Trial Outcomes & Findings for A Study to Evaluate the Safety and Effect of Treatment With Experimental Antiviral Drugs in Combination With Peginterferon Alpha-2a and Ribavirin in People With Hepatitis C Virus Who Did Not Respond to Treatment in a Previous AbbVie/Abbott Combination Study (NCT NCT01609933)
NCT ID: NCT01609933
Last Updated: 2018-06-19
Results Overview
SVR12 was defined as hepatitis C virus ribonucleic acid (HCV RNA) level less than lower limit of quantitation \[LLOQ\] 12 weeks after the last dose of study drugs (DAAs plus pegIFN alpha-2a and RBV).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
32 participants
Primary outcome timeframe
12 weeks after last dose of study drugs (DAAs plus pegIFN alpha-2a and RBV); approximately 36 weeks after subject's initial dose of study drug in Substudy 1
Results posted on
2018-06-19
Participant Flow
The study included a 42-day screening period.
Participant milestones
| Measure |
2-DAA + PegIFN/RBV
2-direct-acting antiviral (2-DAA: ABT-450 \[paritaprevir\] 200 mg once daily \[QD\], ritonavir 100 mg QD, ABT-267 \[ombitasvir\] 25 mg QD) plus pegylated interferon alpha-2a (pegIFN) 180 mcg once weekly and Ribavirin (RBV) weight-based dosing, 1000 to 1200 mg divided twice daily (BID) for 24 weeks and followed by pegIFN and RBV alone for an additional 24 weeks.
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|---|---|
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Overall Study
STARTED
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32
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Overall Study
COMPLETED
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28
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Overall Study
NOT COMPLETED
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4
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Reasons for withdrawal
| Measure |
2-DAA + PegIFN/RBV
2-direct-acting antiviral (2-DAA: ABT-450 \[paritaprevir\] 200 mg once daily \[QD\], ritonavir 100 mg QD, ABT-267 \[ombitasvir\] 25 mg QD) plus pegylated interferon alpha-2a (pegIFN) 180 mcg once weekly and Ribavirin (RBV) weight-based dosing, 1000 to 1200 mg divided twice daily (BID) for 24 weeks and followed by pegIFN and RBV alone for an additional 24 weeks.
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|---|---|
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Overall Study
Adverse Event
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1
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Overall Study
Withdrawal by Subject
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3
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Baseline Characteristics
A Study to Evaluate the Safety and Effect of Treatment With Experimental Antiviral Drugs in Combination With Peginterferon Alpha-2a and Ribavirin in People With Hepatitis C Virus Who Did Not Respond to Treatment in a Previous AbbVie/Abbott Combination Study
Baseline characteristics by cohort
| Measure |
2-DAA + PegIFN/RBV
n=32 Participants
2-direct-acting antiviral (2-DAA: ABT-450 \[paritaprevir\] 200 mg once daily \[QD\], ritonavir 100 mg QD, ABT-267 \[ombitasvir\] 25 mg QD) plus pegylated interferon alpha-2a (pegIFN) 180 mcg once weekly and Ribavirin (RBV) weight-based dosing, 1000 to 1200 mg divided twice daily (BID) for 24 weeks and followed by pegIFN and RBV alone for an additional 24 weeks.
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|---|---|
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Age, Continuous
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51.4 years
STANDARD_DEVIATION 9.77 • n=93 Participants
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Sex: Female, Male
Female
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7 Participants
n=93 Participants
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Sex: Female, Male
Male
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25 Participants
n=93 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=93 Participants
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Race (NIH/OMB)
Asian
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0 Participants
n=93 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=93 Participants
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Race (NIH/OMB)
Black or African American
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2 Participants
n=93 Participants
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Race (NIH/OMB)
White
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30 Participants
n=93 Participants
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Race (NIH/OMB)
More than one race
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0 Participants
n=93 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=93 Participants
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PRIMARY outcome
Timeframe: 12 weeks after last dose of study drugs (DAAs plus pegIFN alpha-2a and RBV); approximately 36 weeks after subject's initial dose of study drug in Substudy 1Population: ITT population
SVR12 was defined as hepatitis C virus ribonucleic acid (HCV RNA) level less than lower limit of quantitation \[LLOQ\] 12 weeks after the last dose of study drugs (DAAs plus pegIFN alpha-2a and RBV).
