Clinical trial NCT02781571
Conditions: Hepatitis C Virus Infection
Sponsor: Gilead Sciences
Start date: 2016-07-27; Completion date: 2017-07-28
Enrollment: 79 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of sofosbuvir /velpatasvir (SOF/VEL) fixed-dose combination (FDC) in participants with chronic hepatitis C virus (HCV) who have received a liver transplant.

Detailed description:

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

Protocol documents:
Prot_000.pdf: 


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SAP_001.pdf: 
STATISTICAL ANALYSIS PLAN
Study Title:
A Phase 2, Multicenter, Open-Label Study to Evaluate the 
Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed Dose 
Combination in Subjects with Chronic HCV Infection Who Have 
Received a Liver Transplant
Name of Test Drug:
Sofosbuvir/Velpatasvir Fixed-Dose Combination
Study Number:
GS-US-342-2104
Protocol Version/Date:
Original/19 February 2016
Analysis Type:
Final Analysis (SVR12)
Analysis Plan Version:
Version 1
Analysis Plan Date:
10 August 2017
Analysis Plan Author:
CONFIDENTIAL AND PROPRIETARY INFORMATION
PPD


SOF/VEL FDC
GS-US-342-2104
Statistical Analysis Plan
Version 1
CONFIDENTIAL
Page 2
10 August 2017
TABLE OF CONTENTS
TABLE OF CONTENTS ..............................................................................................................................................2
LIST OF IN-TEXT TABLES........................................................................................................................................3
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.
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
3.1.4.
Pharmacokinetic Analysis Set..............................................................................................10
3.2.
Subject Grouping ...................................................................................................................................10
3.3.
Strata and Covariates..............................................................................................................................10
3.4.
Examination of Subject Subsets.............................................................................................................10
3.5.
Multiple Comparisons............................................................................................................................11
3.6.
Missing Data and Outliers......................................................................................................................11
3.6.1.
Missing Data ........................................................................................................................11
3.6.2.
Outliers.................................................................................................................................12
3.7.
Data Handling Conventions and Transformations .................................................................................12
3.8.
Visit Windows........................................................................................................................................13
3.8.1.
Definition of Study Day .......................................................................................................13
3.8.2.
Analysis Windows................................................................................................................14
3.8.3.
Selection of Data in the Event of Multiple Records in an Analysis
Window................................................................................................................................15
4.
SUBJECT DISPOSITION ..................................................................................................................................16
4.1.
Subject Enrollment, Screen Failures, and Disposition ...........................................................................16
4.1.1.
Subject Enrollment...............................................................................................................16
A summary of subjects enrolled and treated will be provided for each country and 
investigator within country for the “SOF/VEL 12 Weeks” group for 
subjects in the safety analysis set. ........................................................................................16
4.1.2.
Screen Failures .....................................................................................................................16
4.1.3.
Subject 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.....................................................................................................18
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


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6.1.
Primary Efficacy Endpoint.....................................................................................................................21
6.1.1.
Definition of the Primary Efficacy Endpoint .......................................................................21
6.1.2.
Statistical Hypothesis for the Primary Efficacy Endpoint....................................................21
6.1.3.
Primary Analysis of the Primary Efficacy Endpoint ............................................................21
6.1.4.
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
6.3.
Exploratory Efficacy Endpoints.............................................................................................................23
6.3.1.
Definition of 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
7.1.5.1.
Definition of Treatment-Emergent .................................................................24
7.1.5.2.
Incomplete Dates ............................................................................................25
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 ...................................................................................................28
7.2.2.1.
Treatment-Emergent Laboratory Abnormalities.............................................28
7.2.2.2.
Summaries of Laboratory Abnormalities........................................................28
7.3.
Body Weight, Height, and Vital Signs...................................................................................................28
7.4.
Prior and Concomitant Medications.......................................................................................................29
7.5.
Concomitant Immunosuppressants.........................................................................................................30
7.6.
Investigator Electrocardiogram Assessment ..........................................................................................30
7.7.
Other Safety Measures ...........................................................................................................................30
7.8.
Changes From Protocol-Specified Safety Analyses...............................................................................30
8.
PHARMACOKINETIC ANALYSES ................................................................................................................31
9.
REFERENCES ...................................................................................................................................................32
10.
SOFTWARE.......................................................................................................................................................33
11.
SAP REVISION..................................................................................................................................................34
12.
APPENDICES ....................................................................................................................................................35
Appendix 1.
Table of Contents for Statistical Tables, Figures, and Listings ..............................................36
LIST OF IN-TEXT TABLES
Table 3-1.
Analysis Windows for On-treatment HCV RNA, Vital Signs and Safety Laboratory 
Data ........................................................................................................................................14
Table 3-2.
Analysis Windows for Posttreatment HCV RNA, Vital Signs and 
Hematology/Chemistry Safety Laboratory Data ....................................................................14


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LIST OF ABBREVIATIONS
AE
adverse event
ALT
alanine aminotransferase
APTT
activated partial thromboplastin time
AST
aspartate transaminase
ATC
anatomical therapeutic chemical
BLQ
below the limit of quantitation
BMI
body mass index
BPM
beats per minute
CI
confidence interval
CSR
clinical study report
DAA
direct acting antiviral
ECG
Electrocardiogram
eCRF
electronic case report form
eCrCl
estimated creatinine clearance
EOT
end of treatment
FAS
full analysis set
FDC
fixed dose combination
FU
follow-up
GGT
gamma-glutamyl transferase
HbsAg
hepatitis B surface antigen
HCV
hepatitis C virus
HIV
human immunodeficiency virus
HLGT
high level group term
HLT
high level term
ID
Identification
INR
international normalized ratio for prothrombin time
IWRS
Interactive Web Response System
LLT
lower level term
LLOQ
lower limit of quantitation
MCV
mean corpuscular volume
MDMA
Methylenedroxymethamphetamine 
MedDRA
Medical Dictionary for Regulatory Activities
PD
Pharmacodynamics
PEG
pegylated interferon
PK
Pharmacokinetics
PT
preferred term
Q1
first quartile
Q3
third quartile


