Trial Outcomes & Findings for Ombitasvir/ABT-450/Ritonavir and Dasabuvir Therapy With Low Dose Ribavirin (RBV), Full Dose RBV or RBV Add-On in Treatment Naive Genotype 1a Hepatitis C Virus Infected Adults (NCT NCT02493855)

Last Updated: 2017-10-31

Results Overview

HCV viral kinetics in plasma during therapy were modeled through non-linear mixed effect models, including a rapid first phase of initial decline and a slower second phase decline. The slope of the second phase decline was estimated for each treatment arm.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

46 participants

Primary outcome timeframe

From Week 0 to Week 2

Results posted on

2017-10-31

Participant Flow

This study was conducted at one clinic in France and one clinic in the United States. Participants were treatment-naïve adults with hepatitis C virus (HCV) genotype (GT)1a infection without cirrhosis.

Participants were randomized to Arms A or B in a 1:1 ratio first, and once those arms fully enrolled, Arm C was enrolled. Randomization to Arms A and B was stratified by site.

Participant milestones

Participant milestones
Measure	Arm A: Ribavirin Full Dose for Last 10 Weeks Participants received ombitasvir/ABT-450/ritonavir 25 mg/150 mg/100 mg once daily (QD) + dasabuvir 250 mg twice daily (BID) for 12 weeks and weight-based ribavirin (1000 mg or 1200 mg split BID) for the last 10 weeks.	Arm B: Ribavirin Full Dose for 12 Weeks Participants received ombitasvir/ABT-450/ritonavir 25 mg/150 mg/100 mg once daily (QD) + dasabuvir 250 mg twice daily (BID) and weight-based ribavirin (1000 mg or 1200 mg split BID) for 12 weeks.	Arm C: Ribavirin Low-dose for 12 Weeks Participants received ombitasvir/ABT-450/ritonavir 25 mg/150 mg/100 mg once daily (QD) + dasabuvir 250 mg twice daily (BID) and 600 mg ribavirin once daily for 12 weeks.
Overall Study STARTED	21	19	6
Overall Study COMPLETED	19	18	6
Overall Study NOT COMPLETED	2	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm A: Ribavirin Full Dose for Last 10 Weeks Participants received ombitasvir/ABT-450/ritonavir 25 mg/150 mg/100 mg once daily (QD) + dasabuvir 250 mg twice daily (BID) for 12 weeks and weight-based ribavirin (1000 mg or 1200 mg split BID) for the last 10 weeks.	Arm B: Ribavirin Full Dose for 12 Weeks Participants received ombitasvir/ABT-450/ritonavir 25 mg/150 mg/100 mg once daily (QD) + dasabuvir 250 mg twice daily (BID) and weight-based ribavirin (1000 mg or 1200 mg split BID) for 12 weeks.
Overall Study Non-compliance	1	0
Overall Study Adverse Event	0	1
Overall Study Withdrawal by Subject	1	0

Baseline Characteristics

Ombitasvir/ABT-450/Ritonavir and Dasabuvir Therapy With Low Dose Ribavirin (RBV), Full Dose RBV or RBV Add-On in Treatment Naive Genotype 1a Hepatitis C Virus Infected Adults

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm A: Ribavirin Full Dose for Last 10 Weeks n=21 Participants Participants received ombitasvir/ABT-450/ritonavir 25 mg/150 mg/100 mg once daily (QD) + dasabuvir 250 mg twice daily (BID) for 12 weeks and weight-based ribavirin (1000 mg or 1200 mg split BID) for the last 10 weeks.	Arm B: Ribavirin Full Dose for 12 Weeks n=19 Participants Participants received ombitasvir/ABT-450/ritonavir 25 mg/150 mg/100 mg once daily (QD) + dasabuvir 250 mg twice daily (BID) and weight-based ribavirin (1000 mg or 1200 mg split BID) for 12 weeks.	Arm C: Ribavirin Low-dose for 12 Weeks n=6 Participants Participants received ombitasvir/ABT-450/ritonavir 25 mg/150 mg/100 mg once daily (QD) + dasabuvir 250 mg twice daily (BID) and 600 mg ribavirin once daily for 12 weeks.	Total n=46 Participants Total of all reporting groups
Age, Continuous	44.9 years STANDARD_DEVIATION 11.96 • n=5 Participants	46.0 years STANDARD_DEVIATION 12.78 • n=7 Participants	36.7 years STANDARD_DEVIATION 15.79 • n=5 Participants	44.3 years STANDARD_DEVIATION 12.88 • n=4 Participants
Age, Customized < 55 years	17 Participants n=5 Participants	14 Participants n=7 Participants	5 Participants n=5 Participants	36 Participants n=4 Participants
Age, Customized ≥ 55 - 65 years	4 Participants n=5 Participants	5 Participants n=7 Participants	1 Participants n=5 Participants	10 Participants n=4 Participants
Age, Customized ≥ 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	12 Participants n=7 Participants	4 Participants n=5 Participants	27 Participants n=4 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	7 Participants n=7 Participants	2 Participants n=5 Participants	19 Participants n=4 Participants
Race/Ethnicity, Customized White	16 Participants n=5 Participants	14 Participants n=7 Participants	4 Participants n=5 Participants	34 Participants n=4 Participants
Race/Ethnicity, Customized Black of African American	4 Participants n=5 Participants	3 Participants n=7 Participants	1 Participants n=5 Participants	8 Participants n=4 Participants
Race/Ethnicity, Customized Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race/Ethnicity, Customized American Indian or Alaskan Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race/Ethnicity, Customized Mutli Race	1 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	4 Participants n=4 Participants

