Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed-Dose C... | NCT01768286

NCT01768286

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
LDV/SOF 12 Weeks	Experimental	Participants will receive LDV/SOF FDC for 12 weeks.	Drug: LDV/SOF
LDV/SOF+RBV 12 Weeks	Experimental	Participants will receive LDV/SOF FDC plus RBV for 12 weeks.	Drug: LDV/SOF Drug: RBV
LDV/SOF 24 Weeks	Experimental	Participants will receive LDV/SOF FDC for 24 weeks.	Drug: LDV/SOF
LDV/SOF+RBV 24 Weeks	Experimental	Participants will receive LDV/SOF FDC plus RBV for 24 weeks.	Drug: LDV/SOF Drug: RBV

Interventions

Name	Type	Description	Arm Group Labels	Other Names
LDV/SOF	Drug	Ledipasvir (LDV) 90 mg/sofosbuvir (SOF) 400 mg fixed-dose combination (FDC) tablet administered orally once daily	LDV/SOF 12 Weeks LDV/SOF 24 Weeks

Outcomes Module

Primary Outcomes

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, 25 IU/mL) 12 weeks following the last dose of study drug.	Posttreatment Week 12
Incidence of Adverse Events Leading to Permanent Discontinuation From Any Study Drug	The percentage of participants who experienced an adverse event leading to permanent discontinuation from any study drug was summarized.	Up to 24 weeks

Secondary Outcomes

Measure	Description	Time Frame
Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)	SVR4 and SVR24 were defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively.	Posttreatment Weeks 4 and 24
Percentage of Participants With HCV RNA < LLOQ at Week 1

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Jenny Yang, PharmD	Gilead Sciences	Study Director

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
27553375	Derived	Grebely J, Mauss S, Brown A, Bronowicki JP, Puoti M, Wyles D, Natha M, Zhu Y, Yang J, Kreter B, Brainard DM, Yun C, Carr V, Dore GJ. Efficacy and Safety of Ledipasvir/Sofosbuvir With and Without Ribavirin in Patients With Chronic HCV Genotype 1 Infection Receiving Opioid Substitution Therapy: Analysis of Phase 3 ION Trials. Clin Infect Dis. 2016 Dec 1;63(11):1405-1411. doi: 10.1093/cid/ciw580. Epub 2016 Aug 23.
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IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	LDV/SOF 12 Weeks	Ledipasvir (LDV) 90 mg/sofosbuvir (SOF) 400 mg fixed-dose combination (FDC) tablet once daily for 12 weeks
FG001	LDV/SOF+RBV 12 Weeks	LDV 90 mg/SOF 400 mg FDC tablet once daily plus ribavirin (RBV) tablets (1000-1200 mg daily based on weight) for 12 weeks

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Pharmacologic Actions

Molecular Mechanisms of Pharmacological Action

Masking Info

LDV/SOF+RBV 12 Weeks

LDV/SOF+RBV 24 Weeks

Safety Analysis Set: participants were randomized and received at least one dose of study drug. Participants failed a previous HCV treatment regimen consisting of pegylated interferon alfa-2a (Pegasys) or pegylated interferon alfa-2b (Pegintron) plus ribavirin (RBV), with or without a protease inhibitor (PI).

Arm/Group Information

ID	Title	Description
BG000	LDV/SOF 12 Weeks	LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
BG001	LDV/SOF+RBV 12 Weeks	LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 12 weeks
BG002	LDV/SOF 24 Weeks	LDV 90 mg/SOF 400 mg FDC tablet once daily for 24 weeks
BG003	LDV/SOF+RBV 24 Weeks	LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 24 weeks
BG004	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00056± 6.9 BG00157± 8.0 BG00256± 8.3 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00035 BG00140 BG002

Race/Ethnicity, Customized

Number

participants

Title

Denominators

Categories

Black or African American

Title	Measurements
	BG00024 BG00116 BG002

Race/Ethnicity, Customized

Number

participants

Title

Denominators

Categories

Hispanic/Latino

Title	Measurements
	BG0007 BG00112 BG002

HCV RNA

Mean

Standard Deviation

log10 IU/mL

Title

Denominators

Categories

Title	Measurements
	BG0006.5± 0.44 BG0016.4± 0.54 BG002

HCV RNA Category

Number

participants

Title

Denominators

Categories

< 800,000 IU/mL

Title	Measurements
	BG0006 BG00113 BG002

HCV Genotype

Number

participants

Title

Denominators

Categories

Genotype 1a

Title	Measurements
	BG00086 BG00188 BG002

IL28b Status

CC, CT, and TT alleles are different forms of the IL28b gene.

