Trial Outcomes & Findings for Study to Evaluate Adverse Events and Change in Disease Activity in Adult and Adolescent Participants With Acute Hepatitis C Virus (HCV) Infection on Treatment With Oral Tablets of Glecaprevir (GLE)/Pibrentasvir (PIB) (NCT NCT04903626)

Last Updated: 2025-04-06

Results Overview

SVR12 is defined as the hepatitis C virus (HCV) ribonucleic acid (RNA) level less than the lower limit of quantification (\< LLOQ) 12 weeks after the last dose of study treatment. Efficacy was demonstrated if the lower bound of the 2-sided 95% CI for the percentage of participants achieving SVR12 was greater than 90.5%.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

286 participants

Primary outcome timeframe

12 weeks after last dose of study treatment (Week 20)

Results posted on

2025-04-06

Participant Flow

Participant milestones

Participant milestones
Measure	Glecaprevir/Pibrentasvir Participants treated once daily (QD) with glecaprevir/pibrentasvir 300 mg/120 mg for 8 weeks.
Overall Study STARTED	286
Overall Study COMPLETED	278
Overall Study NOT COMPLETED	8

Reasons for withdrawal

Reasons for withdrawal
Measure	Glecaprevir/Pibrentasvir Participants treated once daily (QD) with glecaprevir/pibrentasvir 300 mg/120 mg for 8 weeks.
Overall Study Lost to Follow-up	6
Overall Study Withdrawal by Subject	1
Overall Study Other, Not Specified	1

Baseline Characteristics

Study to Evaluate Adverse Events and Change in Disease Activity in Adult and Adolescent Participants With Acute Hepatitis C Virus (HCV) Infection on Treatment With Oral Tablets of Glecaprevir (GLE)/Pibrentasvir (PIB)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Glecaprevir/Pibrentasvir n=286 Participants Participants treated QD with glecaprevir/pibrentasvir 300 mg/120 mg for 8 weeks.
Age, Continuous	43.7 years STANDARD_DEVIATION 11.71 • n=5 Participants
Sex: Female, Male Female	31 Participants n=5 Participants
Sex: Female, Male Male	255 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	76 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	210 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race/Ethnicity, Customized White	246 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	30 Participants n=5 Participants
Race/Ethnicity, Customized Asian	7 Participants n=5 Participants
Race/Ethnicity, Customized Multiple	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks after last dose of study treatment (Week 20)

Population: ITT Population: all enrolled participants who received at least 1 dose of study treatment.

Outcome measures

Outcome measures
Measure	Glecaprevir/Pibrentasvir n=286 Participants Participants treated QD with glecaprevir/pibrentasvir 300 mg/120 mg for 8 weeks.
Percentage of Participants Achieving Sustained Virologic Response 12 Weeks Post-treatment (SVR12) in the Intention-to-Treat (ITT) Population	96.2 percentage of participants Interval 93.2 to 97.8

SECONDARY outcome

Timeframe: 12 weeks after last dose of study treatment (Week 20)

Population: mITT-VF population: all enrolled participants who received at least one dose of study treatment, excluding those who did not achieve SVR12 for reasons other than virologic failure (i.e., those with HCV reinfection, those who did not achieve SVR12 due to early premature discontinuation of study treatment, and those who were missing HCV RNA data in the SVR12 window after backward imputation).

SVR12 is defined as the HCV RNA level \< LLOQ 12 weeks after the last dose of study treatment. Efficacy was demonstrated if the lower bound of the 2-sided 95% CI for the percentage of participants achieving SVR12 was greater than 92.7%. This efficacy analysis was performed only if success was demonstrated for the primary efficacy analysis, following a fixed-sequence testing procedure.

Outcome measures

Outcome measures
Measure	Glecaprevir/Pibrentasvir n=275 Participants Participants treated QD with glecaprevir/pibrentasvir 300 mg/120 mg for 8 weeks.
Percentage of Participants Achieving SVR12 in the Modified ITT-Virologic Failure (mITT-VF) Population	100 percentage of participants Interval 98.6 to 100.0

SECONDARY outcome

Timeframe: Up to Week 8

Population: ITT Population: all enrolled participants who received at least 1 dose of study treatment.

