Trial Outcomes & Findings for A Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir in Adults With Genotype 1b Chronic Hepatitis C Virus (HCV) Infection and Cirrhosis (NCT NCT02219503)
NCT ID: NCT02219503
Last Updated: 2021-07-12
Results Overview
Sustained Virologic Response 12 (SVR12) is defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (\< LLOQ; \< 25 IU/mL) 12 weeks after the last dose of study drug. The primary efficacy endpoints were non-inferiority and superiority of the percentage of participants who achieved sustained virologic response 12 weeks after treatment in each treatment arm compared with the historical threshold for sofosbuvir and peginterferon (pegIFN)/RBV for the treatment of subjects with HCV GT1b infection and cirrhosis.
COMPLETED
PHASE3
60 participants
Post-treatment Day 1 to Post-treatment Week 12
2021-07-12
Participant Flow
A total of 60 subjects were enrolled and all the subjects completed the study. All 60 subjects were analyzed for both efficacy (included all participants who received at least 1 dose of study drug (ITT)) and safety.
Participant milestones
| Measure |
Ombitasvir/Paritaprevir/Ritonavir Plus Dasabuvir
Ombitasvir/Paritaprevir/Ritonavir (25/150/100 mg once daily) and Dasabuvir (250 mg twice daily) administered for 12 weeks.
|
|---|---|
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Overall Study
STARTED
|
60
|
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Overall Study
COMPLETED
|
60
|
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Overall Study
NOT COMPLETED
|
0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir in Adults With Genotype 1b Chronic Hepatitis C Virus (HCV) Infection and Cirrhosis
Baseline characteristics by cohort
| Measure |
Ombitasvir/Paritaprevir/Ritonavir Plus Dasabuvir
n=60 Participants
Ombitasvir/Paritaprevir/Ritonavir (25/150/100 mg once daily) and Dasabuvir (250 mg twice daily) administered for 12 weeks.
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|---|---|
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Age, Continuous
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59.5 years
STANDARD_DEVIATION 9.53 • n=5 Participants
|
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Sex: Female, Male
Female
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23 Participants
n=5 Participants
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Sex: Female, Male
Male
|
37 Participants
n=5 Participants
|
|
Interleukin 28B (IL28B) Genotype
CC
|
10 participants
n=5 Participants
|
|
Interleukin 28B (IL28B) Genotype
CT
|
36 participants
n=5 Participants
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|
Interleukin 28B (IL28B) Genotype
TT
|
14 participants
n=5 Participants
|
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Interleukin 28B (IL28B) Genotype
Missing
|
0 participants
n=5 Participants
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PRIMARY outcome
Timeframe: Post-treatment Day 1 to Post-treatment Week 12Population: Efficacy analyses included all participants who received at least 1 dose of study drug (ITT).
Sustained Virologic Response 12 (SVR12) is defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (\< LLOQ; \< 25 IU/mL) 12 weeks after the last dose of study drug. The primary efficacy endpoints were non-inferiority and superiority of the percentage of participants who achieved sustained virologic response 12 weeks after treatment in each treatment arm compared with the historical threshold for sofosbuvir and peginterferon (pegIFN)/RBV for the treatment of subjects with HCV GT1b infection and cirrhosis.
Outcome measures
| Measure |
Ombitasvir/Paritaprevir/Ritonavir Plus Dasabuvir
n=60 Participants
Ombitasvir/Paritaprevir/Ritonavir (25/150/100 mg once daily) and Dasabuvir (250 mg twice daily) administered for 12 weeks.
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|---|---|
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Percentage of Participants With Sustained Virologic Response 12 Weeks (SVR12) Post-treatment
|
100 percentage of participants
Interval 94.0 to 100.0
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SECONDARY outcome
Timeframe: Day 1 through Week 12Population: Efficacy analyses included all participants who received at least 1 dose of study drug (ITT).
On-Treatment Virologic Failure is defined as confirmed HCV RNA \>= LLOQ after HCV RNA \< LLOQ during treatment, or confirmed increase from nadir (local minimum value) in HCV RNA \[2 consecutive HCV RNA measurements \> 1 log10 IU/mL above nadir\] at any time point during treatment, or failure to suppress during treatment \[all on-treatment values of HCV RNA \>= LLOQ\] with at least 6 weeks \[defined as active study drug duration ≥ 36 days\] of treatment.
Outcome measures
| Measure |
Ombitasvir/Paritaprevir/Ritonavir Plus Dasabuvir
n=60 Participants
Ombitasvir/Paritaprevir/Ritonavir (25/150/100 mg once daily) and Dasabuvir (250 mg twice daily) administered for 12 weeks.
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|---|---|
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Percentage of Participants With On-Treatment Virologic Failure
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0 percentage of participants
Interval 0.0 to 6.0
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SECONDARY outcome
Timeframe: Post-treatment Day 1 to Post-treatment Week 12Population: Efficacy analyses included all participants who received at least 1 dose of study drug (ITT).
Post- Treatment Relapse is defined as confirmed HCV RNA \>= LLOQ between end of treatment and 12 weeks after last actual dose of active study drug \[up to and including the SVR12 assessment time point\] for a participant with HCV RNA \< LLOQ at Final Treatment Visit who completes treatment.
Outcome measures
| Measure |
Ombitasvir/Paritaprevir/Ritonavir Plus Dasabuvir
n=60 Participants
Ombitasvir/Paritaprevir/Ritonavir (25/150/100 mg once daily) and Dasabuvir (250 mg twice daily) administered for 12 weeks.