Outcome measures
| Measure |
2-DAA + PegIFN/RBV
n=32 Participants
2-direct-acting antiviral (2-DAA: ABT-450 \[paritaprevir\] 200 mg once daily \[QD\], ritonavir 100 mg QD, ABT-267 \[ombitasvir\] 25 mg QD) plus pegylated interferon alpha-2a (pegIFN) 180 mcg once weekly and Ribavirin (RBV) weight-based dosing, 1000 to 1200 mg divided twice daily (BID) for 24 weeks followed by pegIFN and RBV alone for an additional 24 weeks.
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|---|---|
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Percentage of Participants Achieving Sustained Virologic Response 12 Weeks Post Treatment (SVR12)
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81.3 percentage of participants
Interval 64.7 to 91.1
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SECONDARY outcome
Timeframe: 24 weeks after last dose of study drugs (DAAs plus pegIFN alpha-2a and RBV); approximately 48 weeks after subject's initial dose of study drug in Substudy 1Population: ITT population
SVR24 was defined as HCV RNA level less than the LLOQ 24 weeks after the last dose of study drugs (DAAs plus pegIFN alpha-2a and RBV).
Outcome measures
| Measure |
2-DAA + PegIFN/RBV
n=32 Participants
2-direct-acting antiviral (2-DAA: ABT-450 \[paritaprevir\] 200 mg once daily \[QD\], ritonavir 100 mg QD, ABT-267 \[ombitasvir\] 25 mg QD) plus pegylated interferon alpha-2a (pegIFN) 180 mcg once weekly and Ribavirin (RBV) weight-based dosing, 1000 to 1200 mg divided twice daily (BID) for 24 weeks followed by pegIFN and RBV alone for an additional 24 weeks.
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|---|---|
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Percentage of Participants Achieving Virologic Response 24 Weeks Post Treatment (SVR24)
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78.1 percentage of participants
Interval 61.2 to 89.0
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SECONDARY outcome
Timeframe: Treatment weeks 4 through 12 of Substudy 1 (DAAs plus pegIFN alpha-2a and RBV)Population: ITT Population
eRVR was defined as HCV RNA level \< LLOQ at Substudy 1 treatment weeks 4 through 12 without a confirmed HCV RNA \>= LLOQ
Outcome measures
| Measure |
2-DAA + PegIFN/RBV
n=32 Participants
2-direct-acting antiviral (2-DAA: ABT-450 \[paritaprevir\] 200 mg once daily \[QD\], ritonavir 100 mg QD, ABT-267 \[ombitasvir\] 25 mg QD) plus pegylated interferon alpha-2a (pegIFN) 180 mcg once weekly and Ribavirin (RBV) weight-based dosing, 1000 to 1200 mg divided twice daily (BID) for 24 weeks followed by pegIFN and RBV alone for an additional 24 weeks.
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|---|---|
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Percentage of Participants With Extended Rapid Virologic Response (eRVR)
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87.5 percentage of participants
Interval 71.9 to 95.0
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SECONDARY outcome
Timeframe: From first dose of study drug through 30 days after last dose of study drug (DAAs plus pegIFN alpha-2a and RBV) (up to 28 weeks).Population: Safety population (all subjects who received at least 1 dose of study drug)
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs/TESAEs) are defined as any event that began or worsened in severity after initiation of study drug through 30 days post-DAA dosing. For more details on AEs, see the AE section.
Outcome measures
| Measure |
2-DAA + PegIFN/RBV
n=32 Participants
2-direct-acting antiviral (2-DAA: ABT-450 \[paritaprevir\] 200 mg once daily \[QD\], ritonavir 100 mg QD, ABT-267 \[ombitasvir\] 25 mg QD) plus pegylated interferon alpha-2a (pegIFN) 180 mcg once weekly and Ribavirin (RBV) weight-based dosing, 1000 to 1200 mg divided twice daily (BID) for 24 weeks followed by pegIFN and RBV alone for an additional 24 weeks.
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|---|---|
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Number of Participants With Adverse Events
2-DAA TEAE
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29 participants
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Number of Participants With Adverse Events
2-DAA TESAE
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1 participants
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Adverse Events
2-DAA + PegIFN/RBV
Serious events: 1 serious events
Other events: 28 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
2-DAA + PegIFN/RBV
n=32 participants at risk
2-direct-acting antiviral (2-DAA: ABT-450 \[paritaprevir\] 200 mg once daily \[QD\], ritonavir 100 mg QD, ABT-267 \[ombitasvir\] 25 mg QD) plus pegylated interferon alpha-2a (pegIFN) 180 mcg once weekly and Ribavirin (RBV) weight-based dosing, 1000 to 1200 mg divided twice daily (BID) for 24 weeks and followed by pegIFN and RBV alone for an additional 24 weeks.
