A Registry for Subjects With Cirrhosis Who Achieve a Sustained Virologic Response Following Treatment With a Sofosbuvir-Based Regimen Without Interferon for Chronic Hepatitis C Infection
Conditions: Hepatitis C Virus Infection
Sponsor: Gilead Sciences

Study Title: 
Sponsor: 
IND Number: 
EudraCT Number: 
Indication: 
Protocol ID: 
Gilead Study Director/ 
Medical Monitor: 
Protocol Version/Date: 
(rJ GILEAU 
CLINICAL STUDY PROTOCOL 
A Registiy for Subjects with Cinhosis Who Achieve a Sustained 
Virologic Response Following Treatment with a 
Sofosbuvir-Based Regimen without Interferon for Chronic 
Hepatitis C Infection 
Gilead Sciences, Inc. 
333 Lakeside Drive 
Foster City, CA 94404 USA 
115268 
2014-001249-26 
Hepatitis C Vims Infection 
GS-US-337-1431 
Name: 
Telephone: 
Mobile: 
Fax: 
Email: 
Original: 
Amendment 1: 
Amendment 2: 
Amendment 3: 
IPIPD 
IPIPD 
IPIPD 
IPIPD 
PPU 
08 July 2014 
17 October 2014 
17 August 2015 
01 June 2017 
CONFIDENTIALITY STATEMENT 
The info1mation contained in this document, paii icularly unpublished data, is the prope1iy or 
under control of Gilead Sciences, Inc., and is provided to you in confidence as an investigator, 
potential investigator, or consultant, for review by you, your staff, and an applicable Institutional 
Review Board or Independent Ethics Committee. The infonnation is only to be used by you in 
connection with authorized clinical studies of the investigational diug described in the protocol. 
You will not disclose any of the infonnation to others without written authorization from Gilead 
Sciences, Inc., except to the extent necessaiy to obtain infonned consent from those persons to 
whom the diug may be adininistered. 

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TABLE OF CONTENTS
TABLE OF CONTENTS ..............................................................................................................................................2
PROTOCOL SYNOPSIS ..............................................................................................................................................4
GLOSSARY OF ABBREVIATIONS AND DEFINITION OF TERMS......................................................................9
1.
INTRODUCTION ..............................................................................................................................................11
1.1.
Background ............................................................................................................................................11
1.2.
Rationale for This Study ........................................................................................................................11
1.3.
Compliance ............................................................................................................................................12
2.
OBJECTIVES.....................................................................................................................................................13
3.
STUDY DESIGN................................................................................................................................................14
3.1.
Study Design..........................................................................................................................................14
3.2.
Discontinuation Criteria.........................................................................................................................14
4.
SUBJECT POPULATION..................................................................................................................................15
4.1.
Inclusion Criteria....................................................................................................................................15
4.2.
Exclusion Criteria...................................................................................................................................15
5.
INVESTIGATIONAL MEDICINAL PRODUCTS ...........................................................................................16
5.1.
Investigational Medicinal Products........................................................................................................16
5.2.
Prohibited Concomitant Medications.....................................................................................................16
6.
STUDY PROCEDURES ....................................................................................................................................17
6.1.1.
Day 1 Assessments...............................................................................................................17
6.2.
Follow-Up Assessments.........................................................................................................................18
6.2.1.
Weeks 24, 72, 120, 168, and 216 (+/- 4 weeks) ...................................................................18
6.2.2.
Weeks 48, 96, 144, and 192 (+/- 4 weeks) ...........................................................................18
6.2.3.
Week 240/ Study Completion (+/- 4 weeks) ........................................................................19
6.2.4.
Early Termination (ET) Visit ...............................................................................................19
6.3.
Procedures and Specifications................................................................................................................20
6.3.1.
Clinical Laboratory ..............................................................................................................20
6.3.2.
HCV RNA Confirmation and Sequence Analysis................................................................20
6.3.3.
Health Related Quality of Life Surveys ...............................................................................21
6.3.4.
Limited Physical Exam ........................................................................................................21
6.3.5.
Liver Disease Assessment....................................................................................................21
6.3.6.
Endoscopy............................................................................................................................22
6.3.7.
Transient Elastography.........................................................................................................22
6.3.8.
..........................................................................................................22
6.3.9.
MELD Score and Child-Turcotte-Pugh Score......................................................................22
6.3.10.
...............................................................22
7.
ADVERSE EVENTS MANAGEMENT ............................................................................................................23
7.1.
Adverse Events.......................................................................................................................................23
7.2.
Serious Adverse Events..........................................................................................................................23
7.3.
Serious Adverse Event Reporting Requirements ...................................................................................24
7.3.1.
All Serious Adverse Events..................................................................................................24
7.3.2.
Investigator and Sponsor Reporting Requirements for SAEs ..............................................26
7.4.
Clinical Laboratory Abnormalities and Other Abnormal Assessments as Adverse Events or 
Serious Adverse Events..........................................................................................................................26
7.5.
Procedures to be followed in the Event of Pregnancy............................................................................26
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8.
STATISTICAL CONSIDERATIONS................................................................................................................27
8.1.
Analysis Objectives and Endpoints........................................................................................................27
8.1.1.
Analysis Objectives..............................................................................................................27
8.1.2.
Primary Endpoints................................................................................................................27
8.1.3.
Secondary Endpoints............................................................................................................27
8.1.4.
Other Endpoints of Interest ..................................................................................................28
8.2.
Analysis Conventions.............................................................................................................................28
8.2.1.
Analysis Sets ........................................................................................................................28
8.3.
Data Handling Conventions ...................................................................................................................28
8.4.
Interim Analyses ....................................................................................................................................28
8.5.
Demographic Data and Baseline Characteristics ...................................................................................28
8.6.
Efficacy Analysis ...................................................................................................................................29
8.6.1.
Primary Analysis..................................................................................................................29
8.6.2.
Secondary Analyses .............................................................................................................29
8.7.
Safety Analysis.......................................................................................................................................30
8.7.1.
Extent of Exposure...............................................................................................................30
8.7.2.
Adverse Events.....................................................................................................................30
8.7.3.
Other Safety Evaluations......................................................................................................30
8.8.
Pharmacokinetic Analysis......................................................................................................................30
8.9.
Sample Size............................................................................................................................................31
8.10.
Additional Considerations......................................................................................................................31
9.
RESPONSIBILITIES..........................................................................................................................................32
9.1.
Investigator Responsibilities ..................................................................................................................32
9.1.1.
Good Clinical Practice..........................................................................................................32
9.1.2.
Institutional Review Board (IRB)/Independent Ethics Committee (IEC) 
Review and Approval...........................................................................................................32
9.1.3.
Informed Consent.................................................................................................................32
9.1.4.
Confidentiality......................................................................................................................33
9.1.5.
Study Files and Retention of Records ..................................................................................33
9.1.6.
Case Report Forms...............................................................................................................34
9.1.7.
Protocol Compliance............................................................................................................35
9.2.
Sponsor Responsibilities ........................................................................................................................35
9.2.1.
Protocol Modifications.........................................................................................................35
9.2.2.
Study Report and Publications .............................................................................................35
9.3.
Joint Investigator/Sponsor Responsibilities ...........................................................................................36
9.3.1.
Payment Reporting...............................................................................................................36
9.3.2.
Access to Information for Monitoring..................................................................................36
9.3.3.
Access to Information for Auditing or Inspections ..............................................................36
9.3.4.
Study Discontinuation..........................................................................................................36
10.
REFERENCES ...................................................................................................................................................37
11.
APPENDICES ....................................................................................................................................................39
Appendix 1.
Investigator Signature Page....................................................................................................40
Appendix 2.
Study Procedures Table..........................................................................................................41

HCV SVR Cirrhosis Registry
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PROTOCOL SYNOPSIS
Gilead Sciences, Inc.
333 Lakeside Drive
Foster City, CA 94404, USA
Study Title: 
A Registry for Subjects with Cirrhosis Who Achieve a Sustained 
Virologic Response Following Treatment with a Sofosbuvir-Based 
Regimen without Interferon for Chronic Hepatitis C Infection 
IND Number:
EudraCT Number:
115268
2014-001249-26
Study Centers:
Gilead will select which treatment protocols and sites will be included 
in this SVR Cirrhosis Registry study.  
All selected study centers must have at least one subject with 
cirrhosis who achieved a sustained virologic response (SVR) 
following treatment with a sofosbuvir (SOF)-based regimen without 
interferon (IFN) in a Gilead-sponsored hepatitis C (HCV) study, or 
after receiving an all-oral SOF-based regimen outside a clinical study 
at sites pre-selected by Gilead.
Objectives:
The primary objectives of this study are as follows:

To assess the durability of SVR;

To assess clinical progression or regression of liver disease, 
including the incidence of hepatocellular carcinoma (HCC) 
following SVR.
The secondary objective of this study is as follows:

For subjects who received their SOF-based regimen in a Gilead 
parent protocol, to determine whether subsequent detection of 
HCV RNA in subjects who relapse following SVR represents the 
re-emergence of pre-existing virus, the development of resistance 
mutations, or re-infection.
The exploratory objective of this study is as follows: 

.
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Study Design:
This Registry will enroll cirrhotic subjects with or without
decompensated liver disease who have achieved an SVR after 
receiving a SOF-based regimen without IFN while participating in a 
Gilead-sponsored HCV study or an all-oral SOF-based regimen 
outside a clinical study at sites pre-selected by Gilead. 
In order to manage the total study enrollment, Gilead Sciences, Inc. 
will determine which treatment protocols and sites to include in this 
SVR Cirrhosis Registry study. At its sole discretion, Gilead may at
any time discontinue enrollment and/or early withdraw individual
subjects from individual treatment protocols prior to study completion 
(upon written notice to the site) regardless of the progress or outcome 
of the protocol assessments performed.
Once enrolled, subjects will be followed for 5 years. For subjects 
rolling over from a Gilead parent protocol, a Day 1 visit will be 
scheduled within approximately 60 weeks from a subject’s projected 
SVR 24 visit in the treatment protocol, or subjects may enroll from 
the GS-US-248-0122 SVR registry study at any time with Sponsor 
approval. For subjects who enroll after receiving an all-oral SOF-
based regimen outside a clinical study, a Day 1 visit will be scheduled 
within approximately 2 years from the subject’s SVR 12 date. Visits 
will occur at Day 1 and then every 24 weeks at Weeks 24, 48, 72, 96, 
120, 144, 168, 192, 216 and 240.
Target Population:
Subjects with cirrhosis who have achieved an SVR after receiving a 
SOF-based regimen without IFN while participating in a Gilead-
sponsored HCV study may be eligible to enroll in this Registry at 
activated sites. In addition, subjects with cirrhosis who have achieved 
SVR after an all-oral SOF-based regimen outside a clinical study may 
be eligible to enroll in this registry at sites pre-selected by Gilead.
Duration of 
Treatment:
This observational Registry will follow subjects for up to 5 years.

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Diagnosis and Main 
Eligibility Criteria:
To be eligible for participation, a subject must:
1) Provide written informed consent;
2) Have either previously participated in a Gilead-sponsored HCV 
study and received a sofosbuvir-containing regimen without 
interferon; OR
At pre-selected sites only, have received an all-oral SOF-based 
regimen outside a clinical study. These subjects must have 
documentation of the regimen, start and end of treatment dates 
(month and year), and of having achieved SVR12
3) Have achieved SVR either in a Gilead-sponsored study, as 
defined in the treatment protocol; OR, for subjects who enroll 
after receiving an all-oral SOF-based regimen outside a clinical 
study, SVR will be defined as HCV RNA < LLOQ approximately 
12 weeks following last dose of treatment.
4) Have liver cirrhosis, as defined in the treatment protocol, and 
have not had a liver transplant after receiving the SOF-containing
regimen; OR
Subjects who enroll after receiving an all-oral SOF-based regimen 
outside a clinical study, will have had cirrhosis as diagnosed prior 
to initiation of HCV treatment.

HCV SVR Cin·hosis Registry 
Protocol GS-US-337-1431 
Gilead Sciences, Inc. 
Study Procedures/ 
Frequency: 
Test Product, Dose, 
and Mode of 
Administration: 
Reference Therapy, 
Dose, and Mode of 
Administration: 
Criteria for 
Evaluation: 
CONFIDENTIAL 
Final 
Amendment3 
Assessments will include a limited physical exam and a liver disease 
assessment; quality of life surveys will be completed at each visit. 
Endoscopy to evaluate for varices will be perfo1med at Day 1 and 
Week 240. 
At sites with a Fibroscan ®, transient elastography will be perfonned 
at Day 1 and eve1y 48 weeks through Week 240. 
At each visit, subjects will have blood drawn for plasma HCV RNA 
quantification, viral sequencing, chemistiy, hematology, coagulation, 
a,-fetoprotein, lipid panel, HOMA-IR, hemoglobin AI C, FibroTest®, 
ELF (Enhanced Liver Fibrosis) panel, and LOXL2. At Da 1, Week 
96, and Week 240/Earl Te1mination as a 
licable , 
Model for End-Stage Liver Disease (MELD) and 
Child-Turcotte-Pugh (CTP) scores will be calculated at each visit. 
If HCV RNA is detected, a repeat blood sample will be drawn for 
confmnation. If HCV RNA > LLOQ is confnmed the subject will be 
withdrawn from the Registiy. Viral sequence analysis may be 
perfo1med on available blood samples. 
Adverse events detennined to be related to a study procedures 
occuning during the course of this Registiy study will be followed 
and documented in accordance with this protocol. 
No test product will be administered in this Registiy. 
None. 
This is an observational Registiy to follow the incidence of signs, 
symptoms, and laborato1y abnonnalities, as well as radiographic and 
histologic changes, reflective of liver disease pathophysiology. 
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Statistical Methods:
Data from this Registry study will be summarized descriptively. 
Statistical hypothesis testing will not be conducted. All continuous 
variables will be summarized using an 8-number descriptive summary 
(n, mean, standard deviation, and median, Q1, Q3, minimum, 
maximum) by visit. All categorical variables will be summarized by 
number and percentage of subjects in each categorical definition.
Safety data and adverse events, will be listed by subject and 
summarized using the number (proportion) of subjects with events or 
abnormalities for categorical data or using descriptive summary for 
continuous data.
This study will be conducted in accordance with the guidelines of Good Clinical Practice (GCP) 
including archiving of essential documents.

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GLOSSARY OF ABBREVIATIONS AND DEFINITION OF TERMS
AE
Adverse event
ALT
Alanine aminotransferase
AST
Aspartate aminotransferase
BMI
Body mass index
CRO
Contract (or clinical) research organization 
CT
Computed Tomography
CTP
Child-Turcotte-Pugh 
DSPH
Drug Safety and Public Health
eCRF
Electronic case report form(s)
EC
European Commission
ELF
Enhanced liver fibrosis
ET
Early termination (visit)
EU
European Union
EudraCT
European clinical trials database
FDA
(United States) Food and Drug Administration
GCP
Good Clinical Practice (Guidelines)
GGT
Gamma-glutamyl transpeptidase
GSI
Gilead Sciences, Inc.
HCC
Hepatocellular carcinoma
HCV
Hepatitis C virus
HDL
High density lipids
HLT
High level term
HLGT
High level group term
HRQoL
Health Related Quality of Life (surveys)
IB
Investigator’s brochure
ICH
International Conference on Harmonisation
IEC
Independent ethics committee
IFN
Interferon
IL28B
IL28B gene
IND
Investigational New Drug (Application)
INR
International normalized ratio
IRB
Institutional review board
IU
International unit
LDL
Low density lipids
LLT
Low level term
LLOQ
Lower limit of quantification
MedDRA
Medical Dictionary for Regulatory Activities
MELD
Model for End-Stage Liver Disease

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mL
Milliliter
MRI
Magnetic resonance imaging
N
Number
OAV
Oral antiviral
PI
Principal investigator
PT
Prothrombin time or Preferred term
Q1, Q3
Quartiles 1 and 3
RNA
Ribonucleic acid
SADR
Serious Adverse Drug Reaction
SAE
Serious adverse event
SAP
Statistical Analysis Plan
SAS
Statistical Analysis Software
SGOT
Aspartate aminotransferase
SGPT
Alanine aminotransferase
SOC
System Organ Class or Standard of Care
SUSAR
Suspected Unexpected Serious Adverse Reaction
SVR
Sustained virologic response
TBD
To be determined
USA
United States