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RBC
red blood cells
RBV
Ribavirin
RNA
ribonucleic acid
SAE
serious adverse event
SAP
statistical analysis plan
SD
standard deviation
SOC
system organ class
SOF
sofosbuvir (Sovaldi®)
SVR
sustained virologic response
SVRx
sustained virologic response x weeks after stopping study drug
TE
treatment-emergent
TFLs
tables, figures, and listings
TND
target not detected
ULN
upper limit of the normal range
VEL
velpatasvir (previously GS-5816)
WBC
white blood cell
WHO
World Health Organization


SOFNELFDC 
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Statistical Analysis Plan 
L 
INTRODUCTION 
Version 1 
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 rep01t (CSR) 
for Study GS-US-342-2104. This SAP is based on the original protocol dated 19 Febmmy 2016 
and the elecu·onic case rep01t f01m (eCRF). The SAP will be fmalized before data fmalization. 
Any changes made after the fmalization of the SAP will be documented in the CSR. 
1.1. 
Study Objectives 
The prima1y objectives of this study m·e as follows: 
• 
To evaluate the efficacy of study u·eatment with sofosbuvir (SOF)/velpatasvir (VEL, 
GS-5816) fixed dose combination (FDC) for 12 weeks as measured by the prop01tion of 
subjects with sustained virologic response 12 weeks after cessation of study u·eatment 
regimen (SVR12) 
• 
To evaluate the safety and tolerability of the study u·eatment regimen 
The secondmy objectives of this study m·e as follows: 
• 
To dete1mine the prop01tion of subjects who attain SVR at 4 weeks after cessation of 
u·eatment regimen (SVR4) 
• 
To evaluate the kinetics of circulating HCV RNA during study u·eatment and after cessation 
of study u·eahnent regimen 
• 
To evaluate the emergence of viral resistance to SOF and VEL during study u·eatment and 
after cessation of study u·eatment regimen 
The explorat01y objectives of this study are as follows: 
PPO 
1.2. 
Study Design 
This is a multicenter, open-label, Phase 2 study that will evaluate the safety and efficacy of 
SOF/VEL FDC for 12 weeks in subjects with chronic HCV who have received a liver u·ansplant. 
Approximately 80 subjects with recunent HCV post-liver u·ansplant will be emolled and u·eated 
with SOF/VEL FDC tablet once daily for 12 weeks. The emollment tm·get for subjects with HCV 
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genotype 3 infection is approximately 20%; and the enrollment target for subjects with Metavir 
stage 3 or 4 fibrosis/cirrhosis or corresponding fibrosis degree is approximately 20%. 
The schedule of assessments is provided in Appendix 2 of the study protocol.
The total time to complete all study visits is approximately 28 weeks (30 weeks for those 
requiring liver biopsy or additional HCV genotyping at screening), as described below:

28-day screening period (can be extended up to 42 days if liver biopsy or additional HCV 
genotyping is required or for extenuating circumstances) 

A 12-week study treatment period

Up to 12-week post study treatment period
1.3.
Sample Size and Power
Due to the exploratory nature of this study, no formal power calculations were used to determine 
sample size. The sample size was selected based on practical reasons.
With a sample size of 80, the 95% confidence interval will extend at most 23% in length.


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2.
TYPE OF PLANNED ANALYSIS
2.1.
Data Monitoring Committee
This study does not have a Data Monitoring Committee.
2.2.
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], 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
The All Enrolled Analysis Set includes all subjects who were enrolled into the study. Subjects 
will be grouped by assigned treatment at enrollment (ie, SOF/VEL 12 Weeks).
3.1.2.
Full Analysis Set
The Full Analysis Set (FAS) includes all enrolled subjects who took at least 1 dose of the study 
drug. Since all subjects in this study were assigned to and received SOF/VEL for 12 Weeks, the 
FAS will be the same as the Safety Analysis Set. 
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 the study drug. Subjects 
are grouped within the Safety Analysis Set according to the treatment they actually received. 
This is the primary analysis set for safety analyses.


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3.1.4.
Pharmacokinetic Analysis Set
The Pharmacokinetic (PK) Analysis Set includes all subjects who took at least 1 dose of the 
study drug and have at least 1 nonmissing postdose concentration value for the corresponding 
analyte in plasma. The analytes of interest may include SOF and its metabolites GS-566500 and 
GS-331007, and VEL. The PK analysis set will be used for analyses of population PK. Subjects 
will be grouped according to the treatment they actually received.
3.2.
Subject Grouping
The treatment group for all subjects will be “SOF/VEL 12 Weeks”.
In general, the efficacy analyses will be performed for the FAS overall and by HCV genotype 
(1 total [and further broken down for 1a and 1b], 2, 3, 4, 5, and 6). The primary analysis will be 
performed for the “SOF/VEL 12 Weeks” group as described in Section 6.1. HCV genotype will 
be determined by Covance laboratories using the LiPA 2.0 assay or by Sanger NS5B population 
sequencing when results from LiPA 2.0 are unsuccessful, "indeterminate", or resulted in "mixed 
genotype" and to determine genotype 1 subtype if it is not reported.
The safety analyses will be performed for “SOF/VEL 12 Weeks” using the Safety Analysis Set.
3.3.
Strata and Covariates
There are no strata or covariates for this study.
3.4.
Examination of Subject Subsets
Subject subsets will be explored overall and by HCV genotype (1 total [and further broken down 
by 1a, 1b], 2, 3, 4, 5, and 6) for the primary efficacy endpoint, SVR12, including the following:

