Conditions: Hepatitis C Virus Infection
Keywords: Hepatitis C Virus (HCV) Ledipasvir/Sofosbuvir Ribavirin
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 87
Healthy volunteers: no

Brief summary:
The primary objective of this study is to evaluate the efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed dose combination (FDC) for 12 weeks with or without ribavirin (RBV) in participants without cirrhosis, and LDV/SOF FDC for 12 weeks with RBV or LDV/SOF FDC for 24 weeks without RBV in participants with cirrhosis.

Detailed description:

Arms:
arm 1: LDV/SOF for 12 weeks arm 2: LDV/SOF + RBV for 12 weeks arm 3: LDV/SOF + RBV for 12 weeks arm 4: LDV/SOF for 24 weeks

Interventions: intervention 1: LDV/SOF intervention 2: RBV
Intervention descriptions: intervention 1: 90/400 mg FDC tablet administered orally once daily intervention 2: Tablets administered orally in a divided daily dose according to weight-based dosing recommendations (\< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)

Protocol document:
Prot_005.pdf: 


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SAP_007.pdf: 
STATISTICAL ANALYSIS PLAN
Study Title:
A Phase 3b, Multicenter, Open-Label Study to Investigate the
Efficacy and Safety of Ledipasvir/Sofosbuvir, With or Without
Ribavirin, in HCV Infected Subjects Who Have Failed Prior
Treatment With Sofosbuvir-based Therapies
Name of Test Drug:
Ledipasvir/Sofosbuvir (Harvoni) Fixed-Dose Combination
Study Number:
GS-US-337-1746
Protocol Version/Date:
Amendment 2:  23 July 2015
Analysis Type:
SVR12 and Final Analysis
Analysis Plan Version:
Version 1
Analysis Plan Date:
28 March 2017
Analysis Plan Author:
CONFIDENTIAL AND PROPRIETARY INFORMATION
PPD


LDV/SOF FDC
GS-US-337-1746
Statistical Analysis Plan
Version 1
CONFIDENTIAL
Page 2
28 March 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............................................................................................................................................7
1.3.
Sample Size and Power............................................................................................................................8
2.
TYPE OF PLANNED ANALYSIS ......................................................................................................................9
2.1.
Data Monitoring Committee ....................................................................................................................9
2.2.
Interim Analysis.......................................................................................................................................9
2.2.1.
Posttreatment Week 12 Analysis............................................................................................9
2.3.
Final Analysis ..........................................................................................................................................9
3.
GENERAL CONSIDERATIONS FOR DATA ANALYSES............................................................................10
3.1.
Analysis Sets..........................................................................................................................................10
3.1.1.
All Randomized/Enrolled Analysis Set................................................................................10
3.1.2.
Full Analysis Set ..................................................................................................................10
3.1.3.
Safety Analysis Set...............................................................................................................11
3.2.
Subject Grouping ...................................................................................................................................11
3.3.
Strata and Covariates..............................................................................................................................12
3.4.
Examination of Subject Subsets.............................................................................................................12
3.5.
Multiple Comparisons............................................................................................................................13
3.6.
Missing Data and Outliers......................................................................................................................13
3.6.1.
Missing Data ........................................................................................................................13
3.6.2.
Missing Date ........................................................................................................................14
3.6.3.
Outliers.................................................................................................................................14
3.7.
Data Handling Conventions and Transformations .................................................................................14
3.8.
Visit Windows........................................................................................................................................16
3.8.1.
Definition of Study Day .......................................................................................................16
3.8.2.
Analysis Windows................................................................................................................16
3.8.3.
Selection of Data in the Event of Multiple Records in an Analysis 
Window................................................................................................................................18
4.
SUBJECT DISPOSITION ..................................................................................................................................20
4.1.
Subject Enrollment and Disposition.......................................................................................................20
4.2.
Extent of Exposure.................................................................................................................................21
4.2.1.
Duration of Exposure to Study Drug....................................................................................21
4.2.2.
Adherence to Study Drug.....................................................................................................22
4.3.
Protocol Deviations................................................................................................................................23
5.
BASELINE CHARACTERISTICS....................................................................................................................24
5.1.
Demographics ........................................................................................................................................24
5.2.
Baseline Characteristics .........................................................................................................................24
5.3.
Baseline Fibrosis Stage ..........................................................................................................................25
5.4.
Medical History......................................................................................................................................25
6.
EFFICACY ANALYSES ...................................................................................................................................26
6.1.
Primary Efficacy Endpoint.....................................................................................................................26
6.1.1.
Definition of the Primary Efficacy Endpoint .......................................................................26


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6.1.2.
Summary for the Primary Efficacy Endpoint.......................................................................26
6.1.3.
Subgroup Analysis of the Primary Efficacy Endpoint .........................................................27
6.2.
Secondary Efficacy Endpoints ...............................................................................................................28
6.2.1.
Definition of Secondary Efficacy Endpoints........................................................................28
6.2.2.
Analysis Methods for Secondary Antiviral Efficacy Endpoints...........................................28
6.3.
Exploratory Efficacy Endpoints.............................................................................................................29
6.3.1.
Definition of Exploratory Efficacy Endpoints......................................................................29
6.3.2.
Analysis Methods for Exploratory Efficacy Endpoints........................................................30
6.4.
Changes From Protocol-Specified Efficacy Analyses............................................................................30
6.4.1.
Change on FAS definition....................................................................................................30
6.4.2.
Change on Sample Size........................................................................................................31
6.4.3.
Non-inferiority Comparisons ...............................................................................................32
7.
SAFETY ANALYSES........................................................................................................................................33
7.1.
Adverse Events and Deaths....................................................................................................................33
7.1.1.
Adverse Event Dictionary ....................................................................................................33
7.1.2.
Adverse Event Severity........................................................................................................33
7.1.3.
Relationship of Adverse Events to Study Drug....................................................................33
7.1.4.
Serious Adverse Events........................................................................................................33
7.1.5.
Treatment-Emergent Adverse Events...................................................................................33
7.1.6.
Summaries of Adverse Events and Deaths...........................................................................34
7.2.
Laboratory Evaluations ..........................................................................................................................36
7.2.1.
Summaries of Numeric Laboratory Results .........................................................................36
7.2.2.
Graded Laboratory Values ...................................................................................................37
7.3.
Body Weight, Height, and Vital Signs...................................................................................................38
7.4.
Prior and Concomitant Medications.......................................................................................................38
7.5.
Electrocardiogram Results .....................................................................................................................39
7.6.
Other Safety Measures ...........................................................................................................................39
7.7.
Changes From Protocol-Specified Safety Analyses...............................................................................39
8.
REFERENCES ...................................................................................................................................................40
9.
SOFTWARE.......................................................................................................................................................41
10.
SAP REVISION..................................................................................................................................................42
11.
APPENDICES ....................................................................................................................................................43
Appendix 1.
Table of Contents for Statistical Tables, Figures, and Listings ..............................................44
Appendix 2.
Schedule of Assessments........................................................................................................52
Appendix 3.
QOL Score Calculation Algorithms .......................................................................................55
LIST OF IN-TEXT TABLES
Table 3-1.
Analysis Windows for On-treatment HCV RNA, Vital Signs and Safety Laboratory 
Data ........................................................................................................................................17
Table 3-2.
Analysis Windows for Posttreatment HCV RNA, Vital Signs and Safety Laboratory 
Data ........................................................................................................................................18
Table 4-1.
LDV/SOF and RBV tablets needed for each group................................................................22
Table 6-1.
Summary of SVR12 Rates in Phase 2 Studies........................................................................27


