SOF (Sovaldi®) +RBV for 16 or 24 Weeks and SOF+RBV+Peg-IF... | NCT01962441

ID	Type	Description	Link
2013-002641-11	EudraCT Number

Label	Type	Description	Intervention Names
SOF+RBV 16 weeks	Experimental	SOF+RBV for 16 weeks	Drug: SOF Drug: RBV
SOF+RBV 24 weeks	Experimental	SOF+RBV for 24 weeks	Drug: SOF Drug: RBV
SOF+RBV+Peg-IFN 12 weeks	Experimental	SOF+RBV+Peg-IFN for 12 weeks	Drug: SOF Drug: RBV Drug: Peg-IFN
Retreatment Substudy	Experimental	Participants from the SOF+RBV arms (16 weeks or 24 weeks) who experienced virologic failure on treatment, or during the posttreatment period at or before Posttreatment Week 24 may be eligible to enroll into the Retreatment Substudy to receive SOF+RBV+Peg-IFN for 12 weeks.	Drug: SOF Drug: RBV Drug: Peg-IFN

Name	Type	Description	Arm Group Labels	Other Names
SOF	Drug	400 mg tablet administered orally once daily	Retreatment Substudy SOF+RBV 16 weeks SOF+RBV 24 weeks SOF+RBV+Peg-IFN 12 weeks

Measure	Description	Time Frame
Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)	SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.	Posttreatment Week 12
Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event		Up to 24 weeks

Measure	Description	Time Frame
Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)	SVR4 and SVR 24 were defined as HCV RNA < LLOQ at 4 and 24 weeks after stopping study treatment, respectively.	Posttreatment Weeks 4 and 24
Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 8, 12, 16, 20, and 24

Eligibility Module

Eligibility Criteria

Key Inclusion Criteria:

Male or female, age greater than or equal to 18 years.
Confirmed chronic HCV infection.
Subjects will have cirrhosis status assessment; liver biopsy may be required.
Genotype 2 subjects must have cirrhosis of the liver to be eligible.
Treatment-naive or prior treatment failure to ≥12 weeks of an interferon- based regimen that was not discontinued prematurely due to an adverse event
Infection with HCV genotype 2 or 3 as determined at Screening
Body mass index (BMI) greater than or equal to 18 kg/m^2
Screening laboratory values within predefined thresholds.
Liver imaging (e.g., ultrasound) within 6 months of Baseline/Day 1 is required in cirrhotic patients to exclude hepatocellular carcinoma (HCC). In the event of intrahepatic lesions, triple phase CT scan or MRI should be performed to exclude HCC.
Subject must be of generally good health as determined by the Investigator.

Key Exclusion Criteria:

Prior use of any other inhibitor of the HCV nonstructural protein (NS)5B polymerase
Pregnant or nursing female or male with pregnant female partner
History of any other clinically significant chronic liver disease.
HIV or chronic hepatitis B virus (HBV) infection.
Malignancy with the exception of certain resolved skin cancers.
Chronic use of systemically administered immunosuppressive agents.
Clinically-relevant drug or alcohol abuse.
History of solid organ transplantation.
Current or prior history of clinical hepatic decompensation.
History of clinically-significant illness or any other major medical disorder that may interfere with subject treatment, assessment or compliance with the protocol.
Known hypersensitivity to interferon, RBV, the study investigational medicinal product, the metabolites, or formulation excipients.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Name	Affiliation	Role
Gilead Study Director	Gilead Sciences	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
		Riverside	California	92501	United States

PubMed Identifier	Type	Citation	Retractions
26248087	Result	Foster GR, Pianko S, Brown A, Forton D, Nahass RG, George J, Barnes E, Brainard DM, Massetto B, Lin M, Han B, McHutchison JG, Subramanian GM, Cooper C, Agarwal K; BOSON Study Group. Efficacy of sofosbuvir plus ribavirin with or without peginterferon-alfa in patients with hepatitis C virus genotype 3 infection and treatment-experienced patients with cirrhosis and hepatitis C virus genotype 2 infection. Gastroenterology. 2015 Nov;149(6):1462-70. doi: 10.1053/j.gastro.2015.07.043. Epub 2015 Aug 4.

