Clinical trial NCT02738138
Conditions: Hepatitis C Virus Infection Human Immunodeficiency Virus Infection Chronic Hepatitis C Compensated Cirrhosis and Non-cirrhotics
Keywords: HCV Genotype 3 Non-cirrhotic HCV Genotype 1 HCV Genotype 6 Human Immunodeficiency Virus (HIV) Infection HCV Genotype 5 HCV Treatment Naive HCV Genotype 4 HCV Treatment Experienced HCV Genotype 2 Hepatitis C Virus (HCV) Infection Compensated Cirrhosis
Sponsor: AbbVie
Start date: 2016-05-17; Completion date: 2017-06-07
Enrollment: 153 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess the efficacy and safety of ABT-493/ABT-530 in adults with chronic hepatitis C virus genotype 1-6 infection and human immunodeficiency virus-1 co-infection.

Detailed description:

Arms: arm 1: HCV Genotype (GT)1-6/HIV-1 co-infected non-cirrhotic subjects treated with ABT-493/ABT-530 300 mg/120 mg once a day (QD) for 8 weeks arm 2: HCV GT1-6/HIV-1 co-infected subjects with compensated cirrhosis treated with ABT-493/ABT-530 300 mg/120 mg once a day (QD) for 12 weeks
Interventions: intervention 1: ABT-493 coformulated with ABT-530
Intervention descriptions: intervention 1: Tablet

Protocol documents:
Prot_000.pdf: 
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Clinical Study Protocol M14-730
A Multicenter, Open-Label Study to Evaluate the 
Efficacy and Safety of ABT-493/ABT-530 in Adults 
with Chronic Hepatitis C Virus (HCV) Genotype 1 – 6 
Infection and Human Immunodeficiency Virus-1 
(HIV-1) Co-Infection (EXPEDITION-2)
Incorporating Administrative Change 1 and 
Amendments 1, 2 and 3
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SAP_001.pdf: 
Glecaprevir/Pibrentasvir
M14-730 – Statistical Analysis Plan
Version 2.0 – 14 December 2016
1
1.0
Title Page
Statistical Analysis Plan
Study M14-730
A Multicenter, Open-Label Study to Evaluate the 
Efficacy and Safety of ABT-493/ABT-530 in Adults 
with Chronic Hepatitis C Virus (HCV) Genotype 1 – 6 
Infection and Human Immunodeficiency Virus-1 
(HIV-1) Co-Infection (EXPEDITION-2)
14 December 2016
NCT02738138


Glecaprevir/Pibrentasvir
M14-730 – Statistical Analysis Plan
Version 2.0 – 14 December 2016
2
2.0
Table of Contents
1.0
Title Page..................................................................................1
2.0
Table of Contents.....................................................................2
3.0
Introduction .............................................................................5
4.0
Study Objectives, Design and Procedures.............................5
4.1
Objectives ..................................................................................................5
4.2
Design Diagram .........................................................................................6
4.3
Sample Size................................................................................................7
4.3.1
Justification of Success Criteria and Non-Inferiority Margin for 
SVR12 .........................................................................................................8
4.4
Primary Analysis........................................................................................8
5.0
Analysis Populations ...............................................................9
5.1
Definition for Analysis Populations...........................................................9
5.1.1
Intention-to-Treat (ITT) Population...........................................................9
5.1.2
Modified Intention-to-Treat (mITT) Population........................................9
5.1.3
Safety Population.......................................................................................9
5.2
Variables Used for Stratification of Randomization..................................9
6.0
Analysis Conventions ............................................................10
6.1
Definition of Baseline and End of Treatment Assessment ......................10
6.1.1
Baseline....................................................................................................10
6.1.2
Study Days...............................................................................................10
6.2
Definition of Analysis Windows .............................................................11
6.3
Missing Data Imputation..........................................................................14
7.0
Demographics, Baseline Characteristics, Medical 
History, and Other Medications...........................................16
7.1
Demographic and Baseline Characteristics .............................................16
7.2
Medical History .......................................................................................22
7.3
Prior, Concomitant and Post-Treatment Medications..............................23
8.0
Patient Disposition.................................................................23
8.1
Disposition of Safety Population .............................................................23
9.0
Study Drug Exposure and Compliance...............................24
9.1
Exposure ..................................................................................................24


Glecaprevir/Pibrentasvir
M14-730 – Statistical Analysis Plan
Version 2.0 – 14 December 2016
3
9.2
Compliance ..............................................................................................25
10.0
Efficacy Analysis....................................................................25
10.1
General Considerations............................................................................25
10.2
Handling of Multiplicity ..........................................................................30
10.3
Primary Efficacy Analysis .......................................................................30
10.4
Secondary Efficacy Analyses...................................................................31
10.5
Sensitivity Analyses for SVR ..................................................................31
10.5.1
Imputation Approaches............................................................................31
10.6
Efficacy Subgroup Analysis ....................................................................32
10.7
Additional Efficacy Analyses ..................................................................33
10.8
Resistance Analyses.................................................................................35
10.8.1.1
HCV Drug-Resistance Analyses..............................................................35
10.8.1.1.1
Presence of Baseline Resistance-Associated Variants.............................40
10.8.1.2
HIV Drug-Resistance Analyses ...............................................................41
10.9
Patient Reported Outcomes......................................................................42
11.0
Safety Analysis.......................................................................43
11.1
General Considerations............................................................................43
11.2
Analysis of Adverse Events.....................................................................43
11.2.1
Treatment-Emergent Adverse Events ......................................................43
11.2.2
Tabulations of Treatment-Emergent Adverse Events..............................44
11.2.3
Listing of Adverse Events........................................................................47
11.3
Analysis of Laboratory Data....................................................................47
11.3.1
Variables and Criteria Defining Abnormality..........................................48
11.3.2
Statistical Methods...................................................................................49
11.4
Analysis of Vital Signs and Weight.........................................................51
11.4.1
Variables and Criteria Defining Abnormality..........................................51
11.4.2
Statistical Methods...................................................................................52
11.5
Analysis of HIV-1 RNA and Flow Cytometry ........................................53
12.0
Summary of Changes ............................................................56
12.1
Summary of Changes Between the Latest Version of the Protocol 
and SAP Version 1.0................................................................................56
12.2
Summary of Changes Between SAP Version 1.0 and SAP 
Version 2.0...............................................................................................56


Glecaprevir/Pibrentasvir
M14-730 – Statistical Analysis Plan
Version 2.0 – 14 December 2016
4
13.0
References...............................................................................56
List of Tables
Table 1.
Analysis Time Windows for HCV RNA, Resistance Endpoints, 
Laboratory, Vital Sign Measurements, and PRO Instruments 
(Treatment Period)...................................................................................12
Table 2.
Analysis Time Windows for HCV RNA and Resistance Endpoints 
(Post-Treatment Period)...........................................................................13
Table 3.
Analysis Time Windows for HIV-1 RNA and Flow Cytometry 
Samples (Treatment Period).....................................................................13
Table 4.
Analysis Time Windows for HIV-1 RNA and Flow Cytometry 
Samples (Post-Treatment Period) ............................................................14
Table 5.
Laboratory Data, Vital Sign and PRO Instruments Visit Windows 
(Post-Treatment Period)...........................................................................14
Table 6.
Baseline Fibrosis Stage............................................................................19
Table 7.
Child-Pugh Classification of Severity of Cirrhosis .................................20
Table 8.
Clinical Identification of Metabolic Syndrome .......................................21
Table 9.
Medical History eCRF .............................................................................22
Table 10.
List of Genotype-Specific Signature Amino Acid Positions and 
Key Subsets of Amino Acid Positions.....................................................36
Table 11.
Resistance-Associated Variants by DAA Target and HCV 
Genotype..................................................................................................40
Table 12.
Definitions of Toxicity Grades 1, 2, 3, and 4 for Laboratory 
Values ......................................................................................................50
Table 13.
Criteria for Potentially Clinically Significant Vital Sign Values.............52
List of Figures
Figure 1.
Study Design..............................................................................................7


Glecaprevir/Pibrentasvir
M14-730 – Statistical Analysis Plan
Version 2.0 – 14 December 2016
5
3.0
Introduction
This statistical analysis plan (SAP) describes the statistical analyses to be completed by 
the AbbVie Statistics and Statistical Programming Departments, or designee, for 
Study M14-730.
Study M14-730 examines the safety and efficacy of treatment with the combination 
regimen glecaprevir/pibrentasvir for 8 or 12 weeks in HCV genotype 1 – 6 infected 
subjects with HIV-1 co-infection with or without cirrhosis.
This SAP provides details to further elaborate the statistical methods outlined in Clinical 
Study Protocol M14-730 Amendment 3 dated 12 July 2016, and describes analysis 
conventions to guide the statistical programming.  Analyses will be performed using 
SAS® Version 9.3 (SAS Institute, Inc., Cary, NC) or later under the UNIX operating 
system.
4.0
Study Objectives, Design and Procedures
4.1
Objectives
The primary objectives of this study are to compare the SVR12 rates (12-week sustained 
virologic response, SVR12 [HCV RNA < LLOQ 12 weeks following therapy]) of 8 or 
12 weeks of treatment with glecaprevir/pibrentasvir combination in HCV genotype 1 – 6 
infected subjects with HIV-1 co-infection to a pre-defined threshold, based on the 
historical SVR12 rate of the current standard of care (i.e., sofosbuvir/ledipasvir for 
12 weeks or grazoprevir/elbasvir for 12 weeks) and to assess the safety of treatment with 
the combination regimen glecaprevir/pibrentasvir for 8 or 12 weeks in HCV 
genotype 1 – 6 infected subjects with HIV-1 co-infection.
The secondary objectives are to assess the percentages of subjects with on-treatment HCV 
virologic failure and the percentages of subjects with post-treatment HCV relapse among 
HCV genotype 1 – 6 infected subjects with HIV-1 co-infection.


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The pharmacokinetics, emergence and persistence of viral variants, maintenance of HIV 
RNA suppression and emergence of HIV variants will also be assessed for the 
glecaprevir/pibrentasvir treatment regimen.
4.2
Design Diagram
This is a Phase 3, multicenter, open-label study to evaluate the efficacy and safety of the 
combination regimen glecaprevir/pibrentasvir in HCV treatment-naïve (i.e., subject has 
not received a single dose of any approved or investigational anti-HCV medication) or 
treatment-experienced (i.e., subject who has failed prior IFN or pegIFN with or without 
RBV therapy, or SOF plus RBV with or without pegIFN) adults with chronic HCV
GT1 – 6 infection and HIV-1 co-infection with or without cirrhosis (F0-F4; excluding 
GT3 treatment-experienced subjects) for an 8-week (non-cirrhotics) or 12-week 
(cirrhotics) treatment duration.
Subjects must be naïve to treatment with any HIV-1 antiretroviral therapy (ART) or on a 
stable, qualifying HIV-1 ART regimen for at least 8 weeks prior to Screening.  For 
cirrhotic subjects, the qualifying HIV-1 ART regimen must contain one of the following 
ARV agents:  rilpivirine (RPV), raltegravir (RAL), dolutegravir (DTG), or 
elvitegravir/cobicistat (EVG/COBI).  For non-cirrhotic subjects, HIV-1 ART regimens 
containing one of the following ARV agents are also allowed:  darunavir co-administered 
with ritonavir (DRV + RTV) QD, darunavir/cobicistat (DRV/COBI) QD or 
lopinavir/ritonavir (LPV/r) BID.
The study consists of a Treatment Period and a Post-Treatment (PT) Period.
The study was designed to enroll approximately 160 subjects to meet scientific and 
regulatory objectives without enrolling an undue number of subjects in alignment with 
ethical considerations.
A study schematic is shown below in Figure 1.


