Trial Outcomes & Findings for Real World Evidence of the Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C in Colombia (NCT NCT02851069)

NCT ID: NCT02851069

Last Updated: 2019-09-18

Results Overview

SVR12 was defined as plasma hepatitis C virus (HCV) ribonucleic acid (RNA) level ˂50 IU/mL 12 weeks after end of treatment (EoT) (defined as after last actual dose of the ABBVIE REGIMEN \[paritaprevir/ritonavir - ombitasvir ± dasabuvir\] or ribavirin \[RBV\]).

• Recruitment status: COMPLETED
• Target enrollment: 66 participants
• Primary outcome timeframe: 12 weeks (i.e. 70 to 126 days) after the last dose of study drug (up to 24 weeks)
• Results posted on: 2019-09-18

Participant Flow

A total of 66 participants were enrolled in the study; 1 participant never started treatment and thus the safety population was comprised of 65 participants. In this study, the safety population, target population, and core population were identical.

Participant milestones

Measure	ABBVIE REGIMEN ± Ribavirin (RBV) ABBVIE REGIMEN (ombitasvir/paritaprevir/ritonavir with or without dasabuvir), and with or without weight-based ribavirin (± RBV) for 12 or 24 weeks
Overall Study STARTED	65
Overall Study COMPLETED	59
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Measure	ABBVIE REGIMEN ± Ribavirin (RBV) ABBVIE REGIMEN (ombitasvir/paritaprevir/ritonavir with or without dasabuvir), and with or without weight-based ribavirin (± RBV) for 12 or 24 weeks
Overall Study Failure to Return	3
Overall Study Other	3

Baseline Characteristics

Real World Evidence of the Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C in Colombia

Baseline characteristics by cohort

Measure	ABBVIE REGIMEN ± Ribavirin (RBV) n=65 Participants ABBVIE REGIMEN (ombitasvir/paritaprevir/ritonavir with or without dasabuvir), and with or without weight-based ribavirin (± RBV) for 12 or 24 weeks
Age, Continuous	61 years STANDARD_DEVIATION 11.2 • n=5 Participants
Sex: Female, Male Female	45 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	65 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	62 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks (i.e. 70 to 126 days) after the last dose of study drug (up to 24 weeks)

Population: Core Population (CP): defined as all participants of the target population (all participants in the safety population who met inclusion criteria) who were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype).

SVR12 was defined as plasma hepatitis C virus (HCV) ribonucleic acid (RNA) level ˂50 IU/mL 12 weeks after end of treatment (EoT) (defined as after last actual dose of the ABBVIE REGIMEN [paritaprevir/ritonavir - ombitasvir ± dasabuvir] or ribavirin [RBV]).

Outcome measures

Measure	ABBVIE REGIMEN ± Ribavirin (RBV) n=65 Participants ABBVIE REGIMEN (ombitasvir/paritaprevir/ritonavir with or without dasabuvir), and with or without weight-based ribavirin (± RBV) for 12 or 24 weeks
Percentage of Participants Achieving Sustained Virologic Response at 12 Weeks (SVR12) Post-treatment	87.7 percentage of participants Interval 77.5 to 93.6

SECONDARY outcome

Timeframe: Up to EoT, maximum of 24 weeks

Population: CP

Virologic response is defined as HCV RNA level <50 IU/mL.

Outcome measures

Measure	ABBVIE REGIMEN ± Ribavirin (RBV) n=65 Participants ABBVIE REGIMEN (ombitasvir/paritaprevir/ritonavir with or without dasabuvir), and with or without weight-based ribavirin (± RBV) for 12 or 24 weeks
Percentage of Participants With Virologic Response at End of Treatment (EoT)	95.4 percentage of participants Interval 87.3 to 98.4

SECONDARY outcome

Timeframe: Up to EoT, maximum of 24 weeks

Population: CP

Premature study drug discontinuation was defined as participants who prematurely discontinued study drug (ABBVIE REGIMEN or RBV) and who experienced no on-treatment virologic failure (defined as breakthrough [at least 1 documented HCV RNA ˂50 IU/mL followed by HCV RNA ≥50 IU/mL during treatment] or failure to suppress [each measured on-treatment HCV RNA value ≥50 IU/mL]).

Outcome measures

Measure	ABBVIE REGIMEN ± Ribavirin (RBV) n=65 Participants ABBVIE REGIMEN (ombitasvir/paritaprevir/ritonavir with or without dasabuvir), and with or without weight-based ribavirin (± RBV) for 12 or 24 weeks
Number of Participants Meeting Premature Study Drug Discontinuation Premature Termination ABBVIE REGIMEN	4 participants
Number of Participants Meeting Premature Study Drug Discontinuation No Premature Termination ABBVIE REGIMEN	61 participants

SECONDARY outcome

Timeframe: During treatment and 12 weeks (i.e. at least 70 days) after the last dose of study drug (up to 24 weeks)

Population: CP

For a participant to be include in this analysis, the participant needed to meet each and any of the following SVR12 non-response categories:

• On-treatment virologic failure (breakthrough [defined as at least one documented HCV RNA <50 IU/mL followed by HCV RNA ≥50 IU/mL during treatment] or failure to suppress [each measured on-treatment HCV RNA value ≥50 IU/mL]);
• Relapse (defined as HCV RNA <50 IU/mL at actual EoT followed by HCV RNA ≥50 IU/mL post-treatment for participants who completed treatment [not more than 7 days shortened]);
• Premature study drug discontinuation with no on-treatment virologic failure;
• Missing SVR12 data and/or none of the above criteria (including participants with missing SVR12 data).

