GS-5734 to Assess the Antiviral Activity, Longer-Term Clearance of Ebola Virus, and Safety in Male Ebola Survivors With Evidence of Ebola Virus Persistence in Semen

PREVAIL IV: Double-Blind, Randomized, Two-Phase, Placebo-Controlled, Phase II Trial of GS-5734 to Assess the Antiviral Activity, Longer-Term Clearance of Ebola Virus, and Safety in Male Ebola Survivors With Evidence of Ebola Virus Persistence in Semen

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02818582

Enrollment

Registered

2016-06-29

Start date

2016-07-01

Completion date

2020-08-31

Last updated

2022-02-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ebola

Keywords

Liberia, Guinea

Brief summary

Background: Some people have Ebola virus in their body for months after they recover from Ebola virus disease. Some may have health problems from the virus while others are fine. These people may be able to pass the virus to others. There are currently no drugs for people who have survived Ebola virus disease but still have the virus in their body. A new drug, GS-5734, might help get rid of Ebola virus in semen. Objective: To test if GS-5734 helps get rid of Ebola virus in semen and is safe for humans. Eligibility: Men who participated in the Ebola survivor study (PREVAIL III) and have evidence of the Ebola virus in their semen Design: Participants will be screened with: Questions Physical exam Eye exam Blood tests 2 semen samples if they have not had it tested recently Participants must live near the study site in Liberia for 6 months. Participants will be put into 1 of 2 study groups. They will have an infusion of either GS-5734 or a placebo every day for 5 days. A plastic tube is put into an arm vein. The infusion lasts 1 hour. Participants will be observed for 1 hour after. They will provide a semen sample on infusion day 4. After the infusions, participants will have 5 visits in the first month, then 1 per month for 5 more months. These include giving a blood and semen sample. Blood tests are performed before and after each infusion and the last visit (5 month visit) will also include an eye exam. When the study is over, if the study drug works and is safe, participants who got the placebo can get the study drug.

Detailed description

With the unprecedented size of the recent 2014-2016 West African Ebola outbreak, the scientific community is learning a great deal about the psychological and physical consequences of Ebola, Ebola viral persistence in survivors, risk of Ebola disease relapse in survivors, and the potential for survivors to transmit the virus to others. Data from PREVAIL III has demonstrated that persistence of Ebola virus in the semen of male survivors is common. In addition to Ebola virus persistence, Ebola relapse causing clinical disease has been well documented. There are no licensed therapies for the treatment of Ebola virus disease nor for the clearance of persistent Ebola virus in survivors. A safe, effective therapy that can reduce and/or eliminate persistent Ebola virus from semen would reduce the risk of transmission and enable male survivors to resume normal sexual relations without fear of harming loved ones. The mechanism underlying Post-Ebola Syndrome is as yet unknown, but improvement in Post-Ebola signs and symptoms resulting from GS-5734 treatment would be an added benefit. This study is a double-blind, randomized, two-phase (treatment and longer-term follow-up), two- arm trial of GS-5734 versus placebo among male Ebola survivors with persistent Ebola virus RNA in their semen. Participants are randomized 1:1 to receive either 100 mg of GS-5734 or placebo once daily by intravenous catheter for 5 days. Informed by transaminase elevations in prior Phase I studies in normal healthy subjects, a risk-mitigation strategy includes a built-in dose de-escalation. Participants will be stratified by country and on the basis of one versus two positive semen samples for Ebola virus RNA using the Cepheid GeneXpert platform assessed within 42 days prior to study enrollment. The early Data Safety and Monitoring Board (DSMB) review in August 2016 concluded there was no need for a cohort dose reduction. The protocol expanded to Guinea in October 2017, where the outbreak ended later. Currently there is an outbreak in the Democratic Republic of the Congo where the study team may evaluate conducting this study following the completion of the outbreak. Antiviral activity, as well as safety and tolerability, will be assessed during the treatment phase. Longer-term clearance of Ebola virus will be assessed during the 5-month follow-up phase. Primary analyses for the assessment of antiviral activity in the treatment phase will focus on the assay negativity rate (ANR; percentage of genital samples that are negative for Ebola) over the first 28 days of the study, as well as clinical and laboratory adverse events. A sample is considered negative by PCR if the test result is undetectable. Primary analysis for the follow-up phase will focus on the ANR collected monthly from months 2 to 6.

Interventions

DRUGGS-5734

Daily GS-5734 delivered intravenously (IV) for 5 days

OTHERPlacebo Comparator

Placebo delivered intravenously (IV) for 5 days.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

MALE

Age

18 Years to 99 Years

Healthy volunteers

Inclusion criteria

* INCLUSION CRITERIA: Individuals must meet all of the following criteria to be eligible for study participation: * Men more than or equal to 18 years of age. * One of two semen samples with Ebola virus RNA detection (defined as a positive PCR for NP or GP using the GeneXpert assay within 42 days prior to randomization). * Willingness to be available for study evaluations for 6 months. * Willingness to allow storage of biological samples. * Willingness to be followed by a Participant Tracker. * Willingness to refrain from alcohol consumption for study days -7 to 14. * Willingness to comply with MOH & CDC guidance on using a condom for sexual activity and at least through week 24 of the study.

Exclusion criteria

Individuals meeting any of the following criteria will be excluded from study participation: * Estimated glomerular filtration rate less than 60 mL/min/1.73m\^2 * History of significant renal disease * History of significant liver disease * Evidence of liver disease on physical exam such as ascites * Aspartate transaminase (AST) or alanine transaminase (ALT), greater than the upper limit of normal, a prothrombin time 1.1 times greater than the upper limits of normal, normal, or a total bilirubin \> 1.5 times the upper limits of normal(per Division of Acquired Immunodeficiency Syndrome (DAIDS) toxicity tables version 2.0 Nov. 2014). * Presence of Grade 2 or higher abnormalities for: low hemoglobin, low white blood count (WBC), low platelets, or low or high potassium (per DAIDS toxicity tables version 2.0 Nov. 2014). * Presence of greater than Grade 2 abnormalities for low or high sodium (per DAIDS toxicity tables version 2.0 Nov. 2014). * Any condition that, in the opinion of the investigator, would compromise the safety of the study subject or staff, or would prevent proper conduct of the study.

