Hepatitis C
Conditions
Keywords
Chronic hepatitis C, Hepatitis C virus, Sustained virologic response, Hepatitis C, Direct Acting Antiviral
Brief summary
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.
Detailed description
This was a Phase 2/3, multicenter study offered to participants who received at least one dose of an ABT-493- and/or ABT-530-containing regimen at any dose level in an eligible prior AbbVie Phase 2 or 3 study for the treatment of chronic HCV and elected to enroll in this study. The participant must have completed the follow-up period of the prior eligible AbbVie study. Participants were followed for a total of approximately 3 years after their last dose of DAA in the previous HCV clinical study. The 3 years were inclusive of any post-treatment period in the prior study, as well as any gaps between the end of the prior study and enrollment in this study.
Interventions
Sponsors
AbbVie
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Participant is male or female 18 years of age or older 2. Participant has received at least one dose of an ABT-493- and/or ABT- 530 containing regimen in a prior AbbVie hepatitis C virus (HCV) Phase 2 or 3 study 3. The interval between the last dose of the AbbVie direct-acting antiviral agent (DAA) therapy from the previous clinical study and enrollment in Study M13-576 must be no longer than 2 years for subjects who have not been retreated. Participants who have been treated with a commercially available anti-HCV treatment may be enrolled greater than 2 years after the last dose of the AbbVie DAA therapy from the previous clinical study. 4. Participant must voluntarily sign and date the informed consent form approved by an Independent Review Board or Ethics Committee prior to the initiation of any study-specific procedures. 5. Participant completed the post-treatment period of an eligible prior study.
Exclusion criteria
1. The investigator considers the participant unsuitable for the study for any reasons (e.g., failure to comply with study procedures in the prior AbbVie clinical study). 2. Receipt of any investigational HCV antiviral treatment after receiving ABT-493 and/or ABT-530 in the prior study. 3. Participants who experienced non-virologic treatment failure due to premature discontinuation of study drug in prior study of ABT-493/ABT-530. 4. Participation in AbbVie's Study M15-942 protocol for re-treatment for virologic failure in the prior Phase 2 or 3 study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 Regimen | 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). |
| 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 Regimen | 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 compared with baseline, as determined by phylogenetic analysis of the NS3 or NS5A, and/or NS5B gene sequences. |
| Number of Participants With Persistence of Resistance-Associated Amino Acid Variants Among Those Experiencing Virologic Failure | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Aspartate Transaminase to Platelet Ratio Index (APRI) Over Time | 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. |
| Number of Participants With Medical Events Related to Progression of Liver Disease or Hepatitis C Virus Infection | 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 decompensation considered to be significant by the investigator), change in the Child-Pugh category (e.g., change from Child-Pugh Class A to Child-Pugh Class B), the occurrence of hepatocellular carcinoma, liver transplantation and/or death. |
| Mean FibroScan Scores Over Time | 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. |
| Mean Concentration of Interferon Gamma-induced Protein 10 (IP-10) Over Time | 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. |
| Mean FibroTest Score Over Time | 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. |
Countries
Australia, Belgium, Canada, Germany, New Zealand, Puerto Rico, United Kingdom, United States
Participant flow
Pre-assignment details
Full Analysis Set (FAS): all participants who received ABT-493 and/or ABT-530 in a prior Phase 2/3 study and were not retreated prior to enrolling in this study.Three participants who received retreatment prior to enrollment in this study and four participants who did not receive ABT-493 and/or ABT-530 in a prior study were excluded from the FAS.
