Trial Outcomes & Findings for Coadministration of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) With Ribavirin (RBV) in Adults With Genotype 4 (GT4) Hepatitis C Virus (HCV) in Egypt (NCT NCT02247401)

Last Updated: 2021-07-30

Results Overview

SVR12 was defined as 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

160 participants

Primary outcome timeframe

12 weeks after last dose

Results posted on

2021-07-30

Participant Flow

Safety population: All participants who received at least one dose of study drug.

Participant milestones

Participant milestones
Measure	Arm A ABT-450/r/ABT-267 (paritaprevir/ritonavir/ombitasvir; 2 DAA) plus Ribavirin (RBV) for 12 weeks in treatment-naïve and treatment-experienced (with pegylated interferon and ribavirin) participants without cirrhosis.	Arm B ABT-450/r/ABT-267 plus RBV for 12 weeks in treatment-naïve and treatment-experienced (with pegylated interferon and ribavirin) participants with compensated cirrhosis.	Arm C ABT-450/r/ABT-267 plus RBV for 24 weeks in treatment-naïve and treatment-experienced (with pegylated interferon and ribavirin) participants with compensated cirrhosis.
Overall Study STARTED	100	31	29
Overall Study COMPLETED	94	29	27
Overall Study NOT COMPLETED	6	2	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm A ABT-450/r/ABT-267 (paritaprevir/ritonavir/ombitasvir; 2 DAA) plus Ribavirin (RBV) for 12 weeks in treatment-naïve and treatment-experienced (with pegylated interferon and ribavirin) participants without cirrhosis.	Arm B ABT-450/r/ABT-267 plus RBV for 12 weeks in treatment-naïve and treatment-experienced (with pegylated interferon and ribavirin) participants with compensated cirrhosis.	Arm C ABT-450/r/ABT-267 plus RBV for 24 weeks in treatment-naïve and treatment-experienced (with pegylated interferon and ribavirin) participants with compensated cirrhosis.
Overall Study Adverse Event	1	0	0
Overall Study Withdrawal by Subject	4	1	1
Overall Study Lost to Follow-up	1	1	1

Baseline Characteristics

Coadministration of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) With Ribavirin (RBV) in Adults With Genotype 4 (GT4) Hepatitis C Virus (HCV) in Egypt

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm A n=100 Participants ABT-450/r/ABT-267 (paritaprevir/ritonavir/ombitasvir; 2 DAA) plus Ribavirin (RBV) for 12 weeks in treatment-naïve and treatment-experienced (with pegylated interferon and ribavirin) participants without cirrhosis.	Arm B n=31 Participants ABT-450/r/ABT-267 plus RBV for 12 weeks in treatment-naïve and treatment-experienced (with pegylated interferon and ribavirin) participants with compensated cirrhosis.	Arm C n=29 Participants ABT-450/r/ABT-267 plus RBV for 24 weeks in treatment-naïve and treatment-experienced (with pegylated interferon and ribavirin) participants with compensated cirrhosis.	Total n=160 Participants Total of all reporting groups
Age, Continuous	48.6 years STANDARD_DEVIATION 13.14 • n=5 Participants	57.3 years STANDARD_DEVIATION 6.48 • n=7 Participants	55.8 years STANDARD_DEVIATION 8.02 • n=5 Participants	51.6 years STANDARD_DEVIATION 11.91 • n=4 Participants
Sex: Female, Male Female	30 Participants n=5 Participants	2 Participants n=7 Participants	7 Participants n=5 Participants	39 Participants n=4 Participants
Sex: Female, Male Male	70 Participants n=5 Participants	29 Participants n=7 Participants	22 Participants n=5 Participants	121 Participants n=4 Participants

PRIMARY outcome

Timeframe: 12 weeks after last dose

Population: Intent-to-treat population: all participants who received at least 1 dose of study drug.

SVR12 was defined as 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	Arm A n=100 Participants ABT-450/r/ABT-267 (paritaprevir/ritonavir/ombitasvir; 2 DAA) plus Ribavirin (RBV) for 12 weeks in treatment-naïve and treatment-experienced (with pegylated interferon and ribavirin) participants without cirrhosis.	Arm B n=31 Participants ABT-450/r/ABT-267 plus RBV for 12 weeks in treatment-naïve and treatment-experienced (with pegylated interferon and ribavirin) participants with compensated cirrhosis.	Arm C n=29 Participants ABT-450/r/ABT-267 plus RBV for 24 weeks in treatment-naïve and treatment-experienced (with pegylated interferon and ribavirin) participants with compensated cirrhosis.
Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) in Each Treatment Arm	94.0 percentage of participants Interval 87.5 to 97.2	96.8 percentage of participants Interval 83.8 to 99.4	93.1 percentage of participants Interval 78.0 to 98.1

PRIMARY outcome

Timeframe: Screening until 30 days after last dose

Population: Safety Population: all participants 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 reasonable possibility or no reasonable possibility. 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 the first dose of study drug. For more details on adverse events please see the Adverse Event section.