Design outcomes

Primary

Measure	Time frame	Description
Mean Assay Negativity Rate (ANR) for Ebola Virus During the Treatment Phase	Treatment Phase (assessed at days 4, 8, 11, 16, 20, 24, & 28)	Mean assay negativity rate (ANR) of semen samples collected during the treatment phase on days 4, 8, 11, 16, 20, 24, & 28. Average of all time points for negative values were compiled for the collected assay values. Negativity rate per participant was calculated using all time points by calculating the number of negative results over total number of time points (7). The assay negativity rate was averaged over all participants to get the mean assay negativity rate.
Mean Assay Negativity Rate (ANR) for Ebola Virus During the Follow-up Phase	Follow-up phase (assessed on weeks 8, 12, 16, 20, & 24)	Mean assay negativity rate (ANR) of semen samples collected during the follow-up phase on weeks 8, 12, 16, 20, & 24. Average of all time points for negative values were compiled for the collected assay values. Negativity rate per participant was calculated using all time points by calculating the number of negative results over total number of time points (5). The assay negativity rate was averaged over all participants to get the mean assay negativity rate.

Secondary

Measure	Time frame	Description
Participants With Grade 1 AST Level	Treatment phase - Day 1	Participants with grade 1 (1.25 - 2.5 x ULN) aspartate transaminase (AST) level at day 1
Participants With Grade 2 ALT Level	Treatment phase - Day 1	Participants with grade 2 (2.6 - 5.0 x ULN) alanine transaminase (ALT) level at day 1
Participants With Grade 2 AST Level	Treatment phase - Day 1	Participants with grade 2 (2.6 - 5.0 x ULN) aspartate transaminase (AST) level at day 1
Participants With Grade 3 ALT Level	Treatment phase - Day 1	Participants with grade 3 (5.1 - 10.0 x ULN) alanine transaminase (ALT) level at day 1
Participants With Grade 3 AST Level	Treatment phase - Day 1	Participants with grade 3 (5.1 - 10.0 x ULN) aspartate transaminase (AST) level at day 1
Participants With Grade 4 ALT Level	Treatment phase - Day 1	Participants with grade 4 (\> 10 x ULN) alanine transaminase (ALT) level at day 1
Participants With Grade 4 AST Level	Treatment phase - Day 1	Participants with grade 4 (\> 10 x ULN) aspartate transaminase (AST) level at day 1
Mean Assay Negativity Rate (ANR) for Ebola Virus During the Treatment Phase	Treatment Phase (assessed on days 4, 8, 11, 16, 20, 24, & 28)	Mean assay negativity rate (ANR) of semen samples collected during the treatment phase on days 4, 8, 11, 16, 20, 24, & 28. Average of all time points for negative values were compiled for the collected assay values. Negativity rate per participant was calculated using all time points by calculating the number of negative results over total number of time points (7). The assay negativity rate was averaged over all participants to get the mean assay negativity rate.
Mean Assay Negativity Rate (ANR) for Ebola Virus During the Follow-up Phase	Follow-up phase (assessed on weeks 8, 12, 16, 20, & 24)	Mean assay negativity rate (ANR) of semen samples collected during the follow-up phase - weeks 8, 12, 16, 20, & 24. Average of all time points for negative values were compiled for the collected assay values. Negativity rate per participant was calculated using all time points by calculating the number of negative results over total number of time points (5). The assay negativity rate was averaged over all participants to get the mean assay negativity rate.
Number of Participants With Increase in Grade From Baseline for PT Value	Treatment phase - Day 3	Number of participants with increase in grade from baseline in prothrombin time (PT) value at day 3. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). PT grade ranges include grade 1 (1.1 - 1.25 x ULN), grade 2 (1.26 - 1.50 x ULN), grade 3 (1.51 - 3.00 x ULN), & grade 4 (\> 3.00 x ULN)
Mean Change From Baseline in ALT Value at Day 11	Treatment phase - Day 11	Mean change from baseline in alanine transaminase (ALT) value at day 11
Mean Change From Baseline in aPTT Value	Treatment phase - Day 1	Mean change from baseline in activated partial thromboplastin time (aPTT) value at day 1
Mean Change From Baseline in AST Value	Treatment phase - Day 1	Mean change from baseline in aspartate transaminase (AST) Value at day 1
Mean Change From Baseline in INR Value	Treatment phase - Day 1	Mean change from baseline in international normalized ratio (INR) value at day 1
Mean Change From Baseline in PT Value	Treatment phase - Day 1	Mean change from baseline in prothrombin time (PT) value at day 1
Number of Participants With Increase in Grade From Baseline for ALT Value	Treatment phase - Day 1	Number of participants with increase in grade from baseline in alanine transaminase (ALT) value at day 1. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (AE) \[DAIDS AE grading table\] version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). ALT grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), & grade 4 (\> 10 x ULN)
Number of Participants With Increase in Grade From Baseline for aPTT Value	Treatment phase - Day 1	Number of participants with increase in grade from baseline in activated partial thromboplastin time (aPTT) value at day 1. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). aPTT grade ranges include grade 1 (1.1 - 1.66 x ULN), grade 2 (1.67 - 2.33 x ULN), grade 3 (2.34 - 3.00 x ULN), & grade 4 (\> 3.00 x ULN)
Number of Participants With Increase in Grade From Baseline for AST Value	Treatment phase - Day 1	Number of participants with increase in grade from baseline in aspartate transaminase (AST) Value at day 1. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). AST grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), & grade 4 (\> 10 x ULN)
Mean Change From Baseline in ALT Value	Treatment phase - Day 1	Mean change from baseline in alanine transaminase (ALT) value at day 1
Participants With Grade 1 ALT Level	Treatment phase - Day 1	Participants with grade 1 (1.25 - 2.5 x ULN) alanine transaminase (ALT) level at day 1