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LIST OF ABBREVIATIONS
AE
adverse event
ALT
alanine aminotransferase
APRI
AST platelet ratio index
AST
aspartate transaminase
ATC
anatomical therapeutic chemical
BMI
body mass index
BPM
beats per minute
CI
confidence interval
CSR
clinical study report
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
GSI
follow-up
Gilead Sciences, Inc.
HCV
hepatitis C virus
HLGT
high level group term
HLT
high level term
ID
identification
IWRS
Interactive Web Response System
LLT
lower level term
LLOQ
lower limit of quantitation
MedDRA
MH
Medical Dictionary for Regulatory Activities
Mantel-Haenszel
INR
NI
international normalized ratio
non-inferiority
PK
pharmacokinetics
PT
preferred term
Q1
first quartile
Q3
RAV
third quartile
resistance-associated variants
RBC
red blood cell
RNA
ribonucleic acid
SAE
serious adverse event
SAP
statistical analysis plan
SD
standard deviation
SE
standard error


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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
WBC
white blood cell
WHO
World Health Organization


LDVISOFFDC 
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Statistical Analysis Plan 
1. 
INTRODUCTION 
Version 1 
This statistical analysis plan (SAP) describes the statistical analysis methods and data 
presentations to be used in the tables, figmes, and listings (TFLs) in the clinical study report 
(CSR) for Study GS-US-337-1746. The SAP is based on the study protocol amendment 2 dated 
23 July 2015 and the electronic case report fonn (eCRF). However, the study was early 
te1minated after 87 subjects were emolled due to lack of feasibility of emolling originally 
plrumed 430 subjects. Statistical analysis methods also changed conesponding to the sample size 
change. Detailed changes ru·e documented in Section 6.4. 
Any changes made after the fmalization of the SAP will be documented in the CSR. 
1.1. 
Study Objectives 
The primaty objectives of this study ru·e as follows: 
• 
To evaluate the efficacy of treatment with ledipasvir/sofosbuvir fixed-dose combination 
(LDV/SOF FDC) for 12 or 24 weeks, with or without ribavirin (RBV), as measmed by the 
propmtion of subjects with sustained virologic response 12 weeks after discontinuation of 
therapy (SVR12) 
• 
To evaluate the safety and tolerability ofLDV/SOF FDC with or without RBV for 12 or 
24 weeks, as assessed by review of the accumulated safety data. 
The secondruy objectives of this study are as follows: 
• 
To detetmine the proportion of subjects who attain SVR at 4 and 24 weeks after 
discontinuation of therapy (SVR4 and SVR24) 
• 
To detetmine the propottion of subjects with virologic failme 
• 
To evaluate the emergence of viral resistance to SOF and LDV dming treatment and after 
treatment discontinuation among subjects with virologic failme 
The exploratoty objectives of this study are as follows: 
PPO 
I 
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1.2.
Study Design
This is a Phase 3b, multicenter, open label study in adult male and female subjects with chronic 
genotype (GT) 1 or 4 hepatitis C virus (HCV) infection and who have failed prior SOF-based 
HCV therapy, including in combination with simeprevir (SMV) RBV or with RBV 
pegylated inferferon (PEG). 
Approximately 50% of subjects enrolled may have had prior treatment with SOF + SMV RBV. 
Approximately 5% of subjects may be infected with GT 4 HCV.
Approximately 430 subjects are planned to enroll into 2 cohorts:

Cohort 1: subjects without cirrhosis (n=180) will be randomized in a 1:1 ratio into Group 1 
and 2: 
Group 1: LDV/SOF FDC tablet (LDV 90 mg/SOF 400 mg) once daily for 12 weeks
Group 2: LDV/SOF FDC tablet (LDV 90 mg/SOF 400 mg) once daily and RBV at a total 
daily oral dose of 1000-1200 mg divided twice a day (BID) for 12 weeks

Cohort 2: subjects with compensated cirrhosis (n=250) will be randomized in a 1:1 ratio into 
Groups 3 and 4:
Group 3: LDV/SOF FDC tablet (LDV 90 mg/SOF 400 mg) once daily and RBV at a total 
daily oral dose of 1000-1200 mg divided BID for 12 weeks.
Group 4: LDV/SOF FDC tablet (LDV 90 mg/SOF 400 mg) once daily for 24 weeks
Randomization will be stratified by genotype 1 or 4, and by prior SOF therapy in combination 
with SMV or without SMV
The schedule of assessments is provided as an appendix to the SAP (Appendix 2).
The total time to complete all study visits is up to approximately 42 or 54 weeks (group 4 only) 
including the following periods:

Up to 42-day (6-week) screening period

A 12-week treatment period for Groups 1 - 3, and 24-week treatment period for Group 4

Up to 24-week posttreatment period
The study was early terminated after 87 subjects were enrolled due to lack of feasibility of 
enrolling originally planned 430 subjects.


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1.3.
Sample Size and Power
Cohort 1: For the non-inferiority comparison of SVR12 in the noncirrhotic cohort (group 1 vs. 2) 
with a 10% non-inferiority margin, a sample size of 90 subjects per treatment group will provide 
at least 90% power to establish non-inferiority at 1-sided 0.025 level, assuming the SVR12 rates 
are 98% for both groups.
Cohort 2: For the non-inferiority comparison of SVR12 in the compensated cirrhotic cohort 
(group 3 vs. 4) with a 10% non-inferiority margin, a sample size of 125 subjects per treatment 
group will provide at least 90% power to establish non-inferiority at 1-sided 0.025 level,
assuming the SVR12 rates are 95% for both groups.
However, the study was early terminated after 87 subjects were enrolled due to lack of feasibility 
of enrolling originally planned 430 subjects.


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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.
Interim Analysis
2.2.1.
Posttreatment Week 12 Analysis
The analysis for the primary endpoint SVR12 will be conducted after all subjects complete the 
Posttreatment Week 12 visit or prematurely discontinue from study. All the safety and efficacy 
data through the Posttreatment Week 12 visit will be cleaned, finalized and included for the 
analysis. 
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.
Analyses on efficacy will be presented by each treatment group and total for each cohort and 
overall, while on other analyses, like safety analyses, demographics and baseline characteristics 
will be presented by each treatment group for each cohort and overall.
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 by treatment group.
3.1.1.
All Randomized/Enrolled Analysis Set
The All Randomized/Enrolled Analysis Set includes all subjects who were randomized or 
enrolled in the study. Subjects are grouped within the All Randomized/Enrolled Analysis Set 
according to the treatment they actually received. 
3.1.2.
Full Analysis Set
The Full Analysis Set (FAS) includes all enrolled subjects who took at least 1 dose of study drug. 
The study drugs in this study are LDV/SOF FDC, with or without RBV. The difference between 
the FAS definition provided in the protocol and this SAP is documented in Section 6.4.
3.1.2.1.
Full Analysis Set by Randomized Treatment 
Subjects are grouped according to the treatment they were randomized. This is the primary 
analysis set for efficacy analyses. 
3.1.2.2.
Full Analysis Set by Actual Treatment 
Subjects are grouped according to their cirrhotic status and the treatment/duration they actually 
received. This is applied for key efficacy analyses. 


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3.1.3.
Safety Analysis Set
The Safety Analysis Set includes all subjects who took at least 1 dose of study drug. Subjects are
grouped according to the treatment they actually received.
This is the primary analysis set for safety analyses.
3.2.
Subject Grouping
For analyses based on the All Randomized/Enrolled Analysis Set or FAS by Randomized 
Treatment, subjects will be grouped according to the treatment to which they were randomized. 
For analyses based on other analysis sets, such as the Safety Analysis Set and FAS by actual 
treatment, subjects will be grouped according to the actual treatment received. The actual 
treatment received is defined as the randomized treatment except for subjects who received 
treatment that differs from the randomized treatment for the entire treatment duration. In this 
case, the actual treatment received is defined as the treatment received for the entire treatment 
duration. 
Randomized Treatment groups will be:
1. Cohort 1 subjects received LDV/SOF 12 week
2. Cohort 1 subjects received LDV/SOF + RBV 12 weeks
3. Cohort 2 subjects received LDV/SOF + RBV 12 week
4. Cohort 2 subjects received LDV/SOF 24 weeks
Due to randomization errors, cirrhotic subjects might be included in cohort 1 and non-cirrhotic 
subjects might be included in cohort 2 for some efficacy analyses by randomized treatment
group.
Actual Treatment groups will be:
1. Cohort 1 Non-cirrhotic subjects received LDV/SOF 12 week
2. Cohort 1 Non-cirrhotic subjects received LDV/SOF + RBV 12 weeks
3. Cohort 2 Cirrhotic subjects received LDV/SOF + RBV 12 week
4. Cohort 2 Cirrhotic subjects received LDV/SOF 24 weeks


