Combination Therapy for Chronic Hepatitis C Infection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT01805882

Recruitment Status : Completed

First Posted : March 6, 2013

Results First Posted : April 11, 2017

Last Update Posted : June 8, 2017

Sponsor:

Information provided by (Responsible Party):

National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )

Study Type	Interventional
Study Design	Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition	Hepatitis C, Chronic
Interventions	Drug: Sofosbuvir Drug: Ledipasvir Drug: GS-9669 Drug: GS-9451
Enrollment	229

Participant Flow

Recruitment Details
Pre-assignment Details


Arm/Group Title	A: HCV GT-1, tx Naive, 12 Wks Sofosbuvir/Ledipasvir	B: HCV GT-1, tx Naive, 6 Wks Sofosbuvir/Ledipasvir/GS-9669	C: HCV GT-1, tx Naive, 6 Wks Sofosbuvir/Ledipasvir/GS-9451	D Retx: HCV GT-1, Re-Treatment, 12 Wks Sofosbuvir, Ledipasvir	D: HCV GT-1, Tx-relapsed, 12 Wks Sofosbuvir/Ledipasvir	E: HCV GT-4, tx Naive/Expd, 12 Wks Sofosbuvir/Ledipasvir	F: HCV GT-1, tx Naive/Expd 6 Wks Sofosbuvir/Ledipasvir/GS-9451	G: HCV GT-1, tx Naive, 4 Wks Sofosbuvir, Ledipasvir, GS-9451	H: HCV GT-1, tx Naive, 4 Wks Sofos/Ledip/GS-9451/GS-9669
Arm/Group Description	Oral treatment with Sofosbuvir 400m...	Oral treatment with Sofosbuvir 400m...	Oral treatment with Sofosbuvir 400m...	Oral treatment with Sofosbuvir 400m...	Oral treatment with Sofosbuvir 400m...	Oral treatment with Sofosbuvir 400m...	Oral treatment with Sofosbuvir 400m...	Oral Treatment with Sofosbuvir 400m...	Oral Treatment with Sofosbuvir 400m...
Arm/Group Description	Oral treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885), once daily, for 12 weeks in HCV genotype 1, treatment naïve patients	Oral treatment with Sofosbuvir 400mg (GS-7977), Ledipasvir 90mg (GS-5885), GS-9669 500mg, once daily, for 6 weeks in HCV genotype 1, treatment naïve patients	Oral treatment with Sofosbuvir 400mg (GS-7977), Ledipasvir 90mg (GS-5885), GS-9451 80mg, once daily, for 6 weeks in HCV genotype 1, treatment naïve patients	Oral treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885), once daily, 12 weeks in HCV genotype 1 subjects who failed HCV therapy in Arm B or Arm G or Arm H	Oral treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885), once daily, for 12 weeks in HCV genotype 1, treatment-relapsed patients who previously received Sofosbuvir plus Ribavirin	Oral treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885), once daily, 12 weeks in HCV genotype 4 treatment naïve subjects and interferon treament experienced subjects	Oral treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885) and GS-9451 80mg, once daily, 6 weeks in HCV genotype 1 treatment naïve and treatment experienced subjects with advanced liver disease	Oral Treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885) with GS-9451 80mg, once daily, 4 weeks in HCV genotype 1 treatment naïve subjects with early stage liver disease	Oral Treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885) with GS-9451 80mg, and GS-9669 250mg, once daily, 4 weeks in HCV genotype 1 treatment naïve subjects with early stage liver disease
Period Title: Overall Study
Started	20	20	20	34	14	21	50	25	25
Completed	20	20	19	32	14	20	48	25	24
Not Completed	0	0	1	2	0	1	2	0	1

Baseline Characteristics

Arm/Group Title		A: HCV GT-1, tx Naive, 12 Wks Sofosbuvir/Ledipasvir	B: HCV GT-1, tx Naive, 6 Wks Sofosbuvir/Ledipasvir/GS-9669	C: HCV GT-1, tx Naive, 6 Wks Sofosbuvir/Ledipasvir/GS-9451	D Retx: HCV GT-1, Re-Treatment, 12 Wks Sofosbuvir, Ledipasvir	D: HCV GT-1, Tx-relapsed, 12 Wks Sofosbuvir/Ledipasvir	E: HCV GT-4, tx Naive/Expd, 12 Wks Sofosbuvir/Ledipasvir	F: HCV GT-1, tx Naive/Expd 6 Wks Sofosbuvir/Ledipasvir/GS-9451	G: HCV GT-1, tx Naive, 4 Wks Sofosbuvir, Ledipasvir, GS-9451	H: HCV GT-1, tx Naive, 4 Wks Sofos/Ledip/GS-9451/GS-9669	Total
Arm/Group Description		Oral treatment with Sofosbuvir 400m...	Oral treatment with Sofosbuvir 400m...	Oral treatment with Sofosbuvir 400m...	Oral treatment with Sofosbuvir 400m...	Oral treatment with Sofosbuvir 400m...	Oral treatment with Sofosbuvir 400m...	Oral treatment with Sofosbuvir 400m...	Oral Treatment with Sofosbuvir 400m...	Oral Treatment with Sofosbuvir 400m...	Total of all reporting groups
Arm/Group Description		Oral treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885), once daily, for 12 weeks in HCV genotype 1, treatment naïve patients	Oral treatment with Sofosbuvir 400mg (GS-7977), Ledipasvir 90mg (GS-5885), GS-9669 500mg, once daily, for 6 weeks in HCV genotype 1, treatment naïve patients	Oral treatment with Sofosbuvir 400mg (GS-7977), Ledipasvir 90mg (GS-5885), GS-9451 80mg, once daily, for 6 weeks in HCV genotype 1, treatment naïve patients	Oral treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885), once daily, 12 weeks in HCV genotype 1 subjects who failed HCV therapy in Arm B or Arm G or Arm H	Oral treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885), once daily, for 12 weeks in HCV genotype 1, treatment-relapsed patients who previously received Sofosbuvir plus Ribavirin	Oral treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885), once daily, 12 weeks in HCV genotype 4 treatment naïve subjects and interferon treament experienced subjects	Oral treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885) and GS-9451 80mg, once daily, 6 weeks in HCV genotype 1 treatment naïve and treatment experienced subjects with advanced liver disease	Oral Treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885) with GS-9451 80mg, once daily, 4 weeks in HCV genotype 1 treatment naïve subjects with early stage liver disease	Oral Treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885) with GS-9451 80mg, and GS-9669 250mg, once daily, 4 weeks in HCV genotype 1 treatment naïve subjects with early stage liver disease	Total of all reporting groups
Overall Number of Baseline Participants		20	20	20	34	14	21	50	25	25	229
Baseline Analysis Population Description		[Not Specified]
Baseline Analysis Population Description		[Not Specified]
Age, Categorical Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	20 participants	20 participants	20 participants	34 participants	14 participants	21 participants	50 participants	25 participants	25 participants	229 participants
	<=18 years	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Between 18 and 65 years	19 95.0%	19 95.0%	19 95.0%	27 79.4%	11 78.6%	19 90.5%	48 96.0%	24 96.0%	19 76.0%	205 89.5%
	>=65 years	1 5.0%	1 5.0%	1 5.0%	7 20.6%	3 21.4%	2 9.5%	2 4.0%	1 4.0%	6 24.0%	24 10.5%
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	20 participants	20 participants	20 participants	34 participants	14 participants	21 participants	50 participants	25 participants	25 participants	229 participants
	Female	6 30.0%	8 40.0%	4 20.0%	6 17.6%	1 7.1%	7 33.3%	17 34.0%	8 32.0%	6 24.0%	63 27.5%
	Male	14 70.0%	12 60.0%	16 80.0%	28 82.4%	13 92.9%	14 66.7%	33 66.0%	17 68.0%	19 76.0%	166 72.5%
Ethnicity (NIH/OMB) Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	20 participants	20 participants	20 participants	34 participants	14 participants	21 participants	50 participants	25 participants	25 participants	229 participants
	Hispanic or Latino	1 5.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	3 6.0%	1 4.0%	0 0.0%	5 2.2%
	Not Hispanic or Latino	19 95.0%	20 100.0%	20 100.0%	34 100.0%	14 100.0%	21 100.0%	46 92.0%	24 96.0%	25 100.0%	223 97.4%
	Unknown or Not Reported	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	1 2.0%	0 0.0%	0 0.0%	1 0.4%
Race (NIH/OMB) Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	20 participants	20 participants	20 participants	34 participants	14 participants	21 participants	50 participants	25 participants	25 participants	229 participants
	American Indian or Alaska Native	1 5.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	1 4.8%	0 0.0%	0 0.0%	0 0.0%	2 0.9%
	Asian	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Native Hawaiian or Other Pacific Islander	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Black or African American	15 75.0%	19 95.0%	18 90.0%	28 82.4%	13 92.9%	9 42.9%	29 58.0%	19 76.0%	19 76.0%	169 73.8%
	White	3 15.0%	1 5.0%	2 10.0%	5 14.7%	1 7.1%	11 52.4%	17 34.0%	4 16.0%	5 20.0%	49 21.4%
	More than one race	1 5.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	2 4.0%	1 4.0%	0 0.0%	4 1.7%
	Unknown or Not Reported	0 0.0%	0 0.0%	0 0.0%	1 2.9%	0 0.0%	0 0.0%	2 4.0%	1 4.0%	1 4.0%	5 2.2%