Countries

Guinea, Liberia

Participant flow

Participants by arm

Arm	Count
GS-5734 100mg Given Intravenously Daily for 5 Days Male Ebola survivors with persistent Ebola virus in their semen were given GS-5734 100mg intravenously daily for 5 days	20
Normal Saline Given Intravenously Daily for 5 Days Male Ebola survivors with persistent Ebola virus in their semen were given normal saline intravenously daily for 5 days	18
Total	38

Baseline characteristics

Characteristic	Total	GS-5734 100mg Given Intravenously Daily for 5 Days	Normal Saline Given Intravenously Daily for 5 Days
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	0 Participants	0 Participants	0 Participants
Age, Categorical Between 18 and 65 years	38 Participants	20 Participants	18 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants	0 Participants	0 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants	0 Participants	0 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	38 Participants	20 Participants	18 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Black or African American	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) More than one race	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	38 Participants	20 Participants	18 Participants
Race (NIH/OMB) White	0 Participants	0 Participants	0 Participants
Sex: Female, Male Female	0 Participants	0 Participants	0 Participants
Sex: Female, Male Male	38 Participants	20 Participants	18 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 20	0 / 18
other Total, other adverse events	15 / 20	15 / 18
serious Total, serious adverse events	0 / 20	0 / 18

Outcome results

Primary

Mean Assay Negativity Rate (ANR) for Ebola Virus During the Follow-up Phase

Mean assay negativity rate (ANR) of semen samples collected during the follow-up phase on weeks 8, 12, 16, 20, & 24. Average of all time points for negative values were compiled for the collected assay values. Negativity rate per participant was calculated using all time points by calculating the number of negative results over total number of time points (5). The assay negativity rate was averaged over all participants to get the mean assay negativity rate.

Time frame: Follow-up phase (assessed on weeks 8, 12, 16, 20, & 24)

Population: Participants who received intervention

Arm	Measure	Value (MEAN)	Dispersion
GS-5734 100mg Given Intravenously Daily for 5 Days	Mean Assay Negativity Rate (ANR) for Ebola Virus During the Follow-up Phase	0.96 proportion of semen samples	Standard Deviation 0.1
Normal Saline Given Intravenously Daily for 5 Days	Mean Assay Negativity Rate (ANR) for Ebola Virus During the Follow-up Phase	0.81 proportion of semen samples	Standard Deviation 0.29

Primary

Mean Assay Negativity Rate (ANR) for Ebola Virus During the Treatment Phase

Mean assay negativity rate (ANR) of semen samples collected during the treatment phase on days 4, 8, 11, 16, 20, 24, & 28. Average of all time points for negative values were compiled for the collected assay values. Negativity rate per participant was calculated using all time points by calculating the number of negative results over total number of time points (7). The assay negativity rate was averaged over all participants to get the mean assay negativity rate.

Time frame: Treatment Phase (assessed at days 4, 8, 11, 16, 20, 24, & 28)

Population: Participants who received intervention

Arm	Measure	Value (MEAN)	Dispersion
GS-5734 100mg Given Intravenously Daily for 5 Days	Mean Assay Negativity Rate (ANR) for Ebola Virus During the Treatment Phase	0.85 proportion of semen samples	Standard Deviation 0.24
Normal Saline Given Intravenously Daily for 5 Days	Mean Assay Negativity Rate (ANR) for Ebola Virus During the Treatment Phase	0.76 proportion of semen samples	Standard Deviation 0.3

Secondary

Mean Assay Negativity Rate (ANR) for Ebola Virus During the Follow-up Phase

Mean assay negativity rate (ANR) of semen samples collected during the follow-up phase - weeks 8, 12, 16, 20, & 24. Average of all time points for negative values were compiled for the collected assay values. Negativity rate per participant was calculated using all time points by calculating the number of negative results over total number of time points (5). The assay negativity rate was averaged over all participants to get the mean assay negativity rate.

Time frame: Follow-up phase (assessed on weeks 8, 12, 16, 20, & 24)

Population: Participants who had one of two baseline positive semen sample for Ebola virus

Arm	Measure	Value (MEAN)	Dispersion
GS-5734 100mg Given Intravenously Daily for 5 Days	Mean Assay Negativity Rate (ANR) for Ebola Virus During the Follow-up Phase	0.95 proportion of semen samples	Standard Deviation 0.12
Normal Saline Given Intravenously Daily for 5 Days	Mean Assay Negativity Rate (ANR) for Ebola Virus During the Follow-up Phase	0.9 proportion of semen samples	Standard Deviation 0.19

Secondary

Mean Assay Negativity Rate (ANR) for Ebola Virus During the Follow-up Phase

Time frame: Follow-up phase (assessed on weeks 8, 12, 16, 20, & 24)

Population: Participants who had two of two baseline positive semen sample for Ebola virus

Arm	Measure	Value (MEAN)	Dispersion
GS-5734 100mg Given Intravenously Daily for 5 Days	Mean Assay Negativity Rate (ANR) for Ebola Virus During the Follow-up Phase	1 proportion of semen samples	Standard Deviation 0
Normal Saline Given Intravenously Daily for 5 Days	Mean Assay Negativity Rate (ANR) for Ebola Virus During the Follow-up Phase	0.33 proportion of semen samples	Standard Deviation 0.23

Secondary

Mean Assay Negativity Rate (ANR) for Ebola Virus During the Treatment Phase

Time frame: Treatment Phase (assessed on days 4, 8, 11, 16, 20, 24, & 28)

