Clinical trial NCT03118843
Conditions: Hepatitis C Virus Infection
Sponsor: Gilead Sciences
Start date: 2017-04-25; Completion date: 2018-03-19
Enrollment: 31 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary objectives of this study are to determine the efficacy, safety, and tolerability of treatment with sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) fixed-dose combination (FDC) for 12 weeks in participants with chronic hepatitis C virus (HCV) infection with or without cirrhosis, who did not achieve sustained viral response (SVR) after receiving prior treatment in a Gilead-sponsored HCV treatment study of direct-acting antiviral (DAA)-containing regimens.

Detailed description:

Arms: arm 1: SOF/VEL/VOX for 12 weeks
Interventions: intervention 1: SOF/VEL/VOX
Intervention descriptions: intervention 1: 400/100/100 mg FDC tablet administered orally once daily with food

Protocol documents:
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33'
SOFNELNOX FDC 
Protocol GS-US-367-4181 
Final 
Gilead Sciences, Inc. 
Original 
Appendix 1. 
Investigator Signature Page 
GILEAD SCIENCES, INC. 
333 LAKESIDE DR. 
FOSTER CITY, CA 94404 
STUDY ACKNOWLEDGEMENT 
An Open-Label Study to Evaluate The Efficacy And Safety Of 
SofosbuvirNelpatasvirNoxilaprevir Fixed-Dose Combination For 12 Weeks In Subjects 
Who Participated In A Prior Gilead-Sponsored HCV Treatment Study 
GS-US-367-4181, Original, 19 January 2017 
This protocol has been approved by Gilead Sciences, Inc. The following signature documents 
this approval. 
Luisa M. Stamm MD, PhD (Printed) 
Date 
INVESTIGATOR STATEMENT 
I have read the protocol, including all appendices, and I agree that it contains all necessary 
details for me and my staff to conduct this study as described. I will conduct this study as 
outlined herein and will make a reasonable effort to complete the study within the time 
designated. 
I will provide all study personnel under my supervision copies of the protocol and access to all 
information provided by Gilead Sciences, Inc. I will discuss this material with them to ensure 
that they are fully informed about the drugs and the study. 
Principal Investigator Name 
(Printed) 
Date 
CONFIDENTIAL 
Page 63 
Signature 
Site Number 
19 January 2017 


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SAP_001.pdf: 
STATISTICAL ANALYSIS PLAN
Study Title:
An Open-Label Study to Evaluate the Safety And Efficacy of 
Sofosbuvir/Velpatasvir/Voxilaprevir Fixed-Dose Combination 
for 12 Weeks in Subjects who Participated in a Prior 
Gilead-Sponsored HCV Treatment Study
Name of Test Drug:
Sofosbuvir/Velpatasvir/Voxilaprevir
Study Number:
GS-US-367-4181
Protocol Version (Date):
Original (19 January 2017)
Analysis Type:
Final Analysis (SVR 12)
Analysis Plan Version:
Version 1.0 
Analysis Plan Date:
10 April 2018
Analysis Plan Author:
CONFIDENTIAL AND PROPRIETARY INFORMATION
PPD


Sofosbuvir/Velpatasvir/Voxilaprevir FDC
GS-US-367-4181
Statistical Analysis Plan
Version 1.0
CONFIDENTIAL
Page 2
10 April 2018
TABLE OF CONTENTS
TABLE OF CONTENTS ..............................................................................................................................................2
LIST OF ABBREVIATIONS........................................................................................................................................4
1.
INTRODUCTION ................................................................................................................................................6
1.1.
Study Objectives ......................................................................................................................................6
1.2.
Study Design............................................................................................................................................6
1.3.
Sample Size and Power............................................................................................................................7
2.
TYPE OF PLANNED ANALYSIS ......................................................................................................................8
2.1.
Data Monitoring Committee ....................................................................................................................8
2.2.
Interim Analysis.......................................................................................................................................8
2.3.
Final Analysis ..........................................................................................................................................8
3.
GENERAL CONSIDERATIONS FOR DATA ANALYSES..............................................................................9
3.1.
Analysis Sets............................................................................................................................................9
3.1.1.
All Enrolled Analysis Set.......................................................................................................9
3.1.2.
Full Analysis Set ....................................................................................................................9
3.1.3.
Safety Analysis Set.................................................................................................................9
3.2.
Subject Grouping .....................................................................................................................................9
3.3.
Strata and Covariates................................................................................................................................9
3.4.
Examination of Subject Subsets.............................................................................................................10
3.5.
Multiple Comparisons............................................................................................................................10
3.6.
Missing Data and Outliers......................................................................................................................10
3.6.1.
Missing Data ........................................................................................................................10
3.6.2.
Outliers.................................................................................................................................11
3.7.
Data Handling Conventions and Transformations .................................................................................11
3.8.
Visit Windows........................................................................................................................................13
3.8.1.
Definition of Study Day .......................................................................................................13
3.8.2.
Analysis Windows................................................................................................................13
3.8.3.
Selection of Data in the Event of Multiple Records in an Analysis 
Window................................................................................................................................14
4.
SUBJECT DISPOSITION ..................................................................................................................................16
4.1.
Subject Enrollment and Disposition.......................................................................................................16
4.2.
Extent of Exposure.................................................................................................................................17
4.2.1.
Duration of Exposure to Study Drug....................................................................................17
4.2.2.
Adherence to Study Drug.....................................................................................................17
4.3.
Protocol Deviations................................................................................................................................18
5.
BASELINE CHARACTERISTICS....................................................................................................................19
5.1.
Demographics ........................................................................................................................................19
5.2.
Other Baseline Characteristics ...............................................................................................................19
5.3.
Medical History......................................................................................................................................20
6.
EFFICACY ANALYSES ...................................................................................................................................21
6.1.
Primary Efficacy Endpoint.....................................................................................................................21
6.1.1.
Definition of the Primary Efficacy Endpoint .......................................................................21
6.1.2.
Primary Analysis of the Primary Efficacy Endpoint ............................................................21
6.1.3.
Subgroup Analysis of the Primary Efficacy Endpoint .........................................................21
6.2.
Secondary Efficacy Endpoints ...............................................................................................................21
6.2.1.
Definition of Secondary Efficacy Endpoints........................................................................21
6.2.2.
Analysis Methods for Secondary Efficacy Endpoints..........................................................22