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Figure 1.
Study Design
*
HCV GT3 treatment-experienced subjects are not eligible for this study.
Eligible subjects will be allocated to one of the following treatment arms:
●
Arm A:  HCV GT1 – 6/HIV-1 co-infected non-cirrhotic subjects will be 
treated with glecaprevir/pibrentasvir 300 mg/120 mg once a day (QD) for 
8 weeks.
●
Arm B:  HCV GT1 – 6/HIV-1 co-infected subjects with compensated cirrhosis 
will be treated with glecaprevir/pibrentasvir 300 mg/120 mg once a day (QD) 
for 12 weeks.
4.3
Sample Size
The study plans to enroll approximately a total of 160 subjects.  A maximum of 
approximately 110 HCV GT-1 infected subjects will be enrolled.  A minimum of 10% 
(n = 16) of the overall study population will be subjects with compensated cirrhosis.  The 
primary efficacy endpoint of SVR12 will be assessed for the ITT population.  
With 160 subjects and assuming that 97% of the subjects achieve SVR12, this study has 
greater than 90% power to demonstrate non inferiority to the historical control SVR12 rate 
(i.e., a two-sided 95% lower confidence bound above 90%) using a one-sample test for 
superiority using EAST 6.3.  No adjustment for dropout is applicable because subjects 
who do not have data at Post-Treatment Week 12 (after imputing) are counted as failures 
for SVR12. 


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4.3.1
Justification of Success Criteria and Non-Inferiority Margin 
for SVR12
Efficacy of the glecaprevir/pibrentasvir regimen in this study will be established by 
demonstrating non-inferiority to a historical control regimen.  The SVR12 rate of the 
historical control regimen was calculated, and a threshold was determined by subtracting a 
non-inferiority margin from the historical SVR12 rate.  Efficacy will be established if the 
lower 95% confidence bound of the SVR12 rate for the glecaprevir/pibrentasvir regimen is
greater than the threshold. 
To align with the Phase 3 studies of glecaprevir/pibrentasvir in the HCV mono-infected 
population, a non-inferiority margin of 6% was chosen for this study.  In addition, 
consideration was given to the fact that limited efficacy data exists for non-GT1 
HCV/HIV co-infected patients.
A historical SVR12 rate of 96% for the current standard of care will be used and is based 
on the SVR12 rates for sofosbuvir/ledipasvir for 12 weeks (96%; 321/335) and 
grazoprevir/elbasvir for 12 weeks (96%; 210/218).1,2  To establish non-inferiority to the 
historical control, a margin of 6% is applied to the historical control rate of 96%, resulting 
in a threshold of 90%.
4.4
Primary Analysis
The primary analysis will occur after all subjects have completed the PT Week 12 Visit or 
prematurely discontinued the study.  For the primary analysis, data will be locked after 
performing data cleaning.  Results from the primary analysis (e.g., SVR12 data) will be 
described in the primary clinical study report (CSR) that is planned to be included as part 
of submissions to regulatory agencies to support possible labeling changes.
The final analysis will be conducted when all subjects enrolled in the study have 
completed the 24 week post-treatment visit or prematurely discontinued from the study.  
Data after the primary analysis will be added to a new version of the database which will 
be cleaned and locked at the end of the study and included in the final CSR.


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5.0
Analysis Populations
5.1
Definition for Analysis Populations
5.1.1
Intention-to-Treat (ITT) Population
All enrolled subjects who receive at least one dose of study drug will be included in the 
ITT population.
Efficacy analyses will be performed on the overall ITT population, combining Arms A 
and B.
5.1.2
Modified Intention-to-Treat (mITT) Population
Sensitivity analyses of SVR12 as described in Section 10.5, when applicable, will be 
performed on the intention-to-treat population modified to exclude subjects not of eligible 
genotypes (e.g., subjects of multiple/mixed genotypes or a treatment-experienced subject 
determined to be HCV GT3 according to Lipa, Sanger or phylogenetic analyses as 
described in Section 10.8 under HCV Genotype/Subtype) (mITT-GT), and on the 
mITT-GT population modified to exclude subjects who did not achieve SVR12 for reasons 
other than virologic failure (mITT-GT-VF). 
5.1.3
Safety Population
All subjects who receive at least one dose of study drug will be included in the safety 
population.  Safety and demographic analyses will be performed on the safety population.  
Safety and demographic analyses will be performed for each treatment arm and on the 
overall safety population, combining Arms A and B.
5.2
Variables Used for Stratification of Randomization
This study is not randomized.  Eligible subjects will be enrolled into a treatment arm 
based on cirrhotic status.


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6.0
Analysis Conventions
6.1
Definition of Baseline and End of Treatment Assessment
6.1.1
Baseline
The baseline value refers to the last non-missing measurement collected before the 
first dose of study drug is received.  The protocol specifies that all Day 1 assessments 
(other than intensive PK samples) are to be performed prior to administering the first dose 
of study drug.  Therefore, all Day 1 assessments for which time is not collected will be 
assumed to be pre-dose and the baseline value will be the last non-missing measurement 
collected on or before the first day of study drug administration.
All Day 1 assessments with time available must be before the time of first dose to be 
considered baseline and the last non-missing measurement collected before the date and 
time of the first dose of study drug will be considered the baseline value.  If multiple 
measurements that are prior to dosing are recorded on the same date and with the same 
time or if time is not available, then the average of these measurements will be considered 
the baseline value.  The same baseline value will be used for analyses of the Treatment 
and Post-Treatment Periods.
Safety assessments that are related to a serious adverse event that occurred on the 
first dose day are excluded when applying this algorithm.
6.1.2
Study Days
Study days are calculated for each time point relative to the first dose of study drug.  
Study days are negative values when the time point of interest is prior to the first study 
drug dose day.  Study days are positive values when the time point of interest is after the 
first study drug dose day.  There is no Study Day 0.  Study Day 1 is the day of the 
first dose of study drug.


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Study Drug End Days (Days Relative to the Last Dose of Study Drug)
Study drug end days are calculated for each time point relative to the last dose of study 
drug.  The last day of study drug dosing is defined as Study Drug End Day 0.  Days 
before it have negative study drug end days and days after it have positive study drug end 
days.
Final Treatment Value
The final treatment value is defined as the last non-missing measurement collected after 
Study Day 1 and on or before Study Drug End Day 2.
Final Post-Treatment Value
The final post-treatment value for each subject is the last non-missing measurement 
collected after Study Drug End Day 2 and on or before Study Drug End Day 999.
6.2
Definition of Analysis Windows
For efficacy analyses of HCV RNA and resistance, the time windows specified in Table 1
and Table 2 describe how efficacy data are assigned to protocol-specified time points 
during the Treatment and PT Periods, respectively.  All time points and corresponding 
time windows are defined based on the date/time of blood sample collection.
For samples of plasma HIV-1 RNA levels and flow cytometry (including but not limited 
to CD4+ T-cell and CD8+ T-cell counts [absolute and percent]), the time windows 
specified in Table 3 and Table 4 describes how data are assigned to protocol specified 
time points.
For laboratory data and vital signs, the time windows specified in Table 1 and Table 5
describes how data are assigned to protocol specified time points.
If more than one assessment is included in a time window, the assessment closest (except 
in analyses of SVR) to the nominal time will be used.  If there are two observations 
equally distant to the nominal time, the latest one will be used in analyses.  For analyses 


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of SVR (e.g., SVR12) and the analysis of HIV virologic outcomes at the end of treatment 
and Post-Treatment Week 12 using the FDA snapshot algorithm, the last value in the 
window will be used. 
If multiple measurements are made on the same day for a safety laboratory parameter or a 
vital sign parameter, the average of the values will be used to calculate descriptive 
statistics and in analyses of the mean change from baseline.  For summaries of shifts from 
baseline and potentially clinically significant values, multiple values on the same day will 
not be averaged; all values will be considered for these analyses.
Table 1.
Analysis Time Windows for HCV RNA, Resistance Endpoints, 
Laboratory, Vital Sign Measurements, and PRO Instruments 
(Treatment Period)
Scheduled Visit
Nominal Day (Study Day)
Time Window (Study Day Range)
Day 1/Baselinea
1
≤ 1a
Week 1
7
2 to 10
Week 2
14
11 to 21
Week 4
28
22 to 42
Week 8
56
43 to 70
Week 12b
84
71 to 98
Final Treatment Visitc
2 to ≤ 2 days after last dose of study drug
a.
Day of first dose of study drug.
b.
For 12-week treatment only.
c.
The last value within the window will be used to define the Final Treatment Visit value.  The upper bound of this 
Final window is Study Drug End Day ≤ 2.
Note:
Data must also have Study Drug End Day ≤ 2 for all windows.  The result closest to the scheduled time point 
will be used.  PRO instruments are collected at Day 1 and End of Treatment Visit, which can be at Weeks 8 or 
12 depending on treatment assignment.


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Table 2.
Analysis Time Windows for HCV RNA and Resistance Endpoints 
(Post-Treatment Period)
Scheduled Visita
Nominal Day
(Study Drug End Day)
Time Window
(Study Drug End Day Range)
Post-Treatment Week 2
14
3 to 21
Post-Treatment Week 4
28
22 to 42
Post-Treatment Week 8
56
43 to 70
Post-Treatment Week 12
84
71 to 126
Post-Treatment Week 24
168
127 to 999
SVR4
b
28
3 to 56
SVR12
b
84
57 to 126
SVR24
b
168
127 to 210
a.
Post-Treatment Visits are applicable to subjects who received at least one dose of study drug.
b.
For SVR windows, the last value in the window will be used.
Note:
The result closest to the scheduled time point will be used, except for SVR4, SVR12, and SVR24.  Data must 
also have Study Drug End Day > 2 for all windows.  Study Drug End Day 0 is defined as the day of the last 
dose of study drug.
Table 3.
Analysis Time Windows for HIV-1 RNA and Flow Cytometry 
Samples (Treatment Period)
Scheduled Visit
Nominal Day (Study Day)
Time Window (Study Day Range)
Day 1/Baselinea
1
≤ 1a
Week 2
14
2 to 21
Week 4
28
22 to 42
Week 8
56
43 to 70
Week 12b
84
71 to 98
Final Treatment Visitc
2 to ≤ 2 days after last dose of study drug
a.
Day of first dose of study drug. 
b.
For 12-week treatment only.
c.
The last value within the window will be used to define the Final Treatment Visit value.  The upper bound of this 
Final window is Study Drug End Day ≤ 2.
Note:
Data must also have Study Drug End Day ≤ 2 for all windows.  The result closest to the scheduled time point 
will be used.  Flow cytometry samples are collected at Day 1, Week 4, and End of Treatment visit, which can 
be at Weeks 8 or 12 depending on treatment assignment. 


