Trial Outcomes & Findings for A Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Adults With Chronic Hepatitis C Virus Genotype 1, 2, 4, 5 or 6 Infection and Compensated Cirrhosis (NCT NCT02642432)

NCT ID: NCT02642432

Last Updated: 2021-07-13

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: 146 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

Measure	ABT-493/ABT-530 ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks.
Overall Study STARTED	146
Overall Study COMPLETED	138
Overall Study NOT COMPLETED	8

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 Adverse Event	2
Overall Study Withdrew Consent	1
Overall Study Lost to Follow-up	2
Overall Study Other	3

Baseline Characteristics

A Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Adults With Chronic Hepatitis C Virus Genotype 1, 2, 4, 5 or 6 Infection and Compensated Cirrhosis

Baseline characteristics by cohort

Measure	ABT-493/ABT-530 n=146 Participants ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks.
Age, Continuous	60.12 years STANDARD_DEVIATION 10.43 • n=5 Participants
Sex: Female, Male Female	56 Participants n=5 Participants
Sex: Female, Male Male	90 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

Measure	ABT-493/ABT-530 n=146 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)	99.3 percentage of participants Interval 98.0 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

Measure	ABT-493/ABT-530 n=146 Participants ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks.
Percentage of Participants With On-treatment Virologic Failure	0.0 percentage of participants Interval 0.0 to 2.6

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

Measure	ABT-493/ABT-530 n=144 Participants ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks.
Percentage of Participants With Post-treatment Relapse	0.7 percentage of participants Interval 0.1 to 3.8

Adverse Events

ABT-493/ABT-530

Serious events: 11 serious events

Other events: 63 other events

Deaths: 0 deaths

Serious adverse events

Measure	ABT-493/ABT-530 n=146 participants at risk ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks.
Gastrointestinal disorders GASTRIC ULCER	0.68% 1/146 • 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 event with an onset date that is 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 OESOPHAGEAL VARICES HAEMORRHAGE	0.68% 1/146 • 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 event with an onset date that is 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.
Infections and infestations ENDOPHTHALMITIS	0.68% 1/146 • 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 event with an onset date that is 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.
Infections and infestations RECTAL ABSCESS	0.68% 1/146 • 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 event with an onset date that is 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.
Infections and infestations URINARY TRACT INFECTION	0.68% 1/146 • 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 event with an onset date that is 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.
Investigations TUMOUR MARKER INCREASED	0.68% 1/146 • 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 event with an onset date that is 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.
Metabolism and nutrition disorders HYPERGLYCAEMIA	0.68% 1/146 • 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 event with an onset date that is 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.
Metabolism and nutrition disorders HYPOGLYCAEMIA	0.68% 1/146 • 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 event with an onset date that is 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) HEPATOCELLULAR CARCINOMA	1.4% 2/146 • 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 event with an onset date that is 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 SYNCOPE	0.68% 1/146 • 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 event with an onset date that is 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.
Psychiatric disorders ALCOHOL ABUSE	0.68% 1/146 • 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 event with an onset date that is 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.
Respiratory, thoracic and mediastinal disorders EPISTAXIS	0.68% 1/146 • 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 event with an onset date that is 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

Measure	ABT-493/ABT-530 n=146 participants at risk ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks.
Gastrointestinal disorders DIARRHOEA	8.2% 12/146 • 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 event with an onset date that is 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	8.9% 13/146 • 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 event with an onset date that is 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	18.5% 27/146 • 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 event with an onset date that is 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.
Infections and infestations URINARY TRACT INFECTION	6.2% 9/146 • 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 event with an onset date that is 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	13.7% 20/146 • 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 event with an onset date that is 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	9.6% 14/146 • 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 event with an onset date that is 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

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