Sofosbuvir/Velpatasvir/Voxilaprevir FDC
GS-US-367-4181
Statistical Analysis Plan
Version 1.0
CONFIDENTIAL
Page 3
10 April 2018
6.3.
Exploratory Efficacy Endpoints.............................................................................................................23
6.3.1.
Definition of Exploratory Efficacy Endpoints......................................................................23
6.3.2.
Analysis Methods for Exploratory Efficacy Endpoints........................................................23
6.4.
Changes From Protocol-Specified Efficacy Analyses............................................................................23
7.
SAFETY ANALYSES........................................................................................................................................24
7.1.
Adverse Events and Deaths....................................................................................................................24
7.1.1.
Adverse Event Dictionary ....................................................................................................24
7.1.2.
Adverse Event Severity........................................................................................................24
7.1.3.
Relationship of Adverse Events to Study Drug....................................................................24
7.1.4.
Serious Adverse Events........................................................................................................24
7.1.5.
Treatment-Emergent Adverse Events...................................................................................24
7.1.6.
Summaries of Adverse Events and Deaths...........................................................................25
7.2.
Laboratory Evaluations ..........................................................................................................................26
7.2.1.
Summaries of Numeric Laboratory Results .........................................................................27
7.2.2.
Graded Laboratory Values ...................................................................................................27
7.3.
Body Weight, Height, and Vital Signs...................................................................................................28
7.4.
Prior and Concomitant Medications.......................................................................................................28
7.5.
Electrocardiogram Results .....................................................................................................................29
7.6.
Other Safety Measures ...........................................................................................................................29
7.7.
Changes From Protocol-Specified Safety Analyses...............................................................................29
8.
REFERENCES ...................................................................................................................................................30
9.
SOFTWARE.......................................................................................................................................................31
10.
SAP REVISION..................................................................................................................................................32
11.
APPENDICES ....................................................................................................................................................33
Appendix 1.
Study Procedures Table..........................................................................................................34


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LIST OF ABBREVIATIONS
AE
adverse event
ALT
alanine aminotransferase
AST
aspartate aminotransferase
ATC
anatomical therapeutic chemical
BLQ
below the limit of quantitation
BMI
body mass index
CI
confidence interval
CRF
case report form
CSR
clinical study report
CTCAE
Common Toxicity Criteria for Adverse Events
DAA
direct-acting antiviral
DMC
data monitoring committee
ECG
electrocardiogram
eCRF
electronic case report form
eGFR
estimated glomerular filtration rate
EOT
end of treatment
FAS
full analysis set
FDC
fixed-dose combination
FU
follow-up
FU-x
posttreatment follow-up Week x
Gilead
Gilead Sciences, Inc.
Hb
hemoglobin
HCV
hepatitis C virus
HLGT
high-level group term
HLT
high-level term
ICH
International Conference on Harmonization (of Technical Requirements for Registration of 
Pharmaceuticals for Human Use)
ID
identification
INR
international normalization ratio
IWRS
Interactive Web Response System
LLOQ
lower limit of quantification
MedDRA
Medical Dictionary for Regulatory Activities
PP
per protocol
PK
pharmacokinetics
PT
preferred term
Q1
first quartile
Q3
third quartile
QRS
electrocardiographic deflection between the beginning of the Q wave and termination of the 
S wave representing time for ventricular depolarization


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QT
electrocardiographic interval between the beginning of the Q wave and termination of the T wave 
representing the time for both ventricular depolarization and repolarization to occur
QTc
QT interval corrected for heart rate
QTcB
QT interval corrected for heart rate using Bazett’s formula
QTcF
QT interval corrected for heart rate using Fridericia’s formula
RBC
red blood cell
RNA
ribonucleic acid
RR
electrocardiographic interval representing the time measurement between the R wave of one 
heartbeat and the R wave of the preceding heartbeat
SAE
serious adverse event
SAP
statistical analysis plan
SD
standard deviation
SE
standard error
SF-36
short form health survey
SOC
system organ class
SOF
sofosbuvir (Sovaldi®)
SVR
sustained virologic response
SVRx
sustained virologic response x weeks after cessation of treatment
TEAE
treatment-emergent adverse events
TFLs
tables, figures, and listings
ULN
upper limit of normal
VEL
velpatasvir (GS-5816)
VOX
voxilaprevir (GS-9857)
WBC
white blood cell
WHO
World Health Organization


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1.
INTRODUCTION
This statistical analysis plan (SAP) describes the statistical analysis methods and data 
presentations to be used in tables, figures, and listings (TFLs) in the clinical study report (CSR) 
for Study GS-US-367-4181. This SAP is based on the study protocol dated 19JAN2017 and the 
electronic case report form (eCRF). The SAP will be finalized before database finalization. Any 
changes made after the finalization of the SAP will be documented in the CSR.
1.1.
Study Objectives
The primary objectives of this study are as follows:

To determine the efficacy of treatment with sofosbuvir (SOF)/velpatasvir (VEL)/voxilaprevir 
(VOX) fixed dose combination (FDC) for 12 weeks as measured by the proportion of 
subjects with sustained viral response 12 weeks after cessation of treatment (SVR12)

To evaluate the safety and tolerability of treatment with SOF/VEL/VOX FDC
The secondary objectives of this study are as follows:

To determine the proportion of subjects who attain SVR at 4 weeks after cessation of 
treatment (SVR4)

To evaluate the proportion of subjects with virologic failure

To evaluate the kinetics of circulating HCV RNA during treatment and after cessation of 
treatment

To evaluate the emergence of viral resistance to SOF, VEL, and VOX during treatment and 
after cessation of treatment
1.2.
Study Design
This is a multicenter, open-label Phase 3 study that will evaluate the safety and efficacy of 
SOF/VEL/VOX FDC for 12 weeks in subjects with chronic HCV infection with or without 
cirrhosis, who have received prior treatment in a Gilead sponsored HCV treatment study of DAA 
containing regimens. There will be one treatment group of approximately 50 subjects:

SOF/VEL/VOX  FDC (400/100/100 mg) once daily with food for 12 weeks
The schedules of assessments for the study are provided as appendixes to the SAP (see Study 
Procedures Table, Appendix 1).


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The total time to complete all study visits is up to approximately 30 weeks including the 
following periods:

Up to 42-day (6-week) screening period

12-week treatment period

Up to 12-week posttreatment period
1.3.
Sample Size and Power
Approximately 50 subjects will be enrolled in this study. The sample size is based on the number 
of subjects who failed to achieve SVR12 in prior Gilead-sponsored HCV treatment studies and 
are eligible to be enrolled into this study.


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2.
TYPE OF PLANNED ANALYSIS
2.1.
Data Monitoring Committee
This study does not have a data monitoring committee (DMC).
2.2.
Interim Analysis
No formal interim analysis is planned.
2.3.
Final Analysis
After all subjects have completed the study, outstanding data queries have been resolved, and the 
database has been cleaned and finalized, the final analysis of the data will be performed.


