Trial Outcomes & Findings for HCV-HIV Co-infected Patient Cohort in Thailand (NCT NCT02247440)
NCT ID: NCT02247440
Last Updated: 2019-06-03
Results Overview
Number of Participants with Sustained Virological Response 6 Months After Treatment Discontinuation,
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
18 participants
Primary outcome timeframe
6 months after end of treatment, i.e. 1.5 years after treatment initiation
Results posted on
2019-06-03
Participant Flow
Participant milestones
| Measure |
PegINF-ribavirin
Peg-interferon + ribavirin under HIV physician supervision Peg-interferon alpha 2-b initial dosing is 1.5 micrograms/kg (subcutaneous injection) once a week
Ribavirin initial dosing in the morning and in the evening:
1. For genotypes 2, 3: ribavirin 400 mg (i.e. 800 mg daily).
2. For genotypes 1, 4, 5 and 6:
* 800 mg/day, if bodyweight \<65 kg,
* 1000 mg/day, if bodyweight between 66-80 kg,
* 1200 mg/day, if bodyweight between 81-105 kg,
* 1400 mg/day, if bodyweight \>105 kg.
Duration: 48 weeks
Peg-interferon + ribavirin under HIV physician supervision: Peg-interferon + ribavirin under HIV physician supervision
|
|---|---|
|
Overall Study
STARTED
|
18
|
|
Overall Study
COMPLETED
|
14
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
PegINF-ribavirin
Peg-interferon + ribavirin under HIV physician supervision Peg-interferon alpha 2-b initial dosing is 1.5 micrograms/kg (subcutaneous injection) once a week
Ribavirin initial dosing in the morning and in the evening:
1. For genotypes 2, 3: ribavirin 400 mg (i.e. 800 mg daily).
2. For genotypes 1, 4, 5 and 6:
* 800 mg/day, if bodyweight \<65 kg,
* 1000 mg/day, if bodyweight between 66-80 kg,
* 1200 mg/day, if bodyweight between 81-105 kg,
* 1400 mg/day, if bodyweight \>105 kg.
Duration: 48 weeks
Peg-interferon + ribavirin under HIV physician supervision: Peg-interferon + ribavirin under HIV physician supervision
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Lack of Efficacy
|
3
|
Baseline Characteristics
HCV-HIV Co-infected Patient Cohort in Thailand
Baseline characteristics by cohort
| Measure |
PegINF-ribavirin
n=18 Participants
Peg-interferon + ribavirin under HIV physician supervision Peg-interferon alpha 2-b initial dosing is 1.5 micrograms/kg (subcutaneous injection) once a week
Ribavirin initial dosing in the morning and in the evening:
1. For genotypes 2, 3: ribavirin 400 mg (i.e. 800 mg daily).
2. For genotypes 1, 4, 5 and 6:
* 800 mg/day, if bodyweight \<65 kg,
* 1000 mg/day, if bodyweight between 66-80 kg,
* 1200 mg/day, if bodyweight between 81-105 kg,
* 1400 mg/day, if bodyweight \>105 kg.