age (< 65 years, ≥65 years)

sex at birth (male, female)

race (white, black, all other races)

ethnicity (Hispanic or Latino, non-Hispanic or Latino)

baseline BMI (< 30 kg/m2, ≥ 30 kg/m2)

cirrhosis (no, yes)

baseline HCV RNA (< 800,000 IU/mL, ≥ 800,000 IU/mL)

baseline alanine aminotransferase (ALT)  (≤1.5 × upper limit of normal [ULN], 
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
IL28B (CC, non-CC; with non-CC further broken down to CT, TT)

prior HCV treatment (treatment naive, treatment-experienced)

prior HCV treatment experience and cirrhosis status (ie, treatment naive with cirrhosis, 
treatment-experienced with cirrhosis, treatment naive without cirrhosis, treatment-
experienced without cirrhosis)
3.5.
Multiple Comparisons
No multiplicity adjustment will be made since SVR12 is the primary efficacy endpoint.
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. 
For subjects with a missing last dose date of study drug, imputation rules are described in 
Section 3.8.1. The handling of missing or incomplete dates for adverse event (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 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 of any study drug is greater than or equal to the lower bound of a visit window, and the 
value at the visit is missing, then 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 an HCV RNA 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 
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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 rules
described above, will the corresponding continuous value 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 for each subject. 
Age (in years) on the date of the first dose of study drug and sex at birth 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 in place of the first dose date of study drug for calculations. For some countries, 
only birth year is collected on the eCRF. In those cases, “01 January” will be used for the 
unknown birth day and month for the purpose of age calculation, unless age is captured on the 
CRF.
Non-PK data that are continuous in nature but are less than the lower limit of quantitation 
(LLOQ) 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, version 2.0 was used to 
determine HCV RNA results in this study. The LLOQ of the assay is 15 IU/mL.


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When the calculated HCV RNA IU/mL is within the linear range of the assay, then the result will 
be report as the “<< numeric value>> IU/mL.” This result will be referred to in this document as 
the numeric result or as “≥ LLOQ detected” for the categorical result.
When HCV RNA is not detected, the result is reported as “No HCV RNA 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 
(ie, 14 HCV RNA 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.
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 the study drug will be the end date on study drug administration eCRF for 
the record where the “subject permanently discontinued” flag is ‘Yes’. 
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). 


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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.
Table 3-1.
Analysis Windows for On-treatment HCV RNA, Vital Signs and 
Safety Laboratory Data
Nominal Visit
(SOF/VEL 12 Weeks)
Nominal Day
Lower Limit
Upper Limit
Baselinea
1
(none)
1
Week 2
14
2
21
Week 4
28
22
42
Week 8
56
43
70
Week 12a
84
71
≥85
a
Coagulation and urinalysis tests will only be collected at baseline and Week 12.
HCV RNA, vital sign, and safety laboratory data collected after the last dose date + 3 days will 
be assigned to a posttreatment follow-up (FU) visit. 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 Signs and 
Hematology/Chemistry Safety Laboratory Data
Nominal FUa Visit
HCV RNA
Vital Signs and Safety Laboratory Datab
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
a
FU-x visit = posttreatment Week-x follow-up visit.
b
Vital signs and hematology/chemistry safety labs will only be summarized for the FU-4 visit (up to 30 days after last dose).
Coagulation and urinalysis tests are not collected at posttreatment visits.
ECG data collected at the screening visit will be listed using the nominal visit.


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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, the average (arithmetic mean) will be used for the baseline value. 

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 
the 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, Screen Failures, and Disposition
4.1.1.
Subject Enrollment
A summary of subjects enrolled and treated will be provided for each country and investigator 
within country for the “SOF/VEL 12 Weeks” group for subjects in the safety analysis set.
4.1.2.
Screen Failures
Reasons for screen failure will be summarized for each screen that was performed for the study. 
The total number of screens and number of screen failures will be provided. Screen failures will 
be split into the following 2 groups:
Percentages will be calculated for the screen failure rate (denominator is number of screens), 
each inclusion/exclusion criteria not met (denominator is screen fails that did not meet criteria), 
and reasons for non-enrollment (denominator is screen fails that met eligibility criteria). A listing 
of reasons for screen failure will be provided, sorted by screening IDs for subjects who were 
screened but not treated.
4.1.3.
Subject Disposition
The summary of subject disposition will be provided for “SOF/VEL 12 Weeks”. The summary 
will present the number of subjects enrolled, and the number of subjects in each of the categories 
listed below.

Treated (Safety Analysis Set) 

In FAS

In PK Analysis Set

Completed study treatment

Did not complete study treatment with reasons for premature discontinuation of study 
treatment

Completed study

Did not complete the study with reasons for premature discontinuation of study


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For the percentage of subjects who completed or did not complete study treatment or study, the 
denominator for the percentage calculation will be the total number of subjects in the Safety 
Analysis Set. Among subjects who completed study treatment and who discontinued study
treatment, the number and percentage of subjects will be summarized for the following:

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 and 
thereafter (With HCV FU-4 but No FU-12 and thereafter)
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 and thereafter.”
In addition, the total number of subjects who were screened, enrolled, and the number of subjects 
in each of the disposition categories listed above will be depicted by a flowchart.
The following by-subject listings will be provided by subject identification (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 treatment and/or study

Lot number(s)
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 (ie, total duration [in days] divided by 7) using up to 1 decimal place
(eg, 4.5 weeks).
The total duration of exposure to study drug (ie, weeks) will be summarized using descriptive 
statistics (n, mean, SD, median, Q1, Q3, minimum, and maximum) and using the number
(ie, cumulative counts) and percentage of subjects exposed through the following time periods: 
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A 3-day window is applied to the last planned on-treatment visit to match with the 
protocol-specified visit window. A summary will be provided for the “SOF/VEL 12 Weeks”
group 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 eCRF 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 will be assessed based on the total amount of study drug 
administered relative to the total amount of study drug prescribed at baseline.
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 (400/100 mg) prescribed for 12 weeks 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 study drug bottles are dispensed on or after the date 
that 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 “SOF/VEL 12 Weeks” group 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.