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3.
GENERAL CONSIDERATIONS FOR DATA ANALYSES
Analysis results will be presented using descriptive statistics. For categorical variables, the 
number and percentage of subjects in each category will be presented; for continuous variables, 
the number of subjects [n], mean, standard deviation [SD] or standard error [SE], median, first 
quartile [Q1], third quartile [Q3], minimum, and maximum will be presented.
Data collected in the study will be presented in by-subject listings for all subjects in the Safety 
Analysis Set, unless otherwise specified. All by-subject listings will be presented by subject 
identification (ID) number in ascending order, unless otherwise specified.
3.1.
Analysis Sets
Analysis sets define the subjects to be included in an analysis. Analysis sets and their definitions 
are provided in this section. The number of subjects eligible for each analysis set will be 
provided. Subjects who were excluded from each analysis set will be summarized or provided in 
a by-subject listing with reasons for exclusion. 
3.1.1.
All Enrolled Analysis Set
All Enrolled Analysis Set includes all subjects enrolled in the study after screening. 
3.1.2.
Full Analysis Set
The Full Analysis Set (FAS) includes all enrolled subjects who took at least 1 dose of study drug.
This is a single arm study. The study drug received in this study is SOF/VEL/VOX FDC.
This is the primary analysis set for efficacy analyses.
3.1.3.
Safety Analysis Set
The Safety Analysis Set includes all subjects who took at least 1 dose of study drug. 
This is the primary analysis set for safety analyses.
3.2.
Subject Grouping
There will be single treatment group for efficacy and safety analyses:

SOF/VEL/VOX  FDC (400/100/100 mg) once daily with food for 12 weeks
3.3.
Strata and Covariates
This study does not use a stratified randomization schedule for enrolling subjects. No covariates 
will be included in efficacy and safety analyses.


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3.4.
Examination of Subject Subsets
The primary efficacy endpoint SVR12 will be analyzed for the following subsets:

age (< 65 years, 65 years)

sex (male, female)

race (black, non-black)

ethnicity (Hispanic or Latino, non-Hispanic or Latino)

region (US, non-US)

baseline body mass index (BMI) (< 30 kg/m2 , ≥ 30 kg/m2) 

cirrhosis (presence, absence, missing)

baseline HCV RNA (< 800,000 IU/mL, ≥ 800,000 IU/mL)

HCV genotype (1 further broken down to 1a and 1b, 2, 3, 4, 5, 6, or other, as appropriate)

baseline ALT (≤1.5 × upper limit of normal [ULN], > 1.5 × ULN)

IL28B (CC, non-CC; with non-CC further broken down to CT, TT)

prior Gilead study assigned HCV treatment (SOF/VEL/VOX 8 weeks, SOF/VEL 12 weeks
and other)

adherence to study regimen (<80%, ≥80%)

study treatment status (completed study treatment, discontinued study treatment)
3.5.
Multiple Comparisons
Adjustments for multiplicity will not be made because no statistical testing will be performed in 
this study.
3.6.
Missing Data and Outliers
3.6.1.
Missing Data
In general, missing data will not be imputed unless methods for handling missing data are 
specified. 


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For missing last dose date of study drug, imputation rules are described in Section 3.8.1. The 
handling of missing or incomplete dates for AE onset is described in Section 7.1.5.2, and for
prior and concomitant medications in Section 7.4.
For analyses of categorical HCV RNA data, missing posttreatment HCV RNA data will have the 
missing data imputed. Missing on-treatment HCV RNA will have the missing data imputed up to 
the time of the last dose (for on-treatment displays). If the study day associated with the last 
dosing date is greater than or equal to the lower bound of a visit window, and the value at the 
visit is missing, the value will be imputed. If the study day associated with the last dosing date is 
less than the lower bound of a visit window then the on-treatment value at that visit will remain 
missing. 
If a data point is missing and is preceded and followed in time by values that are “< LLOQ target 
not detected (TND)”, then the missing data point will be set to “< LLOQ TND”. If a data point is 
missing and preceded and followed by values that are “< LLOQ detected”, or preceded by 
“< LLOQ detected” and followed by “< LLOQ TND”, or preceded by “< LLOQ TND” and 
followed by “< LLOQ detected”, then the missing value will be set to “< LLOQ detected”. In 
these situations the data point will be termed a bracketed success; otherwise, the data point will 
be termed a bracketed failure (ie, ≥LLOQ detected). If a data point is missing and is not 
bracketed, the missing data point will also be termed a failure (ie, ≥LLOQ detected).
For the analyses of continuous HCV RNA efficacy data, when and only when a missing HCV 
RNA value is imputed as < LLOQ TND or < LLOQ detected according to the imputation rule 
described above, the corresponding continuous value will be imputed to LLOQ – 1 IU/mL. No 
other imputation will be performed for continuous HCV RNA data.
3.6.2.
Outliers
Outliers will be identified during the data management and data analysis process, but no 
sensitivity analyses will be conducted. All data will be included in the data analysis.
3.7.
Data Handling Conventions and Transformations
By-subject listings will be presented for all subjects in the Safety Analysis Set sorted by subject 
ID number, visit date, and time (if applicable) unless otherwise specified. Data collected on log 
forms, such as AEs, will be presented in chronological order within subject. 
Age (in years) on the date of the first dose of study drug will be used for analyses and 
presentation in listings.
If a subject was not dosed with study drug at all, then the date the informed consent was signed 
will be used instead of the first dose date of study drug. For some countries, only birth year or 
birth year and month are collected on the eCRF. In those cases, “01 January” will be used for the 
unknown birth day and month, and “15” will be used for the unknown birth day for the purpose 
of age calculation, unless age is captured on the CRF. 


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Non-PK Data that are continuous in nature but are less than the lower limit of quantitation or 
above the upper limit of quantitation will be imputed as follows:

A value that is one unit less than the limit of quantitation will be used for calculation of 
descriptive statistics if the datum is reported in the form of “x” (where x is considered the 
limit of quantitation). For example, if the values are reported as < 50 and < 5.0, values of 
49 and 4.9, respectively, will be used for calculation of summary statistics.  An exception for 
this rule is any value reported < 1. For the values reported as < 1 or < 0.1, value of 0.9 or 
0.09 will be used for calculation of summary statistics.

A value that is one unit above the limit of quantitation will be used for calculation of 
descriptive statistics if the datum is reported in the form of “> x” (where x is considered the 
limit of quantitation). Values with decimal points will follow the same logic as above.