Duration: 48 weeks
Peg-interferon + ribavirin under HIV physician supervision: Peg-interferon + ribavirin under HIV physician supervision
|
|---|---|
|
Age, Continuous
|
44.2 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Asian
|
18 Participants
n=99 Participants
|
|
Region of Enrollment
Thailand
|
18 participants
n=99 Participants
|
|
Body Mass Index
|
21.8 kg/m^2
n=99 Participants
|
|
HCV RNA
|
5.83 log10 IU/mL
n=99 Participants
|
|
HCV genotypes
Gt 1a
|
2 Participants
n=99 Participants
|
|
HCV genotypes
Gt 1b
|
8 Participants
n=99 Participants
|
|
HCV genotypes
Gt 3a
|
5 Participants
n=99 Participants
|
|
HCV genotypes
Gt 3b
|
1 Participants
n=99 Participants
|
|
HCV genotypes
Gt 6a/b
|
1 Participants
n=99 Participants
|
|
HCV genotypes
Gt 6c-l
|
1 Participants
n=99 Participants
|
|
IL 28B polymorphism
CC
|
14 Participants
n=99 Participants
|
|
IL 28B polymorphism
CT
|
4 Participants
n=99 Participants
|
|
Liver fibrosis stage
F2
|
1 Participants
n=99 Participants
|
|
Liver fibrosis stage
F3
|
4 Participants
n=99 Participants
|
|
Liver fibrosis stage
F4
|
13 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 6 months after end of treatment, i.e. 1.5 years after treatment initiationNumber of Participants with Sustained Virological Response 6 Months After Treatment Discontinuation,
Outcome measures
| Measure |
PegINF-ribavirin
n=18 Participants
Peg-interferon + ribavirin under HIV physician supervision Peg-interferon alpha 2-b initial dosing is 1.5 micrograms/kg (subcutaneous injection) once a week
Ribavirin initial dosing in the morning and in the evening:
1. For genotypes 2, 3: ribavirin 400 mg (i.e. 800 mg daily).
2. For genotypes 1, 4, 5 and 6:
* 800 mg/day, if bodyweight \<65 kg,
* 1000 mg/day, if bodyweight between 66-80 kg,
* 1200 mg/day, if bodyweight between 81-105 kg,
* 1400 mg/day, if bodyweight \>105 kg.
Duration: 48 weeks
Peg-interferon + ribavirin under HIV physician supervision: Peg-interferon + ribavirin under HIV physician supervision
|
|---|---|
|
Number of Participants With Sustained Virological Response 6 Months After Treatment Discontinuation
|
10 Participants
|
SECONDARY outcome
Timeframe: From initiation of treatment to 6 months after treatment discontinuationNumber of participants with at least a serious adverse events associated with study treatment (peg-interferon and ribavirin).
Outcome measures
| Measure |
PegINF-ribavirin
n=18 Participants
Peg-interferon + ribavirin under HIV physician supervision Peg-interferon alpha 2-b initial dosing is 1.5 micrograms/kg (subcutaneous injection) once a week
Ribavirin initial dosing in the morning and in the evening:
1. For genotypes 2, 3: ribavirin 400 mg (i.e. 800 mg daily).
2. For genotypes 1, 4, 5 and 6:
* 800 mg/day, if bodyweight \<65 kg,
* 1000 mg/day, if bodyweight between 66-80 kg,
* 1200 mg/day, if bodyweight between 81-105 kg,
* 1400 mg/day, if bodyweight \>105 kg.
Duration: 48 weeks
Peg-interferon + ribavirin under HIV physician supervision: Peg-interferon + ribavirin under HIV physician supervision
|
|---|---|
|
Number of Participants With at Least a Serious Adverse Events Associated With Study Treatment (Peg-interferon and Ribavirin)
|
1 Participants
|
SECONDARY outcome
Timeframe: At time of treatment discontinuation (whatever its date) and 6 months thereafterNumber of participants grouped by HIV-1 RNA concentrations (Detected vs. Not Detected).
Outcome measures
| Measure |
PegINF-ribavirin
n=18 Participants
Peg-interferon + ribavirin under HIV physician supervision Peg-interferon alpha 2-b initial dosing is 1.5 micrograms/kg (subcutaneous injection) once a week
Ribavirin initial dosing in the morning and in the evening:
1. For genotypes 2, 3: ribavirin 400 mg (i.e. 800 mg daily).
2. For genotypes 1, 4, 5 and 6:
* 800 mg/day, if bodyweight \<65 kg,
* 1000 mg/day, if bodyweight between 66-80 kg,
* 1200 mg/day, if bodyweight between 81-105 kg,
* 1400 mg/day, if bodyweight \>105 kg.
