72)
|
0.26%
1/384 • Baseline up to Follow-up (Week 72)
|
|
Skin and subcutaneous tissue disorders
Toxic skin eruption
|
0.00%
0/379 • Baseline up to Follow-up (Week 72)
|
0.26%
1/384 • Baseline up to Follow-up (Week 72)
|
|
Vascular disorders
Hypertension
|
0.26%
1/379 • Baseline up to Follow-up (Week 72)
|
0.26%
1/384 • Baseline up to Follow-up (Week 72)
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/379 • Baseline up to Follow-up (Week 72)
|
0.52%
2/384 • Baseline up to Follow-up (Week 72)
|
|
Vascular disorders
Thrombophlebitis
|
0.26%
1/379 • Baseline up to Follow-up (Week 72)
|
0.00%
0/384 • Baseline up to Follow-up (Week 72)
|
|
Cardiac disorders
Angina unstable
|
0.26%
1/379 • Baseline up to Follow-up (Week 72)
|
0.00%
0/384 • Baseline up to Follow-up (Week 72)
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/379 • Baseline up to Follow-up (Week 72)
|
0.26%
1/384 • Baseline up to Follow-up (Week 72)
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/379 • Baseline up to Follow-up (Week 72)
|
0.26%
1/384 • Baseline up to Follow-up (Week 72)
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/379 • Baseline up to Follow-up (Week 72)
|
0.26%
1/384 • Baseline up to Follow-up (Week 72)
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/379 • Baseline up to Follow-up (Week 72)
|
0.26%
1/384 • Baseline up to Follow-up (Week 72)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/379 • Baseline up to Follow-up (Week 72)
|
0.26%
1/384 • Baseline up to Follow-up (Week 72)
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/379 • Baseline up to Follow-up (Week 72)
|
0.26%
1/384 • Baseline up to Follow-up (Week 72)
|
|
Musculoskeletal and connective tissue disorders
Muscle haemorrhage
|
0.00%
0/379 • Baseline up to Follow-up (Week 72)
|
0.26%
1/384 • Baseline up to Follow-up (Week 72)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.53%
2/379 • Baseline up to Follow-up (Week 72)
|
0.00%
0/384 • Baseline up to Follow-up (Week 72)
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.26%
1/379 • Baseline up to Follow-up (Week 72)
|
0.00%
0/384 • Baseline up to Follow-up (Week 72)
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/379 • Baseline up to Follow-up (Week 72)
|
0.26%
1/384 • Baseline up to Follow-up (Week 72)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/379 • Baseline up to Follow-up (Week 72)
|
0.26%
1/384 • Baseline up to Follow-up (Week 72)
|
|
General disorders
Pyrexia
|
0.53%
2/379 • Baseline up to Follow-up (Week 72)
|
0.00%
0/384 • Baseline up to Follow-up (Week 72)
|
|
General disorders
Fatigue
|
0.00%
0/379 • Baseline up to Follow-up (Week 72)
|
0.26%
1/384 • Baseline up to Follow-up (Week 72)
|
|
Hepatobiliary disorders
Hepatic failure
|
0.26%
1/379 • Baseline up to Follow-up (Week 72)
|
0.00%
0/384 • Baseline up to Follow-up (Week 72)
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/379 • Baseline up to Follow-up (Week 72)
|
0.26%
1/384 • Baseline up to Follow-up (Week 72)
|
|
Hepatobiliary disorders
Portal vein thrombosis
|
0.00%
0/379 • Baseline up to Follow-up (Week 72)
|
0.26%
1/384 • Baseline up to Follow-up (Week 72)
|
|
Injury, poisoning and procedural complications
Chemical peritonitis
|
0.26%
1/379 • Baseline up to Follow-up (Week 72)
|
0.00%
0/384 • Baseline up to Follow-up (Week 72)
|
|
Injury, poisoning and procedural complications
Meniscus lesion
|
0.26%
1/379 • Baseline up to Follow-up (Week 72)
|
0.00%
0/384 • Baseline up to Follow-up (Week 72)
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/379 • Baseline up to Follow-up (Week 72)
|
0.26%
1/384 • Baseline up to Follow-up (Week 72)
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/379 • Baseline up to Follow-up (Week 72)
|
0.26%
1/384 • Baseline up to Follow-up (Week 72)
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/379 • Baseline up to Follow-up (Week 72)
|
0.26%
1/384 • Baseline up to Follow-up (Week 72)
|
|
Eye disorders
Visual impairment
|
0.00%
0/379 • Baseline up to Follow-up (Week 72)
|
0.26%
1/384 • Baseline up to Follow-up (Week 72)
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/379 • Baseline up to Follow-up (Week 72)
|
0.26%
1/384 • Baseline up to Follow-up (Week 72)
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/379 • Baseline up to Follow-up (Week 72)
|
0.26%
1/384 • Baseline up to Follow-up (Week 72)
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.00%
0/379 • Baseline up to Follow-up (Week 72)
|
0.26%
1/384 • Baseline up to Follow-up (Week 72)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic neoplasm malignant
|
0.00%
0/379 • Baseline up to Follow-up (Week 72)
|
0.26%
1/384 • Baseline up to Follow-up (Week 72)
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/379 • Baseline up to Follow-up (Week 72)
|
0.26%
1/384 • Baseline up to Follow-up (Week 72)
|
Other adverse events
| Measure |
Simeprevir+Placebo+Peginterferon Alfa-2a+Ribavirin
n=379 participants at risk
Simeprevir (TMC435) 150 milligram (mg) capsule, orally, once daily for 12 weeks, along with 2 telaprevir (TVR) matched placebo tablets 3 times a day for 12 weeks, and peginterferon alfa-2a and ribavirin for 48 weeks.
