Trial Outcomes & Findings for A Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Subjects With Genotype 1 Infection (NCT NCT02604017)
NCT ID: NCT02604017
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. The primary efficacy endpoint was noninferiority of the percentage of participants who achieved SVR12 in the 12-week treatment group compared with the historical control rate for HCV GT1 subjects who are treatment-naïve or treated with pegylated-interferon alfa-2a or alfa-2b and ribavirin (pegIFN/RBV).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
703 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 for 12 Weeks
ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks.
|
ABT-493/ABT-530 for 8 Weeks
ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 8 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
352
|
351
|
|
Overall Study
COMPLETED
|
346
|
343
|
|
Overall Study
NOT COMPLETED
|
6
|
8
|
Reasons for withdrawal
| Measure |
ABT-493/ABT-530 for 12 Weeks
ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks.
|
ABT-493/ABT-530 for 8 Weeks
ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 8 weeks.
|
|---|---|---|
|
Overall Study
Withdrew Consent
|
0
|
2
|
|
Overall Study
Lost to Follow-up
|
5
|
6
|
|
Overall Study
Other
|
1
|
0
|
Baseline Characteristics
A Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Subjects With Genotype 1 Infection
Baseline characteristics by cohort
| Measure |
ABT-493/ABT-530 for 12 Weeks
n=352 Participants
ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks.
|
ABT-493/ABT-530 for 8 Weeks
n=351 Participants
ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 8 weeks.
|
Total
n=703 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
50.27 years
STANDARD_DEVIATION 11.62 • n=5 Participants
|
51.58 years
STANDARD_DEVIATION 11.90 • n=7 Participants
|
50.93 years
STANDARD_DEVIATION 11.77 • n=5 Participants
|
|
Sex: Female, Male
Female
|
176 Participants
n=5 Participants
|
184 Participants
n=7 Participants
|
360 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
176 Participants
n=5 Participants
|
167 Participants
n=7 Participants
|
343 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeks after the last actual dose of study drugPopulation: All participants in the ITT population who were mono-infected HCV GT1, DAA-naïve; 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. The primary efficacy endpoint was noninferiority of the percentage of participants who achieved SVR12 in the 12-week treatment group compared with the historical control rate for HCV GT1 subjects who are treatment-naïve or treated with pegylated-interferon alfa-2a or alfa-2b and ribavirin (pegIFN/RBV).
Outcome measures
| Measure |
ABT-493/ABT-530 for 12 Weeks
n=332 Participants
ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks.
|
ABT-493/ABT-530 for 8 Weeks
ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 8 weeks.
|
|---|---|---|
|
Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) in Mono-infected Hepatitis C Virus Genotype 1 (HCV GT1), Direct-acting Antiviral Agent (DAA) Naïve Participants in the 12-Week Treatment Arm
|
99.7 percentage of participants
|
—
|
PRIMARY outcome
Timeframe: 12 weeks after last actual dose of study drugPopulation: All participants in the ITT population who were mono-infected HCV GT1 DAA-naïve (excluding those who discontinued/experienced virologic failure by Week 8 or had no HCV RNA value at Week 12 or later); participants with missing data after backwards imputation were imputed as nonresponders.
SVR12 was defined as plasma HCV RNA level \<LLOQ 12 weeks after the last dose of study drug. The primary efficacy endpoint was noninferiority of the percentage of mono-infected HCV GT1, DAA-naïve participants (excluding those who discontinued/experienced virologic failure by Week 8 or had no HCV RNA value at Week 12 or later) who achieved SVR12 in the 8-week treatment arm compared with the 12-week treatment arm.
Outcome measures
| Measure |
ABT-493/ABT-530 for 12 Weeks
n=331 Participants
ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks.
|
ABT-493/ABT-530 for 8 Weeks
n=332 Participants
ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 8 weeks.
|
|---|---|---|
|
Percentage of Participants With SVR12: Noninferiority of 8-Week Arm to 12-Week Arm in Mono-infected HCV GT1, DAA-Naïve Participants, Excluding Those Who Discontinued/Experienced Virologic Failure by Week 8 or Had No HCV RNA Value at Week 12 or Later
|
100.0 percentage of participants
Interval 98.9 to 100.0
|
100 percentage of participants
Interval 98.9 to 100.0
|
PRIMARY outcome
Timeframe: 12 weeks after the last actual dose of study drugPopulation: All participants in the ITT population who were mono-infected HCV GT1, DAA-naïve; participants with missing data after backwards imputation were imputed as nonresponders.
SVR12 was defined as plasma HCV RNA level \<LLOQ 12 weeks after the last dose of study drug. The primary efficacy endpoint was noninferiority of the percentage of mono-infected HCV GT1, DAA-naïve participants who achieved SVR12 in the 8-week treatment arm compared with the 12-week treatment arm.
