Trial Outcomes & Findings for Real World Evidence of the Effectiveness of Paritaprevir/Ritonavir (r) - Ombitasvir, + Dasabuvir Without Ribavirin in Participants With Chronic Hepatitis C and Compensated Liver Cirrhosis in the Russian Federation (NCT NCT03053180)

NCT ID: NCT03053180

Last Updated: 2019-03-14

Results Overview

SVR12 was defined as hepatitis C virus (HCV) ribonucleic acid (RNA) levels less than 50 IU/mL 12 weeks after the last dose of study drug.

• Recruitment status: COMPLETED
• Target enrollment: 60 participants
• Primary outcome timeframe: 12 weeks after the last dose of study drug (week 24)
• Results posted on: 2019-03-14

Participant Flow

A total of 60 participants signed the written patient authorization form and were enrolled into the study in 7 investigational sites located in Russia.

Participant milestones

Measure	Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir Participants with chronic hepatitis C (CHC) genotype 1b (GT1b) and compensated liver cirrhosis received paritaprevir/ritonavir (r), ombitasvir and dasabuvir (3 direct-acting antiviral agent \[3DAA\] ABBVIE REGIMEN) for 12 weeks. The prescription of a treatment regimen was at the discretion of the physician in accordance with local clinical practice and label, was made independently from this observational study and preceded the decision to offer a patient the opportunity to participate in this study.
Overall Study STARTED	60
Overall Study COMPLETED	59
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure

Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir Participants with chronic hepatitis C (CHC) genotype 1b (GT1b) and compensated liver cirrhosis received paritaprevir/ritonavir (r), ombitasvir and dasabuvir (3 direct-acting antiviral agent \[3DAA\] ABBVIE REGIMEN) for 12 weeks. The prescription of a treatment regimen was at the discretion of the physician in accordance with local clinical practice and label, was made independently from this observational study and preceded the decision to offer a patient the opportunity to participate in this study.

Overall Study Failure to Return

1

Baseline Characteristics

Real World Evidence of the Effectiveness of Paritaprevir/Ritonavir (r) - Ombitasvir, + Dasabuvir Without Ribavirin in Participants With Chronic Hepatitis C and Compensated Liver Cirrhosis in the Russian Federation

Baseline characteristics by cohort

Measure	Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir n=59 Participants Participants with chronic hepatitis C (CHC) genotype 1b (GT1b) and compensated liver cirrhosis received paritaprevir/ritonavir (r), ombitasvir and dasabuvir (3DAA ABBVIE REGIMEN) for 12 weeks.
Age, Continuous	50.3 years STANDARD_DEVIATION 11.40 • n=5 Participants
Sex: Female, Male Female	30 Participants n=5 Participants
Sex: Female, Male Male	29 Participants n=5 Participants
Race/Ethnicity, Customized White	59 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks after the last dose of study drug (week 24)

Population: Core population

SVR12 was defined as hepatitis C virus (HCV) ribonucleic acid (RNA) levels less than 50 IU/mL 12 weeks after the last dose of study drug.

Outcome measures

Measure	Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir n=59 Participants Participants with chronic hepatitis C (CHC) genotype 1b (GT1b) and compensated liver cirrhosis received paritaprevir/ritonavir (r), ombitasvir and dasabuvir (3DAA ABBVIE REGIMEN) for 12 weeks.
Percentage of Participants Achieving Sustained Virological Response 12 Weeks Post-treatment (SVR12)	98.3 percentage of participants Interval 90.91 to 99.96

SECONDARY outcome

Timeframe: End of treatment, maximum of 12 weeks

Population: Core population

Virological response is defined as HCV RNA less than 50 IU/mL.

Outcome measures

Measure	Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir n=59 Participants Participants with chronic hepatitis C (CHC) genotype 1b (GT1b) and compensated liver cirrhosis received paritaprevir/ritonavir (r), ombitasvir and dasabuvir (3DAA ABBVIE REGIMEN) for 12 weeks.
Percentage of Participants Achieving Virological Response at End of Treatment (EoT)	100.0 percentage of participants Interval 93.94 to 100.0

SECONDARY outcome

Timeframe: End of treatment (week 12) and up to 12 weeks after the end of treatment.

Population: Core population

Relapse was defined as participants with a virologic response (VR; HCV RNA < 50 IU/mL) at end of treatment (EOT) followed by HCV RNA ≥ 50 IU/mL at any time after the end of treatment.

Outcome measures

Measure	Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir n=59 Participants Participants with chronic hepatitis C (CHC) genotype 1b (GT1b) and compensated liver cirrhosis received paritaprevir/ritonavir (r), ombitasvir and dasabuvir (3DAA ABBVIE REGIMEN) for 12 weeks.
Percentage of Participants With Relapse	0.0 percentage of participants Interval 0.0 to 6.06

SECONDARY outcome

Timeframe: 12 weeks

Population: Core population

Breakthrough was defined as at least one documented HCV RNA < 50 IU/mL followed by HCV RNA ≥ 50 IU/mL during treatment.

Outcome measures

Measure	Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir n=59 Participants Participants with chronic hepatitis C (CHC) genotype 1b (GT1b) and compensated liver cirrhosis received paritaprevir/ritonavir (r), ombitasvir and dasabuvir (3DAA ABBVIE REGIMEN) for 12 weeks.
Percentage of Participants With Breakthrough	0.0 percentage of participants Interval 0.0 to 6.06

SECONDARY outcome

Timeframe: 12 weeks

Population: Core population

Failure to suppress was defined as each measured on-treatment HCV RNA value ≥ 50 IU/mL.

Outcome measures

Measure	Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir n=59 Participants Participants with chronic hepatitis C (CHC) genotype 1b (GT1b) and compensated liver cirrhosis received paritaprevir/ritonavir (r), ombitasvir and dasabuvir (3DAA ABBVIE REGIMEN) for 12 weeks.
Percentage of Participants With Failure to Suppress	0.0 percentage of participants Interval 0.0 to 6.06

SECONDARY outcome

Timeframe: 12 weeks after the last dose of study drug (week 24)

Population: Core population

Outcome measures

Measure	Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir n=59 Participants Participants with chronic hepatitis C (CHC) genotype 1b (GT1b) and compensated liver cirrhosis received paritaprevir/ritonavir (r), ombitasvir and dasabuvir (3DAA ABBVIE REGIMEN) for 12 weeks.
Percentage of Participants With Missing SVR12 Data	1.7 percentage of participants Interval 0.04 to 9.09

Adverse Events

Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Measure	Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir n=60 participants at risk Participants with chronic hepatitis C (CHC) genotype 1b (GT1b) and compensated liver cirrhosis received paritaprevir/ritonavir (r), ombitasvir and dasabuvir (3DAA ABBVIE REGIMEN) for 12 weeks.
Hepatobiliary disorders Hyperbilirubinaemia	1.7% 1/60 • From first dose of the 3DAA ABBVIE REGIMEN through 30 days after last dose (up to 16 weeks).

Other adverse events

Measure	Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir n=60 participants at risk Participants with chronic hepatitis C (CHC) genotype 1b (GT1b) and compensated liver cirrhosis received paritaprevir/ritonavir (r), ombitasvir and dasabuvir (3DAA ABBVIE REGIMEN) for 12 weeks.
Infections and infestations Ascariasis	1.7% 1/60 • From first dose of the 3DAA ABBVIE REGIMEN through 30 days after last dose (up to 16 weeks).

Additional Information

Global Medical Services

AbbVie

Phone: 800-633-9110

Email: abbvieclinicaltrials@abbvie.com

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