A Phase 3 interventional study of Glecaprevir/Pibrentasvir in Hepatitis C Virus (HCV), sponsored by AbbVie. Completed at 25 sites in 9 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-07-30.
Sponsored by AbbVie · Phase 3, Interventional, and Treatment
A Phase 3b, open-label, multicenter study to evaluate the efficacy and safety of glecaprevir/pibrentasvir for an 8- or 12-week treatment duration in participants with chronic hepatitis C virus (HCV) genotype (GT) 5 or 6 infection, with or without compensated cirrhosis respectively.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 84 is below the median of 120 across 4,200 interventional studies indexed under Infections.
Browse Infections 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.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Non-cirrhotic participants with hepatitis C virus genotype 5 or 6 received oral glecaprevir/pibrentasir (300 mg/120 mg) once daily with food for 8 weeks, according to label.
Drug: Glecaprevir/Pibrentasvir
Participants with hepatitis C virus genotype 5 or 6 and compensated cirrhosis received oral glecaprevir/pibrentasir (300 mg/120 mg) once daily with food for 12 weeks, according to label.
Drug: Glecaprevir/Pibrentasvir
Fixed-dose combination tablets taken orally once a day.
Also known as: ABT-493/ABT-530, MAVYRET™
Percentage of Participants With Sustained Virologic Response 12 Weeks Post Treatment (SVR12)
SVR12 is defined as hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification (LLOQ; less than 15 IU/mL) 12 weeks after the last actual dose of study drug.
Time frame: 12 weeks after last dose of study drug (week 20 or 24 depending on the treatment regimen)
Percentage of Participants With On-treatment HCV Virologic Failure
HCV virologic failure was defined as one of the following conditions: * confirmed HCV RNA ≥ 100 IU/mL after HCV RNA \< 15 IU/mL during the Treatment Period; or confirmed increase from nadir in HCV RNA (two consecutive HCV RNA measurements \> 1 log10 IU/mL above nadir) at any time point during the Treatment Period; or * HCV RNA ≥ 15 IU/mL at end of treatment with at least 6 weeks of treatment, where the HCV RNA value must be collected on or after Study Drug Day 36 and study drug duration ≥ 36 days.
Time frame: 8 or 12 weeks (depending on the treatment regimen)
Percentage of Participants With Relapse
Relapse was defined as confirmed HCV RNA ≥ 15 IU/mL between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment as planned with HCV RNA \< 15 IU/mL at the end of treatment and had post-treatment HCV RNA data; participants who had been shown to be re-infected were not considered to have relapsed.
Time frame: End of treatment (week 8 or 12 depending on the treatment regimen) through 12 weeks after the end of treatment.
This study was conducted in 24 hospitals or clinics in Europe (Belgium, France), Oceania (Australia, New Zealand), North America (Canada, USA), South Africa, and southeast Asia (Singapore, Vietnam). Participants were screened between January 17, 2017, and December 26, 2017.
| Milestone | Genotype 5-infected | Genotype 6-infected |
|---|---|---|
| Started | 23 | 61 |
| Completed | 23 | 60 |
| Not completed | 0 | 1 |
| Withdrew: Patient left the country | 0 | 1 |
SVR12 is defined as hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification (LLOQ; less than 15 IU/mL) 12 weeks after the last actual dose of study drug.
| percentage of participants | Genotype 5-infected | Genotype 6-infected |
|---|---|---|
| Percentage of Participants With Sustained Virologic Response 12 Weeks Post Treatment (SVR12) | 95.7 (79.0 to 99.2) | 98.4 (91.3 to 99.7) |
HCV virologic failure was defined as one of the following conditions: * confirmed HCV RNA ≥ 100 IU/mL after HCV RNA \< 15 IU/mL during the Treatment Period; or confirmed increase from nadir in HCV RNA (two consecutive HCV RNA measurements \> 1 log10 IU/mL above nadir) at any time point during the Treatment Period; or * HCV RNA ≥ 15 IU/mL at end of treatment with at least 6 weeks of treatment, where the HCV RNA value must be collected on or after Study Drug Day 36 and study drug duration ≥ 36 days.