Outcome Measures

1.Primary Outcome


Title	The Proportion of Subjects Who Achieve Sustained Viral Response (SVR12) 12 Weeks After the Stop of Treatment Drugs
Description	The primary outcome was the proportion of patients with sustained vira...
Description	The primary outcome was the proportion of patients with sustained viral response measured 12 weeks after the stop of treatment. The viral response was assessed by serum HCV RNA concentrations lower than 43 IU/mL - the lower limit of quantification.
Time Frame	12 weeks after stop of treatment

Outcome Measure Data

Analysis Population Description

Subjects who received treatment drugs per arm as listed in the Outcome Measure Description


Arm/Group Title	A: HCV GT-1, tx Naive, 12 Wks Sofosbuvir/Ledipasvir	B: HCV GT-1, tx Naive, 6 Wks Sofosbuvir/Ledipasvir/GS-9669	C: HCV GT-1, tx Naive, 6 Wks Sofosbuvir/Ledipasvir/GS-9451	D Retx: HCV GT-1, Re-Treatment, 12 Wks Sofosbuvir, Ledipasvir	D: HCV GT-1, Tx-relapsed, 12 Wks Sofosbuvir/Ledipasvir	E: HCV GT-4, tx Naive/Expd, 12 Wks Sofosbuvir/Ledipasvir	F: HCV GT-1, tx Naive/Expd 6 Wks Sofosbuvir/Ledipasvir/GS-9451	G: HCV GT-1, tx Naive, 4 Wks Sofosbuvir, Ledipasvir, GS-9451	H: HCV GT-1, tx Naive, 4 Wks Sofos/Ledip/GS-9451/GS-9669
Arm/Group Description:	Oral treatment with Sofosbuvir 400m...	Oral treatment with Sofosbuvir 400m...	Oral treatment with Sofosbuvir 400m...	Oral treatment with Sofosbuvir 400m...	Oral treatment with Sofosbuvir 400m...	Oral treatment with Sofosbuvir 400m...	Oral treatment with Sofosbuvir 400m...	Oral Treatment with Sofosbuvir 400m...	Oral Treatment with Sofosbuvir 400m...
Arm/Group Description:	Oral treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885), once daily, for 12 weeks in HCV genotype 1, treatment naïve patients	Oral treatment with Sofosbuvir 400mg (GS-7977), Ledipasvir 90mg (GS-5885), GS-9669 500mg, once daily, for 6 weeks in HCV genotype 1, treatment naïve patients	Oral treatment with Sofosbuvir 400mg (GS-7977), Ledipasvir 90mg (GS-5885), GS-9451 80mg, once daily, for 6 weeks in HCV genotype 1, treatment naïve patients	Oral treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885), once daily, 12 weeks in HCV genotype 1 subjects who failed HCV therapy in Arm B or Arm G or Arm H	Oral treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885), once daily, for 12 weeks in HCV genotype 1, treatment-relapsed patients who previously received Sofosbuvir plus Ribavirin	Oral treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885), once daily, 12 weeks in HCV genotype 4 treatment naïve subjects and interferon treament experienced subjects	Oral treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885) and GS-9451 80mg, once daily, 6 weeks in HCV genotype 1 treatment naïve and treatment experienced subjects with advanced liver disease	Oral Treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885) with GS-9451 80mg, once daily, 4 weeks in HCV genotype 1 treatment naïve subjects with early stage liver disease	Oral Treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885) with GS-9451 80mg, and GS-9669 250mg, once daily, 4 weeks in HCV genotype 1 treatment naïve subjects with early stage liver disease
Overall Number of Participants Analyzed	20	20	20	34	14	21	50	25	25
Measure Type: Number Number (95% Confidence Interval) Unit of Measure: percentage of subjects
	100 (83 to 100)	95 (75 to 100)	95 (75 to 100)	91.2 (76 to 98)	100 (83 to 100)	95 (76 to 100)	76 (60 to 85)	40 (21 to 61)	20 (7 to 41)

Adverse Events

Time Frame	[Not Specified]
Adverse Event Reporting Description	[Not Specified]