Abbreviations: EoT=end of treatment.

Outcome measures

Measure	ABBVIE REGIMEN ± Ribavirin (RBV) n=65 Participants ABBVIE REGIMEN (ombitasvir/paritaprevir/ritonavir with or without dasabuvir), and with or without weight-based ribavirin (± RBV) for 12 or 24 weeks
Percentage of Participants Meeting Each and Any SVR12 Non-response Criteria Non-response 12 weeks after EoT	12.3 percentage of participants
Percentage of Participants Meeting Each and Any SVR12 Non-response Criteria On-treatment virologic failure	1.5 percentage of participants
Percentage of Participants Meeting Each and Any SVR12 Non-response Criteria Relapse	1.5 percentage of participants
Percentage of Participants Meeting Each and Any SVR12 Non-response Criteria Premature treatment discontinuation	4.6 percentage of participants
Percentage of Participants Meeting Each and Any SVR12 Non-response Criteria Missing SVR12 data/None of the above criteria	4.6 percentage of participants

SECONDARY outcome

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

Population: CP

Relapse was defined as confirmed 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 in participants who were treated.

Outcome measures

Measure	ABBVIE REGIMEN ± Ribavirin (RBV) n=65 Participants ABBVIE REGIMEN (ombitasvir/paritaprevir/ritonavir with or without dasabuvir), and with or without weight-based ribavirin (± RBV) for 12 or 24 weeks
Percentage of Participants With Relapse	1.5 percentage of participants

SECONDARY outcome

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

Population: CP of participants with EoT response whose last post-treatment HCV RNA test result did not show virologic response

Relapse was defined as confirmed HCV RNA <50 IU/mL at EoT followed by HCV RNA ≥50 IU/mL post treatment in participants who completed treatment (actual duration of ABBVIE REGIMEN is not shortened more than 7 days) and had HCV RNA results available in the SVR12 window.

Outcome measures

Measure	ABBVIE REGIMEN ± Ribavirin (RBV) n=57 Participants ABBVIE REGIMEN (ombitasvir/paritaprevir/ritonavir with or without dasabuvir), and with or without weight-based ribavirin (± RBV) for 12 or 24 weeks
Percentage of Participants With Relapse at EoT	1.8 percentage of participants Interval 0.3 to 9.3

SECONDARY outcome

Timeframe: Up to EoT, maximum of 24 weeks

Population: CP

Viral breakthrough was defined as at least 1 documented HCV RNA <50 IU/mL followed by HCV RNA ≥ 50 IU/mL during treatment.

Outcome measures

Measure	ABBVIE REGIMEN ± Ribavirin (RBV) n=65 Participants ABBVIE REGIMEN (ombitasvir/paritaprevir/ritonavir with or without dasabuvir), and with or without weight-based ribavirin (± RBV) for 12 or 24 weeks
Percentage of Participants With Viral Breakthrough	0.0 percentage of participants Interval 0.0 to 7.4

SECONDARY outcome

Timeframe: Up to EoT, maximum of 24 weeks

Population: CP

On-treatment virologic failure was defined as breakthrough (at least 1 documented HCV RNA <50 IU/mL followed by HCV RNA≥ 50 IU/mL during treatment) or failure to suppress (each measured on-treatment HCV RNA value ≥50 IU/mL).

Outcome measures

Measure	ABBVIE REGIMEN ± Ribavirin (RBV) n=65 Participants ABBVIE REGIMEN (ombitasvir/paritaprevir/ritonavir with or without dasabuvir), and with or without weight-based ribavirin (± RBV) for 12 or 24 weeks
Percentage of Participants Meeting On-treatment Virologic Failure	1.5 percentage of participants

SECONDARY outcome

Timeframe: Week 4

Population: CP

RVR4 was defined as HCV RNA < 50 IU/mL at Week 4.

Outcome measures

Measure	ABBVIE REGIMEN ± Ribavirin (RBV) n=65 Participants ABBVIE REGIMEN (ombitasvir/paritaprevir/ritonavir with or without dasabuvir), and with or without weight-based ribavirin (± RBV) for 12 or 24 weeks
Percentage of Participants With Rapid Virologic Response at Week 4 (RVR4)	66.2 percentage of participants Interval 54.0 to 76.5

SECONDARY outcome

Timeframe: 24 weeks after EoT (up to 24 weeks)

Population: CP participants with an SVR24 assessment

SVR24 was defined as HCV RNA < 50 IU/mL 24 weeks after EoT. During the course of the study, standard of care was changing and it was no longer common practice to assess SVR24.

Outcome measures

Measure	ABBVIE REGIMEN ± Ribavirin (RBV) n=9 Participants ABBVIE REGIMEN (ombitasvir/paritaprevir/ritonavir with or without dasabuvir), and with or without weight-based ribavirin (± RBV) for 12 or 24 weeks
Percentage of Participants With Sustained Virologic Response at 24 Weeks (SVR24) After EoT	44.4 percentage of participants Interval 18.9 to 73.3

OTHER_PRE_SPECIFIED outcome

Timeframe: EoT (up to 24 weeks)

Population: CP participants contributing to summary statistics. Changes were only calculated for participants with non-missing assessments at both time points.