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5.
BASELINE CHARACTERISTICS
5.1.
Demographics
Subject demographic variables (ie, age, sex, race, and ethnicity) will be summarized. Age will be 
summarized using descriptive statistics (n, mean, SD, median, Q1, Q3, minimum, and 
maximum). Age categories (< 65 years, ≥65 years), sex, race, and ethnicity will be summarized 
as the number and percentage of subjects. Age is calculated in years on the date of first dose of 
study drug. For this study, only the year of the birthdate will be reported in eCRFs per country 
regulations; the month and day will be set to January 01 for purposes of calculating the subject’s 
age. 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 “SOF/VEL 12 Weeks” group for the Safety Analysis Set, and by 
HCV Genotype and Overall for the FAS (as described in Section 3.2 of this SAP).
A by-subject demographic listing will be provided by subject ID number in ascending order.
5.2.
Other Baseline Characteristics
Other baseline characteristics include: 

HCV genotype (for this study a separate table will be produced by HCV genotype and by 
subtype within each genotype)

baseline body mass index (BMI; in kg/m2) as a continuous variable and as categories 
(< 30 kg/m2, ≥30 kg/m2)

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 × ULN, > 1.5 × ULN)

cirrhosis (no, yes)

baseline estimated creatinine clearance (eCrCl) using the Cockcroft-Gault equation

prior HCV treatment (treatment-naive, treatment-experienced)

most recent HCV treatment (DAA ± PEG + RBV, IFN ± RBV, PEG ± RBV) for treatment-
experienced subjects

most recent HCV treatment response (non-responder, relapse/breakthrough, early treatment 
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
years from most recent liver transplantation on date of first dose of study drug

prior HCV treatment experience and cirrhosis status (treatment naive with cirrhosis, 
treatment-experienced with cirrhosis, treatment naive without cirrhosis, treatment-
experienced without cirrhosis)
Estimated creatinine clearance will be calculated by the Cockcroft-Gault method: eCrCLCG
(mL/min) = [(140 – age (yrs)) × weight (kg) × (0.85 if female)] / (serum creatinine (mg/dL) × 
72), where weight is actual weight in kilograms.
The summary of demographics and baseline characteristics will be provided for the “SOF/VEL 
12 Weeks” group for the Safety Analysis Set; and overall and by HCV Genotype for the FAS 
(using the groupings described in Section 3.2 of this SAP). Continuous variables will be 
summarized using descriptive statistics (n, mean, SD, median, Q1, Q3, minimum, and 
maximum) and categorical variables using the number and percentage of subjects.
A summary of immunosuppressants administered at baseline to prevent rejection of the liver 
transplant will be presented for the Safety Analysis Set.
A by-subject listing of baseline characteristics will be provided by subject ID number in 
ascending order. The type of assay used to determine the HCV genotype (Abbott RealTime HCV 
genotype II assay [ie, LiPA 2.0] or Sanger NS5B population genotype and subtype and the 
corresponding results will also be displayed in this listing).
A separate by-subject data listing for cirrhosis determination will be provided for all subjects at 
screening.
A separate by-subject data listing of liver imaging results performed within 6 months of Day 1 to 
screen for hepatocellular carcinoma for subjects with cirrhosis will be provided.
A separate by-subject data listing for prior HCV treatment and response will be provided for all 
subjects who took prior HCV medications. The listing will display the prior HCV regimen and 
treatment, the treatment duration, and the prior HCV treatment response for 
treatment-experienced subjects.
5.3.
Medical History
A by-subject listing of disease-specific medical history will be provided by subject ID number 
(in ascending 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 discontinuation of the study drug in the FAS. The COBAS® AmpliPrep/COBAS®
TaqMan® HCV Quantitative Test, v2.0 will be used to measure HCV RNA.
6.1.2.
Statistical Hypothesis for the Primary Efficacy Endpoint
No hypothesis testing will be performed.
6.1.3.
Primary Analysis of the Primary Efficacy Endpoint
The estimate of SVR12 and a 2-sided 95% exact CI based on the Clopper-Pearson method will 
be provided for the “SOF/VEL 12 Weeks” group {Clopper 1934}. In addition, point estimates 
and 95% confidence intervals will be provided by HCV genotype (as described in Section 3.2 of 
this SAP).
6.1.4.
Subgroup Analysis of the Primary Efficacy Endpoint
Point estimates and the 2-sided 95% exact CI based on the Clopper-Pearson method will be 
provided for the SVR12 rate overall and by HCV genotype (1 total [and further broken down for
1a and 1b], 2, 3, 4, 5, and 6) for each subgroup outlined in Section 3.4. SVR12 rates will be 
summarized by categories of early viral response to explore possible early on-treatment 
predictors of SVR12.
6.2.
Secondary Efficacy Endpoints
6.2.1.
Definition of Secondary Efficacy Endpoints
Secondary efficacy endpoints include the following:

The proportion of subjects with HCV RNA < LLOQ at 4 weeks after discontinuation of 
study treatment (SVR4)

The proportion of subjects with HCV RNA < LLOQ while on treatment by study visit

HCV RNA (log10 IU/mL) and change from baseline in HCV RNA (log10 IU/mL) by visit 
through end of treatment (EOT)


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
The proportion of subjects with virologic failure as the following
On-treatment virologic failure
o
HCV RNA ≥ LLOQ after having previously had 2 consecutive 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)
o
> 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)
o
HCV RNA persistently ≥ LLOQ through 12 weeks of treatment (ie, nonresponse)
Relapse
o
HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA 
< LLOQ at EOT, 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
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 CI based on the 
Clopper-Pearson method will be provided for the proportion of subjects with HCV RNA 
< LLOQ at each visit for “SOF/VEL 12 Weeks” and by HCV genotype (1 total [and further 
broken down for 1a and 1b], 2, 3, 4, 5, and 6). 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 in tabular displays. 
Summary statistics will be presented for absolute values and change from baseline in HCV RNA 
(log10 IU/mL) by visit through the end of treatment. 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 for “SOF/VEL 12 Weeks” and by HCV 
genotype (1 total [and further broken down for 1a and 1b], 2, 3, 4, 5, and 6) according to the 
rules specified above.


