Real World Evidence of the Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin and Patient Support Program in Patients With Chronic Hepatitis C
- Conditions
- Chronic Hepatitis C
- Interventions
- Behavioral: Patient support program
- Registration Number
- NCT02803138
- Lead Sponsor
- AbbVie
- Brief Summary
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.
- Detailed Description
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 \[SVR24\]).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 256
Not provided
- None
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Participants with HCV genotype 1 or 4 Patient support program 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 Participants with HCV genotype 1 or 4 Ombitasvir/paritaprevir/ritonavir 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 Participants with HCV genotype 1 or 4 Dasabuvir 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 Participants with HCV genotype 1 or 4 Ribavirin 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
- Primary Outcome Measures
Name Time Method Percentage of Participants Achieving Sustained Virologic Response 12 Weeks Post-treatment (SVR12) 12 weeks after the last actual dose of study drug 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.
- Secondary Outcome Measures
Name Time Method Percentage of Participants With Virologic Response at End of Treatment (EoT) Up to 24 weeks 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 With Sufficient Follow-up Who Achieved Sustained Virological Response 12 Weeks Posttreatment 12 weeks (at least 70 days) after the last actual dose of study drug 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 failurePercentage of Participants With Relapse Up to 48 weeks after the last actual dose of study drug 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 With Viral Breakthrough Up to 24 weeks 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 With On-treatment Virologic Failure 12 weeks after the last actual dose of study drug 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 Meeting Relapse Criteria 12 weeks after the last actual dose of study drug 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 Meeting Premature Study Drug Discontinuation Criteria 12 weeks after the last actual dose of study drug Premature study drug discontinuation was defined as participants who prematurely discontinued study drug with no on-treatment virologic failure.
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 12 weeks after the last actual dose of study drug 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.
Trial Locations
- Locations (18)
Ha'Emek Medical Center /ID# 153695
🇮🇱Afula, Israel
Assaf Harofeh Medical Center /ID# 153708
🇮🇱Be'er Ya'akov, Israel
The Edith Wolfson Medical Cent /ID# 153706
🇮🇱Holon, Israel
Soroka Medical Center /ID# 169357
🇮🇱Be'er Sheva, HaDarom, Israel
Rabin Medical Center /ID# 153696
🇮🇱Petakh Tikva, Tel-Aviv, Israel
Rabin Medical Center /ID# 158648
🇮🇱Petakh Tikva, Tel-Aviv, Israel
Maccabi Health Services /ID# 158647
🇮🇱Gush Dan, Israel
Tel Aviv Sourasky Medical Ctr /ID# 153693
🇮🇱Tel Aviv-Yafo, Tel-Aviv, Israel
Hillel Yaffe Medical Center /ID# 153702
🇮🇱Hadera, Israel
Soroka Medical Ctr /ID# 153697
🇮🇱Be'er Sheva, Israel
Bnai Zion Medical Center /ID# 153700
🇮🇱Haifa, Israel
Rambam Health Care Campus /ID# 153694
🇮🇱Haifa, Israel
Shaare Zedek Medical Center /ID# 153699
🇮🇱Jerusalem, Israel
The Lady Davis Carmel MC /ID# 153692
🇮🇱Haifa, Israel
Hadassah /ID# 153701
🇮🇱Jerusalem, Israel
Western Galilee Medical Center /ID# 153705
🇮🇱Nahariya, Israel
Sheba Medical Center /ID# 153707
🇮🇱Ramat Gan, Israel
Meir Medical Center /ID# 153698
🇮🇱Kfar Saba, Israel