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3.3.
Strata and Covariates
Approximately 430 subjects will be enrolled into 2 cohorts.  In each cohort, subjects will be 
randomized at a 1:1 ratio into two treatment groups (Non-cirrhotic subjects for cohort 1 and 
Cirrhotic subjects for cohort 2) via the interactive web response system (IWRS) using a stratified 
randomization schedule.
Stratification will be based on the following variables: 

HCV genotype 1 or 4

Prior SOF therapy in combination with SMV or without SMV
If there are discrepancies in stratification factor values between the IWRS and the clinical
database, the values recorded in the clinical database will be used for analyses and a listing is 
provided to document those discrepancies.
3.4.
Examination of Subject Subsets
Subsetting of subjects based on randomization stratification factors will be explored for subgroup 
analyses. If there are discrepancies in stratification factor values between the IWRS and the 
clinical database, the values recorded in the clinical database will be used for analyses. 
The subject subsets will be explored for the primary efficacy endpoint, SVR12 and Virologic 
Outcomes using both FAS populations. The presumed prognostic baseline characteristics include 
the following:

age (< 65 years, ≥ 65 years)

sex (male, female)

race (white, black, other)

ethnicity (Hispanic or Latino, not Hispanic or Latino)

baseline BMI (< 30 kg/m2, ≥ 30 kg/m2)

baseline RAVs (yes, no, not-determined)

baseline albumin (<=3.5 g/dL, >3.5 g/dL)

baseline platelets (<=75,000/µL,  75,000 - <=100,000/µL, >100,000/µL)

HCV subgenotype (1, 4; with 1 further broken down to 1a, 1b, No confirmed subtype)

cirrhosis (presence, absence, missing if any)


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
IL28B (CC, non-CC; with non-CC further broken down to CT, TT)

baseline HCV RNA (< 800,000 IU/mL, ≥ 800,000 IU/mL)

prior HCV treatment experience (treatment naive, treatment expreienced)

the most recent HCV treatment combinations (SOF + SMV, SOF + SMV + RBV, SOF + 
RBV, SOF + PEG + RBV)

number of prior HCV treatment regimens (1, 2, or 3 or more)

completed study treatment, discontinued study treatment 

adherence to study regimen (< 80%, ≥ 80%)

adherence to LDV/SOF (< 80%, ≥ 80%)

adherence to RBV (Group 2 and 3 only) (< 80%, ≥ 80%)
3.5.
Multiple Comparisons
No multiplicity adjustment will be made for testing since the statistical comparisons performed
are for exploratory purpose only between group 1 vs group 2, and between group 3 vs group 4 
due to small sample size actually enrolled.
3.6.
Missing Data and Outliers
In general, missing data will not be imputed unless methods for handling missing data are 
specified. 
3.6.1.
Missing Data
For missing last dosing 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.” 


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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) 
except for SVR24, which will be imputed according to SVR12 status. Success for SVR12 who 
have no further HCV RNA measurements collected will be counted as a success for SVR24 due 
to the high correlation between these 2 endpoints.
For the analyses of continuous HCV RNA efficacy data, 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. 
For health-related quality of life data including SF-36, CLDQ-HCV, FACIT-F, and 
WPAI:Hep C, missing data at on-treatment visits, posttreatment follow-up Week 4 (FU-4) visit, 
and posttreatment follow-up Week 12 (FU-12) visit will not be imputed. Last posttreatment 
observation carried forward will be used for imputation of missing data at posttreatment 
follow-up Week 24 visit.
3.6.2.
Missing Date 
For missing last dosing 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 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.
3.6.3.
Outliers
Outliers will be identified during 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 and sex at birth will be used for analyses 
and presentation in listings.


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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. 
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, version 2.0 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 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 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.


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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
Cohort 1: Subjects Without Cirrhosis
Group 1 (LDV/SOF 12 Weeks)
Group 2 (LDV/SOF+RBV 12 Weeks)
Nominal Day
Lower Limit
Upper Limit
Nominal Day
Lower Limit
Upper Limit
Baseline
1
(none)
1
1
(none)
1
Week 1
7
2
11
7
2
11
Week 2
14
12
21
14
12
21
Week 4
28
22
42
28
22
42
Week 8
56
43
70
56
43
70
Week 12
84
71
≥85
84
71
≥85
Nominal Visit
Cohort 2: Subjects With Cirrhosis
Group 3 (LDV/SOF+RBV 12 Weeks)
Group 4 (LDV/SOF 24 Weeks)
Nominal Day
Lower Limit
Upper Limit
Nominal Day
Lower Limit
Upper Limit
Baseline
1
(none)
1
1
(none)
1
Week 1
7
2
11
7
2
11
Week 2
14
12
21
14
12
21
Week 4
28
22
42
28
22
42
Week 8
56
43
70
56
43
70
Week 12
84
71
≥85
84
71
98
Week 16
NA
112
99
126
Week 20
NA
140
127
154
Week 24
NA
168
155
≥168
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) 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.


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Table 3-2.
Analysis Windows for Posttreatment HCV RNA, Vital Signs and 
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
84
31
146
FU-24
168
147
210
168
147
210
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), the time windows after 
FU-4 was for listing purpose only. 
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 
electrocardiogram (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. 

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.


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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 and investigator within a 
country by treatment group for each cohort and overall. The summary will present the number 
and percentage of subjects in the Safety Analysis Set. For each column, the denominator for the 
percentage calculation will be the total number of subjects analyzed for that column. 
A summary of subject disposition will be provided by treatment group for each cohort and 
overall. This summary will present the number of subjects screened, the number of subjects 
Randomized/enrolled and the number of subjects in each of the categories listed below. 

Subjects Randomized but Never Treated

Subjects in Safety Analysis Set

Subject in Full Analysis Set by Randomized Treatment

Subject in Full Analysis Set by Actual Treatment

Subject in Completed study treatment

Subject in did not complete study treatment with reasons for premature discontinuation of 
study treatment

Subject in completed the study

Subject in 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 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.”


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In addition, the total number of subjects who were randomized, 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 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 
(n, mean, SD, median, Q1, Q3, minimum, and maximum) and using the number of subjects 
(ie, cumulative counts) and percentage of subjects exposed through the following time periods: 
baseline (Day 1), Week 1 (Day 7), Week 2 (Day 14), Week 4 (Day 28), Week 10 (Day 70),
Week 12 (Day 84), and Week 16 (Day 112), Week 20 (Day 140), and Week 24 (Day 168), with 
Week 16 to Week 24 for group 4 only. A 3-day window is applied to the last planned on-
treatment visit to match with the protocol-specified visit window, ie, Groups 1 -3 subjects will 
have number of subjects exposed through week 12 calculated as the number of subjects who 
were exposed study drug for at least 81 days. Similarly, Group 4 subjects will have number of 
subjects exposed through week 24 calculated as the number of subjects who were exposed study 
drug for at least 165 days. Summaries will be provided by treatment group for each cohort and 
overall for the Safety Analysis Set.


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4.2.2.
Adherence to Study Drug
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:







returned
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. 
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 LDV/SOF/±RBV (90/400 mg, ±RBV total 1000-1200mg 
divided BID if prescribed) prescribed for 12 weeks or 24 weeks (for group 4), total number of 
tablets needed for LDV/SOF and RBV is as specified in Table 4-1.
Table 4-1.
LDV/SOF and RBV tablets needed for each group
Cohort 1
Cohort 2
Group 1
LDV/SOF 12 
Weeks
Group 2
LDV/SOF+RBV 
12 Weeks
Group 3
LDV/SOF+RBV 
12 Weeks
Group 1
LDV/SOF 
24 Weeks
LDV/SOF
Tablets
84 
84
84
168
RBV Tablets
NA
5x84 (420) for baseline weight 
< 75 kg
6x84 (504) for baseline 
weight >=75 kg
5x84 (420) for baseline weight 
< 75 kg
6x84 (504) for baseline 
weight >=75 kg
NA
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.