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1.
INTRODUCTION
1.1.
Background
Hepatitis C Virus (HCV) infection is a global health challenge with an estimated 
180 million individuals infected worldwide {Ghany et al 2009}. The total HCV-infected 
population in the United States is estimated to be over 3 million people, with the vast majority 
infected with genotype 1 {Kershenobich et al 2011}. Up to 85% of individuals infected with HCV 
fail to clear the virus and progress to chronic infection. Consequences of chronic infection 
include cirrhosis and hepatocellular carcinoma (HCC). The annual rate of progression to 
cirrhosis in chronic HCV infected patients with advanced fibrosis is ~10%. Approximately 1 to 
4% of patients per year with established cirrhosis will progress to hepatocellular carcinoma 
{Degos et al 2000}, {Dienstag et al 2011}, {Nishiguchi et al 1995}, {Serfaty et al 1998}. Given the 
asymptomatic nature of early infection, the slow progression to chronic liver disease, and the 
lack of adequate screening in at risk individuals, it is expected that the prevalence of subjects 
diagnosed with HCV-related complications will peak over the next 2 decades {Hoofnagle et al 
2006}, {World Health Organization (WHO) 2000}, {El-Serag 2004}, {Davis et al 2003}. Complications 
of chronic hepatitis C account for the majority of liver transplants in the United States {Brown 
2005}. In 2007 alone, it is estimated that over 15,000 people in the United States died from 
HCV-related complications. HCV now surpasses human immunodeficiency virus (HIV) as a 
cause of death in the United States {Ly et al 2012}.
1.2.
Rationale for This Study
Chronic hepatitis C virus infection can cause chronic liver disease, cirrhosis, liver failure, 
hepatocellular carcinoma, transplant and/or death. The progression to cirrhosis is often clinically 
silent, and some patients are not known to have hepatitis C until they present with complications 
of end-stage liver disease or HCC. The features of decompensated cirrhosis include development 
of ascites, upper gastrointestinal bleeding secondary to varices or portal hypertensive 
gastropathy, hepatorenal syndrome and hepatic encephalopathy. In the U.S., deaths associated 
with chronic HCV are more likely to be caused from decompensated cirrhosis rather than HCC. 
Studies have estimated the 3, 5, and 10-year survival rates of compensated cirrhosis to be 96%, 
91%, and 79%, respectively. {Chen et al 2006} The cumulative probability of an episode of 
clinical decompensation is 5% at 1 year, and increases to 30% at 10 years from the diagnosis of 
cirrhosis. {Chen et al 2006} Once decompensated cirrhosis occurs, the 5-year survival rate falls to 
50%. {Chen et al 2006}
Attaining a sustained virologic response (SVR) after HCV treatment has been linked to a 
reduction in all-cause mortality, as well as liver related liver transplantation, hepatocellular 
cancer, and hepatic decompensation {van der Meer et al 2012}, {Morgan et al 2013}. To date, 
however, studies that link SVR with such clinical outcomes have been limited to subjects who 
attain an SVR after an interferon (IFN)-containing regimen. The goal of this study is to 
prospectively follow subjects with cirrhosis who have attained SVR after treatment with an IFN-
free regimen. This study will evaluate the durability of SVR as well as the incidence rate of 
clinical events in those with cirrhosis. 

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1.3.
Compliance
This study will be conducted in compliance with this protocol, Good Clinical Practice (GCP), 
and all applicable regulatory requirements.

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2.
OBJECTIVES
The primary objectives of this study are:

To assess the durability of SVR;

To assess clinical progression or regression of liver disease, including the incidence of 
hepatocellular carcinoma (HCC) following SVR.
The secondary objective of this study is:

For subjects who received their SOF-based regimen in a Gilead parent protocol, to determine 
whether subsequent detection of HCV RNA in subjects who relapse following SVR 
represents the re-emergence of pre-existing virus, the development of resistance mutations,
or re-infection.
The exploratory objective of this study is:

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3.
STUDY DESIGN
3.1.
Study Design
This Registry will enroll cirrhotic subjects with or without decompensated liver disease who 
have achieved an SVR after receiving a SOF-based regimen without IFN while participating in a 
Gilead-sponsored HCV study; or, at a subset of sites preselected by Gilead, who have previously 
received an all-oral SOF-based regimen outside a clinical study. For subjects enrolling from a 
Gilead parent protocol, the definitions of cirrhosis and of SVR are defined in the Gilead-
sponsored treatment protocol.
Subjects who enroll after receiving an all-oral SOF-based regimen outside a clinical study, will 
have had cirrhosis confirmed prior to initiation of HCV treatment.
In order to manage the total study enrollment, Gilead Sciences, Inc. will determine which 
treatment protocols and sites to include in this SVR Cirrhosis Registry study. At its sole 
discretion, Gilead may at any time discontinue enrollment and/or early withdraw individual 
subjects from individual treatment protocols prior to study completion (upon written notice to the 
site) regardless of the progress or outcome of the protocol assessments performed.
Once enrolled, subjects will be followed for up to 5 years.  For subjects rolling over from a 
Gilead parent protocol, a Day 1 visit will be scheduled within approximately 60 weeks from a 
subject’s projected SVR 24 visit in the treatment protocol, or subjects may enroll from the 
GS-US-248-0122 SVR registry study at any time with Sponsor approval. For subjects who enroll 
after receiving an all-oral SOF-based regimen outside a clinical study, a Day 1 visit will be 
scheduled within approximately 2 years from the subject’s SVR 12 date. Visits will occur at 
Day 1 and then every 24 weeks at Weeks 24, 48, 72, 96, 120, 144, 168, 192, 216 and 240.
3.2.
Discontinuation Criteria
Registry participation will be discontinued in the following instances:

Subjects who experience virologic relapse or re-infection defined as HCV RNA > LLOQ on 
two samples collected at least one week apart;

Subjects who have a liver transplant;

Subjects who request to discontinue for any reason; it is important to clearly determine and 
document the specific reason for withdrawal of consent;

Discontinuation of the Registry and/or subjects at the request of Gilead, regulatory agency or 
an Institutional Review Board (IRB)/Independent Ethics Committee (IEC).
If a subject meets withdrawal criteria or discontinues participation for any reason, the subject 
should complete an Early Termination visit.

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4.
SUBJECT POPULATION
4.1.
Inclusion Criteria
Subjects must meet all of the following inclusion criteria to be eligible for participation in this 
study.
1) Willing and able to provide written informed consent;
2) Have either previously participated in a Gilead-sponsored HCV study and received a 
sofosbuvir-containing regimen without interferon; OR
At pre-selected sites only, have received an all-oral SOF-based regimen outside a clinical 
study.  These subjects must have documentation of the regimen, start and end of treatment
dates (month and year), and of having achieved SVR12
3) Have achieved SVR either in a Gilead-sponsored study, as defined in the treatment protocol;
OR for subjects who enroll after receiving an all-oral SOF-based regimen outside a clinical 
study, SVR will be defined as HCV RNA < LLOQ approximately 12 weeks following last 
dose of treatment.
4) Have liver cirrhosis, as defined in the treatment protocol, and have not had a liver transplant 
after receiving a SOF-containing regimen; OR
Subjects who enroll after receiving an all-oral SOF-based regimen outside a clinical study, 
will have had cirrhosis as diagnosed prior to initiation of HCV treatment.
4.2.
Exclusion Criteria
Subjects who meet either of the following exclusion criteria are not to be enrolled in this study.
1) Subject plans to initiate a new course of HCV therapy, including approved products and any 
investigational agents, during the course of this Registry;
2) History of clinically-significant illness or any other major medical disorder that may interfere 
with the subject follow-up, assessments or compliance with the protocol.

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5.
INVESTIGATIONAL MEDICINAL PRODUCTS
5.1.
Investigational Medicinal Products
This is a long-term observational follow-up Registry. No investigational medicinal product will 
be administered.
5.2.
Prohibited Concomitant Medications
Subjects will not receive any antiviral therapy for HCV infection while participating in this 
Registry. If a subject requires HCV antiviral therapy, they will be discontinued from the 
Registry. There are no other concomitant medications which would preclude subjects from 
participating in this Registry.