On-treatment virologic failure is defined as confirmed increase in HCV RNA of \> 1 log\^10 IU/mL above the lowest post-baseline value during treatment, confirmed HCV RNA \>= 100 IU/mL after HCV RNA \< LLOQ during treatment, or HCV RNA \>= LLOQ at the end of treatment (EOT) with at least 6 weeks of treatment.

Outcome measures

Outcome measures
Measure	Glecaprevir/Pibrentasvir n=286 Participants Participants treated QD with glecaprevir/pibrentasvir 300 mg/120 mg for 8 weeks.
Percentage of Participants With On-Treatment Virologic Failure in the ITT Population	0 percentage of participants Interval 0.0 to 1.3

SECONDARY outcome

Timeframe: Up to 12 weeks after the last dose of study treatment (Week 20)

Population: ITT Population: all enrolled participants who received at least 1 dose of study treatment. Participants who completed treatment as planned with HCV RNA \< LLOQ at the EOT and with at least 1 PT HCV RNA value.

PT relapse is defined as confirmed HCV RNA \>= LLOQ between the EOT and 12 weeks after the last dose of study treatment among participants who completed treatment as planned (study treatment duration \>= 52 days) with HCV RNA \< LLOQ at the EOT and with at least 1 PT HCV RNA value, excluding cases of reinfection.

Outcome measures

Outcome measures
Measure	Glecaprevir/Pibrentasvir n=278 Participants Participants treated QD with glecaprevir/pibrentasvir 300 mg/120 mg for 8 weeks.
Percentage of Participants With Post-Treatment (PT) Relapse in the ITT Population	0 percentage of participants Interval 0.0 to 1.4

SECONDARY outcome

Timeframe: Up to 12 weeks after the last dose of study treatment (Week 20)

Population: ITT Population: all enrolled participants who received at least 1 dose of study treatment.

PT reinfection is defined as confirmed HCV RNA \>= LLOQ in the PT period in a participant who had HCV RNA \< LLOQ at the final treatment visit, along with the PT detection of a different HCV genotype, subtype, or clade compared with baseline.

Outcome measures

Outcome measures
Measure	Glecaprevir/Pibrentasvir n=286 Participants Participants treated QD with glecaprevir/pibrentasvir 300 mg/120 mg for 8 weeks.
Percentage of Participants With PT Reinfection With HCV in the ITT Population	0.7 percentage of participants Interval 0.2 to 2.5