Number

participants

Title

Denominators

Categories

Title	Measurements
	BG00010 BG00111 BG002

Prior HCV Treatment

IFN-alfa-2b = interferon-alfa 2b; PEG-IFN-alfa-2a = pegylated interferon alfa-2a; PEG-IFN-alfa-2b - pegylated interferon alfa-2b; RBV = ribavirin; PI = protease inhibitor

Number

participants

Title

Denominators

Categories

PEG-IFN-alfa-2a or PEG-IFN-alfa-2b+RBV

Title	Measurements
	BG00043 BG001

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, 25 IU/mL) 12 weeks following the last dose of study drug.

Full Analysis Set: participants who were randomized and received at least one dose of study drug.

Posted

Number

percentage of participants

Posttreatment Week 12

ID	Title	Description
OG000	LDV/SOF 12 Weeks	LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
OG001	LDV/SOF+RBV 12 Weeks	LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 12 weeks
OG002	LDV/SOF 24 Weeks	LDV 90 mg/SOF 400 mg FDC tablet once daily for 24 weeks
OG003	LDV/SOF+RBV 24 Weeks	LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 24 weeks

Units	Counts
Participants	OG000109 OG001111 OG002109 OG003

Title

Denominators

Categories

Title	Measurements
	OG00093.6 OG00196.4 OG00299.1 OG003

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000		Binomial test		<0.001	A 2-sided 1-sample binomial test was used to compare over the historical SVR12 rate of 25%. To control the family-wise type I error rate at 0.05, the Hochberg procedure was applied, from which the adjusted p-values were obtained.					2-Sided								Superiority or Other
OG001

Primary

Incidence of Adverse Events Leading to Permanent Discontinuation From Any Study Drug

The percentage of participants who experienced an adverse event leading to permanent discontinuation from any study drug was summarized.

Safety Analysis Set

Posted

Number

percentage of participants

Up to 24 weeks

ID	Title	Description
OG000	LDV/SOF 12 Weeks	LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
OG001	LDV/SOF+RBV 12 Weeks	LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 12 weeks
OG002	LDV/SOF 24 Weeks	LDV 90 mg/SOF 400 mg FDC tablet once daily for 24 weeks
OG003	LDV/SOF+RBV 24 Weeks	LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 24 weeks

Secondary

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

SVR4 and SVR24 were defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively.

Full Analysis Set

Posted

Number

percentage of participants

Posttreatment Weeks 4 and 24

ID	Title	Description
OG000	LDV/SOF 12 Weeks	LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
OG001	LDV/SOF+RBV 12 Weeks	LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 12 weeks
OG002	LDV/SOF 24 Weeks	LDV 90 mg/SOF 400 mg FDC tablet once daily for 24 weeks
OG003	LDV/SOF+RBV 24 Weeks	LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 24 weeks

Secondary

Percentage of Participants With HCV RNA < LLOQ at Week 1

Full Analysis Set

Posted

Number

percentage of participants

Week 1

ID	Title	Description
OG000	LDV/SOF 12 Weeks	LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
OG001	LDV/SOF+RBV 12 Weeks	LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 12 weeks
OG002	LDV/SOF 24 Weeks	LDV 90 mg/SOF 400 mg FDC tablet once daily for 24 weeks
OG003	LDV/SOF+RBV 24 Weeks	LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 24 weeks

Units	Counts
Participants

Secondary

Percentage of Participants With HCV RNA < LLOQ at Week 2

Full Analysis Set

Posted

Number

percentage of participants

Week 2

ID	Title	Description
OG000	LDV/SOF 12 Weeks	LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
OG001	LDV/SOF+RBV 12 Weeks	LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 12 weeks
OG002	LDV/SOF 24 Weeks	LDV 90 mg/SOF 400 mg FDC tablet once daily for 24 weeks
OG003	LDV/SOF+RBV 24 Weeks	LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 24 weeks

