Trial Outcomes & Findings for A Study to Evaluate Chronic Hepatitis C Virus (HCV) Infection in Cirrhotic Adults With Genotype 1b (GT1b) Infection (NCT NCT02216422)

Last Updated: 2016-06-29

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. Participants with missing data were imputed as failures.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

36 participants

Primary outcome timeframe

Post-treatment Day 1 to Post-treatment Week 12

Results posted on

2016-06-29

Participant Flow

A total of 36 participants were enrolled and all the participants completed the study. All 36 participants were analyzed for both efficacy (included all participants who received at least 1 dose of study drug (ITT)) and safety.

Participant milestones

Participant milestones
Measure	Ombitasvir/Paritaprevir/Ritonavir Plus Dasabuvir With RBV Ombitasvir/Paritaprevir/Ritonavir (25/150/100 mg once daily) and Dasabuvir (250 mg twice daily) co-administered with weight-based Ribavirin (RBV; twice daily) for 12 weeks.
Overall Study STARTED	36
Overall Study COMPLETED	36
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study to Evaluate Chronic Hepatitis C Virus (HCV) Infection in Cirrhotic Adults With Genotype 1b (GT1b) Infection

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ombitasvir/Paritaprevir/Ritonavir Plus Dasabuvir With RBV n=36 Participants Ombitasvir/Paritaprevir/Ritonavir (25/150/100 mg once daily) and Dasabuvir (250 mg twice daily) co-administered with weight-based Ribavirin (RBV; twice daily) for 12 weeks.
Age, Continuous	51.6 years STANDARD_DEVIATION 7.91 • n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants
Sex: Female, Male Male	23 Participants n=5 Participants
Interleukin 28B (IL28B) CC	4 participants n=5 Participants
Interleukin 28B (IL28B) CT	25 participants n=5 Participants
Interleukin 28B (IL28B) TT	7 participants n=5 Participants
Interleukin 28B (IL28B) Missing	0 participants n=5 Participants

PRIMARY outcome

Timeframe: Post-treatment Day 1 to Post-treatment Week 12

Population: Efficacy analyses included all participants who received at least 1 dose of study drug (ITT).

Outcome measures

Outcome measures
Measure	Ombitasvir/Paritaprevir/Ritonavir Plus Dasabuvir With RBV n=36 Participants Ombitasvir/Paritaprevir/Ritonavir (25/150/100 mg once daily) and Dasabuvir (250 mg twice daily) co-administered with weight-based Ribavirin (RBV; twice daily) for 12 weeks.
Percentage of Participants With Sustained Virologic Response 12 Weeks (SVR12) Post-treatment	100 percentage of participants Interval 90.4 to 100.0

SECONDARY outcome

Timeframe: Day 1 through Week 12

Population: 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

Outcome measures
Measure	Ombitasvir/Paritaprevir/Ritonavir Plus Dasabuvir With RBV n=36 Participants Ombitasvir/Paritaprevir/Ritonavir (25/150/100 mg once daily) and Dasabuvir (250 mg twice daily) co-administered with weight-based Ribavirin (RBV; twice daily) for 12 weeks.
Percentage of Participants With On-Treatment Virologic Failure	0 percentage of participants Interval 0.0 to 9.6

SECONDARY outcome

Timeframe: Post-treatment Day 1 to Post-treatment Week 12

Population: 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

Outcome measures
Measure	Ombitasvir/Paritaprevir/Ritonavir Plus Dasabuvir With RBV n=36 Participants Ombitasvir/Paritaprevir/Ritonavir (25/150/100 mg once daily) and Dasabuvir (250 mg twice daily) co-administered with weight-based Ribavirin (RBV; twice daily) for 12 weeks.
Percentage of Participants With Post-Treatment Relapse	0 percentage of participants Interval 0.0 to 9.6

Adverse Events

Ombitasvir/Paritaprevir/Ritonavir Plus

Serious events: 0 serious events

Other events: 21 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Ombitasvir/Paritaprevir/Ritonavir Plus n=36 participants at risk Ombitasvir/Paritaprevir/Ritonavir (25/150/100 mg once daily) and Dasabuvir (250 mg twice daily) co-administered with weight-based Ribavirin (RBV; twice daily) for 12 weeks.
Blood and lymphatic system disorders ANAEMIA	22.2% 8/36 • 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 36 weeks).
Blood and lymphatic system disorders LEUKOPENIA	5.6% 2/36 • 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 36 weeks).
Gastrointestinal disorders ABDOMINAL PAIN UPPER	5.6% 2/36 • 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 36 weeks).
Gastrointestinal disorders NAUSEA	5.6% 2/36 • 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 36 weeks).
General disorders ASTHENIA	22.2% 8/36 • 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 36 weeks).
General disorders FATIGUE	5.6% 2/36 • 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 36 weeks).
Hepatobiliary disorders HYPERBILIRUBINAEMIA	8.3% 3/36 • 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 36 weeks).
Infections and infestations UPPER RESPIRATORY TRACT INFECTION	5.6% 2/36 • 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 36 weeks).
Musculoskeletal and connective tissue disorders ARTHRALGIA	5.6% 2/36 • 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 36 weeks).
Nervous system disorders HEADACHE	11.1% 4/36 • 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 36 weeks).
Psychiatric disorders INSOMNIA	5.6% 2/36 • 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 36 weeks).
Respiratory, thoracic and mediastinal disorders COUGH	13.9% 5/36 • 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 36 weeks).
Respiratory, thoracic and mediastinal disorders DYSPNOEA EXERTIONAL	5.6% 2/36 • 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 36 weeks).
Skin and subcutaneous tissue disorders PRURITUS	5.6% 2/36 • 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 36 weeks).

Additional Information

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