Arm/Group Title	A: HCV GT-1, tx Naive, 12 Wks Sofosbuvir/Ledipasvir	B: HCV GT-1, tx Naive, 6 Wks Sofosbuvir/Ledipasvir/GS-9669	C: HCV GT-1, tx Naive, 6 Wks Sofosbuvir/Ledipasvir/GS-9451	D Retx: HCV GT-1, Re-Treatment, 12 Wks Sofosbuvir, Ledipasvir	D: HCV GT-1, Tx-relapsed, 12 Wks Sofosbuvir/Ledipasvir	E: HCV GT-4, tx Naive/Expd, 12 Wks Sofosbuvir/Ledipasvir	F: HCV GT-1, tx Naive/Expd 6 Wks Sofosbuvir/Ledipasvir/GS-9451	G: HCV GT-1, tx Naive, 4 Wks Sofosbuvir, Ledipasvir, GS-9451	H: HCV GT-1, tx Naive, 4 Wks Sofos/Ledip/GS-9451/GS-9669
Arm/Group Description	Oral treatment with Sofosbuvir 400m...	Oral treatment with Sofosbuvir 400m...	Oral treatment with Sofosbuvir 400m...	Oral treatment with Sofosbuvir 400m...	Oral treatment with Sofosbuvir 400m...	Oral treatment with Sofosbuvir 400m...	Oral treatment with Sofosbuvir 400m...	Oral Treatment with Sofosbuvir 400m...	Oral Treatment with Sofosbuvir 400m...
Arm/Group Description	Oral treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885), once daily, for 12 weeks in HCV genotype 1, treatment naïve patients	Oral treatment with Sofosbuvir 400mg (GS-7977), Ledipasvir 90mg (GS-5885), GS-9669 500mg, once daily, for 6 weeks in HCV genotype 1, treatment naïve patients	Oral treatment with Sofosbuvir 400mg (GS-7977), Ledipasvir 90mg (GS-5885), GS-9451 80mg, once daily, for 6 weeks in HCV genotype 1, treatment naïve patients	Oral treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885), once daily, 12 weeks in HCV genotype 1 subjects who failed HCV therapy in Arm B or Arm G or Arm H	Oral treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885), once daily, for 12 weeks in HCV genotype 1, treatment-relapsed patients who previously received Sofosbuvir plus Ribavirin	Oral treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885), once daily, 12 weeks in HCV genotype 4 treatment naïve subjects and interferon treament experienced subjects	Oral treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885) and GS-9451 80mg, once daily, 6 weeks in HCV genotype 1 treatment naïve and treatment experienced subjects with advanced liver disease	Oral Treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885) with GS-9451 80mg, once daily, 4 weeks in HCV genotype 1 treatment naïve subjects with early stage liver disease	Oral Treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885) with GS-9451 80mg, and GS-9669 250mg, once daily, 4 weeks in HCV genotype 1 treatment naïve subjects with early stage liver disease
All-Cause Mortality
	A: HCV GT-1, tx Naive, 12 Wks Sofosbuvir/Ledipasvir	B: HCV GT-1, tx Naive, 6 Wks Sofosbuvir/Ledipasvir/GS-9669	C: HCV GT-1, tx Naive, 6 Wks Sofosbuvir/Ledipasvir/GS-9451	D Retx: HCV GT-1, Re-Treatment, 12 Wks Sofosbuvir, Ledipasvir	D: HCV GT-1, Tx-relapsed, 12 Wks Sofosbuvir/Ledipasvir	E: HCV GT-4, tx Naive/Expd, 12 Wks Sofosbuvir/Ledipasvir	F: HCV GT-1, tx Naive/Expd 6 Wks Sofosbuvir/Ledipasvir/GS-9451	G: HCV GT-1, tx Naive, 4 Wks Sofosbuvir, Ledipasvir, GS-9451	H: HCV GT-1, tx Naive, 4 Wks Sofos/Ledip/GS-9451/GS-9669
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	--/--	--/--	--/--	--/--	--/--	--/--	--/--	--/--	--/--
Serious Adverse Events Serious Adverse Events
	A: HCV GT-1, tx Naive, 12 Wks Sofosbuvir/Ledipasvir	B: HCV GT-1, tx Naive, 6 Wks Sofosbuvir/Ledipasvir/GS-9669	C: HCV GT-1, tx Naive, 6 Wks Sofosbuvir/Ledipasvir/GS-9451	D Retx: HCV GT-1, Re-Treatment, 12 Wks Sofosbuvir, Ledipasvir	D: HCV GT-1, Tx-relapsed, 12 Wks Sofosbuvir/Ledipasvir	E: HCV GT-4, tx Naive/Expd, 12 Wks Sofosbuvir/Ledipasvir	F: HCV GT-1, tx Naive/Expd 6 Wks Sofosbuvir/Ledipasvir/GS-9451	G: HCV GT-1, tx Naive, 4 Wks Sofosbuvir, Ledipasvir, GS-9451	H: HCV GT-1, tx Naive, 4 Wks Sofos/Ledip/GS-9451/GS-9669
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/20 (0.00%)	0/20 (0.00%)	2/20 (10.00%)	1/34 (2.94%)	1/14 (7.14%)	0/21 (0.00%)	2/50 (4.00%)	0/25 (0.00%)	1/25 (4.00%)
Cardiac disorders
Angina pectoris ^†	0/20 (0.00%)	0/20 (0.00%)	0/20 (0.00%)	1/34 (2.94%)	0/14 (0.00%)	0/21 (0.00%)	0/50 (0.00%)	0/25 (0.00%)	0/25 (0.00%)
Bradycardia ^†	0/20 (0.00%)	0/20 (0.00%)	0/20 (0.00%)	0/34 (0.00%)	0/14 (0.00%)	0/21 (0.00%)	0/50 (0.00%)	0/25 (0.00%)	1/25 (4.00%)
Ear and labyrinth disorders
Vertigo ^†	0/20 (0.00%)	0/20 (0.00%)	1/20 (5.00%)	0/34 (0.00%)	0/14 (0.00%)	0/21 (0.00%)	0/50 (0.00%)	0/25 (0.00%)	0/25 (0.00%)
Gastrointestinal disorders
Colitis ^†	0/20 (0.00%)	0/20 (0.00%)	0/20 (0.00%)	0/34 (0.00%)	0/14 (0.00%)	0/21 (0.00%)	1/50 (2.00%)	0/25 (0.00%)	0/25 (0.00%)
General disorders
Pain ^†	0/20 (0.00%)	0/20 (0.00%)	1/20 (5.00%)	0/34 (0.00%)	0/14 (0.00%)	0/21 (0.00%)	0/50 (0.00%)	0/25 (0.00%)	0/25 (0.00%)
Infections and infestations
Influenza ^†	0/20 (0.00%)	0/20 (0.00%)	0/20 (0.00%)	0/34 (0.00%)	1/14 (7.14%)	0/21 (0.00%)	0/50 (0.00%)	0/25 (0.00%)	0/25 (0.00%)
Injury, poisoning and procedural complications
Transfusion reaction ^†	0/20 (0.00%)	0/20 (0.00%)	0/20 (0.00%)	0/34 (0.00%)	0/14 (0.00%)	0/21 (0.00%)	1/50 (2.00%)	0/25 (0.00%)	0/25 (0.00%)