The EQ-5D-5L is a 2-part instrument for use as a measure of health outcome, designed for self-completion by participants. The 5 items in the questionnaire comprise 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each of which are rated on 5 levels of severity (1: indicating no problem, 2: indicating slight problems, 3: indicating moderate problems, 4: indicating severe problems, 5: indicating extreme problems), and a separate VAS. The higher the score, the worse the quality of life. For the VAS, the higher the score, the better the quality of life. Participant responses to the EQ-5D-5L were used to generate a health status index (HSI). HSI ranges is anchored at 0 (dead) and 1 (full health).

Outcome measures

Measure	ABBVIE REGIMEN ± Ribavirin (RBV) n=53 Participants ABBVIE REGIMEN (ombitasvir/paritaprevir/ritonavir with or without dasabuvir), and with or without weight-based ribavirin (± RBV) for 12 or 24 weeks
EuroQol 5 Dimension 5 Level (EQ-5D-5L) Questionnaire Index Score: Change From Baseline to EoT	0.005 units on a scale Standard Deviation 0.143

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 weeks post EoT (up to 24 weeks)

Population: CP participants contributing to summary statistics. Changes were only calculated for participants with non-missing assessments at both time points.

The EQ-5D-5L is a 2-part instrument for use as a measure of health outcome, designed for self-completion by participants. The 5 items in the questionnaire comprise 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each of which are rated on 5 levels of severity (1: indicating no problem, 2: indicating slight problems, 3: indicating moderate problems, 4: indicating severe problems, 5: indicating extreme problems), and a separate VAS. The higher the score, the worse the quality of life. For the VAS, the higher the score, the better the quality of life. Participant responses to the EQ-5D-5L were used to generate a HSI. HSI ranges is anchored at 0 (dead) and 1 (full health).

Outcome measures

Measure	ABBVIE REGIMEN ± Ribavirin (RBV) n=54 Participants ABBVIE REGIMEN (ombitasvir/paritaprevir/ritonavir with or without dasabuvir), and with or without weight-based ribavirin (± RBV) for 12 or 24 weeks
EQ-5D-5L Questionnaire Index Score: Change From Baseline to 12 Weeks Post EoT	0.039 units on a scale Standard Deviation 0.122

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 weeks post EoT (up to 24 weeks)

Population: CP participants contributing to summary statistics. Changes were only calculated for participants with non-missing assessments at both time points.

The EQ-5D-5L is a 2-part instrument for use as a measure of health outcome, designed for self-completion by participants. The 5 items in the questionnaire comprise 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each of which are rated on 5 levels of severity (1: indicating no problem, 2: indicating slight problems, 3: indicating moderate problems, 4: indicating severe problems, 5: indicating extreme problems), and a separate VAS. The higher the score, the worse the quality of life. For the VAS, the higher the score, the better the quality of life. Participant responses to the EQ-5D-5L were used to generate a HSI. HSI ranges is anchored at 0 (dead) and 1 (full health).

Outcome measures

Measure	ABBVIE REGIMEN ± Ribavirin (RBV) n=22 Participants ABBVIE REGIMEN (ombitasvir/paritaprevir/ritonavir with or without dasabuvir), and with or without weight-based ribavirin (± RBV) for 12 or 24 weeks
EQ-5D-5L Questionnaire Index Score: Change From Baseline to 24 Weeks Post EoT	0.046 units on a scale Standard Deviation 0.111

OTHER_PRE_SPECIFIED outcome

Timeframe: End of Treatment (up to 24 weeks)

Population: CP participants contributing to summary statistics. Changes were only calculated for participants with non-missing assessments at both time points.

The EQ-5D-5L is a 2-part instrument for use as a measure of health outcome, designed for self-completion by participants. Participants also rated their perception of their overall health on a separate VAS. The scale is numbered from 0 to 100. The higher the score, the better the quality of life.

Outcome measures

Measure	ABBVIE REGIMEN ± Ribavirin (RBV) n=54 Participants ABBVIE REGIMEN (ombitasvir/paritaprevir/ritonavir with or without dasabuvir), and with or without weight-based ribavirin (± RBV) for 12 or 24 weeks
EQ-5D-5L Questionnaire VAS: Change From Baseline to EoT	5.7 units on a scale Standard Deviation 10.40

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 weeks post EoT (up to 24 weeks)

Population: CP participants contributing to summary statistics. Changes were only calculated for participants with non-missing assessments at both time points.

The EQ-5D-5L is a 2-part instrument for use as a measure of health outcome, designed for self-completion by participants. Participants also rated their perception of their overall health on a separate VAS. The scale is numbered from 0 to 100. The higher the score, the better the quality of life.

Outcome measures

Measure	ABBVIE REGIMEN ± Ribavirin (RBV) n=53 Participants ABBVIE REGIMEN (ombitasvir/paritaprevir/ritonavir with or without dasabuvir), and with or without weight-based ribavirin (± RBV) for 12 or 24 weeks
EQ-5D-5L Questionnaire VAS: Change From Baseline to 12 Weeks Post EoT	7.5 units on a scale Standard Deviation 16.12

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 weeks post EoT (up to 24 weeks)

Population: CP participants contributing to summary statistics. Changes were only calculated for participants with non-missing assessments at both time points.