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Table 4.
Analysis Time Windows for HIV-1 RNA and Flow Cytometry 
Samples (Post-Treatment Period)
Scheduled Visit
Nominal Day
(Study Drug End Day)
Time Window
(Study Drug End Day Range)
Post-Treatment Week 4
28
3 to 56
Post-Treatment Week 12
84
57 to 999
Note:
The result closest to the scheduled time point will be used.  Data must also have Study Drug End Day > 2 for 
all windows.  Study Drug End Day 0 is defined as the day of the last dose of study drug. 
Table 5.
Laboratory Data, Vital Sign and PRO Instruments Visit Windows 
(Post-Treatment Period)
Scheduled Time
Nominal Day
(Study Drug End Day)
Time Window
(Study Drug End Days Range)
Post-Treatment Week 2
14
3 to 21
Post-Treatment Week 4
28
22 to 42
Post-Treatment Week 8
56
43 to 70
Post-Treatment Week 12
84
71 to 126
Post-Treatment Week 24
168
127 to 999
Final Post-Treatment Visita
> 2 days after the last dose of study drug
a.
The last value within the Post-Treatment Period window will be used to define the final post-treatment value.  The 
lower bound of this Final window is Study Drug End Day 3.
Note:
The result closest to the scheduled time point will be used.  Data must also have Study Drug End Day > 2.  
Vital signs are collected at every PT visit; hematology, chemistry, urinalysis, and coagulation panels are 
collected at PTW4 and PTDC (if subject discontinued prior to PTW4). For subjects with compensated 
cirrhosis at baseline, chemistry and coagulation panels are collected to calculate the Child Pugh Score.  PRO 
instruments are collected at PTW12 and PTW24 only.
6.3
Missing Data Imputation
Missing Data Imputation for SVR
HCV RNA values will be selected for analysis based on the analysis windows defined in 
Section 6.2.
For analyses of SVR, subjects' missing visit values will have backward imputation 
applied, if possible.  For backward imputation, if the nearest HCV RNA value after the 


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SVR window is unquantifiable or undetectable, then it will be used to impute the HCV 
RNA value in the SVR window.  If a subject is missing an HCV RNA value within the 
appropriate SVR window after performing backward imputation, then this value will be 
imputed with an HCV RNA value from a local laboratory if present; otherwise, the HCV 
RNA value will be missing.  Subjects with missing HCV RNA data in the analysis 
window, after imputations, will be imputed as a failure.
Regardless of the imputation method described above, if a subject starts another treatment 
for HCV, then all HCV RNA values for this subject measured on or after the start date of 
the new HCV treatment will be excluded from analyses.  The subject will be considered a 
failure for summaries of viral response at all time points after the start of the new HCV 
treatment. 
Missing Data Imputation for Virologic Failure
If HCV RNA values from the central laboratory are missing but a local laboratory value is 
present in the appropriate time period, then the local laboratory value will be used to 
assess post-treatment relapse and on-treatment virologic failure. 
Missing Data Imputation for PRO Questionnaires
The handling of missing data for patient reported outcomes (PROs) will be as follows.  If 
a respondent answers at least 50% of the items in a multi-item scale of the SF-36v2, the 
missing items will be imputed with the average score of the answered items in the same 
scale.  In cases where the respondent did not answer at least 50% of the items, the score 
for that domain will be considered missing.  The Mental and Physical Component 
Summary measures will not be computed if any domain is missing.  The missing items of 
the FSS questionnaire will be imputed with the average score of the answered items as 
long as more than 50% of the items on the FSS are answered.  For EQ-5D-3L index and 
VAS scores, no imputation will be performed for missing items.


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7.0
Demographics, Baseline Characteristics, Medical 
History, and Other Medications
The safety population will be used to summarize demographics and baseline 
characteristics.
The safety population will be used to summarize medical history and previous, 
concomitant, and post-treatment medications.
7.1
Demographic and Baseline Characteristics
Categorical demographic and baseline characteristic variables will be summarized with 
the number and percentage of subjects.  Continuous variables will be summarized with 
descriptive statistics (number of non-missing observations, mean, standard deviation, 
median, maximum and minimum).   
Continuous demographic variables include age, weight, height, waist circumference, and 
body mass index (BMI).  Categorical demographic variables include sex, race, black race 
(black or non-black), ethnicity, age category (< 65 or ≥ 65 years; < 75 or ≥ 75 years), BMI 
category (< 30, or ≥ 30 kg/m2), country, and geographic region (North America, Europe, 
or rest of world [ROW]).
When defining geographic region, sites in the United States and Puerto Rico will be 
grouped under North America; sites in Belarus, Germany, France, Poland, Russia, and the 
United Kingdom will be grouped under Europe; sites in Australia will be grouped 
together as ROW).
Continuous baseline characteristics include baseline log10 HCV RNA level, homeostasis 
model of assessment – insulin resistance (HOMA-IR), creatinine clearance, eGFR, 
platelet count, albumin, CD4+ T-cell count, GGT, LDL, HDL, APRI, FIB-4, AST, ALT, 
total, direct, and indirect bilirubin for all subjects.


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Categorical baseline characteristics include: 
●
HCV genotype (1, 2, 3, 4, 5, or 6) and available subtype (as determined by the 
central laboratory);
●
Prior HCV treatment history (naïve or experienced);
○
For treatment-experienced subjects, type of previous regimen (IFN- or 
SOF-based);
○
For treatment-experienced subjects, type of non-response to previous 
treatment (on-treatment nonresponder or breakthrough, post-treatment 
relapse, or unknown/other);
●
Prior HCV DAA treatment history:
○
DAA-naïve (i.e., treatment naïve or treatment-experienced with IFN or 
pegIFN with or without RBV);
○
DAA-experienced (i.e., treatment-experienced with sofosbuvir with RBV 
with or without pegIFN); 
●
HIV-1 treatment status (naïve to ART, on a stable ART);
●
HIV-1 ART regimen (for those on stable ART):
o
N(t)RTI Backbone:  TDF, TAF, ABC
o
Anchor ARV:  RAL, DTG, EVG, RPV, DRV, LPV/r
●
Baseline CD4+ T-cell (< 200, 200 to < 350, 350 to < 500, or ≥500 cells/mm3) 
count;
●
IL28B genotype (CC, CT, or TT; CC or non-CC); 
●
Baseline HCV RNA level (< 1,000,000 or ≥ 1,000,000 IU/mL, < 6,000,000 or 
≥ 6,000,000 IU/mL);
●
Baseline fibrosis stage (equivalent to Metavir F0 – F1, F2, F3, or F4 [if 
applicable]);
●
Baseline platelet count (< 90 or ≥ 90 × 109/L); 
●
Baseline albumin (< 35 or ≥ 35 g/L); 
●
Baseline creatinine clearance (< 60, ≥ 60 to < 90, ≥ 90 mL/min);
●
Baseline eGFR (< 60, ≥ 60 to < 90, ≥ 90 mL/min/1.73 m2);
●
History of diabetes (yes/no);


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●
History of bleeding disorders (yes/no);
●
History of depression or bipolar disorder (yes/no);
●
History of cardiovascular disease (yes/no);
●
Baseline metabolic syndrome (yes/no);
●
Injection drug use (yes, within last 12 months; yes, more than 12 months ago; 
or no);
●
Subject on stable opiate substitution (yes/no);
●
Tobacco use (user, ex-user, or non-user);
●
Alcohol use (drinker, ex-drinker, or non-drinker); 
●
Concomitant use of Proton Pump Inhibitors (PPIs).
In addition, for cirrhotic subjects, the following will be summarized:
●
Baseline Child-Pugh score (5, 6, or > 6) ,
The last HIV-1 medications taken prior to Day 1, as recorded on the CRF 'ARV Dosing 
Prior to Visit' will be the data source for the summary of baseline HIV-1 ART regimen.
Any concomitant medication coded to the WHO Drug Dictionary ATC code of A02BC 
will be counted as a PPI.
If the IL28B genotype result is not available from a sample collected on Day 1, then a 
result available from a sample collected at any time during the study will be used to 
summarize IL28B genotype.  IL28B rs12979860 will be resulted as C/C, C/T, or T/T by 
the central laboratory.
Baseline fibrosis stage is defined for subjects with non-missing liver biopsy scores, 
FibroScan scores, or FibroTest scores.  Only one score will be used to categorize each 
subject even if a subject has more than one score recorded.  If a biopsy score is present, 
then it will be used to categorize the subject, regardless of the FibroScan/FibroTest score.  
Similarly, if a FibroScan score is present along with a FibroTest score, then the FibroScan 
score will be used to categorize the subject.  If biopsy and FibroScan scores are not 


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present and more than one FibroTest result is available, then the baseline FibroTest result 
(i.e., last non-missing FibroTest result on or before Day 1) will be used to categorize the 
subject.  Subjects will be categorized as F0 – F1, F2, F3, or F4 according to Table 6.
Table 6.
Baseline Fibrosis Stage
Baseline Fibrosis 
Stage, Metavir 
Equivalents
Liver Biopsy Metavir, 
Batts Ludwig, Knodell, 
IASL, Scheuer, or 
Laennec Score
Liver Biopsy 
Ishak Score
FibroScan (kPa)
FibroTest*
F0 – F1
0 or 1
0, 1, or 2
< 8.8
≤ 0.48
F2 
2
3
≥ 8.8 to < 9.6
0.49 to 0.58
F3
3
4
≥ 9.6 to < 12.5
0.59 to < 0.75
F4
4
≥ 5
≥ 12.5
≥ 0.75
*
APRI will not be used to derive Baseline Fibrosis Stage.  However, per inclusion/exclusion criteria, subjects need 
to have concordant FibroTest and APRI scores in order to determine eligibility.
Presence or absence of cirrhosis will be determined as collected in EDC ("What is the 
subject's cirrhosis status?" – "cirrhotic" or "non-cirrhotic"). 
Baseline Child-Pugh score will be calculated according to Table 7.


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Table 7.
Child-Pugh Classification of Severity of Cirrhosis
Parameter
Points Assigned for Observed Findings
1
2
3
Total bilirubin, μmol/L (mg/dL)
< 34.2
(< 2)
34.2 – 51.3
(2 – 3)
> 51.3
(> 3)
Serum albumin, g/L (g/dL)
> 35
(> 3.5)
28 – 35
(2.8 – 3.5)
< 28
(< 2.8)
INR
< 1.7
1.7 – 2.3
> 2.3
Ascites*
None
Slight
Moderate to 
severe
Hepatic encephalopathy**
None
Grade 1 or 2
(or suppressed with medication)
Grade 3 or 4
(or refractory)
*
None.
Slight ascites = Ascites detectable only by ultrasound examination.
Moderate ascites = Ascites manifested by moderate symmetrical distension of the abdomen.
Severe ascites = Large or gross ascites with marked abdominal distension.
**
Grade 0:  normal consciousness, personality, neurological examination, electroencephalogram.
Grade 1:  restless, sleep disturbed, irritable/agitated, tremor, impaired handwriting, 5 cps waves.
Grade 2:  lethargic, time-disoriented, inappropriate behavior, asterixis, ataxia, slow triphasic waves.
Grade 3:  somnolent, stuporous, place-disoriented, hyperactive reflexes, rigidity, slower waves.
Grade 4:  unarousable coma, no personality/behavior, decerebrate, slow 2 to 3 cps delta activity.
Baseline APRI and FIB-4 are defined as the equations below.  Subjects who do not have 
concurrent AST and platelet values at baseline will be excluded from the summary of 
baseline APRI.  Age is defined in years at baseline.  Subjects who do not have concurrent 
values of AST, ALT, and platelet count at baseline, or subjects who are missing age will 
be excluded from the summary of FIB-4.
APRI =
	
  (/)
	
 (   )(/)
 !!  "#$%  (&'(/))
× 100
FIB-4 =
Age (years) ×  AST Level (U/L)
Platelet Count (10B/L) × CALT (U/L)


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Subjects will be classified as having metabolic syndrome if at least 3 of the 
5 characteristics in Table 8 are present.
Table 8.
Clinical Identification of Metabolic Syndrome
Risk Factor
Defining Level in 
Conventional Units
Defining Level in SI Units
Abdominal obesity, given as waist 
circumference
Men
> 40 in
> 102 cm
Women
> 35 in
> 88 cm
Triglycerides
≥ 150 mg/dL
≥ 1.695 mmol/L
HDL cholesterol
Men
< 40 mg/dL
< 1.03452 mmol/L
Women
< 50 mg/dL
< 1.29315 mmol/L
Blood pressure (BP)
Systolic BP ≥ 130 or Diastolic BP 
≥ 85 mmHg
Systolic BP ≥ 130 or 
Diastolic BP ≥ 85 mmHg
Fasting glucose
≥ 100 mg/dL
≥ 5.5507 mmol/L
Reference:  Grundy 2004.3
Histories of diabetes, bleeding disorders, depression or bipolar disorder, and 
cardiovascular disease will be based on the Medical History (MH) eCRF, as defined in 
Table 9.