Participants by arm
| Arm | Count |
|---|---|
| HCV-infected Participants Hepatitis C virus (HCV)-infected participants who received ABT-493 and/or ABT-530 in prior Phase 2 or 3 clinical studies with these agents for the treatment of chronic HCV and were not retreated prior to entering this study. No AbbVie study drug was administered in this study. The baseline data presented below are values at the time of the prior study start. | 377 |
| Total | 377 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 1 |
| Overall Study | Lost to Follow-up | 42 |
| Overall Study | Other, not specified | 32 |
| Overall Study | Withdrew consent | 15 |
Baseline characteristics
| Characteristic | HCV-infected Participants |
|---|---|
| Age, Continuous | 54.1 years STANDARD_DEVIATION 10.96 |
| Baseline Cirrhosis Status No | 312 Participants |
| Baseline Cirrhosis Status Yes | 65 Participants |
| Baseline HCV RNA level | 6.2573 log10 IU/mL STANDARD_DEVIATION 0.829 |
| Baseline HIV-1/HCV coinfection status No | 370 Participants |
| Baseline HIV-1/HCV coinfection status Yes | 7 Participants |
| Baseline injection drug use status Missing | 3 Participants |
| Baseline injection drug use status No | 193 Participants |
| Baseline injection drug use status Yes | 181 Participants |
| HCV Genotype 1 | 168 Participants |
| HCV Genotype 2 | 76 Participants |
| HCV Genotype 3 | 106 Participants |
| HCV Genotype 4 | 14 Participants |
| HCV Genotype 5 | 7 Participants |
| HCV Genotype 6 | 6 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 2 Participants |
| Race/Ethnicity, Customized Asian | 16 Participants |
| Race/Ethnicity, Customized Black or African American | 29 Participants |
| Race/Ethnicity, Customized Multi race | 1 Participants |
| Race/Ethnicity, Customized Native Hawaiian or other Pacific Islander | 1 Participants |
| Race/Ethnicity, Customized White | 328 Participants |
| Sex: Female, Male Female | 172 Participants |
| Sex: Female, Male Male | 205 Participants |
| Study Drug Regimens Received in Prior Abbvie Study ABT-450/r + ABT-530 + RBV-12 wks | 4 Participants |
| Study Drug Regimens Received in Prior Abbvie Study ABT-493 200 mg QD + ABT-530 120 mg QD-12 wks | 57 Participants |
| Study Drug Regimens Received in Prior Abbvie Study ABT-493 200 mg QD + ABT-530 120 mg QD + RBV-12 wks | 10 Participants |
| Study Drug Regimens Received in Prior Abbvie Study ABT-493 200 mg QD + ABT-530 40 mg QD-12 wks | 34 Participants |
| Study Drug Regimens Received in Prior Abbvie Study ABT-493 200 mg QD + ABT-530 80 mg QD-12 wks | 1 Participants |
| Study Drug Regimens Received in Prior Abbvie Study ABT-493 300 mg QD + ABT-530 120 mg QD-12 wks | 20 Participants |
| Study Drug Regimens Received in Prior Abbvie Study ABT-493 300 mg QD + ABT-530 120 mg QD-16 wks | 1 Participants |
| Study Drug Regimens Received in Prior Abbvie Study ABT-493 300 mg QD + ABT-530 120 mg QD-8 wks | 13 Participants |
| Study Drug Regimens Received in Prior Abbvie Study ABT-493 300 mg QD + ABT-530 120 mg QD + RBV-12 wks | 5 Participants |
| Study Drug Regimens Received in Prior Abbvie Study ABT-493/ABT-530 300 mg/120 mg QD-12 wks | 134 Participants |
| Study Drug Regimens Received in Prior Abbvie Study ABT-493/ABT-530 300 mg/120 mg QD-16 wks | 24 Participants |
| Study Drug Regimens Received in Prior Abbvie Study ABT-493/ABT-530 300 mg/120 mg QD- 8 wks | 74 Participants |
| Treatment Status Prior to Previous Study Naive | 265 Participants |
| Treatment Status Prior to Previous Study NS5A- and PI- experienced | 12 Participants |
| Treatment Status Prior to Previous Study NS5A-experienced/PI naive | 10 Participants |
| Treatment Status Prior to Previous Study PI-experienced/NS5A naive | 7 Participants |
| Treatment Status Prior to Previous Study PRS-experienced | 83 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 377 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 377 |
Outcome results
Primary
Number of Participants With Persistence of Resistance-Associated Amino Acid Variants Among Those Experiencing Virologic Failure
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.