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For the SVR12 endpoint analysis, a summruy table of the number and prop01i ion of subjects with 
SVR12, virologic failure, and Other will be created. All subjects who achieve SVR12 will be 
categorized as SVR12. Virologic failure will be descriptively summru·ized as "on-treatment 
virologic failure" and relapse (which will be broken down by study dmg completed yes/no). 
Subjects who do not achieve SVR12 and do not meet criteria for virologic failure 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; othe1wise, the 
denominator will be the number of subjects in the F AS. Virologic outcomes will be provided for 
"SOFNEL 12 Weeks" and by HCV genotype (1 total [and further broken down for 1a and 1b], 
2, 3, 4, 5, and 6 as described above. Sepru·ate listings will be provided for subjects with virologic 
failure and for subjects who meet the criteria for "Other". 
In addition, a summruy table of the number and prop01iion of subjects with HCV RNA 
< LLOQ and :::: LLOQ at the posttreatment follow-up visit (observed and imputed, with reasons 
for imputation) will be provided for each posttreatment follow-up visit. Results will be displayed 
for "SOFNEL 12 Weeks" and by HCV genotype (1 total [and fmi her broken down for 1a and 
1 b ], 2, 3, 4, 5, and 6). The 2-sided 95% Clopper-Pearson exact Cis will be presented for the 
prop01iion of subjects with HCV RNA < LLOQ. 
Dmg resistant substitutions will be analyzed as pati of a separate Virology Study Rep01i . 
6.3. 
Exploratory Efficacy Endpoints 
6.3.1. 
Definition of Exploratory Efficacy Endpoints 
PD 
I 
6.4. 
Changes From Protocol-Specified Efficacy Analyses 
There are no planned changes fi:om protocol-specified efficacy analyses. 
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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 using the Gilead Grading 
Scale for Severity of Adverse Events and Laboratory Abnormalities. 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 the 
relationship to study drug will be considered to be related to study drug for summary purposes. 
However, by-subject data listings will show the relationship as missing from that captured on the 
eCRF.
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 Drug Safety and 
Public Health 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 an 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 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 for the “SOF/VEL 12 Weeks” group for
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 SOF/VEL, any AE that led to interruption 
of SOF/VEL. 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, for the “SOF/VEL 12 Weeks” group 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 


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Multiple events will be counted once only 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 within any treatment group

AEs of Grade 3 or above

AEs related to study drug

All SAEs

AEs leading to premature discontinuation of study drug

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 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 date of study drug plus 30 days. 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 “< 50” was recorded, a value of 49
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. Hemolyzed test results will 
not be included in the analysis, but they will be listed in by-subject laboratory listings.
For this study, an enzymatic serum creatinine test was used (reflex test) when the sample was 
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the enzymatic serum creatinine test will be used in place of a missing serum creatinine value per 
the standard methodology, when appropriate. Covance Laboratories has conducted correlation 
testing to show that the results of these 2 tests are similar and can be pooled for analysis.
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 the “SOF/VEL 12 Weeks” group for ALT, aspartate transaminase (AST), total bilirubin, 
alkaline phosphatase, hemoglobin, reticulocytes, white blood cells (WBC), neutrophils, 
lymphocytes, platelets, and international normalized ratio (INR) as follows:

Baseline values 

Values at each postbaseline 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 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 reported number of digits, SD to reported number of digits plus 1.
Median (Q1, Q3) of the observed values for ALT, AST, total bilirubin, alkaline phosphatase, 
hemoglobin, reticulocytes, WBC, neutrophils, lymphocytes, and platelets will be plotted using a 
line plot for the “SOF/VEL 12 Weeks” group 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).
The percentage of subjects with at least 1 postbaseline (up to 30 days post last dose) hemoglobin 
value < 10 g/dL and < 8.5 g/dL will be summarized for the “SOF/VEL 12 Weeks” group. The 
denominator will be the number of subjects with at least 1 postbaseline hemoglobin value. Note 
that a subject with a minimum hemoglobin value on treatment of 8.3 g/dL would be counted in 
both categories.
A listing of subjects meeting the criteria for postbaseline hemoglobin < 10 g/dL and < 8.5 g/dL 
will be provided.


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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. If the relevant baseline laboratory value is missing, then any 
abnormality of at least Grade 1 will be considered treatment emergent.
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 for the “SOF/VEL 12 Weeks” group 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. By-subject listings of laboratory data will be 
provided by subject ID number and visit in chronological order.
7.3.
Body Weight, Height, and Vital Signs
Vital signs (systolic and diastolic blood pressure [mmHg], and 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) for the 
“SOF/VEL 12 Weeks” group. The baseline value will be defined as the last available value 
collected on or prior to the date of first dose of study drug. Change from baseline to a 
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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 body weight, height, BMI, and vital signs (systolic and diastolic blood 
pressure [mmHg], pulse [beats/min], respiration [breaths/min], and body temperature [°C]) will 
be provided by subject ID number and visit in chronological order. 
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 the study drug
Concomitant medications (other than study drug and drugs administered to prevent rejection of 
the transplanted organ) will be summarized by Anatomical Therapeutic Chemical (ATC) drug 
class Level 2, and preferred name using the number and percentage of subjects for the 
“SOF/VEL 12 Weeks” 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 alphabetically by ATC 
drug class and then by descending frequency of preferred names within an ATC drug class. For 
drugs with the same frequency, sorting of preferred names 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 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 and 
immunosuppressants given to prevent rejection of the transplanted liver) will be provided in a 
by-subject listing sorted by subject ID number and administration date in chronological order.