The limit of quantitation will be used for calculation of descriptive statistics if the datum is 
reported in the form of “≤ x” or “≥ x” (where x is considered the limit of quantitation).
The COBAS®AmpliPrep/COBAS® TaqMan® HCV Quantitative Test v2.0 was used to determine 
HCV RNA results in this study. The lower limit of quantitation (LLOQ) of the assay is 
15 IU/mL.
When the calculated IU/mL is within the linear range of the assay, then the result will be 
reported as the “<< numeric value>> IU/mL”. This result will be referred to in this document as 
the numeric result or as “≥ LLOQ detected” for categorical result.
When HCV RNA is not detected, the result is reported as “HCV RNA not detected” or “target 
not detected”. This result will be referred to in this document as “< LLOQ target not detected” or 
“< LLOQ TND”.
When the HCV RNA IU/mL is less than LLOQ of the assay, the result is reported as 
“< 15 IU/mL HCV RNA detected”. This result will be referred to in this document as “< LLOQ 
detected”.
The overall category of HCV RNA < LLOQ includes “< LLOQ TND” and “< LLOQ detected.”
For numerical HCV RNA data, values below LLOQ will be set to the LLOQ – 1 IU/mL. HCV 
RNA values returned as “target not detected” will also be set to LLOQ – 1 IU/mL.
If methods based on the assumption that the data are normally distributed are not adequate, 
analyses may be performed on transformed data (eg, log10 scale) or nonparametric analysis 
methods may be used, as appropriate.


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3.8.
Visit Windows
3.8.1.
Definition of Study Day
Study day is the day relative to the date of the first dose of study drug. Study Day 1 will be 
defined as the day of first dose of study drug administration.
Study day will be calculated from the date of first dose of study drug administration and derived 
as follows:

For postdose study days: Assessment Date – First Dose Date + 1

For days prior to the first dose: Assessment Date – First Dose Date
The last dose date for an individual study drug will be the end date on study drug administration 
eCRF for the record where the “subject permanently discontinued” flag is ‘Yes’. The last dose 
date will be defined as the maximum of the last dose dates of individual study drugs in a 
treatment group.
If there are subjects for whom the date of last study drug is unknown due to the reason that the 
subject was lost to follow-up and not able to be contacted, the date of last dose will be estimated 
using the maximum of nonmissing study drug start or stop dates, visit dates and laboratory 
collection dates (posttreatment visits and unscheduled visits are not included).
3.8.2.
Analysis Windows
Subject visits might not occur on protocol-specified days. Therefore, for the purpose of analysis, 
observations will be assigned to analysis windows.
In general, the baseline value will be the last nonmissing value on or prior to the first dose date 
of study drug. 
HCV RNA, vital signs, and safety laboratory data collected up to the last dose date + 3 days are 
considered to be on-treatment data and HCV RNA, vital signs and safety laboratory data 
collected after the last dose date + 3 days are considered posttreatment data. The analysis 
windows for on-treatment HCV RNA, vital signs and safety laboratory data are provided in 
Table 3-1.


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Table 3-1.
Analysis Windows for On-treatment HCV RNA, Vital Signs and 
Safety Laboratory Data
Nominal Visit
Nominal Day
Lower Limit
Upper Limit
Baseline
1
(none)
1
Week 2
14
2
21
Week 4
28
22
42
Week 8
56
43
70
Week 12
84
71
≥ 85
HCV RNA, vital sign, and safety laboratory data collected after the last dose date + 3 days will 
be assigned to the posttreatment follow-up (FU) visits. Visit windows will be calculated from the 
last dose date (ie, FU Day = collection date minus the last dose date) as shown in Table 3-2.
Table 3-2.
Analysis Windows for Posttreatment HCV RNA, Vital Sign and 
Safety Laboratory Data
Nominal 
FU a Visit
HCV RNA
Vital Signs and Safety Laboratory Data b
Nominal FU Day
Lower Limit
Upper Limit
Nominal FU Day
Lower Limit
Upper Limit
FU-4
28
21
69
28
4
30
FU-12
84
70
146
NA
NA
NA
a.
FU-x visit = posttreatment Week-x follow-up visit.
b.
Vital signs and safety labs will only be summarized for the FU-4 visit (up to 30 days after last dose).
3.8.3.
Selection of Data in the Event of Multiple Records in an Analysis Window
Depending on the statistical analysis method, single values may be required for each analysis 
window. For example, change from baseline by visit usually requires a single value, whereas a 
time-to-event analysis would not require 1 value per analysis window. 
If multiple valid nonmissing numeric observations exist in an analysis window, records will be 
chosen based on the following rules if a single value is needed:

For baseline, the last available record on or prior to the date of the first dose of study drug 
will be selected. If there are multiple records with the same time or no time recorded on the 
same day, average (arithmetic mean) will be used for the baseline value. If multiple ECG 
measurements occur on the same day prior to first dose of any study drug, the average will be 
used as baseline for continuous data, regardless of the timing of these multiple ECG 
measurements.


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
For postbaseline visits: 
The record closest to the nominal day for that visit will be selected except for HCV RNA 
posttreatment follow-up visits, for which the latest record in the analysis window will be 
selected. 
If there are 2 records that are equidistant from the nominal day, the later record will be 
selected.
If there is more than 1 record on the selected day, the average will be taken, unless 
otherwise specified.
If multiple valid nonmissing categorical observations exist in a window, records will be selected
as follows:

For baseline, the last available record on or prior to the date of the first dose of study drug
will be selected. If there are multiple records with the same time or no time recorded on the 
same day, the value with the lowest severity will be selected (eg, normal will be selected over 
abnormal). If multiple ECG measurements occur on the same day prior to first dose of any 
study drug, the value with the lowest severity will be selected regardless of the timing of 
these multiple ECG measurements.

For postbaseline visits, follow the same rules described above for postbaseline numeric 
observations, except that if there are multiple records on the same day, the most conservative 
value will be selected (eg, abnormal will be selected over normal).


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4.
SUBJECT DISPOSITION
4.1.
Subject Enrollment and Disposition
A summary of subject enrollment will be provided for each country, investigator within a 
country. The summary will present the number and percentage of subjects in the Safety Analysis 
Set. The denominator for the percentage calculation will be the total number of subjects in the 
Safety Analysis Set. 
A summary of subject disposition will be provided for the study overall. This summary will 
present the number of subjects screened, the number of subjects enrolled, the number of subjects 
enrolled but never treated, and the number and percentage of subjects in each of the categories 
listed below. For the “Treated” category, the denominator for the percentage calculation will be 
the total number of subjects enrolled. For all other categories, the denominator for the percentage 
calculation will be the total number of subjects in the Safety Analysis Set. 