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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 regimen and for each individual 
study drug by treatment group for each cohort and overall for the Safety Analysis Set. 
Categorical displays will be provided for the number of subjects who are at least 80% adherent to 
their drug regimen (ie, adherence is ≥80% for each of the study drugs). No inferential statistics 
will be provided for duration of exposure and adherence to study drug.
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 randomization or 
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, ethnicity, and region) will be summarized.
Age will be summarized by descriptive statistics (n, mean, SD, median, Q1, Q3, minimum, and 
maximum). Age categories (< 65 years, ≥65 years), sex, race, ethnicity and region will be 
summarized by the numbers and percentages of subjects. Age is calculated in years at the date of 
initial study drug administration. If a subject did not receive study drug after enrollment or 
randomization, 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 and for the FAS by randomized treatment.
A by-subject demographic listing, which includes the date the informed consent was signed, will 
be provided by subject ID number in ascending order.
5.2.
Baseline Characteristics
Baseline data is defined as data collected on Day 1 predose or last available data collection in the 
screening period, if not collected on Day 1. Summarization on baseline characteristics will be 
also performed on the Safety Analysis Set and on FAS by randomized treatment. Baseline 
characteristics include: 

Body mass index (BMI; in kg/m2) as a continuous variable and as categories (< 30 kg/m2, 
≥30 kg/m2)

HCV subgenotype (1 and further specified if coded as 1a , 1b or No confirmed subtype; 4, 
others if collected)

IL28B (CC, Non-CC, further specify Non-CC with CT, TT ) 

baseline HCV RNA (log10 IU/mL) as a continuous variable and as categories 
(< 800,000 IU/mL, ≥800,000 IU/mL)

Baseline RAVs (yes, no, not-determined)

Baseline albumin (<=3.5 g/dL, >3.5 g/dL)

baseline platelets (<=75,000/µL,  75,000 -<= 100,000/µL, >100,000/µL)

Prior HCV treatment experience (treatment naïve, treatment experienced) as categorical 
variable. For treatment experienced subjects, summarizations on the most recent HCV 
treatment combinations (SOF + SMV, SOF + SMV + RBV, SOF + RBV, SOF + PEG + 
RBV), and on prior HCV treatment response (Non-Responder, Relapse/Breakthrough, Other
with specific reasons) will be provided.   


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
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 mass in kilograms.
These baseline characteristics will be summarized 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. 
A by-subject listing of other baseline characteristics will be provided by subject ID number in 
ascending order.
A separate by-subject data listing for cirrhosis determination and prior HCV treatment and 
response will be provided for all subjects at screening.
5.3.
Baseline Fibrosis Stage
The baseline fibrosis stage is determined using liver biopsy results. Once the liver biopsy results 
are not available, the Fibrotest results are used instead, with the cut off values of 0.21, 0.31, 0.58, 
and 0.72 for F0, F1, F2, F3, and F4 respectively.
The baseline fibrosis stage will be summarized as categorical variable. Summarization will be 
performed on the Safety Analysis Set and on FAS by randomized treatment. The 2-sided 95% 
exact CI of the proportion based on Clopper-Pearson method will be provided {Clopper 1934}.
A by-subject listing of the baseline fibrosis stage will be provided by subject ID number in 
ascending order.
5.4.
Medical History
Medical history collected at screening will be coded using the most recent available Medical 
Dictionary for Regulatory Activities (MedDRA). Medical history will be summarized by system 
organ class (SOC), preferred term (PT), treatment group for each cohort, and overall. Subjects 
who report 2 or more medical history items that are coded to the same SOC and/or PT will be 
counted only once by the unique coded term in the summary. The summary will be provided for 
the Safety Analysis Set. No inferential statistics will be generated.
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
All the efficacy analyses are conducted on FAS by randomized treatment and on FAS by actual 
treatment, unless specified otherwise. 
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, version 2.0 will be used to measure HCV RNA. HCV 
genotype and subtype will be determined using the Siemens VERSANT® HCV Genotype INNO-
LiPA 2.0 Assay, or other alternative assay decided by Gilead. 
6.1.2.
Summary for the Primary Efficacy Endpoint
The primary efficacy endpoint is SVR12 (HCV RNA < LLOQ 12 weeks after discontinuation 
of therapy). The primary analysis will be performed after all enrolled subjects have been 
followed through 12 weeks posttreatment or discontinued from study.
In the primary efficacy analysis, the SVR12 rate will be summarized by FAS by randomized 
treatment and by FAS by actual treatment, the 2-sided 95% exact CI of SVR12 based on 
Clopper-Pearson method will be provided {Clopper 1934}. 
In Cohort 1, a non-inferiority test of SVR12 rates will be performed comparing Group 1 and 2. A
non-inferiority margin of 10% will be applied. Non-inferiority will be established if the lower
bound of the 2-sided 95% confidence interval (CI) of the difference in SVR12 (Group 1 - Group
2) is greater than -10%. The CI will be constructed using stratum-adjusted Mantel-Haenszel
(MH) proportions, stratified by the randomization stratification factors (i.e., genotype 1or 4; prior
SOF therapy in combination with SMV or without SMV).
A similar non-inferiority tests of SVR12 rates will be performed comparing Group 3 and 4 in
Cohort 2. The NI margin of 10% is chosen primarily based on clinical judgment. The statistical
justification of a NI margin is based on a two-step process in which: 1) we estimate the treatment
benefit of the control regimens (LDV/SOF + RBV for 12 weeks for cohort 1; LDV/SOF for 24
weeks for cohort 2) and the historical control (M1), and 2) we define a margin which preserve
some fraction of the treatment benefit characterized in Step 1 above (M2).
The M1 and M2 in the current study design as follows:

M1 = the smallest treatment benefit of the control regimens over the historical control

M2 = 50% of M1


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Based on the Phase 2 ELECTRON-2, GS-US-337-1118, and SYNERGY data, the SVR12 rates
for LDV/SOF + RBV for 12 weeks are summarized below:
Table 6-1.
Summary of SVR12 Rates in Phase 2 Studies
Study
SVR12 Rates
LDV/SOF 12 Weeks
LDV/SOF + RBV 12 Weeks
Electron-2
n/a
Without cirrhosis:
100% (19/19)
GS-US-337-1118
With cirrhosis:
100% (14/14)
Without cirrhosis:
100% (36/36)
SYNERGY
Advanced liver disease
(Knodell score 3, 4)
100% (7/7)
Other (Knodell score 0, 1)
100% (7/7)
Overall
100% (7/7) 
95% CI: (59%, 100%)
100% (7/7) 
95% CI: (59%, 100%)
100% (14/14) 
95% CI: (77%, 
100%)
100% (55/55) 
95% CI: (94%, 
100%)
The smallest treatment benefit of LDV/SOF 12 weeks and LDV/SOF + RBV 12 weeks are 59% and 77%, 
respectively (the smaller lower bound of the two 95% CIs).
Note: SVR12 rate of LDV/SOF for 24 weeks is assumed to be at least as high as that of LDV/SOF for 12 weeks.
Since there is no approved standard of care in this patient population, a spontaneous SVR12 rate
of at most 5% is assumed as the historical control rate. Using the smallest treatment benefit for 
the control regimens (ie, the smaller of 59% and 77%) and the highest spontaneous SVR12 rate 
of the historical control, M1=59%-5%=54%. Based on these conservative estimates, a 10% NI 
margin would retain at least ensure at least 81.5% of the treatment benefit of LDV/SOF + RBV 
for 12 weeks or LDV/SOF for 24 weeks over the historical control.
However, due to the actual sample size for this study is much smaller than the originally planned 
sample size, the tests are for exploratory purpose only and the interpretation needs to be cautious 
since the actual sample size does not have enough power for the test.
6.1.3.
Subgroup Analysis of the Primary Efficacy Endpoint
Point estimates and 95% exact confidence intervals (CIs) of the SVR12 rates based on Clopper-
Pearson method will be displayed {20839} on FAS by randomized treatment and FAS by actual 
treatment for each subgroup. Subgroups are outlined in Section 3.4. Subgroup factors used for 
randomization will be summarized separately.
SVR12 rates will be summarized by categories of early viral response to explore possible early 
on-treatment predictors of SVR12. The relationship between SVR12 and study drug dose 
reduction and modification are also explored. 
Forest plot of SVR12 by Subgroup and treatment groups for each cohort will be provided. No 
statistical comparisons are performed for the subgroup analyses.