The EQ-5D-5L is a 2-part instrument for use as a measure of health outcome, designed for self-completion by participants. Participants also rated their perception of their overall health on a separate VAS. The scale is numbered from 0 to 100. The higher the score, the better the quality of life.

Outcome measures

Measure	ABBVIE REGIMEN ± Ribavirin (RBV) n=22 Participants ABBVIE REGIMEN (ombitasvir/paritaprevir/ritonavir with or without dasabuvir), and with or without weight-based ribavirin (± RBV) for 12 or 24 weeks
EQ-5D-5L Questionnaire VAS: Change From Baseline to 24 Weeks Post EoT	4.0 units on a scale Standard Deviation 12.41

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline (Day 0)

Population: CP

Co-morbidities/co-infections were defined as hepatitis C virus (HCV) co-infections (human immunodeficiency virus [HIV] or hepatitis B virus [HBV], tuberculosis, schistosomiasis), liver/chronic hepatitis C (CHC) related co-morbidities (liver transplantation, hepatocellular carcinoma, non-alcoholic steatosis, alcoholic liver disease, primary biliary cirrhosis, auto-immune hepatitis, Wilson disease, cryoglobulinemia, porphyria cutanea tarda, auto-immune skin disease), and other co-morbidities (chronic kidney disease, psychiatric disorders, diabetes mellitus, insulin resistance, metabolic syndrome, lipid disorder, cardiovascular disease, immunologically mediated disease, hyper-/hypothyroidism, hemophilia, Thalassemia, sickle cell anemia, V. Willebrand disease, psychoactive substance dependency, kidney transplant, or other).

Outcome measures

Measure	ABBVIE REGIMEN ± Ribavirin (RBV) n=65 Participants ABBVIE REGIMEN (ombitasvir/paritaprevir/ritonavir with or without dasabuvir), and with or without weight-based ribavirin (± RBV) for 12 or 24 weeks
Number of Participants With Co-morbidities at Baseline (Day 0) All co-morbidities and co-infections	58 participants
Number of Participants With Co-morbidities at Baseline (Day 0) HCV Co-infections	2 participants
Number of Participants With Co-morbidities at Baseline (Day 0) Liver and/or CHC related co-morbidities	5 participants
Number of Participants With Co-morbidities at Baseline (Day 0) Other Co-morbidities	57 participants
Number of Participants With Co-morbidities at Baseline (Day 0) Kidney Transplantation	3 participants
Number of Participants With Co-morbidities at Baseline (Day 0) Chronic Kidney Disease	7 participants
Number of Participants With Co-morbidities at Baseline (Day 0) Psychiatric Disorders	3 participants
Number of Participants With Co-morbidities at Baseline (Day 0) Diabetes Mellitus	14 participants
Number of Participants With Co-morbidities at Baseline (Day 0) Lipid Disorder	4 participants
Number of Participants With Co-morbidities at Baseline (Day 0) Hypothyroidism	17 participants
Number of Participants With Co-morbidities at Baseline (Day 0) Cardiovascular disease	28 participants
Number of Participants With Co-morbidities at Baseline (Day 0) Hemophilia	2 participants
Number of Participants With Co-morbidities at Baseline (Day 0) Other	40 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 0 to EoT, maximum 24 weeks

Population: Safety Population: defined as all enrolled participants who received at least one dose of the ABBVIE REGIMEN

This includes all participants that took at least 1 concomitant medication from the time when the decision was made to initiate treatment with the ABBVIE REGIMEN until after the last dose.

Abbreviations: ACE= angiotensin-converting-enzyme; GERD=gastroesophageal reflux.

Outcome measures

Measure	ABBVIE REGIMEN ± Ribavirin (RBV) n=65 Participants ABBVIE REGIMEN (ombitasvir/paritaprevir/ritonavir with or without dasabuvir), and with or without weight-based ribavirin (± RBV) for 12 or 24 weeks
Number of Participants With Concomitant Medications Number taking at least 1 co-medication	55 participants
Number of Participants With Concomitant Medications Beta Blocking Agents	18 participants
Number of Participants With Concomitant Medications Thyroid Therapy	17 participants
Number of Participants With Concomitant Medications Vitamins	16 participants
Number of Participants With Concomitant Medications Angiotensin II Antagonists	15 participants
Number of Participants With Concomitant Medications Drugs for Peptic Ulcer and GERD	13 participants
Number of Participants With Concomitant Medications Blood glucose lowering	11 participants
Number of Participants With Concomitant Medications Diuretics	11 participants
Number of Participants With Concomitant Medications Analgesics	9 participants
Number of Participants With Concomitant Medications Calcium Channel Blockers	8 participants
Number of Participants With Concomitant Medications ACE Inhibitors	5 participants
Number of Participants With Concomitant Medications Mineral Supplements	5 participants
Number of Participants With Concomitant Medications Antidepressants	4 participants
Number of Participants With Concomitant Medications Corticosteroids	4 participants
Number of Participants With Concomitant Medications Drugs for treatment of bone disease	4 participants
Number of Participants With Concomitant Medications HMG COA Reductase Inhibitors	4 participants
Number of Participants With Concomitant Medications Anti-anemic	3 participants
Number of Participants With Concomitant Medications Antibacterials	3 participants
Number of Participants With Concomitant Medications Antithrombotic	3 participants
Number of Participants With Concomitant Medications Dermatologicals	3 participants
Number of Participants With Concomitant Medications Drugs for Constipation	3 participants
Number of Participants With Concomitant Medications Immunosuppressive agents	3 participants
Number of Participants With Concomitant Medications Anti-asthmatics	2 participants
Number of Participants With Concomitant Medications Insulin and Analogues	2 participants
Number of Participants With Concomitant Medications Anti-andrenergic Antihypertensives	1 participants
Number of Participants With Concomitant Medications Anti-arrhythmics	1 participants
Number of Participants With Concomitant Medications Antidiarrheals	1 participants
Number of Participants With Concomitant Medications Anti-inflammatory/antirheumatic products	1 participants
Number of Participants With Concomitant Medications Antineoplastic,immunomodulating agents, cytostatic	1 participants
Number of Participants With Concomitant Medications Antipsychotics	1 participants
Number of Participants With Concomitant Medications Antivirals for HIV, combinations	1 participants
Number of Participants With Concomitant Medications Antivirals, reverse transcriptase inhibitors HIV	1 participants
Number of Participants With Concomitant Medications Benzodiazepine derivatives	1 participants
Number of Participants With Concomitant Medications Bile therapy	1 participants
Number of Participants With Concomitant Medications Blood substitutes/perfusion solutions	1 participants
Number of Participants With Concomitant Medications Hemostatics/vitamin K	1 participants
Number of Participants With Concomitant Medications Lipotropics	1 participants
Number of Participants With Concomitant Medications Other antivirals, HIV treatment	1 participants
Number of Participants With Concomitant Medications Other Sex hormones	1 participants
Number of Participants With Concomitant Medications Vasoprotectives	1 participants