Time frame: From Day 1 to Month 12
Population: Participants who experienced virologic failure in previous study or in the current study with available sequencing data for NS3/4A and/or NS5A
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| HCV-infected Participants | Number of Participants With Persistence of Resistance-Associated Amino Acid Variants Among Those Experiencing Virologic Failure | NS3 Variants at Months 3, 6, and 12 | 1 participants |
| HCV-infected Participants | Number of Participants With Persistence of Resistance-Associated Amino Acid Variants Among Those Experiencing Virologic Failure | NS5A Variants at Months 3, 6, and 12 | 1 participants |
Primary
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 Regimen
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).
Time frame: From the end of treatment in the previous study up to 3 years post-treatment
Population: Full Analysis Set (FAS):all participants who received ABT-493 and/or ABT-530 in a prior Phase 2 /3 study and were not retreated prior to enrolling in this study.Three participants who received retreatment prior to enrollment in this study and four participants who did not receive ABT-493 and/or ABT-530 in a prior study were excluded from the FAS.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| HCV-infected Participants | 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 Regimen | 99.5 percentage of participants |
Primary
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 Regimen
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 compared with baseline, as determined by phylogenetic analysis of the NS3 or NS5A, and/or NS5B gene sequences.
Time frame: From the end of treatment in the previous study up to 3 years post-treatment
Population: Full Analysis Set (FAS):all participants who received ABT-493 and/or ABT-530 in a prior Phase 2 /3 study and were not retreated prior to enrolling in this study.Three participants who received retreatment prior to enrollment in this study and four participants who did not receive ABT-493 and/or ABT-530 in a prior study were excluded from the FAS.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| HCV-infected Participants | 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 Regimen | Reinfection overall | 0.3 percentage of participants |
| HCV-infected Participants | 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 Regimen | Relapse overall | 0.3 percentage of participants |
Secondary
Mean Aspartate Transaminase to Platelet Ratio Index (APRI) Over Time
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.
Time frame: From Day 1 up to 3 years post-treatment
Population: Full Analysis Set (FAS):all participants who received ABT-493 and/or ABT-530 in a prior Phase 2 /3 study and were not retreated prior to enrolling in this study. Three participants who received retreatment prior to enrollment in this study and four participants who did not receive ABT-493 and/or ABT-540 in a prior study were excluded from the FAS.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HCV-infected Participants | Mean Aspartate Transaminase to Platelet Ratio Index (APRI) Over Time | Day 1 | 0.317 ratio | Standard Deviation 0.2268 |
| HCV-infected Participants | Mean Aspartate Transaminase to Platelet Ratio Index (APRI) Over Time | Month 3 | 0.303 ratio | Standard Deviation 0.2171 |
| HCV-infected Participants | Mean Aspartate Transaminase to Platelet Ratio Index (APRI) Over Time | Month 6 | 0.298 ratio | Standard Deviation 0.2101 |
| HCV-infected Participants | Mean Aspartate Transaminase to Platelet Ratio Index (APRI) Over Time | Month 12 | 0.230 ratio | — |
| HCV-infected Participants | Mean Aspartate Transaminase to Platelet Ratio Index (APRI) Over Time | Month 18 | 0.262 ratio | Standard Deviation 0.0589 |
| HCV-infected Participants | Mean Aspartate Transaminase to Platelet Ratio Index (APRI) Over Time | Month 24 | 0.275 ratio | Standard Deviation 0.162 |
| HCV-infected Participants | Mean Aspartate Transaminase to Platelet Ratio Index (APRI) Over Time | Month 30 | 0.227 ratio | Standard Deviation 0.1084 |
| HCV-infected Participants | Mean Aspartate Transaminase to Platelet Ratio Index (APRI) Over Time | Month 36 | 0.215 ratio | Standard Deviation 0.1768 |
Secondary
Mean Concentration of Interferon Gamma-induced Protein 10 (IP-10) Over Time
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.