Treated (Safety Analysis Set) 

In FAS

Completed study treatment

Did not complete study treatment with reasons for premature discontinuation of study 
treatment

Completed the study

Did not complete the study with reason for premature discontinuation of study
Among subjects who completed study treatment and who discontinued study treatment, the 
number and percentage of subjects will be summarized for:

Who had no HCV posttreatment Week 4 assessment and thereafter (No HCV FU-4 and 
thereafter)

Who had HCV posttreatment Week 4 assessment but no HCV posttreatment Week 12 
assessment (With HCV FU-4 but No FU-12)
If a subject did not have any HCV RNA assessment ≥ 21 days after the last dose of any study 
drug (ie, lower bound of FU-4 visit for HCV RNA data), the subject is categorized as having 
“No HCV FU-4 and thereafter”. If a subject had the HCV FU-4 assessment but did not have any 
HCV RNA assessment ≥ 70 days after the last dose of any study drug (ie, lower bound of FU-12 
visit for HCV RNA data), the subject is categorized as having “With HCV FU-4 but No FU-12”.


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In addition, the total number of subjects who were enrolled, and the number of subjects in each 
of the disposition categories listed above will be displayed in a flowchart.
The following by-subject listings will be provided by subject ID number in ascending order to 
support the above summary tables:

Disposition for subjects who complete study treatment and study

Disposition for subjects who did not complete study treatment and/or study with reasons for 
premature discontinuation of study drug and/or study

Lot number and kit ID (if applicable)
4.2.
Extent of Exposure 
Extent of exposure to study drug will be examined by assessing the total duration of study drug 
exposure and the level of adherence to the study drug regimen specified in the protocol. 
4.2.1.
Duration of Exposure to Study Drug 
Total duration of exposure to study drug will be defined as last dose date minus first dose date 
plus 1, regardless of any temporary interruptions in study drug administration, and will be 
expressed in weeks using up to 1 decimal place (eg, 4.5 weeks). 
The total duration of exposure to study drug will be summarized using descriptive statistics 
(number of subjects [n], mean, standard deviation [SD], median, first quartile [Q1], third quartile 
[Q3], minimum, and maximum) and using the number (ie, cumulative counts) and percentage of 
subjects exposed through  the following time periods: Baseline (Day 1), Week 2 (Day 14),
Week 4 (Day 28), Week 8 (Day 56), Week 12 (Day 84). A 3-day window is applied to the last 
planned on-treatment visit to match with the protocol-specified visit window. Summaries will be 
provided for the Safety Analysis Set. 
4.2.2.
Adherence to Study Drug
The total number of tablets administered will be summarized using descriptive statistics (n, 
mean, SD, median, Q1, Q3, minimum, and maximum). 
The presumed total number of tablets administered to a subject will be determined by the data 
collected on the drug accountability CRF using the following formula:







ed
administer
not 
Tablets
of
No.
Dispensed
Tablets
of
No.
ed
Administer
Doses
of
Number 
Total
The level of adherence to the study drug regimen will be assessed based on the total amount of 
study drug administered relative to the total amount of study drug prescribed at baseline.


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The level of adherence will be expressed in percentage using the following formula:
100
  
baseline
at 
Prescribed
Drug
Study 
of
Amount 
Total
  
ed
Administer
Drug
Study 
of
Amount 
Total
(%)
Adherence
of
Level








Note: If calculated adherence is greater than 100%, the result will be set to 100%.
In this study, the total amount of SOF/VEL/VOX (400/100/100 mg) prescribed for 12 weeks of 
treatment would require 84 tablets.
Subjects who prematurely discontinue study drug for lack of efficacy (ie, virologic failure) will 
have the total amount of study drug prescribed calculated up to the first date when virologic 
failure criteria were met. For virologic failure confirmed by 2 consecutive measurements the date 
of the first measurement will be used. If there are study drug bottles dispensed on or after the 
subject first met virologic failure criteria, these bottles will not be included in the calculation of 
adherence. If a bottle is dispensed and the bottle is returned empty, then the number of tablets 
returned will be entered as zero. If a bottle is dispensed but not returned (missing), the number of 
tablets taken from that bottle will be counted as zero.
Descriptive statistics for the level of adherence (n, mean, SD, median, Q1, Q3, minimum, and 
maximum) with the number and percentage of subjects belonging to adherence categories (eg, 
{< 80%, ≥ 80 to < 90%, ≥ 90%}) will be provided for the Safety Analysis Set. No inferential 
statistics will be provided. 
A separate by-subject listing of study drug administration and drug accountability will be 
provided by subject ID number (in ascending order) and visit (in chronological order).
4.3.
Protocol Deviations 
A summary of important protocol deviations will be provided by the Clinical Operations group 
for subjects in the Safety Analysis Set.
Subjects who received study drug other than their treatment assignment at enrollment will be 
listed with the start and stop dates that they received incorrect study treatment.


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5.
BASELINE CHARACTERISTICS
5.1.
Demographics 
Subject demographic variables (ie, age, sex, race, and ethnicity) will be summarized for study
overall using descriptive statistics (n, mean, SD, median, Q1, Q3, minimum, and maximum) for 
age, and using the numbers and percentages of subjects for age categories (< 65 years, 
≥65 years), sex, race, and ethnicity. Age is calculated in years at the date of initial study drug 
administration. If a subject did not receive study drug after enrollment, the subject’s age will be 
calculated from the date that the subject signed the informed consent form. The summary of 
demographic data will be provided for the Safety Analysis Set.
A by-subject demographic listing will be provided by subject ID number in ascending order.
5.2.
Other Baseline Characteristics
Other baseline characteristics include:

region (US, non-US)

body mass index (BMI; in kg/m2) as a continuous variable and as categories (< 30 kg/m2, 
≥30 kg/m2) 

HCV genotype (1 [further broken down to 1a and 1b], 2, 3, 4, 5, 6, or other)

cirrhosis (presence, absence, missing)

cirrhosis determination method (FibroTest and APRI, liver biopsy, transient elastography)

IL28B (CC, non-CC; with non-CC further broken down to CT, TT) 

baseline HCV RNA (log10 IU/mL) as a continuous variable and as categories 
(< 800,000 IU/mL, ≥ 800,000 IU/mL)

baseline ALT (U/L) as a continuous variable and as categories (≤1.5 x ULN, > 1.5 x ULN)

prior Gilead study assigned HCV treatment (SOF/VEL/VOX 8 weeks, SOF/VEL 12 weeks 
and other)

estimated glomerular filtration rate (eGFR) using the Cockcroft-Gault equation
eGFR will be calculated by the Cockcroft-Gault method: eGFRCG (mL/min) = [(140 – age (yrs)) 
× weight (kg) × (0.85 if female)] / (serum creatinine (mg/dL) × 72), where weight is total body 
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These baseline characteristics will be summarized for study overall using descriptive statistics (n, 
mean, SD, median, Q1, Q3, minimum, and maximum) for continuous variables and using the 
numbers and percentages of subjects for categorical variables. The summary of baseline 
characteristics will be provided for the Safety Analysis Set.
A by-subject listing of other baseline characteristics will be provided by subject ID number in 
ascending order.
5.3.
Medical History
General medical history (ie, conditions not specific to the disease being studied) data will be
collected at screening and listed only. General medical history data will not be coded. A by-
subject listing of disease-specific medical history will be provided by subject ID number (in 
ascending order) and medical history of abnormalities (in chronological order).


