Trial Outcomes & Findings for A Study of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir With or Without Sofosbuvir and Ribavirin in Direct-Acting Antiviral Agent Treatment-Experienced Adults With Chronic Hepatitis C Virus Infection (NCT NCT02356562)

Last Updated: 2017-12-20

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

PHASE2

Target enrollment

29 participants

Primary outcome timeframe

12 weeks after the last dose of active drug

Results posted on

2017-12-20

Participant Flow

Efficacy, safety, and demographic analyses were performed separately for the 2 study parts using the intent-to-treat (ITT) population, which consists of all enrolled participants who received at least one dose of study drug.

The intent-to-treat (ITT) population consisted of all enrolled participants who received at least 1 dose of study drug.

Participant milestones

Participant milestones
Measure	Part 1, 3-DAA With SOF With or Without RBV 3-DAA (ombitasvir/paritaprevir/ritonavir 25 mg/150 mg/100 mg once daily \[QD\] and dasabuvir 250 mg twice daily \[BID\]) and sofosbuvir (SOF) 400 mg QD with or without ribavirin (RBV; weight-based dosing 1000 or 1200 mg divided BID or renally adjusted for participants with creatinine clearance \< 50 mL/min) for 12 or 24 weeks	Part 2, 3-DAA With RBV 3-DAA (ombitasvir/paritaprevir/ritonavir 25 mg/150 mg/100 mg QD and dasabuvir 250 mg BID) with RBV (weight-based dosing 1000 or 1200 mg divided BID or renally adjusted for participants with creatinine clearance \< 50 mL/min) for 24 weeks
Overall Study STARTED	22	7
Overall Study COMPLETED	20	6
Overall Study NOT COMPLETED	2	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Part 1, 3-DAA With SOF With or Without RBV 3-DAA (ombitasvir/paritaprevir/ritonavir 25 mg/150 mg/100 mg once daily \[QD\] and dasabuvir 250 mg twice daily \[BID\]) and sofosbuvir (SOF) 400 mg QD with or without ribavirin (RBV; weight-based dosing 1000 or 1200 mg divided BID or renally adjusted for participants with creatinine clearance \< 50 mL/min) for 12 or 24 weeks	Part 2, 3-DAA With RBV 3-DAA (ombitasvir/paritaprevir/ritonavir 25 mg/150 mg/100 mg QD and dasabuvir 250 mg BID) with RBV (weight-based dosing 1000 or 1200 mg divided BID or renally adjusted for participants with creatinine clearance \< 50 mL/min) for 24 weeks
Overall Study Withdrawal by Subject	0	1
Overall Study Re-entered treatment in a previous study	1	0
Overall Study site closure	1	0

Baseline Characteristics

A Study of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir With or Without Sofosbuvir and Ribavirin in Direct-Acting Antiviral Agent Treatment-Experienced Adults With Chronic Hepatitis C Virus Infection

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Part 1, 3-DAA With SOF With or Without RBV n=22 Participants 3-DAA (ombitasvir/paritaprevir/ritonavir 25 mg/150 mg/100 mg once daily \[QD\] and dasabuvir 250 mg twice daily \[BID\]) and sofosbuvir (SOF) 400 mg QD with or without ribavirin (RBV; weight-based dosing 1000 or 1200 mg divided BID or renally adjusted for participants with creatinine clearance \< 50 mL/min) for 12 or 24 weeks	Part 2, 3-DAA With RBV n=7 Participants 3-DAA (ombitasvir/paritaprevir/ritonavir 25 mg/150 mg/100 mg QD and dasabuvir 250 mg BID) with RBV (weight-based dosing 1000 or 1200 mg divided BID or renally adjusted for participants with creatinine clearance \< 50 mL/min) for 24 weeks	Total n=29 Participants Total of all reporting groups
Age, Continuous	58.0 years STANDARD_DEVIATION 6.41 • n=93 Participants	65.3 years STANDARD_DEVIATION 9.60 • n=4 Participants	NA years STANDARD_DEVIATION NA • n=27 Participants
Sex: Female, Male Female	7 Participants n=93 Participants	1 Participants n=4 Participants	8 Participants n=27 Participants
Sex: Female, Male Male	15 Participants n=93 Participants	6 Participants n=4 Participants	21 Participants n=27 Participants

PRIMARY outcome

Timeframe: 12 weeks after the last dose of active drug

Population: All Part 1 participants who received at least 1 dose of study drug (ITT population). Per protocol, data from Parts 1 and 2 were not combined for analysis.

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	Part 1, 3-DAA With SOF With or Without RBV n=22 Participants 3-DAA (ombitasvir/paritaprevir/ritonavir 25 mg/150 mg/100 mg once daily \[QD\] and dasabuvir 250 mg twice daily \[BID\]) and sofosbuvir (SOF) 400 mg QD with or without ribavirin (RBV; weight-based dosing 1000 or 1200 mg divided BID or renally adjusted for participants with creatinine clearance \< 50 mL/min) for 12 or 24 weeks	Part 2, 3-DAA With RBV 3-DAA (ombitasvir/paritaprevir/ritonavir 25 mg/150 mg/100 mg QD and dasabuvir 250 mg BID) with RBV (weight-based dosing 1000 or 1200 mg divided BID or renally adjusted for participants with creatinine clearance \< 50 mL/min) for 24 weeks
Percentage of Part 1 Participants With Sustained Virologic Response 12 (SVR12) Weeks Posttreatment	95.5 percentage of participants Interval 78.2 to 99.2	—

SECONDARY outcome

Timeframe: 12 weeks after the last dose of active drug

Population: All Part 2 participants who received at least 1 dose of study drug (ITT population). Per protocol, data from Parts 1 and 2 were not combined for analysis.