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|---|---|
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Cardiac disorders
MYOCARDIAL INFARCTION
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3.1%
1/32 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug through 30 days after the last dose of DAA (2-DAA + pegIFN alpha-2a and RBV) dosing (up to 28 weeks).
TEAEs and TESAEs are defined as any AE with an onset date that is after the first dose of study drug through 30 days after the last dose of DAAs (up to 28 weeks) and were collected whether elicited or spontaneously reported by the participant.
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Other adverse events
| Measure |
2-DAA + PegIFN/RBV
n=32 participants at risk
2-direct-acting antiviral (2-DAA: ABT-450 \[paritaprevir\] 200 mg once daily \[QD\], ritonavir 100 mg QD, ABT-267 \[ombitasvir\] 25 mg QD) plus pegylated interferon alpha-2a (pegIFN) 180 mcg once weekly and Ribavirin (RBV) weight-based dosing, 1000 to 1200 mg divided twice daily (BID) for 24 weeks and followed by pegIFN and RBV alone for an additional 24 weeks.
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|---|---|
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Blood and lymphatic system disorders
LYMPHOPENIA
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6.2%
2/32 • Number of events 2 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug through 30 days after the last dose of DAA (2-DAA + pegIFN alpha-2a and RBV) dosing (up to 28 weeks).
TEAEs and TESAEs are defined as any AE with an onset date that is after the first dose of study drug through 30 days after the last dose of DAAs (up to 28 weeks) and were collected whether elicited or spontaneously reported by the participant.
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Blood and lymphatic system disorders
NEUTROPENIA
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21.9%
7/32 • Number of events 10 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug through 30 days after the last dose of DAA (2-DAA + pegIFN alpha-2a and RBV) dosing (up to 28 weeks).
TEAEs and TESAEs are defined as any AE with an onset date that is after the first dose of study drug through 30 days after the last dose of DAAs (up to 28 weeks) and were collected whether elicited or spontaneously reported by the participant.
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Eye disorders
VISION BLURRED
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6.2%
2/32 • Number of events 3 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug through 30 days after the last dose of DAA (2-DAA + pegIFN alpha-2a and RBV) dosing (up to 28 weeks).
TEAEs and TESAEs are defined as any AE with an onset date that is after the first dose of study drug through 30 days after the last dose of DAAs (up to 28 weeks) and were collected whether elicited or spontaneously reported by the participant.
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Gastrointestinal disorders
ABDOMINAL PAIN UPPER
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9.4%
3/32 • Number of events 3 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug through 30 days after the last dose of DAA (2-DAA + pegIFN alpha-2a and RBV) dosing (up to 28 weeks).
TEAEs and TESAEs are defined as any AE with an onset date that is after the first dose of study drug through 30 days after the last dose of DAAs (up to 28 weeks) and were collected whether elicited or spontaneously reported by the participant.
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Gastrointestinal disorders
ANAL PRURITUS
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6.2%
2/32 • Number of events 2 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug through 30 days after the last dose of DAA (2-DAA + pegIFN alpha-2a and RBV) dosing (up to 28 weeks).
TEAEs and TESAEs are defined as any AE with an onset date that is after the first dose of study drug through 30 days after the last dose of DAAs (up to 28 weeks) and were collected whether elicited or spontaneously reported by the participant.
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Gastrointestinal disorders
DIARRHOEA
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18.8%
6/32 • Number of events 7 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug through 30 days after the last dose of DAA (2-DAA + pegIFN alpha-2a and RBV) dosing (up to 28 weeks).
TEAEs and TESAEs are defined as any AE with an onset date that is after the first dose of study drug through 30 days after the last dose of DAAs (up to 28 weeks) and were collected whether elicited or spontaneously reported by the participant.
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Gastrointestinal disorders
DRY MOUTH
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6.2%
2/32 • Number of events 2 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug through 30 days after the last dose of DAA (2-DAA + pegIFN alpha-2a and RBV) dosing (up to 28 weeks).
TEAEs and TESAEs are defined as any AE with an onset date that is after the first dose of study drug through 30 days after the last dose of DAAs (up to 28 weeks) and were collected whether elicited or spontaneously reported by the participant.
