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    Clinical Trial Results:
    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

    Summary
    EudraCT number
    		 2015-000452-24
    Trial protocol
    		 BE   DE  
    Global end of trial date
    04 Dec 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    09 Oct 2020
    First version publication date
    09 Oct 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    M13-576
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02441283
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    AbbVie
    Sponsor organisation address
    AbbVie House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire, United Kingdom, SL6-4UB
    Public contact
    Global Medical Services, AbbVie, 001 8006339110, abbvieclinicaltrials@abbvie.com
    Scientific contact
    Global Medical Services, AbbVie, 001 8006339110, abbvieclinicaltrials@abbvie.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    04 Dec 2019
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    04 Dec 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    This was a long-term, Phase 2/3, multicenter, follow-up study to evaluate the durability of sustained virologic response (SVR), persistence of direct-acting antiviral agent (DAA) resistance, and clinical outcomes for subjects 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. The subject must have completed the follow-up period of the prior eligible AbbVie study. To be included in the analyses, the subject must not have been retreated prior to enrolling in this study. Subjects 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.
    Protection of trial subjects
    Subject read and understood the information provided about the study and gave written permission.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    22 Jun 2015
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Australia: 39
    Country: Number of subjects enrolled
    Canada: 18
    Country: Number of subjects enrolled
    New Zealand: 12
    Country: Number of subjects enrolled
    Puerto Rico: 24
    Country: Number of subjects enrolled
    United States: 222
    Country: Number of subjects enrolled
    United Kingdom: 26
    Country: Number of subjects enrolled
    Belgium: 30
    Country: Number of subjects enrolled
    Germany: 6
    Worldwide total number of subjects
    377
    EEA total number of subjects
    62
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    320
    From 65 to 84 years
    57
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Full Analysis Set (FAS):subjects who rcvd ABT-493 and/or ABT-530 in a prior Phase 2/3 study and weren’t retreated prior to enrolling in this study. 3 subjects were retreated prior to enrollment in this study and 4 didn’t receive ABT-493 and/or ABT-540 in prior study and were excluded from the FAS. Baseline data= values at time of prior study start.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 HCV-infected Participants
    Arm 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.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Glecaprevir
    Investigational medicinal product code
    Other name
    ABT-493
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    ABT-493 was not administered in this study. This study was a follow-up for participants who received the drug in prior studies.

    Investigational medicinal product name
    Pibrentasvir
    Investigational medicinal product code
    Other name
    ABT-530
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    ABT-530 was not administered in this study. This study was a follow-up for participants who received the drug in prior studies.

    Number of subjects in period 1
    		HCV-infected Participants
    Started
    377
    Completed
    287
    Not completed
    90
         Death
    1
         Other, not specified
    32
         Lost to follow-up
    42
         Withdrew consent
    15

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall Study
    Reporting group description
    		 Full Analysis Set (FAS): all subjects 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 subjects who received retreatment prior to enrollment in this study and four subjects who did not receive ABT-493 and/or ABT-540 in a prior study were excluded from the FAS.

    Reporting group values
    		 Overall Study Total
    Number of subjects
    		 377 377
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 54.1 ( 10.96 ) -
    Gender categorical
    Units: Subjects
        Female
    		 172 172
        Male
    		 205 205

    End points

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    End points reporting groups
    Reporting group title
    HCV-infected Participants
    Reporting 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.

    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

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    End point 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 [1]
    End point 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).
    End point type
    Primary
    End point timeframe
    From the end of treatment in the previous study up to 3 years post-treatment
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical analysis was not applicable for this endpoint.
    End point values
    		 HCV-infected Participants
    Number of subjects analysed
    376 [2]
    Units: Percentage of participants
        number (not applicable)
    99.5
    Notes
    [2] - Subjects rcvd ABT-493 +/- ABT-530 in prior Phase 2/3 study and weren’t retreated before this study
    No statistical analyses for this end point

    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

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    End point 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 [3]
    End point 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.
    End point type
    Primary
    End point timeframe
    From the end of treatment in the previous study up to 3 years post-treatment
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical analysis was not applicable for this endpoint.
    End point values
    		 HCV-infected Participants
    Number of subjects analysed
    376 [4]
    Units: percentage of participants
    number (not applicable)
        Relapse overall
    0.3
        Reinfection overall
    0.3
    Notes
    [4] - Subjects rcvd ABT-493 +/- ABT-530 in prior Phase 2/3 study and weren’t retreated before this study
    No statistical analyses for this end point

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

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    End point title
    		 Number of Participants With Persistence of Resistance-Associated Amino Acid Variants Among Those Experiencing Virologic Failure [5]
    End point 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.
    End point type
    Primary
    End point timeframe
    From Day 1 to Month 12
    Notes
    [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical analysis was not applicable for this endpoint.
    End point values
    		 HCV-infected Participants
    Number of subjects analysed
    1 [6]
    Units: participants
        NS3 Variants at Months 3, 6, and 12
    1
        NS5A Variants at Months 3, 6, and 12
    1
    Notes
    [6] - Subjects w/ virologic failure in prior/current study and NS3/4A and/or NS5A sequencing data
    No statistical analyses for this end point

