Trial Outcomes & Findings for The Efficacy and Safety of ABT-493/ABT-530 in Adults With Chronic Hepatitis C Virus Genotype 4, 5, or 6 Infection (ENDURANCE-4) (NCT NCT02636595)

Results Overview

SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification \[\<LLOQ\]) 12 weeks after the last dose of study drug.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

121 participants

Primary outcome timeframe

12 weeks after the last actual dose of study drug

Results posted on

2021-07-13

Participant Flow

This study included a 35-day screening period.

Participant milestones

Participant milestones
Measure	ABT-493/ABT-530 ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks.
Overall Study STARTED	121
Overall Study COMPLETED	119
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	ABT-493/ABT-530 ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks.
Overall Study Lost to Follow-up	1
Overall Study Other	1

Baseline Characteristics

The Efficacy and Safety of ABT-493/ABT-530 in Adults With Chronic Hepatitis C Virus Genotype 4, 5, or 6 Infection (ENDURANCE-4)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ABT-493/ABT-530 n=121 Participants ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks.
Age, Continuous	52.66 years STANDARD_DEVIATION 10.95 • n=5 Participants
Sex: Female, Male Female	44 Participants n=5 Participants
Sex: Female, Male Male	77 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks after the last actual dose of study drug

Population: Intent-to-treat (ITT) population: all participants who received at least 1 dose of study drug; participants with missing data after backwards imputation were imputed as nonresponders.

SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification \[\<LLOQ\]) 12 weeks after the last dose of study drug.

Outcome measures

Outcome measures
Measure	ABT-493/ABT-530 n=121 Participants ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks.
Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)	99.2 percentage of participants Interval 97.6 to 100.0

SECONDARY outcome

Timeframe: Treatment weeks 1, 2, 4, 8, and 12 (end of treatment) or premature discontinuation from treatment

Population: All participants who received at least 1 dose of study drug (ITT population).

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

Outcome measures

Outcome measures
Measure	ABT-493/ABT-530 n=121 Participants ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks.
Percentage of Participants With On-treatment Virologic Failure	0 percentage of participants Interval 0.0 to 3.1

SECONDARY outcome

Timeframe: From the end of treatment through 12 weeks after the last dose of study drug

Population: All participants who received at least 1 dose of study drug, completed treatment, and had HCV RNA \<LLOQ at the final treatment visit.

Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA levels \< LLOQ at the end of treatment, excluding reinfection.

Outcome measures

Outcome measures
Measure	ABT-493/ABT-530 n=118 Participants ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks.
Percentage of Participants With Post-treatment Relapse	0 percentage of participants Interval 0.0 to 3.2

Adverse Events

ABT-493/ABT-530

Serious events: 1 serious events

Other events: 59 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	ABT-493/ABT-530 n=121 participants at risk ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks.
Nervous system disorders TRANSIENT ISCHAEMIC ATTACK	0.83% 1/121 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug (up to 16 weeks). TEAEs and TESAEs are defined as any AE or SAE with an onset date after the first dose of study drug until 30 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.

Other adverse events

Other adverse events
Measure	ABT-493/ABT-530 n=121 participants at risk ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks.
Gastrointestinal disorders DIARRHOEA	6.6% 8/121 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug (up to 16 weeks). TEAEs and TESAEs are defined as any AE or SAE with an onset date after the first dose of study drug until 30 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Gastrointestinal disorders NAUSEA	9.9% 12/121 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug (up to 16 weeks). TEAEs and TESAEs are defined as any AE or SAE with an onset date after the first dose of study drug until 30 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
General disorders ASTHENIA	9.1% 11/121 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug (up to 16 weeks). TEAEs and TESAEs are defined as any AE or SAE with an onset date after the first dose of study drug until 30 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
General disorders FATIGUE	17.4% 21/121 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug (up to 16 weeks). TEAEs and TESAEs are defined as any AE or SAE with an onset date after the first dose of study drug until 30 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Nervous system disorders HEADACHE	20.7% 25/121 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug (up to 16 weeks). TEAEs and TESAEs are defined as any AE or SAE with an onset date after the first dose of study drug until 30 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Skin and subcutaneous tissue disorders PRURITUS	7.4% 9/121 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug (up to 16 weeks). TEAEs and TESAEs are defined as any AE or SAE with an onset date after the first dose of study drug until 30 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.

Additional Information

Global Medical Services

AbbVie

Phone: 800-633-9110

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