Trial Outcomes & Findings for Individualized Triple-therapy Using Boceprevir in HIV-positive Patients With Hepatitis C (NCT NCT01925183)
NCT ID: NCT01925183
Last Updated: 2017-03-16
Results Overview
Defined as HCV-RNA negativity by a sensitive assay
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
6 participants
Primary outcome timeframe
Follow-up week 12 (FU12)
Results posted on
2017-03-16
Participant Flow
Participant milestones
| Measure |
28 Weeks of Treatment Duration
All patients will receive 4 weeks of pegylated interferon/ribavirin (PEGIFN/RBV) lead-in. Patients with undetectable hepatitis C virus (HCV)-RNA at treatment week 8 will be treated with 24 weeks of boceprevir (BOC)/PEGIFN/RBV triple-therapy resulting in a total treatment duration of 28 weeks.
Pegylated interferon alpha-2a: 180mcg once weekly; subcutaneous injection
Ribavirin: 600mg two times daily (BID) (e.g. 3x200mg at 6am, 3x200mg at 6pm) in patients ≥75kg body weight; 2x200mg at 6am and 3x200mg at 6pm in patients \<75kg; orally
Boceprevir: 800mg three times daily (TID) (e.g. 4x200mg at 6am, 4x200mg at 2pm, 4x200mg at 10pm); orally
|
48 Weeks of Treatment Duration
All patients will receive 4 weeks of PEGIFN/RBV lead-in. Patients with detectable HCV-RNA at treatment week 8 will receive 44 weeks of BOC/PEGIFN/RBV triple-therapy and a total treatment duration of 48 weeks
Pegylated interferon alpha-2a: 180mcg once weekly; subcutaneous injection
Ribavirin: 600mg two times daily (BID) (e.g. 3x200mg at 6am, 3x200mg at 6pm) in patients ≥75kg body weight; 2x200mg at 6am and 3x200mg at 6pm in patients \<75kg; orally
Boceprevir: 800mg three times daily (TID) (e.g. 4x200mg at 6am, 4x200mg at 2pm, 4x200mg at 10pm); orally
|
|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
|
Overall Study
COMPLETED
|
2
|
3
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
28 Weeks of Treatment Duration
All patients will receive 4 weeks of pegylated interferon/ribavirin (PEGIFN/RBV) lead-in. Patients with undetectable hepatitis C virus (HCV)-RNA at treatment week 8 will be treated with 24 weeks of boceprevir (BOC)/PEGIFN/RBV triple-therapy resulting in a total treatment duration of 28 weeks.
Pegylated interferon alpha-2a: 180mcg once weekly; subcutaneous injection
Ribavirin: 600mg two times daily (BID) (e.g. 3x200mg at 6am, 3x200mg at 6pm) in patients ≥75kg body weight; 2x200mg at 6am and 3x200mg at 6pm in patients \<75kg; orally
Boceprevir: 800mg three times daily (TID) (e.g. 4x200mg at 6am, 4x200mg at 2pm, 4x200mg at 10pm); orally
|
48 Weeks of Treatment Duration
All patients will receive 4 weeks of PEGIFN/RBV lead-in. Patients with detectable HCV-RNA at treatment week 8 will receive 44 weeks of BOC/PEGIFN/RBV triple-therapy and a total treatment duration of 48 weeks
Pegylated interferon alpha-2a: 180mcg once weekly; subcutaneous injection
Ribavirin: 600mg two times daily (BID) (e.g. 3x200mg at 6am, 3x200mg at 6pm) in patients ≥75kg body weight; 2x200mg at 6am and 3x200mg at 6pm in patients \<75kg; orally
Boceprevir: 800mg three times daily (TID) (e.g. 4x200mg at 6am, 4x200mg at 2pm, 4x200mg at 10pm); orally
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
Baseline Characteristics
Individualized Triple-therapy Using Boceprevir in HIV-positive Patients With Hepatitis C
Baseline characteristics by cohort
| Measure |
28 Weeks of Treatment Duration
n=3 Participants
All patients will receive 4 weeks of PEGIFN/RBV lead-in. Patients with undetectable HCV-RNA at treatment week 8 will be treated with 24 weeks of BOC/PEGIFN/RBV triple-therapy resulting in a total treatment duration of 28 weeks.
