Adults 18 to 80, any sex, with Hepatitis C. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percentage of Participants Who Maintained a Sustained Virologic Response (SVR) Out of Those Who Achieved SVR12 in a Prior Study With an ABT-493- and/or ABT-530-containing RegimenPrimary· From the end of treatment in the previous study up to 3 years post-treatment
Maintaining a sustained virologic response (SVR) is defined as having Hepatitis C virus ribonucleic acid (HCV RNA) value consistently below the lower limit of quantification (\< LLOQ) from the end of treatment in the previous study throughout Study M13-576 (this study).
Group
Value
95% CI
HCV-infected Participants
99.5
Percentage of Participants Who Relapsed or Had a New Hepatitis C Virus (HCV) Infection at Any Time up to the Last Follow-up in This Study Among Participants Who Achieved SVR12 in a Prior Study With an ABT-493- and/or ABT-530-containing RegimenPrimary· From the end of treatment in the previous study up to 3 years post-treatment
Relapse was defined as confirmed Hepatitis C virus ribonucleic acid (HCV RNA) greater than or equal to the lower limit of quantification (≥ LLOQ) between end of treatment and up to and including the last HCV RNA measurement collected in this study for a participant with HCV RNA \< LLOQ at Final Treatment Visit who completed treatment, excluding reinfection. HCV reinfection was defined as confirmed HCV RNA ≥ LLOQ after the end of treatment in a participant who had HCV RNA \< LLOQ at Final Treatment Visit, along with the post-treatment detection of a different HCV genotype, subtype, or clade com
Relapse overall
Group
Value
95% CI
HCV-infected Participants
0.3
Reinfection overall
Group
Value
95% CI
HCV-infected Participants
0.3
Number of Participants With Persistence of Resistance-Associated Amino Acid Variants Among Those Experiencing Virologic FailurePrimary· From Day 1 to Month 12
Plasma samples for HCV resistance testing were collected at study visits. The variants in nonstructural viral protein 3 (NS3) and nonstructural viral protein 5A (NS5A) at amino acid positions of interest were analyzed by next generation sequencing relative to baseline and prototypic reference sequences.
NS3 Variants at Months 3, 6, and 12
Group
Value
95% CI
HCV-infected Participants
1
NS5A Variants at Months 3, 6, and 12
Group
Value
95% CI
HCV-infected Participants
1
Number of Participants With Medical Events Related to Progression of Liver Disease or Hepatitis C Virus InfectionSecondary· After Day 1 up to 3 years post-treatment
Any events (i.e., diagnoses) related to liver disease progression and/or HCV infection considered to be clinically significant by the investigator that began or worsened after Day 1 were documented until the end of the study or initiation of re-treatment for HCV (if applicable). Significant events related to liver disease progression include the development of cirrhosis, events indicative of hepatic decompensation, (including: variceal bleeding, new ascites, spontaneous bacterial peritonitis, hepatic encephalopathy, hepato-renal syndrome, hepatic hydrothorax or other evidence of hepatic decomp
Medical events related to liver disease or HCV inf
Group
Value
95% CI
HCV-infected Participants
7
Development of cirrhosis
Group
Value
95% CI
HCV-infected Participants
0
Liver decompensation (Variceal bleeding)
Group
Value
95% CI
HCV-infected Participants
0
Liver decompensation (Ascites)
Group
Value
95% CI
HCV-infected Participants
0
Liver decomp (spontaneous bacterial peritonitis)
Group
Value
95% CI
HCV-infected Participants
0
Liver decompensation (hepatic encephalopathy)
Group
Value
95% CI
HCV-infected Participants
0
Liver decompensation (hepatorenal syndrome)
Group
Value
95% CI
HCV-infected Participants
0
Liver decompensation (hepatic hydrothorax)
Group
Value
95% CI
HCV-infected Participants
0
Mean Concentration of Interferon Gamma-induced Protein 10 (IP-10) Over TimeSecondary· From Day 1 up to 3 years post-treatment
A plasma sample for IP-10 testing was collected at study visits for all participants, until the end of the study or initiation of re-treatment for HCV (if applicable). IP-10 is used to assess liver fibrosis in participants with chronic liver disease.