Adverse Events

ABBVIE REGIMEN

Serious events: 5 serious events

Other events: 5 other events

Deaths: 0 deaths

ABBVIE REGIMEN Plus Ribavirin (RBV)

Serious events: 2 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Measure	ABBVIE REGIMEN n=49 participants at risk ABBVIE REGIMEN: ombitasvir/paritaprevir/ritonavir with or without dasabuvir for 12 or 24 weeks in Hepatitis C Virus Genotype 1 (HCV + GT1) participants according to standard of care within local label recommendations for their specific disease characteristics (cirrhotic status, genotype).	ABBVIE REGIMEN Plus Ribavirin (RBV) n=16 participants at risk ABBVIE REGIMEN plus ribavirin (RBV): ombitasvir/paritaprevir/ritonavir with or without dasabuvir and with weight-based RBV for 12 or 24 weeks in HCV + GT1 participants according to standard of care within local label recommendations for their specific disease characteristics (cirrhotic status, genotype).
Blood and lymphatic system disorders ANAEMIA	2.0% 1/49 • Number of events 1 • Safety was assessed only as treatment emergent adverse events (TEAEs) as recorded by the treating physician. TEAEs were collected after the first dose of study drug through 30 days after last dose of study drug. TEAEs were defined as any adverse event (AE) with onset date after the first dose of study drug until 30 days after last dose of study drug. Serious adverse events were reported to AbbVie from the time the physician obtained the participant's informed consent form until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment.	0.00% 0/16 • Safety was assessed only as treatment emergent adverse events (TEAEs) as recorded by the treating physician. TEAEs were collected after the first dose of study drug through 30 days after last dose of study drug. TEAEs were defined as any adverse event (AE) with onset date after the first dose of study drug until 30 days after last dose of study drug. Serious adverse events were reported to AbbVie from the time the physician obtained the participant's informed consent form until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment.
Cardiac disorders CORONARY ARTERY DISEASE	2.0% 1/49 • Number of events 1 • Safety was assessed only as treatment emergent adverse events (TEAEs) as recorded by the treating physician. TEAEs were collected after the first dose of study drug through 30 days after last dose of study drug. TEAEs were defined as any adverse event (AE) with onset date after the first dose of study drug until 30 days after last dose of study drug. Serious adverse events were reported to AbbVie from the time the physician obtained the participant's informed consent form until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment.	0.00% 0/16 • Safety was assessed only as treatment emergent adverse events (TEAEs) as recorded by the treating physician. TEAEs were collected after the first dose of study drug through 30 days after last dose of study drug. TEAEs were defined as any adverse event (AE) with onset date after the first dose of study drug until 30 days after last dose of study drug. Serious adverse events were reported to AbbVie from the time the physician obtained the participant's informed consent form until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment.
Gastrointestinal disorders HAEMORRHOIDAL HAEMORRHAGE	0.00% 0/49 • Safety was assessed only as treatment emergent adverse events (TEAEs) as recorded by the treating physician. TEAEs were collected after the first dose of study drug through 30 days after last dose of study drug. TEAEs were defined as any adverse event (AE) with onset date after the first dose of study drug until 30 days after last dose of study drug. Serious adverse events were reported to AbbVie from the time the physician obtained the participant's informed consent form until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment.	6.2% 1/16 • Number of events 1 • Safety was assessed only as treatment emergent adverse events (TEAEs) as recorded by the treating physician. TEAEs were collected after the first dose of study drug through 30 days after last dose of study drug. TEAEs were defined as any adverse event (AE) with onset date after the first dose of study drug until 30 days after last dose of study drug. Serious adverse events were reported to AbbVie from the time the physician obtained the participant's informed consent form until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment.
Gastrointestinal disorders RECTAL HAEMORRHAGE	0.00% 0/49 • Safety was assessed only as treatment emergent adverse events (TEAEs) as recorded by the treating physician. TEAEs were collected after the first dose of study drug through 30 days after last dose of study drug. TEAEs were defined as any adverse event (AE) with onset date after the first dose of study drug until 30 days after last dose of study drug. Serious adverse events were reported to AbbVie from the time the physician obtained the participant's informed consent form until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment.	6.2% 1/16 • Number of events 1 • Safety was assessed only as treatment emergent adverse events (TEAEs) as recorded by the treating physician. TEAEs were collected after the first dose of study drug through 30 days after last dose of study drug. TEAEs were defined as any adverse event (AE) with onset date after the first dose of study drug until 30 days after last dose of study drug. Serious adverse events were reported to AbbVie from the time the physician obtained the participant's informed consent form until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment.
Hepatobiliary disorders HEPATIC CIRRHOSIS	2.0% 1/49 • Number of events 1 • Safety was assessed only as treatment emergent adverse events (TEAEs) as recorded by the treating physician. TEAEs were collected after the first dose of study drug through 30 days after last dose of study drug. TEAEs were defined as any adverse event (AE) with onset date after the first dose of study drug until 30 days after last dose of study drug. Serious adverse events were reported to AbbVie from the time the physician obtained the participant's informed consent form until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment.	0.00% 0/16 • Safety was assessed only as treatment emergent adverse events (TEAEs) as recorded by the treating physician. TEAEs were collected after the first dose of study drug through 30 days after last dose of study drug. TEAEs were defined as any adverse event (AE) with onset date after the first dose of study drug until 30 days after last dose of study drug. Serious adverse events were reported to AbbVie from the time the physician obtained the participant's informed consent form until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment.