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6.
STUDY PROCEDURES
The study procedures to be conducted for each subject enrolled in the study are presented in 
tabular form in Appendix 2 and described in the text that follows. 
The investigator must document any deviation from protocol procedures and notify the sponsor 
or contract research organization (CRO).
6.1.1.
Day 1 Assessments
For subjects enrolled from a Gilead parent protocol, a Day 1 visit will be scheduled within 
approximately 60 weeks from a subject’s projected SVR 24 visit in the treatment protocol; or 
subjects may enroll from the GS-US-248-0122 SVR registry study at any time with Sponsor 
approval. For subjects who enroll after receiving an all-oral SOF-based regimen outside a 
clinical study, a Day 1 visit will be scheduled within approximately 2 years from the subject’s 
SVR 12 date. 
Subjects will be asked to come in fasting for this visit. The following will be performed and 
documented at Day 1:

Obtain written informed consent (may be obtained prior to Day 1)

  

Review eligibility criteria

Complete Health Related Quality of Life (HRQoL) Surveys

Conduct limited physical exam

Collect information for liver disease assessment. For subjects who enrolled having received 
an all-oral SOF-based regimen outside a clinical study, the liver disease assessment at 
screening will include a medical history of clinical liver-associated events and the start and 
stop dates of their most recent occurrences.

Obtain blood samples (For subjects enrolling from the GS-US-248-0122 study, blood 
samples do not need to be collected for both studies if the ET from GS-US-248-0122 and D 1 
visit from GS-US-337-1431 are done on the same day)

Perform endoscopy (+/- 6 months, no need to repeat if subject has available endoscopy
results performed within 6 months prior to Day 1 as standard of care)

Perform transient elastography (+ 4 weeks, at sites with a Fibroscan®)

Record any serious adverse events or adverse events that are related to protocol-required 
procedures occurring after signing of the consent form
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6.2.
Follow-Up Assessments
Follow-up assessment visits will be scheduled based on the Day 1 visit date.
6.2.1.
Weeks 24, 72, 120, 168, and 216 (+/- 4 weeks)
Subjects will be asked to come in fasting for these visits.  The following procedures will be 
performed and documented:

Complete Health Related Quality of Life (HRQoL) surveys

Conduct limited physical exam

Collect information for liver disease assessment

Obtain blood samples (For subjects enrolling from the GS-US-248-0122 study, blood 
samples do not need to be collected for both studies if the ET from GS-US-248-0122 and D 1 
visit from GS-US-337-1431 are done on the same day)

Record any serious adverse events or adverse events that are related to protocol-required 
procedures
6.2.2.
Weeks 48, 96, 144, and 192 (+/- 4 weeks)
Subjects will be asked to come in fasting for these visits. The following procedures will be 
performed and documented:

Complete Health Related Quality of Life (HRQoL) Surveys 

Conduct limited physical exam 

Collect information for liver disease assessment

Obtain blood samples (For subjects enrolling from the GS-US-248-0122 study, blood 
samples do not need to be collected for both studies if the ET from GS-US-248-0122 and D 1 
visit from GS-US-337-1431 are done on the same day)

Perform transient elastography (at sites with a Fibroscan®)

Record any serious adverse events or adverse events that are related to protocol-required 
procedures

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6.2.3. 
Week 240/ Study Completion(+/- 4 weeks) 
Final 
Amendment3 
Subjects will be asked to come in fasting for this visit. The following procedures will be 
perfo1med and documented: 
• 
Complete Health Related Quality of Life (HRQoL) smveys 
• 
Conduct limited physical exam 
• 
Collect info1mation for liver disease assessment 
• 
Obtain blood samples 
• 
Perfo1m transient elastography (at sites with a Fibroscan®) 
• 
Perfo1m endoscopy (within 6 months prior to Week 240, no need to repeat if subject has 
available endoscopy results peifonned as standard of care; refer to Section 6.3.6) 
• 
• 
Record any serious adverse events or adverse events that are related to protocol required 
procedures 
6.2.4. 
Early Termination (ET) Visit 
Subjects discontinuing the Registiy for any reason should undergo the Early Te1mination (ET) 
visit. Subjects will be asked to come in fasting for this visit and the following procedures will be 
perfo1med and documented: 
• 
Complete Health Related Quality of Life (HRQoL) Smveys 
• 
Conduct limited physical exam 
• 
Collect info1mation for liver disease assessment 
• 
Obtain blood samples. 
• 
Perfo1m ti·ansient elastography (at sites with a Fibroscan®) 
• 
Record any serious adverse events or adverse events that are related to protocol-required 
procedures 
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6.3. 
Procedures and Specifications 
6.3.1. 
Clinical Laboratory 
Blood Collection 
Final 
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The following clinical laborato1y assessments will be perfonned at each visit. Subjects must be 
fasting at least 8 hours prior to each visit. If the subject does not anive to clinic fasting, they may 
return anytime in the next 4 weeks to provide a fasting sample. 
Hematology: Platelets 
Chemistiy: Alanine aminou-ansferase (ALT/SGPT), aspartate aminou-ansferase (AST/SGOT), 
albumin, total bilirnbin, direct bilirnbin, Creatinine 
Coagulation Test: INR, prothrombin time (PT) 
Additional Tests: 
• 
Alpha-fetoprotein (a-fetoprotein) level 
• 
FibroTest®: alpha-2-macroglobulin, alpha-2-globulin (haptoglobin), apolipoprotein Al , 
GGT, and total bilirnbin 
• 
Enhanced Liver Fibrosis (ELF) panel: hyaluronic acid, amino-tenninal propeptide of type III 
collagen, and TIMP-1 
• 
Fasting lipid panel: low-density lipoprotein (LDL), high-density lipoprotein (HDL), 
ti·iglycerides, total cholesterol 
• 
Hemoglobin Al C (HbAlc) 
• 
HOMA-IR (fasting insulin x fasting glucose / 405) 
• 
LOXL2 levels 
Virological Tests: Plasma HCV RNA, and viral sequence analysis (if applicable) 
6.3.2. 
HCV RNA Confirmation and Sequence Analysis 
If at any time during the course of the registiy a subject's HCV RNA result is > LLOQ, the 
subject will be asked to return for a confinnation sample to be drawn for detennining virologic 
relapse or re-infection. Virologic relapse is defined as HCV RNA > LLOQ on two samples 
collected at least one week apart with the same vims present prior to ti·eatinent in the ti·eatinent 
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protocol. Re-infection is defined as HCV RNA > LLOQ on two samples collected at least one 
week apart with a different virus than that present prior to treatment in the treatment protocol.  
HCV sequencing will be performed if HCV RNA is sufficient. The specific HCV genes to be 
sequenced will be based on the specific oral antiviral (OAV) agent(s) administered to the subject 
in the Gilead-sponsored treatment protocol.
For subjects who enroll after receiving an all-oral SOF-based regimen outside a clinical study, 
HCV RNA results > LLOQ will be confirmed, as above; sequencing may be performed if 
appropriate, given available information.
6.3.3.
Health Related Quality of Life Surveys
Quality of life surveys included in this study are Short Form-36 (SF-36), Chronic Liver Disease 
Questionnaire (CLDQ-HCV), and Work Productivity and Activity Impairment Questionnaire: 
Hepatitis C (WPAI: Hepatitis C) which will be completed by subjects and collected at each visit. 
Subjects should read the questionnaires and write/mark answers directly onto the paper 
questionnaires prior to any other study assessments. Sites will mail completed surveys with a 
transmittal sheet to a data entry vendor as directed. 
6.3.4.
Limited Physical Exam
The limited physical exam includes height (at Day 1 only) and weight measurements for 
calculation of BMI. Assessments for ascites and encephalopathy will be conducted at each visit 
for calculation of CTP score.
6.3.5.
Liver Disease Assessment
Information will be collected at each visit for a liver disease assessment. Day 1 assessment will 
include determining whether any of the following have occurred since the last parent-protocol 
study visit prior to Day 1 for patients who achieved SVR in a Gilead-sponsored study or since 
the completion of the HCV therapy resulting in SVR prior to Day 1 for subjects who enroll after 
receiving an all-oral SOF-based regimen outside a clinical study. Assessment at all other study 
visits will include determining whether any of the following have occurred since the last study 
visit through Week 240 or early termination (unless otherwise specified). For subjects enrolled 
having received an all-oral SOF-based regimen outside a clinical study, the screening liver 
disease assessment will include the start and stop date of any clinical liver-associated events.