ID	Title	Description
FG000	SOF+RBV 16 Weeks, Then Retreatment	Randomized Period: Sofosbuvir (Sovaldi®; SOF) 400 mg tablet administered orally once daily + ribavirin (RBV) tablets administered orally (1000 or 1200 mg daily based on weight) for 16 weeks Retreatment Period: Participants who experienced virologic failure during treatment or relapsed at or before Posttreatment Week 24 during the Randomized Period were eligible to enroll into the Retreatment Period to receive SOF+Peg-IFN+RBV for 12 weeks.

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)

SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.

Full Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug.

Posted

Number

percentage of participants

Posttreatment Week 12

ID	Title	Description
OG000	SOF+RBV 16 Weeks	SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for 16 weeks
OG001	SOF+RBV 24 Weeks	SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for 24 weeks
OG002	SOF+RBV+Peg-IFN 12 Weeks	SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) + Peg-IFN 180 µg administered subcutaneously once weekly for 12 weeks

Units	Counts
Participants	OG000196 OG001199 OG002197

Title

Denominators

Categories

Title	Measurements
	OG00071.9 OG00185.4 OG00292.9

Primary

Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event

Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug.

Posted

Number

percentage of participants

Up to 24 weeks

ID	Title	Description
OG000	SOF+RBV 16 Weeks	SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for 16 weeks
OG001	SOF+RBV 24 Weeks	SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for 24 weeks
OG002	SOF+RBV+Peg-IFN 12 Weeks	SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) + Peg-IFN 180 µg administered subcutaneously once weekly for 12 weeks

Units	Counts
Participants

Secondary

Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)

SVR4 and SVR 24 were defined as HCV RNA < LLOQ at 4 and 24 weeks after stopping study treatment, respectively.

Full Analysis Set

Posted

Number

percentage of participants

Posttreatment Weeks 4 and 24

ID	Title	Description
OG000	SOF+RBV 16 Weeks	SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for 16 weeks
OG001	SOF+RBV 24 Weeks	SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for 24 weeks
OG002	SOF+RBV+Peg-IFN 12 Weeks	SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) + Peg-IFN 180 µg administered subcutaneously once weekly for 12 weeks

Units	Counts

Secondary

Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 8, 12, 16, 20, and 24

Participants in the Full Analysis Set with available data were analyzed.

Posted

Number

percentage of participants

Weeks 1, 2, 4, 8, 12, 16, 20, and 24

ID	Title	Description
OG000	SOF+RBV 16 Weeks	SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for 16 weeks
OG001	SOF+RBV 24 Weeks	SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for 24 weeks
OG002	SOF+RBV+Peg-IFN 12 Weeks	SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) + Peg-IFN 180 µg administered subcutaneously once weekly for 12 weeks

Units	Counts
Participants

Secondary

HCV RNA at Weeks 1, 2, 4, 8, and 12

Participants in the Full Analysis Set with available data were analyzed.

Posted

Mean

Standard Deviation

log10 IU/mL

Weeks 1, 2, 4, 8, and 12

ID	Title	Description
OG000	SOF+RBV 16 Weeks	SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for 16 weeks
OG001	SOF+RBV 24 Weeks	SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for 24 weeks
OG002	SOF+RBV+Peg-IFN 12 Weeks	SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) + Peg-IFN 180 µg administered subcutaneously once weekly for 12 weeks

Units	Counts
Participants

Secondary

Change From Baseline in HCV RNA at Weeks 1, 2, 4, 8, and 12

Participants in the Full Analysis Set with available data were analyzed.

Posted

Mean

Standard Deviation

log10 IU/mL

Baseline; Weeks 1, 2, 4, 8, and 12

ID	Title	Description
OG000	SOF+RBV 16 Weeks	SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for 16 weeks
OG001	SOF+RBV 24 Weeks	SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for 24 weeks
OG002	SOF+RBV+Peg-IFN 12 Weeks	SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) + Peg-IFN 180 µg administered subcutaneously once weekly for 12 weeks

Units	Counts
Participants

Secondary

Percentage of Participants Experiencing On-Treatment Virologic Failure

On-treatment virologic failure was defined as:

Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or
Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or
Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)

Full Analysis Set

Posted

Number

percentage of participants

Up to 24 weeks

ID	Title	Description
OG000	SOF+RBV 16 Weeks	SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for 16 weeks
OG001	SOF+RBV 24 Weeks	SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for 24 weeks
OG002	SOF+RBV+Peg-IFN 12 Weeks	SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) + Peg-IFN 180 µg administered subcutaneously once weekly for 12 weeks

Secondary

Percentage of Participants Experiencing Viral Relapse

Viral relapse is defined as HCV RNA ≥ LLOQ during the post-treatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available post-treatment measurement.