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

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    End point title
    		 Number of Participants With Medical Events Related to Progression of Liver Disease or Hepatitis C Virus Infection
    End point 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.
    End point type
    Secondary
    End point timeframe
    After Day 1 up to 3 years post-treatment
    End point values
    		 HCV-infected Participants
    Number of subjects analysed
    377 [7]
    Units: participants
        Medical events related to liver disease or HCV inf
    7
        Development of cirrhosis
    0
        Liver decompensation (Variceal bleeding)
    0
        Liver decompensation (Ascites)
    0
        Liver decomp (spontaneous bacterial peritonitis)
    0
        Liver decompensation (hepatic encephalopathy)
    0
        Liver decompensation (hepatorenal syndrome)
    0
        Liver decompensation (hepatic hydrothorax)
    0
        Liver decompensation (other [PI's discretion])
    0
        Change in Child-Pugh Score in subject w/cirrhosis
    0
        Hepatocellular carcinoma (HCC)
    5
        Liver transplantation occurred
    0
        Death
    0
        Regenerated node in the liver
    1
        Cholangiocarcinoma/differentiated adenocarcinoma
    1
    Notes
    [7] - Subjects rcvd ABT-493 +/- ABT-530 in prior Phase 2/3 study and weren’t retreated before this study
    No statistical analyses for this end point

    Secondary: Mean Concentration of Interferon Gamma-induced Protein 10 (IP-10) Over Time

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    End point title
    		 Mean Concentration of Interferon Gamma-induced Protein 10 (IP-10) Over Time
    End point 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. Values of 999 in the standard deviation fields in the table below indicate not calculable due to n=1 subject.
    End point type
    Secondary
    End point timeframe
    From Day 1 up to 3 years post-treatment
    End point values
    		 HCV-infected Participants
    Number of subjects analysed
    374 [8]
    Units: ng/L
    arithmetic mean (standard deviation)
        Day 1 (n=374)
    146.884 ( 116.6272 )
        Month 3 (n=363)
    147.606 ( 118.5143 )
        Month 6 (n=336)
    148.959 ( 119.0047 )
        Month 12 (n=1)
    224.400 ( 999 )
        Month 18 (n=7)
    133.300 ( 50.2647 )
        Month 24 (n=234)
    140.185 ( 97.2769 )
        Month 30 (n=88)
    164.244 ( 276.9176 )
        Month 36 (n=1)
    120.600 ( 999 )
    Notes
    [8] - Subjects rcvd ABT-493 +/- ABT-530 in prior Phase 2/3 study and weren’t retreated before this study
    No statistical analyses for this end point

    Secondary: Mean FibroTest Score Over Time

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    End point title
    		 Mean FibroTest Score Over Time
    End point 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. The value of 999 in the standard deviation field in the table below indicates not calculable due to n=1 subject.
    End point type
    Secondary
    End point timeframe
    From Day 1 up to 3 years post-treatment
    End point values
    		 HCV-infected Participants
    Number of subjects analysed
    367 [9]
    Units: units on a scale
    arithmetic mean (standard deviation)
        Day 1 (n=367)
    0.354 ( 0.2341 )
        Month 3 (n=347)
    0.363 ( 0.2383 )
        Month 6 (n=333)
    0.353 ( 0.2311 )
        Month 12 (n=2)
    0.405 ( 0.0919 )
        Month 18 (n=5)
    0.272 ( 0.1281 )
        Month 24 (n=227)
    0.321 ( 0.2156 )
        Month 30 (n=68)
    0.261 ( 0.1667 )
        Month 36 (n=1)
    0.190 ( 999 )
    Notes
    [9] - Subjects rcvd ABT-493 +/- ABT-530 in prior Phase 2/3 study and weren’t retreated before this study
    No statistical analyses for this end point

    Secondary: Mean Aspartate Transaminase to Platelet Ratio Index (APRI) Over Time

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    End point title
    		 Mean Aspartate Transaminase to Platelet Ratio Index (APRI) Over Time
    End point 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. The value of 999 in the standard deviation field in the table below indicates not calculable due to n=1 subject.
    End point type
    Secondary
    End point timeframe
    From Day 1 up to 3 years post-treatment
    End point values
    		 HCV-infected Participants
    Number of subjects analysed
    367 [10]
    Units: ratio
    arithmetic mean (standard deviation)
        Day 1 (n=367)
    0.317 ( 0.2268 )
        Month 3 (n=352)
    0.303 ( 0.2171 )
        Month 6 (n=333)
    0.298 ( 0.2101 )
        Month 12 (n=1)
    0.230 ( 999 )
        Month 18 (n=5)
    0.262 ( 0.0589 )
        Month 24 (n=232)
    0.275 ( 0.1620 )
        Month 30 (n=69)
    0.227 ( 0.1084 )
        Month 36 (n=2)
    0.215 ( 0.1768 )
    Notes
    [10] - Subjects rcvd ABT-493 +/- ABT-530 in prior Phase 2/3 study and weren’t retreated before this study
    No statistical analyses for this end point