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7.5.
Concomitant Immunosuppressants
Immunosuppressant medications administered to prevent rejection of the transplanted liver will 
be summarized separately by Anatomical Therapeutic Chemical (ATC) drug class Level 2, and 
preferred name. The WHO preferred name and drug code will be attached to the clinical 
database. Immunosuppressants taken while the subject is receiving study drug will be 
summarized by WHO drug class and generic name. Definitions for concomitant medications and 
imputations for partial dates are as described for concomitant medications. The summary of 
concomitant immunosuppressant medications will be ordered alphabetically by ATC drug class
and then by descending frequency of preferred names within an ATC drug class.
The number and percentage of subjects with any change in concomitant immunosuppressant 
medication will be summarized overall by reason for change (drug-drug interaction [DDI], 
protocol defined change [PDC], improvement in organ function [IOF], renal insufficiency [RIS], 
failing graft [FGR], and other [OTH]).  The denominator for percentage calculation is the 
number of subjects taking any concomitant immunosuppressant for the safety analysis set. 
Similarly, for each drug class, the number and percentage of subjects with a dose change will be 
summarized by reason for change (denominator will be number of subjects receiving a 
concomitant drug in that class). The classes will be calcineurin inhibitors (ciclosporin, 
tacrolimus), rapamycin inhibitors (sirolimus, everolimus), purine/pyrimidine synthesis inhibitors 
(mycophenolate and its derivatives), antimetabolites (azathioprine), and corticosteroids
(prednisone, prednisolone, methylprednisolone). A subject may have more than 1 reason for 
change recorded, and may appear in more than 1 change category.
A listing of immunosuppressant drugs administered to subjects will be provided, including the 
reason for any dose modification. If suspected drug-drug interaction is the reason marked for a 
dose change, whether the drug-drug interaction was confirmed will be included.
For subjects who take calcineurin or mTOR inhibitors (a class of drugs that inhibit the 
mechanistic target of rampamycin) and have blood concentrations collected, a listing will be 
provided. This listing will be sorted by subject ID, calcineurin or mTOR inhibitor name, and date 
of collection for the blood sample.
7.6.
Investigator Electrocardiogram Assessment
A by-subject listing for ECG assessment results at screening will be provided by subject ID 
number. A separate listing will be provided for subjects with clinically significant ECG 
abnormalities.
7.7.
Other Safety Measures
A listing of pregnancies and rejection episodes will be provided.
7.8.
Changes From Protocol-Specified Safety Analyses
There are no deviations from the protocol-specified safety analyses.


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8.
PHARMACOKINETIC ANALYSES
The plasma concentrations of SOF and its metabolites GS-566500 and GS-331007, and VEL will 
be determined using validated bioanalytical assays. 
For all subjects, a single PK blood sample will be collected at any time for each on-treatment 
visit except for Study Day 1.
Population PK models for SOF, GS-331007, and VEL previously developed for regulatory 
submission may be applied to the data of this study. PK parameters (AUCtau and Cmax of SOF 
and GS-331007, and AUCtau, Cmax, and Ctau for VEL) may be estimated for the simulated SOF, 
GS-331007, and VEL concentration data using respective population PK models. The drug 
concentrations and population PK model-derived PK parameters for SOF, GS-331007, and VEL 
will be listed, as appropriate.


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9.
REFERENCES
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.


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10.
SOFTWARE
SAS® Software Version 9.2. SAS Institute Inc., Cary, NC, USA.


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11.
SAP REVISION
Revision Date
(DD MMM YYYY)
Section
Summary of Revision
Reason for Revision


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12.
APPENDICES
Appendix 1.
Table of Contents for Statistical Tables, Figures, and Listings


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Appendix 1.
Table of Contents for Statistical Tables, Figures, and Listings
Table Number
Title
Analysis Set
15.8.1.1
Subjects Enrolled and Treated by Country and Investigator
Safety Analysis Set
15.8.1.2
Subject Disposition
All Enrolled Analysis Set
15.8.1.3
Reasons for Screen Failure
Screened Subjects
15.8.3.1
Demographics and Baseline Characteristics
Safety Analysis Set
15.8.3.2*
Demographics and Baseline Characteristics by HCV Genotype and 
Overall
Full Analysis Set
15.8.3.3
HCV Genotype and Subtype
Safety Analysis Set
15.8.3.4
Baseline Immunosuppressant Medications
Safety Analysis Set
15.8.4
Adherence to Study Drug
Safety Analysis Set
15.9.1*
SVR12
Full Analysis Set
15.9.2.1.1*
Virologic Outcomes
Full Analysis Set
15.9.2.1.2*
Virologic Outcomes by Visit During Posttreatment Follow Up
Full Analysis Set
15.9.2.2*
SVR by Visit During Posttreatment Follow Up
Full Analysis Set
15.9.2.3*
Proportion of Subjects with HCV RNA Less than LLOQ While on 
Treatment by Visit
Full Analysis Set
15.9.2.4*
HCV RNA (log10 IU/mL) and Change from Baseline by Visit 
Through End of Treatment
Full Analysis Set
15.9.4.1*
SVR12 by Subgroup
Full Analysis Set
15.9.4.2*
SVR12 by Early Viral Response
Full Analysis Set
15.11.1
Duration of Exposure to Study Regimen
Safety Analysis Set
15.11.2.1.1
Adverse Events: Brief Summary
Safety Analysis Set
15.11.2.1.2
All Treatment-Emergent Adverse Events
Safety Analysis Set
15.11.2.1.3
Treatment-Emergent Adverse Events That Occurred in At Least 
5% of Subjects by Preferred Term
Safety Analysis Set
15.11.2.2.1
Treatment-Emergent Adverse Events of Grade 3 or Above
Safety Analysis Set
15.11.2.2.2
Treatment-Emergent Adverse Events of Grade 3 or Above by 
Preferred Term
Safety Analysis Set
15.11.2.2.3
Treatment-Emergent Adverse Events of Grade 2 or Above
Safety Analysis Set
15.11.2.3.1
Treatment-Emergent Treatment-Related Adverse Events
Safety Analysis Set
15.11.2.3.2
Treatment-Emergent Treatment-Related Adverse Events by 
Preferred Term
Safety Analysis Set
15.11.2.3.3
Treatment-Emergent Treatment-Related Adverse Events of 
Grade 3 or Above
Safety Analysis Set
15.11.2.3.4
Treatment-Emergent Treatment-Related Adverse Events of 
Grade 2 or Above
Safety Analysis Set