PRIMARY outcome

Timeframe: From Week 0 to Week 2

Population: Participants with evaluable HCV RNA to calculate the slope of the second phase. Three participants were excluded due to algorithm non-convergence in the non-linear modeling process.

Outcome measures

Outcome measures
Measure	Arm A: Ribavirin Full Dose for Last 10 Weeks n=20 Participants Participants received ombitasvir/ABT-450/ritonavir 25 mg/150 mg/100 mg once daily (QD) + dasabuvir 250 mg twice daily (BID) for 12 weeks and weight-based ribavirin (1000 mg or 1200 mg split BID) for the last 10 weeks.	Arm B: Ribavirin Full Dose for 12 Weeks n=17 Participants Participants received ombitasvir/ABT-450/ritonavir 25 mg/150 mg/100 mg once daily (QD) + dasabuvir 250 mg twice daily (BID) and weight-based ribavirin (1000 mg or 1200 mg split BID) for 12 weeks.	Arm C: Ribavirin Low-dose for 12 Weeks n=6 Participants Participants received ombitasvir/ABT-450/ritonavir 25 mg/150 mg/100 mg once daily (QD) + dasabuvir 250 mg twice daily (BID) and 600 mg ribavirin once daily for 12 weeks.
Slope of the Second Phase Decline in Plasma HCV Ribonucleic Acid (RNA) Levels During Treatment	0.0036 1/day Interval 0.0006 to 0.0128	0.0046 1/day Interval -0.0003 to 0.0155	0.0051 1/day Interval 0.0031 to 0.0076

Adverse Events

Arm A: Ribavirin Full Dose for Last 10 Weeks

Serious events: 1 serious events

Other events: 17 other events

Deaths: 0 deaths

Arm B: Ribavirin Full Dose for 12 Weeks

Serious events: 0 serious events

Other events: 16 other events

Deaths: 0 deaths

Arm C: Ribavirin Low-dose for 12 Weeks

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Arm A: Ribavirin Full Dose for Last 10 Weeks n=21 participants at risk Participants received ombitasvir/ABT-450/ritonavir 25 mg/150 mg/100 mg once daily (QD) + dasabuvir 250 mg twice daily (BID) for 12 weeks and weight-based ribavirin (1000 mg or 1200 mg split BID) for the last 10 weeks.	Arm B: Ribavirin Full Dose for 12 Weeks n=19 participants at risk Participants received ombitasvir/ABT-450/ritonavir 25 mg/150 mg/100 mg once daily (QD) + dasabuvir 250 mg twice daily (BID) and weight-based ribavirin (1000 mg or 1200 mg split BID) for 12 weeks.	Arm C: Ribavirin Low-dose for 12 Weeks n=6 participants at risk Participants received ombitasvir/ABT-450/ritonavir 25 mg/150 mg/100 mg once daily (QD) + dasabuvir 250 mg twice daily (BID) and 600 mg ribavirin once daily for 12 weeks.
Psychiatric disorders DEPRESSION	4.8% 1/21 • From first dose of study drug until 30 days after last dose; up to 16 weeks.	0.00% 0/19 • From first dose of study drug until 30 days after last dose; up to 16 weeks.	0.00% 0/6 • From first dose of study drug until 30 days after last dose; up to 16 weeks.
Psychiatric disorders DRUG DEPENDENCE	4.8% 1/21 • From first dose of study drug until 30 days after last dose; up to 16 weeks.	0.00% 0/19 • From first dose of study drug until 30 days after last dose; up to 16 weeks.	0.00% 0/6 • From first dose of study drug until 30 days after last dose; up to 16 weeks.

Other adverse events

Additional Information

Global Medical Services

AbbVie

Phone: 800-633-9110

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.
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Restriction type: OTHER