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Table 9.
Medical History eCRF
Medical History eCRF
Subgroup
Body System
Condition/Diagnosis
Diabetes
Metabolic
Diabetes mellitus
Bleeding disorders
Blood
Clotting/bleeding problems
Factor deficiency
Hemophilia
Von Willebrand disease
Depression or bipolar disorder
Neurologic and Psychiatric 
System
Bipolar disorder
Depression
Cardiovascular disease
Cardiovascular
Angina
Cardiac arrhythmia
Cardiovascular disease
Congenital heart disease
Congestive heart failure
Coronary artery disease
Hypertension
Myocardial infarction
Myocarditis
Peripheral vascular 
disease-arterial
Peripheral vascular 
disease-venous
Valvular heart disease
Vasculitis
7.2
Medical History
Medical history data will be summarized and presented using body systems and 
conditions/diagnoses as captured on the eCRF.  The body systems will be presented in 
alphabetical order and the conditions/diagnoses will be presented in alphabetical order 
within each body system.  The number and percentage of subjects with a particular 
condition/diagnosis will be summarized for all treated subjects.  Subjects reporting more 


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than one condition/diagnosis within a body system will be counted only once for that 
body system.
7.3
Prior, Concomitant and Post-Treatment Medications
A prior medication is defined as any medication taken prior to the date of the first dose of 
study drug.  A concomitant medication is defined as any medication that started prior to 
the date of the first dose of study drug and continued to be taken on or after the first dose 
of study drug or any medication that started on or after the date of the first dose of study 
drug, but not after the date of the last dose of study drug.  A post-treatment medication for
the treatment of HCV is defined as any medication taken on or after the last dose of study 
drug and entered as "Post-treatment HCV medications" on the eCRF.
The number and percentage of subjects taking prior medications, concomitant 
medications, and post-treatment HCV medications will be summarized by generic drug 
name based on the WHO Drug Dictionary.  The prior HCV medications taken by the 
treatment experienced subjects will be summarized separately from other prior 
medications.
8.0
Patient Disposition
The number and percentage of subjects who screen failed for any reason, and for each 
screen fail reason, will be summarized for all subjects who screen failed.
8.1
Disposition of Safety Population
The number of subjects in each of the following categories will be summarized overall 
and by investigator for each treatment arm and overall.  
●
Randomized subjects;
●
Subjects who took at least one dose of study drug;
●
Subjects who completed study drug;
●
Subjects who prematurely discontinued study drug; 
●
Subjects who completed the study;


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●
Subjects who prematurely discontinued from the study;
●
Subjects ongoing in the Post-Treatment Period at the time of the primary 
analysis.
The number and percentage of subjects who discontinued study drug will be summarized 
by reason (all reasons) and by primary reason (per eCRF) for each treatment arm and 
overall.  Similar summaries will be provided for discontinuations from the study.
The number and percentage of subjects with reported study drug interruptions will be 
summarized by treatment arm.
Reasons for study drug interruptions will be presented in the CSR listings.
9.0
Study Drug Exposure and Compliance
9.1
Exposure
The duration of exposure to study drug will be summarized for the safety population.  
Duration of exposure is defined for each subject as the last study drug dose date minus the 
first study drug dose date plus 1 day.
Descriptive statistics (mean, standard deviation, median, minimum, and maximum) will 
be presented for exposure during the treatment period.
Study drug duration will be summarized with frequencies and percentages using the 
following categories:
●
1 to 15 days
●
16 to 30 days
●
31 to 45 days
●
46 to 60 days
●
61 to 75 days
●
76 to 90 days
●
> 90 days


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In addition, the number and percentage of subjects with study drug duration of ≥ 52 days
for Arm A and ≥ 77 days for Arm B will be summarized.
9.2
Compliance
At each visit (starting with the Week 4 visit) during the Treatment Period, the total 
number of tablets dispensed and returned is recorded.  The compliance for study drug 
(glecaprevir/pibrentasvir) during the treatment period will be calculated as the percentage 
of tablets taken relative to the total tablets expected to be taken.  The total number of 
tablets expected to be taken will be equal to the total number of tablets that should have 
been taken per the protocol for the duration that the subject was in the Treatment Period 
(date of last dose of study drug – date of first dose of study drug + 1).  Study drug 
interruptions recorded on the eCRF will not be subtracted from the duration.
A subject is considered to be compliant if the percentage is between 80% and 120%.  
Compliance will be calculated for each subject and summarized with the mean, median, 
standard deviation, minimum, and maximum for each treatment arm and overall.  A 
listing of compliance for each subject will be provided.  The percentage of compliant 
subjects will be summarized for each treatment arm and overall, based on data as 
observed.  An additional summary of the percentage of compliant subjects, overall and by 
treatment arm, will be provided where subjects who are missing study drug accountability 
records will be imputed as non-compliant.
10.0
Efficacy Analysis
10.1
General Considerations
General Considerations
All efficacy analyses will be performed on the ITT population, unless otherwise specified.  
To support the primary analysis, sensitivity analyses will be conducted using the 
mITT-GT and mITT-GT-VF populations.


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Missing data will be imputed as described in Section 6.3 for analyses of the HCV RNA 
endpoints of SVR.
Plasma HCV RNA levels will be determined for each sample collected by the central 
laboratory using the Roche COBAS® AmpliPrep/COBAS® TaqMan® HCV Quantitative 
Test, v2.0.  The lower limit of detection (LLOD) and lower limit of quantification 
(LLOQ) for this assay (regardless of genotype) are both 15 IU/mL.
HCV RNA results that are detectable but not quantifiable are reported as "< 15 IU/ML 
HCV RNA DETECTED" and those that are undetectable are reported as "HCV RNA 
NOT DETECTED" in the database. 
The notation "HCV RNA < LLOQ" is used to represent all HCV RNA values 
< 15 IU/mL, including values reported as "HCV RNA NOT DETECTED" or 
"< 15 IU/ML HCV RNA DETECTED."  HCV RNA ≥ LLOQ are all quantifiable values 
of 15 IU/mL or greater.
Definitions for Efficacy Endpoints
A confirmed quantifiable value during treatment is defined as any two consecutive HCV 
RNA measurements ≥ LLOQ (or 100 IU/mL for Breakthrough), either both during 
treatment or at the final treatment measurement and the next consecutive post-treatment 
measurement.  A confirmed quantifiable post-treatment value is defined as any 
two consecutive post-treatment HCV RNA measurements ≥ LLOQ.
Breakthrough = confirmed HCV RNA ≥ 100 IU/mL after HCV RNA < LLOQ during 
the Treatment Period; or confirmed increase from nadir in HCV RNA (two consecutive 
HCV RNA measurements > 1 log10 IU/mL above nadir) at any time point during the 
Treatment Period.  A single breakthrough value (≥ 100 IU/mL or > 1 log10 above nadir) 
followed by lost to follow-up also will be considered a breakthrough (i.e., will not require 
confirmation).


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EOT failure = HCV RNA ≥ LLOQ at end of treatment with at least 6 weeks of treatment, 
where the HCV RNA value must be collected on or after Study Drug Day 36 and study 
drug duration ≥ 36 days.
On-treatment virologic failure = Breakthrough or EOT failure.
SVR4 = HCV RNA < LLOQ in the SVR4 window (4 weeks after the last actual dose of 
study drug) without any confirmed quantifiable (≥ LLOQ) post-treatment value before or 
during that SVR window.
SVR12 = HCV RNA < LLOQ in the SVR12 window (12 weeks after the last actual dose of 
study drug) without any confirmed quantifiable (≥ LLOQ) post-treatment value before or 
during that SVR window. 
SVR24 = HCV RNA < LLOQ in the SVR24 window (24 weeks after the last actual dose of 
study drug) without any confirmed quantifiable (≥ LLOQ) post-treatment value before or 
during that SVR window.
Relapse12 = confirmed HCV RNA ≥ LLOQ between end of treatment and 12 weeks after 
last actual dose of study drug (up to and including the SVR12 assessment time point) for a 
subject with HCV RNA < LLOQ at Final Treatment Visit who completed treatment 
(defined as study drug duration ≥ 52 days for Arm A, and ≥ 77 days for Arm B), 
excluding reinfection as described below. 
Relapse24 = confirmed HCV RNA ≥ LLOQ within the SVR24 window for a subject who 
achieved SVR12 and has HCV RNA data available in the SVR24 window, excluding 
reinfection.
Relapseoverall = confirmed HCV RNA ≥ LLOQ between end of treatment and up to and 
including the last HCV RNA measurement collected in the PT Period for a subject with 
HCV RNA < LLOQ at Final Treatment Visit who completed treatment (defined as study 
drug duration ≥52 days for Arm A, and ≥ 77 days for Arm B), excluding reinfection.


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Virologic failure = On-treatment virologic failure or Relapseoverall.
Only subjects who have at least one post-treatment HCV RNA value will be included in 
analyses of relapse.  For the analysis of relapse, completion of treatment is defined as any 
subject with study drug duration of 52 days or greater for Arm A, and 77 days or greater 
for Arm B.  If the last available post-treatment value is ≥ LLOQ, then the subject will be 
considered a relapse (i.e., will not require confirmation).
HCV reinfection is defined as confirmed HCV RNA ≥ LLOQ after the end of treatment in 
a subject 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.  Reinfection in the case of the same HCV subtype is defined as a clade switch, 
as indicated by the lack of clustering between the baseline and post-treatment sequences 
by phylogenetic analysis.  If phylogenetic analysis is not possible due to technical 
difficulties, HCV reinfection may be determined with a confirmed HCV genotype or 
subgenotype switch by the Versant HCV Genotype Inno-LiPA Assay v2.0 or Sanger 
assay.
Post-treatment relapse is defined as described earlier (Relapse12, Relapse24,
Relapseoverall), and no genotype, subtype, or clade switch compared with baseline as 
determined by phylogenetic analysis of the NS3 or NS5A gene sequences.  If 
phylogenetic analysis is not possible due to technical difficulties, the subject will be 
defined as having a post-treatment relapse unless an HCV genotype or subgenotype 
switch is confirmed by the Versant HCV Genotype Inno-LiPA Assay v2.0 or Sanger 
assay.
Reasons for SVR12 Non-Response
Subjects who do not achieve SVR12 (SVR12 non-responders) will be categorized as 
having:
1.
On-treatment virologic failure (see On-treatment virologic failure definition);


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2.
Relapse (defined according to the Relapse12 definition for subjects who complete 
treatment);
3.
Prematurely discontinued study drug with no on-treatment virologic failure 
(defined as any SVR12 non-responder who prematurely discontinued study drug 
[study drug duration < 52 days for subjects in Arm A, and < 77 days for subjects in 
Arm B] and did not meet the On-treatment virologic failure definition);
4.
HCV reinfection (see definition described earlier);
5.
Missing follow-up data in the SVR12 window (defined as any subject who 
completed study drug without data in the SVR12 window after applying the 
imputation rules and not meeting the definitions of [1], [2], [3], or [4]);
6.
Other (defined as any SVR12 non-responder not meeting the definitions of 
[1] – [5]). 
Reasons for SVR24 Non-Response
Subjects who do not achieve SVR24 (SVR24 non-responders) will be categorized as 
having:
1.
On-treatment virologic failure (see On-treatment virologic failure definition);
2.
Relapse (defined according to the Relapse12 definition for subjects who complete 
treatment);
3.
Relapsed after achieving SVR12 (see Relapse24 definition);
4.
Prematurely discontinued study drug with no on-treatment virologic failure 
(defined as any SVR24 non-responder who prematurely discontinued study drug 
[study drug duration < 52 days for subjects in Arm A, and < 77 days for subjects in 
Arm B] and did not meet the On-treatment virologic failure, Relapse12, or 
Relapse24 definitions);
5.
HCV reinfection;


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6.
Missing follow-up data in the SVR24 window (defined as any subject who 
completed study drug without data in the SVR24 window after applying the 
imputation rules and not meeting the definitions of [1], [2], [3], [4], or [5]);
7.
Other (defined as any SVR24 non-responder not meeting the definitions of 
[1] – [6]).
10.2
Handling of Multiplicity
There will be no adjustment for multiple comparisons.  The primary efficacy analysis 
includes testing of a single hypothesis and no hypotheses will tested for the secondary 
efficacy analyses.
10.3
Primary Efficacy Analysis
The primary efficacy endpoint is SVR12 (HCV RNA < LLOQ 12 weeks after the last 
actual dose of study drug) in the ITT population.  The number and percentage of subjects 
achieving SVR12 will be summarized and a two-sided 95% confidence interval will be 
calculated using the normal approximation to the binomial.  If the SVR12 rate is 100%, 
then the Wilson's score method will be used to calculate the confidence interval.
The percentage of subjects treated with glecaprevir/pibrentasvir and achieving SVR12 will 
be non-inferior to the 96% SVR12 rate of the current standard of care 
(i.e., sofosbuvir/ledipasvir for 12 weeks [96%; 321/335]2 or grazoprevir/elbasvir for 
12 weeks [96%; 210/218]1) if the lower confidence bound of the 2-sided 95% confidence 
interval of the percentage of subjects with SVR12 is > 90%.
A summary of reasons for SVR12 non-response (e.g., on-treatment virologic failure, 
relapse, other) will be provided.  A listing of subjects who do not achieve SVR12 by 
reason for non-response will also be provided.