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6.2.
Secondary Efficacy Endpoints
6.2.1.
Definition of Secondary Efficacy Endpoints
The following secondary antiviral efficacy endpoints will be analyzed:

The proportion of subjects with HCV RNA < LLOQ (ie, < 15 IU/mL) at 4 , 12 and 24 weeks 
after discontinuation of therapy (SVR 4, SVR12 and SVR 24)

The proportion of subjects with HCV RNA below LLOQ (ie, < 15 IU/mL) by study visit

HCV RNA (log10 IU/mL) and change from baseline in HCV RNA (log10 IU/mL) through end 
of treatment

The proportion of subjects with virologic failure as the following:
On-treatment virologic failure
o
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)
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 8 weeks of treatment (ie nonresponse)
Relapse 
o
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
6.2.2.
Analysis Methods for Secondary Antiviral Efficacy Endpoints
The point estimates of SVR4, SVR12, SVR24 rates and their 2-sided 95% exact confidence 
intervals (CIs) based on Clopper-Pearson method will be provided as applicable {Clopper 1934},
on FAS by randomized treatment and FAS by actual treatment.
For analyses of HCV RNA < LLOQ (ie, < 15 IU/mL) 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 categorical imputation rules described in Section 3.6. The 2-sided 95% exact confidence 
interval based on Clopper-Pearson method will be provided for the proportion. The overall 
category for “HCV RNA < LLOQ” will be split into the following 2 subcategories: “< LLOQ 


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TND" for subjects with target not detected and"< LLOQ detected" for subjects with < LLOQ in 
tabula!' displays. 
Graphs for the prop01iion of subjects with HCV RNA < LLOQ over time on treatment and 
during the posttreatment follow-up period will be displayed. 
Smnmmy statistics will be presented for absolute values and change from baseline in HCV RNA 
(log10 IU/mL) by visit through end of treatment (EOT). Imputationmles described in Section 3.6 
will be used to assign HCV RNA values for missing values at a visit that m·e bracketed by 
"< LLOQ 1ND" and/or"< LLOQ detected". Othe1wise, a missing= excluded analysis will be 
perf01med. Plots of the mean± SD and median (Ql, Q3) of absolute values and changes from 
baseline in HCV RNA through end of treatment will be presented. 
For the SVR12 endpoint analysis, a summa1y table ofthe 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 smnmm·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 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; othe1w ise, the 
denominator will be the number of subjects in F AS by randomized treatment or F AS by actual 
treatment, depending on the analyses population used. 
A concordance table between SVR12 and SVR24 will be provided by treatment group for each 
coh01i and overall. Subjects with both observed SVR12 and observed SVR24 data will be 
included for this analysis. 
6.3. 
Exploratory Efficacy Endpoints 
6.3.1. 
Definition of Exploratory Efficacy Endpoints 
PPD 
I 
I 
I 
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6.3.2. 
Analysis Methods for Exploratory Efficacy Endpoints 
PD 
6.4. 
Changes From Protocol-Specified Efficacy Analyses 
6.4.1. 
Change on F AS definition 
Version 1 
The protocol defined F AS as all randomized subjects who took at least 1 dose of study dmg. 
Subjects are grouped according to the treatment they were randomized. 
Due to randomization en ors, two new F AS populations are defined and used for efficacy 
analyses: 
Full Analysis Set by Randomized Treatment: this is the same as the F AS defmition in the 
protocol. One ci.nhotic patient (subject ID = PPD wrongly randomized into group 1 
(SOF/LDV 12 weeks) was extended to 24 week treatment for etlmical reasons. 
Full Analysis Set by Actual Treatment: this F AS population is defmed based on the Cinhotic 
status of tl1e subject and the treatment/duration the subject actually received. For example, the 
subject PPD (in the group 1 for Full Analysis Set by Randomized Treatment) is in group 4 for 
analysis since his status is cinhotic and received 24 week SOF/LDV. 
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Four subjects dosed were randomized wrongly or took wrong drug. The details and decisions for 
those subjects are as follows:
Subject 
 
Issue:   Subject was cirrhotic and wrongly randomized to Cohort 1 Group 1 (LDV/SOF 
12 weeks); 
Decision: LDV/SOF was extended to 24 weeks 
Actual treatment group: Cohort 2 Group 4 (LDV/SOF 24 weeks)
Subject 
 
Issue: Subject was non-cirrhotic and randomized to Cohort 1 Group 2 (LDV/SOF +RBV 
12 weeks) but no RBV was provided; 
Decision: Subject was kept to take LDV/SOF without RBV for 12 weeks
Actual treatment group: Cohort 1 Group 1 (LDV/SOF 12 weeks)
Subject 
 
Issue:   Subject was non-cirrhotic and wrongly randomized to Cohort 2 Group 3 
(LDV/SOF+RBV 12 weeks)
Decision: Subject was kept to take LDV/SOF+RBV for 12 weeks
Actual treatment group: Cohort 1 Group 2 (LDV/SOF+RBV 12 weeks)
Subject 
 
Issue:   Subject was non-cirrhotic and wrongly randomized to Cohort 2 Group 4 
(LDV/SOF 24 weeks); 
Decision: Subject need to take LDV/SOF for only 12 weeks
Actual treatment group: Cohort 1 Group 1 (LDV/SOF 12 weeks)
6.4.2.
Change on Sample Size
The initial sample size planned was 430, with 90 each in groups 1 and 2, and 125 each in group 3 
and 4 to obtain a 10% non-inferiority margin at 1-sided 0.025 level and 90% power, for the
comparisons between group 1 and 2, and between group 3 and 4. 
Due to lack of feasibility of enrolling subjects, the study was early terminated after 87 subjects 
enrolled, with 17, 17, 26, 27 randomized in groups 1-4 respectively. Five subjects randomized 
were never dosed so final analyses set has only 82 subjects (15, 17, 26, 24 for randomization 
groups 1-4 respectively, while 16, 17, 25, 24 for actual treatment groups 1-4 respectively).
Details for subjects with different treatment groups in the two FAS populations are specified in 
Section 6.4.1.
PPD
PPD
PPD
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6.4.3.
Non-inferiority Comparisons
Although the non-inferiority comparisons of SVR12 in the non-cirrhotic cohort (group 1 vs. 2) 
and in the compensated cirrhotic cohort (group 3 vs. 4) were performed, the results are for 
exploratory purpose only and the interpretation needs to be cautious since the actual sample size 
does not have enough power for the test.