Population: Participants who had one of two baseline positive semen sample for Ebola virus

Arm	Measure	Value (MEAN)	Dispersion
GS-5734 100mg Given Intravenously Daily for 5 Days	Mean Assay Negativity Rate (ANR) for Ebola Virus During the Treatment Phase	0.86 proportion of semen samples	Standard Deviation 0.24
Normal Saline Given Intravenously Daily for 5 Days	Mean Assay Negativity Rate (ANR) for Ebola Virus During the Treatment Phase	0.86 proportion of semen samples	Standard Deviation 0.19

Secondary

Mean Assay Negativity Rate (ANR) for Ebola Virus During the Treatment Phase

Time frame: Treatment Phase (assessed on days 4, 8, 11, 16, 20, 24, & 28)

Population: Participants who had two of two baseline positive semen sample for Ebola virus

Arm	Measure	Value (MEAN)	Dispersion
GS-5734 100mg Given Intravenously Daily for 5 Days	Mean Assay Negativity Rate (ANR) for Ebola Virus During the Treatment Phase	0.79 proportion of semen samples	Standard Deviation 0.25
Normal Saline Given Intravenously Daily for 5 Days	Mean Assay Negativity Rate (ANR) for Ebola Virus During the Treatment Phase	0.28 proportion of semen samples	Standard Deviation 0.35

Secondary

Mean Change From Baseline in ALT Value

Mean change from baseline in alanine transaminase (ALT) value at day 3

Time frame: Treatment phase - Day 3

Population: Participants who received intervention

Arm	Measure	Value (MEAN)	Dispersion
GS-5734 100mg Given Intravenously Daily for 5 Days	Mean Change From Baseline in ALT Value	4.05 IU/L	Standard Deviation 12.25
Normal Saline Given Intravenously Daily for 5 Days	Mean Change From Baseline in ALT Value	10.28 IU/L	Standard Deviation 18.05

Secondary

Mean Change From Baseline in ALT Value

Mean change from baseline in alanine transaminase (ALT) value at day 2

Time frame: Treatment phase - Day 2

Population: Participants who received intervention

Arm	Measure	Value (MEAN)	Dispersion
GS-5734 100mg Given Intravenously Daily for 5 Days	Mean Change From Baseline in ALT Value	2.25 IU/L	Standard Deviation 11.61
Normal Saline Given Intravenously Daily for 5 Days	Mean Change From Baseline in ALT Value	-0.56 IU/L	Standard Deviation 7.25

Secondary

Mean Change From Baseline in ALT Value

Mean change from baseline in alanine transaminase (ALT) value at day 1

Time frame: Treatment phase - Day 1

Population: Participants who received intervention

Arm	Measure	Value (MEAN)	Dispersion
GS-5734 100mg Given Intravenously Daily for 5 Days	Mean Change From Baseline in ALT Value	3.6 IU/L	Standard Deviation 11.94
Normal Saline Given Intravenously Daily for 5 Days	Mean Change From Baseline in ALT Value	-2.22 IU/L	Standard Deviation 7.48

Secondary

Mean Change From Baseline in ALT Value

Mean change from baseline in alanine transaminase (ALT) value at at day 24

Time frame: Treatment phase - Day 24

Population: Participants who received intervention

Arm	Measure	Value (MEAN)	Dispersion
GS-5734 100mg Given Intravenously Daily for 5 Days	Mean Change From Baseline in ALT Value	-0.65 IU/L	Standard Deviation 7.21
Normal Saline Given Intravenously Daily for 5 Days	Mean Change From Baseline in ALT Value	-0.67 IU/L	Standard Deviation 6.89

Secondary

Mean Change From Baseline in ALT Value

Mean change from baseline in alanine transaminase (ALT) value at week 20

Time frame: Follow-up phase - Week 20

Population: Participants who received intervention

Arm	Measure	Value (MEAN)	Dispersion
GS-5734 100mg Given Intravenously Daily for 5 Days	Mean Change From Baseline in ALT Value	-1.55 IU/L	Standard Deviation 8.24
Normal Saline Given Intravenously Daily for 5 Days	Mean Change From Baseline in ALT Value	-1.72 IU/L	Standard Deviation 8.04

Secondary

Mean Change From Baseline in ALT Value

Mean change from baseline in alanine transaminase (ALT) value at day 8

Time frame: Treatment phase - Day 8

Population: Participants who received intervention

Arm	Measure	Value (MEAN)	Dispersion
GS-5734 100mg Given Intravenously Daily for 5 Days	Mean Change From Baseline in ALT Value	21.45 IU/L	Standard Deviation 21.09
Normal Saline Given Intravenously Daily for 5 Days	Mean Change From Baseline in ALT Value	4.89 IU/L	Standard Deviation 7.88

Secondary

Mean Change From Baseline in ALT Value

Mean change from baseline in alanine transaminase (ALT) value at week 24

Time frame: Follow-up phase - Week 24

Population: Participants who received intervention and had lab value available at baseline and treatment/follow-up day/week. One subject had missing lab value.