Hepatobiliary disorders HEPATIC FIBROSIS	2.0% 1/49 • Number of events 1 • Safety was assessed only as treatment emergent adverse events (TEAEs) as recorded by the treating physician. TEAEs were collected after the first dose of study drug through 30 days after last dose of study drug. TEAEs were defined as any adverse event (AE) with onset date after the first dose of study drug until 30 days after last dose of study drug. Serious adverse events were reported to AbbVie from the time the physician obtained the participant's informed consent form until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment.	0.00% 0/16 • Safety was assessed only as treatment emergent adverse events (TEAEs) as recorded by the treating physician. TEAEs were collected after the first dose of study drug through 30 days after last dose of study drug. TEAEs were defined as any adverse event (AE) with onset date after the first dose of study drug until 30 days after last dose of study drug. Serious adverse events were reported to AbbVie from the time the physician obtained the participant's informed consent form until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment.
Hepatobiliary disorders HEPATOTOXICITY	2.0% 1/49 • Number of events 1 • Safety was assessed only as treatment emergent adverse events (TEAEs) as recorded by the treating physician. TEAEs were collected after the first dose of study drug through 30 days after last dose of study drug. TEAEs were defined as any adverse event (AE) with onset date after the first dose of study drug until 30 days after last dose of study drug. Serious adverse events were reported to AbbVie from the time the physician obtained the participant's informed consent form until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment.	0.00% 0/16 • Safety was assessed only as treatment emergent adverse events (TEAEs) as recorded by the treating physician. TEAEs were collected after the first dose of study drug through 30 days after last dose of study drug. TEAEs were defined as any adverse event (AE) with onset date after the first dose of study drug until 30 days after last dose of study drug. Serious adverse events were reported to AbbVie from the time the physician obtained the participant's informed consent form until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment.
Hepatobiliary disorders HYPERBILIRUBINAEMIA	2.0% 1/49 • Number of events 1 • Safety was assessed only as treatment emergent adverse events (TEAEs) as recorded by the treating physician. TEAEs were collected after the first dose of study drug through 30 days after last dose of study drug. TEAEs were defined as any adverse event (AE) with onset date after the first dose of study drug until 30 days after last dose of study drug. Serious adverse events were reported to AbbVie from the time the physician obtained the participant's informed consent form until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment.	0.00% 0/16 • Safety was assessed only as treatment emergent adverse events (TEAEs) as recorded by the treating physician. TEAEs were collected after the first dose of study drug through 30 days after last dose of study drug. TEAEs were defined as any adverse event (AE) with onset date after the first dose of study drug until 30 days after last dose of study drug. Serious adverse events were reported to AbbVie from the time the physician obtained the participant's informed consent form until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment.
Infections and infestations PERITONITIS BACTERIAL	2.0% 1/49 • Number of events 1 • Safety was assessed only as treatment emergent adverse events (TEAEs) as recorded by the treating physician. TEAEs were collected after the first dose of study drug through 30 days after last dose of study drug. TEAEs were defined as any adverse event (AE) with onset date after the first dose of study drug until 30 days after last dose of study drug. Serious adverse events were reported to AbbVie from the time the physician obtained the participant's informed consent form until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment.	0.00% 0/16 • Safety was assessed only as treatment emergent adverse events (TEAEs) as recorded by the treating physician. TEAEs were collected after the first dose of study drug through 30 days after last dose of study drug. TEAEs were defined as any adverse event (AE) with onset date after the first dose of study drug until 30 days after last dose of study drug. Serious adverse events were reported to AbbVie from the time the physician obtained the participant's informed consent form until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment.
Renal and urinary disorders URINARY TRACT INFECTION	2.0% 1/49 • Number of events 1 • Safety was assessed only as treatment emergent adverse events (TEAEs) as recorded by the treating physician. TEAEs were collected after the first dose of study drug through 30 days after last dose of study drug. TEAEs were defined as any adverse event (AE) with onset date after the first dose of study drug until 30 days after last dose of study drug. Serious adverse events were reported to AbbVie from the time the physician obtained the participant's informed consent form until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment.	0.00% 0/16 • Safety was assessed only as treatment emergent adverse events (TEAEs) as recorded by the treating physician. TEAEs were collected after the first dose of study drug through 30 days after last dose of study drug. TEAEs were defined as any adverse event (AE) with onset date after the first dose of study drug until 30 days after last dose of study drug. Serious adverse events were reported to AbbVie from the time the physician obtained the participant's informed consent form until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment.