Units	Counts
Participants

Secondary

Percentage of Participants With HCV RNA < LLOQ at Week 4

Full Analysis Set

Posted

Number

percentage of participants

Week 4

ID	Title	Description
OG000	LDV/SOF 12 Weeks	LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
OG001	LDV/SOF+RBV 12 Weeks	LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 12 weeks
OG002	LDV/SOF 24 Weeks	LDV 90 mg/SOF 400 mg FDC tablet once daily for 24 weeks
OG003	LDV/SOF+RBV 24 Weeks	LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 24 weeks

Units	Counts
Participants

Secondary

Percentage of Participants With HCV RNA < LLOQ at Week 8

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

Posted

Number

percentage of participants

Week 8

ID	Title	Description
OG000	LDV/SOF 12 Weeks	LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
OG001	LDV/SOF+RBV 12 Weeks	LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 12 weeks
OG002	LDV/SOF 24 Weeks	LDV 90 mg/SOF 400 mg FDC tablet once daily for 24 weeks
OG003	LDV/SOF+RBV 24 Weeks	LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 24 weeks

Units	Counts
Participants

Secondary

Percentage of Participants With HCV RNA < LLOQ at Week 12

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

Posted

Number

percentage of participants

Week 12

ID	Title	Description
OG000	LDV/SOF 12 Weeks	LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
OG001	LDV/SOF+RBV 12 Weeks	LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 12 weeks
OG002	LDV/SOF 24 Weeks	LDV 90 mg/SOF 400 mg FDC tablet once daily for 24 weeks
OG003	LDV/SOF+RBV 24 Weeks	LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 24 weeks

Units	Counts

Secondary

Percentage of Participants With HCV RNA < LLOQ at Week 24

Participants in the Full Analysis Set with available data were analyzed. Participants in the LDV/SOF 12 Weeks and LDV/SOF+RBV 12 Weeks groups did not continue treatment past Week 12 and are not included in the analysis.

Posted

Number

percentage of participants

Week 24

ID	Title	Description
OG000	LDV/SOF 12 Weeks	LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
OG001	LDV/SOF+RBV 12 Weeks	LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 12 weeks
OG002	LDV/SOF 24 Weeks	LDV 90 mg/SOF 400 mg FDC tablet once daily for 24 weeks
OG003	LDV/SOF+RBV 24 Weeks	LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 24 weeks

Secondary

Change From Baseline in HCV RNA at Week 1

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

Posted

Mean

Standard Deviation

log10 IU/mL

Baseline; Week 1

ID	Title	Description
OG000	LDV/SOF 12 Weeks	LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
OG001	LDV/SOF+RBV 12 Weeks	LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 12 weeks
OG002	LDV/SOF 24 Weeks	LDV 90 mg/SOF 400 mg FDC tablet once daily for 24 weeks
OG003	LDV/SOF+RBV 24 Weeks	LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 24 weeks

Units	Counts
Participants

Secondary

Change From Baseline in HCV RNA at Week 2

Full Analysis Set

Posted

Mean

Standard Deviation

log10 IU/mL

Baseline; Week 2

ID	Title	Description
OG000	LDV/SOF 12 Weeks	LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
OG001	LDV/SOF+RBV 12 Weeks	LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 12 weeks
OG002	LDV/SOF 24 Weeks	LDV 90 mg/SOF 400 mg FDC tablet once daily for 24 weeks
OG003	LDV/SOF+RBV 24 Weeks	LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 24 weeks

Units	Counts
Participants

Secondary

Change From Baseline in HCV RNA at Week 4

Full Analysis Set

Posted

Mean

Standard Deviation

log10 IU/mL

Baseline; Week 4

ID	Title	Description
OG000	LDV/SOF 12 Weeks	LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
OG001	LDV/SOF+RBV 12 Weeks	LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 12 weeks
OG002	LDV/SOF 24 Weeks	LDV 90 mg/SOF 400 mg FDC tablet once daily for 24 weeks
OG003	LDV/SOF+RBV 24 Weeks	LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 24 weeks