Duration: 48 weeks
Peg-interferon + ribavirin under HIV physician supervision: Peg-interferon + ribavirin under HIV physician supervision
|
|---|---|
|
Number of Participants Grouped by HIV-1 RNA Concentrations
HIV-1 RNA not detected
|
16 Participants
|
|
Number of Participants Grouped by HIV-1 RNA Concentrations
HIV-1 RNA detected
|
1 Participants
|
|
Number of Participants Grouped by HIV-1 RNA Concentrations
Missing
|
1 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From initiation of treatment to the first 48 weeks of treatmentNumber of participants completed the first 24 and 48 weeks of treatment.
Outcome measures
| Measure |
PegINF-ribavirin
n=18 Participants
Peg-interferon + ribavirin under HIV physician supervision Peg-interferon alpha 2-b initial dosing is 1.5 micrograms/kg (subcutaneous injection) once a week
Ribavirin initial dosing in the morning and in the evening:
1. For genotypes 2, 3: ribavirin 400 mg (i.e. 800 mg daily).
2. For genotypes 1, 4, 5 and 6:
* 800 mg/day, if bodyweight \<65 kg,
* 1000 mg/day, if bodyweight between 66-80 kg,
* 1200 mg/day, if bodyweight between 81-105 kg,
* 1400 mg/day, if bodyweight \>105 kg.
Duration: 48 weeks
Peg-interferon + ribavirin under HIV physician supervision: Peg-interferon + ribavirin under HIV physician supervision
|
|---|---|
|
Number of Participants Completed the First 24 and 48 Weeks of Treatment
Completed the first 24 weeks of treatment
|
14 Participants
|
|
Number of Participants Completed the First 24 and 48 Weeks of Treatment
Completed the first 48 weeks of treatment
|
14 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From initiation of treatment to 6 months after treatment discontinuationNumber of adverse events (AE) by severity grade. The severity grading scale is based on the DAIDS grading table, the grading scale ranging from grades 1 to 5: Grade 1 indicates a mild event, Grade 2 indicates a moderate event, Grade 3 indicates a severe event, Grade 4 indicates a potentially life-threatening event, and Grade 5 indicates death.
Outcome measures
| Measure |
PegINF-ribavirin
n=18 Participants
Peg-interferon + ribavirin under HIV physician supervision Peg-interferon alpha 2-b initial dosing is 1.5 micrograms/kg (subcutaneous injection) once a week
Ribavirin initial dosing in the morning and in the evening:
1. For genotypes 2, 3: ribavirin 400 mg (i.e. 800 mg daily).
2. For genotypes 1, 4, 5 and 6:
* 800 mg/day, if bodyweight \<65 kg,
* 1000 mg/day, if bodyweight between 66-80 kg,
* 1200 mg/day, if bodyweight between 81-105 kg,
* 1400 mg/day, if bodyweight \>105 kg.
Duration: 48 weeks
Peg-interferon + ribavirin under HIV physician supervision: Peg-interferon + ribavirin under HIV physician supervision
|
|---|---|
|
Number of Adverse Events by Severity Grade
AE grade 1
|
18 events
|
|
Number of Adverse Events by Severity Grade
AE grade 2
|
7 events
|
|
Number of Adverse Events by Severity Grade
AE grade 3
|
1 events
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From initiation of treatment to the first 48 weeks of treatmentPopulation: 1. subject discontinued treatment after week 1 2. subjects discontinued treatment after week 12 1 subject discontinued treatment after week 24
Number of participants able to perform self-injections of peg-interferon.
Outcome measures
| Measure |
PegINF-ribavirin
n=18 Participants
Peg-interferon + ribavirin under HIV physician supervision Peg-interferon alpha 2-b initial dosing is 1.5 micrograms/kg (subcutaneous injection) once a week
Ribavirin initial dosing in the morning and in the evening:
1. For genotypes 2, 3: ribavirin 400 mg (i.e. 800 mg daily).
2. For genotypes 1, 4, 5 and 6:
* 800 mg/day, if bodyweight \<65 kg,
* 1000 mg/day, if bodyweight between 66-80 kg,
* 1200 mg/day, if bodyweight between 81-105 kg,
* 1400 mg/day, if bodyweight \>105 kg.