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10.4
Secondary Efficacy Analyses
The secondary efficacy endpoints are:
●
The percentage of subjects with on-treatment HCV virologic failure (defined 
as On-treatment virologic failure),
●
The percentage of subjects with post-treatment HCV relapse (defined as 
Relapse12; subjects with reinfection will be summarized separately).
The number and percentage of subjects with on-treatment virologic failure and 
post-treatment relapse (Relapse12) will be summarized along with two-sided 95% Wilson 
score intervals.
10.5
Sensitivity Analyses for SVR
As sensitivity analyses, the percentage of subjects in the mITT-GT and mITT-GT-VF 
populations achieving SVR12, as applicable, will be summarized, as well as the 
corresponding two-sided 95% confidence interval using a Wilson score interval and a 
normal approximation to the binomial distribution.
As a sensitivity analysis, a two-sided 95% confidence interval for the SVR12 rate in the 
ITT population will be calculated using a Wilson score interval.
Listings of subjects excluded from the mITT-GT, and mITT-GT-VF populations will be 
provided, as applicable.
10.5.1
Imputation Approaches
In addition to imputing SVR12 as described in Section 6.3, SVR12 will also be presented 
using the following method to impute missing HCV RNA values:
●
imputing any missing HCV RNA values in the SVR12 window by carrying 
forward the last non-missing (post-baseline) HCV RNA value prior to the 
SVR12 window;


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●
imputing as described in Section 6.3 but treat SVR12 non-responders who were 
categorized as "prematurely discontinued study drug with no on-treatment 
virologic failure" or "missing follow-up data in the SVR12 window" as 
successes.
The percentage of subjects with SVR12 will then be presented along with two-sided 95% 
normal and Wilson score confidence intervals.
10.6
Efficacy Subgroup Analysis
The percentage (and two-sided Wilson score confidence intervals) of subjects with SVR12
in the ITT population will be presented for the following subgroups if data are available:
●
HCV genotype (1, 2, 3, 4, 5, or 6) and available subtype (as defined in 
Section 10.8);
●
Prior HCV treatment history (treatment-naïve or treatment-experienced);
○
For treatment-experienced subjects, type of previous regimen (IFN- or 
SOF-based);
●
IL28B genotype (CC or non-CC);
●
Sex (male or female);
●
Age (< 65 or ≥ 65 years) and (< 75 or ≥ 75 years);
●
Race (White, Black/African-American, Asian, or other) and (black or 
non-black);
●
Ethnicity (Hispanic or Latino, Not Hispanic or Latino);
●
Baseline BMI (< 30, or ≥ 30 kg/m2);
●
Baseline HCV RNA level (< 1,000,000 or ≥ 1,000,000 IU/mL) and 
(< 6,000,000 or ≥ 6,000,000 IU/mL);
●
Cirrhosis status (yes/no);
●
Baseline platelet count (< 90 or ≥ 90 × 109/L);
●
Baseline albumin (< 35 or ≥ 35 g/L);
●
Baseline creatinine clearance (< 60, ≥ 60 to < 90, ≥ 90 mL/min);
●
Baseline eGFR (< 60, ≥ 60 to < 90, ≥ 90 mL/min/1.73 m2); 


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●
Geographic region (North America, Europe, Rest of world);
●
Country (as appropriate);
●
History of diabetes (yes/no);
●
Baseline metabolic syndrome (yes/no);
●
Former injection drug user (yes, within last 12 months; yes, more than 
12 months ago; or no);
●
Subject on stable opiate substitution (yes/no);
●
Baseline CD4+ Count (< 200, 200 to < 350, 350 to < 500, or ≥500 cells/mm3);
●
Presence of baseline resistance-associated variants (any NS3/4A variant 
[yes/no]; any NS5A variant [yes/no]; any NS3/4A and any NS5A variant 
[yes/no], any NS3/4A or any NS5A variant [yes/no]), and (NS3/NS4A variant 
only, NS5A variant only, both NS3/4A variant and NS5A variant, or none);
●
Concomitant use of Proton Pump Inhibitors (PPIs) (yes/no).
For subjects with cirrhosis only:
●
Baseline Child-Pugh Score (5, 6, or > 6).
The 2-sided 95% Wilson score confidence interval will be produced if there are at least 
10 subjects in the subgroup.
For the subgroup analyses, the presence of baseline resistance-associated variants as listed 
above are defined in Section 10.8.1.1.1; this subgroup analysis will be performed in the 
mITT-GT-VF population.
10.7
Additional Efficacy Analyses
The following additional efficacy endpoints will be summarized and analyzed for the ITT 
population:
●
The percentage of subjects with HCV RNA < LLOQ at each post-baseline visit 
in the Treatment Period (using data as observed);
●
The percentage of subjects with SVR4;


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●
The percentage of subjects with SVR24;
●
The percentage of subjects who relapsed after achieving SVR12 (Relapse24);
●
The percentage of subjects with virologic failure through Post-Treatment 
Week 12 (i.e., the SVR12 non-responders due to on-treatment virologic failure 
or Relapse12)
In the above analyses for SVR, virologic failure, and relapse, the percentage of subjects 
with a two-sided 95% Wilson score interval will be summarized.  Imputations for missing 
data will be performed as described in Section 6.3 for analysis of SVR, where a missing 
response will be imputed as a failure after performing the described imputation.  All other 
endpoints will be presented using data as observed.
The difference of the percentage of subjects achieving SVR12 in the ITT population and 
the SVR12 rate of the historical rate for HCV/HIV co-infected subjects (96%) justified in 
Section 4.3.1 will be calculated with a normal approximation interval.
A summary of the subjects who completed treatment and relapsed (defined as 
Relapseoverall) will be prepared displaying the number of subjects relapsing overall and by 
SVR visit window (within the SVR4, SVR12, SVR24 windows or after SVR24 window), 
including the subject number and the SVR visit window corresponding to the 
first occurrence of relapse.  A similar listing will be prepared for subjects who 
prematurely discontinued treatment and relapsed after having HCV RNA < LLOQ at their 
Final Treatment Visit.
The number and percentage of subjects who do not achieve SVR24 will be summarized by 
reason for non-response (as defined in Section 10.1).  A listing of subject numbers and 
reason for non-response will be prepared.  
The concordance between SVR12 and SVR24 will be assessed by the agreement between 
SVR12 and SVR24 and the positive predictive value (PPV) and negative predictive value 
(NPV) of SVR12 on SVR24.  The agreement between SVR12 and SVR24 is a percentage 
defined as the number of subjects achieving both SVR12 and SVR24 and the number of 


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subjects where both SVR12 and SVR24 are not achieved.  The PPV of SVR12 on SVR24 is 
the proportion of subjects who achieve SVR12 and SVR24 out of all subjects who achieved 
SVR12.  The NPV of SVR12 on SVR24 is the proportion of subjects who neither achieve 
SVR12 nor SVR24 out of all subjects who did not achieve SVR12.  Similarly, the 
concordance between SVR4 and SVR12 will be summarized. 
10.8
Resistance Analyses
10.8.1.1
HCV Drug-Resistance Analyses
For all subjects, full length NS3/4A or NS5A from baseline samples will be sequenced by 
next generation sequencing (NGS).  For subjects who experience virologic failure 
(on-treatment virologic failure or post-treatment relapse as defined in Section 10.1), full 
length NS3/4A and NS5A genes from the first sample after virologic failure with HCV 
RNA ≥ 1000 IU/mL will be sequenced by NGS.  An appropriate subtype specific 
prototypic reference sequence will be used for comparison with sequences from samples.  
Subjects who experience virologic failure will be referred to as subjects in the primary 
virologic failure (PVF) population, and a listing by subject that includes HCV 
genotype/subtype, IL28B genotype, reason for SVR12 non-response, time point(s) 
sequenced as closest to time of VF, and HCV RNA value at the VF time point(s) will be 
produced for these subjects.  In addition, all listings described below will display HCV 
genotype/subtype and reason for SVR12 non-response in the subject identifier for each 
subject.  A separate listing will summarize all subjects in the PVF population for whom 
no sequencing was performed (e.g., lost to follow-up while HCV RNA ≤ 1000 IU/mL).
Subjects treated with study drug who do not achieve SVR12 due to reasons other than 
virologic failure (prematurely discontinued study drug with no on-treatment virologic 
failure, HCV reinfection, missing SVR12 data or other reasons as described in 
Section 10.1, Reasons for SVR12 Non-Response), but have a time point with HCV RNA 
≥1000 IU/mL after treatment discontinuation, will have the sample at that time point 
sequenced.  These subjects will be referred to as the non-PVF population.  A listing of all 
subjects in the non-PVF population with post-baseline sequencing available will be 


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created that is similar to the listing of subjects in the PVF population with post-baseline 
sequencing available.
For each DAA target, resistance-associated signature amino acid positions and a key 
subset of amino acid positions are listed in Table 10.  Appropriate subtype-specific 
prototypic reference sequence will be used for comparison with sequences from samples.
Table 10.
List of Genotype-Specific Signature Amino Acid Positions and Key 
Subsets of Amino Acid Positions
Genotype
Signature Amino Acid Positions
Key Subset of Amino Acid 
Positions
NS3/4A
1a
36, 43, 54, 55, 56, 80, 107, 122, 132, 155, 156, 
158, 168, and 170
155, 156, 168
1b
36, 54, 55, 56, 80, 107, 122, 155, 156, 158, 
168, 170, and 175
155, 156, 168
2, 3, 4, 5, 6
36, 43, 54, 55, 56, 80, 155, 156, 166 (GT3 
only) and 168
155, 156, 168
NS5A
1a
24, 28, 29, 30, 31, 32, 58, 62, 92, and 93
24, 28, 30, 31, 58, 92, 93
1b
24, 28, 29, 30, 31, 32, 54, 58, 62, 92, and 93
24, 28, 30, 31, 58, 92, 93
2, 3, 4, 5, 6
24, 28, 29, 30, 31, 32, 58, 92, and 93
24, 28, 30, 31, 58, 92, 93
Included time points for analyses on samples from subjects who do not achieve SVR12 are 
1) the sample closest in time after failure/discontinuation with an HCV RNA level of 
≥1000 IU/mL, and 2) 24 weeks post-DAA treatment, provided that resistance-associated 
variants were detected at the time of failure/discontinuation. 
The following definitions will be used in the resistance analyses:
●
Baseline variant:  a variant by NGS in a baseline sample (≥ 2% or ≥ 15% 
prevalence within a subject's viral population depending on variant frequency 
threshold utilized) that was not present in the appropriate prototypic reference 
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●
Variant at signature amino acid position: variant (relative to reference) present 
by NGS at a detection threshold of 2% or 15% (depending on variant 
frequency threshold utilized) in a baseline or a post-baseline sample at a 
signature amino acid position
●
Post-baseline variant:  an amino acid variant in a post-baseline time point 
sample that was not detected at baseline (< 2%) in the subject and is detectable 
in ≥ 2% of the sequences from the post-baseline sample
●
Enriched variant:  variant present in both the baseline and a post-baseline 
sample whose prevalence in the post-baseline sample is at least 20 percentage 
points greater than the prevalence in the baseline sample 
[(post-baseline % – baseline %) ≥ 20]
●
Treatment-emergent variant by NGS: A post-baseline variant or an enriched 
variant
Analysis will be performed separately for each HCV genotype/subtype within each 
listing.
Analysis 1:  The following analyses will be performed for all subjects:
●
A listing of all baseline variants (2% detection threshold) at signature 
resistance-associated amino acid positions for each DAA target (NS3/4A and 
NS5A) (ITT). 
●
A listing of all baseline variants (15% detection threshold) at non-signature 
resistance-associated amino acid positions for each DAA target (NS3/4A and 
NS5A) for subjects in PVF population.
●
The number and percentage of subjects with baseline variants at detection-
thresholds of 2% and 15% for variants at signature amino acid positions (ITT).  
This table includes prevalence of each baseline variant, and a summary of the 
number of subjects with variants in NS3 only, NS5A only, any in NS3, any in 
NS5A, any in NS3 or NS5A, and any in NS3 + NS5A.
●
Total number and percentage of subjects with baseline polymorphisms at a key 
subset of amino acid positions in NS3 only, NS5A only, any in NS3, any in 