    Secondary: Mean FibroScan scores over time

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    End point title
    		 Mean FibroScan scores over time
    End point 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. The value of 999 in the standard deviation field in the table below indicates not calculable due to n=1 subject.
    End point type
    Secondary
    End point timeframe
    Up to 3 years post-treatment
    End point values
    		 HCV-infected Participants
    Number of subjects analysed
    23 [11]
    Units: kPa
    arithmetic mean (standard deviation)
        Day 1 (n=7)
    13.014 ( 12.6850 )
        Month 3 (n=5)
    6.880 ( 4.6677 )
        Month 6 (n=10)
    10.780 ( 5.9260 )
        Month 12 (n=10)
    7.700 ( 4.2208 )
        Month 18 (n=8)
    6.913 ( 2.8002 )
        Month 24 (n=23)
    6.757 ( 3.1564 )
        Month 30 (n=1)
    9.400 ( 999 )
    Notes
    [11] - Subjects rcvd ABT-493 +/- ABT-530 in prior Phase 2/3 study and weren’t retreated before this study
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    SAEs reasonably related to interventional study procedures or to ABT-530 and/or ABT-493 Tx in the prior study were collected from Day 1 through the last study procedure or discontinuation from study, whichever was later, up to 3 years post-treatment.
    Adverse event reporting additional description
    An adverse event is any untoward medical occurrence as a result of a study procedure or considered by the investigator to be reasonably related to exposure to ABT-493 and/or ABT-530 in the prior study. Deaths were collected as a medical event from consent until study end. SAEs outside of the study time frame and nonserious AEs were not collected.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.0
    Reporting groups
    Reporting group title
    HCV-infected Participants-- FAS
    Reporting 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.

    Serious adverse events
    		 HCV-infected Participants-- FAS
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 377 (0.00%)
         number of deaths (all causes)
    1
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 HCV-infected Participants-- FAS
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 377 (0.00%)
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: Nonserious adverse events were not collected for this study.

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    03 Apr 2015
    Amendment 1 • Included the reporting of any SAEs considered by the investigator to be reasonably related to exposure to ABT-530 and/or ABT-493 in the prior study because it was possible that a subject enrolled in this study may have experienced a SAE that the investigator believed to be reasonably related to their exposure to ABT-530 and/or ABT-493 in the prior study • Included the requirement to record, in the CRF, the concomitant medications used to treat SAEs considered to be related to the subject's exposure to ABT-530 and/or ABT-493 in the previous study • Clarified the use of the Roche COBAS® AmpliPrep/COBAS® TaqMan® HCV Quantitative Test, v2.0 and provided a revised LLOQ of 15 IU/mL for all HCV genotypes using this assay • Added Protocol M15-410 to Appendix C • Added the Child-Pugh classification definitions to Appendix D
    19 Jul 2016
    Amendment 2 • Changed Phase from 2 to 2/3 to reflect addition of subjects from Phase 3 studies • Revised Secondary Objectives to include all laboratory tests/scores: those required by study to be presented in final analysis • Changed anticipated no. of subjects/sites to reflect potential enrollment from Phase 3 studies • Clarified that all subjects failing Tx in prior study would be offered this study if they had not/would not be receiving immediate Tx in AbbVie Study M15-942 • Added Exclusion Criterion 3 (Subjects experiencing non-virologic treatment failure due to premature discontinuation of study drug in prior study of ABT-493/ABT-530 may not participate), to exclude any non-virologic treatment failure who did not complete study drug • Added Exclusion Criterion 4 (Subjects enrolling in Study M15-942 for retreatment are not eligible for Study M13-576), to specify that subjects who were re-treated in Study M15-942 could not enroll because they could not be in both studies • Appendix D: expanded list of Phase 3 studies from which subjects could be enrolled • Revised to allow for re-treatment with commercially available HCV medications any time after treatment with study drugs in prior AbbVie HCV Phase 2/3 studies (prior to/during participation in Study M13-576). Subjects who were re-treated were to be followed to SVR12, to assess posttreatment Wk 12 (SVR12) outcomes of HCV re-treatment among subjects who experienced a virology failure in a prior study • Added requirement for a posttreatment Wk 12 (SVR12) visit for all re-treated VFs, since SVR12 assessment is generally accepted standard for SVR • Added requirement for Child-Pugh Score and Classification for all cirrhotic subjects at Day 1 and every 6 mos • Removed archived serum sample requirement • Updated sequencing method for resistance analysis to more sensitive deep sequencing
    09 Oct 2017
    Amendment 3 • Removed collection of alpha fetoprotein, as it is an unreliable test for screening for liver disease including HCC and was no longer recommended in the AASLD HCV guidelines current at the time • Clarified Inclusion Criterion 3 by adding a sentence to note that subjects who had been re-treated with a commercially available anti-HCV treatment were able to enroll in the study greater than 2 years after the last dose of the AbbVie DAA therapy from the previous AbbVie clinical study. The 2-year timeframe did not apply to subjects who had been re-treated, for whom blood samples were not to be collected to evaluate the persistence of resistance substitutions • Screening for HCC by liver ultrasound was added to the final study visit for cirrhotic subjects, in order to screen them for development of HCC as part of long-term follow-up

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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