Other adverse events

Measure	ABBVIE REGIMEN n=49 participants at risk ABBVIE REGIMEN: ombitasvir/paritaprevir/ritonavir with or without dasabuvir for 12 or 24 weeks in Hepatitis C Virus Genotype 1 (HCV + GT1) participants according to standard of care within local label recommendations for their specific disease characteristics (cirrhotic status, genotype).	ABBVIE REGIMEN Plus Ribavirin (RBV) n=16 participants at risk ABBVIE REGIMEN plus ribavirin (RBV): ombitasvir/paritaprevir/ritonavir with or without dasabuvir and with weight-based RBV for 12 or 24 weeks in HCV + GT1 participants according to standard of care within local label recommendations for their specific disease characteristics (cirrhotic status, genotype).
Blood and lymphatic system disorders ANAEMIA	0.00% 0/49 • Safety was assessed only as treatment emergent adverse events (TEAEs) as recorded by the treating physician. TEAEs were collected after the first dose of study drug through 30 days after last dose of study drug. TEAEs were defined as any adverse event (AE) with onset date after the first dose of study drug until 30 days after last dose of study drug. Serious adverse events were reported to AbbVie from the time the physician obtained the participant's informed consent form until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment.	12.5% 2/16 • Number of events 2 • Safety was assessed only as treatment emergent adverse events (TEAEs) as recorded by the treating physician. TEAEs were collected after the first dose of study drug through 30 days after last dose of study drug. TEAEs were defined as any adverse event (AE) with onset date after the first dose of study drug until 30 days after last dose of study drug. Serious adverse events were reported to AbbVie from the time the physician obtained the participant's informed consent form until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment.
Gastrointestinal disorders DIARRHOEA	6.1% 3/49 • Number of events 3 • Safety was assessed only as treatment emergent adverse events (TEAEs) as recorded by the treating physician. TEAEs were collected after the first dose of study drug through 30 days after last dose of study drug. TEAEs were defined as any adverse event (AE) with onset date after the first dose of study drug until 30 days after last dose of study drug. Serious adverse events were reported to AbbVie from the time the physician obtained the participant's informed consent form until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment.	0.00% 0/16 • Safety was assessed only as treatment emergent adverse events (TEAEs) as recorded by the treating physician. TEAEs were collected after the first dose of study drug through 30 days after last dose of study drug. TEAEs were defined as any adverse event (AE) with onset date after the first dose of study drug until 30 days after last dose of study drug. Serious adverse events were reported to AbbVie from the time the physician obtained the participant's informed consent form until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment.
General disorders OEDEMA PERIPHERAL	0.00% 0/49 • Safety was assessed only as treatment emergent adverse events (TEAEs) as recorded by the treating physician. TEAEs were collected after the first dose of study drug through 30 days after last dose of study drug. TEAEs were defined as any adverse event (AE) with onset date after the first dose of study drug until 30 days after last dose of study drug. Serious adverse events were reported to AbbVie from the time the physician obtained the participant's informed consent form until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment.	6.2% 1/16 • Number of events 1 • Safety was assessed only as treatment emergent adverse events (TEAEs) as recorded by the treating physician. TEAEs were collected after the first dose of study drug through 30 days after last dose of study drug. TEAEs were defined as any adverse event (AE) with onset date after the first dose of study drug until 30 days after last dose of study drug. Serious adverse events were reported to AbbVie from the time the physician obtained the participant's informed consent form until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment.
General disorders TREATMENT FAILURE	0.00% 0/49 • Safety was assessed only as treatment emergent adverse events (TEAEs) as recorded by the treating physician. TEAEs were collected after the first dose of study drug through 30 days after last dose of study drug. TEAEs were defined as any adverse event (AE) with onset date after the first dose of study drug until 30 days after last dose of study drug. Serious adverse events were reported to AbbVie from the time the physician obtained the participant's informed consent form until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment.	6.2% 1/16 • Number of events 1 • Safety was assessed only as treatment emergent adverse events (TEAEs) as recorded by the treating physician. TEAEs were collected after the first dose of study drug through 30 days after last dose of study drug. TEAEs were defined as any adverse event (AE) with onset date after the first dose of study drug until 30 days after last dose of study drug. Serious adverse events were reported to AbbVie from the time the physician obtained the participant's informed consent form until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment.
Hepatobiliary disorders HEPATITIS C	0.00% 0/49 • Safety was assessed only as treatment emergent adverse events (TEAEs) as recorded by the treating physician. TEAEs were collected after the first dose of study drug through 30 days after last dose of study drug. TEAEs were defined as any adverse event (AE) with onset date after the first dose of study drug until 30 days after last dose of study drug. Serious adverse events were reported to AbbVie from the time the physician obtained the participant's informed consent form until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment.	6.2% 1/16 • Number of events 1 • Safety was assessed only as treatment emergent adverse events (TEAEs) as recorded by the treating physician. TEAEs were collected after the first dose of study drug through 30 days after last dose of study drug. TEAEs were defined as any adverse event (AE) with onset date after the first dose of study drug until 30 days after last dose of study drug. Serious adverse events were reported to AbbVie from the time the physician obtained the participant's informed consent form until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment.