Outcome measures

Outcome measures
Measure	Arm A n=100 Participants ABT-450/r/ABT-267 (paritaprevir/ritonavir/ombitasvir; 2 DAA) plus Ribavirin (RBV) for 12 weeks in treatment-naïve and treatment-experienced (with pegylated interferon and ribavirin) participants without cirrhosis.	Arm B n=31 Participants ABT-450/r/ABT-267 plus RBV for 12 weeks in treatment-naïve and treatment-experienced (with pegylated interferon and ribavirin) participants with compensated cirrhosis.	Arm C n=29 Participants ABT-450/r/ABT-267 plus RBV for 24 weeks in treatment-naïve and treatment-experienced (with pegylated interferon and ribavirin) participants with compensated cirrhosis.
Number of Participants With Adverse Events	80 Participants	26 Participants	25 Participants

SECONDARY outcome

Timeframe: Up to 12 or 24 weeks after first dose

Population: Intent-to-treat population: all participants who received at least 1 dose of study drug.

On-treatment virologic failure was defined as quantifiable HCV RNA throughout the entire treatment period with at least 6 weeks of treatment, confirmed HCV RNA greater than the LLOQ after previously having unquantifiable HCV RNA, or a confirmed increase from nadir of at least one log10 in HCV RNA during treatment.

Outcome measures

Outcome measures
Measure	Arm A n=100 Participants ABT-450/r/ABT-267 (paritaprevir/ritonavir/ombitasvir; 2 DAA) plus Ribavirin (RBV) for 12 weeks in treatment-naïve and treatment-experienced (with pegylated interferon and ribavirin) participants without cirrhosis.	Arm B n=31 Participants ABT-450/r/ABT-267 plus RBV for 12 weeks in treatment-naïve and treatment-experienced (with pegylated interferon and ribavirin) participants with compensated cirrhosis.	Arm C n=29 Participants ABT-450/r/ABT-267 plus RBV for 24 weeks in treatment-naïve and treatment-experienced (with pegylated interferon and ribavirin) participants with compensated cirrhosis.
Percentage of Participants With On-treatment Virologic Failure in Each Treatment Arm	1.0 percentage of participants Interval 0.2 to 5.4	3.2 percentage of participants Interval 0.6 to 16.2	3.4 percentage of participants Interval 0.6 to 17.2

SECONDARY outcome

Timeframe: Up to 12 weeks after first dose

Population: Intent-to-treat population: all participants who received at least 1 dose of study drug.

Post-treatment relapse was defined as 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 \< LLOQ at the end of treatment.

Outcome measures

Outcome measures
Measure	Arm A n=98 Participants ABT-450/r/ABT-267 (paritaprevir/ritonavir/ombitasvir; 2 DAA) plus Ribavirin (RBV) for 12 weeks in treatment-naïve and treatment-experienced (with pegylated interferon and ribavirin) participants without cirrhosis.	Arm B n=30 Participants ABT-450/r/ABT-267 plus RBV for 12 weeks in treatment-naïve and treatment-experienced (with pegylated interferon and ribavirin) participants with compensated cirrhosis.	Arm C n=28 Participants ABT-450/r/ABT-267 plus RBV for 24 weeks in treatment-naïve and treatment-experienced (with pegylated interferon and ribavirin) participants with compensated cirrhosis.
Percentage of Participants With Post-treatment Relapse Within 12 Weeks Following End of Treatment in Each Arm	3.1 percentage of participants Interval 1.0 to 8.6	0.0 percentage of participants Interval 0.0 to 11.4	0.0 percentage of participants Interval 0.0 to 12.1

Adverse Events

Arm A

Serious events: 2 serious events

Other events: 79 other events

Deaths: 0 deaths

Arm B

Serious events: 0 serious events

Other events: 24 other events

Deaths: 0 deaths

Arm C

Serious events: 2 serious events

Other events: 25 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Arm A n=100 participants at risk ABT-450/r/ABT-267 (paritaprevir/ritonavir/ombitasvir; 2 DAA) plus Ribavirin (RBV) for 12 weeks in treatment-naïve and treatment-experienced (with pegylated interferon and ribavirin) participants without cirrhosis.	Arm B n=31 participants at risk ABT-450/r/ABT-267 plus RBV for 12 weeks in treatment-naïve and treatment-experienced (with pegylated interferon and ribavirin) participants with compensated cirrhosis.	Arm C n=29 participants at risk ABT-450/r/ABT-267 plus RBV for 24 weeks in treatment-naïve and treatment-experienced (with pegylated interferon and ribavirin) participants with compensated cirrhosis.
Gastrointestinal disorders OESOPHAGEAL VARICES HAEMORRHAGE	0.00% 0/100 • 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 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% 0/31 • 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 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.	3.4% 1/29 • 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 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.
Hepatobiliary disorders BILE DUCT STONE	0.00% 0/100 • 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 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% 0/31 • 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 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.	3.4% 1/29 • 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 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.
Hepatobiliary disorders CHOLECYSTITIS ACUTE	0.00% 0/100 • 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 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% 0/31 • 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 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.	3.4% 1/29 • 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 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 APNOEA	1.0% 1/100 • 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 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% 0/31 • 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 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% 0/29 • 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 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.
Vascular disorders DEEP VEIN THROMBOSIS	1.0% 1/100 • 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 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% 0/31 • 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 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% 0/29 • 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 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

Additional Information

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