Trial Outcomes & Findings for Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C - An Observational Study (NCT NCT02798315)

NCT ID: NCT02798315

Last Updated: 2018-12-31

Results Overview

SVR12 defined as the HCV ribonucleic acid (RNA) level less than 50 IU/mL 12 weeks after the last dose of study drug

• Recruitment status: COMPLETED
• Target enrollment: 40 participants
• Primary outcome timeframe: 12 weeks (i.e. at least 70 days) after the last dose of study drug
• Results posted on: 2018-12-31

Participant Flow

Participant milestones

Measure	Participants With Hepatitis C Virus (HCV) Genotype 1 or 4 Participants with HCV genotype 1 or 4 receiving paritaprevir/r - ombitasvir with or without dasabuvir (ABBVIE REGIMEN) ± ribavirin (RBV).
Overall Study STARTED	40
Overall Study COMPLETED	39
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	Participants With Hepatitis C Virus (HCV) Genotype 1 or 4 Participants with HCV genotype 1 or 4 receiving paritaprevir/r - ombitasvir with or without dasabuvir (ABBVIE REGIMEN) ± ribavirin (RBV).
Overall Study Failure to return	1

Baseline Characteristics

Participants with a nonmissing baseline and end-of-treatment (EOT) assessment

Baseline characteristics by cohort

Measure	Participants With HCV Genotype 1 or 4 n=40 Participants Participants with HCV genotype 1 or 4 receiving paritaprevir/r - ombitasvir with or without dasabuvir (ABBVIE REGIMEN) ± RBV.
Age, Continuous	49 years STANDARD_DEVIATION 13.9 • n=40 Participants
Sex: Female, Male Female	20 Participants n=40 Participants
Sex: Female, Male Male	20 Participants n=40 Participants
Race/Ethnicity, Customized Other (Not Specified)	40 Participants n=40 Participants
Patient Activation Measure 13 (PAM-13)	55.0 units on a scale n=37 Participants • Participants with a nonmissing baseline and end-of-treatment (EOT) assessment

PRIMARY outcome

Timeframe: 12 weeks (i.e. at least 70 days) after the last dose of study drug

Population: Core population: all participants who were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype).

SVR12 defined as the HCV ribonucleic acid (RNA) level less than 50 IU/mL 12 weeks after the last dose of study drug

Outcome measures

Measure	Participants With HCV Genotype 1 or 4 n=39 Participants Participants with HCV genotype 1 or 4 receiving paritaprevir/r - ombitasvir with or without dasabuvir (ABBVIE REGIMEN) ± RBV.
Percentage of Participants Achieving Sustained Virological Response 12 Weeks Post-treatment (SVR12)	100 percentage of participants Interval 91.0 to 100.0

SECONDARY outcome

Timeframe: Up to EoT, maximum of 24 weeks

Population: Core population: all participants who were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype).

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

Outcome measures

Measure	Participants With HCV Genotype 1 or 4 n=39 Participants Participants with HCV genotype 1 or 4 receiving paritaprevir/r - ombitasvir with or without dasabuvir (ABBVIE REGIMEN) ± RBV.
Percentage of Participants With Virological Response at End of Treatment (EoT)	100 percentage of participants Interval 91.0 to 100.0

SECONDARY outcome

Timeframe: Up to EoT, maximum of 24 weeks

Population: Core population: all participants who were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype).

Relapse defined as HCV RNA less than 50 IU/mL at EoT followed by HCV RNA greater than or equal to 50 IU/mL.

Outcome measures

Measure	Participants With HCV Genotype 1 or 4 n=39 Participants Participants with HCV genotype 1 or 4 receiving paritaprevir/r - ombitasvir with or without dasabuvir (ABBVIE REGIMEN) ± RBV.
Percentage of Participants With Relapse at EoT	0 percentage of participants

SECONDARY outcome

Timeframe: Up to EoT, maximum of 24 weeks

Population: Core population: all participants who were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype).

Breakthrough defined as at least 1 documented HCV RNA less than 50 IU/mL followed by HCV RNA greater than or equal to 50 IU/mL during treatment.