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NS5A, any in NS3 or NS5A, and any in NS3 + NS5A (ITT), by subtype, and 
total.
●
Total number and percentage of subjects with baseline polymorphisms at a key 
subset of amino acid positions in NS3 only, NS5A only, any in NS3, any in 
NS5A, any in NS3 or NS5A, and any in NS3 + NS5A (ITT), by genotype, and 
total.
Analysis 2:  The impact of baseline variants on treatment outcome will be assessed for 
mITT-GT-VF population as follows:  for each variant, the SVR12 rate will be calculated 
for subjects with and without the variant and the two rates will be compared using Fisher's 
exact test.  Analysis will be grouped by HCV genotype/subtype and DAA target (NS3 or 
NS5A).  The analysis will include the number of subjects within each genotype/subtype 
with variants in NS3 only, NS5A only, any in NS3, any in NS5A, any in NS3 or NS5A, 
and any in NS3 + NS5A.
The following will be included in the analyses of impact of baseline variants on treatment 
outcome:
●
Variants at signature amino acid positions (vs no variant at that position), 
using detection thresholds of both 2% and 15%.  The analysis will include the 
number of subjects with variants in NS3 only, in NS5A only, any in NS3, any 
in NS5A, any in NS3 or NS5A, and any in NS3 + NS5A.
●
Variants at each non-signature amino acid position at a detection threshold of 
15%.
●
Each variant at signature amino acid position (vs not that variant) using 
detection thresholds of 2% and 15%.  The analysis will include the number of 
subjects with variants in NS3 only, in NS5A only, any in NS3, any in NS5A, 
any in NS3 or NS5A, and any in NS3 + NS5A.
Analysis 3:  In subjects with or without polymorphisms in NS3 only, in NS5A only, any 
in NS3, any in NS5A, any in NS3 or NS5A, and any in NS3 + NS5A at the key subset of 
amino acid positions at 15% detection threshold, the SVR12 rate will be calculated, and 
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Analysis will be separated by HCV subtype.  The following tables will be provided 
(mITT-GT-VF):
●
Comparison of SVR12 rates by subtype, and total (including all subtypes)
●
Comparison of SVR12 rates by genotype, and total (including all subtypes)
Analysis 4:  (will be available in the primary CSR and will be updated in the final 
CSR for the study):
The following analyses will be performed for subjects who do not achieve SVR12 (with 
separate summaries for subjects in PVF and non-PVF populations) and have post-baseline 
resistance data available:
●
Listings by subject of all treatment-emergent variants relative to the baseline 
amino acid sequences will be provided for each DAA target (NS3/4A and 
NS5A). 
●
Listings by subject of all variants at signature amino acid positions in a post-
baseline time point for each DAA target (NS3and NS5A).
●
The persistence of post-baseline variants at signature resistance-associated 
amino acid positions for each target (NS3 and NS5A) from subjects will be 
assessed at Post-Treatment Week 24.  Listings by subject and time point of all 
treatment-emergent variants will be provided for each DAA target (NS3 and 
NS5A).
HCV Genotype/Subtype
Phylogenetic analysis will be conducted on HCV sequence from baseline samples for all 
subjects in order to accurately determine subtype.
Subjects' HCV genotype and subtype may be assessed based on the Inno-LiPA 2.0 Assay 
used by the Central lab (Covance), the HCV genotype determination by Sanger 
sequencing a region of NS5B by the Central lab (Covance) and/or from phylogenetic 
analysis of the full length NS3/4A, and/or NS5A sequences performed by AbbVie.  If the 


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phylogenetic analysis is available, then it will be used to determine the subject's HCV 
genotype and subtype.  If it is not available, then the Sanger sequencing assay result will 
be used to determine the subject's HCV genotype and subtype, if available.  Finally, if 
neither the phylogenetic analysis result nor the Sanger sequencing assay results is 
available, then the Inno-LIPA assay results will be used to categorize the subject.  This 
subtype information will be presented in summaries of efficacy subgroup analyses.  The 
baseline characteristic summary will use the results from the central laboratory (Sanger 
sequencing or Inno-LiPA 2.0 Assay [if Sanger sequencing not available]).
A summary of HCV subtype as provided by the central laboratory (Sanger sequencing or 
Inno-LiPA 2.0 Assay [if Sanger sequencing not available]) versus phylogenetic analysis 
also will be provided.
10.8.1.1.1
Presence of Baseline Resistance-Associated Variants
For the efficacy subgroup analyses defined in Section 10.6, any NS3/4A variant and any 
NS5A variant are defined as follows, where baseline resistance-associated variants based 
on ≥ 15% NGS detection threshold are considered.  Signature amino acid positions of 
NS3/4A and NS5A by HCV genotype are listed in Table 11.
Table 11.
Resistance-Associated Variants by DAA Target and HCV Genotype 
Target
Genotype
Signature Amino Acid Positions 
(All Variants at These 
Positions Are to Be Included)
Other Specific Variants
NS3/4A
1, 2, 3, 4, 5, 6
155, 156, 168
NS5A
1a
28, 30, 31, 93
H58D, E62A
1b
31, 93
2
24, 28, 30, 92, and 93
3
24, 28, 30, 31, 58, and 93
4
24, 28, 30, 31, and 93
5
24, 28, 30, 31, 58, 92, and 93
6
24, 28, 30, 31, 58, 92, and 93


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For example, according to Table 11, all subjects with any baseline variant at amino acid 
positions 155, 156, or 168 will be counted as having any NS3/4A variant at baseline; any 
HCV genotype 2 subjects with any baseline variant at amino acid positions 24, 28, 30, 92, 
or 93 will be counted as having any NS5A variant at baseline.
The number and percent of subjects in the mITT-GT-VF population will be summarized 
for the presence of baseline resistance-associated variants of:
1.
Any NS3/4A variant at baseline (yes/no);
2.
Any NS5A variant at baseline (yes/no);
3.
Any NS3/4A variant at baseline or any NS5A variant at baseline (yes/no); 
4.
Both NS3/4A and NS5A variant at baseline (i.e., any NS3/4A variant at baseline 
and any NS5A variant at baseline) (yes/no);
5.
Presence or absence of any variant 
5a.
Any NS3/4A variant at baseline only (i.e., without baseline NS5A variants);
5b.
Any NS5A variant at baseline only (i.e., without baseline NS3/4A variants); 
5c.
Both NS3/4A and NS4A variant at baseline; 
5d.
None (i.e., no baseline variant in either NS3/4A or in NS5A at baseline).
10.8.1.2
HIV Drug-Resistance Analyses
If a subject develops a confirmed, plasma HIV-1 RNA level ≥ 500 copies/mL after 
starting the study, the subject's HIV-1 PR, RT, and/or IN sequences, as applicable, will be 
analyzed by Monogram Biosciences using the GenoSure® Prime drug resistance assays.  
The number of subjects who demonstrate HIV genotypic resistance and the genotypic 
resistant mutations detected in the samples obtained from these subjects will be tabulated 
and summarized.  Resistance will be defined as described by the IAS-USA Panel.7


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10.9
Patient Reported Outcomes
The following instruments will be used to collect patient reported outcomes (PROs):  
SF-36 version 2 (SF-36v2), Fatigue Severity Scale (FSS), and EuroQol-5 Dimensions-3 
Level (EQ-5D-3L). 
Subject's responses to the EQ-5D-3L will be combined into a unique health state using a 
5-digit code with 1 digit from each of the 5 dimensions.  The EQ-5D-3L states will be 
converted into a single preference-weighted health utility index score by applying 
weights.4,5  The VAS score will be analyzed separately.
The SF-36v2 measures dimensions of a patient's functional health and well-being in 
8 domains and also provides 2 summary scores that characterize a patient's mental 
(Mental Component Summary; MCS) and physical (Physical Component Summary; PCS) 
health status.  Imputation will be applied to each domain as described in Section 6.3.  The 
score for each of the 8 domains ranges from 0 to 100 and will be normalized according to 
the user manual.6  The standardization of the normalized scores will provide the 
norm-based scores with a mean of 50 and a SD of 10.  The two summary scores are based 
on the norm-based scores.  Per the SF-36v2 instrument manual, score for any item with 
multiple responses will be set to "missing."  Subject's responses to the SF-36v2 will be 
summarized for the PCS and MCS measures and eight individual domain measures.
The FSS measures the impact of fatigue over the past week on specific types of 
functioning.  The survey consists of 9 questions using a 7-point Likert scale.  A total score 
is calculated as the average of the individual item responses (adding up all the answers 
and dividing by nine).  Higher FSS scores indicate a higher degree of impact of fatigue.  
Imputation will be applied to the total score as described in Section 6.3.
Summary statistics (n, mean) at each visit and for change from baseline (n, mean, SD, 
minimum, and maximum) to each visit will be provided for the SF-36v2 (MCS and PCS) 
scores; FSS total score; and EQ-5D-3L health index score and VAS score and will be 
summarized descriptively at each visit and for change from baseline to each visit.