Units	Counts
Participants

Secondary

Change From Baseline in HCV RNA at Week 8

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

Posted

Mean

Standard Deviation

log10 IU/mL

Baseline; Week 8

ID	Title	Description
OG000	LDV/SOF 12 Weeks	LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
OG001	LDV/SOF+RBV 12 Weeks	LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 12 weeks
OG002	LDV/SOF 24 Weeks	LDV 90 mg/SOF 400 mg FDC tablet once daily for 24 weeks
OG003	LDV/SOF+RBV 24 Weeks	LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 24 weeks

Units	Counts
Participants

Secondary

Percentage of Participants With Virologic Failure

Virologic failure was defined as on-treatment virologic failure or virologic relapse.

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)

Virologic relapse was defined as confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit.

Full Analysis Set

Posted

Number

percentage of participants

Baseline to posttreatment Week 24

ID	Title	Description
OG000	LDV/SOF 12 Weeks	LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
OG001	LDV/SOF+RBV 12 Weeks	LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 12 weeks
OG002	LDV/SOF 24 Weeks	LDV 90 mg/SOF 400 mg FDC tablet once daily for 24 weeks
OG003

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	LDV/SOF 12 Weeks	LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks	0	109	73	109
EG001	LDV/SOF+RBV 12 Weeks	LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 12 weeks	0	111	96	111
EG002	LDV/SOF 24 Weeks	LDV 90 mg/SOF 400 mg FDC tablet once daily for 24 weeks	6	109	87	109
EG003	LDV/SOF+RBV 24 Weeks	LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 24 weeks	3	111	100	111