Imaging of the liver performed as part of standard of care (eg, CT, MRI, or Ultrasound; 
results, if available)

Liver biopsy or endoscopy to evaluate for varices (results, if available)

Clinical liver-associated events including reports of hepatic encephalopathy, hepatocellular 
carcinoma, hepatorenal syndrome, hepatopulmonary syndrome, portopulmonary 
hypertension, hepatic hydrothorax, bleeding varices or spontaneous bacterial peritonitis

Liver transplant (at any time prior to Day 1 and during the study)

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Endoscopy 
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An endoscopy will be perfonned to evaluate for varices at Day 1 (+/- 6 months) and within 
6 months prior to Week 240. There is no need to repeat if subject has available endoscopy 
results perfonned within 6 months prior to Day 1 or Week 240 as part of standard of care. The 
results of the endoscopy will be recorded into the clinical database. 
6.3.7. 
Transient Elastography 
A trnnsient elastography will be perfo1med to assess the liver at Day 1 (+ 4 weeks) and eve1y 
48 weeks(+/- 4 weeks) through Week 240 at sites with a Fibroscan®. The results of the scan will 
be recorded into the clinical database. 
6.3.8. 
6.3.9. 
MELD Score and Child-Turcotte-Pugh Score 
Model for End-Stage Liver Disease (MELD) Score and Child-Turcotte-Pugh (CTP) data will be 
calculated at each visit. 
For the components of the MELD score and the components of the CTP score which are based 
on laborato1y values, the data will be obtained from the central laborato1y, and the scores will be 
calculated within the clinical database. 
6.3.10. 
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7.
ADVERSE EVENTS MANAGEMENT
7.1.
Adverse Events
This study is a long-term observational Registry in which no study medication will be 
administered. Adverse events related to the Gilead-sponsored treatment protocol will be followed 
in accordance with that protocol. Adverse events related to an all-oral SOF-based regimen used 
outside a clinical study should be reported as described in the locally approved product 
information utilizing the usual means for spontaneous reporting.
As a consequence, adverse event reporting in this Registry will be restricted to the following:

Any adverse event occurring as a consequence of procedures required by this Registry 
protocol will be followed and documented in accordance with provisions outlined below.
For purposes of this Registry, an adverse event (AE) is any untoward medical occurrence in a 
clinical study subject associated with procedures required by this Registry protocol. An AE can 
therefore be any unfavorable and/or unintended sign, symptom, or disease temporally associated 
with procedures required by this Registry (e.g., hematoma following venipuncture).  
An AE does not include the following for this Registry:

Any medical condition or clinically significant laboratory abnormality with an onset date 
before the consent form is signed and before Day 1 visit is not an AE.

Any medical condition or clinically significant laboratory abnormality with an onset date 
after the consent form is signed that is related to the Gilead-sponsored treatment protocol or 
to an all-oral SOF-based regimen used outside a clinical study.  
7.2.
Serious Adverse Events
Any serious adverse event (SAE) occurring during the Gilead-sponsored treatment protocol will 
be followed, documented and reported under that treatment protocol. Similarly, any new SAEs 
occurring while the subject is participating in the Registry that are considered to be related to the 
study drugs administered or procedures in the treatment protocol will be followed, documented 
and reported under the Gilead-sponsored treatment protocol or as per locally approved product 
information. Any serious adverse event related to an all-oral SOF-based regimen used outside a 
clinical study should be reported as described in the locally approved product information 
utilizing the usual means for spontaneous reporting.
The only SAEs that will be reported under this Registry are events considered to be related to 
procedures required by the Registry protocol. A serious adverse event is defined as follows:
Any adverse event that results in any of the following outcomes: 

Death

Life-threatening (the subject was at immediate risk of death at the time of the event; it does 
not refer to an event that hypothetically might have caused death if it were more severe)

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
In-patient hospitalization or prolongation of existing hospitalization (excluding, for example, 
those for study therapy or placement of an indwelling catheter, unless associated with other 
SAEs)

Persistent or significant disability/incapacity

Congenital anomaly/birth defect in the offspring of a subject who received investigational 
medicinal product.  All pregnancy events will be followed to resolution/outcome in the 
Gilead-sponsored treatment protocol

Other: medically significant events that may not be immediately life-threatening or result in 
death or hospitalization, but based upon appropriate medical and scientific judgment, may 
jeopardize the subject or may require medical or surgical intervention to prevent one of the 
outcomes listed above
Clarification of Serious Adverse Events

Death is an outcome of an AE, and not an adverse event in itself.

“Life-threatening” means that the subject was at immediate risk of death from the event as it 
occurred. This does not include an event that might have led to death if it had occurred with 
greater severity.

“In-patient hospitalization” means the subject has been formally admitted to a hospital for 
medical reasons, for any length of time. This may or may not be overnight. It does not 
include presentation and care within an emergency department.
The relationship to study procedures (e.g., invasive procedures such as venipuncture) should be 
assessed using the following considerations:

No: Evidence exists that the AE has an etiology other than the study procedure.

Yes: The AE occurred as a result of protocol required procedures such as venipuncture.
7.3.
Serious Adverse Event Reporting Requirements
7.3.1.
All Serious Adverse Events
Gilead Sciences is required to expedite to worldwide regulatory authorities reports of SAEs, 
Serious Adverse Drug Reactions (SADRs) or Suspected Unexpected Serious Adverse Reactions 
(SUSARs) in line with relevant legislation, including the applicable US FDA Code of Federal 
Regulation, the European Commission Clinical Trials Directive (2001/20/EC); therefore, 
Gilead Sciences (or the CRO on the behalf of Gilead Sciences) must be notified immediately 
regarding the occurrence of any SAE or SADR that occurs after the subject consents to 
participate in the Registry, including SAEs/SADRs resulting from protocol-required procedures 
as defined in relevant legislation including 2001/20/EC, performed from Day 1 onwards. The 
procedure for reporting SAEs is as follows:

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• 
All AEs and SAEs will be recorded in the electronic case repo1t fonn ( eCRF) database within 
the timelines outlined in the eCRF completion guideline. 
Electronic Serious Adverse Event (eSAE) Repo1t ing Process 
• 
Site personnel record all SAE data in the eCRF database and from there transinit the SAE 
infonnation to Gilead Dmg Safety and Public Health (DSPH) within 24 hours of the 
investigator's knowledge of the event. Detailed instructions can be found in the eCRF 
completion guidelines. 
• If for any reason it is not possible to record the SAE infonnation electr·onically, i.e., the 
eCRF database is not functioning, record the SAE on the paper serious adverse event 
repo1t ing fo1m and submit within 24 hours to: 
Gilead Sciences DSPH: 
Gilead Sciences Study 
Director / Medical Monitor: 
Fax: 
E-mail: 
Name: 
Telephone: 
Mobile: 
Fax: 
Email: 
IPIPD 
PPU 
IPD 
IPD 
IPD 
IPIPD 
PPU 
• 
As soon as it is possible to do so, any SAE reported via paper must be tr·anscribed into the 
eCRF Database according to instructions in the eCRF completion guidelines. 
• If an SAE has been repo1ted via a paper fonn because the eCRF database has been locked, no 
fuither action is necessaiy. 
• 
For fatal or life-threatening events, copies of hospital case repo1ts, autopsy repo1ts, and other 
docUlllents are also to be subinitted by e-mail or fax when requested and applicable. 
Transinission of such docUlllents should occur without personal subject identification, 
maintaining the tr·aceability of a docUlllent to the subject identifiers. 
• 
Gilead Sciences may request additional info1mation from the investigator to ensure the 
timely completion of accurate safety repo1ts. 
• 
Any medications necessaiy for tr·eatinent of the SAE must be recorded onto the event 
description section of the SAE fonn. 
The investigator must take all therapeutic measures necessaiy for resolution of the SAE. 
Follow-up of SAEs will continue through the last day on the Registry and/or until a conclusive 
outcome ( eg, resolved, resolved with sequelae, lost to follow-up, fatal) is achieved. 
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7.3.2.
Investigator and Sponsor Reporting Requirements for SAEs
Any SAE deemed by the investigator to be related to a protocol-required procedure should be 
collected and reported throughout the Registry study and reported to Gilead Sciences DSPH 
using the SAE report form.
An SAE may qualify for reporting to regulatory authorities. All Investigators will receive a 
safety letter notifying them of relevant SUSAR reports. The Investigator should notify the 
IRB/IEC as soon as is practical, of serious events in writing where this is required by local 
regulatory authorities, and in accordance with the local institutional policy.
In accordance with the EU Clinical Trials Directive (2001/20/EC), Gilead will notify worldwide 
regulatory authorities and the relevant Ethics Committees in concerned Member States of 
applicable SUSARs.
7.4.
Clinical Laboratory Abnormalities and Other Abnormal Assessments as 
Adverse Events or Serious Adverse Events
Lab abnormalities are usually not recorded as AEs or SAEs. Laboratory abnormalities will only 
be recorded as an AE/SAE if they are related to a protocol required procedure. 
7.5.
Procedures to be followed in the Event of Pregnancy
Procedures to be followed in the event of pregnancy occurring on the treatment protocol are 
detailed in the Gilead-sponsored treatment protocol. No additional pregnancy reporting 
requirements are included in this Registry protocol.