Participants in the Full Analysis Set with available data were analyzed.

Posted

Number

percentage of participants

Up to Posttreatment Week 24

ID	Title	Description
OG000	SOF+RBV 16 Weeks	SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for 16 weeks
OG001	SOF+RBV 24 Weeks	SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for 24 weeks
OG002	SOF+RBV+Peg-IFN 12 Weeks	SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) + Peg-IFN 180 µg administered subcutaneously once weekly for 12 weeks

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Acute coronary syndrome	Cardiac disorders	MedDRA 18.0 and 19.0	Systematic Assessment	EG0001 affected196 at risk EG0010 affected199 at risk EG0020 affected197 at risk EG0030 affected30 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 18.0 and 19.0	Systematic Assessment	EG0000 affected196 at risk EG0011 affected199 at risk EG0021 affected197 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA 18.0 and 19.0	Systematic Assessment	EG0000 affected196 at risk EG0011 affected199 at risk EG0020 affected197 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 18.0 and 19.0	Systematic Assessment	EG0000 affected196 at risk EG0010 affected199 at risk EG0021 affected197 at risk EG003
Pancreatitis	Gastrointestinal disorders	MedDRA 18.0 and 19.0	Systematic Assessment	EG0001 affected196 at risk EG0011 affected199 at risk EG0020 affected197 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 18.0 and 19.0	Systematic Assessment	EG0000 affected196 at risk EG0010 affected199 at risk EG0021 affected197 at risk EG003
Chest pain	General disorders	MedDRA 18.0 and 19.0	Systematic Assessment	EG0001 affected196 at risk EG0010 affected199 at risk EG0020 affected197 at risk EG003
Cellulitis	Infections and infestations	MedDRA 18.0 and 19.0	Systematic Assessment	EG0001 affected196 at risk EG0010 affected199 at risk EG0020 affected197 at risk EG003
Pneumonia	Infections and infestations	MedDRA 18.0 and 19.0	Systematic Assessment	EG0000 affected196 at risk EG0010 affected199 at risk EG0021 affected197 at risk EG003
Respiratory tract infection	Infections and infestations	MedDRA 18.0 and 19.0	Systematic Assessment	EG0000 affected196 at risk EG0010 affected199 at risk EG0021 affected197 at risk EG003
Subcutaneous abscess	Infections and infestations	MedDRA 18.0 and 19.0	Systematic Assessment	EG0000 affected196 at risk EG0011 affected199 at risk EG0020 affected197 at risk EG003
Overdose	Injury, poisoning and procedural complications	MedDRA 18.0 and 19.0	Systematic Assessment	EG0000 affected196 at risk EG0011 affected199 at risk EG0020 affected197 at risk EG003
Snake bite	Injury, poisoning and procedural complications	MedDRA 18.0 and 19.0	Systematic Assessment	EG0000 affected196 at risk EG0010 affected199 at risk EG0021 affected197 at risk EG003
Haemoglobin decreased	Investigations	MedDRA 18.0 and 19.0	Systematic Assessment	EG0000 affected196 at risk EG0010 affected199 at risk EG0021 affected197 at risk EG003
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA 18.0 and 19.0	Systematic Assessment	EG0001 affected196 at risk EG0010 affected199 at risk EG0020 affected197 at risk EG003
Flank pain	Musculoskeletal and connective tissue disorders	MedDRA 18.0 and 19.0	Systematic Assessment	EG0000 affected196 at risk EG0011 affected199 at risk EG0020 affected197 at risk EG003
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 18.0 and 19.0	Systematic Assessment	EG0000 affected196 at risk EG0011 affected199 at risk EG0020 affected197 at risk EG003
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 18.0 and 19.0	Systematic Assessment	EG0000 affected196 at risk EG0010 affected199 at risk EG0020 affected197 at risk EG003
Adenocarcinoma of colon	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0 and 19.0	Systematic Assessment	EG0001 affected196 at risk EG0010 affected199 at risk EG0020 affected197 at risk EG003
Hepatocellular carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0 and 19.0	Systematic Assessment	EG0000 affected196 at risk EG0011 affected199 at risk EG0020 affected197 at risk EG003
Loss of consciousness	Nervous system disorders	MedDRA 18.0 and 19.0	Systematic Assessment	EG0000 affected196 at risk EG0010 affected199 at risk EG0021 affected197 at risk EG003
Syncope	Nervous system disorders	MedDRA 18.0 and 19.0	Systematic Assessment	EG0000 affected196 at risk EG0011 affected199 at risk EG0021 affected197 at risk EG003
Alcohol abuse	Psychiatric disorders	MedDRA 18.0 and 19.0	Systematic Assessment	EG0000 affected196 at risk EG0011 affected199 at risk EG0020 affected197 at risk EG003
Alcohol withdrawal syndrome	Psychiatric disorders	MedDRA 18.0 and 19.0	Systematic Assessment	EG0000 affected196 at risk EG0010 affected199 at risk EG0021 affected197 at risk EG003