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Gastrointestinal disorders
NAUSEA
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28.1%
9/32 • Number of events 9 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug through 30 days after the last dose of DAA (2-DAA + pegIFN alpha-2a and RBV) dosing (up to 28 weeks).
TEAEs and TESAEs are defined as any AE with an onset date that is after the first dose of study drug through 30 days after the last dose of DAAs (up to 28 weeks) and were collected whether elicited or spontaneously reported by the participant.
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General disorders
ASTHENIA
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6.2%
2/32 • Number of events 2 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug through 30 days after the last dose of DAA (2-DAA + pegIFN alpha-2a and RBV) dosing (up to 28 weeks).
TEAEs and TESAEs are defined as any AE with an onset date that is after the first dose of study drug through 30 days after the last dose of DAAs (up to 28 weeks) and were collected whether elicited or spontaneously reported by the participant.
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General disorders
CHILLS
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9.4%
3/32 • Number of events 3 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug through 30 days after the last dose of DAA (2-DAA + pegIFN alpha-2a and RBV) dosing (up to 28 weeks).
TEAEs and TESAEs are defined as any AE with an onset date that is after the first dose of study drug through 30 days after the last dose of DAAs (up to 28 weeks) and were collected whether elicited or spontaneously reported by the participant.
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General disorders
FATIGUE
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34.4%
11/32 • Number of events 13 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug through 30 days after the last dose of DAA (2-DAA + pegIFN alpha-2a and RBV) dosing (up to 28 weeks).
TEAEs and TESAEs are defined as any AE with an onset date that is after the first dose of study drug through 30 days after the last dose of DAAs (up to 28 weeks) and were collected whether elicited or spontaneously reported by the participant.
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General disorders
FEELING ABNORMAL
|
6.2%
2/32 • Number of events 2 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug through 30 days after the last dose of DAA (2-DAA + pegIFN alpha-2a and RBV) dosing (up to 28 weeks).
TEAEs and TESAEs are defined as any AE with an onset date that is after the first dose of study drug through 30 days after the last dose of DAAs (up to 28 weeks) and were collected whether elicited or spontaneously reported by the participant.
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General disorders
INFLUENZA LIKE ILLNESS
|
18.8%
6/32 • Number of events 6 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug through 30 days after the last dose of DAA (2-DAA + pegIFN alpha-2a and RBV) dosing (up to 28 weeks).
TEAEs and TESAEs are defined as any AE with an onset date that is after the first dose of study drug through 30 days after the last dose of DAAs (up to 28 weeks) and were collected whether elicited or spontaneously reported by the participant.
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General disorders
PAIN
|
9.4%
3/32 • Number of events 4 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug through 30 days after the last dose of DAA (2-DAA + pegIFN alpha-2a and RBV) dosing (up to 28 weeks).
TEAEs and TESAEs are defined as any AE with an onset date that is after the first dose of study drug through 30 days after the last dose of DAAs (up to 28 weeks) and were collected whether elicited or spontaneously reported by the participant.
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General disorders
PYREXIA
|
12.5%
4/32 • Number of events 4 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug through 30 days after the last dose of DAA (2-DAA + pegIFN alpha-2a and RBV) dosing (up to 28 weeks).
TEAEs and TESAEs are defined as any AE with an onset date that is after the first dose of study drug through 30 days after the last dose of DAAs (up to 28 weeks) and were collected whether elicited or spontaneously reported by the participant.
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Hepatobiliary disorders
JAUNDICE
|
6.2%
2/32 • Number of events 2 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug through 30 days after the last dose of DAA (2-DAA + pegIFN alpha-2a and RBV) dosing (up to 28 weeks).
TEAEs and TESAEs are defined as any AE with an onset date that is after the first dose of study drug through 30 days after the last dose of DAAs (up to 28 weeks) and were collected whether elicited or spontaneously reported by the participant.
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Infections and infestations
BRONCHITIS
|
6.2%
2/32 • Number of events 3 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug through 30 days after the last dose of DAA (2-DAA + pegIFN alpha-2a and RBV) dosing (up to 28 weeks).
TEAEs and TESAEs are defined as any AE with an onset date that is after the first dose of study drug through 30 days after the last dose of DAAs (up to 28 weeks) and were collected whether elicited or spontaneously reported by the participant.
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|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
9.4%
3/32 • Number of events 3 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug through 30 days after the last dose of DAA (2-DAA + pegIFN alpha-2a and RBV) dosing (up to 28 weeks).