Pegylated interferon alpha-2a: 180mcg once weekly; subcutaneous injection
Ribavirin: 600mg two times daily (BID) (e.g. 3x200mg at 6am, 3x200mg at 6pm) in patients ≥75kg body weight; 2x200mg at 6am and 3x200mg at 6pm in patients \<75kg; orally
Boceprevir: 800mg three times daily (TID) (e.g. 4x200mg at 6am, 4x200mg at 2pm, 4x200mg at 10pm); orally
|
48 Weeks of Treatment Duration
n=3 Participants
All patients will receive 4 weeks of PEGIFN/RBV lead-in. Patients with detectable HCV-RNA at treatment week 8 will receive 44 weeks of BOC/PEGIFN/RBV triple-therapy and a total treatment duration of 48 weeks
Pegylated interferon alpha-2a: 180mcg once weekly; subcutaneous injection
Ribavirin: 600mg two times daily (BID) (e.g. 3x200mg at 6am, 3x200mg at 6pm) in patients ≥75kg body weight; 2x200mg at 6am and 3x200mg at 6pm in patients \<75kg; orally
Boceprevir: 800mg three times daily (TID) (e.g. 4x200mg at 6am, 4x200mg at 2pm, 4x200mg at 10pm); orally
|
Total
n=6 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Follow-up week 12 (FU12)Defined as HCV-RNA negativity by a sensitive assay
Outcome measures
| Measure |
28 Weeks of Treatment Duration
n=3 Participants
All patients will receive 4 weeks of PEGIFN/RBV lead-in. Patients with undetectable HCV-RNA at treatment week 8 will be treated with 24 weeks of BOC/PEGIFN/RBV triple-therapy resulting in a total treatment duration of 28 weeks.
Pegylated interferon alpha-2a: 180mcg once weekly; subcutaneous injection
Ribavirin: 600mg two times daily (BID) (e.g. 3x200mg at 6am, 3x200mg at 6pm) in patients ≥75kg body weight; 2x200mg at 6am and 3x200mg at 6pm in patients \<75kg; orally
Boceprevir: 800mg three times daily (TID) (e.g. 4x200mg at 6am, 4x200mg at 2pm, 4x200mg at 10pm); orally
|
48 Weeks of Treatment Duration
n=3 Participants
All patients will receive 4 weeks of PEGIFN/RBV lead-in. Patients with detectable HCV-RNA at treatment week 8 will receive 44 weeks of BOC/PEGIFN/RBV triple-therapy and a total treatment duration of 48 weeks
Pegylated interferon alpha-2a: 180mcg once weekly; subcutaneous injection
Ribavirin: 600mg two times daily (BID) (e.g. 3x200mg at 6am, 3x200mg at 6pm) in patients ≥75kg body weight; 2x200mg at 6am and 3x200mg at 6pm in patients \<75kg; orally
Boceprevir: 800mg three times daily (TID) (e.g. 4x200mg at 6am, 4x200mg at 2pm, 4x200mg at 10pm); orally
|
|---|---|---|
|
Proportion of Subjects With Sustained Virologic Response (SVR12)
|
3 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: Baseline (BL) to Follow-up week 12 (FU12)Outcome measures
| Measure |
28 Weeks of Treatment Duration
n=3 Participants
All patients will receive 4 weeks of PEGIFN/RBV lead-in. Patients with undetectable HCV-RNA at treatment week 8 will be treated with 24 weeks of BOC/PEGIFN/RBV triple-therapy resulting in a total treatment duration of 28 weeks.
Pegylated interferon alpha-2a: 180mcg once weekly; subcutaneous injection
Ribavirin: 600mg two times daily (BID) (e.g. 3x200mg at 6am, 3x200mg at 6pm) in patients ≥75kg body weight; 2x200mg at 6am and 3x200mg at 6pm in patients \<75kg; orally
Boceprevir: 800mg three times daily (TID) (e.g. 4x200mg at 6am, 4x200mg at 2pm, 4x200mg at 10pm); orally
|
48 Weeks of Treatment Duration
n=3 Participants
All patients will receive 4 weeks of PEGIFN/RBV lead-in. Patients with detectable HCV-RNA at treatment week 8 will receive 44 weeks of BOC/PEGIFN/RBV triple-therapy and a total treatment duration of 48 weeks
Pegylated interferon alpha-2a: 180mcg once weekly; subcutaneous injection
Ribavirin: 600mg two times daily (BID) (e.g. 3x200mg at 6am, 3x200mg at 6pm) in patients ≥75kg body weight; 2x200mg at 6am and 3x200mg at 6pm in patients \<75kg; orally
Boceprevir: 800mg three times daily (TID) (e.g. 4x200mg at 6am, 4x200mg at 2pm, 4x200mg at 10pm); orally
|
|---|---|---|
|
Proportions of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Adverse events (AEs)
|
3 Participants
|
3 Participants
|
|
Proportions of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Serious adverse events (SAEs)
|
0 Participants
|
1 Participants
|
Adverse Events
28 Weeks of Treatment Duration
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
48 Weeks of Treatment Duration
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
28 Weeks of Treatment Duration
n=3 participants at risk
All patients will receive 4 weeks of PEGIFN/RBV lead-in. Patients with undetectable HCV-RNA at treatment week 8 will be treated with 24 weeks of BOC/PEGIFN/RBV triple-therapy resulting in a total treatment duration of 28 weeks.