Depression	Psychiatric disorders	MedDRA 18.0 and 19.0	Systematic Assessment	EG0001 affected196 at risk EG0010 affected199 at risk EG0021 affected197 at risk EG003
Drug abuse	Psychiatric disorders	MedDRA 18.0 and 19.0	Systematic Assessment	EG0000 affected196 at risk EG0011 affected199 at risk EG0020 affected197 at risk EG003
Hallucination	Psychiatric disorders	MedDRA 18.0 and 19.0	Systematic Assessment	EG0000 affected196 at risk EG0010 affected199 at risk EG0021 affected197 at risk EG003
Suicidal ideation	Psychiatric disorders	MedDRA 18.0 and 19.0	Systematic Assessment	EG0001 affected196 at risk EG0010 affected199 at risk EG0020 affected197 at risk EG003
Pleuritic pain	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0 and 19.0	Systematic Assessment	EG0000 affected196 at risk EG0010 affected199 at risk EG0021 affected197 at risk EG003
Miscarriage of partner	Social circumstances	MedDRA 18.0 and 19.0	Systematic Assessment	EG0000 affected196 at risk EG0011 affected199 at risk EG0020 affected197 at risk EG003
Orthostatic hypotension	Vascular disorders	MedDRA 18.0 and 19.0	Systematic Assessment	EG0001 affected196 at risk EG0010 affected199 at risk EG0020 affected197 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 18.0 and 19.0	Systematic Assessment	EG0004 affected196 at risk EG0017 affected199 at risk EG00212 affected197 at risk EG0030 affected30 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 18.0 and 19.0	Systematic Assessment	EG0000 affected196 at risk EG0010 affected199 at risk EG00211 affected197 at risk EG003
Dry eye	Eye disorders	MedDRA 18.0 and 19.0	Systematic Assessment	EG0003 affected196 at risk EG0015 affected199 at risk EG0025 affected197 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA 18.0 and 19.0	Systematic Assessment	EG0008 affected196 at risk EG0018 affected199 at risk EG00211 affected197 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	MedDRA 18.0 and 19.0	Systematic Assessment	EG0007 affected196 at risk EG00110 affected199 at risk EG0029 affected197 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 18.0 and 19.0	Systematic Assessment	EG00021 affected196 at risk EG00118 affected199 at risk EG00227 affected197 at risk EG003
Dry mouth	Gastrointestinal disorders	MedDRA 18.0 and 19.0	Systematic Assessment	EG0003 affected196 at risk EG0017 affected199 at risk EG00212 affected197 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA 18.0 and 19.0	Systematic Assessment	EG00010 affected196 at risk EG00112 affected199 at risk EG00211 affected197 at risk EG003
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 18.0 and 19.0	Systematic Assessment	EG0004 affected196 at risk EG0018 affected199 at risk EG0023 affected197 at risk EG003
Mouth ulceration	Gastrointestinal disorders	MedDRA 18.0 and 19.0	Systematic Assessment	EG0005 affected196 at risk EG0013 affected199 at risk EG0025 affected197 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 18.0 and 19.0	Systematic Assessment	EG00032 affected196 at risk EG00134 affected199 at risk EG00250 affected197 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 18.0 and 19.0	Systematic Assessment	EG00010 affected196 at risk EG00121 affected199 at risk EG00219 affected197 at risk EG003
Asthenia	General disorders	MedDRA 18.0 and 19.0	Systematic Assessment	EG0002 affected196 at risk EG0013 affected199 at risk EG00210 affected197 at risk EG003
Chills	General disorders	MedDRA 18.0 and 19.0	Systematic Assessment	EG0003 affected196 at risk EG0014 affected199 at risk EG00221 affected197 at risk EG003
Fatigue	General disorders	MedDRA 18.0 and 19.0	Systematic Assessment	EG00074 affected196 at risk EG00183 affected199 at risk EG00292 affected197 at risk EG003
Influenza like illness	General disorders	MedDRA 18.0 and 19.0	Systematic Assessment	EG0007 affected196 at risk EG0018 affected199 at risk EG00239 affected197 at risk EG003
Injection site rash	General disorders	MedDRA 18.0 and 19.0	Systematic Assessment	EG0000 affected196 at risk EG0010 affected199 at risk EG0025 affected197 at risk EG003
Pyrexia	General disorders	MedDRA 18.0 and 19.0	Systematic Assessment	EG0005 affected196 at risk EG0017 affected199 at risk EG00229 affected197 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA 18.0 and 19.0	Systematic Assessment	EG00012 affected196 at risk EG00114 affected199 at risk EG0027 affected197 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 18.0 and 19.0	Systematic Assessment	EG0008 affected196 at risk EG00110 affected199 at risk EG0023 affected197 at risk EG003