TEAEs and TESAEs are defined as any AE with an onset date that is after the first dose of study drug through 30 days after the last dose of DAAs (up to 28 weeks) and were collected whether elicited or spontaneously reported by the participant.
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Infections and infestations
VIRAL INFECTION
|
6.2%
2/32 • Number of events 2 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug through 30 days after the last dose of DAA (2-DAA + pegIFN alpha-2a and RBV) dosing (up to 28 weeks).
TEAEs and TESAEs are defined as any AE with an onset date that is after the first dose of study drug through 30 days after the last dose of DAAs (up to 28 weeks) and were collected whether elicited or spontaneously reported by the participant.
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Infections and infestations
VIRAL UPPER RESPIRATORY TRACT INFECTION
|
6.2%
2/32 • Number of events 2 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug through 30 days after the last dose of DAA (2-DAA + pegIFN alpha-2a and RBV) dosing (up to 28 weeks).
TEAEs and TESAEs are defined as any AE with an onset date that is after the first dose of study drug through 30 days after the last dose of DAAs (up to 28 weeks) and were collected whether elicited or spontaneously reported by the participant.
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Investigations
NEUTROPHIL COUNT DECREASED
|
9.4%
3/32 • Number of events 7 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug through 30 days after the last dose of DAA (2-DAA + pegIFN alpha-2a and RBV) dosing (up to 28 weeks).
TEAEs and TESAEs are defined as any AE with an onset date that is after the first dose of study drug through 30 days after the last dose of DAAs (up to 28 weeks) and were collected whether elicited or spontaneously reported by the participant.
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Investigations
WEIGHT DECREASED
|
6.2%
2/32 • Number of events 2 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug through 30 days after the last dose of DAA (2-DAA + pegIFN alpha-2a and RBV) dosing (up to 28 weeks).
TEAEs and TESAEs are defined as any AE with an onset date that is after the first dose of study drug through 30 days after the last dose of DAAs (up to 28 weeks) and were collected whether elicited or spontaneously reported by the participant.
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Investigations
WHITE BLOOD CELL COUNT DECREASED
|
15.6%
5/32 • Number of events 7 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug through 30 days after the last dose of DAA (2-DAA + pegIFN alpha-2a and RBV) dosing (up to 28 weeks).
TEAEs and TESAEs are defined as any AE with an onset date that is after the first dose of study drug through 30 days after the last dose of DAAs (up to 28 weeks) and were collected whether elicited or spontaneously reported by the participant.
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
6.2%
2/32 • Number of events 2 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug through 30 days after the last dose of DAA (2-DAA + pegIFN alpha-2a and RBV) dosing (up to 28 weeks).
TEAEs and TESAEs are defined as any AE with an onset date that is after the first dose of study drug through 30 days after the last dose of DAAs (up to 28 weeks) and were collected whether elicited or spontaneously reported by the participant.
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
9.4%
3/32 • Number of events 4 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug through 30 days after the last dose of DAA (2-DAA + pegIFN alpha-2a and RBV) dosing (up to 28 weeks).
TEAEs and TESAEs are defined as any AE with an onset date that is after the first dose of study drug through 30 days after the last dose of DAAs (up to 28 weeks) and were collected whether elicited or spontaneously reported by the participant.
|
|
Musculoskeletal and connective tissue disorders
MUSCLE SPASMS
|
6.2%
2/32 • Number of events 2 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug through 30 days after the last dose of DAA (2-DAA + pegIFN alpha-2a and RBV) dosing (up to 28 weeks).
TEAEs and TESAEs are defined as any AE with an onset date that is after the first dose of study drug through 30 days after the last dose of DAAs (up to 28 weeks) and were collected whether elicited or spontaneously reported by the participant.
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
6.2%
2/32 • Number of events 2 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug through 30 days after the last dose of DAA (2-DAA + pegIFN alpha-2a and RBV) dosing (up to 28 weeks).
TEAEs and TESAEs are defined as any AE with an onset date that is after the first dose of study drug through 30 days after the last dose of DAAs (up to 28 weeks) and were collected whether elicited or spontaneously reported by the participant.
|
|
Nervous system disorders
DISTURBANCE IN ATTENTION
|
9.4%
3/32 • Number of events 3 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug through 30 days after the last dose of DAA (2-DAA + pegIFN alpha-2a and RBV) dosing (up to 28 weeks).