SVR12 was defined as plasma HCV RNA level \<LLOQ 12 weeks after the last dose of study drug

Outcome measures

Outcome measures
Measure	Part 1, 3-DAA With SOF With or Without RBV n=7 Participants 3-DAA (ombitasvir/paritaprevir/ritonavir 25 mg/150 mg/100 mg once daily \[QD\] and dasabuvir 250 mg twice daily \[BID\]) and sofosbuvir (SOF) 400 mg QD with or without ribavirin (RBV; weight-based dosing 1000 or 1200 mg divided BID or renally adjusted for participants with creatinine clearance \< 50 mL/min) for 12 or 24 weeks	Part 2, 3-DAA With RBV 3-DAA (ombitasvir/paritaprevir/ritonavir 25 mg/150 mg/100 mg QD and dasabuvir 250 mg BID) with RBV (weight-based dosing 1000 or 1200 mg divided BID or renally adjusted for participants with creatinine clearance \< 50 mL/min) for 24 weeks
Percentage of Part 2 Participants With Sustained Virologic Response 12 (SVR12) Weeks Post-treatment	85.7 percentage of participants Interval 48.7 to 97.4	—

SECONDARY outcome

Timeframe: Up to week 24

Population: All participants who received at least 1 dose of study drug (ITT population). Per protocol, data from Parts 1 and 2 were not combined for analysis.

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

Outcome measures

Outcome measures
Measure	Part 1, 3-DAA With SOF With or Without RBV n=22 Participants 3-DAA (ombitasvir/paritaprevir/ritonavir 25 mg/150 mg/100 mg once daily \[QD\] and dasabuvir 250 mg twice daily \[BID\]) and sofosbuvir (SOF) 400 mg QD with or without ribavirin (RBV; weight-based dosing 1000 or 1200 mg divided BID or renally adjusted for participants with creatinine clearance \< 50 mL/min) for 12 or 24 weeks	Part 2, 3-DAA With RBV n=7 Participants 3-DAA (ombitasvir/paritaprevir/ritonavir 25 mg/150 mg/100 mg QD and dasabuvir 250 mg BID) with RBV (weight-based dosing 1000 or 1200 mg divided BID or renally adjusted for participants with creatinine clearance \< 50 mL/min) for 24 weeks
Percentage of Participants With On-treatment Virologic Failure	0.0 percentage of participants Interval 0.0 to 14.9	14.3 percentage of participants Interval 2.6 to 51.3

SECONDARY outcome

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

Population: All participants who received at least 1 dose of study drug (ITT population) with HCV RNA \< LLOQ at the end of treatment and completed treatment. Per protocol, data from Parts 1 and 2 were not combined for analysis.

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

Outcome measures

Outcome measures
Measure	Part 1, 3-DAA With SOF With or Without RBV n=21 Participants 3-DAA (ombitasvir/paritaprevir/ritonavir 25 mg/150 mg/100 mg once daily \[QD\] and dasabuvir 250 mg twice daily \[BID\]) and sofosbuvir (SOF) 400 mg QD with or without ribavirin (RBV; weight-based dosing 1000 or 1200 mg divided BID or renally adjusted for participants with creatinine clearance \< 50 mL/min) for 12 or 24 weeks	Part 2, 3-DAA With RBV n=6 Participants 3-DAA (ombitasvir/paritaprevir/ritonavir 25 mg/150 mg/100 mg QD and dasabuvir 250 mg BID) with RBV (weight-based dosing 1000 or 1200 mg divided BID or renally adjusted for participants with creatinine clearance \< 50 mL/min) for 24 weeks
Percentage of Participants With Post-Treatment Relapse	4.8 percentage of participants Interval 0.8 to 22.7	0.0 percentage of participants Interval 0.0 to 39.0

Adverse Events

Part 1, 3-DAA With SOF With or Without RBV

Serious events: 2 serious events

Other events: 20 other events

Deaths: 0 deaths

Part 2, 3-DAA With RBV

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Part 1, 3-DAA With SOF With or Without RBV n=22 participants at risk 3-DAA (ombitasvir/paritaprevir/ritonavir \[25 mg/150 mg/100 mg once daily \[QD\] and dasabuvir \[250 mg twice daily \[BID\]) and sofosbuvir (SOF) 400 mg QD with or without ribavirin (RBV; weight-based dosing 1000 or 1200 mg divided BID or renally adjusted for participants with creatinine clearance \< 50 mL/min) for 12 or 24 weeks.	Part 2, 3-DAA With RBV n=7 participants at risk 3-DAA (ombitasvir/paritaprevir/ritonavir \[25 mg/150 mg/100 mg QD and dasabuvir \[250 mg BID) with RBV (weight-based dosing 1000 or 1200 mg divided BID or renally adjusted for participants with creatinine clearance \< 50 mL/min) for 24 weeks.
Infections and infestations CELLULITIS	4.5% 1/22 • 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 28 weeks). TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is on or after the date of 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% 0/7 • 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 28 weeks). TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is on or after the date of 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 PNEUMONIA	4.5% 1/22 • 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 28 weeks). TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is on or after the date of 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% 0/7 • 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 28 weeks). TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is on or after the date of 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

Additional Information

Global Medical Services

AbbVie

Phone: 800-633-9110

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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.
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