Duration: 48 weeks
Peg-interferon + ribavirin under HIV physician supervision: Peg-interferon + ribavirin under HIV physician supervision
|
|---|---|
|
Number of Participants Able to Perform Self-injections of Peg-interferon
Week 0 to Week 12 · PegINF injected
|
17 Participants
|
|
Number of Participants Able to Perform Self-injections of Peg-interferon
Week 0 to Week 12 · PegINF not injected
|
0 Participants
|
|
Number of Participants Able to Perform Self-injections of Peg-interferon
Week 12 to Week 16 · PegINF injected
|
16 Participants
|
|
Number of Participants Able to Perform Self-injections of Peg-interferon
Week 12 to Week 16 · PegINF not injected
|
1 Participants
|
|
Number of Participants Able to Perform Self-injections of Peg-interferon
Week 16 to Week 28 · PegINF injected
|
15 Participants
|
|
Number of Participants Able to Perform Self-injections of Peg-interferon
Week 16 to Week 28 · PegINF not injected
|
0 Participants
|
|
Number of Participants Able to Perform Self-injections of Peg-interferon
Week 28 to Week 32 · PegINF injected
|
13 Participants
|
|
Number of Participants Able to Perform Self-injections of Peg-interferon
Week 28 to Week 32 · PegINF not injected
|
1 Participants
|
|
Number of Participants Able to Perform Self-injections of Peg-interferon
Week 32 to Week 48 · PegINF injected
|
14 Participants
|
|
Number of Participants Able to Perform Self-injections of Peg-interferon
Week 32 to Week 48 · PegINF not injected
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From initiation of treatment to the first 48 weeks of treatmentPopulation: 1. subject discontinued treatment after week 1 2. subjects discontinued treatment after week 12 1 subject discontinued treatment after week 24
Number of participants with ribavirin compliance at ≥ 95%, 80% - 95%, and \< 80%.
Outcome measures
| Measure |
PegINF-ribavirin
n=18 Participants
Peg-interferon + ribavirin under HIV physician supervision Peg-interferon alpha 2-b initial dosing is 1.5 micrograms/kg (subcutaneous injection) once a week
Ribavirin initial dosing in the morning and in the evening:
1. For genotypes 2, 3: ribavirin 400 mg (i.e. 800 mg daily).
2. For genotypes 1, 4, 5 and 6:
* 800 mg/day, if bodyweight \<65 kg,
* 1000 mg/day, if bodyweight between 66-80 kg,
* 1200 mg/day, if bodyweight between 81-105 kg,
* 1400 mg/day, if bodyweight \>105 kg.