Outcome measures
| Measure |
ABT-493/ABT-530 for 12 Weeks
n=332 Participants
ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks.
|
ABT-493/ABT-530 for 8 Weeks
n=335 Participants
ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 8 weeks.
|
|---|---|---|
|
Percentage of Participants With SVR12: Noninferiority of 8-Week Treatment Arm to 12-Week Treatment Arm in Mono-infected HCV GT1, DAA-Naïve Participants
|
99.7 percentage of participants
Interval 99.1 to 100.0
|
99.1 percentage of participants
Interval 98.1 to 100.0
|
SECONDARY outcome
Timeframe: 12 weeks after last actual dose of study drugPopulation: All participants in the ITT population who were mono-infected HCV GT1; participants with missing data after backwards imputation were imputed as nonresponders.
SVR12 was defined as plasma HCV RNA level \<LLOQ 12 weeks after the last dose of study drug.
Outcome measures
| Measure |
ABT-493/ABT-530 for 12 Weeks
n=334 Participants
ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks.
|
ABT-493/ABT-530 for 8 Weeks
n=336 Participants
ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 8 weeks.
|
|---|---|---|
|
Percentage of Participants With SVR12 in Mono-infected HCV GT1 Participants
|
99.7 percentage of participants
Interval 98.3 to 99.9
|
99.1 percentage of participants
Interval 97.4 to 99.7
|
SECONDARY outcome
Timeframe: 12 weeks after last actual dose of study drugPopulation: All participants in the ITT population; participants with missing data after backwards imputation were imputed as nonresponders.
SVR12 was defined as plasma HCV RNA level \<LLOQ 12 weeks after the last dose of study drug.
Outcome measures
| Measure |
ABT-493/ABT-530 for 12 Weeks
n=352 Participants
ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks.
|
ABT-493/ABT-530 for 8 Weeks
n=351 Participants
ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 8 weeks.
|
|---|---|---|
|
Percentage of Participants With SVR12
|
99.7 percentage of participants
Interval 98.4 to 99.9
|
99.1 percentage of participants
Interval 97.5 to 99.7
|
SECONDARY outcome
Timeframe: 12 weeks after last actual dose of study drugPopulation: All participants in the ITT population who were co-infected HCV GT1/HIV-1; participants with missing data after backwards imputation were imputed as nonresponders.
SVR12 was defined as plasma HCV RNA level \<LLOQ 12 weeks after the last dose of study drug.
Outcome measures
| Measure |
ABT-493/ABT-530 for 12 Weeks
n=18 Participants
ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks.
|
ABT-493/ABT-530 for 8 Weeks
n=15 Participants
ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 8 weeks.
|
|---|---|---|
|
Percentage of Participants With SVR12 in Co-infected HCV GT1/Human Immunodeficiency Virus Type 1 (HIV-1) Participants
|
100.0 percentage of participants
Interval 82.4 to 100.0
|
100.0 percentage of participants
Interval 79.6 to 100.0
|
SECONDARY outcome
Timeframe: 12 weeks after last actual dose of study drugPopulation: All participants in the ITT population who were HCV GT1-infected, prior SOF-treatment experienced; participants with missing data after backwards imputation were imputed as nonresponders.
SVR12 was defined as plasma HCV RNA level \<LLOQ 12 weeks after the last dose of study drug.
Outcome measures
| Measure |
ABT-493/ABT-530 for 12 Weeks
n=2 Participants
ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks.
|
ABT-493/ABT-530 for 8 Weeks
n=1 Participants
ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 8 weeks.
|
|---|---|---|
|
Percentage of Participants With SVR12 in HCV GT1-infected, Prior Sofosbuvir (SOF) Treatment-Experienced Participants
|
100.0 percentage of participants
Interval 34.2 to 100.0
|
100.0 percentage of participants
Interval 20.7 to 100.0
|
SECONDARY outcome
Timeframe: Treatment Weeks 1, 2, 4, 8 (end of treatment for 8-week treatment arm), and 12 (end of treatment for 12-week treatment arm) or premature discontinuation from treatmentPopulation: 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 for 12 Weeks
n=352 Participants
ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks.
|
ABT-493/ABT-530 for 8 Weeks
n=351 Participants
ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 8 weeks.
|
|---|---|---|
|
Percentage of Participants With On-treatment Virologic Failure
|
0.0 percentage of particpants
Interval 0.0 to 1.1
|
0.3 percentage of particpants
Interval 0.1 to 1.6
|
SECONDARY outcome
Timeframe: Treatment Weeks 1, 2, 4, 8 (end of treatment for 8-week treatment arm), and 12 (end of treatment for 12-week treatment arm) or premature discontinuation from treatmentPopulation: All participants in the ITT population who were mono-infected HCV GT1, DAA-naïve.