Arm	Measure	Value (MEAN)	Dispersion
GS-5734 100mg Given Intravenously Daily for 5 Days	Mean Change From Baseline in ALT Value	-0.89 IU/L	Standard Deviation 6.74
Normal Saline Given Intravenously Daily for 5 Days	Mean Change From Baseline in ALT Value	22.67 IU/L	Standard Deviation 104.56

Secondary

Mean Change From Baseline in ALT Value

Mean change from baseline in alanine transaminase (ALT) value at day 5

Time frame: Treatment phase - Day 5

Population: Participants who received intervention

Arm	Measure	Value (MEAN)	Dispersion
GS-5734 100mg Given Intravenously Daily for 5 Days	Mean Change From Baseline in ALT Value	13.15 IU/L	Standard Deviation 14.64
Normal Saline Given Intravenously Daily for 5 Days	Mean Change From Baseline in ALT Value	9.22 IU/L	Standard Deviation 14.97

Secondary

Mean Change From Baseline in ALT Value

Mean change from baseline in alanine transaminase (ALT) value at day 4

Time frame: Treatment phase - Day 4

Population: Participants who received intervention

Arm	Measure	Value (MEAN)	Dispersion
GS-5734 100mg Given Intravenously Daily for 5 Days	Mean Change From Baseline in ALT Value	8.45 IU/L	Standard Deviation 13.2
Normal Saline Given Intravenously Daily for 5 Days	Mean Change From Baseline in ALT Value	11.78 IU/L	Standard Deviation 20.74

Secondary

Mean Change From Baseline in ALT Value

Mean change from baseline in alanine transaminase (ALT) value at day 16

Time frame: Treatment phase - Day 16

Population: Participants who received intervention and had lab value available at baseline and treatment/follow-up day/week. One subject had missing lab value.

Arm	Measure	Value (MEAN)	Dispersion
GS-5734 100mg Given Intravenously Daily for 5 Days	Mean Change From Baseline in ALT Value	3.53 IU/L	Standard Deviation 9.06
Normal Saline Given Intravenously Daily for 5 Days	Mean Change From Baseline in ALT Value	-0.06 IU/L	Standard Deviation 8.91

Secondary

Mean Change From Baseline in ALT Value

Mean change from baseline in alanine transaminase (ALT) value at week 16

Time frame: Follow-up phase - Week 16

Population: Participants who received intervention

Arm	Measure	Value (MEAN)	Dispersion
GS-5734 100mg Given Intravenously Daily for 5 Days	Mean Change From Baseline in ALT Value	5.95 IU/L	Standard Deviation 24.56
Normal Saline Given Intravenously Daily for 5 Days	Mean Change From Baseline in ALT Value	-0.11 IU/L	Standard Deviation 4.56

Secondary

Mean Change From Baseline in ALT Value

Mean change from baseline in alanine transaminase (ALT) Value at week 12

Time frame: Follow-up phase - Week 12

Population: Participants who received intervention

Arm	Measure	Value (MEAN)	Dispersion
GS-5734 100mg Given Intravenously Daily for 5 Days	Mean Change From Baseline in ALT Value	3.1 IU/L	Standard Deviation 18.29
Normal Saline Given Intravenously Daily for 5 Days	Mean Change From Baseline in ALT Value	-1.78 IU/L	Standard Deviation 8.99

Secondary

Mean Change From Baseline in ALT Value

Mean change from baseline in alanine transaminase (ALT) value at week 8

Time frame: Follow-up phase - Week 8

Population: Participants who received intervention

Arm	Measure	Value (MEAN)	Dispersion
GS-5734 100mg Given Intravenously Daily for 5 Days	Mean Change From Baseline in ALT Value	-2.15 IU/L	Standard Deviation 6.28
Normal Saline Given Intravenously Daily for 5 Days	Mean Change From Baseline in ALT Value	-1.22 IU/L	Standard Deviation 7.01

Secondary

Mean Change From Baseline in ALT Value

Mean change from baseline in alanine transaminase (ALT) value at at day 28

Time frame: Treatment phase - Day 28

Population: Participants who received intervention

Arm	Measure	Value (MEAN)	Dispersion
GS-5734 100mg Given Intravenously Daily for 5 Days	Mean Change From Baseline in ALT Value	0.4 IU/L	Standard Deviation 10.08
Normal Saline Given Intravenously Daily for 5 Days	Mean Change From Baseline in ALT Value	-2.06 IU/L	Standard Deviation 9.67

Secondary

Mean Change From Baseline in ALT Value at Day 11

Mean change from baseline in alanine transaminase (ALT) value at day 11

Time frame: Treatment phase - Day 11

Population: Participants who received intervention

Arm	Measure	Value (MEAN)	Dispersion
GS-5734 100mg Given Intravenously Daily for 5 Days	Mean Change From Baseline in ALT Value at Day 11	8.65 IU/L	Standard Deviation 10.91
Normal Saline Given Intravenously Daily for 5 Days	Mean Change From Baseline in ALT Value at Day 11	1.78 IU/L	Standard Deviation 8.18

Secondary

Mean Change From Baseline in aPTT Value

Mean change from baseline in activated partial thromboplastin time (aPTT) value at day 5

Time frame: Treatment phase - Day 5

Population: Participants who received intervention and had lab value available at baseline and treatment/follow-up day/week. One subject had missing lab value.

Arm	Measure	Value (MEAN)	Dispersion
GS-5734 100mg Given Intravenously Daily for 5 Days	Mean Change From Baseline in aPTT Value	1.29 Seconds	Standard Deviation 4.63
Normal Saline Given Intravenously Daily for 5 Days	Mean Change From Baseline in aPTT Value	-1.24 Seconds	Standard Deviation 4.15

Secondary

Mean Change From Baseline in aPTT Value

Mean change from baseline in activated partial thromboplastin time (aPTT) value at week 24

Time frame: Follow-up phase - Week 24

Population: Participants who received intervention and had lab value available at baseline and treatment/follow-up day/week. Two subjects had missing lab value.

Arm	Measure	Value (MEAN)	Dispersion
GS-5734 100mg Given Intravenously Daily for 5 Days	Mean Change From Baseline in aPTT Value	-0.39 Seconds	Standard Deviation 4.6
Normal Saline Given Intravenously Daily for 5 Days	Mean Change From Baseline in aPTT Value	0.41 Seconds	Standard Deviation 4.7

Secondary

Mean Change From Baseline in aPTT Value

Mean change from baseline in activated partial thromboplastin time (aPTT) value at week 20

Time frame: Follow-up phase - Week 20

Population: Participants who received intervention and had lab value available at baseline and treatment/follow-up day/week. One subject had missing lab value.