Pegylated interferon alpha-2a: 180mcg once weekly; subcutaneous injection
Ribavirin: 600mg two times daily (BID) (e.g. 3x200mg at 6am, 3x200mg at 6pm) in patients ≥75kg body weight; 2x200mg at 6am and 3x200mg at 6pm in patients \<75kg; orally
Boceprevir: 800mg three times daily (TID) (e.g. 4x200mg at 6am, 4x200mg at 2pm, 4x200mg at 10pm); orally
|
48 Weeks of Treatment Duration
n=3 participants at risk
All patients will receive 4 weeks of PEGIFN/RBV lead-in. Patients with detectable HCV-RNA at treatment week 8 will receive 44 weeks of BOC/PEGIFN/RBV triple-therapy and a total treatment duration of 48 weeks
Pegylated interferon alpha-2a: 180mcg once weekly; subcutaneous injection
Ribavirin: 600mg two times daily (BID) (e.g. 3x200mg at 6am, 3x200mg at 6pm) in patients ≥75kg body weight; 2x200mg at 6am and 3x200mg at 6pm in patients \<75kg; orally
Boceprevir: 800mg three times daily (TID) (e.g. 4x200mg at 6am, 4x200mg at 2pm, 4x200mg at 10pm); orally
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Abscess soft tissue
|
0.00%
0/3 • Baseline (BL) to Follow-up week 12 (FU12)
|
33.3%
1/3 • Number of events 1 • Baseline (BL) to Follow-up week 12 (FU12)
|
Other adverse events
| Measure |
28 Weeks of Treatment Duration
n=3 participants at risk
All patients will receive 4 weeks of PEGIFN/RBV lead-in. Patients with undetectable HCV-RNA at treatment week 8 will be treated with 24 weeks of BOC/PEGIFN/RBV triple-therapy resulting in a total treatment duration of 28 weeks.
Pegylated interferon alpha-2a: 180mcg once weekly; subcutaneous injection
Ribavirin: 600mg two times daily (BID) (e.g. 3x200mg at 6am, 3x200mg at 6pm) in patients ≥75kg body weight; 2x200mg at 6am and 3x200mg at 6pm in patients \<75kg; orally
Boceprevir: 800mg three times daily (TID) (e.g. 4x200mg at 6am, 4x200mg at 2pm, 4x200mg at 10pm); orally
|
48 Weeks of Treatment Duration
n=3 participants at risk
All patients will receive 4 weeks of PEGIFN/RBV lead-in. Patients with detectable HCV-RNA at treatment week 8 will receive 44 weeks of BOC/PEGIFN/RBV triple-therapy and a total treatment duration of 48 weeks
Pegylated interferon alpha-2a: 180mcg once weekly; subcutaneous injection
Ribavirin: 600mg two times daily (BID) (e.g. 3x200mg at 6am, 3x200mg at 6pm) in patients ≥75kg body weight; 2x200mg at 6am and 3x200mg at 6pm in patients \<75kg; orally
Boceprevir: 800mg three times daily (TID) (e.g. 4x200mg at 6am, 4x200mg at 2pm, 4x200mg at 10pm); orally
|
|---|---|---|
|
Immune system disorders
Psoriasis
|
33.3%
1/3 • Number of events 1 • Baseline (BL) to Follow-up week 12 (FU12)
|
0.00%
0/3 • Baseline (BL) to Follow-up week 12 (FU12)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3 • Baseline (BL) to Follow-up week 12 (FU12)
|
33.3%
1/3 • Number of events 1 • Baseline (BL) to Follow-up week 12 (FU12)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
33.3%
1/3 • Number of events 1 • Baseline (BL) to Follow-up week 12 (FU12)
|
0.00%
0/3 • Baseline (BL) to Follow-up week 12 (FU12)
|
|
Blood and lymphatic system disorders
Anaemia
|
100.0%
3/3 • Number of events 3 • Baseline (BL) to Follow-up week 12 (FU12)
|
33.3%
1/3 • Number of events 1 • Baseline (BL) to Follow-up week 12 (FU12)
|
|
Blood and lymphatic system disorders
Neutropenia
|
33.3%
1/3 • Number of events 1 • Baseline (BL) to Follow-up week 12 (FU12)