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6.
EFFICACY ANALYSES
6.1.
Primary Efficacy Endpoint
6.1.1.
Definition of the Primary Efficacy Endpoint
The primary efficacy endpoint is SVR12 defined as HCV RNA < LLOQ (ie, < 15 IU/mL) 
12 weeks after cessation of treatment in the FAS. The COBAS®AmpliPrep/COBAS® TaqMan®
HCV Quantitative Test v2.0 will be used to measure HCV RNA.
6.1.2.
Primary Analysis of the Primary Efficacy Endpoint
No inferential statistics will be provided for efficacy endpoints. No statistical comparison will be 
conducted.
The point estimate of SVR12 rate and 2-sided 95% exact confidence interval (CI) based on 
Clopper-Pearson method will be provided {Clopper 1934} for the FAS. 
6.1.3.
Subgroup Analysis of the Primary Efficacy Endpoint
The point estimate of SVR12 rate and 2-sided 95% exact confidence interval (CI) based on 
Clopper-Pearson method will be provided {Clopper 1934} for the FAS, and also for each 
subgroup specified in Section 3.4. 
A Forest plot will graphically present estimates and 95% confidence intervals of SVR12 rates for
each subgroup.
6.2.
Secondary Efficacy Endpoints
6.2.1.
Definition of Secondary Efficacy Endpoints
Secondary efficacy endpoints include the following:

The percentage of subjects who attain SVR at 4 weeks after stopping therapy, defined as 
HCV RNA < LLOQ (ie, < 15 IU/mL) 4 weeks after stopping treatment (SVR 4)

The percentage of subjects with HCV RNA below LLOQ on treatment

HCV RNA (log10 IU/mL) and change from baseline in HCV RNA (log10 IU/mL) through end 
of treatment (EOT)


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
The percentage of subjects with virologic failure as the following:
On-treatment virologic failure
HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ, while on 
treatment, confirmed with 2 consecutive values (note, second confirmation value can be 
posttreatment), or last available on-treatment measurement with no subsequent follow-up
values (ie, breakthrough)
> 1 log10IU/mL increase in HCV RNA from nadir while on treatment, confirmed with 
2 consecutive values (note, second confirmation value can be posttreatment), or last 
available on-treatment measurement with no subsequent follow-up values (ie, rebound)
HCV RNA persistently ≥ LLOQ through 8 weeks of treatment (ie nonresponse)
Relapse 
HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA 
< LLOQ at end of treatment, confirmed with 2 consecutive values or last available 
posttreatment measurement

Characterization of HCV drug resistance substitutions at baseline, during, and after therapy 
with SOF/VEL/VOX
6.2.2.
Analysis Methods for Secondary Efficacy Endpoints
For analyses of HCV RNA < LLOQ by visit while on treatment and during the posttreatment 
(SVR) follow-up period, subjects will be assigned a value at each visit based on the analysis visit 
windows specified in Section 3.8.2. Missing values will be imputed based on the categorical 
imputation rules described in Section 3.6.1. The 2-sided 95% exact confidence interval based on 
Clopper-Pearson method will be provided for the percentage of subjects with HCV RNA 
< LLOQ at each visit for FAS. The overall category for “HCV RNA < LLOQ” will be split into 
the following 2 subcategories: “< LLOQ TND” for subjects with target not detected and 
“< LLOQ detected” for subjects with < LLOQ detected in tabular displays. 
Graphs for the percentage of subjects with HCV RNA < LLOQ over time during treatment will 
be displayed.
Summary statistics will be presented for absolute values and change from baseline in HCV RNA 
(log10 IU/mL) by visit through EOT. Imputation rules described in Section 3.6.1 will be used to 
assign HCV RNA values for missing values at a visit that are bracketed by “< LLOQ TND” 
and/or “< LLOQ detected”. Otherwise, a missing = excluded analysis will be performed. Plots of 
the mean ± SD and median (Q1, Q3) of absolute values and changes from baseline in HCV RNA 
through EOT will be presented.


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For the SVR12 endpoint analysis, a summary table of the number and percentage of subjects 
with SVR12, virologic failure (VF), and Other will be created. All subjects who achieve SVR12 
will be categorized as SVR12. Virologic failure will be descriptively summarized as “on-
treatment virologic failure” and relapse (which will be broken down by study drug completed 
yes/no). Subjects who do not achieve SVR12 and do not meet criteria for VF will be categorized 
as Other. The denominator for relapse will be the number of subjects who had HCV RNA 
< LLOQ on their last observed on-treatment HCV RNA measurement; otherwise, the 
denominator will be the number of subjects in the FAS. 
In addition, a summary table of the number and percentage of subjects with HCV RNA < LLOQ 
and >= LLOQ at the posttreatment follow-up visit (observed and imputed, with reasons for 
imputed) will be provided for each posttreatment follow-up visit. 95% Clopper-Pearson exact 
CIs will be presented for the overall proportion of subjects with HCV RNA < LLOQ.
6.3.
Exploratory Efficacy Endpoints
6.3.1.
Definition of Exploratory Efficacy Endpoints
 
 
 
6.3.2.
Analysis Methods for Exploratory Efficacy Endpoints
 
6.4.
Changes From Protocol-Specified Efficacy Analyses
PPD
PPD
PPD


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7.
SAFETY ANALYSES
7.1.
Adverse Events and Deaths
7.1.1.
Adverse Event Dictionary
Clinical and laboratory adverse events (AEs) will be coded using the current version of 
MedDRA. System organ class (SOC), high-level group term (HLGT), high-level term (HLT), 
preferred term (PT), and lower-level term (LLT) will be provided in the AE dataset.
7.1.2.
Adverse Event Severity
Adverse events are graded by the investigator as Grade 1, 2, 3, or 4 according to toxicity criteria 
specified in the protocol. The severity grade of events for which the investigator did not record 
severity will be categorized as “missing” for tabular summaries and data listings and the most 
severe will be considered (for sorting purpose only) in data presentation.
7.1.3.
Relationship of Adverse Events to Study Drug
Related AEs are those for which the investigator selected “Related” on the AE eCRF to the 
question of “Related to Study Treatment”. Events for which the investigator did not record 
relationships to study drug will be considered related to study drug for summary purposes. 
However, by-subject data listings will show the relationship as missing from that captured on the 
CRF.
7.1.4.
Serious Adverse Events
Serious adverse events (SAEs) will be identified and captured as SAEs if AEs met the definitions 
of SAE specified in the study protocol. Serious adverse events captured and stored in the clinical 
database will be reconciled with the SAE database from the Gilead Pharmacovigilance and 
Epidemiology Department before database finalization.
7.1.5.
Treatment-Emergent Adverse Events
7.1.5.1.
Definition of Treatment Emergent
Treatment-emergent adverse events (TEAEs) are defined as one or both of the following:

Any AEs with an onset date on or after the study drug start date and no later than 30 days 
after permanent discontinuation of study drug.