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7.
SAFETY ANALYSES
All the safety analyses are conducted on Safety Analysis Set, unless specified otherwise. 
7.1.
Adverse Events and Deaths
7.1.1.
Adverse Event Dictionary
Clinical and laboratory AEs will be coded using the most recent available MedDRA code. 
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 case report form 
(CRF) 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 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 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 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 a 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 treatment group for each cohort and 
overall and by the number and percentage of subjects who had the following: any AE, any AE of 
Grade 3 or above, any treatment-related AE, any treatment-related AE of Grade 3 or above, any
SAE, any treatment-related SAE, any AE that led to premature discontinuation of any study 
drug, any AE that led to premature discontinuation of LDV/SOF, any AE that led to premature
discontinuation of RBV, any AE that led to modification or interruption of any study drug, any 
AE that led to interruption of LDV/SOF, any AE that led to modification or interruption of RBV. 
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, by treatment group in each cohort on the Safety Analysis Set as follows:

All AEs

AEs of Grade 3 or above

All treatment-related AEs 

Treatment-related AEs of Grade 3 or above

All SAEs

All treatment-related SAEs 

AEs leading to premature discontinuation of any study drug

Adverse Events Leading to Modification or Interruption of Any Study Drug


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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 of the overall treatment group 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 also be summarized by PT only, in order of 
descending incidence within the overall treatment group for:

AEs that occurred in at least 5% of subjects within any treatment group

AEs of Grade 3 or above

All treatment-related AEs

All SAEs

AEs leading to premature discontinuation of any study drug

AEs leading to premature discontinuation of LDV/SOF

AEs leading to premature discontinuation of RBV (groups 2 and 3 only)

AEs leading to premature discontinuation of all study drugs

AEs leading to modification or interruption of any study drug

AEs leading to modification or interruption of RBV (groups 2 and 3 only)
In addition to the by-treatment summaries described above, data listings will be provided for the 
following:

All AEs

AEs of Grade 3 or above

SAEs

Deaths

AEs leading to premature discontinuation of any study drug 

Adverse Events Leading to Modification or Interruption of Any Study Drug


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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 last dose of any study drug plus 30 days 
for subjects who have permanently discontinued study drug. 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. 
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 
by treatment group for ALT, AST, total bilirubin, alkaline phosphatase, white blood cell (WBC) 
counts, neutrophils, lymphocytes, hemoglobin, platelets, reticulocytes, and international 
normalized ratio (INR) as follows:

Baseline values 

Values at each postbaseline visit for hemoglobin and platelets, and at EOT and FU4 for other 
analytes specified above

Change from baseline at each postbaseline visit for hemoglobin and platelets, and at EOT 
and FU4 for other analytes specified above
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 reported number of digits, SD to reported number of digits plus 1.
Median (Q1, Q3) of the observed values for hemoglobin and platelets will be plotted using a line 
plot by treatment group and 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).


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The number of subjects with hemoglobin < 10 g/dL and < 8.5 g/dL at any postbaseline visits (up 
to 30 days after the last dose of any study drug) will be summarized by treatment group. 
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 to laboratory results for analysis as Grade 0, Grade 1 (mild), 
Grade 2 (moderate), Grade 3 (severe), or Grade 4 (potentially life threatening). Grade 0 includes 
all values that do not meet criteria for an abnormality of at least Grade 1. Some laboratory tests 
have laboratory toxicity 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.
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 by analyte and treatment group; 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 of study drug 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.


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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) by treatment 
group. 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 [°C]) 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 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, concomitant, or both using the following definitions:

Prior medications: any medications taken prior to the initial study drug dosing date 

Concomitant medications: any medications initially taken on or after the initial study drug 
dosing date and within the study drug’s treatment period (including study drug’s therapeutic 
reach).

Prior and concomitant medications: any medications taken both prior to and on or after the 
initial study drug dosing date and within the study drug’s treatment period (including study 
drug’s therapeutic reach); or any medications taken prior to the Baseline visit date with a stop 
date of “continuing” 
Concomitant medications will be summarized by Anatomical Therapeutic Chemical (ATC) drug 
class Level 2, and 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 descending active treatment group 
frequency of ATC drug classes and then preferred names within an ATC medical class. 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.


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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) will be provided in a 
by-subject listing sorted by subject ID number and administration date in chronological order.
7.5.
Electrocardiogram Results
ECG examination is only conducted at baseline visit, a summary of the investigators’ assessment 
of ECG results at baseline will be presented by treatment group for each cohort using the 
following categories: normal; abnormal, not clinically significant; abnormal, clinically 
significant; or missing. The number and percentage of subjects will be presented. 
A by-subject listing for ECG assessment results at baseline 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
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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9.
SOFTWARE
SAS® Software Version 9.2 or higher. 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.
Table of Contents for Statistical Tables, Figures, and Listings
Appendix 2.
Schedule of Assessments
Appendix 3.
QOL Score Calculation Algorithms


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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 Randomized and Treated by Country and Investigator
Safety Analysis Set
15.8.1.2
Subjects Randomized and Treated by Randomization Stratum
Safety Analysis Set
15.8.1.3
Subject Disposition 
Screened Subjects
15.8.1.4
Reasons for Screen Failure
Screened Subjects
15.8.3.1
Demographics
Safety Analysis Set
15.8.3.2
Demographics
Full Analysis Set by 
Randomized Treatment
15.8.3.3
Baseline Characteristics
Safety Analysis Set
15.8.3.4
Baseline Characteristics
Full Analysis Set by 
Randomized Treatment
15.8.3.5
Baseline Fibrosis Stage
Safety Analysis Set
15.8.3.6
Baseline Fibrosis Stage
Full Analysis Set by 
Randomized Treatment
15.8.3.7
Medical History
Safety Analysis Set
15.8.4
Adherence to Study Drug
Safety Analysis Set
15.9.1.1
SVR12
Full Analysis Set by 
Randomized Treatment
15.9.1.2
SVR12
Full Analysis Set by 
Actual Treatment
15.9.2.1.1
Virologic Outcomes
Full Analysis Set by 
Randomized Treatment
15.9.2.1.2
Virologic Outcomes
Full Analysis Set by 
Actual Treatment
15.9.2.1.3
Virologic Outcomes by Subgroup 
Full Analysis Set by 
Randomized Treatment
15.9.2.1.4
Virologic Outcomes by Subgroup 
Full Analysis Set by 
Actual Treatment
15.9.2.1.5
Virologic Outcomes by Visit During Posttreatment Follow Up
Full Analysis Set by 
Randomized Treatment
15.9.2.1.6
Virologic Outcomes by Visit During Posttreatment Follow Up
Full Analysis Set by 
Actual Treatment
15.9.2.2
SVR by Visit During Posttreatment Follow Up
Full Analysis Set by 
Randomized Treatment
15.9.2.3
SVR by Visit During Posttreatment Follow Up
Full Analysis Set by 
Actual Treatment
15.9.2.4
Concordance Between SVR12 and SVR24
Full Analysis Set by 
Randomized Treatment


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Table Number
Title
Analysis Set
15.9.2.5
Proportion of Subjects with HCV RNA Less than LLOQ While on 
Treatment by Visit
Full Analysis Set by 
Randomized Treatment
15.9.2.6
HCV RNA (log10 IU/mL) and Change from Baseline by Visit 
Through End of Treatment
Full Analysis Set by 
Randomized Treatment
15.9.4.1
SVR12 by Subgroup 
Full Analysis Set by 
Randomized Treatment
15.9.4.2
SVR12 by Subgroup 
Full Analysis Set by 
Actual Treatment
15.9.4.3
SVR12 by Early Viral Response
Full Analysis Set by 
Randomized Treatment
15.9.4.4
SVR12 by Early Viral Response
Full Analysis Set by 
Actual Treatment
15.9.4.5
SVR12 by Dose Modifications
Full Analysis Set by 
Randomized Treatment
15.9.4.6
SVR12 by Dose Modifications
Full Analysis Set by 
Actual Treatment
15.9.4.7
SVR12 by Randomization Strata
Full Analysis Set by 
Randomized Treatment
15.9.4.8
SVR12 by Randomization Strata
Full Analysis Set by 
Actual Treatment
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 in Any Treatment Group 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
15.11.2.3.1
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
15.11.2.4.1
Adverse Events Leading to Modification or Interruption of Any 
Study Drug
Safety Analysis Set
15.11.2.4.2
Adverse Events Leading to Modification or Interruption of Any 
Study Drug by Preferred Term
Safety Analysis Set
15.11.2.4.3
Adverse Events Leading to Modification or Interruption of RBV by 
Preferred Term
Safety Analysis Set


