A Study to Assess Resistance and Durability of Response to ABT-493 and/or ABT-530

• Sponsor: AbbVie (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02441283
• Collaborator: (none)
• Enrollment: 384
• Locations: 42
• Arm: 1
• Actual Duration (Months): 51.8
• Patients Per Site: 9.1
• Patients Per Site Per Month: 0.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hepatitis C	Drug: ABT-493; Drug: ABT-530	Phase 2/Phase 3

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 384 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: A Follow-up Study to Assess Resistance and Durability of Response to AbbVie Direct-Acting Antiviral Agent (DAA) Therapy (ABT-493 and/or ABT-530) in Subjects Who Participated in Phase 2 or 3 Clinical Studies for the Treatment of Chronic Hepatitis C Virus (HCV) Infection
• Actual Study Start Date: Jun 22, 2015
• Actual Primary Completion Date: Oct 15, 2019
• Actual Study Completion Date: Oct 15, 2019

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: 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.	Drug: ABT-493; ABT-493 was not administered in this study. This study was a follow-up for participants who received the drug in prior studies.; Other Names: Glecaprevir ; Drug: ABT-530; ABT-530 was not administered in this study. This study was a follow-up for participants who received the drug in prior studies.; Other Names: Pibrentasvir

Outcome Measures

Primary Outcome Measures

1. 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).

2. 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.

3. 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 Outcome Measures

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Digestive Health Specialists of the Southeast /ID# 136725	Dothan	Alabama	United States	36305
2	Felizarta /ID# 141033	Bakersfield	California	United States	93301
3	Southern California Res. Ctr. /ID# 141799	Coronado	California	United States	92118-1408
4	Research & Education, Inc. /ID# 169591	San Diego	California	United States	92105
5	eStudySite San Diego /ID# 141040	San Diego	California	United States	92120
6	eStudySite San Diego /ID# 141047	San Diego	California	United States	92120
7	eStudySite San Diego /ID# 141048	San Diego	California	United States	92120
8	Midway Immunology and Research /ID# 169477	Fort Pierce	Florida	United States	34982
9	Delta Research Partners /ID# 141028	Bastrop	Louisiana	United States	71220
10	Louisiana Research Ctr. LLC /ID# 141024	Shreveport	Louisiana	United States	71105-6800
11	Henry Ford Health System /ID# 141039	Detroit	Michigan	United States	48202
12	Binghamton Gastroenterology /ID# 141026	Binghamton	New York	United States	13903
13	Carolinas Center for Liver Dis /ID# 155390	Statesville	North Carolina	United States	28677-3471
14	Northwest Gastroenterology Cli /ID# 141036	Portland	Oregon	United States	97210
15	Gastro One /ID# 169478	Germantown	Tennessee	United States	38138
16	Quality Medical Research, PLLC /ID# 141042	Nashville	Tennessee	United States	37211
17	TX Clinical Research Institute /ID# 141037	Arlington	Texas	United States	76012
18	Inquest Clinical Research /ID# 141045	Baytown	Texas	United States	77521-2415
19	TX Liver Inst, Americ Res Corp /ID# 136727	San Antonio	Texas	United States	78215
20	Bon Secours St. Mary's Hospita /ID# 165106	Richmond	Virginia	United States	23226
21	St. Vincent's Hospital, Darlinghurst /ID# 155395	Darlinghurst	New South Wales	Australia	2010
22	St. Vincents Hospital /ID# 155394	East Lismore	New South Wales	Australia	2480
23	Westmead Hospital /ID# 155392	Westmead	New South Wales	Australia	2145
24	Royal Brisbane and Women's Hospital /ID# 155396	Herston	Queensland	Australia	4029
25	Royal Adelaide Hospital /ID# 155391	Adelaide	South Australia	Australia	5000
26	Royal Melbourne Hospital /ID# 155393	Parkville	Victoria	Australia	3050
27	Cliniques Universitaires Saint Luc /ID# 155397	Woluwe-Saint-Lambert	Bruxelles-Capitale	Belgium	1200
28	CHU St. Pierre /ID# 155399	Brussels		Belgium	1000
29	UZ Leuven /ID# 155398	Leuven		Belgium	3000
30	University of Calgary /ID# 155400	Calgary	Alberta	Canada	T2N 4Z6
31	Toronto Liver Centre /ID# 155401	Toronto	Ontario	Canada	M6H 3M1
32	Universitätsklinikum Frankfurt /ID# 169817	Frankfurt am Main	Hessen	Germany	60590
33	Mauss, Schmutz, Hegener, Athma /ID# 155402	Dusseldorf		Germany	40237
34	Gastroenterologisch-Hepatologi /ID# 169820	Kiel		Germany	24146
35	Auckland City Hospital /ID# 155403	Auckland		New Zealand	1023
36	Gastro-Hepato & Geriatric Ctr /ID# 141060	Ponce		Puerto Rico	00716
37	Klinical Investigations Group /ID# 141059	San Juan		Puerto Rico	00909
38	Innovative Care P.S.C. /ID# 141061	San Juan		Puerto Rico	00959
39	The Royal London Hospital /ID# 155405	London	London, City Of	United Kingdom	E1 1BB
40	King's College Hospital NHS /ID# 155406	London		United Kingdom	SE5 9RS
41	St. Mary's Hospital /ID# 155404	London		United Kingdom	W2 1NY
42	Derriford Hospital /ID# 155407	Plymouth		United Kingdom	PL6 8DH