Investigations
Haemoglobin decreased ^†	0/20 (0.00%)	0/20 (0.00%)	0/20 (0.00%)	0/34 (0.00%)	0/14 (0.00%)	0/21 (0.00%)	1/50 (2.00%)	0/25 (0.00%)	0/25 (0.00%)
† Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	A: HCV GT-1, tx Naive, 12 Wks Sofosbuvir/Ledipasvir	B: HCV GT-1, tx Naive, 6 Wks Sofosbuvir/Ledipasvir/GS-9669	C: HCV GT-1, tx Naive, 6 Wks Sofosbuvir/Ledipasvir/GS-9451	D Retx: HCV GT-1, Re-Treatment, 12 Wks Sofosbuvir, Ledipasvir	D: HCV GT-1, Tx-relapsed, 12 Wks Sofosbuvir/Ledipasvir	E: HCV GT-4, tx Naive/Expd, 12 Wks Sofosbuvir/Ledipasvir	F: HCV GT-1, tx Naive/Expd 6 Wks Sofosbuvir/Ledipasvir/GS-9451	G: HCV GT-1, tx Naive, 4 Wks Sofosbuvir, Ledipasvir, GS-9451	H: HCV GT-1, tx Naive, 4 Wks Sofos/Ledip/GS-9451/GS-9669
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	17/20 (85.00%)	20/20 (100.00%)	20/20 (100.00%)	34/34 (100.00%)	14/14 (100.00%)	17/21 (80.95%)	48/50 (96.00%)	24/25 (96.00%)	25/25 (100.00%)
Cardiac disorders
Coronary artery disease ^†	0/20 (0.00%)	0/20 (0.00%)	0/20 (0.00%)	1/34 (2.94%)	0/14 (0.00%)	0/21 (0.00%)	0/50 (0.00%)	0/25 (0.00%)	0/25 (0.00%)
Ear and labyrinth disorders
Ear pain ^†	1/20 (5.00%)	0/20 (0.00%)	0/20 (0.00%)	0/34 (0.00%)	0/14 (0.00%)	0/21 (0.00%)	0/50 (0.00%)	0/25 (0.00%)	0/25 (0.00%)
Vertigo ^†	0/20 (0.00%)	0/20 (0.00%)	1/20 (5.00%)	0/34 (0.00%)	0/14 (0.00%)	0/21 (0.00%)	0/50 (0.00%)	0/25 (0.00%)	0/25 (0.00%)
Eye disorders
Conjunctival haemorrhage ^†	0/20 (0.00%)	0/20 (0.00%)	0/20 (0.00%)	0/34 (0.00%)	0/14 (0.00%)	0/21 (0.00%)	1/50 (2.00%)	0/25 (0.00%)	0/25 (0.00%)
Lacrimation increased ^†	0/20 (0.00%)	0/20 (0.00%)	1/20 (5.00%)	0/34 (0.00%)	0/14 (0.00%)	0/21 (0.00%)	0/50 (0.00%)	0/25 (0.00%)	0/25 (0.00%)
Gastrointestinal disorders
Abdominal distension ^†	0/20 (0.00%)	0/20 (0.00%)	0/20 (0.00%)	0/34 (0.00%)	0/14 (0.00%)	0/21 (0.00%)	0/50 (0.00%)	0/25 (0.00%)	2/25 (8.00%)
Abdominal pain ^†	1/20 (5.00%)	1/20 (5.00%)	0/20 (0.00%)	0/34 (0.00%)	0/14 (0.00%)	0/21 (0.00%)	1/50 (2.00%)	0/25 (0.00%)	4/25 (16.00%)
Abdominal tenderness ^†	0/20 (0.00%)	0/20 (0.00%)	0/20 (0.00%)	0/34 (0.00%)	0/14 (0.00%)	0/21 (0.00%)	0/50 (0.00%)	0/25 (0.00%)	1/25 (4.00%)
Constipation ^†	0/20 (0.00%)	2/20 (10.00%)	1/20 (5.00%)	2/34 (5.88%)	1/14 (7.14%)	0/21 (0.00%)	3/50 (6.00%)	3/25 (12.00%)	3/25 (12.00%)
Diarrhoea ^†	1/20 (5.00%)	6/20 (30.00%)	3/20 (15.00%)	0/34 (0.00%)	1/14 (7.14%)	3/21 (14.29%)	4/50 (8.00%)	1/25 (4.00%)	5/25 (20.00%)
Dry mouth ^†	0/20 (0.00%)	0/20 (0.00%)	1/20 (5.00%)	0/34 (0.00%)	0/14 (0.00%)	1/21 (4.76%)	1/50 (2.00%)	4/25 (16.00%)	3/25 (12.00%)
Dyspepsia ^†	0/20 (0.00%)	0/20 (0.00%)	1/20 (5.00%)	0/34 (0.00%)	0/14 (0.00%)	1/21 (4.76%)	0/50 (0.00%)	0/25 (0.00%)	1/25 (4.00%)
Flatulence ^†	0/20 (0.00%)	1/20 (5.00%)	0/20 (0.00%)	0/34 (0.00%)	1/14 (7.14%)	0/21 (0.00%)	2/50 (4.00%)	0/25 (0.00%)	0/25 (0.00%)
Gastritis ^†	1/20 (5.00%)	0/20 (0.00%)	0/20 (0.00%)	0/34 (0.00%)	0/14 (0.00%)	0/21 (0.00%)	0/50 (0.00%)	0/25 (0.00%)	0/25 (0.00%)
Nausea ^†	0/20 (0.00%)	2/20 (10.00%)	2/20 (10.00%)	1/34 (2.94%)	0/14 (0.00%)	2/21 (9.52%)	5/50 (10.00%)	0/25 (0.00%)	8/25 (32.00%)
Peptic ulcer ^†	0/20 (0.00%)	0/20 (0.00%)	0/20 (0.00%)	0/34 (0.00%)	0/14 (0.00%)	0/21 (0.00%)	1/50 (2.00%)	0/25 (0.00%)	0/25 (0.00%)
Stomatitis ^†	0/20 (0.00%)	0/20 (0.00%)	0/20 (0.00%)	0/34 (0.00%)	0/14 (0.00%)	0/21 (0.00%)	0/50 (0.00%)	0/25 (0.00%)	1/25 (4.00%)
Vomiting ^†	1/20 (5.00%)	2/20 (10.00%)	0/20 (0.00%)	1/34 (2.94%)	0/14 (0.00%)	0/21 (0.00%)	3/50 (6.00%)	0/25 (0.00%)	0/25 (0.00%)
General disorders
Face oedema ^†	0/20 (0.00%)	0/20 (0.00%)	0/20 (0.00%)	0/34 (0.00%)	0/14 (0.00%)	0/21 (0.00%)	1/50 (2.00%)	0/25 (0.00%)	0/25 (0.00%)
Fatigue ^†	1/20 (5.00%)	2/20 (10.00%)	4/20 (20.00%)	2/34 (5.88%)	0/14 (0.00%)	3/21 (14.29%)	6/50 (12.00%)	4/25 (16.00%)	4/25 (16.00%)
Influenza like illness ^†	0/20 (0.00%)	1/20 (5.00%)	0/20 (0.00%)	0/34 (0.00%)	0/14 (0.00%)	0/21 (0.00%)	0/50 (0.00%)	0/25 (0.00%)	0/25 (0.00%)
Localised oedema ^†	0/20 (0.00%)	1/20 (5.00%)	0/20 (0.00%)	0/34 (0.00%)	0/14 (0.00%)	2/21 (9.52%)	0/50 (0.00%)	1/25 (4.00%)	1/25 (4.00%)
Non-cardiac chest pain ^†	0/20 (0.00%)	0/20 (0.00%)	0/20 (0.00%)	1/34 (2.94%)	0/14 (0.00%)	0/21 (0.00%)	0/50 (0.00%)	0/25 (0.00%)	0/25 (0.00%)
Oedema peripheral ^†	0/20 (0.00%)	0/20 (0.00%)	0/20 (0.00%)	0/34 (0.00%)	0/14 (0.00%)	0/21 (0.00%)	1/50 (2.00%)	0/25 (0.00%)	0/25 (0.00%)
Pain ^†	2/20 (10.00%)	2/20 (10.00%)	1/20 (5.00%)	0/34 (0.00%)	0/14 (0.00%)	1/21 (4.76%)	1/50 (2.00%)	1/25 (4.00%)	0/25 (0.00%)
Pyrexia ^†	0/20 (0.00%)	0/20 (0.00%)	1/20 (5.00%)	0/34 (0.00%)	0/14 (0.00%)	0/21 (0.00%)	0/50 (0.00%)	0/25 (0.00%)	0/25 (0.00%)
Immune system disorders
Hypersensitivity ^†	0/20 (0.00%)	0/20 (0.00%)	0/20 (0.00%)	1/34 (2.94%)	0/14 (0.00%)	0/21 (0.00%)	0/50 (0.00%)	0/25 (0.00%)	0/25 (0.00%)
Seasonal allergy ^†	0/20 (0.00%)	0/20 (0.00%)	0/20 (0.00%)	0/34 (0.00%)	0/14 (0.00%)	0/21 (0.00%)	0/50 (0.00%)	1/25 (4.00%)	0/25 (0.00%)
Infections and infestations
