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

Real World Evidence of the Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Participants With Chronic Hepatitis C - An Observational Study in Greece

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02725866

Enrollment

216

Registered

2016-04-01

Start date

2016-04-05

Completion date

2017-10-31

Last updated

2019-03-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Hepatitis C

Keywords

Observational Study, Sustained Virological Response, Chronic Hepatitis C genotype 1, Chronic Hepatitis C, Ombitasvir/paritaprevir/ritonavir ± dasabuvir, Chronic Hepatitis C genotype 4

Brief summary

The interferon-free combination regimen of paritaprevir/ritonavir/ombitasvir 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 is the first effectiveness research examining the ABBVIE REGIMEN ± RBV, used according to the local label, under real-world conditions in Greece 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. 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 hepatitis C virus (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 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 \[SVR24\]).

Interventions

DRUGParitaprevir/ritonavir/ombitasvir

Co-formulated tablet

DRUGDasabuvir

Tablet

DRUGRibavirin

Tablet

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 99 Years

Healthy volunteers

Inclusion criteria

* Treatment-naïve or -experienced adult male or female participants with confirmed chronic hepatitis C (CHC), genotype 1 or 4, receiving combination therapy with the interferon-free ABBVIE REGIMEN ± ribavirin (RBV) according to standard of care and in line with the current local label * If RBV was co-administered with the ABBVIE REGIMEN, it had to be prescribed in line with the current local label (with special attention to contraception requirements and contraindication during pregnancy) * Participants had to voluntarily sign and date an informed consent form prior to inclusion into the study * Participant must not have participated or intended to participate in a concurrent interventional therapeutic trial

Exclusion criteria

* None

Design outcomes

Primary

Measure	Time frame	Description
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 plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than 50 IU/mL 12 weeks after the last actual dose of study drug. The core population (CP) consisted of participants who met all inclusion criteria and were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype). The core population with sufficient follow-up data 12 weeks after the last actual dose of study drug (CPSFU12) was defined as all CP 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

Secondary

Measure	Time frame	Description
Percentage of Participants With Relapse	Up to 24 weeks	Relapse was defined as plasma 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 plasma 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 plasma 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 With Virologic Response at End of Treatment (EoT)	Up to 24 weeks	Virologic response was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than 50 IU/mL at the end of 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 was documented.
Percentage of Participants Meeting Relapse Criteria	12 weeks after the last actual dose of study drug	Relapse was defined as plasma 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.

Participant flow

Pre-assignment details

Safety population: all enrolled participants who received at least one dose of the ABBVIE REGIMEN. The prescribed ABBVIE REGIMEN needed to be known.

Participants by arm

Arm	Count
Participants With HCV Genotype 1 or 4 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 (tablet; 1000 or 1200 mg divided twice a day) up to 24 weeks	216
Total	216

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Failure to return	6
Overall Study	Insufficient virological response	1
Overall Study	Other, not specified	4
Overall Study	Withdrew consent	3

Baseline characteristics

Characteristic	Participants With HCV Genotype 1 or 4
Age, Continuous	56 years STANDARD_DEVIATION 13
Hepatitis C genotype Genotype 1	151 Participants
Hepatitis C genotype Genotype 4	65 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants
Race (NIH/OMB) Asian	1 Participants
Race (NIH/OMB) Black or African American	2 Participants
Race (NIH/OMB) More than one race	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants
Race (NIH/OMB) White	211 Participants
Sex: Female, Male Female	101 Participants
Sex: Female, Male Male	115 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 216
other Total, other adverse events	21 / 216
serious Total, serious adverse events	7 / 216

Outcome results

Primary

Percentage of Participants Achieving Sustained Virologic Response 12 Weeks Post-treatment (SVR12)

SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than 50 IU/mL 12 weeks after the last actual dose of study drug. The core population (CP) consisted of participants who met all inclusion criteria and were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype). The core population with sufficient follow-up data 12 weeks after the last actual dose of study drug (CPSFU12) was defined as all CP 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