Outcome measures

Measure	Participants With HCV Genotype 1 or 4 n=39 Participants Participants with HCV genotype 1 or 4 receiving paritaprevir/r - ombitasvir with or without dasabuvir (ABBVIE REGIMEN) ± RBV.
Percentage of Participants With Breakthrough.	0 percentage of participants

SECONDARY outcome

Timeframe: 12 weeks (i.e. at least 70 days) after the last dose of study drug

Population: Core population: all participants who were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype).

On-treatment virologic failure defined as breakthrough (at least 1 documented HCV RNA less than 50 IU/mL followed by HCV RNA greater than or equal to 50 IU/mL during treatment) or failure to suppress (each measured on-treatment HCV RNA value greater than or equal to 50 IU/mL). Relapse (defined as HCV RNA <50 IU/mL at EoT or at the last on-treatment HCV RNA measurement followed by HCV RNA ≥50 IU/mL post-treatment).

Outcome measures

Measure	Participants With HCV Genotype 1 or 4 n=39 Participants Participants with HCV genotype 1 or 4 receiving paritaprevir/r - ombitasvir with or without dasabuvir (ABBVIE REGIMEN) ± RBV.
Percentage of Participants Meeting the SVR Non-response Categories of On-treatment Virologic Failure or Relapse On-treatment virologic failure	0 percentage of participants
Percentage of Participants Meeting the SVR Non-response Categories of On-treatment Virologic Failure or Relapse Relapse	0 percentage of participants

SECONDARY outcome

Timeframe: 12 weeks (i.e. at least 70 days) after the last dose of study drug

Population: Core population: all participants who were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype).

Premature study drug discontinuation category is defined as participants who prematurely discontinued study drug and who experienced no on-treatment virologic failure. The final SVR non-response category was defined as missing SVR12 data and/or none of the above criteria.

Outcome measures

Measure	Participants With HCV Genotype 1 or 4 n=39 Participants Participants with HCV genotype 1 or 4 receiving paritaprevir/r - ombitasvir with or without dasabuvir (ABBVIE REGIMEN) ± RBV.
Percentage of Participants Meeting the SVR Non-response Categories of Premature Study Drug Discontinuation or Missing SVR12 Data and/or None of the Above Criteria Premature study drug discontinuation	0 percentage of participants
Percentage of Participants Meeting the SVR Non-response Categories of Premature Study Drug Discontinuation or Missing SVR12 Data and/or None of the Above Criteria Missing SVR12 data / other	0 percentage of participants

SECONDARY outcome

Timeframe: Up to 48 weeks

Population: Core population: all participants who were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype).

Percentage of the DAA dose taken in relation to the target dose of DAA (cumulative dose taken divided by target dose in percent), presented as the number of participants taking > 95% to ≤ 105% of the target dose and those taking > 80% to ≤ 95% of the target dose.

Outcome measures

Measure	Participants With HCV Genotype 1 or 4 n=39 Participants Participants with HCV genotype 1 or 4 receiving paritaprevir/r - ombitasvir with or without dasabuvir (ABBVIE REGIMEN) ± RBV.
Adherence to ABBVIE Regimen: Percentage of the Direct-acting Antiviral (DAA) Dose Taken in Relation to the Target Dose of DAA > 95% to ≤ 105% of target dose	38 Participants
Adherence to ABBVIE Regimen: Percentage of the Direct-acting Antiviral (DAA) Dose Taken in Relation to the Target Dose of DAA > 80% to ≤ 95% of target dose	1 Participants

SECONDARY outcome

Timeframe: Up to 48 weeks

Population: Core population: all participants who were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype) and were prescribed RBV.

Percentage of the RBV dose taken in relation to the target dose of RBV (cumulative dose taken divided by target dose in percent), presented as the number of participants taking > 95% to ≤ 105% of the target dose and those taking > 80% to ≤ 95% of the target dose.