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|---|---|
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Percentage of Participants With Post-Treatment Relapse
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0 percentage of participants
Interval 0.0 to 6.0
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Adverse Events
Ombitasvir/Paritaprevir/Ritonavir Plus Dasabuvir
Serious adverse events
| Measure |
Ombitasvir/Paritaprevir/Ritonavir Plus Dasabuvir
n=60 participants at risk
Ombitasvir/Paritaprevir/Ritonavir (25/150/100 mg once daily) and Dasabuvir (250 mg twice daily) administered for 12 weeks.
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|---|---|
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Nervous system disorders
SYNCOPE
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1.7%
1/60 • AEs and SAEs were collected from the time of study drug administration to 30 days after last dose of study drug (12 weeks); SAEs were also collected from the time that informed consent was obtained until the end of the study (up to 42 weeks).
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Vascular disorders
HYPOTENSION
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1.7%
1/60 • AEs and SAEs were collected from the time of study drug administration to 30 days after last dose of study drug (12 weeks); SAEs were also collected from the time that informed consent was obtained until the end of the study (up to 42 weeks).
|
Other adverse events
| Measure |
Ombitasvir/Paritaprevir/Ritonavir Plus Dasabuvir
n=60 participants at risk
Ombitasvir/Paritaprevir/Ritonavir (25/150/100 mg once daily) and Dasabuvir (250 mg twice daily) administered for 12 weeks.
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|---|---|
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Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
5.0%
3/60 • AEs and SAEs were collected from the time of study drug administration to 30 days after last dose of study drug (12 weeks); SAEs were also collected from the time that informed consent was obtained until the end of the study (up to 42 weeks).
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Gastrointestinal disorders
DIARRHOEA
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20.0%
12/60 • AEs and SAEs were collected from the time of study drug administration to 30 days after last dose of study drug (12 weeks); SAEs were also collected from the time that informed consent was obtained until the end of the study (up to 42 weeks).
|
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Gastrointestinal disorders
DYSPEPSIA
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6.7%
4/60 • AEs and SAEs were collected from the time of study drug administration to 30 days after last dose of study drug (12 weeks); SAEs were also collected from the time that informed consent was obtained until the end of the study (up to 42 weeks).
|
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Gastrointestinal disorders
NAUSEA
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6.7%
4/60 • AEs and SAEs were collected from the time of study drug administration to 30 days after last dose of study drug (12 weeks); SAEs were also collected from the time that informed consent was obtained until the end of the study (up to 42 weeks).
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General disorders
FATIGUE
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21.7%
13/60 • AEs and SAEs were collected from the time of study drug administration to 30 days after last dose of study drug (12 weeks); SAEs were also collected from the time that informed consent was obtained until the end of the study (up to 42 weeks).
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Infections and infestations
INFLUENZA
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6.7%
4/60 • AEs and SAEs were collected from the time of study drug administration to 30 days after last dose of study drug (12 weeks); SAEs were also collected from the time that informed consent was obtained until the end of the study (up to 42 weeks).
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Infections and infestations
NASOPHARYNGITIS
|
6.7%
4/60 • AEs and SAEs were collected from the time of study drug administration to 30 days after last dose of study drug (12 weeks); SAEs were also collected from the time that informed consent was obtained until the end of the study (up to 42 weeks).
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Musculoskeletal and connective tissue disorders
ARTHRALGIA
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10.0%
6/60 • AEs and SAEs were collected from the time of study drug administration to 30 days after last dose of study drug (12 weeks); SAEs were also collected from the time that informed consent was obtained until the end of the study (up to 42 weeks).
|
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Musculoskeletal and connective tissue disorders
MYALGIA
|
6.7%
4/60 • AEs and SAEs were collected from the time of study drug administration to 30 days after last dose of study drug (12 weeks); SAEs were also collected from the time that informed consent was obtained until the end of the study (up to 42 weeks).
|
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Nervous system disorders
DIZZINESS
|
10.0%
6/60 • AEs and SAEs were collected from the time of study drug administration to 30 days after last dose of study drug (12 weeks); SAEs were also collected from the time that informed consent was obtained until the end of the study (up to 42 weeks).
|
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Nervous system disorders
HEADACHE
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18.3%
11/60 • AEs and SAEs were collected from the time of study drug administration to 30 days after last dose of study drug (12 weeks); SAEs were also collected from the time that informed consent was obtained until the end of the study (up to 42 weeks).
|
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Psychiatric disorders
INSOMNIA
|
10.0%
6/60 • AEs and SAEs were collected from the time of study drug administration to 30 days after last dose of study drug (12 weeks); SAEs were also collected from the time that informed consent was obtained until the end of the study (up to 42 weeks).
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
6.7%
4/60 • AEs and SAEs were collected from the time of study drug administration to 30 days after last dose of study drug (12 weeks); SAEs were also collected from the time that informed consent was obtained until the end of the study (up to 42 weeks).
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Skin and subcutaneous tissue disorders
PRURITUS
|
10.0%
6/60 • AEs and SAEs were collected from the time of study drug administration to 30 days after last dose of study drug (12 weeks); SAEs were also collected from the time that informed consent was obtained until the end of the study (up to 42 weeks).
|
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Skin and subcutaneous tissue disorders
PRURITUS GENERALISED
|
5.0%
3/60 • AEs and SAEs were collected from the time of study drug administration to 30 days after last dose of study drug (12 weeks); SAEs were also collected from the time that informed consent was obtained until the end of the study (up to 42 weeks).
|
|
Vascular disorders
HYPERTENSION
|
5.0%
3/60 • AEs and SAEs were collected from the time of study drug administration to 30 days after last dose of study drug (12 weeks); SAEs were also collected from the time that informed consent was obtained until the end of the study (up to 42 weeks).
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Additional Information
Global Medical Services
AbbVie
Results disclosure agreements
- Principal investigator is a sponsor employee AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
- Publication restrictions are in place
Restriction type: OTHER