| percentage of participants | Genotype 5-infected | Genotype 6-infected |
|---|---|---|
| Percentage of Participants With On-treatment HCV Virologic Failure | 0.0 (0.0 to 14.3) | 1.6 (0.3 to 8.7) |
Relapse was defined as confirmed HCV RNA ≥ 15 IU/mL between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment as planned with HCV RNA \< 15 IU/mL at the end of treatment and had post-treatment HCV RNA data; participants who had been shown to be re-infected were not considered to have relapsed.
| percentage of participants | Genotype 5-infected | Genotype 6-infected |
|---|---|---|
| Percentage of Participants With Relapse | 4.3 (0.8 to 21.0) | 0.0 (0.0 to 6.0) |
Collected over From first dose of study drug through 30 days after the last dose of study drug; 12 or 16 weeks depending on the treatment regimen.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Glecaprevir/Pibrentasvir | 0/84 (0%) | 5/84 (6%) | 26/84 (31%) |
| Event | Glecaprevir/Pibrentasvir |
|---|---|
| ANAEMIABlood and lymphatic system disorders | 1/84 |
| ESCHERICHIA PYELONEPHRITISInfections and infestations | 1/84 |
| GASTRIC ULCER HELICOBACTERInfections and infestations | 1/84 |
| GIARDIASISInfections and infestations | 1/84 |
| PULMONARY TUBERCULOSISInfections and infestations | 1/84 |
| VIRAL INFECTIONInfections and infestations | 1/84 |
| MAJOR DEPRESSIONPsychiatric disorders | 1/84 |
| Event | Glecaprevir/Pibrentasvir |
|---|---|
| FATIGUEGeneral disorders | 11/84 |
| HEADACHENervous system disorders | 11/84 |
| DIZZINESSNervous system disorders | 6/84 |
| NAUSEAGastrointestinal disorders | 5/84 |
| INSOMNIAPsychiatric disorders | 5/84 |
All enrolled participants
| Age, Continuous(years) | Genotype 5-infected | Genotype 6-infected | Total |
|---|---|---|---|
| Median | 68.0 (24 to 76) | 54.0 (30 to 79) | 59.0 (24 to 79) |
| Age, Customized(Participants) | Genotype 5-infected | Genotype 6-infected | Total |
|---|---|---|---|
| < 65 years | 8 | 45 | 53 |
| ≥ 65 years | 15 | 16 | 31 |
| Sex: Female, Male(Participants) | Genotype 5-infected | Genotype 6-infected | Total |
|---|---|---|---|
| Female | 13 | 32 | 45 |
| Male | 10 | 29 | 39 |
| Ethnicity (NIH/OMB)(Participants) | Genotype 5-infected | Genotype 6-infected | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 23 | 61 | 84 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race/Ethnicity, Customized(Participants) | Genotype 5-infected | Genotype 6-infected | Total |
|---|---|---|---|
| White | 21 | 4 | 25 |
| Black or African American | 1 | 0 | 1 |
| Asian | 1 | 56 | 57 |
| Multi-race | 0 | 1 | 1 |
| Region of Enrollment(participants) | Genotype 5-infected | Genotype 6-infected | Total |
|---|---|---|---|
| New Zealand | 1 | 3 | 4 |
| Canada | 0 | 13 | 13 |
| Vietnam | 0 | 12 | 12 |
| Singapore | 0 | 4 | 4 |
| Belgium | 8 | 0 | 8 |
| United States | 0 | 15 | 15 |
| South Africa | 3 | 1 | 4 |
| Australia | 0 | 8 | 8 |
| France | 11 | 5 | 16 |
| Cirrhosis Status(Participants) | Genotype 5-infected | Genotype 6-infected | Total |
|---|---|---|---|
| Cirrhotic | 3 | 6 | 9 |
| Non-cirrhotic | 20 | 55 | 75 |
| Prior HCV Treatment History(Participants) | Genotype 5-infected | Genotype 6-infected | Total |
|---|---|---|---|
| Naive | 19 | 57 | 76 |
| Experienced | 4 | 4 | 8 |
1 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Supporting information: Study protocol, Sap, Csr, Analytic code
This study is completed, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.
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