Bronchitis ^†	1/20 (5.00%)	0/20 (0.00%)	0/20 (0.00%)	0/34 (0.00%)	0/14 (0.00%)	0/21 (0.00%)	0/50 (0.00%)	0/25 (0.00%)	0/25 (0.00%)
Cellulitis ^†	0/20 (0.00%)	0/20 (0.00%)	0/20 (0.00%)	0/34 (0.00%)	0/14 (0.00%)	0/21 (0.00%)	2/50 (4.00%)	1/25 (4.00%)	0/25 (0.00%)
Chlamydial infection ^†	0/20 (0.00%)	0/20 (0.00%)	0/20 (0.00%)	0/34 (0.00%)	0/14 (0.00%)	1/21 (4.76%)	0/50 (0.00%)	0/25 (0.00%)	0/25 (0.00%)
Diarrhoea infectious ^†	0/20 (0.00%)	0/20 (0.00%)	0/20 (0.00%)	0/34 (0.00%)	0/14 (0.00%)	0/21 (0.00%)	0/50 (0.00%)	1/25 (4.00%)	0/25 (0.00%)
Herpes zoster ^†	0/20 (0.00%)	0/20 (0.00%)	0/20 (0.00%)	0/34 (0.00%)	1/14 (7.14%)	0/21 (0.00%)	0/50 (0.00%)	0/25 (0.00%)	0/25 (0.00%)
Hordeolum ^†	0/20 (0.00%)	0/20 (0.00%)	1/20 (5.00%)	1/34 (2.94%)	0/14 (0.00%)	0/21 (0.00%)	0/50 (0.00%)	0/25 (0.00%)	0/25 (0.00%)
Nasopharyngitis ^†	4/20 (20.00%)	1/20 (5.00%)	1/20 (5.00%)	0/34 (0.00%)	0/14 (0.00%)	0/21 (0.00%)	3/50 (6.00%)	1/25 (4.00%)	0/25 (0.00%)
Sinusitis ^†	0/20 (0.00%)	0/20 (0.00%)	0/20 (0.00%)	0/34 (0.00%)	0/14 (0.00%)	0/21 (0.00%)	1/50 (2.00%)	0/25 (0.00%)	0/25 (0.00%)
Staphylococcal infection ^†	1/20 (5.00%)	0/20 (0.00%)	0/20 (0.00%)	0/34 (0.00%)	0/14 (0.00%)	0/21 (0.00%)	0/50 (0.00%)	0/25 (0.00%)	0/25 (0.00%)
Tooth infection ^†	0/20 (0.00%)	0/20 (0.00%)	0/20 (0.00%)	1/34 (2.94%)	0/14 (0.00%)	0/21 (0.00%)	0/50 (0.00%)	0/25 (0.00%)	0/25 (0.00%)
Upper respiratory tract infection ^†	0/20 (0.00%)	0/20 (0.00%)	0/20 (0.00%)	0/34 (0.00%)	0/14 (0.00%)	2/21 (9.52%)	1/50 (2.00%)	0/25 (0.00%)	0/25 (0.00%)
Urethritis trichomonal ^†	0/20 (0.00%)	0/20 (0.00%)	0/20 (0.00%)	1/34 (2.94%)	0/14 (0.00%)	0/21 (0.00%)	0/50 (0.00%)	0/25 (0.00%)	0/25 (0.00%)
Urinary tract infection ^†	0/20 (0.00%)	0/20 (0.00%)	0/20 (0.00%)	2/34 (5.88%)	0/14 (0.00%)	0/21 (0.00%)	1/50 (2.00%)	0/25 (0.00%)	0/25 (0.00%)
Vaginitis bacterial ^†	0/20 (0.00%)	0/20 (0.00%)	1/20 (5.00%)	0/34 (0.00%)	0/14 (0.00%)	0/21 (0.00%)	0/50 (0.00%)	0/25 (0.00%)	0/25 (0.00%)
Wound infection ^†	0/20 (0.00%)	0/20 (0.00%)	0/20 (0.00%)	1/34 (2.94%)	0/14 (0.00%)	0/21 (0.00%)	0/50 (0.00%)	0/25 (0.00%)	0/25 (0.00%)
Injury, poisoning and procedural complications
Arthropod bite ^†	0/20 (0.00%)	0/20 (0.00%)	0/20 (0.00%)	0/34 (0.00%)	0/14 (0.00%)	0/21 (0.00%)	1/50 (2.00%)	0/25 (0.00%)	0/25 (0.00%)
Injury ^†	0/20 (0.00%)	0/20 (0.00%)	1/20 (5.00%)	0/34 (0.00%)	0/14 (0.00%)	0/21 (0.00%)	1/50 (2.00%)	0/25 (0.00%)	0/25 (0.00%)
Laceration ^†	0/20 (0.00%)	0/20 (0.00%)	1/20 (5.00%)	1/34 (2.94%)	0/14 (0.00%)	0/21 (0.00%)	0/50 (0.00%)	0/25 (0.00%)	0/25 (0.00%)
Muscle strain ^†	1/20 (5.00%)	0/20 (0.00%)	0/20 (0.00%)	0/34 (0.00%)	0/14 (0.00%)	0/21 (0.00%)	0/50 (0.00%)	1/25 (4.00%)	1/25 (4.00%)
Investigations
Activated partial thromboplastin time prolonged ^†	0/20 (0.00%)	0/20 (0.00%)	0/20 (0.00%)	0/34 (0.00%)	0/14 (0.00%)	0/21 (0.00%)	2/50 (4.00%)	1/25 (4.00%)	1/25 (4.00%)
Alanine aminotransferase increased ^†	1/20 (5.00%)	2/20 (10.00%)	0/20 (0.00%)	2/34 (5.88%)	0/14 (0.00%)	0/21 (0.00%)	8/50 (16.00%)	1/25 (4.00%)	1/25 (4.00%)
Amylase increased ^†	0/20 (0.00%)	0/20 (0.00%)	0/20 (0.00%)	5/34 (14.71%)	0/14 (0.00%)	1/21 (4.76%)	11/50 (22.00%)	3/25 (12.00%)	1/25 (4.00%)
Aspartate aminotransferase increased ^†	2/20 (10.00%)	2/20 (10.00%)	2/20 (10.00%)	3/34 (8.82%)	0/14 (0.00%)	0/21 (0.00%)	9/50 (18.00%)	2/25 (8.00%)	2/25 (8.00%)
Blood alkaline phosphatase increased ^†	0/20 (0.00%)	2/20 (10.00%)	0/20 (0.00%)	0/34 (0.00%)	0/14 (0.00%)	2/21 (9.52%)	1/50 (2.00%)	0/25 (0.00%)	1/25 (4.00%)
Blood bicarbonate abnormal ^†	0/20 (0.00%)	0/20 (0.00%)	0/20 (0.00%)	2/34 (5.88%)	1/14 (7.14%)	0/21 (0.00%)	4/50 (8.00%)	0/25 (0.00%)	1/25 (4.00%)
Blood bilirubin increased ^†	0/20 (0.00%)	1/20 (5.00%)	5/20 (25.00%)	0/34 (0.00%)	1/14 (7.14%)	2/21 (9.52%)	2/50 (4.00%)	0/25 (0.00%)	3/25 (12.00%)
Blood cholesterol increased ^†	4/20 (20.00%)	3/20 (15.00%)	3/20 (15.00%)	17/34 (50.00%)	3/14 (21.43%)	5/21 (23.81%)	4/50 (8.00%)	7/25 (28.00%)	5/25 (20.00%)
Blood creatine phosphokinase increased ^†	2/20 (10.00%)	0/20 (0.00%)	0/20 (0.00%)	0/34 (0.00%)	0/14 (0.00%)	0/21 (0.00%)	0/50 (0.00%)	0/25 (0.00%)	0/25 (0.00%)
Blood creatinine increased ^†	0/20 (0.00%)	1/20 (5.00%)	4/20 (20.00%)	6/34 (17.65%)	2/14 (14.29%)	3/21 (14.29%)	1/50 (2.00%)	1/25 (4.00%)	0/25 (0.00%)
Haemoglobin decreased ^†	0/20 (0.00%)	1/20 (5.00%)	3/20 (15.00%)	0/34 (0.00%)	0/14 (0.00%)	1/21 (4.76%)	6/50 (12.00%)	0/25 (0.00%)	0/25 (0.00%)
Lipase increased ^†	1/20 (5.00%)	0/20 (0.00%)	0/20 (0.00%)	0/34 (0.00%)	1/14 (7.14%)	2/21 (9.52%)	4/50 (8.00%)	0/25 (0.00%)	1/25 (4.00%)
Low density lipoprotein increased ^†	2/20 (10.00%)	2/20 (10.00%)	0/20 (0.00%)	10/34 (29.41%)	3/14 (21.43%)	5/21 (23.81%)	3/50 (6.00%)	5/25 (20.00%)	4/25 (16.00%)
Lymphocyte count decreased ^†	0/20 (0.00%)	0/20 (0.00%)	0/20 (0.00%)	0/34 (0.00%)	0/14 (0.00%)	1/21 (4.76%)	2/50 (4.00%)	0/25 (0.00%)	0/25 (0.00%)
Neutrophil count decreased ^†	4/20 (20.00%)	1/20 (5.00%)	1/20 (5.00%)	3/34 (8.82%)	1/14 (7.14%)	2/21 (9.52%)	3/50 (6.00%)	2/25 (8.00%)	3/25 (12.00%)