|
33.3%
1/3 • Number of events 1 • Baseline (BL) to Follow-up week 12 (FU12)
|
|
Blood and lymphatic system disorders
Platelet count decreased
|
100.0%
3/3 • Number of events 3 • Baseline (BL) to Follow-up week 12 (FU12)
|
66.7%
2/3 • Number of events 2 • Baseline (BL) to Follow-up week 12 (FU12)
|
|
Nervous system disorders
Headache
|
33.3%
1/3 • Number of events 1 • Baseline (BL) to Follow-up week 12 (FU12)
|
33.3%
1/3 • Number of events 1 • Baseline (BL) to Follow-up week 12 (FU12)
|
|
General disorders
Fatigue
|
100.0%
3/3 • Number of events 3 • Baseline (BL) to Follow-up week 12 (FU12)
|
66.7%
2/3 • Number of events 3 • Baseline (BL) to Follow-up week 12 (FU12)
|
|
General disorders
Influenza like illness
|
33.3%
1/3 • Number of events 1 • Baseline (BL) to Follow-up week 12 (FU12)
|
0.00%
0/3 • Baseline (BL) to Follow-up week 12 (FU12)
|
|
General disorders
Pyrexia
|
33.3%
1/3 • Number of events 1 • Baseline (BL) to Follow-up week 12 (FU12)
|
0.00%
0/3 • Baseline (BL) to Follow-up week 12 (FU12)
|
|
Nervous system disorders
Depression
|
0.00%
0/3 • Baseline (BL) to Follow-up week 12 (FU12)
|
33.3%
1/3 • Number of events 1 • Baseline (BL) to Follow-up week 12 (FU12)
|
|
Nervous system disorders
Insomnia
|
33.3%
1/3 • Number of events 1 • Baseline (BL) to Follow-up week 12 (FU12)
|
66.7%
2/3 • Number of events 2 • Baseline (BL) to Follow-up week 12 (FU12)
|
|
Gastrointestinal disorders
Abdominal pain
|
33.3%
1/3 • Number of events 1 • Baseline (BL) to Follow-up week 12 (FU12)
|
0.00%
0/3 • Baseline (BL) to Follow-up week 12 (FU12)
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3 • Baseline (BL) to Follow-up week 12 (FU12)
|
66.7%
2/3 • Number of events 2 • Baseline (BL) to Follow-up week 12 (FU12)
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • Baseline (BL) to Follow-up week 12 (FU12)
|
66.7%
2/3 • Number of events 2 • Baseline (BL) to Follow-up week 12 (FU12)
|
|
Gastrointestinal disorders
Diarrhoea
|
33.3%
1/3 • Number of events 1 • Baseline (BL) to Follow-up week 12 (FU12)
|
33.3%
1/3 • Number of events 1 • Baseline (BL) to Follow-up week 12 (FU12)
|
|
Gastrointestinal disorders
Glossodynia
|
0.00%
0/3 • Baseline (BL) to Follow-up week 12 (FU12)
|
33.3%
1/3 • Number of events 1 • Baseline (BL) to Follow-up week 12 (FU12)
|
|
Gastrointestinal disorders
Toothache
|
33.3%
1/3 • Number of events 1 • Baseline (BL) to Follow-up week 12 (FU12)
|
0.00%
0/3 • Baseline (BL) to Follow-up week 12 (FU12)
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/3 • Baseline (BL) to Follow-up week 12 (FU12)
|
33.3%
1/3 • Number of events 1 • Baseline (BL) to Follow-up week 12 (FU12)
|
|
Skin and subcutaneous tissue disorders
Hair loss
|
0.00%
0/3 • Baseline (BL) to Follow-up week 12 (FU12)
|
66.7%
2/3 • Number of events 2 • Baseline (BL) to Follow-up week 12 (FU12)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
33.3%
1/3 • Number of events 1 • Baseline (BL) to Follow-up week 12 (FU12)
|
33.3%
1/3 • Number of events 1 • Baseline (BL) to Follow-up week 12 (FU12)
|
Additional Information
Markus Peck-Radosavljevic (Principal Investigator)
Division of Gastroenterology and Hepatology, Department of Internal Medicine III, Medical University of Vienna
Phone: +43 1 40400
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place