An observational study in Chronic Hepatitis C, sponsored by AbbVie. Completed at 18 sites in Israel. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-10-11.
Sponsored by AbbVie · Observational
The interferon-free combination regimen of ombitasvir/paritaprevir/ritonavir/ with or without dasabuvir (ABBVIE REGIMEN) ± ribavirin (RBV) for the treatment of chronic hepatitis C (CHC) has been shown to be safe and effective in randomized controlled clinical trials with strict inclusion and exclusion criteria under well controlled conditions. This observational study was the first effectiveness research examining the ABBVIE REGIMEN ± RBV, used according to local label, under real world conditions in Israel in a clinical practice patient population.
This was a prospective, multi-center observational study in participants receiving the interferon-free ABBVIE REGIMEN ± RBV in Israel. 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 the participant the opportunity to participate in this study. Adults chronically infected with HCV, receiving the interferon-free ABBVIE REGIMEN, were offered the opportunity to participate in this study during a routine clinical visit at the participating sites. Follow-up visits, treatment, procedures, and diagnostic methods followed physicians' routine clinical practice. Data were collected at the following time windows: baseline, early on-treatment visit, mid-treatment visit (for participants with a treatment duration of 24 weeks), end of treatment (EoT), early post-treatment and 12 and 24 weeks after the end of treatment (representing sustained virologic response 12 weeks after the end of treatment [SVR12] and sustained virologic response 24 weeks after the end of treatment [SVR24]).
2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.
This study's enrollment of 256 is close to the median of 250 across 687 observational studies indexed under Hepatitis A.
Browse Hepatitis A studies →AbbVie is the lead sponsor of 953 studies on the registry; 136 are open to participants now.
Of its 350 completed or terminated interventional studies of FDA-regulated products, 210 (60%) have results posted.
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Participants with chronic hepatitis C virus infection, genotype 1 or 4, receiving combination therapy with the interferon-free ABBVIE REGIMEN ± ribavirin.
Exclusion Criteria:
Ombitasvir/paritaprevir/ritonavir (two 12.5 mg/75 mg/50 mg co-formulated tablets once daily); ± dasabuvir (tablet; 250 mg twice daily); ± weight-based ribavirin (tablets; 1000 or 1200 mg divided twice a day) up to 24 weeks
Drug: Ombitasvir/paritaprevir/ritonavir · Drug: Dasabuvir · Drug: Ribavirin · Behavioral: Patient support program
Co-formulated tablet
Also known as: Ombitasvir also known as ABT-267, Paritaprevir also known as ABT-450
Tablet
Also known as: ABT-333
Tablet
Supportive services provided to participants included reminder calls, emails, text messages, a Care Coach, and educational/informational materials.
Percentage of Participants Achieving Sustained Virologic Response 12 Weeks Post-treatment (SVR12)
SVR12 was defined as hepatitis C virus ribonucleic acid (HCV RNA) level less than 50 IU/mL 12 weeks after the last actual dose of study drug.
Time frame: 12 weeks after the last actual dose of study drug
Percentage of Participants With Virologic Response at End of Treatment (EoT)
Virologic response was defined as hepatitis C virus ribonucleic acid (HCV RNA) level less than 50 IU/mL at the end of treatment.
Time frame: Up to 24 weeks
Percentage of Participants With Sufficient Follow-up Who Achieved Sustained Virological Response 12 Weeks Posttreatment
Sustained virologic response was defined as hepatitis C virus ribonucleic acid (HCV RNA) levels less than 50 IU/mL 12 weeks after the last dose of study drug. The core population with sufficient follow-up data 12 weeks after the last actual dose of study drug (CPSFU12) was defined as all participants who fulfilled one of the following criteria: * evaluable HCV RNA data ≥70 days after the last actual dose of the ABBVIE REGIMEN * an HCV RNA value ≥50 IU/mL at the last measurement post-baseline * HCV RNA \<50 IU/mL at the last measurement post-baseline, but no HCV RNA measurement ≥70 days after the last actual dose of the ABBVIE REGIMEN due to reasons related to safety (e.g. dropped out due to AE) or virologic failure
Time frame: 12 weeks (at least 70 days) after the last actual dose of study drug
Percentage of Participants With Relapse
Relapse was defined as hepatitis C virus ribonucleic acid (HCV RNA) level less than 50 IU/mL at the end of treatment followed by HCV RNA level greater than or equal to 50 IU/mL.
Time frame: Up to 48 weeks after the last actual dose of study drug
Percentage of Participants With Viral Breakthrough
Viral breakthrough was defined as at least 1 documented hepatitis C virus ribonucleic acid (HCV RNA) level less than 50 IU/mL followed by HCV RNA level greater than or equal to 50 IU/mL during treatment.