Arm	Measure	Value (MEAN)	Dispersion
GS-5734 100mg Given Intravenously Daily for 5 Days	Mean Change From Baseline in aPTT Value	1.83 Seconds	Standard Deviation 5.04
Normal Saline Given Intravenously Daily for 5 Days	Mean Change From Baseline in aPTT Value	0.75 Seconds	Standard Deviation 6.8

Secondary

Mean Change From Baseline in aPTT Value

Mean change from baseline in activated partial thromboplastin time (aPTT) value at day 8

Time frame: Treatment phase - Day 8

Population: Participants who received intervention and had lab value available at baseline and treatment/follow-up day/week. One subject had missing lab value.

Arm	Measure	Value (MEAN)	Dispersion
GS-5734 100mg Given Intravenously Daily for 5 Days	Mean Change From Baseline in aPTT Value	3.92 Seconds	Standard Deviation 6.43
Normal Saline Given Intravenously Daily for 5 Days	Mean Change From Baseline in aPTT Value	0.34 Seconds	Standard Deviation 2.84

Secondary

Mean Change From Baseline in aPTT Value

Mean change from baseline in activated partial thromboplastin time (aPTT) value at day 11

Time frame: Treatment phase - Day 11

Population: Participants who received intervention and had lab value available at baseline and treatment/follow-up day/week. One subject had missing lab value.

Arm	Measure	Value (MEAN)	Dispersion
GS-5734 100mg Given Intravenously Daily for 5 Days	Mean Change From Baseline in aPTT Value	-1.41 Seconds	Standard Deviation 3.6
Normal Saline Given Intravenously Daily for 5 Days	Mean Change From Baseline in aPTT Value	-0.17 Seconds	Standard Deviation 2.97

Secondary

Mean Change From Baseline in aPTT Value

Mean change from baseline in activated partial thromboplastin time (aPTT) value at day 16

Time frame: Treatment phase - Day 16

Population: Participants who received intervention and had lab value available at baseline and treatment/follow-up day/week. Three subjects had missing lab value.

Arm	Measure	Value (MEAN)	Dispersion
GS-5734 100mg Given Intravenously Daily for 5 Days	Mean Change From Baseline in aPTT Value	-0.18 Seconds	Standard Deviation 4.76
Normal Saline Given Intravenously Daily for 5 Days	Mean Change From Baseline in aPTT Value	0.26 Seconds	Standard Deviation 4.33

Secondary

Mean Change From Baseline in aPTT Value

Mean change from baseline in activated partial thromboplastin time (aPTT) value at day 24

Time frame: Treatment phase - Day 24

Population: Participants who received intervention and had lab value available at baseline and treatment/follow-up day/week. One subject had missing lab value.

Arm	Measure	Value (MEAN)	Dispersion
GS-5734 100mg Given Intravenously Daily for 5 Days	Mean Change From Baseline in aPTT Value	-0.27 Seconds	Standard Deviation 4.72
Normal Saline Given Intravenously Daily for 5 Days	Mean Change From Baseline in aPTT Value	0.76 Seconds	Standard Deviation 4.2

Secondary

Mean Change From Baseline in aPTT Value

Mean change from baseline in activated partial thromboplastin time (aPTT) value at day 28

Time frame: Treatment phase - Day 28

Population: Participants who received intervention and had lab value available at baseline and treatment/follow-up day/week. Two subjects had missing lab value.

Arm	Measure	Value (MEAN)	Dispersion
GS-5734 100mg Given Intravenously Daily for 5 Days	Mean Change From Baseline in aPTT Value	0.52 Seconds	Standard Deviation 3.91
Normal Saline Given Intravenously Daily for 5 Days	Mean Change From Baseline in aPTT Value	0.24 Seconds	Standard Deviation 5.18

Secondary

Mean Change From Baseline in aPTT Value

Mean change from baseline in activated partial thromboplastin time (aPTT) value at week 16

Time frame: Follow-up phase - Week 16

Population: Participants who received intervention and had lab value available at baseline and treatment/follow-up day/week. Two subjects had missing lab value.

Arm	Measure	Value (MEAN)	Dispersion
GS-5734 100mg Given Intravenously Daily for 5 Days	Mean Change From Baseline in aPTT Value	0.78 Seconds	Standard Deviation 4.84
Normal Saline Given Intravenously Daily for 5 Days	Mean Change From Baseline in aPTT Value	1.37 Seconds	Standard Deviation 5.22

Secondary

Mean Change From Baseline in aPTT Value

Mean change from baseline in activated partial thromboplastin time (aPTT) value at day 1

Time frame: Treatment phase - Day 1

Population: Participants who received intervention and had lab value available at baseline and treatment/follow-up day/week. One subject had missing lab value.

Arm	Measure	Value (MEAN)	Dispersion
GS-5734 100mg Given Intravenously Daily for 5 Days	Mean Change From Baseline in aPTT Value	0.34 Seconds	Standard Deviation 5.13
Normal Saline Given Intravenously Daily for 5 Days	Mean Change From Baseline in aPTT Value	0.24 Seconds	Standard Deviation 2.6

Secondary

Mean Change From Baseline in aPTT Value

Mean change from baseline in activated partial thromboplastin time (aPTT) value at day 2

Time frame: Treatment phase - Day 2

Population: Participants who received intervention and had lab value available at baseline and treatment/follow-up day/week. One subject had missing lab value.

Arm	Measure	Value (MEAN)	Dispersion
GS-5734 100mg Given Intravenously Daily for 5 Days	Mean Change From Baseline in aPTT Value	-0.9 Seconds	Standard Deviation 4.28
Normal Saline Given Intravenously Daily for 5 Days	Mean Change From Baseline in aPTT Value	-1.45 Seconds	Standard Deviation 2.04

Secondary

Mean Change From Baseline in aPTT Value

Mean change from baseline in activated partial thromboplastin time (aPTT) value at week 12

Time frame: Follow-up phase - Week 12

Population: Participants who received intervention and had lab value available at baseline and treatment/follow-up day/week. One subject had missing lab value.