|
Telaprevir+Placebo+Peginterferon Alfa-2a+Ribavirin
n=384 participants at risk
2 Telaprevir (TVR) tablets, orally, 3 times a day along with 150 mg TMC435 matched placebo capsule once daily for 12 weeks, in addition to peginterferon alfa-2a and ribavirin for 48 weeks.
|
|---|---|---|
|
General disorders
Fatigue
|
34.8%
132/379 • Baseline up to Follow-up (Week 72)
|
40.4%
155/384 • Baseline up to Follow-up (Week 72)
|
|
General disorders
Pyrexia
|
22.7%
86/379 • Baseline up to Follow-up (Week 72)
|
26.3%
101/384 • Baseline up to Follow-up (Week 72)
|
|
General disorders
Asthenia
|
21.1%
80/379 • Baseline up to Follow-up (Week 72)
|
18.0%
69/384 • Baseline up to Follow-up (Week 72)
|
|
General disorders
Influenza like illness
|
16.9%
64/379 • Baseline up to Follow-up (Week 72)
|
17.2%
66/384 • Baseline up to Follow-up (Week 72)
|
|
General disorders
Chills
|
5.8%
22/379 • Baseline up to Follow-up (Week 72)
|
10.4%
40/384 • Baseline up to Follow-up (Week 72)
|
|
General disorders
Injection site erythema
|
3.7%
14/379 • Baseline up to Follow-up (Week 72)
|
7.0%
27/384 • Baseline up to Follow-up (Week 72)
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
37.5%
142/379 • Baseline up to Follow-up (Week 72)
|
46.6%
179/384 • Baseline up to Follow-up (Week 72)
|
|
Skin and subcutaneous tissue disorders
Rash
|
17.4%
66/379 • Baseline up to Follow-up (Week 72)
|
26.0%
100/384 • Baseline up to Follow-up (Week 72)
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
10.3%
39/379 • Baseline up to Follow-up (Week 72)
|
7.8%
30/384 • Baseline up to Follow-up (Week 72)
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
8.7%
33/379 • Baseline up to Follow-up (Week 72)
|
15.4%
59/384 • Baseline up to Follow-up (Week 72)
|
|
Blood and lymphatic system disorders
Anaemia
|
25.1%
95/379 • Baseline up to Follow-up (Week 72)
|
40.9%
157/384 • Baseline up to Follow-up (Week 72)
|
|
Blood and lymphatic system disorders
Neutropenia
|
21.6%
82/379 • Baseline up to Follow-up (Week 72)
|
20.3%
78/384 • Baseline up to Follow-up (Week 72)
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
10.6%
40/379 • Baseline up to Follow-up (Week 72)
|
12.0%
46/384 • Baseline up to Follow-up (Week 72)
|
|
Gastrointestinal disorders
Nausea
|
19.5%
74/379 • Baseline up to Follow-up (Week 72)
|
28.6%
110/384 • Baseline up to Follow-up (Week 72)
|
|
Gastrointestinal disorders
Diarrhoea
|
13.5%
51/379 • Baseline up to Follow-up (Week 72)
|
15.6%
60/384 • Baseline up to Follow-up (Week 72)
|
|
Gastrointestinal disorders
Dyspepsia
|
6.6%
25/379 • Baseline up to Follow-up (Week 72)
|
7.6%
29/384 • Baseline up to Follow-up (Week 72)
|
|
Gastrointestinal disorders
Abdominal pain upper
|
6.3%
24/379 • Baseline up to Follow-up (Week 72)
|
6.5%
25/384 • Baseline up to Follow-up (Week 72)
|
|
Gastrointestinal disorders
Vomiting
|
6.1%
23/379 • Baseline up to Follow-up (Week 72)
|
9.4%
36/384 • Baseline up to Follow-up (Week 72)
|
|
Gastrointestinal disorders
Constipation
|
5.5%
21/379 • Baseline up to Follow-up (Week 72)
|
2.6%
10/384 • Baseline up to Follow-up (Week 72)
|