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Table Number
Title
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
15.11.5.1
Adverse Events Leading to Premature Discontinuation of Any Study 
Drug
Safety Analysis Set
15.11.5.2
Adverse Events Leading to Premature Discontinuation of Any Study 
Drug by Preferred Term
Safety Analysis Set
15.11.5.3
Adverse Events Leading to Premature Discontinuation of LDV/SOF 
by Preferred Term
Safety Analysis Set
15.11.5.4
Adverse Events Leading to Premature Discontinuation of RBV by 
Preferred Term
Safety Analysis Set
15.11.5.5
Adverse Events Leading to Premature Discontinuation of All Study 
Drugs 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 (x 10^3 /uL) and Change from Baseline by Visit
Safety Analysis Set
15.11.6.1.8
WBC (x 10^3 /uL) and Change from Baseline by Visit
Safety Analysis Set
15.11.6.1.9
Neutrophils (x 10^3 /uL) and Change from Baseline by Visit
Safety Analysis Set
15.11.6.1.10
Lymphocytes (x 10^3 /uL) and Change from Baseline by Visit
Safety Analysis Set
15.11.6.1.11
Platelets (x 10^3 /uL) 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
Concomitant Medications
Safety Analysis Set
15.11.7.5
Summary of 12-Lead ECG Assessment at Baseline
Safety Analysis Set
15.12.1.1
Summary of SF-36 Quality of Life Questionnaire
Full Analysis Set by 
Randomized Treatment


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Table Number
Title
Analysis Set
15.12.1.2
Summary of SF-36 Quality of Life Questionnaire
Full Analysis Set by 
Actual Treatment
15.12.2.1
Summary of CLDQ-HCV Quality of Life Questionnaire
Full Analysis Set by 
Randomized Treatment
15.12.2.2
Summary of CLDQ-HCV Quality of Life Questionnaire
Full Analysis Set by 
Actual Treatment
15.12.3.1
Summary of FACIT-F Quality of Life Questionnaire
Full Analysis Set by 
Randomized Treatment
15.12.3.2
Summary of FACIT-F Quality of Life Questionnaire
Full Analysis Set by 
Actual Treatment
15.12.4.1
Summary of WPAI: Hep C Quality of Life Questionnaire
Full Analysis Set by 
Randomized Treatment
15.12.4.2
Summary of WPAI: Hep C Quality of Life Questionnaire
Full Analysis Set by 
Actual Treatment


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Figure Number
Title
Analysis Set
15.8.1
Subject Disposition
Screened Subjects-by 
Randomized Treatment 
Group
15.8.2
Subject Disposition
Screened Subjects-by 
Actual Treatment Group
15.9.1
Proportion of Subjects with HCV RNA < LLOQ While on 
Treatment by Visit
Full Analysis Set by 
Randomized Treatment
Group
15.9.2
Mean ± SD Change from Baseline in HCV RNA (log10 IU/mL) by 
Treatment Group by Visit Through End of Treatment
Full Analysis Set by 
Randomized Treatment
15.9.3
Median (Q1, Q3) Change from Baseline in HCV RNA 
(log10 IU/mL) by Treatment Group by Visit Through End of 
Treatment
Full Analysis Set by 
Randomized Treatment
15.9.4
Mean ± SD HCV RNA (log10 IU/mL) by Treatment Group by Visit 
Through End of Treatment
Full Analysis Set by 
Randomized Treatment
15.9.5
Median (Q1, Q3) HCV RNA (log10 IU/mL) by Treatment Group by 
Visit Through End of Treatment
Full Analysis Set by 
Randomized Treatment
15.9.6.1
Forest Plot of SVR12 by Subgroup
Full Analysis Set by 
Randomized Treatment
15.9.6.2
Forest Plot of SVR12 by Subgroup
Full Analysis Set by 
Actual Treatment
15.9.7
Forest Plot of SVR12 by Randomization Strata
Full Analysis Set by 
Randomized Treatment
15.10.1
Median (Q1, Q3) Hemoglobin (g/dL) by Visit
Safety Analysis Set
15.10.2
Median (Q1, Q3) Platelets (x 10^3 /uL) by Visit
Safety Analysis Set
15.11.1.1
Mean +/- SD Change from Baseline in SF-36 by Visit
Full Analysis Set by 
Randomized Treatment
15.11.1.2
Mean +/- SD Change from Baseline in SF-36 by Visit
Full Analysis Set by 
Actual Treatment
15.11.2.1
Mean +/- SD Change from Baseline in CLDQ-HCV by Visit
Full Analysis Set by 
Randomized Treatment
15.11.2.2
Mean +/- SD Change from Baseline in CLDQ-HCV by Visit
Full Analysis Set by 
Actual Treatment
15.11.3.1
Mean +/- SD Change from Baseline in FACIT-F by Visit
Full Analysis Set by 
Randomized Treatment
15.11.3.2
Mean +/- SD Change from Baseline in FACIT-F by Visit
Full Analysis Set by 
Actual Treatment
15.11.4.1
Mean +/- SD Change from Baseline in WPAI: Hep C by Visit
Full Analysis Set by 
Randomized Treatment


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Figure Number
Title
Analysis Set
15.11.4.2
Mean +/- SD Change from Baseline in WPAI: Hep C by Visit
Full Analysis Set by 
Actual Treatment


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Listing Number
Title
Analysis Set
16.1.1
Lot Number and Kit ID
Safety Analysis Set
16.1.2
Randomization Scheme and Code
All Randomized 
Subjects
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 with Reasons for Premature Discontinuation of 
Study Treatment and/or Study
Safety Analysis Set
16.2.2.1
Inclusion and Exclusion Criteria 
Subjects Not Treated
16.2.2.2
Subjects Randomized and Treated Who Did Not Meet Eligibility 
Criteria
Safety Analysis Set
16.2.2.3
Randomization Stratification Discrepancies Between IWRS and 
Database Values
Safety Analysis Set
16.2.2.4
Subjects Who Received Incorrect Study Drug Based on 
Randomized Treatment Assignment
Safety Analysis Set
16.2.3
Subjects Who Were Excluded from Safety and Full Analysis Sets
All Randomized 
Subjects
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
16.2.4.3.1
Medical History
Safety Analysis Set
16.2.4.3.2
Prior HCV Treatment and Response
Safety Analysis Set
16.2.4.4
Prior and Concomitant Medications
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
16.2.6.1
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 
16.2.6.4
Subjects with Relapse after Posttreatment Week 12
Safety Analysis Set 
16.2.6.5
SF-36 Quality of Life Questionnaire
Safety Analysis Set 
16.2.6.6
CLDQ-HCV Quality of Life Questionnaire
Safety Analysis Set 
16.2.6.7
FACIT-F Quality of Life Questionnaire
Safety Analysis Set 
16.2.6.8
WPAI: Hep C Quality of Life Questionnaire
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


LDV/SOF FDC
GS-US-337-1746
Statistical Analysis Plan
Version 1
CONFIDENTIAL
Page 51
28 March 2017
Listing Number
Title
Analysis Set
16.2.7.4
Serious Adverse Events
Safety Analysis Set
16.2.7.5
Adverse Events Leading to Premature Discontinuation of Any 
Study Drug
Safety Analysis Set
16.2.7.6
Adverse Events Leading to Modification or Interruption of Any 
Study Drug
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
16.2.8.1.3
Subjects with Treatment-Emergent Grade 3 or Above Laboratory 
Abnormalities
Safety Analysis Set
16.2.8.1.4.1
Hematology: Hematocrit, Hemoglobin, Reticulocytes, MCV, 
RBC, WBC, and Platelets
Safety Analysis Set
16.2.8.1.4.2
Hematology: WBC, Neutrophils, and Lymphocytes
Safety Analysis Set
16.2.8.1.4.3
Hematology: Eosinophils, Basophils, and Monocytes
Safety Analysis Set
16.2.8.1.5
Coagulation: INR and APTT
Safety Analysis Set
16.2.8.1.6
Serum Chemistry: Sodium, Potassium, Creatine Kinase, 
Creatinine, Estimated GFR (Cockcroft-Gault), and Glucose
Safety Analysis Set
16.2.8.1.7
Serum Chemistry: AST, ALT, Total Bilirubin, Direct Bilirubin, 
Alkaline Phosphatase, GGT, Albumin, and Lipase
Safety Analysis Set
16.2.8.1.8
Urinalysis: Urine Blood, Glucose, pH, Protein, Urobilinogen, and 
Leukocyte Esterase
Safety Analysis Set
16.2.8.2.1
Vital Signs
Safety Analysis Set
16.2.8.2.2
Height, Weight, and BMI
Safety Analysis Set
16.2.8.3
Pregnancy
Safety Analysis Set
16.2.8.4
12-Lead Electrocardiogram Results at Baseline
Safety Analysis Set