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The following analyses of patient reported outcomes (PROs) also will be performed:
●
Number and percentage of subjects who have ever experienced an increase 
from baseline up through each applicable time point of greater than or equal to 
2.5 points in the SF-36 MCS and PCS, along with two-sided 95% Normal CI;
●
Number and percentage of subjects who have ever experienced an increase 
from baseline up through each applicable time point of greater than or equal to 
5 points in the SF-36 domain scores, along with two-sided 95% Normal CI;
●
Number and percentage of subjects who have ever experienced an increase 
from baseline up through each applicable time point of greater than or equal to 
0.7 in the FSS total score, along with two-sided 95% Normal CI.
If a subject starts another treatment for HCV, then all PRO values for this subject 
measured on or after the start date of the new HCV treatment will be excluded from 
analyses.
11.0
Safety Analysis
11.1
General Considerations
Safety analyses will be performed using the safety population.
11.2
Analysis of Adverse Events
Adverse events will be coded using the Medical Dictionary for Regulatory Activities 
(MedDRA).  The actual version of the MedDRA coding dictionary will be noted in the 
clinical study report.
11.2.1
Treatment-Emergent Adverse Events
Treatment-emergent adverse events are defined as any adverse event (AE) with an onset 
date that is after the first dose of study drug and no more than 30 days after the last dose 
of study drug.  Events where the onset date is the same as the study drug start date are 
assumed to be treatment-emergent.  If an incomplete onset date was collected for an 
adverse event, the event will be assumed to be treatment-emergent, unless there is other 


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evidence that confirms that the event was not treatment-emergent (e.g., the event end date 
was prior to the study drug start date).
11.2.2
Tabulations of Treatment-Emergent Adverse Events
The number and percentage of subjects in each arm and overall with treatment-emergent 
adverse events will be tabulated by primary MedDRA System Organ Class (SOC) and 
preferred term (PT).  The system organ classes will be presented in alphabetical order, and 
the preferred terms will be presented in alphabetical order within each system organ class. 
Adverse Event Overview
An overview of AEs will be presented for each treatment arm and overall consisting of the 
number and percentage of subjects experiencing at least one event for each of the 
following AE categories:
●
Any treatment-emergent adverse event;
●
Treatment-emergent adverse events with a "reasonable possibility" of being 
related to DAAs (glecaprevir/pibrentasvir);
●
Treatment-emergent adverse events of grade 3 or higher;
●
Serious treatment-emergent adverse events;
●
Serious treatment-emergent adverse events with a "reasonable possibility" of 
being related to DAAs (glecaprevir/pibrentasvir);
●
Treatment-emergent adverse events leading to discontinuation of study drug;
●
DAA-related treatment-emergent adverse events leading to discontinuation of 
study drug;
●
Treatment-emergent adverse events of Grade 3 or higher with a "reasonable 
possibility" of being related to DAA (glecaprevir/pibrentasvir);
●
Serious treatment-emergent adverse events leading to discontinuation of study 
drug;
●
Treatment-emergent adverse events leading to interruption of study drug;
●
Treatment-emergent adverse events leading to death;
●
Deaths.


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Adverse Events by SOC and PT
Subjects reporting more than one AE for a given PT will be counted only once for that 
term (most severe/highest grade incident for the severity tables and most related incident 
for the relationship tables).  Subjects reporting more than one AE within an SOC will be 
counted only once for that SOC.  Subjects reporting more than one AE will be counted 
only once in the overall total.
The following summaries of AEs by SOC and PT will be generated by treatment arm and 
overall:
●
Treatment-emergent adverse events;
●
Treatment-emergent adverse events with a "reasonable possibility" of being 
related to DAAs (glecaprevir/pibrentasvir);
●
Serious treatment-emergent adverse events;
●
Serious treatment-emergent adverse events with a "reasonable possibility" of 
being related to DAAs (glecaprevir/pibrentasvir);
●
Grade 3 or higher treatment-emergent adverse events;
●
Treatment-emergent adverse events of Grade 3 or higher with a "reasonable 
possibility" of being related to DAA (glecaprevir/pibrentasvir);
●
Treatment-emergent adverse events leading to discontinuation of study drug;
●
DAA-related treatment-emergent adverse events leading to discontinuation of 
study drug;
●
Serious treatment-emergent adverse events leading to discontinuation of study 
drug;
●
Treatment-emergent adverse events leading to interruption of study drug;
●
Treatment-emergent adverse events leading to death.
A listing of treatment-emergent adverse events grouped by body system and preferred 
term with subject numbers will be created for each treatment arm.


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Adverse Events by PT
The number and percentage of subjects experiencing treatment-emergent adverse events 
will be tabulated according to PT and sorted by overall frequency across the 2 treatment 
arms.  Similar summaries will be provided for Grade 3 or higher treatment-emergent 
adverse events, DAA related treatment-emergent adverse events, DAA-related Grade 3 or 
higher treatment-emergent adverse events, and DAA related treatment-emergent serious 
adverse event. 
Adverse Events by Maximum Severity Grade Level
Treatment-emergent adverse events and DAA-related treatment-emergent adverse event 
will be summarized by maximum severity grade level of each preferred term.  Each 
adverse event will be assigned a grade level (grade 1, 2, 3, 4, or 5) by the investigator.  If 
a subject has an AE with unknown severity, then the subject will be counted in the 
severity grade level category of "unknown," even if the subject has another occurrence of 
the same event with a severity present.  The only exception is if the subject has another 
occurrence of the same AE with the highest grade level (grade 5).  In this case, the subject 
will be counted under the "Grade 5" category.
Adverse Event by Maximum Relationship
Treatment-emergent adverse events also will be summarized by maximum relationship of 
each preferred term to study drug (DAA), as assessed by the investigator.  If a subject has 
an adverse event with unknown relationship, then the subject will be counted in the 
relationship category of "unknown," even if the subject has another occurrence of the 
same event with a relationship present.  The only exception is if the subject has another 
occurrence of the same adverse event with a relationship assessment of "Reasonable 
Possibility."  In this case, the subject will be counted under the "Reasonable Possibility" 
category.


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Other Adverse Events
The number and percentage of subjects experiencing at least one treatment-emergent 
adverse event in the search defined by Product MedDRA Query (PMQ) "Hepatic 
Decompensation and Hepatic Failure" will be presented overall and by SOC and PT.  In 
addition, a listing of treatment-emergent adverse events for subjects meeting the search 
criterion will be provided.
AIDS-Associated Opportunistic Infections Adverse Events
The number and percentage of subjects experiencing treatment-emergent Opportunistic 
Infections (OIs) will be tabulated according to SOC and PT for each treatment group and 
overall.  Subjects reporting more than one OI for a given PT will be counted only once for 
that term.  Subjects reporting more than one OI within a SOC will be counted only once 
for that SOC.  Subjects reporting more than one OI will be counted only once in the 
overall total.
11.2.3
Listing of Adverse Events
The following listings of adverse events will be prepared:
●
All serious adverse events (from the time the subject signed the study-specific 
informed consent through the end of the study),
●
Treatment-emergent serious adverse events,
●
Treatment-emergent adverse events leading to death,
●
Treatment-emergent adverse events leading to discontinuation of study drug,
●
Treatment-emergent adverse events leading to study drug interruption.
11.3
Analysis of Laboratory Data
Data collected from the central and local laboratories, including additional laboratory 
testing due to an SAE, will be used in all analyses.


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11.3.1
Variables and Criteria Defining Abnormality
Hematology variables include:  hematocrit, hemoglobin, red blood cell (RBC) count, 
white blood cell (WBC) count, neutrophils, bands, lymphocytes, monocytes, basophils, 
eosinophils, platelet count, reticulocyte count, prothrombin time (PT), international 
normalized ratio (INR), and activated partial thromboplastin time (aPTT).
Chemistry variables include:  blood urea nitrogen (BUN), creatinine, total bilirubin, direct 
and indirect bilirubin, alanine aminotransferase (ALT), aspartate aminotransferase (AST), 
alkaline phosphatase, sodium, potassium, calcium, inorganic phosphorus, cholesterol, 
total protein, glucose, triglycerides, albumin, chloride, bicarbonate, magnesium, total 
insulin, gamma-glutamyl transferase (GGT), creatinine clearance (calculated using 
Cockcroft-Gault), and estimated glomerular filtration rate (eGFR) calculated using the 
modification of diet in renal disease (MDRD) equation defined below.
Urinalysis variables include:  specific gravity, ketones, pH, protein, blood, glucose, 
urobilinogen, bilirubin, leukocyte esterase, and microscopic (reflexly performed if other 
variables are abnormal).
Some of the above laboratory variables are calculated by the laboratory vendor including 
indirect bilirubin, creatinine clearance, and eGFR by MDRD.  The central lab calculates 
eGFR by MDRD using the following equation, where serum creatinine is measured in 
mg/dL and age is measured in years:
GFR (mL/min/1.73 m2) = 175 × (Serum Creatinine)–1.154 × (Age)–0.203 × 1.212 (if 
Black) × 0.742 (if Female).
The central lab calculates the estimated creatinine clearance (CrCl) based on the following 
Cockcroft-Gault formula:
CrCl (mL/min) = [(140 – age) × (weight in kg) × (0.85 if female)]/[serum 
creatinine (mg/dL) × 72].


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11.3.2
Statistical Methods
The baseline value for clinical laboratory tests will be the last non-missing measurement 
on or before the day of the first dose of study drug.  Values on Day 1 must also be before 
the time of first dose if time is available.  The same baseline value will be used for change 
to Treatment Period visits and change to Post-Treatment Period visits.
Mean changes from baseline to each post-baseline visit, including applicable post 
treatment visits, will be summarized for each treatment arm and overall.  Each protocol-
specified laboratory parameter will be summarized with the sample size, baseline mean, 
visit mean, change from baseline mean, standard deviation, minimum, median, and 
maximum.
The laboratory parameters defined in Table 12 will be assigned a toxicity grade of 1, 2, 3, 
or 4.  The number and percentage of subjects with a maximum toxicity grade of 1, 2, 3 or 
4 will be summarized for each treatment arm and overall.  The post-baseline value must 
be in a toxicity grade that is more extreme than the toxicity grade corresponding to the 
baseline value in order to be counted.  The summary will also include the number and 
percentage of subjects with a maximum of at least Grade 3 for all laboratory parameters in 
Table 12.  A listing of all relevant laboratory parameters will be provided for each subject 
who had an increase to Grade 2 or higher for all laboratory variables in Table 12.


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Table 12.
Definitions of Toxicity Grades 1, 2, 3, and 4 for Laboratory Values
Test
Grade 1
Grade 2
Grade 3
Grade 4
ALT 
> ULN – 3 × ULN
> 3 – 5 × ULN
> 5 – 20 × ULN
> 20 × ULN
AST 
> ULN – 3 × ULN
> 3 – 5 × ULN
> 5 – 20 × ULN
> 20 × ULN
Alkaline 
Phosphatase 
> ULN – 2.5 × ULN
> 2.5 – 5 × ULN
> 5 – 20 × ULN
> 20 × ULN
GGT
> ULN – 2.5 × ULN
> 2.5 – 5 × ULN
> 5 – 20 × ULN
> 20 × ULN
Total Bilirubin
> ULN – 1.5 × ULN
> 1.5 – 3 × ULN
> 3 – 10 × ULN
> 10 × ULN
Hemoglobin 
< LLN – 100 g/L
< 100 – 80 g/L
< 80 g/L
--
White blood cells
< LLN – 3.0 × 109/L
< 3.0 – 2.0 × 109/L
< 2.0 – 1.0 × 109/L
< 1.0 × 109/L
Absolute 
Neutrophil Count
< LLN – 1.5 × 109/L
< 1.5 – 1.0 × 109/L
< 1.0 – 0.5 × 109/L
< 0.5 × 109/L
Platelet count
< LLN – 75.0 × 109/L
< 75.0 – 50.0 × 109/L
< 50.0 – 25.0 × 109/L
< 25.0 × 109/L
INR
> 1 – 1.5 × ULN
> 1.5 – 2.5 × ULN
> 2.5 × ULN
--
Glucose 
(increased)
> ULN – 8.9 mmol/L
> 8.9 – 13.9 mmol/L
> 13.9 – 27.8 mmol/L
> 27.8 mmol/L
Glucose 
(decreased)
< LLN – 3.0 mmol/L
< 3.0 – 2.2 mmol/L
< 2.2 – 1.7 mmol/L
< 1.7 mmol/L
Creatinine
> ULN – 1.5 × ULN
> 1.5 – 3 × ULN
> 3 – 6 × ULN
> 6 × ULN
Creatinine 
clearance
< LLN – 60 mL/min
< 60 – 30 mL/min
< 30 – 15 mL/min
< 15 mL/min
Cholesterol
> ULN – 7.75 mmol/L
> 7.75 –
10.34 mmol/L
> 10.34 –
12.92 mmol/L
> 12.92 mmol/L
Albumin
< LLN – 30 g/L
< 30 – 20 g/L
< 20 g/L
--
Assessment of Hepatotoxicity
The number and percentage of subjects in each treatment arm with maximum 
on-treatment lab values meeting the following criteria for potential hepatotoxicity will be 
summarized:
●
ALT ≥ 3 × ULN and total bilirubin  ≥ 2 × ULN;
●
ALT ≥ 3 × ULN and total bilirubin < 2 × ULN;
●
ALT > 5 × ULN and total bilirubin < 2 × ULN;
●
ALT < 3 × ULN and total bilirubin ≥ 2 × ULN.