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Angina unstable	Cardiac disorders	MedDRA (16.0)	Systematic Assessment	EG0000 affected109 at risk EG0010 affected111 at risk EG0021 affected109 at risk EG0030 affected111 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA (16.0)	Systematic Assessment	EG0000 affected109 at risk EG0010 affected111 at risk EG0021 affected109 at risk EG003
Non-cardiac chest pain	General disorders	MedDRA (16.0)	Systematic Assessment	EG0000 affected109 at risk EG0010 affected111 at risk EG0021 affected109 at risk EG003
Cholecystitis acute	Hepatobiliary disorders	MedDRA (16.0)	Systematic Assessment	EG0000 affected109 at risk EG0010 affected111 at risk EG0020 affected109 at risk EG003
Wound infection	Infections and infestations	MedDRA (16.0)	Systematic Assessment	EG0000 affected109 at risk EG0010 affected111 at risk EG0020 affected109 at risk EG003
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA (16.0)	Systematic Assessment	EG0000 affected109 at risk EG0010 affected111 at risk EG0021 affected109 at risk EG003
Spondylolisthesis	Musculoskeletal and connective tissue disorders	MedDRA (16.0)	Systematic Assessment	EG0000 affected109 at risk EG0010 affected111 at risk EG0021 affected109 at risk EG003
Convulsion	Nervous system disorders	MedDRA (16.0)	Systematic Assessment	EG0000 affected109 at risk EG0010 affected111 at risk EG0021 affected109 at risk EG003
Hepatic encephalopathy	Nervous system disorders	MedDRA (16.0)	Systematic Assessment	EG0000 affected109 at risk EG0010 affected111 at risk EG0021 affected109 at risk EG003
Vaginal prolapse	Reproductive system and breast disorders	MedDRA (16.0)	Systematic Assessment	EG0000 affected109 at risk EG0010 affected111 at risk EG0020 affected109 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA (16.0)	Systematic Assessment	EG0000 affected109 at risk EG0019 affected111 at risk EG0021 affected109 at risk EG00312 affected111 at risk
Nausea	Gastrointestinal disorders	MedDRA (16.0)	Systematic Assessment	EG00013 affected109 at risk EG00120 affected111 at risk EG0027 affected109 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA (16.0)	Systematic Assessment	EG0007 affected109 at risk EG0015 affected111 at risk EG0029 affected109 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA (16.0)	Systematic Assessment	EG0002 affected109 at risk EG0014 affected111 at risk EG0026 affected109 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA (16.0)	Systematic Assessment	EG0002 affected109 at risk EG0013 affected111 at risk EG0020 affected109 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA (16.0)	Systematic Assessment	EG0006 affected109 at risk EG0012 affected111 at risk EG0020 affected109 at risk EG003
Fatigue	General disorders	MedDRA (16.0)	Systematic Assessment	EG00023 affected109 at risk EG00145 affected111 at risk EG00226 affected109 at risk EG003
Irritability	General disorders	MedDRA (16.0)	Systematic Assessment	EG0002 affected109 at risk EG00113 affected111 at risk EG0024 affected109 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA (16.0)	Systematic Assessment	EG0004 affected109 at risk EG0016 affected111 at risk EG0027 affected109 at risk EG003
Bronchitis	Infections and infestations	MedDRA (16.0)	Systematic Assessment	EG0002 affected109 at risk EG0013 affected111 at risk EG0024 affected109 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA (16.0)	Systematic Assessment	EG0003 affected109 at risk EG0015 affected111 at risk EG0023 affected109 at risk EG003
Sinusitis	Infections and infestations	MedDRA (16.0)	Systematic Assessment	EG0001 affected109 at risk EG0016 affected111 at risk EG0023 affected109 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (16.0)	Systematic Assessment	EG0007 affected109 at risk EG00113 affected111 at risk EG0027 affected109 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA (16.0)	Systematic Assessment	EG0005 affected109 at risk EG0016 affected111 at risk EG0028 affected109 at risk EG003
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA (16.0)	Systematic Assessment	EG0001 affected109 at risk EG0018 affected111 at risk EG0022 affected109 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (16.0)	Systematic Assessment	EG0003 affected109 at risk EG0013 affected111 at risk EG0024 affected109 at risk EG003
Headache	Nervous system disorders	MedDRA (16.0)	Systematic Assessment	EG00028 affected109 at risk EG00126 affected111 at risk EG00225 affected109 at risk EG003
Dizziness	Nervous system disorders	MedDRA (16.0)	Systematic Assessment	EG0003 affected109 at risk EG0018 affected111 at risk EG0027 affected109 at risk EG003
Insomnia	Psychiatric disorders	MedDRA (16.0)	Systematic Assessment	EG00010 affected109 at risk EG00118 affected111 at risk EG0024 affected109 at risk EG003
Anxiety	Psychiatric disorders	MedDRA (16.0)	Systematic Assessment	EG0002 affected109 at risk EG0017 affected111 at risk EG0024 affected109 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (16.0)	Systematic Assessment	EG0005 affected109 at risk EG00116 affected111 at risk EG0025 affected109 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (16.0)	Systematic Assessment	EG0000 affected109 at risk EG00116 affected111 at risk EG0023 affected109 at risk EG003
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA (16.0)	Systematic Assessment	EG0006 affected109 at risk EG0013 affected111 at risk EG0021 affected109 at risk EG003
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA (16.0)	Systematic Assessment	EG0000 affected109 at risk EG0015 affected111 at risk EG0020 affected109 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA (16.0)	Systematic Assessment	EG0001 affected109 at risk EG0013 affected111 at risk EG0020 affected109 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA (16.0)	Systematic Assessment	EG0002 affected109 at risk EG00111 affected111 at risk EG0026 affected109 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	MedDRA (16.0)	Systematic Assessment	EG0005 affected109 at risk EG00110 affected111 at risk EG0022 affected109 at risk EG003
Dry skin	Skin and subcutaneous tissue disorders	MedDRA (16.0)	Systematic Assessment	EG0000 affected109 at risk EG0013 affected111 at risk EG0023 affected109 at risk EG003

ID	Term
D019698	Hepatitis C, Chronic
D006505	Hepatitis
D006521	Hepatitis, Chronic
D006526	Hepatitis C
D008107	Liver Diseases
D004066	Digestive System Diseases
D006525	Hepatitis, Viral, Human
D014777	Virus Diseases
D004769	Enterovirus Infections
D010850	Picornaviridae Infections
D012327	RNA Virus Infections
D018178	Flaviviridae Infections

Ancestor Terms

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D002908	Chronic Disease
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
C000595958	ledipasvir, sofosbuvir drug combination

Units	Counts
Participants	OG000109 OG001111 OG002109 OG003111

Facility	Status	City	State	ZIP	Country	Contacts
		Phoenix	Arizona		United States