TEAEs and TESAEs are defined as any AE with an onset date that is after the first dose of study drug through 30 days after the last dose of DAAs (up to 28 weeks) and were collected whether elicited or spontaneously reported by the participant.
|
|
Nervous system disorders
HEADACHE
|
43.8%
14/32 • Number of events 27 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug through 30 days after the last dose of DAA (2-DAA + pegIFN alpha-2a and RBV) dosing (up to 28 weeks).
TEAEs and TESAEs are defined as any AE with an onset date that is after the first dose of study drug through 30 days after the last dose of DAAs (up to 28 weeks) and were collected whether elicited or spontaneously reported by the participant.
|
|
Psychiatric disorders
ANXIETY
|
6.2%
2/32 • Number of events 2 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug through 30 days after the last dose of DAA (2-DAA + pegIFN alpha-2a and RBV) dosing (up to 28 weeks).
TEAEs and TESAEs are defined as any AE with an onset date that is after the first dose of study drug through 30 days after the last dose of DAAs (up to 28 weeks) and were collected whether elicited or spontaneously reported by the participant.
|
|
Psychiatric disorders
DEPRESSION
|
6.2%
2/32 • Number of events 2 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug through 30 days after the last dose of DAA (2-DAA + pegIFN alpha-2a and RBV) dosing (up to 28 weeks).
TEAEs and TESAEs are defined as any AE with an onset date that is after the first dose of study drug through 30 days after the last dose of DAAs (up to 28 weeks) and were collected whether elicited or spontaneously reported by the participant.
|
|
Psychiatric disorders
INSOMNIA
|
25.0%
8/32 • Number of events 10 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug through 30 days after the last dose of DAA (2-DAA + pegIFN alpha-2a and RBV) dosing (up to 28 weeks).
TEAEs and TESAEs are defined as any AE with an onset date that is after the first dose of study drug through 30 days after the last dose of DAAs (up to 28 weeks) and were collected whether elicited or spontaneously reported by the participant.
|
|
Psychiatric disorders
IRRITABILITY
|
12.5%
4/32 • Number of events 4 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug through 30 days after the last dose of DAA (2-DAA + pegIFN alpha-2a and RBV) dosing (up to 28 weeks).
TEAEs and TESAEs are defined as any AE with an onset date that is after the first dose of study drug through 30 days after the last dose of DAAs (up to 28 weeks) and were collected whether elicited or spontaneously reported by the participant.
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
12.5%
4/32 • Number of events 4 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug through 30 days after the last dose of DAA (2-DAA + pegIFN alpha-2a and RBV) dosing (up to 28 weeks).
TEAEs and TESAEs are defined as any AE with an onset date that is after the first dose of study drug through 30 days after the last dose of DAAs (up to 28 weeks) and were collected whether elicited or spontaneously reported by the participant.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
12.5%
4/32 • Number of events 4 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug through 30 days after the last dose of DAA (2-DAA + pegIFN alpha-2a and RBV) dosing (up to 28 weeks).
TEAEs and TESAEs are defined as any AE with an onset date that is after the first dose of study drug through 30 days after the last dose of DAAs (up to 28 weeks) and were collected whether elicited or spontaneously reported by the participant.
|
|
Skin and subcutaneous tissue disorders
DRY SKIN
|
12.5%
4/32 • Number of events 6 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug through 30 days after the last dose of DAA (2-DAA + pegIFN alpha-2a and RBV) dosing (up to 28 weeks).
TEAEs and TESAEs are defined as any AE with an onset date that is after the first dose of study drug through 30 days after the last dose of DAAs (up to 28 weeks) and were collected whether elicited or spontaneously reported by the participant.
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
18.8%
6/32 • Number of events 8 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug through 30 days after the last dose of DAA (2-DAA + pegIFN alpha-2a and RBV) dosing (up to 28 weeks).
TEAEs and TESAEs are defined as any AE with an onset date that is after the first dose of study drug through 30 days after the last dose of DAAs (up to 28 weeks) and were collected whether elicited or spontaneously reported by the participant.
|
|
Skin and subcutaneous tissue disorders
RASH
|
25.0%
8/32 • Number of events 9 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug through 30 days after the last dose of DAA (2-DAA + pegIFN alpha-2a and RBV) dosing (up to 28 weeks).
TEAEs and TESAEs are defined as any AE with an onset date that is after the first dose of study drug through 30 days after the last dose of DAAs (up to 28 weeks) and were collected whether elicited or spontaneously reported by the participant.
|
Additional Information
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