Any AEs leading to premature discontinuation of study drug.


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7.1.5.2.
Incomplete Dates
If the onset date of the AE is incomplete, then the month and year (or year alone if month is not 
recorded) of onset determine whether an AE is treatment emergent, as long as the AE stop date is 
not prior to the first dose date of study drug. The event is considered treatment emergent if both
of the following 2 criteria are met:

The AE onset and end dates are the same as or after the month and year (or year) of the first 
dose date of study drug

The AE onset date is the same as or before the month and year (or year) of the 30th day after
the date of the last dose of study drug 
An AE with completely missing onset and stop dates, or with the onset date missing and a stop 
date later than the first dose date of study drug, will be considered to be treatment emergent.
7.1.6.
Summaries of Adverse Events and Deaths
A brief high-level summary of TEAEs will be provided by the number and percentage of 
subjects who had the following: any AE; any AE of Grade 3 or above; any AE of Grade 2 or 
above; any treatment-related AE; any treatment-related AE of Grade 3 or above; any 
treatment-related AE of Grade 2 or above; any SAE; any treatment-related SAE; any AE that led 
to premature discontinuation of study drug. All deaths (including those that are treatment 
emergent and those that are not treatment emergent) observed during the study will also be 
summarized and included in this table.
Adverse event summaries will provide the number and percentage of subjects with TEAEs by 
SOC and PT based on the Safety Analysis Set as follows:

All AEs

AEs of Grade 3 or above

AEs of Grade 2 or above

All treatment-related AEs

Treatment-related AEs of Grade 3 or above

Treatment-related AEs of Grade 2 or above

All SAEs

All treatment-related SAEs 

All AEs leading to premature discontinuation of study drug

All AEs leading to interruption of study drug

Deaths


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Multiple events will be counted only once per subject in each summary. Adverse events will be 
summarized and listed first in alphabetic order of SOC and then by PT in order of descending
incidence within each SOC. In summaries by severity grade, the most severe grade will be used 
for those AEs that occurred more than once in an individual subject during the study. 
In addition to the above summary tables, TEAEs will be summarized by PT only, in order of 
descending incidence for:

AEs that occurred in at least 5% of subjects 

AEs of Grade 3 or above

All treatment-related AEs

All SAEs

AEs leading to premature discontinuation of study drug

All AEs leading to interruption of study drug
In addition to the summaries described above, data listings will be provided for the following:

All AEs (with a variable indicating whether the event is treatment emergent)

AEs of Grade 3 or above

SAEs

Deaths

AEs leading to premature discontinuation of study drug
7.2.
Laboratory Evaluations
Laboratory data collected during the study will be analyzed and summarized using both 
quantitative and qualitative methods. Summaries of laboratory data will be provided for the 
Safety Analysis Set and will include data collected up to the last dose of study drug plus 30 days
for subjects who have permanently discontinued study drug or all available data at the time of the 
database snapshot for subjects those who were ongoing at the time of an interim analysis. The 
analysis will be based on values reported in conventional units. When values are below the limit 
of quantitation, they will be listed as such, and the closest imputed value will be used for the 
purpose of calculating summary statistics. For example, if “< 0.2” was recorded, a value of 
0.1 will be used for the purpose of calculating summary statistics; if “< 0.1” was recorded, a 
value of 0.09 will be used for the purpose of calculating summary statistics.


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A by-subject listing for laboratory test results will be provided by subject ID number and visit in 
chronological order for hematology, serum chemistry, and urinalysis separately. Values falling 
outside of the relevant reference range and/or having a severity grade of 1 or higher on the 
Gilead Grading Scale for Severity of Adverse Events and Laboratory Abnormalities will be 
flagged in the data listings, as appropriate.
No inferential statistics will be generated.
7.2.1.
Summaries of Numeric Laboratory Results
Descriptive statistics (n, mean, SD, median, Q1, Q3, minimum, and maximum) will be provided 
for ALT, AST, total bilirubin, alkaline phosphatase, hemoglobin, reticulocytes, white blood cell 
(WBC), neutrophils, lymphocytes, platelets, and INR as follows:

Baseline values

Values at each postbaseline time visit

Change from baseline at each postbaseline visit
A baseline laboratory value will be defined as the final assessment performed on or prior to the 
date/time of first dose of study drug. Change from baseline to a postbaseline visit will be defined 
as the visit value minus the baseline value. The mean, median, Q1, Q3, minimum, and maximum 
will be displayed to the reported number of digits; SD to the reported number of digits plus 1.
Median (Q1, Q3) of the observed values for ALT, AST, total bilirubin, alkaline phosphatase, 
hemoglobin, reticulocytes, RBC, WBC, neutrophils, lymphocytes, and platelets will be plotted
using a line plot by visit. 
In the case of multiple values in an analysis window, data will be selected for analysis as 
described in Section 3.8.3 (Selection of Data in the Event of Multiple Records in a Window). 
7.2.2.
Graded Laboratory Values
The Gilead Grading Scale for Severity of Adverse Events and Laboratory Abnormalities will be 
used for assigning toxicity grades (0 to 4) to laboratory results for analysis. Grade 0 includes all 
values that do not meet the criteria for an abnormality of at least Grade 1. Some laboratory tests 
have criteria for both increased and decreased levels; analyses for each direction (ie, increased, 
decreased) will be presented separately. 
7.2.2.1.
Treatment-Emergent Laboratory Abnormalities
Treatment-emergent laboratory abnormalities are defined as values that increase at least 
1 toxicity grade from baseline at any postbaseline time point, up to and including the date of last 
dose of study drug plus 30 days for subjects who permanently discontinued study drug, or all 
available data in the database snapshot for subjects who were still on treatment at the time of an 
interim analysis. If the relevant baseline laboratory value is missing, then any abnormality of at 
least Grade 1 will be considered treatment emergent.