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Table Number
Title
Analysis Set
15.11.2.4
Adverse Events Leading to Interruption of Study Drug by Preferred 
Term 
Safety Analysis Set
15.11.4.1
Treatment-Emergent Serious Adverse Events
Safety Analysis Set
15.11.4.2
Treatment-Emergent Serious Adverse Events by Preferred Term
Safety Analysis Set
15.11.4.3
Treatment-Emergent Treatment-Related Serious Adverse Events
Safety Analysis Set
15.11.5
Adverse Events Leading to Premature Discontinuation of Study 
Drug by Preferred Term
Safety Analysis Set
15.11.6.1.1
ALT (U/L) and Change from Baseline by Visit
Safety Analysis Set
15.11.6.1.2
AST (U/L) and Change from Baseline by Visit
Safety Analysis Set
15.11.6.1.3
Total Bilirubin (mg/dL) and Change from Baseline by Visit
Safety Analysis Set
15.11.6.1.4
Alkaline Phosphatase (U/L) and Change from Baseline by Visit
Safety Analysis Set
15.11.6.1.5
Hemoglobin (g/dL) and Change from Baseline by Visit
Safety Analysis Set
15.11.6.1.6
Subjects with Postbaseline Hemoglobin < 10 g/dL and < 8.5 g/dL
Safety Analysis Set
15.11.6.1.7
Reticulocytes (× 103 /μL) and Change from Baseline by Visit
Safety Analysis Set
15.11.6.1.8
WBC (× 103 /μL) and Change from Baseline by Visit
Safety Analysis Set
15.11.6.1.9
Neutrophils (× 103 /μL) and Change from Baseline by Visit
Safety Analysis Set
15.11.6.1.10
Lymphocytes (× 103 /μL) and Change from Baseline by Visit
Safety Analysis Set
15.11.6.1.11
Platelets (× 103 /μL) and Change from Baseline by Visit
Safety Analysis Set
15.11.6.1.12
INR and Change from Baseline by Visit
Safety Analysis Set
15.11.6.2
Treatment-Emergent Graded Laboratory Abnormalities
Safety Analysis Set
15.11.6.3
Treatment-Emergent Grade 3 or Above Laboratory Abnormalities
Safety Analysis Set
15.11.7.1
Systolic Blood Pressure (mmHg) and Change from Baseline by 
Visit
Safety Analysis Set
15.11.7.2
Diastolic Blood Pressure (mmHg) and Change from Baseline 
by Visit
Safety Analysis Set
15.11.7.3
Pulse (bpm) and Change from Baseline by Visit
Safety Analysis Set
15.11.7.4.1
Concomitant Medications
Safety Analysis Set
15.11.7.4.2
Concomitant Immunosuppressant Medications
Safety Analysis Set
15.11.7.7.3
Subjects with Changes in Concomitant Immunosuppressant 
Medication Dose by Reason for Change
Safety Analysis Set
*
Groups are SOF/VEL 12 Weeks; and by HCV GT (1 Total, 1a, 1b, 2, 3, 4, 5, and 6).


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Figure Number
Title
Analysis Set
15.8.1
Subject Disposition
Screened Subjects
15.9.2.4
Proportion of Subjects with HCV RNA < LLOQ While on 
Treatment by Visit
Full Analysis Set
15.9.2.5.1
Mean ± SD Change from Baseline in HCV RNA (log10 IU/mL) 
by Visit Through End of Treatment
Full Analysis Set
15.9.2.5.2
Median (Q1, Q3) Change from Baseline in HCV RNA 
(log10 IU/mL) by Visit Through End of Treatment
Full Analysis Set
15.9.2.5.3
Mean ± SD HCV RNA (log10 IU/mL) by Visit Through End of 
Treatment
Full Analysis Set
15.9.2.5.4
Median (Q1, Q3) HCV RNA (log10 IU/mL) by Visit Through 
End of Treatment
Full Analysis Set
15.11.6.1
Median (Q1, Q3) ALT (U/L) by Visit
Safety Analysis Set
15.11.6.2
Median (Q1, Q3) AST (U/L) by Visit
Safety Analysis Set
15.11.6.3
Median (Q1, Q3) Total Bilirubin (mg/dL) by  Visit
Safety Analysis Set
15.11.6.4
Median (Q1, Q3) Alkaline Phosphatase (U/L) by Visit
Safety Analysis Set
15.11.6.5
Median (Q1, Q3) Hemoglobin (g/dL) by Visit
Safety Analysis Set
15.11.6.6
Median (Q1, Q3) Reticulocytes (× 103 /μL) by Visit
Safety Analysis Set
15.11.6.7
Median (Q1, Q3) WBC (× 103 /μL) by Visit
Safety Analysis Set
15.11.6.8
Median (Q1, Q3) Neutrophils (× 103 /μL) by Visit
Safety Analysis Set
15.11.6.9
Median (Q1, Q3) Lymphocytes (× 103 /μL) by Visit
Safety Analysis Set
15.11.6.10
Median (Q1, Q3) Platelets (× 103 /μL) by Visit
Safety Analysis Set