|
Gastrointestinal disorders
Abdominal pain
|
2.9%
11/379 • Baseline up to Follow-up (Week 72)
|
5.7%
22/384 • Baseline up to Follow-up (Week 72)
|
|
Gastrointestinal disorders
Dry mouth
|
2.9%
11/379 • Baseline up to Follow-up (Week 72)
|
6.5%
25/384 • Baseline up to Follow-up (Week 72)
|
|
Gastrointestinal disorders
Anorectal discomfort
|
2.6%
10/379 • Baseline up to Follow-up (Week 72)
|
8.3%
32/384 • Baseline up to Follow-up (Week 72)
|
|
Gastrointestinal disorders
Anal pruritus
|
2.4%
9/379 • Baseline up to Follow-up (Week 72)
|
10.9%
42/384 • Baseline up to Follow-up (Week 72)
|
|
Gastrointestinal disorders
Haemorrhoids
|
1.6%
6/379 • Baseline up to Follow-up (Week 72)
|
9.9%
38/384 • Baseline up to Follow-up (Week 72)
|
|
Nervous system disorders
Headache
|
27.2%
103/379 • Baseline up to Follow-up (Week 72)
|
31.2%
120/384 • Baseline up to Follow-up (Week 72)
|
|
Nervous system disorders
Dizziness
|
6.9%
26/379 • Baseline up to Follow-up (Week 72)
|
11.2%
43/384 • Baseline up to Follow-up (Week 72)
|
|
Nervous system disorders
Dysgeusia
|
4.0%
15/379 • Baseline up to Follow-up (Week 72)
|
9.4%
36/384 • Baseline up to Follow-up (Week 72)
|
|
Psychiatric disorders
Insomnia
|
14.0%
53/379 • Baseline up to Follow-up (Week 72)
|
19.0%
73/384 • Baseline up to Follow-up (Week 72)
|
|
Psychiatric disorders
Depression
|
9.2%
35/379 • Baseline up to Follow-up (Week 72)
|
5.2%
20/384 • Baseline up to Follow-up (Week 72)
|
|
Psychiatric disorders
Mood altered
|
9.2%
35/379 • Baseline up to Follow-up (Week 72)
|
8.3%
32/384 • Baseline up to Follow-up (Week 72)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
17.4%
66/379 • Baseline up to Follow-up (Week 72)
|
13.8%
53/384 • Baseline up to Follow-up (Week 72)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
7.9%
30/379 • Baseline up to Follow-up (Week 72)
|
10.4%
40/384 • Baseline up to Follow-up (Week 72)
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
12.4%
47/379 • Baseline up to Follow-up (Week 72)
|
16.4%
63/384 • Baseline up to Follow-up (Week 72)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.8%
41/379 • Baseline up to Follow-up (Week 72)
|
11.7%
45/384 • Baseline up to Follow-up (Week 72)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.7%
18/379 • Baseline up to Follow-up (Week 72)
|
7.8%
30/384 • Baseline up to Follow-up (Week 72)
|
|
Metabolism and nutrition disorders
Decreased appetite
|
14.2%
54/379 • Baseline up to Follow-up (Week 72)
|
16.7%
64/384 • Baseline up to Follow-up (Week 72)
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.79%
3/379 • Baseline up to Follow-up (Week 72)
|
7.3%
28/384 • Baseline up to Follow-up (Week 72)
|
|
Infections and infestations
Urinary tract infection
|
3.2%
12/379 • Baseline up to Follow-up (Week 72)
|
5.5%
21/384 • Baseline up to Follow-up (Week 72)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee A copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested in writing, such publication will be withheld for up to an additional 60 days.
- Publication restrictions are in place
Restriction type: OTHER