Time frame: From Day 1 up to 3 years post-treatment
Population: Full Analysis Set (FAS):all participants who received ABT-493 and/or ABT-530 in a prior Phase 2 /3 study and were not retreated prior to enrolling in this study.Three participants who received retreatment prior to enrollment in this study and four participants who did not receive ABT-493 and/or ABT-530 in a prior study were excluded from the FAS.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HCV-infected Participants | Mean Concentration of Interferon Gamma-induced Protein 10 (IP-10) Over Time | Day 1 | 146.884 ng/L | Standard Deviation 116.6272 |
| HCV-infected Participants | Mean Concentration of Interferon Gamma-induced Protein 10 (IP-10) Over Time | Month 3 | 147.606 ng/L | Standard Deviation 118.5143 |
| HCV-infected Participants | Mean Concentration of Interferon Gamma-induced Protein 10 (IP-10) Over Time | Month 6 | 148.959 ng/L | Standard Deviation 119.0047 |
| HCV-infected Participants | Mean Concentration of Interferon Gamma-induced Protein 10 (IP-10) Over Time | Month 12 | 224.400 ng/L | — |
| HCV-infected Participants | Mean Concentration of Interferon Gamma-induced Protein 10 (IP-10) Over Time | Month 18 | 133.300 ng/L | Standard Deviation 50.2647 |
| HCV-infected Participants | Mean Concentration of Interferon Gamma-induced Protein 10 (IP-10) Over Time | Month 24 | 140.185 ng/L | Standard Deviation 97.2769 |
| HCV-infected Participants | Mean Concentration of Interferon Gamma-induced Protein 10 (IP-10) Over Time | Month 30 | 164.244 ng/L | Standard Deviation 276.9176 |
| HCV-infected Participants | Mean Concentration of Interferon Gamma-induced Protein 10 (IP-10) Over Time | Month 36 | 120.600 ng/L | — |
Secondary
Mean FibroScan Scores Over Time
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.
Time frame: Up to 3 years post-treatment
Population: Full Analysis Set (FAS):all participants who received ABT-493 and/or ABT-530 in a prior Phase 2 /3 study and were not retreated prior to enrolling in this study.Three participants who received retreatment prior to enrollment in this study and four participants who did not receive ABT-493 and/or ABT-540 in a prior study were excluded from the FAS.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HCV-infected Participants | Mean FibroScan Scores Over Time | Day 1 | 13.014 kPa | Standard Deviation 12.685 |
| HCV-infected Participants | Mean FibroScan Scores Over Time | Month 3 | 6.880 kPa | Standard Deviation 4.6677 |
| HCV-infected Participants | Mean FibroScan Scores Over Time | Month 6 | 10.780 kPa | Standard Deviation 5.926 |
| HCV-infected Participants | Mean FibroScan Scores Over Time | Month 12 | 7.700 kPa | Standard Deviation 4.2208 |
| HCV-infected Participants | Mean FibroScan Scores Over Time | Month 18 | 6.913 kPa | Standard Deviation 2.8002 |
| HCV-infected Participants | Mean FibroScan Scores Over Time | Month 24 | 6.757 kPa | Standard Deviation 3.1564 |
| HCV-infected Participants | Mean FibroScan Scores Over Time | Month 30 | 9.400 kPa | — |
Secondary
Mean FibroTest Score Over Time
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.
Time frame: From Day 1 up to 3 years post-treatment
Population: Full Analysis Set (FAS):all participants who received ABT-493 and/or ABT-530 in a prior Phase 2 /3 study and were not retreated prior to enrolling in this study.Three participants who received retreatment prior to enrollment in this study and four participants who did not receive ABT-493 and/or ABT-540 in a prior study were excluded from the FAS.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HCV-infected Participants | Mean FibroTest Score Over Time | Day 1 | 0.354 units on a scale | Standard Deviation 0.2341 |
| HCV-infected Participants | Mean FibroTest Score Over Time | Month 3 | 0.363 units on a scale | Standard Deviation 0.2383 |
| HCV-infected Participants | Mean FibroTest Score Over Time | Month 6 | 0.353 units on a scale | Standard Deviation 0.2311 |
| HCV-infected Participants | Mean FibroTest Score Over Time | Month 12 | 0.405 units on a scale | Standard Deviation 0.0919 |
| HCV-infected Participants | Mean FibroTest Score Over Time | Month 18 | 0.272 units on a scale | Standard Deviation 0.1281 |
| HCV-infected Participants | Mean FibroTest Score Over Time | Month 24 | 0.321 units on a scale | Standard Deviation 0.2156 |
| HCV-infected Participants | Mean FibroTest Score Over Time | Month 30 | 0.261 units on a scale | Standard Deviation 0.1667 |
| HCV-infected Participants | Mean FibroTest Score Over Time | Month 36 | 0.190 units on a scale | — |
Secondary
Number of Participants With Medical Events Related to Progression of Liver Disease or Hepatitis C Virus Infection
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 decompensation considered to be significant by the investigator), change in the Child-Pugh category (e.g., change from Child-Pugh Class A to Child-Pugh Class B), the occurrence of hepatocellular carcinoma, liver transplantation and/or death.