Arm	Measure	Value (MEAN)	Dispersion
GS-5734 100mg Given Intravenously Daily for 5 Days	Mean Change From Baseline in aPTT Value	0.5 Seconds	Standard Deviation 3.95
Normal Saline Given Intravenously Daily for 5 Days	Mean Change From Baseline in aPTT Value	1.29 Seconds	Standard Deviation 3.17

Secondary

Mean Change From Baseline in aPTT Value

Mean change from baseline in activated partial thromboplastin time (aPTT) value at day 3

Time frame: Treatment phase - Day 3

Population: Participants who received intervention and had lab value available at baseline and treatment/follow-up day/week. One subject had missing lab value.

Arm	Measure	Value (MEAN)	Dispersion
GS-5734 100mg Given Intravenously Daily for 5 Days	Mean Change From Baseline in aPTT Value	-0.03 Seconds	Standard Deviation 4.28
Normal Saline Given Intravenously Daily for 5 Days	Mean Change From Baseline in aPTT Value	-1.42 Seconds	Standard Deviation 3.91

Secondary

Mean Change From Baseline in aPTT Value

Mean change from baseline in activated partial thromboplastin time (aPTT) value at day 4

Time frame: Treatment phase - Day 4

Population: Participants who received intervention and had lab value available at baseline and treatment/follow-up day/week. One subject had missing lab value.

Arm	Measure	Value (MEAN)	Dispersion
GS-5734 100mg Given Intravenously Daily for 5 Days	Mean Change From Baseline in aPTT Value	3.82 Seconds	Standard Deviation 11.84
Normal Saline Given Intravenously Daily for 5 Days	Mean Change From Baseline in aPTT Value	-2.24 Seconds	Standard Deviation 2.29

Secondary

Mean Change From Baseline in aPTT Value

Mean change from baseline in activated partial thromboplastin time (aPTT) value at week 8

Time frame: Follow-up phase - Week 8

Population: Participants who received intervention and had lab value available at baseline and treatment/follow-up day/week. Two subjects had missing lab value.

Arm	Measure	Value (MEAN)	Dispersion
GS-5734 100mg Given Intravenously Daily for 5 Days	Mean Change From Baseline in aPTT Value	1.16 Seconds	Standard Deviation 3.65
Normal Saline Given Intravenously Daily for 5 Days	Mean Change From Baseline in aPTT Value	0.62 Seconds	Standard Deviation 3.67

Secondary

Mean Change From Baseline in AST Value

Mean change from baseline in aspartate transaminase (AST) Value at day 1

Time frame: Treatment phase - Day 1

Population: Participants who received intervention

Arm	Measure	Value (MEAN)	Dispersion
GS-5734 100mg Given Intravenously Daily for 5 Days	Mean Change From Baseline in AST Value	2.45 IU/L	Standard Deviation 8.34
Normal Saline Given Intravenously Daily for 5 Days	Mean Change From Baseline in AST Value	-1.89 IU/L	Standard Deviation 7.38

Secondary

Mean Change From Baseline in AST Value

Mean change from baseline in aspartate transaminase (AST) Value at day 2

Time frame: Treatment phase - Day 2

Population: Participants who received intervention

Arm	Measure	Value (MEAN)	Dispersion
GS-5734 100mg Given Intravenously Daily for 5 Days	Mean Change From Baseline in AST Value	-0.2 IU/L	Standard Deviation 5.95
Normal Saline Given Intravenously Daily for 5 Days	Mean Change From Baseline in AST Value	0.06 IU/L	Standard Deviation 5.56

Secondary

Mean Change From Baseline in AST Value

Mean change from baseline in aspartate transaminase (AST) value at day 3

Time frame: Treatment phase - Day 3

Population: Participants who received intervention

Arm	Measure	Value (MEAN)	Dispersion
GS-5734 100mg Given Intravenously Daily for 5 Days	Mean Change From Baseline in AST Value	0.35 IU/L	Standard Deviation 6.9
Normal Saline Given Intravenously Daily for 5 Days	Mean Change From Baseline in AST Value	10.39 IU/L	Standard Deviation 20.13

Secondary

Mean Change From Baseline in AST Value

Mean change from baseline in aspartate transaminase (AST) value at day 4

Time frame: Treatment phase - Day 4

Population: Participants who received intervention

Arm	Measure	Value (MEAN)	Dispersion
GS-5734 100mg Given Intravenously Daily for 5 Days	Mean Change From Baseline in AST Value	5.6 IU/L	Standard Deviation 9.08
Normal Saline Given Intravenously Daily for 5 Days	Mean Change From Baseline in AST Value	5.72 IU/L	Standard Deviation 15.94

Secondary

Mean Change From Baseline in AST Value

Mean change from baseline in aspartate transaminase (AST) value at day 5

Time frame: Treatment phase - Day 5

Population: Participants who received intervention

Arm	Measure	Value (MEAN)	Dispersion
GS-5734 100mg Given Intravenously Daily for 5 Days	Mean Change From Baseline in AST Value	8.15 IU/L	Standard Deviation 9.35
Normal Saline Given Intravenously Daily for 5 Days	Mean Change From Baseline in AST Value	2.44 IU/L	Standard Deviation 9.51

Secondary

Mean Change From Baseline in AST Value

Mean change from baseline in aspartate transaminase (AST) value at day 8

Time frame: Treatment phase - Day 8

Population: Participants who received intervention

Arm	Measure	Value (MEAN)	Dispersion
GS-5734 100mg Given Intravenously Daily for 5 Days	Mean Change From Baseline in AST Value	9.4 IU/L	Standard Deviation 12.83
Normal Saline Given Intravenously Daily for 5 Days	Mean Change From Baseline in AST Value	1.39 IU/L	Standard Deviation 7.69