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8.
STATISTICAL CONSIDERATIONS
8.1.
Analysis Objectives and Endpoints
Treatment regimen is defined in the Gilead-sponsored treatment protocol.
8.1.1.
Analysis Objectives
The primary objectives of this study are:

To assess the durability of SVR;

To assess clinical progression or regression of liver disease, including the incidence of 
hepatocellular carcinoma (HCC) following SVR
The secondary objective of this study is:

For subjects who received their SOF-based regimen in a Gilead parent protocol, to determine 
whether subsequent detection of HCV RNA in subjects who relapse following SVR 
represents the re-emergence of pre-existing virus, the development of resistance mutations,
or re-infection
The exploratory objective of this study is:

8.1.2.
Primary Endpoints
The primary endpoints are:

The proportion of subjects maintaining SVR at Week 240;

The proportion of subjects who develop liver disease progression or regression, as assessed 
by clinical and laboratory parameters;

The proportion of subjects who develop HCC through Week 240
8.1.3.
Secondary Endpoints
The secondary endpoints will be assessed in subjects who received their SOF-based regimen in a 
Gilead parent protocol, as follows:

The proportion of subjects with detectable HCV RNA due to re-emergence of pre-existing 
virus through Week 240;

The proportion of subjects with detectable HCV resistance mutations through Week 240

The proportion of subjects with detectable HCV RNA due to re-infection through Week 240
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8.1.4.
Other Endpoints of Interest
8.2.
Analysis Conventions
All individual subject data will be listed as measured. All statistical summaries and analyses will 
be performed using SASsoftware (SAS Institute, Cary, North Carolina, USA).
8.2.1.
Analysis Sets
8.2.1.1.
Safety Analysis Set
The analysis set includes all enrolled subjects. Both the safety and efficacy analyses will be 
based on the safety analysis set.
8.3.
Data Handling Conventions
Missing data can have an impact upon the interpretation of the trial data. In general, values for 
missing data will not be imputed.  
All available data for subjects who do not complete the study will be included in data listings.
HCV RNA values below the LLOQ for the assay will be set to the lower limit minus 1 for 
calculation of summary statistics for the actual HCV RNA values and the change from baseline 
values by study visit. The reported values will be provided in the HCV RNA listing.
For selected analyses of early time point data, HCV RNA data (IU/mL) may be transformed to 
the logarithmic (base 10) scale (log10 IU/mL).
8.4.
Interim Analyses
Interim analyses may be performed on an ad hoc basis.
8.5.
Demographic Data and Baseline Characteristics
Demographic and baseline measurements will be summarized using standard descriptive 
methods.
Demographic summaries will include sex, self-identified race/ethnicity, and age.
Baseline characteristics data will include a summary of HCV RNA levels, liver function tests, 
platelets, coagulation test, α-fetoprotein, and HCV genotype and IL28B genotype, if known.
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8.6.
Efficacy Analysis
All continuous endpoints will be summarized using an 8-number descriptive summary (n, mean, 
standard deviation, median, Q1, Q3, minimum and maximum). All categorical endpoints will be 
summarized by the number and percent of subjects meeting the endpoint. Ninety-five percent
confidence intervals will also be reported.  
8.6.1.
Primary Analysis
The proportion of subjects who maintain an SVR through Week 240 will be estimated using a 
Kaplan-Meier model, allowing for censored observations due to early discontinuation from the 
Registry.
The proportion of subjects who develop clinical progression or regression of liver disease 
through Week 240 will be estimated using a Kaplan-Meier model, allowing for censored 
observations due to early discontinuation from the Registry.
The proportion of subjects who develop HCC through Week 240 will be estimated using a 
Kaplan-Meier model, allowing for censored observations due to early discontinuation from the 
Registry.
8.6.2.
Secondary Analyses
The proportion of subjects with detectable HCV RNA due to re-emergence of pre-existing virus
through Week 240 will be summarized by number and percent of subjects by time point using 
the same model as in the primary analysis.
The proportion of subjects with detectable HCV resistance mutations through Week 240 will be 
summarized by number and percent of subjects by time point.
The proportion of subjects with detectable HCV RNA due to re-infection through Week 240 will 
be summarized by number and percent of subjects by time point.
Clinical laboratory test results related to liver disease progression or regression (ie, ALT, AST, 
bilirubin, albumin, platelets, PT and/or INR, and α-fetoprotein) will be listed by subject. 
Reference ranges provided by the laboratory for each parameter will be used to evaluate the 
clinical significance of laboratory test results. Values falling outside of the relevant reference 
range will be flagged, as appropriate, in the data listings. Abnormalities in clinical laboratory test 
results will be summarized by enumeration of the number of subjects with values falling outside 
of the reference range by study day. Laboratory data will be descriptively summarized over time 
by study day and by the change from Baseline.

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Clinical signs and symptoms related to liver disease progression or regression will be 
summarized by frequency and percent of subjects. Applicable clinical signs assessed include 
ascites, hepatic encephalopathy, varices, spontaneous bacterial peritonitis, HCC and transplant. 
In addition, Child-Turcotte-Pugh score will be included with the following categories, A (5-6), 
B (7-9), and C (10-15).
Descriptive summaries and listings will be provided for additional efficacy evaluations of the 
quality of life endpoints.
8.7.
Safety Analysis
Analysis of safety measures will be descriptive and will include subjects in the Safety analysis 
set. Missing observations will be excluded from analysis of safety measures. All safety data
collected on or after the date of enrollment through the remainder of the study will be 
summarized. 
8.7.1.
Extent of Exposure
This is a Registry study with no active treatment; hence, extent of exposure to study drug is not 
applicable.
8.7.2.
Adverse Events
Clinical and laboratory adverse events will be coded using the Medical Dictionary for 
Regulatory Activities (MedDRA). System Organ Class (SOC), High-Level Group Term 
(HLGT), High-Level Term (HLT), Preferred Term (PT), and Lower-Level Term (LLT) will be 
attached to the clinical database.
Events will be summarized by the date of onset for the event. An adverse event is defined as an 
event that begins or worsens on or after the date the ICF is signed through study completion or 
study discontinuation and is classified as related to study procedure.  
Adverse events, including SAEs by the above definition, will be listed by subject. The frequency 
of subjects who experience adverse events will be summarized overall, by treatment regimen and 
by severity.
SAEs that do not meet the above definition will not be captured or summarized.
Data listings will be provided for subjects who discontinued the study due to an adverse event by 
the above definition.
8.7.3.
Other Safety Evaluations
No other safety assessments are planned.
8.8.
Pharmacokinetic Analysis
No pharmacokinetic analysis is planned.

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8.9.
Sample Size
Due to the observational nature of this study, no formal power or sample size calculations were 
used. 
8.10.
Additional Considerations
Any additional statistical analyses and/or method for this study will be described in the Statistical 
Analysis Plan (SAP).

