An observational study in Hepatitis C, sponsored by AbbVie. Completed at 156 sites in 9 countries. Per ClinicalTrials.gov, last updated 2021-05-19.
Sponsored by AbbVie · Observational
The interferon- and ribavirin- (RBV) free combination regimen of glecaprevir plus pibrentasvir (GLE/PIB) for the treatment of genotypes 1 to 6 of chronic hepatitis C (CHC) viral infection has been shown to be safe and effective in randomized controlled clinical trials.
This observational study is an effectiveness research examining the regimen of GLE/PIB, used according to local label, under real world conditions in a clinical practice patient population.
Patients receiving GLE/PIB who have started the treatment combination recommended in the current local label for their disease characteristics.
Exclusion Criteria:
None.
Participants receiving combination therapy with the glecaprevir plus pibrentasvir (GLE/PIB) regimen according to standard of care, international guidelines and in line with the current local label.
Percentage of participants achieving sustained virological response 12 weeks post-treatment (SVR12)
SVR12 defined as the hepatitis C virus (HCV) ribonucleic acid (RNA) level less than the lower limit of quantification 12 weeks after the last dose of Glecaprevir plus Pibrentasvir
Time frame: 12 weeks (i.e. at least 70 days) after the last dose of Glecaprevir plus Pibrentasvir
Percentage of Participants Taking Concomitant Medications
The percentage of participants taking concomitant medications from the decision to initiate treatment through 12 weeks after the last dose of glecaprevir plus pibrentasvir.
Time frame: Up to approximately 28 weeks
Percentage of Glecaprevir plus Pibrentasvir (GLE/PIB) Doses Taken out of that Prescribed
The percentage of GLE/PIB doses taken by participant in relation to the prescribed target dose (number of pills taken out of the number of pills that should have been taken).
Time frame: Up to approximately 16 weeks
Changes from Baseline in Estimated Glomerular Filtration Rate (eGFR)
Among participants with renal impairment, changes from baseline during treatment in estimated glomerular filtration rate (eGFR determined by Modification of Diet in Renal Disease \[MDRD\] equation).
Time frame: Up to 16 weeks
Number of Healthcare Resource Utilization (HCRU)
Health Care Resource Utilization (HCRU) for a participant will be the total number of visits/touchpoints (face to face or phone call) with an Health Care Provider (HCP) or designee in relation to their HCV infection during the study.
Time frame: Up to approximately 28 weeks
Percentage of Participants Using Each Treatment Regimen
Percentage of participants using each treatment regimen (intended treatment duration of 8, 12, or 16 weeks)
Time frame: Up to 16 weeks
Percentage of Participants with Co-morbidities
The percentage of participants with co-morbidities at baseline.
Time frame: Baseline (Day 1)
Showing the first 100 of 156 sites across 9 countries.
Plan to share: Undecided
This study is completed, as verified in May 2021. You cannot join it, but the record below documents what was studied.
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