Duration: 48 weeks
Peg-interferon + ribavirin under HIV physician supervision: Peg-interferon + ribavirin under HIV physician supervision
|
|---|---|
|
Number of Participants With Ribavirin Compliance at ≥ 95%, 80% - 95%, and < 80%
Week 44 to Week 48 · Compliance < 80%
|
0 Participants
|
|
Number of Participants With Ribavirin Compliance at ≥ 95%, 80% - 95%, and < 80%
Week 0 to Week 2 · Compliance < 80%
|
0 Participants
|
|
Number of Participants With Ribavirin Compliance at ≥ 95%, 80% - 95%, and < 80%
Week 0 to Week 2 · Compliance 80% - 95%
|
2 Participants
|
|
Number of Participants With Ribavirin Compliance at ≥ 95%, 80% - 95%, and < 80%
Week 0 to Week 2 · Compliance ≥ 95%
|
15 Participants
|
|
Number of Participants With Ribavirin Compliance at ≥ 95%, 80% - 95%, and < 80%
Week 2 to Week 4 · Compliance < 80%
|
1 Participants
|
|
Number of Participants With Ribavirin Compliance at ≥ 95%, 80% - 95%, and < 80%
Week 2 to Week 4 · Compliance 80% - 95%
|
1 Participants
|
|
Number of Participants With Ribavirin Compliance at ≥ 95%, 80% - 95%, and < 80%
Week 2 to Week 4 · Compliance ≥ 95%
|
15 Participants
|
|
Number of Participants With Ribavirin Compliance at ≥ 95%, 80% - 95%, and < 80%
Week 4 to Week 12 · Compliance < 80%
|
0 Participants
|
|
Number of Participants With Ribavirin Compliance at ≥ 95%, 80% - 95%, and < 80%
Week 4 to Week 12 · Compliance 80% - 95%
|
0 Participants
|
|
Number of Participants With Ribavirin Compliance at ≥ 95%, 80% - 95%, and < 80%
Week 4 to Week 12 · Compliance ≥ 95%
|
17 Participants
|
|
Number of Participants With Ribavirin Compliance at ≥ 95%, 80% - 95%, and < 80%
Week 12 to Week 16 · Compliance < 80%
|
0 Participants
|
|
Number of Participants With Ribavirin Compliance at ≥ 95%, 80% - 95%, and < 80%
Week 12 to Week 16 · Compliance 80% - 95%
|
1 Participants
|
|
Number of Participants With Ribavirin Compliance at ≥ 95%, 80% - 95%, and < 80%
Week 12 to Week 16 · Compliance ≥ 95%
|
16 Participants
|
|
Number of Participants With Ribavirin Compliance at ≥ 95%, 80% - 95%, and < 80%
Week 16 to Week 20 · Compliance < 80%
|
0 Participants
|
|
Number of Participants With Ribavirin Compliance at ≥ 95%, 80% - 95%, and < 80%
Week 16 to Week 20 · Compliance 80% - 95%
|
0 Participants
|
|
Number of Participants With Ribavirin Compliance at ≥ 95%, 80% - 95%, and < 80%
Week 16 to Week 20 · Compliance ≥ 95%
|
15 Participants
|
|
Number of Participants With Ribavirin Compliance at ≥ 95%, 80% - 95%, and < 80%
Week 20 to Week 24 · Compliance < 80%
|
0 Participants
|
|
Number of Participants With Ribavirin Compliance at ≥ 95%, 80% - 95%, and < 80%
Week 20 to Week 24 · Compliance 80% - 95%
|
2 Participants
|
|
Number of Participants With Ribavirin Compliance at ≥ 95%, 80% - 95%, and < 80%
Week 20 to Week 24 · Compliance ≥ 95%
|
13 Participants
|
|
Number of Participants With Ribavirin Compliance at ≥ 95%, 80% - 95%, and < 80%
Week 24 to Week 28 · Compliance < 80%
|
1 Participants
|
|
Number of Participants With Ribavirin Compliance at ≥ 95%, 80% - 95%, and < 80%
Week 24 to Week 28 · Compliance 80% - 95%
|
0 Participants
|
|
Number of Participants With Ribavirin Compliance at ≥ 95%, 80% - 95%, and < 80%
Week 24 to Week 28 · Compliance ≥ 95%
|
14 Participants
|
|
Number of Participants With Ribavirin Compliance at ≥ 95%, 80% - 95%, and < 80%
Week 28 to Week 32 · Compliance < 80%
|
1 Participants
|
|
Number of Participants With Ribavirin Compliance at ≥ 95%, 80% - 95%, and < 80%
Week 28 to Week 32 · Compliance 80% - 95%
|
0 Participants
|
|
Number of Participants With Ribavirin Compliance at ≥ 95%, 80% - 95%, and < 80%