LDV/SOF FDC
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Statistical Analysis Plan
Version 1
CONFIDENTIAL
Page 52
28 March 2017
Appendix 2.
Schedule of Assessments
On-Treatment Study Week (3 Days)
Posttreatment Study 
Week (5 Days)
Screen
Baseline/
Day 1a
1
2
4
8
12
16 b
20 b
24 b
ET
4c
12c
24
Clinical Assessments
Informed Consent
X
Determine Eligibility
X
X
Medical History
X
Historical Resistance Test Datad
X
Physical Examination
X
X
X e
X e
X
Height
X
Weight
X
X
Vital Signs
X
X
X
X
X
X
X
X
X
X
X
X
X
X
12-Lead ECG
X
Imaging for HCCf
X
Adverse Events
X
X
X
X
X
X
X
X
X
X
X
X
Concomitant Medications
X
X
X
X
X
X
X
X
X
X
X
X
Pregnancy Prevention 
Counseling
X
X
X
X
X
X
X
X
X
X
X
X
X
Health Related Quality of Life
Surveys
X
X
X
X
X
X
X
Study Drug Dispensing
Xg
X
X
Xh
Xh
Xh
Review of Study Medication
Adherence (Pill Count)
X
X
X
X
X
X
X
X
X


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Statistical Analysis Plan
Version 1
CONFIDENTIAL
Page 53
28 March 2017
On-Treatment Study Week (3 Days)
Posttreatment Study 
Week (5 Days)
Screen
Baseline/
Day 1a
1
2
4
8
12
16 b
20 b
24 b
ET
4c
12c
24
Laboratory Assessments
Hematology, Chemistry
X
X
X
X
X
X
X
X
X
X
X
X
Coagulation Tests
X
X
X
X
X
HCV RNA
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Viral Sequencing/phenotypingi
X
X
X
X
X
X
X
X
X
X
X
X
X
Pregnancy Testingj
X
X
X
X
X
X
X
X
X
Xk
Xk
Xk
Urinalysis & Urine Drug Screen
X
HCV Genotyping, IL28B
X
HCV, HIV, HBV Serology
X
TSH, HbA1c, Fibrotest®/APRI
X
Future Research Blood Samplel
X
X
X
X
a
Baseline/Day 1 assessments must be performed prior to dosing
b
On-Treatment Visits at Weeks 16, 20 and 24 are only applicable to subjects in study group 4
c
All subjects will complete the posttreatment Week 4 and Week 12 visits ; subjects with HCV RNA < LLOQ at the posttreatment (PT) Week 12 visit will complete the PT 
Week 24 visit 
d
Collect and record  information regarding historical resistance test data if available
e
A physical exam will be performed at the end of treatment visit (Week 12 for study groups 1,2,3;  and Week 24 for study group 4)
f
Liver imaging within 6 months prior to Baseline/Day 1 is required in subjects with cirrhosis to exclude HCC
g
The IWRS will provide randomization to study Group
h 
Study drug dispensing at Week 12, 16 and 20 is only applicable to study group 4
i
Plasma samples will be collected and stored for potential HCV sequencing/phenotyping and other virology studies.
j
For females of childbearing potential only: serum β-hCG at Screening, urine test thereafter. If urine is positive, confirm immediately with serum β-hCG


LDV/SOF FDC
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Statistical Analysis Plan
Version 1
CONFIDENTIAL
Page 54
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k
Females of childbearing potential in study Groups 2 & 3 will have additional urine pregnancy testing every 4 weeks for a minimum of 6 months following last dose of RBV. 
If required by local regulations, additional pregnancy tests beyond 6 months may be added. In the event of a positive urine pregnancy result, subjects will be instructed to 
return to the clinic as soon as possible for a serum pregnancy test. Pregnancy test kits will be dispensed to female subjects of childbearing potential at the 4 and 12 Week 
posttreatment visits to self-monitor for pregnancy. The subject will be contacted by telephone monthly to confirm that urine pregnancy testing has been performed 
posttreatment and to record the outcome. Alternatively, if required by local regulations or preferred by the investigator or subject, the subject may return to the clinic for urine 
pregnancy tests.
l
Sample for optional future research will be collected at the Baseline/Day 1 visit and at the end of treatment (Week 12 for study groups 1,2,3;  and Week 24 for study group 4) 
for subjects who have not opted out 


LDV/SOF FDC
GS-US-337-1746
Statistical Analysis Plan
Version 1
CONFIDENTIAL
Page 55
28 March 2017
Appendix 3.
QOL Score Calculation Algorithms
CLDQ – HCV
CLDQ-HCV scores are calculated using subject responses to 29 questions in the questionnaire. If 
Ri is the score for the patient’s response to the item i, for i=1, 2, …., 29 then the 4 domain scores 
are calculated as follows:

Activity/Energy (AE) = Mean of {R1, R3, R4, R5, R7, R18}

Emotion (EM) = Mean of {R6, R8, R9, R11, R16, R23, R24, R27, R28}

Worry (WO) = Mean of {R14, R15, R17, R19, R20, R21, R22, R29}

Systemic (SY) = Mean of {R2, R10, R12, R13, R25, R26}
Here “Mean” is the average of nonmissing items (SAS mean function). Each score is calculated 
only if at least half of corresponding items are not missing. Otherwise, the score will be missing.
Over all CLDQ-HCV score is calculated by taking the mean of 4 domain scores {AE, EM, 
WO, SY}.
FACIT-F
Patient responses to 40 questions in FACIT-F questionnaire are rated in 0-4 score.
If less than 50% of responses in the corresponding domain are missing, the subscales for 
five domains are calculated as follows:

Physical WEL

l-Being (PWB) = 7 × Mean of {GP1-GP7}

Social/Family Well-Being (SWB) = 7 × Mean of {GS1-GS7}

Emotional Well-Being (EWB) = 6 × Mean of {GE1-GE6}

Functional Well-Being (FWB) = 7 × Mean of {GF1-GF7}

Fatigue Subscale (FS) = 13 × Mean of {HI7, HI12, An1-An5, An7, An8 An12, An14-An16}
and

FACIT-F Trial Outcome Index (TOI) = PWB+FWB+FS
If less than 20% of all 40 questions are not missing, 


LDV/SOF FDC
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Statistical Analysis Plan
Version 1
CONFIDENTIAL
Page 56
28 March 2017

TACIT-F Total Score = PWB+SWB+EWB+FWB+FS
WAPI: Hepatitis C
The response to Question 1 of this questionnaire provides the binary endpoint whether or not the 
subject had been in a paid employment during the week prior to assessment.
If the subject had been in a paid employment (Response to Q1 is “Yes”) at the visit when 
questionnaire was given, then following three scores are derived:

Percent work time missed due to hepatitis C = 100 × Q2 / (Q2 + Q4)

Percent impairment while working due to hepatitis C = 100 × Q5 / 10

Percent overall work impairment due to hepatitis C = 


















10
5
)
4
2
2
1
)
4
2
(
2
100
Q
Q
Q
Q
Q
Q
Q
Question 6 is applicable to all subjects:

Percent activity impairment due to hepatitis C = 100 × Q6 / 10.


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