Day 1
Group
Value
95% CI
HCV-infected Participants
146.884
± 116.6272
Month 3
Group
Value
95% CI
HCV-infected Participants
147.606
± 118.5143
Month 6
Group
Value
95% CI
HCV-infected Participants
148.959
± 119.0047
Month 12
Group
Value
95% CI
HCV-infected Participants
224.400
Month 18
Group
Value
95% CI
HCV-infected Participants
133.300
± 50.2647
Month 24
Group
Value
95% CI
HCV-infected Participants
140.185
± 97.2769
Month 30
Group
Value
95% CI
HCV-infected Participants
164.244
± 276.9176
Month 36
Group
Value
95% CI
HCV-infected Participants
120.600
Mean FibroTest Score Over TimeSecondary· From Day 1 up to 3 years post-treatment
A serum sample for FibroTest evaluation was collected at study visits for all participants, until the end of the study or initiation of re-treatment for HCV (if applicable). FibroTest uses six biomarkers to generate a score that correlates to the degree of liver damage in participants. Scores range from 0 to 1, with higher scores indicating more severe liver fibrosis.
Day 1
Group
Value
95% CI
HCV-infected Participants
0.354
± 0.2341
Month 3
Group
Value
95% CI
HCV-infected Participants
0.363
± 0.2383
Month 6
Group
Value
95% CI
HCV-infected Participants
0.353
± 0.2311
Month 12
Group
Value
95% CI
HCV-infected Participants
0.405
± 0.0919
Month 18
Group
Value
95% CI
HCV-infected Participants
0.272
± 0.1281
Month 24
Group
Value
95% CI
HCV-infected Participants
0.321
± 0.2156
Month 30
Group
Value
95% CI
HCV-infected Participants
0.261
± 0.1667
Month 36
Group
Value
95% CI
HCV-infected Participants
0.190
Mean Aspartate Transaminase to Platelet Ratio Index (APRI) Over TimeSecondary· From Day 1 up to 3 years post-treatment
A serum sample for aspartate transaminase evaluation and platelets were collected at study visits for all participants, until the end of the study or initiation of re-treatment for HCV (if applicable). The aspartate transaminase to platelet ratio index (APRI) is used to assess liver fibrosis in participants with chronic liver disease. Scores range from 0 to ≥ 2.0, with scores \< 0.5 predictive of no liver fibrosis; scores \>1.5 significant fibrosis; and scores \> 2.0 indicative of cirrhosis.
Day 1
Group
Value
95% CI
HCV-infected Participants
0.317
± 0.2268
Month 3
Group
Value
95% CI
HCV-infected Participants
0.303
± 0.2171
Month 6
Group
Value
95% CI
HCV-infected Participants
0.298
± 0.2101
Month 12
Group
Value
95% CI
HCV-infected Participants
0.230
Month 18
Group
Value
95% CI
HCV-infected Participants
0.262
± 0.0589
Month 24
Group
Value
95% CI
HCV-infected Participants
0.275
± 0.1620
Month 30
Group
Value
95% CI
HCV-infected Participants
0.227
± 0.1084
Month 36
Group
Value
95% CI
HCV-infected Participants
0.215
± 0.1768
Mean FibroScan Scores Over TimeSecondary· Up to 3 years post-treatment
The FibroScan test is used to assess liver fibrosis in participants with chronic liver disease. This was not performed as a study procedure, but any available results from source documents were summarized. For participants with Hepatitis C infection, a Fibroscan score of 2-7 kPa indicates no liver scarring or mild scarring; a score of 8 or 9 is associated with moderate liver scarring; 9-14 indicates severe liver scarring; and 14 or higher is indicative of advanced liver scarring, cirrhosis.
Day 1
Group
Value
95% CI
HCV-infected Participants
13.014
± 12.6850
Month 3
Group
Value
95% CI
HCV-infected Participants
6.880
± 4.6677
Month 6
Group
Value
95% CI
HCV-infected Participants
10.780
± 5.9260
Month 12
Group
Value
95% CI
HCV-infected Participants
7.700
± 4.2208
Month 18
Group
Value
95% CI
HCV-infected Participants
6.913
± 2.8002
Month 24
Group
Value
95% CI
HCV-infected Participants
6.757
± 3.1564
Month 30
Group
Value
95% CI
HCV-infected Participants
9.400
Sponsor's own description
This was a long-term follow-up study to evaluate the durability of sustained virologic response (SVR), persistence of direct-acting antiviral agent (DAA) resistance, and clinical outcomes for participants who received glecaprevir (ABT-493) and/or pibrentasvir (ABT-530) in prior AbbVie Phase 2 or 3 clinical studies for the treatment of chronic hepatitis C virus (HCV) infection.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
NCT02243293 — A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Co-Administration of ABT-493 and ABT-530 With and With
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Sponsor: as reported to ClinicalTrials.gov by AbbVie
Last refreshed: 21 September 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02441283.