Week 28 to Week 32 · Compliance ≥ 95%
|
13 Participants
|
|
Number of Participants With Ribavirin Compliance at ≥ 95%, 80% - 95%, and < 80%
Week 32 to Week 36 · Compliance < 80%
|
0 Participants
|
|
Number of Participants With Ribavirin Compliance at ≥ 95%, 80% - 95%, and < 80%
Week 32 to Week 36 · Compliance 80% - 95%
|
0 Participants
|
|
Number of Participants With Ribavirin Compliance at ≥ 95%, 80% - 95%, and < 80%
Week 32 to Week 36 · Compliance ≥ 95%
|
14 Participants
|
|
Number of Participants With Ribavirin Compliance at ≥ 95%, 80% - 95%, and < 80%
Week 36 to Week 44 · Compliance < 80%
|
0 Participants
|
|
Number of Participants With Ribavirin Compliance at ≥ 95%, 80% - 95%, and < 80%
Week 36 to Week 44 · Compliance 80% - 95%
|
1 Participants
|
|
Number of Participants With Ribavirin Compliance at ≥ 95%, 80% - 95%, and < 80%
Week 36 to Week 44 · Compliance ≥ 95%
|
13 Participants
|
|
Number of Participants With Ribavirin Compliance at ≥ 95%, 80% - 95%, and < 80%
Week 44 to Week 48 · Compliance 80% - 95%
|
0 Participants
|
|
Number of Participants With Ribavirin Compliance at ≥ 95%, 80% - 95%, and < 80%
Week 44 to Week 48 · Compliance ≥ 95%
|
14 Participants
|
Adverse Events
PegINF-ribavirin
Serious events: 2 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
PegINF-ribavirin
n=18 participants at risk
Peg-interferon + ribavirin under HIV physician supervision Peg-interferon alpha 2-b initial dosing is 1.5 micrograms/kg (subcutaneous injection) once a week
Ribavirin initial dosing in the morning and in the evening:
1. For genotypes 2, 3: ribavirin 400 mg (i.e. 800 mg daily).
2. For genotypes 1, 4, 5 and 6:
* 800 mg/day, if bodyweight \<65 kg,
* 1000 mg/day, if bodyweight between 66-80 kg,
* 1200 mg/day, if bodyweight between 81-105 kg,
* 1400 mg/day, if bodyweight \>105 kg.
Duration: 48 weeks
Peg-interferon + ribavirin under HIV physician supervision: Peg-interferon + ribavirin under HIV physician supervision
|
|---|---|
|
Gastrointestinal disorders
Gastritis
|
5.6%
1/18 • Number of events 1 • From enrollment until 6 months after treatment discontinuation
|
|
Blood and lymphatic system disorders
Neutropenia
|
5.6%
1/18 • Number of events 1 • From enrollment until 6 months after treatment discontinuation
|
Other adverse events
| Measure |
PegINF-ribavirin
n=18 participants at risk
Peg-interferon + ribavirin under HIV physician supervision Peg-interferon alpha 2-b initial dosing is 1.5 micrograms/kg (subcutaneous injection) once a week
Ribavirin initial dosing in the morning and in the evening:
1. For genotypes 2, 3: ribavirin 400 mg (i.e. 800 mg daily).
2. For genotypes 1, 4, 5 and 6:
* 800 mg/day, if bodyweight \<65 kg,
* 1000 mg/day, if bodyweight between 66-80 kg,
* 1200 mg/day, if bodyweight between 81-105 kg,
* 1400 mg/day, if bodyweight \>105 kg.
Duration: 48 weeks
Peg-interferon + ribavirin under HIV physician supervision: Peg-interferon + ribavirin under HIV physician supervision
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
44.4%
8/18 • Number of events 9 • From enrollment until 6 months after treatment discontinuation
|
|
Blood and lymphatic system disorders
Neutropenia
|
55.6%
10/18 • Number of events 30 • From enrollment until 6 months after treatment discontinuation
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
44.4%
8/18 • Number of events 14 • From enrollment until 6 months after treatment discontinuation
|
Additional Information
Gonzague Jourdain
Institut de Recherche pour le Developpement
Phone: +66818830065
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place