Trial Outcomes & Findings for Efficacy and Safety of Glecaprevir/Pibrentasvir (ABT-493/ABT-530) in Treatment-Naive and Treatment-Experienced Asian Adults With Chronic Hepatitis C Virus Genotype (GT) 1 to GT6 Infection With Compensated Cirrhosis and With or Without Human Immunodeficiency Virus Co-Infection (NCT NCT03235349)

Last Updated: 2019-11-21

Results Overview

SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification (LLOQ; 15 IU/mL) 12 weeks after the last dose of study drug.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

160 participants

Primary outcome timeframe

12 weeks after the last actual dose of study drug, Week 24 or Week 28 depending on the treatment regimen.

Results posted on

2019-11-21

Participant Flow

The study was conducted at 34 sites in China and South Korea. Eligible participants were chronic hepatitis C (HCV) genotype (GT)1-6-infected adults with compensated cirrhosis with or without HIV co-infection who were HCV treatment-naïve or treatment-experienced with regimens containing interferon (IFN), pegylated IFN, ribavirin, and/or sofosbuvir.

Participant milestones

Participant milestones
Measure	Glecaprevir/Pibrentasvir Participants received oral glecaprevir/pibrentasvir 300 mg/120 mg once daily (QD) for 12 or 16 weeks. Participants received treatment for 12 weeks with the exception of treatment-experienced, genotype 3-infected participants who received treatment for 16 weeks.
Overall Study STARTED	160
Overall Study COMPLETED	158
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Glecaprevir/Pibrentasvir Participants received oral glecaprevir/pibrentasvir 300 mg/120 mg once daily (QD) for 12 or 16 weeks. Participants received treatment for 12 weeks with the exception of treatment-experienced, genotype 3-infected participants who received treatment for 16 weeks.
Overall Study Adverse Event	1
Overall Study Other	1

Baseline Characteristics

Efficacy and Safety of Glecaprevir/Pibrentasvir (ABT-493/ABT-530) in Treatment-Naive and Treatment-Experienced Asian Adults With Chronic Hepatitis C Virus Genotype (GT) 1 to GT6 Infection With Compensated Cirrhosis and With or Without Human Immunodeficiency Virus Co-Infection

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Glecaprevir/Pibrentasvir n=160 Participants Participants received oral glecaprevir/pibrentasvir 300 mg/120 mg once daily (QD) for 12 or 16 weeks. Participants received treatment for 12 weeks with the exception of treatment-experienced, genotype 3-infected participants who received treatment for 16 weeks.
Age, Continuous	57.83 years STANDARD_DEVIATION 11.27 • n=5 Participants
Age, Customized < 65 years	120 Participants n=5 Participants
Age, Customized ≥ 65 years	40 Participants n=5 Participants
Sex: Female, Male Female	80 Participants n=5 Participants
Sex: Female, Male Male	80 Participants n=5 Participants
Race/Ethnicity, Customized Asian	160 Participants n=5 Participants
Region of Enrollment South Korea	37 Participants n=5 Participants
Region of Enrollment China	123 Participants n=5 Participants
HCV Genotype Genotype 1	85 Participants n=5 Participants
HCV Genotype Genotype 2	53 Participants n=5 Participants
HCV Genotype Genotype 3	14 Participants n=5 Participants
HCV Genotype Genotype 4	1 Participants n=5 Participants
HCV Genotype Genotype 5	0 Participants n=5 Participants
HCV Genotype Genotype 6	7 Participants n=5 Participants
Prior HCV Treatment History Treatment-naive	110 Participants n=5 Participants
Prior HCV Treatment History Treatment-experienced	50 Participants n=5 Participants
HCV Ribonucleic Acid (RNA) Level	6.16 log₁₀ IU/mL STANDARD_DEVIATION 0.74 • n=5 Participants
Human Immunodeficiency Virus (HIV) Co-infection Status Hepatitis C infection only	160 Participants n=5 Participants
Human Immunodeficiency Virus (HIV) Co-infection Status HCV / HIV co-infection	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks after the last actual dose of study drug, Week 24 or Week 28 depending on the treatment regimen.

Population: All enrolled participants who received at least 1 dose of study drug. Backward imputation, where applicable, was used to impute missing data. Participants with missing data after backward imputation were counted as non-responders.

SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification (LLOQ; 15 IU/mL) 12 weeks after the last dose of study drug.

Outcome measures

Outcome measures
Measure	Glecaprevir/Pibrentasvir n=160 Participants Participants received oral glecaprevir/pibrentasvir 300 mg/120 mg once daily (QD) for 12 or 16 weeks. Participants received treatment for 12 weeks with the exception of treatment-experienced, genotype 3-infected participants who received treatment for 16 weeks.
Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)	99.4 percentage of participants Interval 98.2 to 100.0

SECONDARY outcome

Timeframe: 12 or 16 weeks depending on the treatment regimen

Population: All enrolled participants who received at least 1 dose of study drug.