Adverse Events

Glecaprevir/Pibrentasvir

Serious events: 12 serious events

Other events: 49 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Glecaprevir/Pibrentasvir n=286 participants at risk Participants treated QD with glecaprevir/pibrentasvir 300 mg/120 mg for 8 weeks.
Gastrointestinal disorders ENTEROCOLITIS	0.35% 1/286 • Number of events 1 • Screening (Day -30) through Post-treatment Week 12 (Week 20) or premature discontinuation.
Gastrointestinal disorders ILEUS	0.35% 1/286 • Number of events 1 • Screening (Day -30) through Post-treatment Week 12 (Week 20) or premature discontinuation.
Gastrointestinal disorders RECTAL PERFORATION	0.35% 1/286 • Number of events 1 • Screening (Day -30) through Post-treatment Week 12 (Week 20) or premature discontinuation.
Infections and infestations ABSCESS LIMB	0.70% 2/286 • Number of events 2 • Screening (Day -30) through Post-treatment Week 12 (Week 20) or premature discontinuation.
Infections and infestations BACTERAEMIA	0.35% 1/286 • Number of events 1 • Screening (Day -30) through Post-treatment Week 12 (Week 20) or premature discontinuation.
Infections and infestations CELLULITIS	0.35% 1/286 • Number of events 1 • Screening (Day -30) through Post-treatment Week 12 (Week 20) or premature discontinuation.
Infections and infestations MONKEYPOX	0.35% 1/286 • Number of events 1 • Screening (Day -30) through Post-treatment Week 12 (Week 20) or premature discontinuation.
Infections and infestations PERIORBITAL CELLULITIS	0.35% 1/286 • Number of events 1 • Screening (Day -30) through Post-treatment Week 12 (Week 20) or premature discontinuation.
Infections and infestations SEPTIC EMBOLUS	0.35% 1/286 • Number of events 1 • Screening (Day -30) through Post-treatment Week 12 (Week 20) or premature discontinuation.
Infections and infestations STAPHYLOCOCCAL INFECTION	0.35% 1/286 • Number of events 1 • Screening (Day -30) through Post-treatment Week 12 (Week 20) or premature discontinuation.
Injury, poisoning and procedural complications ALCOHOL POISONING	0.35% 1/286 • Number of events 1 • Screening (Day -30) through Post-treatment Week 12 (Week 20) or premature discontinuation.
Injury, poisoning and procedural complications ANKLE FRACTURE	0.35% 1/286 • Number of events 1 • Screening (Day -30) through Post-treatment Week 12 (Week 20) or premature discontinuation.
Injury, poisoning and procedural complications CRANIOFACIAL FRACTURE	0.35% 1/286 • Number of events 1 • Screening (Day -30) through Post-treatment Week 12 (Week 20) or premature discontinuation.
Injury, poisoning and procedural complications OVERDOSE	0.35% 1/286 • Number of events 1 • Screening (Day -30) through Post-treatment Week 12 (Week 20) or premature discontinuation.
Injury, poisoning and procedural complications RIB FRACTURE	0.35% 1/286 • Number of events 1 • Screening (Day -30) through Post-treatment Week 12 (Week 20) or premature discontinuation.
Injury, poisoning and procedural complications ROAD TRAFFIC ACCIDENT	0.35% 1/286 • Number of events 1 • Screening (Day -30) through Post-treatment Week 12 (Week 20) or premature discontinuation.
Injury, poisoning and procedural complications TOXICITY TO VARIOUS AGENTS	0.35% 1/286 • Number of events 1 • Screening (Day -30) through Post-treatment Week 12 (Week 20) or premature discontinuation.
Metabolism and nutrition disorders HYPOGLYCAEMIA	0.35% 1/286 • Number of events 1 • Screening (Day -30) through Post-treatment Week 12 (Week 20) or premature discontinuation.
Psychiatric disorders DRUG ABUSE	0.35% 1/286 • Number of events 1 • Screening (Day -30) through Post-treatment Week 12 (Week 20) or premature discontinuation.
Psychiatric disorders SUBSTANCE-INDUCED PSYCHOTIC DISORDER	0.35% 1/286 • Number of events 1 • Screening (Day -30) through Post-treatment Week 12 (Week 20) or premature discontinuation.
Reproductive system and breast disorders PELVIC PAIN	0.35% 1/286 • Number of events 1 • Screening (Day -30) through Post-treatment Week 12 (Week 20) or premature discontinuation.

Other adverse events

Other adverse events
Measure	Glecaprevir/Pibrentasvir n=286 participants at risk Participants treated QD with glecaprevir/pibrentasvir 300 mg/120 mg for 8 weeks.
Gastrointestinal disorders DIARRHOEA	6.3% 18/286 • Number of events 18 • Screening (Day -30) through Post-treatment Week 12 (Week 20) or premature discontinuation.
General disorders FATIGUE	6.6% 19/286 • Number of events 19 • Screening (Day -30) through Post-treatment Week 12 (Week 20) or premature discontinuation.
Infections and infestations NASOPHARYNGITIS	5.2% 15/286 • Number of events 17 • Screening (Day -30) through Post-treatment Week 12 (Week 20) or premature discontinuation.

Additional Information

Global Medical Services

AbbVie

Phone: 800-633-9110

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place