Platelet count decreased ^†	3/20 (15.00%)	1/20 (5.00%)	2/20 (10.00%)	1/34 (2.94%)	0/14 (0.00%)	2/21 (9.52%)	5/50 (10.00%)	0/25 (0.00%)	0/25 (0.00%)
Tuberculin test positive ^†	1/20 (5.00%)	0/20 (0.00%)	0/20 (0.00%)	0/34 (0.00%)	1/14 (7.14%)	0/21 (0.00%)	0/50 (0.00%)	0/25 (0.00%)	0/25 (0.00%)
White blood cell count decreased ^†	0/20 (0.00%)	0/20 (0.00%)	0/20 (0.00%)	0/34 (0.00%)	0/14 (0.00%)	1/21 (4.76%)	1/50 (2.00%)	0/25 (0.00%)	0/25 (0.00%)
Metabolism and nutrition disorders
Decreased appetite ^†	0/20 (0.00%)	0/20 (0.00%)	0/20 (0.00%)	0/34 (0.00%)	0/14 (0.00%)	0/21 (0.00%)	0/50 (0.00%)	1/25 (4.00%)	0/25 (0.00%)
Diabetes mellitus ^†	0/20 (0.00%)	0/20 (0.00%)	0/20 (0.00%)	1/34 (2.94%)	0/14 (0.00%)	0/21 (0.00%)	0/50 (0.00%)	0/25 (0.00%)	0/25 (0.00%)
Hypercalcaemia ^†	0/20 (0.00%)	0/20 (0.00%)	0/20 (0.00%)	4/34 (11.76%)	0/14 (0.00%)	1/21 (4.76%)	3/50 (6.00%)	2/25 (8.00%)	2/25 (8.00%)
Hyperglycaemia ^†	6/20 (30.00%)	9/20 (45.00%)	9/20 (45.00%)	12/34 (35.29%)	6/14 (42.86%)	8/21 (38.10%)	20/50 (40.00%)	6/25 (24.00%)	9/25 (36.00%)
Hyperkalaemia ^†	0/20 (0.00%)	0/20 (0.00%)	0/20 (0.00%)	0/34 (0.00%)	0/14 (0.00%)	0/21 (0.00%)	0/50 (0.00%)	0/25 (0.00%)	1/25 (4.00%)
Hypernatraemia ^†	1/20 (5.00%)	0/20 (0.00%)	1/20 (5.00%)	4/34 (11.76%)	0/14 (0.00%)	0/21 (0.00%)	2/50 (4.00%)	2/25 (8.00%)	6/25 (24.00%)
Hypoalbuminaemia ^†	4/20 (20.00%)	8/20 (40.00%)	8/20 (40.00%)	0/34 (0.00%)	2/14 (14.29%)	2/21 (9.52%)	3/50 (6.00%)	0/25 (0.00%)	1/25 (4.00%)
Hypocalcaemia ^†	0/20 (0.00%)	0/20 (0.00%)	2/20 (10.00%)	0/34 (0.00%)	0/14 (0.00%)	0/21 (0.00%)	1/50 (2.00%)	0/25 (0.00%)	0/25 (0.00%)
Hypoglycaemia ^†	2/20 (10.00%)	1/20 (5.00%)	0/20 (0.00%)	4/34 (11.76%)	1/14 (7.14%)	2/21 (9.52%)	4/50 (8.00%)	3/25 (12.00%)	1/25 (4.00%)
Hypokalaemia ^†	1/20 (5.00%)	1/20 (5.00%)	0/20 (0.00%)	4/34 (11.76%)	0/14 (0.00%)	1/21 (4.76%)	2/50 (4.00%)	1/25 (4.00%)	3/25 (12.00%)
Hypomagnesaemia ^†	1/20 (5.00%)	1/20 (5.00%)	3/20 (15.00%)	0/34 (0.00%)	0/14 (0.00%)	0/21 (0.00%)	1/50 (2.00%)	0/25 (0.00%)	0/25 (0.00%)
Hyponatraemia ^†	0/20 (0.00%)	1/20 (5.00%)	1/20 (5.00%)	0/34 (0.00%)	1/14 (7.14%)	0/21 (0.00%)	3/50 (6.00%)	2/25 (8.00%)	0/25 (0.00%)
Hypophosphataemia ^†	7/20 (35.00%)	6/20 (30.00%)	4/20 (20.00%)	8/34 (23.53%)	2/14 (14.29%)	6/21 (28.57%)	5/50 (10.00%)	4/25 (16.00%)	0/25 (0.00%)
Musculoskeletal and connective tissue disorders
Arthralgia ^†	2/20 (10.00%)	0/20 (0.00%)	1/20 (5.00%)	0/34 (0.00%)	0/14 (0.00%)	0/21 (0.00%)	1/50 (2.00%)	1/25 (4.00%)	1/25 (4.00%)
Back pain ^†	1/20 (5.00%)	0/20 (0.00%)	1/20 (5.00%)	0/34 (0.00%)	1/14 (7.14%)	0/21 (0.00%)	0/50 (0.00%)	1/25 (4.00%)	0/25 (0.00%)
Flank pain ^†	0/20 (0.00%)	0/20 (0.00%)	0/20 (0.00%)	0/34 (0.00%)	0/14 (0.00%)	0/21 (0.00%)	1/50 (2.00%)	0/25 (0.00%)	0/25 (0.00%)
Muscle spasms ^†	0/20 (0.00%)	0/20 (0.00%)	0/20 (0.00%)	0/34 (0.00%)	0/14 (0.00%)	0/21 (0.00%)	1/50 (2.00%)	1/25 (4.00%)	1/25 (4.00%)
Musculoskeletal stiffness ^†	1/20 (5.00%)	0/20 (0.00%)	0/20 (0.00%)	0/34 (0.00%)	0/14 (0.00%)	0/21 (0.00%)	0/50 (0.00%)	0/25 (0.00%)	0/25 (0.00%)
Myalgia ^†	1/20 (5.00%)	0/20 (0.00%)	0/20 (0.00%)	0/34 (0.00%)	1/14 (7.14%)	1/21 (4.76%)	3/50 (6.00%)	0/25 (0.00%)	1/25 (4.00%)
Neck pain ^†	0/20 (0.00%)	0/20 (0.00%)	0/20 (0.00%)	0/34 (0.00%)	0/14 (0.00%)	0/21 (0.00%)	0/50 (0.00%)	0/25 (0.00%)	1/25 (4.00%)
Osteoporosis ^†	0/20 (0.00%)	0/20 (0.00%)	0/20 (0.00%)	0/34 (0.00%)	0/14 (0.00%)	0/21 (0.00%)	1/50 (2.00%)	0/25 (0.00%)	0/25 (0.00%)
Pain in extremity ^†	1/20 (5.00%)	0/20 (0.00%)	0/20 (0.00%)	0/34 (0.00%)	0/14 (0.00%)	0/21 (0.00%)	0/50 (0.00%)	0/25 (0.00%)	0/25 (0.00%)
Nervous system disorders
Dizziness ^†	1/20 (5.00%)	2/20 (10.00%)	0/20 (0.00%)	0/34 (0.00%)	0/14 (0.00%)	0/21 (0.00%)	3/50 (6.00%)	1/25 (4.00%)	6/25 (24.00%)
Headache ^†	5/20 (25.00%)	5/20 (25.00%)	0/20 (0.00%)	1/34 (2.94%)	2/14 (14.29%)	2/21 (9.52%)	4/50 (8.00%)	1/25 (4.00%)	7/25 (28.00%)
Hypoaesthesia ^†	0/20 (0.00%)	0/20 (0.00%)	1/20 (5.00%)	0/34 (0.00%)	0/14 (0.00%)	0/21 (0.00%)	0/50 (0.00%)	0/25 (0.00%)	0/25 (0.00%)
Somnolence ^†	0/20 (0.00%)	0/20 (0.00%)	0/20 (0.00%)	0/34 (0.00%)	0/14 (0.00%)	0/21 (0.00%)	0/50 (0.00%)	0/25 (0.00%)	1/25 (4.00%)
Tension headache ^†	0/20 (0.00%)	0/20 (0.00%)	0/20 (0.00%)	0/34 (0.00%)	0/14 (0.00%)	0/21 (0.00%)	1/50 (2.00%)	0/25 (0.00%)	0/25 (0.00%)
Tremor ^†	0/20 (0.00%)	0/20 (0.00%)	0/20 (0.00%)	0/34 (0.00%)	0/14 (0.00%)	1/21 (4.76%)	0/50 (0.00%)	0/25 (0.00%)	0/25 (0.00%)
Psychiatric disorders
Affective disorder ^†	0/20 (0.00%)	0/20 (0.00%)	0/20 (0.00%)	0/34 (0.00%)	0/14 (0.00%)	0/21 (0.00%)	0/50 (0.00%)	0/25 (0.00%)	1/25 (4.00%)
Alcohol abuse ^†	0/20 (0.00%)	0/20 (0.00%)	0/20 (0.00%)	1/34 (2.94%)	0/14 (0.00%)	0/21 (0.00%)	0/50 (0.00%)	0/25 (0.00%)	0/25 (0.00%)
Anxiety ^†	0/20 (0.00%)	0/20 (0.00%)	0/20 (0.00%)	0/34 (0.00%)	0/14 (0.00%)	0/21 (0.00%)	1/50 (2.00%)	0/25 (0.00%)	0/25 (0.00%)
Depression ^†	0/20 (0.00%)	0/20 (0.00%)	1/20 (5.00%)	0/34 (0.00%)	0/14 (0.00%)	0/21 (0.00%)	0/50 (0.00%)	0/25 (0.00%)	0/25 (0.00%)