Time frame: Up to 24 weeks
Percentage of Participants With On-treatment Virologic Failure
On-treatment virologic failure was defined as breakthrough (at least 1 documented hepatitis C virus ribonucleic acid (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).
Time frame: 12 weeks after the last actual dose of study drug
Percentage of Participants Meeting Relapse Criteria
Relapse was defined as hepatitis C virus ribonucleic acid (HCV RNA) less than 50 IU/mL at end of treatment or at the last on-treatment HCV RNA measurement followed by HCV RNA greater than or equal to 50 IU/mL post-treatment.
Time frame: 12 weeks after the last actual dose of study drug
Percentage of Participants Meeting Premature Study Drug Discontinuation Criteria
Premature study drug discontinuation was defined as participants who prematurely discontinued study drug with no on-treatment virologic failure.
Time frame: 12 weeks after the last actual dose of study drug
Percentage of Participants With Missing Sustained Virologic Response 12 Weeks Post-Treatment (SVR12) Data and/or Nonresponders Who Did Not Meet Specific SVR12 Nonresponder Criteria
The number of participants with missing SVR12 data or SVR12 nonresponder participants who did not meet criteria for on-treatment virologic failure, relapse, premature treatment discontinuation, and who did not have an Insufficient virological response reported was documented.
Time frame: 12 weeks after the last actual dose of study drug
| Milestone | Participants With HCV Genotype 1 or 4 |
|---|---|
| Started | 236 |
| Completed | 166 |
| Not completed | 70 |
| Withdrew: Failure to return | 38 |
| Withdrew: Insufficient virological response | 2 |
| Withdrew: Withdrawn consent | 1 |
| Withdrew: Death | 1 |
| Withdrew: Other, not specified | 28 |
SVR12 was defined as hepatitis C virus ribonucleic acid (HCV RNA) level less than 50 IU/mL 12 weeks after the last actual dose of study drug.
| percentage of participants | Participants With HCV Genotype 1 or 4 |
|---|---|
| Percentage of Participants Achieving Sustained Virologic Response 12 Weeks Post-treatment (SVR12) | 70.6 (64.4 to 76.1) |
Virologic response was defined as hepatitis C virus ribonucleic acid (HCV RNA) level less than 50 IU/mL at the end of treatment.
| percentage of participants | Participants With HCV Genotype 1 or 4 |
|---|---|
| Percentage of Participants With Virologic Response at End of Treatment (EoT) | 82.0 (76.5 to 86.5) |
Sustained virologic response was defined as hepatitis C virus ribonucleic acid (HCV RNA) levels less than 50 IU/mL 12 weeks after the last dose of study drug. The core population with sufficient follow-up data 12 weeks after the last actual dose of study drug (CPSFU12) was defined as all participants who fulfilled one of the following criteria: * evaluable HCV RNA data ≥70 days after the last actual dose of the ABBVIE REGIMEN * an HCV RNA value ≥50 IU/mL at the last measurement post-baseline * HCV RNA \<50 IU/mL at the last measurement post-baseline, but no HCV RNA measurement ≥70 days after the last actual dose of the ABBVIE REGIMEN due to reasons related to safety (e.g. dropped out due to AE) or virologic failure
| percentage of participants | Participants With HCV Genotype 1 or 4 |
|---|---|
| Percentage of Participants With Sufficient Follow-up Who Achieved Sustained Virological Response 12 Weeks Posttreatment | 95.8 (91.7 to 98.0) |
Relapse was defined as hepatitis C virus ribonucleic acid (HCV RNA) level less than 50 IU/mL at the end of treatment followed by HCV RNA level greater than or equal to 50 IU/mL.
| percentage of participants | Participants With HCV Genotype 1 or 4 |
|---|---|
| Percentage of Participants With Relapse | 0.0 (0.0 to 2.4) |
Viral breakthrough was defined as at least 1 documented hepatitis C virus ribonucleic acid (HCV RNA) level less than 50 IU/mL followed by HCV RNA level greater than or equal to 50 IU/mL during treatment.
| percentage of participants | Participants With HCV Genotype 1 or 4 |
|---|---|
| Percentage of Participants With Viral Breakthrough | 0.0 (0.0 to 3.7) |
On-treatment virologic failure was defined as breakthrough (at least 1 documented hepatitis C virus ribonucleic acid (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).