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 for 12 Weeks
n=332 Participants
ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks.
|
ABT-493/ABT-530 for 8 Weeks
n=335 Participants
ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 8 weeks.
|
|---|---|---|
|
Percentage of Participants With On-treatment Virologic Failure in Mono-infected HCV GT1, DAA-Naïve Participants
|
0.0 percentage of participants
Interval 0.0 to 1.1
|
0.3 percentage of participants
Interval 0.1 to 1.7
|
SECONDARY outcome
Timeframe: From the end of treatment through 12 weeks after the last dose of study drugPopulation: 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 for 12 Weeks
n=352 Participants
ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks.
|
ABT-493/ABT-530 for 8 Weeks
n=349 Participants
ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 8 weeks.
|
|---|---|---|
|
Percentage of Participants With Post-treatment Relapse
|
0.0 percentage of participants
Interval 0.0 to 1.1
|
0.0 percentage of participants
Interval 0.0 to 1.1
|
SECONDARY outcome
Timeframe: From the end of treatment through 12 weeks after the last dose of study drugPopulation: All participants in the ITT population who were mono-infected HCV GT1, DAA-naïve, 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 for 12 Weeks
n=332 Participants
ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks.
|
ABT-493/ABT-530 for 8 Weeks
n=333 Participants
ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 8 weeks.
|
|---|---|---|
|
Percentage of Participants With Post-treatment Relapse in Mono-infected HCV GT1, DAA-Naïve Participants
|
0.0 percentage of participants
Interval 0.0 to 1.1
|
0.0 percentage of participants
Interval 0.0 to 1.1
|
Adverse Events
ABT-493/ABT-530 for 12 Weeks
Serious events: 4 serious events
Other events: 130 other events
Deaths: 0 deaths
ABT-493/ABT-530 for 8 Weeks
Serious events: 5 serious events
Other events: 133 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ABT-493/ABT-530 for 12 Weeks
n=352 participants at risk
ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks.
|
ABT-493/ABT-530 for 8 Weeks
n=351 participants at risk
ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 8 weeks.
|
|---|---|---|
|
Cardiac disorders
ANGINA UNSTABLE
|
0.00%
0/352 • 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 or worsening 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.
|
0.28%
1/351 • 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 or worsening 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.
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
0.28%
1/352 • 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 or worsening 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.
|
0.00%
0/351 • 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 or worsening 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
IRRITABLE BOWEL SYNDROME
|
0.28%
1/352 • 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 or worsening 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.
|
0.00%
0/351 • 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 or worsening 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
BRONCHITIS
|
0.28%
1/352 • 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 or worsening 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.
|
0.00%
0/351 • 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 or worsening 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.
|
|
Injury, poisoning and procedural complications
ALCOHOL POISONING
|
0.28%
1/352 • 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 or worsening 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.
|
0.00%
0/351 • 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 or worsening 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.
|
|
Injury, poisoning and procedural complications
ARTERIAL INJURY
|
0.00%
0/352 • 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 or worsening 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.
|
0.28%
1/351 • 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 or worsening 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.
|
|
Injury, poisoning and procedural complications
RADIUS FRACTURE
|
0.00%
0/352 • 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 or worsening 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.
|
0.28%
1/351 • 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 or worsening 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.
|
|
Injury, poisoning and procedural complications
TOXICITY TO VARIOUS AGENTS
|
0.28%
1/352 • 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 or worsening 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.
|
0.00%
0/351 • 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 or worsening 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)
UTERINE LEIOMYOMA
|
0.00%
0/352 • 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 or worsening 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.
|
0.28%
1/351 • 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 or worsening 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
TRANSIENT ISCHAEMIC ATTACK
|
0.00%
0/352 • 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 or worsening 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.
|
0.28%
1/351 • 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 or worsening 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
SUICIDE ATTEMPT
|
0.00%
0/352 • 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 or worsening 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.
|
0.28%
1/351 • 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 or worsening 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
PNEUMONIA ASPIRATION
|
0.28%
1/352 • 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 or worsening 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.
|
0.00%
0/351 • 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 or worsening 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 for 12 Weeks
n=352 participants at risk
ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks.
|
ABT-493/ABT-530 for 8 Weeks
n=351 participants at risk
ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 8 weeks.
|
|---|---|---|
|
Gastrointestinal disorders
NAUSEA
|
8.2%
29/352 • 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 or worsening 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.
|
5.4%
19/351 • 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 or worsening 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
|
12.2%
43/352 • 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 or worsening 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.
|
8.8%
31/351 • 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 or worsening 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
NASOPHARYNGITIS
|
8.8%
31/352 • 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 or worsening 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.
|
6.3%
22/351 • 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 or worsening 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
|
17.6%
62/352 • 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 or worsening 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.
|
19.4%
68/351 • 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 or worsening 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
INSOMNIA
|
4.3%
15/352 • 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 or worsening 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.
|
6.0%
21/351 • 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 or worsening 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
|
4.8%
17/352 • 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 or worsening 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.
|
5.7%
20/351 • 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 or worsening 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
Global Medical Services
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