Sponsors and Collaborators

• AbbVie

Investigators

• Study Director: AbbVie Inc., AbbVie

Study Documents (Full-Text)

• Study Protocol - Oct 9, 2017
• Statistical Analysis Plan - Aug 23, 2019

More Information

Publications

None provided.

• Responsible Party: AbbVie
• ClinicalTrials.gov Identifier: NCT02441283
• Other Study ID Numbers: M13-576; 2015-000452-24
• First Posted: May 12, 2015
• Last Update Posted: Sep 21, 2020
• Last Verified: Aug 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by AbbVie: Chronic hepatitis C; Hepatitis C virus; Sustained virologic response; Hepatitis C; Direct Acting Antiviral
• Additional relevant MeSH terms: Hepatitis A; Hepatitis C; Hepatitis

Study Results

Participant Flow

Pre-assignment Detail	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/Group Title	HCV-infected Participants
Arm/Group Description	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.
Period Title: Overall Study
STARTED	377
COMPLETED	287
NOT COMPLETED	90

Baseline Characteristics

Arm/Group Title	HCV-infected Participants
Arm/Group Description	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.
Overall Participants	377
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	54.1 (10.96)
Sex: Female, Male (Count of Participants)
Female	172 45.6%
Male	205 54.4%
Race/Ethnicity, Customized (Count of Participants)
White	328 87%
Black or African American	29 7.7%
Asian	16 4.2%
American Indian or Alaska Native	2 0.5%
Native Hawaiian or other Pacific Islander	1 0.3%
Multi race	1 0.3%
HCV Genotype (Count of Participants)
1	168 44.6%
2	76 20.2%
3	106 28.1%
4	14 3.7%
5	7 1.9%
6	6 1.6%
Baseline Cirrhosis Status (Count of Participants)
Yes	65 17.2%
No	312 82.8%
Treatment Status Prior to Previous Study (Count of Participants)
Naive	265 70.3%
PRS-experienced	83 22%
NS5A-experienced/PI naive	10 2.7%
NS5A- and PI- experienced	12 3.2%
PI-experienced/NS5A naive	7 1.9%
Baseline HIV-1/HCV coinfection status (Count of Participants)
Yes	7 1.9%
No	370 98.1%
Baseline injection drug use status (Count of Participants)
Yes	181 48%
No	193 51.2%
Missing	3 0.8%
Baseline HCV RNA level (log10 IU/mL) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [log10 IU/mL]	6.2573 (0.82900)
Study Drug Regimens Received in Prior Abbvie Study (Count of Participants)
ABT-450/r + ABT-530 + RBV-12 wks	4 1.1%
ABT-493 200 mg QD + ABT-530 40 mg QD-12 wks	34 9%
ABT-493 200 mg QD + ABT-530 80 mg QD-12 wks	1 0.3%
ABT-493 200 mg QD + ABT-530 120 mg QD-12 wks	57 15.1%
ABT-493 200 mg QD + ABT-530 120 mg QD + RBV-12 wks	10 2.7%
ABT-493 300 mg QD + ABT-530 120 mg QD-8 wks	13 3.4%
ABT-493 300 mg QD + ABT-530 120 mg QD-12 wks	20 5.3%
ABT-493 300 mg QD + ABT-530 120 mg QD-16 wks	1 0.3%
ABT-493 300 mg QD + ABT-530 120 mg QD + RBV-12 wks	5 1.3%
ABT-493/ABT-530 300 mg/120 mg QD- 8 wks	74 19.6%
ABT-493/ABT-530 300 mg/120 mg QD-12 wks	134 35.5%
ABT-493/ABT-530 300 mg/120 mg QD-16 wks	24 6.4%

Outcome Measures

1. Primary Outcome

Title	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
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	HCV-infected Participants
Arm/Group Description	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.
Measure Participants	376
Number [percentage of participants]	99.5 26.4%

2. Primary Outcome

Title	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
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	HCV-infected Participants
Arm/Group Description	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.
Measure Participants	376
Relapse overall	0.3 0.1%
Reinfection overall	0.3 0.1%