Infections and infestations CYSTITIS	0.00% 0/49 • Safety was assessed only as treatment emergent adverse events (TEAEs) as recorded by the treating physician. TEAEs were collected after the first dose of study drug through 30 days after last dose of study drug. TEAEs were defined as any adverse event (AE) with onset date after the first dose of study drug until 30 days after last dose of study drug. Serious adverse events were reported to AbbVie from the time the physician obtained the participant's informed consent form until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment.	6.2% 1/16 • Number of events 1 • Safety was assessed only as treatment emergent adverse events (TEAEs) as recorded by the treating physician. TEAEs were collected after the first dose of study drug through 30 days after last dose of study drug. TEAEs were defined as any adverse event (AE) with onset date after the first dose of study drug until 30 days after last dose of study drug. Serious adverse events were reported to AbbVie from the time the physician obtained the participant's informed consent form until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment.
Musculoskeletal and connective tissue disorders BACK PAIN	0.00% 0/49 • Safety was assessed only as treatment emergent adverse events (TEAEs) as recorded by the treating physician. TEAEs were collected after the first dose of study drug through 30 days after last dose of study drug. TEAEs were defined as any adverse event (AE) with onset date after the first dose of study drug until 30 days after last dose of study drug. Serious adverse events were reported to AbbVie from the time the physician obtained the participant's informed consent form until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment.	6.2% 1/16 • Number of events 1 • Safety was assessed only as treatment emergent adverse events (TEAEs) as recorded by the treating physician. TEAEs were collected after the first dose of study drug through 30 days after last dose of study drug. TEAEs were defined as any adverse event (AE) with onset date after the first dose of study drug until 30 days after last dose of study drug. Serious adverse events were reported to AbbVie from the time the physician obtained the participant's informed consent form until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment.
Psychiatric disorders INSOMNIA	0.00% 0/49 • Safety was assessed only as treatment emergent adverse events (TEAEs) as recorded by the treating physician. TEAEs were collected after the first dose of study drug through 30 days after last dose of study drug. TEAEs were defined as any adverse event (AE) with onset date after the first dose of study drug until 30 days after last dose of study drug. Serious adverse events were reported to AbbVie from the time the physician obtained the participant's informed consent form until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment.	6.2% 1/16 • Number of events 1 • Safety was assessed only as treatment emergent adverse events (TEAEs) as recorded by the treating physician. TEAEs were collected after the first dose of study drug through 30 days after last dose of study drug. TEAEs were defined as any adverse event (AE) with onset date after the first dose of study drug until 30 days after last dose of study drug. Serious adverse events were reported to AbbVie from the time the physician obtained the participant's informed consent form until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment.
Respiratory, thoracic and mediastinal disorders COUGH	0.00% 0/49 • Safety was assessed only as treatment emergent adverse events (TEAEs) as recorded by the treating physician. TEAEs were collected after the first dose of study drug through 30 days after last dose of study drug. TEAEs were defined as any adverse event (AE) with onset date after the first dose of study drug until 30 days after last dose of study drug. Serious adverse events were reported to AbbVie from the time the physician obtained the participant's informed consent form until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment.	6.2% 1/16 • Number of events 1 • Safety was assessed only as treatment emergent adverse events (TEAEs) as recorded by the treating physician. TEAEs were collected after the first dose of study drug through 30 days after last dose of study drug. TEAEs were defined as any adverse event (AE) with onset date after the first dose of study drug until 30 days after last dose of study drug. Serious adverse events were reported to AbbVie from the time the physician obtained the participant's informed consent form until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment.
Skin and subcutaneous tissue disorders PRURITUS	4.1% 2/49 • Number of events 2 • Safety was assessed only as treatment emergent adverse events (TEAEs) as recorded by the treating physician. TEAEs were collected after the first dose of study drug through 30 days after last dose of study drug. TEAEs were defined as any adverse event (AE) with onset date after the first dose of study drug until 30 days after last dose of study drug. Serious adverse events were reported to AbbVie from the time the physician obtained the participant's informed consent form until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment.	12.5% 2/16 • Number of events 2 • Safety was assessed only as treatment emergent adverse events (TEAEs) as recorded by the treating physician. TEAEs were collected after the first dose of study drug through 30 days after last dose of study drug. TEAEs were defined as any adverse event (AE) with onset date after the first dose of study drug until 30 days after last dose of study drug. Serious adverse events were reported to AbbVie from the time the physician obtained the participant's informed consent form 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