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Listing Number
Title
Analysis Set
16.1.6
Lot Numbers and Bottle IDs
Safety Analysis Set
16.1.7
Enrollment Date/Time and Treatment Assignment
All Enrolled Analysis Set
16.2.1.1
Disposition for Subjects Who Completed Study Treatment and 
Study
Safety Analysis Set
16.2.1.2
Disposition for Subjects Who Did Not Complete Study Treatment 
and/or Study
Safety Analysis Set
16.2.2.1
Inclusion and Exclusion Criteria
Subjects Not Treated
16.2.2.2
Subjects Enrolled and Treated Who Did Not Meet 
Eligibility Criteria
Safety Analysis Set
16.2.3
Subjects Who Were Excluded from Safety and Full Analysis Sets
All Enrolled Analysis Set
16.2.4.1
Demographics
Safety Analysis Set
16.2.4.2.1
Baseline Characteristics
Safety Analysis Set
16.2.4.2.2
Cirrhosis Determination
Safety Analysis Set
16.2.4.2.3
Liver Imaging for Subjects with Cirrhosis
Safety Analysis Set 
(Cirrhotic Subjects)
16.2.4.3.1
Medical History
Safety Analysis Set
16.2.4.3.2
Prior HCV Treatment and Response 
Safety Analysis Set
16.2.4.4.1
Prior and Concomitant Medications
Safety Analysis Set
16.2.4.4.2
Immunosuppressant Medications
Safety Analysis Set
16.2.4.4.3
Calcineurin and mTOR Inhibitor Concentrations (ng/mL)
Safety Analysis Set
16.2.5.1
Study Drug Administration
Safety Analysis Set
16.2.5.2
Study Drug Accountability and Adherence
Safety Analysis Set
16.2.5.3
Plasma PK Sampling Details and PK Concentrations
PK Analysis Set
16.2.6.1
HCV RNA (log10 IU/mL) and Change from Baseline
Safety Analysis Set
16.2.6.2
Subjects with Virologic Failure
Safety Analysis Set
16.2.6.3
Subjects with “Other” Virologic Outcome
Safety Analysis Set
16.2.7.1
All Adverse Events
Safety Analysis Set
16.2.7.2
Adverse Events of Grade 3 or Above
Safety Analysis Set
16.2.7.3
Deaths
Safety Analysis Set
16.2.7.4
Serious Adverse Events
Safety Analysis Set
16.2.7.5
Adverse Events Leading to Premature Discontinuation of 
SOF/VEL
Safety Analysis Set
16.2.8.1.1
Subjects with Postbaseline Hemoglobin < 10 g/dL and < 8.5 g/dL
Safety Analysis Set
16.2.8.1.2
Central Laboratory (Covance) Reference Ranges
Safety Analysis Set


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Listing Number
Title
Analysis Set
16.2.8.1.3.1
Subjects with Treatment-Emergent Grade 3 or Above Laboratory 
Abnormalities
Safety Analysis Set
16.2.8.1.3.2
Medical History and Prior and Concomitant Medications for 
Subjects with Treatment-Emergent Grade 3 or Above Laboratory 
Abnormalities of Glucose
Safety Analysis Set
16.2.8.1.4.1
Screen Labs: HBsAg, Anti-HIV Ab, Anti-HCV Ab, HbA1c, and 
Serum Beta hCG
Safety Analysis Set
16.2.8.1.4.2
Drugs of Abuse Screen: Amphetamines/MDMA, Cocaine, 
Methadone, and Opiates
Safety Analysis Set
16.2.8.1.5.1
Hematology: Hematocrit, Hemoglobin, Reticulocytes, MCV, RBC, 
WBC, and Platelets
Safety Analysis Set
16.2.8.1.5.2
Hematology: WBC, Neutrophils, and Lymphocytes
Safety Analysis Set
16.2.8.1.5.3
Hematology: Eosinophils, Basophils, and Monocytes
Safety Analysis Set
16.2.8.1.6
Coagulation: INR and APTT
Safety Analysis Set
16.2.8.1.7.1
Serum Chemistry: Sodium, Potassium, Bicarbonate, Phosphorus, 
and Uric Acid
Safety Analysis Set
16.2.8.1.7.2
Serum Chemistry: AST, ALT, Total Bilirubin, Direct Bilirubin, 
Alkaline Phosphatase, GGT, Albumin, and Lipase
Safety Analysis Set
16.2.8.1.7.3
Serum Chemistry: Creatine Kinase, Creatinine, Estimated 
Creatinine Clearance (Cockcroft-Gault), and Glucose
Safety Analysis Set
16.2.8.1.8.1
Urinalysis: Urine Blood, Glucose, pH, Protein, Urobilinogen, and 
Leukocyte Esterase
Safety Analysis Set
16.2.8.1.8.2
Microscopic Urinalysis for Subjects with Abnormal Macroscopic 
Urinalysis
Safety Analysis Set
16.2.8.2.1
Height, Weight, BMI, and Vital Signs
Safety Analysis Set
16.2.8.2.2.1
12-Lead Electrocardiogram Results
Safety Analysis Set
16.2.8.2.2.2
12-Lead Electrocardiogram Results for Subjects with Clinically 
Significant Abnormalities
Safety Analysis Set
16.2.8.3
Pregnancy
Safety Analysis Set
16.2.8.4
Subjects with Acute Rejection Episodes
Safety Analysis Set