Drug abuse ^†	0/20 (0.00%)	0/20 (0.00%)	0/20 (0.00%)	1/34 (2.94%)	0/14 (0.00%)	0/21 (0.00%)	0/50 (0.00%)	0/25 (0.00%)	0/25 (0.00%)
Insomnia ^†	1/20 (5.00%)	1/20 (5.00%)	1/20 (5.00%)	0/34 (0.00%)	0/14 (0.00%)	1/21 (4.76%)	1/50 (2.00%)	0/25 (0.00%)	0/25 (0.00%)
Irritability ^†	0/20 (0.00%)	0/20 (0.00%)	0/20 (0.00%)	1/34 (2.94%)	0/14 (0.00%)	0/21 (0.00%)	0/50 (0.00%)	0/25 (0.00%)	0/25 (0.00%)
Renal and urinary disorders
Dysuria ^†	0/20 (0.00%)	0/20 (0.00%)	0/20 (0.00%)	0/34 (0.00%)	0/14 (0.00%)	0/21 (0.00%)	1/50 (2.00%)	0/25 (0.00%)	0/25 (0.00%)
Micturition urgency ^†	1/20 (5.00%)	0/20 (0.00%)	0/20 (0.00%)	0/34 (0.00%)	0/14 (0.00%)	0/21 (0.00%)	0/50 (0.00%)	0/25 (0.00%)	0/25 (0.00%)
Pollakiuria ^†	0/20 (0.00%)	0/20 (0.00%)	0/20 (0.00%)	0/34 (0.00%)	0/14 (0.00%)	0/21 (0.00%)	0/50 (0.00%)	0/25 (0.00%)	1/25 (4.00%)
Polyuria ^†	0/20 (0.00%)	1/20 (5.00%)	0/20 (0.00%)	0/34 (0.00%)	0/14 (0.00%)	0/21 (0.00%)	0/50 (0.00%)	0/25 (0.00%)	0/25 (0.00%)
Reproductive system and breast disorders
Balanoposthitis ^†	0/20 (0.00%)	0/20 (0.00%)	0/20 (0.00%)	1/34 (2.94%)	0/14 (0.00%)	0/21 (0.00%)	0/50 (0.00%)	0/25 (0.00%)	0/25 (0.00%)
Postmenopausal haemorrhage ^†	0/20 (0.00%)	0/20 (0.00%)	0/20 (0.00%)	1/34 (2.94%)	0/14 (0.00%)	0/21 (0.00%)	0/50 (0.00%)	0/25 (0.00%)	0/25 (0.00%)
Spermatocele ^†	0/20 (0.00%)	0/20 (0.00%)	0/20 (0.00%)	0/34 (0.00%)	0/14 (0.00%)	0/21 (0.00%)	1/50 (2.00%)	0/25 (0.00%)	0/25 (0.00%)
Vaginal discharge ^†	0/20 (0.00%)	0/20 (0.00%)	0/20 (0.00%)	0/34 (0.00%)	0/14 (0.00%)	0/21 (0.00%)	0/50 (0.00%)	0/25 (0.00%)	1/25 (4.00%)
Respiratory, thoracic and mediastinal disorders
Cough ^†	0/20 (0.00%)	0/20 (0.00%)	0/20 (0.00%)	0/34 (0.00%)	0/14 (0.00%)	0/21 (0.00%)	1/50 (2.00%)	0/25 (0.00%)	0/25 (0.00%)
Dysphonia ^†	0/20 (0.00%)	0/20 (0.00%)	0/20 (0.00%)	1/34 (2.94%)	0/14 (0.00%)	0/21 (0.00%)	0/50 (0.00%)	1/25 (4.00%)	0/25 (0.00%)
Epistaxis ^†	0/20 (0.00%)	0/20 (0.00%)	0/20 (0.00%)	1/34 (2.94%)	0/14 (0.00%)	0/21 (0.00%)	0/50 (0.00%)	0/25 (0.00%)	0/25 (0.00%)
Nasal congestion ^†	0/20 (0.00%)	0/20 (0.00%)	0/20 (0.00%)	0/34 (0.00%)	1/14 (7.14%)	0/21 (0.00%)	0/50 (0.00%)	0/25 (0.00%)	0/25 (0.00%)
Oropharyngeal pain ^†	0/20 (0.00%)	1/20 (5.00%)	1/20 (5.00%)	0/34 (0.00%)	0/14 (0.00%)	0/21 (0.00%)	1/50 (2.00%)	0/25 (0.00%)	0/25 (0.00%)
Productive cough ^†	0/20 (0.00%)	0/20 (0.00%)	0/20 (0.00%)	1/34 (2.94%)	0/14 (0.00%)	0/21 (0.00%)	0/50 (0.00%)	0/25 (0.00%)	0/25 (0.00%)
Rhinitis allergic ^†	0/20 (0.00%)	0/20 (0.00%)	0/20 (0.00%)	0/34 (0.00%)	0/14 (0.00%)	0/21 (0.00%)	1/50 (2.00%)	0/25 (0.00%)	0/25 (0.00%)
Sleep apnoea syndrome ^†	0/20 (0.00%)	0/20 (0.00%)	0/20 (0.00%)	0/34 (0.00%)	0/14 (0.00%)	1/21 (4.76%)	0/50 (0.00%)	0/25 (0.00%)	0/25 (0.00%)
Skin and subcutaneous tissue disorders
Acute generalised exanthematous pustulosis ^†	1/20 (5.00%)	0/20 (0.00%)	0/20 (0.00%)	0/34 (0.00%)	0/14 (0.00%)	0/21 (0.00%)	0/50 (0.00%)	0/25 (0.00%)	0/25 (0.00%)
Dry skin ^†	0/20 (0.00%)	0/20 (0.00%)	0/20 (0.00%)	0/34 (0.00%)	0/14 (0.00%)	0/21 (0.00%)	1/50 (2.00%)	0/25 (0.00%)	0/25 (0.00%)
Night sweats ^†	0/20 (0.00%)	2/20 (10.00%)	0/20 (0.00%)	0/34 (0.00%)	0/14 (0.00%)	0/21 (0.00%)	0/50 (0.00%)	0/25 (0.00%)	0/25 (0.00%)
Pruritus ^†	0/20 (0.00%)	0/20 (0.00%)	0/20 (0.00%)	1/34 (2.94%)	0/14 (0.00%)	0/21 (0.00%)	0/50 (0.00%)	0/25 (0.00%)	0/25 (0.00%)
Rash ^†	2/20 (10.00%)	0/20 (0.00%)	0/20 (0.00%)	1/34 (2.94%)	0/14 (0.00%)	0/21 (0.00%)	1/50 (2.00%)	0/25 (0.00%)	0/25 (0.00%)
Rash maculo-papular ^†	1/20 (5.00%)	1/20 (5.00%)	0/20 (0.00%)	0/34 (0.00%)	0/14 (0.00%)	0/21 (0.00%)	0/50 (0.00%)	0/25 (0.00%)	0/25 (0.00%)
Rash pruritic ^†	0/20 (0.00%)	0/20 (0.00%)	0/20 (0.00%)	0/34 (0.00%)	1/14 (7.14%)	0/21 (0.00%)	1/50 (2.00%)	0/25 (0.00%)	0/25 (0.00%)
Skin lesion ^†	0/20 (0.00%)	0/20 (0.00%)	0/20 (0.00%)	0/34 (0.00%)	0/14 (0.00%)	1/21 (4.76%)	0/50 (0.00%)	0/25 (0.00%)	0/25 (0.00%)
Social circumstances
Ex-tobacco user ^†	0/20 (0.00%)	0/20 (0.00%)	0/20 (0.00%)	1/34 (2.94%)	0/14 (0.00%)	0/21 (0.00%)	0/50 (0.00%)	0/25 (0.00%)	0/25 (0.00%)
Surgical and medical procedures
Supplementation therapy ^†	0/20 (0.00%)	0/20 (0.00%)	0/20 (0.00%)	1/34 (2.94%)	0/14 (0.00%)	0/21 (0.00%)	0/50 (0.00%)	0/25 (0.00%)	0/25 (0.00%)
Surgery ^†	0/20 (0.00%)	0/20 (0.00%)	0/20 (0.00%)	0/34 (0.00%)	0/14 (0.00%)	0/21 (0.00%)	1/50 (2.00%)	0/25 (0.00%)	0/25 (0.00%)
Tooth extraction ^†	0/20 (0.00%)	0/20 (0.00%)	0/20 (0.00%)	1/34 (2.94%)	0/14 (0.00%)	0/21 (0.00%)	1/50 (2.00%)	0/25 (0.00%)	0/25 (0.00%)
Transfusion ^†	0/20 (0.00%)	0/20 (0.00%)	0/20 (0.00%)	0/34 (0.00%)	0/14 (0.00%)	0/21 (0.00%)	1/50 (2.00%)	0/25 (0.00%)	0/25 (0.00%)
Vascular disorders
Hot flush ^†	0/20 (0.00%)	0/20 (0.00%)	0/20 (0.00%)	0/34 (0.00%)	0/14 (0.00%)	0/21 (0.00%)	1/50 (2.00%)	0/25 (0.00%)	0/25 (0.00%)
Hypertension ^†	1/20 (5.00%)	0/20 (0.00%)	1/20 (5.00%)	2/34 (5.88%)	1/14 (7.14%)	0/21 (0.00%)	1/50 (2.00%)	0/25 (0.00%)	0/25 (0.00%)
† Indicates events were collected by systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact