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9.
RESPONSIBILITIES
9.1.
Investigator Responsibilities
9.1.1.
Good Clinical Practice
The investigator will ensure that this study is conducted in accordance with the principles of the 
Declaration of Helsinki (as amended in Edinburgh, Tokyo, Venice, Hong Kong, and South 
Africa), International Conference on Harmonisation (ICH) guidelines, or with the laws and 
regulations of the country in which the research is conducted, whichever affords the greater 
protection to the study subject. These standards are consistent with the European Union Clinical 
Trials Directive 2001/20/EC and Good Clinical Practice Directive 2005/28/EC.
The investigator will ensure adherence to the basic principles of Good Clinical Practice, as 
outlined in 21 CFR 312, subpart D, “Responsibilities of Sponsors and Investigators,” 21 CFR, 
part 50, 1998, and 21 CFR, part 56, 1998.
The investigator and all applicable subinvestigators will comply with 21 CFR, Part 54, 1998, 
providing documentation of their financial interest or arrangements with Gilead, or proprietary 
interests in the investigational drug under study. This documentation must be provided prior to 
the investigator’s (and any subinvestigator’s) participation in the study. The investigator and 
subinvestigator agree to notify Gilead of any change in reportable interests during the study and 
for 1 year following completion of the study. Study completion is defined as the date when the 
last subject completes the protocol-defined activities.
9.1.2.
Institutional Review Board (IRB)/Independent Ethics Committee (IEC) 
Review and Approval
The investigator (or sponsor as appropriate according to local regulations) will submit this 
protocol, informed consent form, and any accompanying material to be provided to the subject 
(such as advertisements, subject information sheets, or descriptions of the study used to obtain 
informed consent) to an IRB/IEC. The investigator will not begin any study subject activities 
until approval from the IRB/IEC has been documented and provided as a letter to the 
investigator.
Before implementation, the investigator will submit to and receive documented approval from 
the IRB/IEC any modifications made to the protocol or any accompanying material to be 
provided to the subject after initial IRB/IEC approval, with the exception of those necessary to 
reduce immediate risk to study subjects.
9.1.3.
Informed Consent
The investigator is responsible for obtaining written informed consent from each individual 
participating in this study after adequate explanation of the aims, methods, objectives, and 
potential hazards of the study and before undertaking any study-related procedures. The 

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investigator must use the most current IRB/IEC-approved consent form for documenting written 
informed consent. Each informed consent (or assent as applicable) will be appropriately signed 
and dated by the subject or the subject’s legally authorized representative and the person 
conducting the consent discussion, and also by an impartial witness if required by IRB/IEC or
local requirements. The consent form will inform subjects about sample retention, and their right 
to receive clinically relevant analysis results.
9.1.4.
Confidentiality
The investigator must assure that subjects’ anonymity will be strictly maintained and that their 
identities are protected from unauthorized parties. Only subject initials, date of birth, another 
unique identifier (as allowed by local law) and an identification code will be recorded on any 
form or biological sample submitted to the Sponsor, IRB or IEC, or laboratory. Laboratory 
specimens must be labeled in such a way as to protect subject identity while allowing the results 
to be recorded to the proper subject. Refer to specific laboratory instructions. NOTE: The 
investigator must keep a log showing codes, names, and addresses for all subjects enrolled in the 
trial. Subject data will be processed in accordance with all applicable regulations.
The investigator agrees that all information received from Gilead, including but not limited to the 
investigator brochure, this protocol, CRF/eCRF, and any other study information, remain the sole 
and exclusive property of Gilead during the conduct of the study and thereafter. This information 
is not to be disclosed to any third party (except employees or agents directly involved in the 
conduct of the study or as required by law) without prior written consent from Gilead. The 
investigator further agrees to take all reasonable precautions to prevent the disclosure by any 
employee or agent of the study site to any third party or otherwise into the public domain.
9.1.5.
Study Files and Retention of Records
The investigator must maintain adequate and accurate records to enable the conduct of the study 
to be fully documented and the study data to be subsequently verified. These documents should 
be classified into at least the following two categories: (1) investigator’s study file, and 
(2) subject clinical source documents.
The investigator’s study file will contain the protocol/amendments, CRF and query forms, IRB 
or IEC and governmental approval with correspondence, informed consent, staff curriculum 
vitae and authorization forms, and other appropriate documents and correspondence.
The required source data should include sequential notes containing at least the following 
information for each subject:

Subject identification (name, date of birth);

Documentation that subject meets eligibility criteria;

Documentation of the reason(s) a consented subject is not enrolled;

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
Participation in study (including study number);

Study discussed and date of informed consent;

Dates of all visits;

Documentation that protocol specific procedures were performed;

Record of all adverse events related to study procedures (start and end date);

Date of study completion and reason for early discontinuation, if it occurs.
All clinical study documents must be retained by the investigator until at least 2 years or 
according to local laws, whichever is longer, after the last approval of a marketing application in 
an ICH region (i.e., United States, Europe, or Japan) and until there are no pending or planned 
marketing applications in an ICH region; or, if no application is filed or if the application is not 
approved for such indication, until 2 years after the investigation is discontinued and regulatory 
authorities have been notified. Investigators may be required to retain documents longer if
specified by regulatory requirements, by local regulations, or by an agreement with Gilead. The 
investigator must notify Gilead before destroying any clinical study records.
Should the investigator wish to assign the study records to another party or move them to another 
location, Gilead must be notified in advance.
If the investigator cannot provide for this archiving requirement at the study site for any or all of 
the documents, special arrangements must be made between the investigator and Gilead to store 
these records securely away from the site so that they can be returned sealed to the investigator 
in case of an inspection. When source documents are required for the continued care of the 
subject, appropriate copies should be made for storage away from the site.
9.1.6.
Case Report Forms
For each subject enrolled, an eCRF will be completed by an authorized study staff member 
whose training for this function is documented according to study procedures. Original entries 
as well as any changes to data fields will be stored in the audit trail of the system. Prior to 
database lock (or any interim time points as described in the clinical data management plan), the 
investigator will use his/her log in credentials to confirm that the forms have been reviewed, and 
that the entries accurately reflect the information in the source documents. The eCRF capture the 
data required per the protocol schedule of events and procedures. System-generated or manual 
queries will be issued to the investigative site staff as data discrepancies are identified. The site 
coordinator is responsible for responding to the queries in a timely manner, within the system, 
either by confirming the data as correct or updating the original entry, and providing the reason 
for the update (eg, data entry error). At the conclusion of the trial, Gilead will provide the site 
with a read-only archive copy of the data entered by that site. This archive must be stored in 
accordance with the records retention requirements outlined in Section 9.1.5.

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The investigator will make available all source documents and other records for this trial to 
Gilead’s appointed study monitors, to IRBs or IECs, or to regulatory authority or health authority 
inspectors.
9.1.7.
Protocol Compliance
The investigator is responsible for ensuring the study is conducted in accordance with the 
procedures and evaluations described in this protocol.
9.2.
Sponsor Responsibilities
9.2.1.
Protocol Modifications
Protocol modifications, except those intended to reduce immediate risk to study subjects, may be 
made only by Gilead. The investigator must submit all protocol modifications to the IRB or IEC
in accordance with local requirements and receive documented IRB or IEC approval before 
modifications can be implemented.
9.2.2.
Study Report and Publications
A clinical study report (CSR) will be prepared and provided to the regulatory agency(ies). Gilead 
will ensure that the report meets the standards set out in the ICH Guideline for Structure and 
Content of Clinical Study Reports (ICH E3). Note that an abbreviated report may be prepared in 
certain cases.
After conclusion of the Registry and without prior written approval from Gilead Sciences, 
investigators in this Registry may communicate, orally present, or publish in scientific journals 
or other scholarly media only after the following conditions have been met:

the results of the Registry in their entirety have been publicly disclosed by or with the 
consent of Gilead Sciences in an abstract, manuscript, or presentation form; or,

the Registry has been completed at all study sites for at least 2 years.
No such communication, presentation, or publication will include Gilead Sciences’ confidential 
information (see Section 9.1.4).
The investigator will submit to Gilead any proposed publication or presentation along with the 
respective scientific journal or presentation forum at least 30 days before submission of the 
publication or presentation. 
The investigator will comply with Gilead’s request to delete references to its confidential 
information (other than the study results) in any paper or presentation and agrees to withhold 
publication or presentation for an additional 60 days in order to obtain patent protection if 
deemed necessary.