Platelet count decreased	Investigations	MedDRA 18.0 and 19.0	Systematic Assessment	EG0000 affected196 at risk EG0010 affected199 at risk EG0023 affected197 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	MedDRA 18.0 and 19.0	Systematic Assessment	EG00013 affected196 at risk EG00116 affected199 at risk EG00235 affected197 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 18.0 and 19.0	Systematic Assessment	EG00010 affected196 at risk EG00115 affected199 at risk EG00225 affected197 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 18.0 and 19.0	Systematic Assessment	EG00010 affected196 at risk EG00114 affected199 at risk EG00215 affected197 at risk EG003
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 18.0 and 19.0	Systematic Assessment	EG0009 affected196 at risk EG00122 affected199 at risk EG00211 affected197 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 18.0 and 19.0	Systematic Assessment	EG00012 affected196 at risk EG00119 affected199 at risk EG00233 affected197 at risk EG003
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 18.0 and 19.0	Systematic Assessment	EG0002 affected196 at risk EG0012 affected199 at risk EG0021 affected197 at risk EG003
Dizziness	Nervous system disorders	MedDRA 18.0 and 19.0	Systematic Assessment	EG00011 affected196 at risk EG00116 affected199 at risk EG00213 affected197 at risk EG003
Dizziness postural	Nervous system disorders	MedDRA 18.0 and 19.0	Systematic Assessment	EG0003 affected196 at risk EG0011 affected199 at risk EG00210 affected197 at risk EG003
Dysgeusia	Nervous system disorders	MedDRA 18.0 and 19.0	Systematic Assessment	EG0006 affected196 at risk EG0014 affected199 at risk EG00210 affected197 at risk EG003
Headache	Nervous system disorders	MedDRA 18.0 and 19.0	Systematic Assessment	EG00061 affected196 at risk EG00172 affected199 at risk EG00270 affected197 at risk EG003
Lethargy	Nervous system disorders	MedDRA 18.0 and 19.0	Systematic Assessment	EG0009 affected196 at risk EG0018 affected199 at risk EG00210 affected197 at risk EG003
Memory impairment	Nervous system disorders	MedDRA 18.0 and 19.0	Systematic Assessment	EG00010 affected196 at risk EG0013 affected199 at risk EG0025 affected197 at risk EG003
Anxiety	Psychiatric disorders	MedDRA 18.0 and 19.0	Systematic Assessment	EG00012 affected196 at risk EG00116 affected199 at risk EG00217 affected197 at risk EG003
Depressed mood	Psychiatric disorders	MedDRA 18.0 and 19.0	Systematic Assessment	EG0008 affected196 at risk EG00111 affected199 at risk EG00217 affected197 at risk EG003
Depression	Psychiatric disorders	MedDRA 18.0 and 19.0	Systematic Assessment	EG0001 affected196 at risk EG0018 affected199 at risk EG00210 affected197 at risk EG003
Insomnia	Psychiatric disorders	MedDRA 18.0 and 19.0	Systematic Assessment	EG00047 affected196 at risk EG00156 affected199 at risk EG00250 affected197 at risk EG003
Irritability	Psychiatric disorders	MedDRA 18.0 and 19.0	Systematic Assessment	EG00017 affected196 at risk EG00125 affected199 at risk EG00221 affected197 at risk EG003
Mood swings	Psychiatric disorders	MedDRA 18.0 and 19.0	Systematic Assessment	EG0003 affected196 at risk EG0017 affected199 at risk EG0025 affected197 at risk EG003
Sleep disorder	Psychiatric disorders	MedDRA 18.0 and 19.0	Systematic Assessment	EG00015 affected196 at risk EG0017 affected199 at risk EG00211 affected197 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0 and 19.0	Systematic Assessment	EG00010 affected196 at risk EG00119 affected199 at risk EG00228 affected197 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0 and 19.0	Systematic Assessment	EG0003 affected196 at risk EG0013 affected199 at risk EG0025 affected197 at risk EG003
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0 and 19.0	Systematic Assessment	EG00022 affected196 at risk EG00122 affected199 at risk EG00230 affected197 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0 and 19.0	Systematic Assessment	EG0007 affected196 at risk EG0012 affected199 at risk EG00212 affected197 at risk EG003
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 18.0 and 19.0	Systematic Assessment	EG0006 affected196 at risk EG0019 affected199 at risk EG00216 affected197 at risk EG003
Dry skin	Skin and subcutaneous tissue disorders	MedDRA 18.0 and 19.0	Systematic Assessment	EG00015 affected196 at risk EG00122 affected199 at risk EG00225 affected197 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 18.0 and 19.0	Systematic Assessment	EG00021 affected196 at risk EG00124 affected199 at risk EG00222 affected197 at risk EG003
Pruritus generalised	Skin and subcutaneous tissue disorders	MedDRA 18.0 and 19.0	Systematic Assessment	EG0009 affected196 at risk EG00116 affected199 at risk EG00215 affected197 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA 18.0 and 19.0	Systematic Assessment	EG00024 affected196 at risk EG00127 affected199 at risk EG00239 affected197 at risk EG003