Time frame: After Day 1 up to 3 years post-treatment
Population: Full Analysis Set (FAS):all participants who received ABT-493 and/or ABT-530 in a prior Phase 2 /3 study and were not retreated prior to enrolling in this study.Three participants who received retreatment prior to enrollment in this study and four participants who did not receive ABT-493 and/or ABT-530 in a prior study were excluded from the FAS.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| HCV-infected Participants | Number of Participants With Medical Events Related to Progression of Liver Disease or Hepatitis C Virus Infection | Medical events related to liver disease or HCV inf | 7 Participants |
| HCV-infected Participants | Number of Participants With Medical Events Related to Progression of Liver Disease or Hepatitis C Virus Infection | Development of cirrhosis | 0 Participants |
| HCV-infected Participants | Number of Participants With Medical Events Related to Progression of Liver Disease or Hepatitis C Virus Infection | Liver decompensation (Variceal bleeding) | 0 Participants |
| HCV-infected Participants | Number of Participants With Medical Events Related to Progression of Liver Disease or Hepatitis C Virus Infection | Liver decompensation (Ascites) | 0 Participants |
| HCV-infected Participants | Number of Participants With Medical Events Related to Progression of Liver Disease or Hepatitis C Virus Infection | Liver decomp (spontaneous bacterial peritonitis) | 0 Participants |
| HCV-infected Participants | Number of Participants With Medical Events Related to Progression of Liver Disease or Hepatitis C Virus Infection | Liver decompensation (hepatic encephalopathy) | 0 Participants |
| HCV-infected Participants | Number of Participants With Medical Events Related to Progression of Liver Disease or Hepatitis C Virus Infection | Liver decompensation (hepatorenal syndrome) | 0 Participants |
| HCV-infected Participants | Number of Participants With Medical Events Related to Progression of Liver Disease or Hepatitis C Virus Infection | Liver decompensation (hepatic hydrothorax) | 0 Participants |
| HCV-infected Participants | Number of Participants With Medical Events Related to Progression of Liver Disease or Hepatitis C Virus Infection | Liver decompensation (other [PI's discretion]) | 0 Participants |
| HCV-infected Participants | Number of Participants With Medical Events Related to Progression of Liver Disease or Hepatitis C Virus Infection | Change in Child-Pugh Score in subject w/cirrhosis | 0 Participants |
| HCV-infected Participants | Number of Participants With Medical Events Related to Progression of Liver Disease or Hepatitis C Virus Infection | Hepatocellular carcinoma (HCC) | 5 Participants |
| HCV-infected Participants | Number of Participants With Medical Events Related to Progression of Liver Disease or Hepatitis C Virus Infection | Liver transplantation occurred | 0 Participants |
| HCV-infected Participants | Number of Participants With Medical Events Related to Progression of Liver Disease or Hepatitis C Virus Infection | Death | 0 Participants |
| HCV-infected Participants | Number of Participants With Medical Events Related to Progression of Liver Disease or Hepatitis C Virus Infection | Regenerated node in the liver | 1 Participants |
| HCV-infected Participants | Number of Participants With Medical Events Related to Progression of Liver Disease or Hepatitis C Virus Infection | Cholangiocarcinoma/differentiated adenocarcinoma | 1 Participants |