| percentage of participants | Participants With HCV Genotype 1 or 4 |
|---|---|
| Percentage of Participants With On-treatment Virologic Failure | 1.3 |
Relapse was defined as hepatitis C virus ribonucleic acid (HCV RNA) less than 50 IU/mL at end of treatment or at the last on-treatment HCV RNA measurement followed by HCV RNA greater than or equal to 50 IU/mL post-treatment.
| percentage of participants | Participants With HCV Genotype 1 or 4 |
|---|---|
| Percentage of Participants Meeting Relapse Criteria | 0 |
Premature study drug discontinuation was defined as participants who prematurely discontinued study drug with no on-treatment virologic failure.
| percentage of participants | Participants With HCV Genotype 1 or 4 |
|---|---|
| Percentage of Participants Meeting Premature Study Drug Discontinuation Criteria | 1.8 |
The number of participants with missing SVR12 data or SVR12 nonresponder participants who did not meet criteria for on-treatment virologic failure, relapse, premature treatment discontinuation, and who did not have an Insufficient virological response reported was documented.
| percentage of participants | Participants With HCV Genotype 1 or 4 |
|---|---|
| Percentage of Participants With Missing Sustained Virologic Response 12 Weeks Post-Treatment (SVR12) Data and/or Nonresponders Who Did Not Meet Specific SVR12 Nonresponder Criteria | 25.9 |
Collected over 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).. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Ombitasvir/Paritaprevir/Ritonavir + Dasabuvir | 1/216 (0.5%) | 4/216 (1.9%) | 15/216 (6.9%) |
| Ombitasvir/Paritaprevir/Ritonavir | 0/6 (0%) | 1/6 (16.7%) | 2/6 (33.3%) |
| Ombitasvir/Paritaprevir/Ritonavir + Dasabuvir + Ribavirin | 0/14 (0%) | 1/14 (7.1%) | 4/14 (28.6%) |
| Event | Ombitasvir/Paritaprevir/Ritonavir + Dasabuvir | Ombitasvir/Paritaprevir/Ritonavir | Ombitasvir/Paritaprevir/Ritonavir + Dasabuvir + Ribavirin |
|---|---|---|---|
| ASCITESGastrointestinal disorders | 0/216 | 1/6 | 0/14 |
| DYSPNOEARespiratory, thoracic and mediastinal disorders | 0/216 | 1/6 | 0/14 |
| HEPATIC FAILUREHepatobiliary disorders | 0/216 | 0/6 | 1/14 |
| HEPATIC ENCEPHALOPATHYNervous system disorders | 0/216 | 0/6 | 1/14 |
| ATRIAL FIBRILLATIONCardiac disorders | 1/216 | 0/6 | 0/14 |
| TOXICITY TO VARIOUS AGENTSInjury, poisoning and procedural complications | 1/216 | 0/6 | 0/14 |
| UPPER LIMB FRACTUREInjury, poisoning and procedural complications | 1/216 | 0/6 | 0/14 |
| SYNOVIAL CYSTMusculoskeletal and connective tissue disorders | 1/216 | 0/6 | 0/14 |
| Event | Ombitasvir/Paritaprevir/Ritonavir + Dasabuvir | Ombitasvir/Paritaprevir/Ritonavir | Ombitasvir/Paritaprevir/Ritonavir + Dasabuvir + Ribavirin |
|---|---|---|---|
| OEDEMA PERIPHERALGeneral disorders | 2/216 | 2/6 | 0/14 |
| VISION BLURREDEye disorders | 0/216 | 1/6 | 1/14 |
| PRURITUSSkin and subcutaneous tissue disorders | 5/216 | 1/6 | 1/14 |
| ANAEMIABlood and lymphatic system disorders | 0/216 | 0/6 | 1/14 |
| ASTHENIAGeneral disorders | 5/216 | 0/6 | 1/14 |
| PHARYNGITISInfections and infestations | 0/216 | 0/6 | 1/14 |
| DIZZINESSNervous system disorders | 4/216 | 0/6 | 1/14 |
Safety population: all enrolled participants who received at least one dose of the ABBVIE REGIMEN. The prescribed ABBVIE REGIMEN needed to be known.
| Age, Continuous(years) | Participants With HCV Genotype 1 or 4 |
|---|---|
| Mean | 56 ± 12.7 |
| Sex: Female, Male(Participants) | Participants With HCV Genotype 1 or 4 |
|---|---|
| Female | 105 |
| Male | 131 |
| Race (NIH/OMB)(Participants) | Participants With HCV Genotype 1 or 4 |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 236 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Hepatitis C genotype(Participants) | Participants With HCV Genotype 1 or 4 |
|---|---|
| Genotype 1a | 12 |
| Genotype 1a/1b | 1 |
| Genotype 1b | 222 |
| Genotype 4 | 1 |
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