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7.2.2.2.
Summaries of Laboratory Abnormalities
Laboratory data that are categorical will be summarized using the number and percentage of 
subjects in the study with the given response at baseline and each scheduled postbaseline visit.
The following summaries (number and percentage of subjects) for treatment-emergent laboratory 
abnormalities will be provided by analyte; subjects will be categorized according to the most 
severe postbaseline abnormality grade for a given analyte:

Graded laboratory abnormalities

Grade 3 or above laboratory abnormalities
For all summaries of laboratory abnormalities, the denominator is the number of subjects with 
nonmissing postbaseline values up to 30 days after last dose for the laboratory parameter of 
interest.
A by-subject listing of treatment-emergent Grade 3 or above laboratory abnormalities will be 
provided by subject ID number and visit in chronological order. This listing will include all test 
results that were collected throughout the study for the analyte of interest, with all applicable 
severity grades or abnormal flags displayed.
7.3.
Body Weight, Height, and Vital Signs
Vital signs (systolic and diastolic blood pressure [mmHg], pulse [beats/min]) at each visit, and 
change from baseline at each visit will be summarized for the Safety Analysis Set using 
descriptive statistics (n, mean, SD, median, Q1, Q3, minimum, and maximum). The baseline 
value will be defined as the last available value collected on or prior to the date/time of first dose 
of study drug. Change from baseline to a postbaseline visit will be defined as the postbaseline 
value minus the baseline value.
In the case of multiple values in an analysis window, data will be selected for analysis as 
described in Section 3.8.3 (Selection of Data in the Event of Multiple Records in a Window). No 
inferential statistics will be generated.
A by-subject listing of vital signs (systolic and diastolic blood pressure [mmHg], pulse 
[beats/min], respiration [breaths/min], and body temperature [oC]) will be provided by subject ID 
number and visit in chronological order. In the same manner, a by-subject listing of body weight,
height, and BMI at baseline will be provided separately.
7.4.
Prior and Concomitant Medications
Medications collected at screening and during the study will be coded using the current version
of the World Health Organization (WHO) Drug dictionary. The medications will be categorized 
as prior or concomitant using the following definitions:

Prior medications: any medications taken and stopped prior to or on the date of first study 
drug administration

Concomitant medications: any medications taken after the date of first study drug 
administration and up to the last dosing date of study drug


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Concomitant medications will be summarized by preferred name using the number and 
percentage of subjects for each treatment group. A subject reporting the same medication more 
than once will be counted only once when calculating the number and percentage of subjects 
who received that medication. The summary of concomitant medications will be ordered by 
preferred term in descending frequency. For drugs with the same frequency, sorting will be done 
alphabetically.
Summaries will be based on the Safety Analysis Set. No inferential statistics will be generated. 
For purposes of analysis, any medication with a stop date that is on or prior to the initial study 
drug dosing date or a start date that is after the last study drug dosing date will be excluded from 
a concomitant medication summary. If a partial stop date is entered, any medication with the 
month and year (if day is missing) or year (if day and month are missing) prior to the initial 
study drug dosing date will be excluded from the concomitant medication summary. If a partial 
start date is entered, then any medication with the month and year (if day is missing) or year (if 
day and month are missing) after the study drug stop date will be excluded from the concomitant 
medication summary. Medications with completely missing dates will be included in the 
concomitant medication summary.
All prior and concomitant medications (other than per-protocol study drugs) will be provided in a 
by-subject listing sorted by subject ID number and administration date in chronological order.
7.5.
Electrocardiogram Results
A by-subject listing for ECG assessment results at Screening will be provided by subject ID 
number.
7.6.
Other Safety Measures
A data listing will be provided for subjects who become pregnant during the study.
7.7.
Changes From Protocol-Specified Safety Analyses
There are no deviations from the protocol-specified safety analyses.


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8.
REFERENCES
Chan IS, Zhang Z. Test-based exact confidence intervals for the difference of two binomial 
proportions. Biometrics 1999;55 (4):1202-9.
Clopper CJ, Pearson ES. The Use of Confidence or Fiducial Limits Illustrated in the Case of the 
Binomial. Dec. Biometrika 1934;26 (4):pp. 404-13.
Koch GG, Carr GJ, Amara IA, Stokes ME, Uryniak TJ. Categorical Data Analysis. Chapter 13 in 
Berry, D.A. (ed.).  Statistical Methodology in the Pharmaceutical Sciences. New 
York: Marcel Dekker, Inc., 1989:pp. 414-21.


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9.
SOFTWARE
SAS® Software Version 9.4. SAS Institute Inc., Cary, NC, USA.


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10.
SAP REVISION
Revision Date
(DD MMM YYYY)
Section
Summary of Revision
Reason for Revision


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11.
APPENDICES
Appendix 1.
Study Procedures Table


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Appendix 1.
Study Procedures Table
Screena
Day 1b
On-Treatment 
Study Week (±3 Days)
Posttreatment 
Study Week (±5 Days)
2
4
8
12/EoT
ET
4
12
Informed Consent
X
Determine Eligibility
X
X
Medical History
X
Physical Examination
X
X
X
X
Height
X
Weight
X
Vital Signs
X
X
X
X
X
X
X
X
12-Lead ECG
X
X
Imaging for HCCc
X
AEs/ SAEsh
X
X
X
X
X
X
X
X
Xh
Concomitant Medications
X
X
X
X
X
X
X
X
Review of Study Drug Compliance (Pill Count)d
X
X
X
X
X
Study Drug Dispensing
X
X
X
Hematology, Chemistry
X
X
X
X
X
X
X
X
Coagulation Tests
X
X
X
X
HCV RNA
X
X
X
X
X
X
X
X
X
HBV DNAi
X
X
X
X
X
X
Viral Sequencing/phenotypingd
X
X
X
X
X
X
X
X
Pregnancy Testinge
X
X
X
X
X
X
X


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Screena
Day 1b
On-Treatment 
Study Week (±3 Days)
Posttreatment 
Study Week (±5 Days)
2
4
8
12/EoT
ET
4
12
Urinalysis,
Urine Drug Screen
X
HCV Genotypingf, IL28B
X
HCV, HIV, HBV Testing
X
HbA1c, Fibrotest®
X
Archive Plasma Sampleg
X
X
X
Single PK Sample
X
X
X
X
X
a.
Screening assessments to be completed within 28 days of the Day 1 visit. The screening window can be extended to 42 days for subjects requiring a liver biopsy, or for 
extenuating circumstances with sponsor approval. 
b.
Day 1 assessments must be performed prior to dosing
c.
Cirrhotic subjects will have liver imaging within 6 months of Day 1 to exclude HCC.
d.
Plasma will be collected for possible viral resistance or other virology studies.
e.
For females of childbearing potential only: serum β-hCG at Screening, urine pregnancy testing will occur every 4 weeks during the dosing period and for 30 days following 
the last dose of study drug. 
f.
HCV genotyping to be performed by the central laboratory utilizing the LiPa assay.
g.
Subjects may opt out of archive sample collection. 
h.
Only SAEs will be collected at post-treatment week visits.
i.
Only for subjects who are HBcAb+ at Screening.