Layout table for Results Point of Contact information

Name/Title:	Shyam Kottilil MD
Organization:	National Institute of Allergy and Infectious Diseases
Phone:	+1 410 706 4872
EMail:	Skottilil@ihv.umaryland.edu

Publications:

Armstrong GL, Wasley A, Simard EP, McQuillan GM, Kuhnert WL, Alter MJ. The prevalence of hepatitis C virus infection in the United States, 1999 through 2002. Ann Intern Med. 2006 May 16;144(10):705-14.

Serfaty L, Aumaître H, Chazouillères O, Bonnand AM, Rosmorduc O, Poupon RE, Poupon R. Determinants of outcome of compensated hepatitis C virus-related cirrhosis. Hepatology. 1998 May;27(5):1435-40.

Davis GL, Albright JE, Cook SF, Rosenberg DM. Projecting future complications of chronic hepatitis C in the United States. Liver Transpl. 2003 Apr;9(4):331-8.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Townsend K, Petersen T, Gordon LA, Kohli A, Nelson A, Seamon C, Gross C, Tang L, Osinusi A, Polis MA, Masur H, Kottilil S. Effect of HIV co-infection on adherence to a 12-week regimen of hepatitis C virus therapy with ledipasvir and sofosbuvir. AIDS. 2016 Jan;30(2):261-6. doi: 10.1097/QAD.0000000000000903.

Petersen T, Townsend K, Gordon LA, Sidharthan S, Silk R, Nelson A, Gross C, Calderón M, Proschan M, Osinusi A, Polis MA, Masur H, Kottilil S, Kohli A. High adherence to all-oral directly acting antiviral HCV therapy among an inner-city patient population in a phase 2a study. Hepatol Int. 2016 Mar;10(2):310-9. doi: 10.1007/s12072-015-9680-7. Epub 2015 Nov 26.

Kohli A, Kattakuzhy S, Sidharthan S, Nelson A, McLaughlin M, Seamon C, Wilson E, Meissner EG, Sims Z, Silk R, Gross C, Akoth E, Tang L, Price A, Jolley TA, Emmanuel B, Proschan M, Teferi G, Chavez J, Abbott S, Osinusi A, Mo H, Polis MA, Masur H, Kottilil S. Four-Week Direct-Acting Antiviral Regimens in Noncirrhotic Patients With Hepatitis C Virus Genotype 1 Infection: An Open-Label, Nonrandomized Trial. Ann Intern Med. 2015 Dec 15;163(12):899-907. doi: 10.7326/M15-0642. Epub 2015 Nov 24.

Wilson EM, Kattakuzhy S, Sidharthan S, Sims Z, Tang L, McLaughlin M, Price A, Nelson A, Silk R, Gross C, Akoth E, Mo H, Subramanian GM, Pang PS, McHutchison JG, Osinusi A, Masur H, Kohli A, Kottilil S. Successful Retreatment of Chronic HCV Genotype-1 Infection With Ledipasvir and Sofosbuvir After Initial Short Course Therapy With Direct-Acting Antiviral Regimens. Clin Infect Dis. 2016 Feb 1;62(3):280-288. doi: 10.1093/cid/civ874. Epub 2015 Oct 31.

Kohli A, Kapoor R, Sims Z, Nelson A, Sidharthan S, Lam B, Silk R, Kotb C, Gross C, Teferi G, Sugarman K, Pang PS, Osinusi A, Polis MA, Rustgi V, Masur H, Kottilil S. Ledipasvir and sofosbuvir for hepatitis C genotype 4: a proof-of-concept, single-centre, open-label phase 2a cohort study. Lancet Infect Dis. 2015 Sep;15(9):1049-1054. doi: 10.1016/S1473-3099(15)00157-7. Epub 2015 Jul 14.

Kohli A, Osinusi A, Sims Z, Nelson A, Meissner EG, Barrett LL, Bon D, Marti MM, Silk R, Kotb C, Gross C, Jolley TA, Sidharthan S, Petersen T, Townsend K, Egerson D, Kapoor R, Spurlin E, Sneller M, Proschan M, Herrmann E, Kwan R, Teferi G, Talwani R, Diaz G, Kleiner DE, Wood BJ, Chavez J, Abbott S, Symonds WT, Subramanian GM, Pang PS, McHutchison J, Polis MA, Fauci AS, Masur H, Kottilil S. Virological response after 6 week triple-drug regimens for hepatitis C: a proof-of-concept phase 2A cohort study. Lancet. 2015 Mar 21;385(9973):1107-13. doi: 10.1016/S0140-6736(14)61228-9. Epub 2015 Jan 13.

Layout table for additonal information

Responsible Party:	National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )
ClinicalTrials.gov Identifier:	NCT01805882
Other Study ID Numbers:	130066 13-I-0066 ( Other Identifier: NIH )
First Submitted:	March 5, 2013
First Posted:	March 6, 2013
Results First Submitted:	February 28, 2017
Results First Posted:	April 11, 2017
Last Update Posted:	June 8, 2017

To Top