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D006525	Hepatitis, Viral, Human
D014777	Virus Diseases
D018178	Flaviviridae Infections
D012327	RNA Virus Infections
D006505	Hepatitis
D008107	Liver Diseases
D004066	Digestive System Diseases

ID	Term
D014542	Uridine Monophosphate
D014500	Uracil Nucleotides
D011742	Pyrimidine Nucleotides
D011743	Pyrimidines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D009711	Nucleotides
D009706	Nucleic Acids, Nucleotides, and Nucleosides
D012265	Ribonucleotides

ID	Title	Description
BG000	SOF+RBV 16 Weeks	SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for 16 weeks
BG001	SOF+RBV 24 Weeks	SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for 24 weeks
BG002	SOF+RBV+Peg-IFN 12 Weeks	SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) + Peg-IFN 180 µg administered subcutaneously once weekly for 12 weeks
BG003	Total	Total of all reporting groups

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Randomized Period: SOF+RBV 16 Weeks	Randomized Period: SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for 16 weeks	196	8	196	173	196
EG001	Randomized Period: SOF+RBV 24 Weeks	Randomized Period: SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for 24 weeks	199	10	199	176	199
EG002	Randomized Period: SOF+RBV+Peg-IFN 12 Weeks	Randomized Period: SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) + Peg-IFN 180 µg administered subcutaneously once weekly for 12 weeks	197	12	197	192	197
EG003	Retreatment Period: SOF+RBV+Peg-IFN 12 Weeks	Retreatment Period: Participants from the SOF+RBV 16 Weeks or 24 Weeks groups who experienced virologic failure during treatment or relapsed at or before Posttreatment Week 24 during the Randomized Period were eligible to enroll into the Retreatment Period to receive SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) + Peg-IFN 180 µg administered subcutaneously once weekly for 12 weeks.	30	1	30	29	30