Outcome measures

Measure	Participants With HCV Genotype 1 or 4 n=33 Participants Participants with HCV genotype 1 or 4 receiving paritaprevir/r - ombitasvir with or without dasabuvir (ABBVIE REGIMEN) ± RBV.
Adherence to RBV: Percentage of RBV Dose Taken in Relation to the Target Dose of RBV > 95% to ≤ 105% of target dose	32 Participants
Adherence to RBV: Percentage of RBV Dose Taken in Relation to the Target Dose of RBV > 80% to ≤ 95% of target dose	1 Participants

SECONDARY outcome

Timeframe: Up to 48 weeks

Population: Core population: all participants who were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype) and were prescribed RBV.

Outcome measures

Measure	Participants With HCV Genotype 1 or 4 n=33 Participants Participants with HCV genotype 1 or 4 receiving paritaprevir/r - ombitasvir with or without dasabuvir (ABBVIE REGIMEN) ± RBV.
Adherence: Percentage of Planned Duration of RBV Taken by Participant	101.0 percentage of planned duration of RBV Standard Deviation 2.00

SECONDARY outcome

Timeframe: Up to 48 weeks

Population: Core population: all participants who were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype) and contributed to the PAM-13.

The PAM-13 item scale is a measure used to assess the patient knowledge, skill, and confidence for self-management. Each of the 13 items can be answered with one of four possible response options, which are "disagree strongly" (1), "disagree" (2), "agree" (3), "agree strongly" (4). Based on responses to the 13-item measure, the score is calculated by adding up the raw scores (range of the sum: 13 - 52) and mapping up the value onto a scale of 0-100 indicating strength of agreement with the 13 items. A higher score indicates that the patient is likely to participate more actively in health care processes and takes more responsibility for his or her health.

Outcome measures

Measure	Participants With HCV Genotype 1 or 4 n=37 Participants Participants with HCV genotype 1 or 4 receiving paritaprevir/r - ombitasvir with or without dasabuvir (ABBVIE REGIMEN) ± RBV.
Change From Baseline in the PAM-13 Questionnaire	7.60 units on a scale Interval 4.5 to 11.3

SECONDARY outcome

Timeframe: Up to EoT, maximum of 24 weeks

Population: Core population: all participants who were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype) and who participated int he PSP.

Percentage of participants using each component of the PSP, including personal support, educational and information material (printed, online) and additional digital and mobile resources (web-portal, app, and reminders).

Outcome measures

Measure	Participants With HCV Genotype 1 or 4 n=37 Participants Participants with HCV genotype 1 or 4 receiving paritaprevir/r - ombitasvir with or without dasabuvir (ABBVIE REGIMEN) ± RBV.
Patient Support Program (PSP) Questionnaire: Utilization of PSP Components Personal support	28 Participants
Patient Support Program (PSP) Questionnaire: Utilization of PSP Components Educational/information material - printed	24 Participants
Patient Support Program (PSP) Questionnaire: Utilization of PSP Components Educational/information material - online	6 Participants
Patient Support Program (PSP) Questionnaire: Utilization of PSP Components Additional resources - web portal	3 Participants
Patient Support Program (PSP) Questionnaire: Utilization of PSP Components Additional resources - app	6 Participants
Patient Support Program (PSP) Questionnaire: Utilization of PSP Components Additional resources - reminders	2 Participants

Adverse Events

Participants With HCV Genotype 1 or 4

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Participants With HCV Genotype 1 or 4 n=40 participants at risk Participants with HCV genotype 1 or 4 receiving paritaprevir/r - ombitasvir with or without dasabuvir (ABBVIE REGIMEN) ± RBV.
Investigations Blood bilirubin increased	5.0% 2/40 • Nonserious adverse events (AEs): up to 48 Weeks. Serious AEs were reported to AbbVie from the time the physician obtains the participant's authorization to use and disclose information until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment.
Investigations Platelet count increased	2.5% 1/40 • Nonserious adverse events (AEs): up to 48 Weeks. Serious AEs were reported to AbbVie from the time the physician obtains the participant's authorization to use and disclose information until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment.
Injury, poisoning and procedural complications Overdose	2.5% 1/40 • Nonserious adverse events (AEs): up to 48 Weeks. Serious AEs were reported to AbbVie from the time the physician obtains the participant's authorization to use and disclose information until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment.

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