On-treatment virologic failure was defined as meeting one of the following: * confirmed increase from nadir in HCV RNA (two consecutive HCV RNA measurements \> 1 log₁₀ IU/mL above nadir) at any time point during the treatment period; or * confirmed HCV RNA greater than or equal to 100 IU/mL after HCV RNA \< 15 IU/mL during the treatment period, or * HCV RNA ≥ 15 IU/mL at end of treatment with at least 6 weeks of treatment.

Outcome measures

Outcome measures
Measure	Glecaprevir/Pibrentasvir n=160 Participants Participants received oral glecaprevir/pibrentasvir 300 mg/120 mg once daily (QD) for 12 or 16 weeks. Participants received treatment for 12 weeks with the exception of treatment-experienced, genotype 3-infected participants who received treatment for 16 weeks.
Percentage of Participants With On-treatment Virologic Failure	0.0 percentage of participants Interval 0.0 to 2.3

SECONDARY outcome

Timeframe: From the end of treatment (Week 12 or 16) through 12 weeks after the last dose of study drug (Weeks 24 or 28 depending on the treatment regimen).

Population: All enrolled participants who received at least one dose of study drug, with HCV RNA \< 15 IU/mL at the end of treatment, at least one post-treatment HCV RNA value, and who completed the assigned treatment.

Post-treatment relapse was defined as confirmed HCV RNA greater than or equal to 15 IU/mL between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA levels \< 15 IU/mL at the end of treatment, excluding re-infection.

Outcome measures

Outcome measures
Measure	Glecaprevir/Pibrentasvir n=159 Participants Participants received oral glecaprevir/pibrentasvir 300 mg/120 mg once daily (QD) for 12 or 16 weeks. Participants received treatment for 12 weeks with the exception of treatment-experienced, genotype 3-infected participants who received treatment for 16 weeks.
Percentage of Participants With Post-treatment Relapse	0.6 percentage of participants Interval 0.1 to 3.5

SECONDARY outcome

Timeframe: 12 weeks after the last actual dose of study drug, Week 24 or Week 28 depending on the treatment regimen

Population: No HCV-HIV co-infected participants were enrolled in the study

SVR12 was defined as plasma HCV RNA level less than LLOQ (15 IU/mL) 12 weeks after the last dose of study drug.

Outcome measures

Outcome data not reported

Adverse Events

Glecaprevir/Pibrentasvir

Serious events: 5 serious events

Other events: 29 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Glecaprevir/Pibrentasvir n=160 participants at risk Participants received oral glecaprevir/pibrentasvir 300 mg/120 mg once daily (QD) for 12 or 16 weeks. Participants received treatment for 12 weeks with the exception of treatment-experienced, genotype 3-infected participants who received treatment for 16 weeks.
Gastrointestinal disorders UPPER GASTROINTESTINAL HAEMORRHAGE	0.62% 1/160 • Number of events 1 • From initiation of study drug through 30 days after last dose; up to 16 or 20 weeks depending on the treatment regimen.
Hepatobiliary disorders BILE DUCT STONE	0.62% 1/160 • Number of events 1 • From initiation of study drug through 30 days after last dose; up to 16 or 20 weeks depending on the treatment regimen.
Hepatobiliary disorders HEPATIC LESION	0.62% 1/160 • Number of events 1 • From initiation of study drug through 30 days after last dose; up to 16 or 20 weeks depending on the treatment regimen.
Infections and infestations LIVER ABSCESS	0.62% 1/160 • Number of events 1 • From initiation of study drug through 30 days after last dose; up to 16 or 20 weeks depending on the treatment regimen.
Psychiatric disorders DEPRESSION	0.62% 1/160 • Number of events 1 • From initiation of study drug through 30 days after last dose; up to 16 or 20 weeks depending on the treatment regimen.

Other adverse events

Other adverse events
Measure	Glecaprevir/Pibrentasvir n=160 participants at risk Participants received oral glecaprevir/pibrentasvir 300 mg/120 mg once daily (QD) for 12 or 16 weeks. Participants received treatment for 12 weeks with the exception of treatment-experienced, genotype 3-infected participants who received treatment for 16 weeks.
Infections and infestations UPPER RESPIRATORY TRACT INFECTION	11.9% 19/160 • Number of events 19 • From initiation of study drug through 30 days after last dose; up to 16 or 20 weeks depending on the treatment regimen.
Infections and infestations URINARY TRACT INFECTION	6.2% 10/160 • Number of events 10 • From initiation of study drug through 30 days after last dose; up to 16 or 20 weeks depending on the treatment regimen.

Additional Information

Global Medical Services

AbbVie

Phone: 800-633-9110

Email: [email protected]

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