3. Primary Outcome

Title	Number of Participants With Persistence of Resistance-Associated Amino Acid Variants Among Those Experiencing Virologic Failure
Description	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

Outcome Measure Data

Analysis Population Description

Participants who experienced virologic failure in previous study or in the current study with available sequencing data for NS3/4A and/or NS5A

Arm/Group Title	HCV-infected Participants
Arm/Group Description	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.
Measure Participants	1
NS3 Variants at Months 3, 6, and 12	1 0.3%
NS5A Variants at Months 3, 6, and 12	1 0.3%

4. Secondary Outcome

Title	Number of Participants With Medical Events Related to Progression of Liver Disease or Hepatitis C Virus Infection
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	HCV-infected Participants
Arm/Group Description	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.
Measure Participants	377
Medical events related to liver disease or HCV inf	7 1.9%
Development of cirrhosis	0 0%
Liver decompensation (Variceal bleeding)	0 0%
Liver decompensation (Ascites)	0 0%
Liver decomp (spontaneous bacterial peritonitis)	0 0%
Liver decompensation (hepatic encephalopathy)	0 0%
Liver decompensation (hepatorenal syndrome)	0 0%
Liver decompensation (hepatic hydrothorax)	0 0%
Liver decompensation (other [PI's discretion])	0 0%
Change in Child-Pugh Score in subject w/cirrhosis	0 0%
Hepatocellular carcinoma (HCC)	5 1.3%
Liver transplantation occurred	0 0%
Death	0 0%
Regenerated node in the liver	1 0.3%
Cholangiocarcinoma/differentiated adenocarcinoma	1 0.3%

5. Secondary Outcome

Title	Mean Concentration of Interferon Gamma-induced Protein 10 (IP-10) Over Time
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	HCV-infected Participants
Arm/Group Description	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.
Measure Participants	374
Day 1	146.884 (116.6272)
Month 3	147.606 (118.5143)
Month 6	148.959 (119.0047)
Month 12	224.400
Month 18	133.300 (50.2647)
Month 24	140.185 (97.2769)
Month 30	164.244 (276.9176)
Month 36	120.600

6. Secondary Outcome

Title	Mean FibroTest Score Over Time
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	HCV-infected Participants
Arm/Group Description	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.
Measure Participants	367
Day 1	0.354 (0.2341)
Month 3	0.363 (0.2383)
Month 6	0.353 (0.2311)
Month 12	0.405 (0.0919)
Month 18	0.272 (0.1281)
Month 24	0.321 (0.2156)
Month 30	0.261 (0.1667)
Month 36	0.190

7. Secondary Outcome

Title	Mean Aspartate Transaminase to Platelet Ratio Index (APRI) Over Time
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	HCV-infected Participants
Arm/Group Description	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.
Measure Participants	367
Day 1	0.317 (0.2268)
Month 3	0.303 (0.2171)
Month 6	0.298 (0.2101)
Month 12	0.230
Month 18	0.262 (0.0589)
Month 24	0.275 (0.1620)
Month 30	0.227 (0.1084)
Month 36	0.215 (0.1768)

8. Secondary Outcome

Title	Mean FibroScan Scores Over Time
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	HCV-infected Participants
Arm/Group Description	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.
Measure Participants	23
Day 1	13.014 (12.6850)
Month 3	6.880 (4.6677)
Month 6	10.780 (5.9260)
Month 12	7.700 (4.2208)
Month 18	6.913 (2.8002)
Month 24	6.757 (3.1564)
Month 30	9.400

Adverse Events

Time Frame	Serious adverse events (SAEs) that the investigator considered reasonably related to interventional study procedures or those considered reasonably related to ABT-530 and/or ABT-493 exposure in the prior study by the investigator were collected from the time of the Day 1 visit of the current study period through the last study procedure or discontinuation from study, whichever was later, up to 3 years post-treatment.
Adverse Event Reporting Description	An adverse event (AE) in this study is defined as any untoward medical occurrence in a patient or clinical investigation subject that occurs as a result of a study procedure, or is considered by the investigator to be reasonably related to exposure to ABT-493 and/or ABT-530 in the previous study. Deaths were collected as a medical event from the time of informed consent through study end. Serious adverse events outside of the study time frame and all nonserious adverse events were not collected.
Arm/Group Title	HCV-infected Participants-- FAS
Arm/Group Description	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.
All Cause Mortality
	HCV-infected Participants-- FAS
	Affected / at Risk (%)	# Events
Total	1/377 (0.3%)
Serious Adverse Events
	HCV-infected Participants-- FAS
	Affected / at Risk (%)	# Events
Total	0/377 (0%)
Other (Not Including Serious) Adverse Events
	HCV-infected Participants-- FAS
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.