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9.3.
Joint Investigator/Sponsor Responsibilities
9.3.1.
Payment Reporting
Investigators and their study staff may be asked to provide services performed under this 
protocol.  If required under the applicable statutory and regulatory requirements, Gilead will 
capture and disclose to Federal and State agencies any expenses paid or reimbursed for such 
services, including any clinical trial payments, meal, travel expenses or reimbursements, 
consulting fees, and any other transfer of value.
9.3.2.
Access to Information for Monitoring
In accordance with regulations and guidelines, the study monitor must have direct access to the 
investigator’s source documentation in order to verify the accuracy of the data recorded in the 
eCRF.
The monitor is responsible for remote review of the eCRF at regular intervals to verify adherence 
to the protocol and the completeness, consistency, and accuracy of the data being entered on 
them. 
Ad hoc monitoring visits may occur on site, at which time the monitor should have access to any 
subject records needed to verify the entries on the eCRF. The investigator agrees to cooperate 
with the monitor to ensure that any problems detected through any type of monitoring (remote or
on site) are resolved.
9.3.3.
Access to Information for Auditing or Inspections
Representatives of regulatory authorities or of Gilead may conduct inspections or audits of the 
clinical study. If the investigator is notified of an inspection by a regulatory authority the 
investigator agrees to notify the Gilead medical monitor immediately. The investigator agrees to 
provide to representatives of a regulatory agency or Gilead access to records, facilities, and 
personnel for the effective conduct of any inspection or audit.
9.3.4.
Study Discontinuation
Both the sponsor and the investigator reserve the right to terminate the study at any time. Should 
this be necessary, both parties will arrange discontinuation procedures and notify the appropriate 
regulatory authority(ies), IRBs, and IECs. In terminating the study, Gilead and the investigator 
will assure that adequate consideration is given to the protection of the subjects’ interests.

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10.
REFERENCES
Brown RS, Jr. Hepatitis C and liver transplantation. Nature 2005;436 (7053):973-8.
Chen SL, Morgan TR. The natural history of hepatitis C virus (HCV) infection. Int J Med Sci 
2006;3 (2):47-52.
Davis GL, Albright JE, Cook SF, Rosenberg DM. Projecting future complications of chronic 
hepatitis C in the United States. Liver Transpl 2003;9 (4):331-8.
Degos F, Christidis C, Ganne-Carrie N, Farmachidi JP, Degott C, Guettier C, et al. Hepatitis C 
virus related cirrhosis: time to occurrence of hepatocellular carcinoma and death. 
Gut 2000;47 (1):131-6.
Dienstag JL, Ghany MG, Morgan TR, Di Bisceglie AM, Bonkovsky HL, Kim HY, et al. A 
prospective study of the rate of progression in compensated, histologically 
advanced chronic hepatitis C. Hepatology 2011;54 (2):396-405.
El-Serag HB. Hepatocellular carcinoma: recent trends in the United States. Gastroenterology 
2004;127 (5 Suppl 1):S27-34.
Ghany MG, Strader DB, Thomas DL, Seeff LB. Diagnosis, management, and treatment of 
hepatitis C: an update. Hepatology 2009;49 (4):1335-74.
Hoofnagle JH, Seeff LB. Peginterferon and ribavirin for chronic hepatitis C. N Engl J Med 
2006;355 (23):2444-51.
Kershenobich D, Razavi HA, Cooper CL, Alberti A, Dusheiko GM, Pol S, et al. Applying a 
system approach to forecast the total hepatitis C virus-infected population size: 
model validation using US data. Liver Int 2011;31 Suppl 2:4-17.
Ly KN, Xing J, Klevens RM, Jiles RB, Ward JW, Holmberg SD. The increasing burden of 
mortality from viral hepatitis in the United States between 1999 and 2007. Ann 
Intern Med 2012;156 (4):271-8.
Morgan RL, Baack B, Smith BD, Yartel A, Pitasi M, Falck-Ytter Y. Eradication of Hepatitis C 
Virus Infection and the Development of Hepatocellular Carcinoma. Ann Intern 
Med 2013;158 (5 (Part I)).
Nishiguchi S, Kuroki T, Nakatani S, Morimoto H, Takeda T, Nakajima S, et al. Randomised trial 
of effects of interferon-alpha on incidence of hepatocellular carcinoma in chronic 
active hepatitis C with cirrhosis. Lancet 1995;346 (8982):1051-5.
Serfaty L, Aumaitre H, Chazouilleres O, Bonnand AM, Rosmorduc O, Poupon RE, et al. 
Determinants of outcome of compensated hepatitis C virus-related cirrhosis. 
Hepatology 1998;27 (5):1435-40.

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van der Meer AJ, Veldt BJ, Feld JJ, Wedemeyer H, Dufour JF, Lammert F, et al. Association 
between sustained virological response and all-cause mortality among patients 
with chronic hepatitis C and advanced hepatic fibrosis. JAMA 2012;308 
(24):2584-93.
World Health Organization (WHO). Hepatitis C Fact sheet N°164. Available at: 
http://www.who.int/mediacentre/factsheets/fs164/en/print.html. Accessed: 25 
May 2007.  2000.

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11.
APPENDICES
Appendix 1.
Investigator Signature Page
Appendix 2.
Study Procedures Table

HCV SVR Cirrhosis Registry 
Protocol GS-US-337-1431 
Gilead Sciences, Inc. 
Appendix 1. 
Investigator Signature Page 
GILEAD SCIENCES, INC. 
333 LAKESIDE DRIVE 
FOSTER CITY, CA 94404 
STUDY ACKNOWLEDGEMENT 
Final 
Amendment 3 
A Registry for Subjects with Cirrhosis Who Achieve a Sustained Virologic Response 
Following Treatment with a Sofosbuvir-Based Regimen without Interferon for Chronic 
Hepatitis C Infection 
GS-US-337-1431, Amendment 3, 01 June 2017 
This protocol has been approved by Gilead Sciences, Inc. The following signature documents 
____ 
_..,.thi-·s"'-""'ao,oro""'v=a~l.~------
IPPD 
I 
~PD 
j (Printed) 
PD 
1gnature 
Study Director/Medical Monitor 
PPD 
ate 
INVESTIGATOR STATEMENT 
I have read the protocol, including all appendices, and I agree that it contains all necessary 
details for me and my staff to conduct this study as described. I will conduct this study as 
outlined herein and will make a reasonable effort to complete the study within the time 
designated. 
I will provide all study personnel under my supervision copies of the protocol and access to all 
information provided by Gilead Sciences, Inc. I will discuss this material with them to ensure 
that they are fully informed about the drugs and the study. 
Principal Investigator Name (Printed) 
Signature 
Date 
Site Number 
CONFIDENTlAL 
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01 June 2017 

HCV SVR Cin·hosis Registry 
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Gilead Sciences, Inc. 
Amendment3 
Appendix 2. 
Study Procedures Table 
Study Week 
Clinical Assessments 
Day l 
24 
48 
72 
96 
120 
144 
168 
192 
216 
240 
ET 
Info1med Consent" 
X 
Quality of Life Sw-veys 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Adverse Events Related to 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Procedures 
Limited Physical Examb 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Liver Disease Assessment° 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Endoscopy 
X 
X 
Transient Elastograph/ 
X 
X 
X 
X 
X 
X 
X 
Liver Biopsye 
X 
Laboratory Assessments 
HCVRNA 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Viral Sequencinl 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Che1nistryg 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Hematology (Platelets) 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Coagulation Test (PT/INR) 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Additional Testsh 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
HCV RNA Confirmation; 
X 
a 
Info1med consent may be obtained prior to Day 1 
b 
Assessment of ascites, encephalopathy, height (at Day 1) and weight; calculated scores include BMI, CTP and MELD 
c 
Liver Disease Assessment: refer to protocol Section 6.3.5 
d 
At sites with a Fibroscan ® equipment 
e 
f 
Plasma w-ill be collected for possible viral sequencing or other virology studies if indicated. 
g 
Includes ALT/SGPT, AST/SGOT, Albumin, Total bilimbin, Direct Bilimbin, Creatinine 
h 
Includes cx-fetoprotein level, FibroTest®, ELF panel, lipid panel, hemoglobin AlC, HOMA-IR and LOXL2 
Only in subjects with HCV RNA >LLOQ 
For subjects who consent 
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