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The maximum ratio relative to the ULN will be used to determine if subjects meet the 
criteria listed above.  The ALT and total bilirubin values do not need to be concurrent in 
order to meet the defined criteria.  For ALT, the post-baseline value must represent an 
increase from the first nadir (including baseline) to be counted.  First nadir is defined as 
the last value prior to the first increase.  For total bilirubin, a subject will be counted if the 
post-baseline laboratory value meets the above criteria regardless of the baseline 
laboratory value (i.e., the post-baseline laboratory value does not need to be worse than 
the baseline laboratory value).
A listing of all liver function tests including ALT, AST, total, indirect and direct bilirubin, 
ratio of direct to total bilirubin, and alkaline phosphatase values will be provided for each 
subject who met any of the potential hepatotoxicity criteria defined above.  The listings 
will be reviewed to assess bilirubin (e.g., mixed or direct predominance) and temporal 
relationships for subjects with ALT ≥ 3 × ULN and total bilirubin ≥ 2 × ULN.
The number and percentage of subjects with post-baseline values during the Treatment 
Period meeting the following criteria for hepatic laboratory parameters will be 
summarized:
●
ALT > 5 × ULN and ≥ 2 × baseline;
●
AST > 5 × ULN and ≥ 2 × baseline;
●
Total bilirubin ≥ 2.0 × ULN and > baseline.
As noted above, a post-baseline value must be more extreme than the baseline value to be 
considered.  A separate listing will be provided that presents all lab values for the subjects 
meeting any of these criteria during treatment.
11.4
Analysis of Vital Signs and Weight
11.4.1
Variables and Criteria Defining Abnormality
Vital sign variables are body temperature, sitting systolic blood pressure, sitting diastolic 
blood pressure, sitting pulse rate, and body weight.


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The criteria for potentially clinically significant vital sign findings are presented in 
Table 13.
Table 13.
Criteria for Potentially Clinically Significant Vital Sign Values
Test/Measurement
Very Low (VL)
Very High (VH)
Systolic Blood Pressure
≤ 90 mmHg AND A decrease of 
≥20 mmHg from baseline
≥ 180 mmHg AND An increase of 
≥20 mmHg from baseline
Diastolic Blood Pressure
≤ 50 mmHg AND A decrease of 
≥15 mmHg from baseline
≥ 105 mmHg AND An increase of 
≥15 mmHg from baseline
Pulse Rate
≤ 50 bpm AND A decrease of 
≥15 bpm from baseline
≥ 120 bpm AND An increase of 
≥15 bpm from baseline
Weight
A decrease of ≥ 15% from baseline
An increase of ≥ 15% from baseline
Body Temperature
> 38.3°C AND An increase of 
≥1.1°C from baseline
11.4.2
Statistical Methods
The baseline value for vital signs will be the last measurement on or before the day of the 
first dose of study drug.  The same baseline value will be used for change to Treatment 
Period visits and change to Post-Treatment Period visits.
Mean changes from baseline to each post-baseline visit, including applicable 
post-treatment visits, will be summarized for each treatment arm.  Each vital sign 
parameter will be summarized with the baseline mean, visit mean, change from baseline 
mean, standard deviation, minimum, median, and maximum.  
The number and percentage of subjects with on-treatment values meeting the specified 
criteria for Potentially Clinically Significant (PCS) vital sign values (Table 13) will be 
summarized for each treatment arm.  A post-baseline value must be more extreme than the 
baseline value to be considered a PCS finding.  A separate listing will be provided that 
presents all vital sign values for the subjects meeting PCS criteria during treatment.


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11.5
Analysis of HIV-1 RNA and Flow Cytometry
Plasma HIV-1 RNA will be measured by the central laboratory using the Roche COBAS 
AmpliPrep/COBAS TaqMan HIV-1 Test, version 2.0.  For specimens with HIV-1 RNA 
results that are detectable but not quantifiable, the results are reported as "< 20 CP/ML 
HIV-1 RNA DETECTED;" for specimens with no HIV RNA detected, the results are 
reported as:  "NO HIV-1 RNA DETECTED."
The analyses of plasma HIV-1 RNA will be conducted only on those subjects who are on 
stable ART.  The analyses for flow cytometry will be conducted on the full safety 
population. 
The following additional safety data will be summarized and analyzed for each treatment 
arm and overall:
●
The percentage of subjects with plasma HIV-1 RNA suppression at the end of 
treatment and at Post-Treatment Week 12 using the FDA Snapshot Algorithm;
●
The number and percentage of subjects with plasma HIV-1 RNA 
< 20 copies/mL at each applicable time point;
●
Change from baseline in CD4+ T-cell count (absolute and percent) to each 
applicable post-baseline time point;
●
Change from baseline in lymphocytes (count) and CD8+ T-cell counts 
(absolute and percentage) to each applicable post-baseline time point;
●
The listing of subjects with a plasma HIV-1 RNA value ≥ 200 copies/mL at 
any baseline or post-baseline visit during the study.
●
The listing of subjects with HIV-1 RNA ≥ 200 copies/mL at any 
two consecutive baseline or post-baseline visits or with HIV-1 RNA 
≥500 copies/mL at any one baseline or post-baseline visit during the study.
●
The listing of subjects with HIV-1 RNA value ≥ 20 copies/mL and 
< 200 copies/mL at any baseline or post-baseline visit during the study.
The analysis of change from baseline in CD4+ T-cell count (absolute and percent), 
lymphocytes (count) and CD8+ T-cell counts (absolute and percent) will report the mean 


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and median values at baseline and at each applicable post-baseline visit, as well as N, 
mean, median, standard deviation (SD), minimum and maximum values for the change 
from baseline within each treatment arm and overall.
Time windows for HIV-1 RNA endpoints to be analyzed using the FDA snapshot 
algorithm are described as follows.
●
The time window for HIV virologic outcomes at the end of treatment is the 
HIV Week 8 window (Treatment Day 43 to 70) for Arm A and Week 12 
window (Treatment Day 71 – 98) for Arm B as described in Table 3.
●
The time window for HIV virologic outcomes at Post-Treatment Week 12 is 
the HIV Post-Treatment Week 12 window (Post-Treatment Day 57 – 999) as 
described in Table 4.
The subject's HIV virologic outcomes at the end of treatment will be determined per the 
FDA Snapshot Algorithm in the order below.  Vital signs visit dates will be used to 
determine a subject's study duration.
1.
HIV virologic failure at EOT = HIV-1 RNA value ≥ 40 copies/mL at the end of 
treatment; or if the subject discontinues study drug due to HIV virologic failure 
with the last HIV-1 RNA value prior to study drug discontinuation ≥40 copies/mL; 
or if the subject discontinues study for reason(s) other than AE or death on or 
before the upper bound of the end of treatment window (Day 70 for Arm A and 
Day 98 for Arm B) with the last HIV-1 RNA value prior to study discontinuation 
≥40 copies/mL. 
2.
HIV-1 RNA suppression (or HIV virologic success) at EOT = HIV-1 RNA 
value < 40 copies/mL at the end of treatment. 
3.
No HIV virologic data at EOT is defined by subcategories as follows: 
●
Discontinued study due to AE or death if the subject prematurely 
discontinues study due to AE or death on or before the upper bound of the end 
of treatment window and has no HIV-1 RNA value in that window; or 


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●
Discontinued study due to other reason if the subject prematurely 
discontinues study due to reason(s) other than AE or death on or before the 
upper bound of the end of treatment window and has no HIV-1 RNA value in 
that window; or 
●
Missing data during window but on study if the subject has not discontinued 
from study on or before the upper bound of the end of treatment window and 
has no HIV-1 RNA value in that window.
The subject's HIV virologic response at Post-Treatment Week 12 will be determined per 
the FDA Snapshot Algorithm in the order below.  Vital signs visit dates will be used to 
determine a subject's study duration.
1.
HIV virologic failure at PTW12 = HIV-1 RNA value ≥ 40 copies/mL in the HIV 
Post-Treatment Week 12 window, or if the subject discontinues study drug due to 
HIV virologic failure with the last HIV-1 RNA value prior to study drug 
discontinuation ≥40 copies/mL; or if the subject discontinues study for reason(s) 
other than AE or death on or before the upper bound of the HIV Post-Treatment 
Week 12 window (Post-Treatment Day 126) with the last HIV-1 RNA value prior 
to study discontinuation ≥40 copies/mL.
2.
HIV-1 RNA suppression (or HIV virologic success) at PTW12 = HIV-1 RNA 
value < 40 copies/mL in the HIV Post-Treatment Week 12 window.
3.
No HIV virologic data at PTW12 is defined by subcategories as follows: 
●
Discontinued study due to AE or death if the subject prematurely 
discontinues study due to AE or death on or before the upper bound of the HIV 
PTW12 window and has no HIV-1 RNA value in that window; or 
●
Discontinued study due to other reason if the subject prematurely 
discontinues study due to reason(s) other than AE or death on or before the 
upper bound of HIV Post-Treatment Week 12 window and has no HIV-1 RNA 
value in that window; or


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●
Missing data during window but on study if the subject has not discontinued 
from study on or before the upper bound of the HIV Post-Treatment Week 12 
window and has no HIV-1 RNA value in that window.
12.0
Summary of Changes
12.1
Summary of Changes Between the Latest Version of the 
Protocol and SAP Version 1.0
1.
Updates were made to the resistance analysis plan to be consistent across the HCV 
glecaprevir/pibrentasvir program.
2.
Updates were made to the subgroup efficacy analysis section to be consistent 
across the HCV glecaprevir/pibrentasvir program
12.2
Summary of Changes Between SAP Version 1.0 and SAP 
Version 2.0
1.
In Section 10.6, "baseline fibrosis stage" was changed to "cirrhosis status."
2.
In Section 10.7, "Arm A" was removed from the analysis of the difference of the 
percentage of subjects achieving SVR12 in the ITT population from the historical 
rate of 96% so that this analysis now includes the entire ITT population.
13.0
References
1.
Rockstroh JK, Nelson M, Katlama C, et al.  Efficacy and safety of grazoprevir 
(MK-5172) and elbasvir (MK-8742) in patients with hepatitis C virus and HIV 
co-infection (C-EDGE CO-INFECTION):  a non-randomised, open-label trial.  
Lancet HIV.  2015;2(8):e319-27.
2.
HARVONI® (ledipasvir and sofosbuvir) tablets [package insert].  Foster City, CA; 
Gilead Sciences, Inc., 2016.


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3.
Grundy SM, Brewer HB Jr, Cleeman JI, et al.  Definition of metabolic syndrome:  
report of the National Heart, Lung, and Blood Institute/American Heart 
Association conference on scientific issues related to definition.  Circulation.  
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4.
Szende A, Williams A.  Measuring self-reported population health:  an 
international perspective based on EQ-5D.  EuroQol Group Monographs 
Volume 1.  SpringMed Publishing; 2004.
5.
Rabin R, Oemar M, Oppe M, et al.  EQ-5D-5L user guide:  basic information on 
how to use the EQ-5D-5L instrument, Version 1.0.  Rotterdam, the Netherlands:  
EuroQol Group; 2011.
6.
Ware JE Jr, Kosinski M, Bjorner JB, et al.  User's manual for the SF-36v2 health 
survey.  2nd ed.  Lincoln, RI:  QualityMetric Incorporated; 2007.
7.
Johnson VA, Calvez V, Huldrych GF, et al.  Update of the drug resistance 
mutations in HIV-1:  March 2013.  Top Antivir Med.  2013;21(1):4-12.