Secondary

Mean Change From Baseline in AST Value

Mean change from baseline in aspartate transaminase (AST) value at day 11

Time frame: Treatment phase - Day 11

Population: Participants who received intervention

Arm	Measure	Value (MEAN)	Dispersion
GS-5734 100mg Given Intravenously Daily for 5 Days	Mean Change From Baseline in AST Value	0.2 IU/L	Standard Deviation 6.87
Normal Saline Given Intravenously Daily for 5 Days	Mean Change From Baseline in AST Value	-0.22 IU/L	Standard Deviation 8.14

Secondary

Mean Change From Baseline in AST Value

Mean change from baseline in aspartate transaminase (AST) value at day 16

Time frame: Treatment phase - Day 16

Population: Participants who received intervention and had lab value available at baseline and treatment/follow-up day/week. One subject had missing lab value.

Arm	Measure	Value (MEAN)	Dispersion
GS-5734 100mg Given Intravenously Daily for 5 Days	Mean Change From Baseline in AST Value	-1.42 IU/L	Standard Deviation 5.34
Normal Saline Given Intravenously Daily for 5 Days	Mean Change From Baseline in AST Value	-0.89 IU/L	Standard Deviation 8.38

Secondary

Mean Change From Baseline in AST Value

Mean change from baseline in aspartate transaminase (AST) value at day 24

Time frame: Treatment phase - Day 24

Population: Participants who received intervention

Arm	Measure	Value (MEAN)	Dispersion
GS-5734 100mg Given Intravenously Daily for 5 Days	Mean Change From Baseline in AST Value	-1.25 IU/L	Standard Deviation 5.22
Normal Saline Given Intravenously Daily for 5 Days	Mean Change From Baseline in AST Value	0.67 IU/L	Standard Deviation 6.89

Secondary

Mean Change From Baseline in AST Value

Mean change from baseline in aspartate transaminase (AST) value at day 28

Time frame: Treatment phase - Day 28

Population: Participants who received intervention

Arm	Measure	Value (MEAN)	Dispersion
GS-5734 100mg Given Intravenously Daily for 5 Days	Mean Change From Baseline in AST Value	0.85 IU/L	Standard Deviation 8.6
Normal Saline Given Intravenously Daily for 5 Days	Mean Change From Baseline in AST Value	-0.83 IU/L	Standard Deviation 9.4

Secondary

Mean Change From Baseline in AST Value

Mean change from baseline in aspartate transaminase (AST) value at week 8

Time frame: Follow-up phase - Week 8

Population: Participants who received intervention

Arm	Measure	Value (MEAN)	Dispersion
GS-5734 100mg Given Intravenously Daily for 5 Days	Mean Change From Baseline in AST Value	-1.7 IU/L	Standard Deviation 5.16
Normal Saline Given Intravenously Daily for 5 Days	Mean Change From Baseline in AST Value	1.39 IU/L	Standard Deviation 7.91

Secondary

Mean Change From Baseline in AST Value

Mean change from baseline in aspartate aminotransferase transaminase (AST) value at week 12

Time frame: Follow-up phase - Week 12

Population: Participants who received intervention

Arm	Measure	Value (MEAN)	Dispersion
GS-5734 100mg Given Intravenously Daily for 5 Days	Mean Change From Baseline in AST Value	5.85 IU/L	Standard Deviation 24.54
Normal Saline Given Intravenously Daily for 5 Days	Mean Change From Baseline in AST Value	1 IU/L	Standard Deviation 8.25

Secondary

Mean Change From Baseline in AST Value

Mean change from baseline in aspartate aminotransferase transaminase (AST) value at week 16

Time frame: Follow-up phase - Week 16

Population: Participants who received intervention

Arm	Measure	Value (MEAN)	Dispersion
GS-5734 100mg Given Intravenously Daily for 5 Days	Mean Change From Baseline in AST Value	11.4 IU/L	Standard Deviation 36.51
Normal Saline Given Intravenously Daily for 5 Days	Mean Change From Baseline in AST Value	1.39 IU/L	Standard Deviation 4.35

Secondary

Mean Change From Baseline in AST Value

Mean change from baseline in aspartate aminotransferase transaminase (AST) value at week 20

Time frame: Follow-up phase - Week 20

Population: Participants who received intervention

Arm	Measure	Value (MEAN)	Dispersion
GS-5734 100mg Given Intravenously Daily for 5 Days	Mean Change From Baseline in AST Value	-0.95 IU/L	Standard Deviation 8.91
Normal Saline Given Intravenously Daily for 5 Days	Mean Change From Baseline in AST Value	-0.67 IU/L	Standard Deviation 8.25

Secondary

Mean Change From Baseline in AST Value

Mean change from baseline in aspartate transaminase (AST) value at week 24

Time frame: Follow-up phase - Week 24

Population: Participants who received intervention and had lab value available at baseline and treatment/follow-up day/week. One subject had missing lab value.

Arm	Measure	Value (MEAN)	Dispersion
GS-5734 100mg Given Intravenously Daily for 5 Days	Mean Change From Baseline in AST Value	-1.05 IU/L	Standard Deviation 6.03
Normal Saline Given Intravenously Daily for 5 Days	Mean Change From Baseline in AST Value	11.61 IU/L	Standard Deviation 51.06

Secondary

Mean Change From Baseline in INR Value

Mean change from baseline in international normalized ratio (INR) value at day 1

Time frame: Treatment phase - Day 1

Population: Participants who received intervention

Arm	Measure	Value (MEAN)	Dispersion
GS-5734 100mg Given Intravenously Daily for 5 Days	Mean Change From Baseline in INR Value	0.02 Ratio	Standard Deviation 0.15
Normal Saline Given Intravenously Daily for 5 Days	Mean Change From Baseline in INR Value	0 Ratio	Standard Deviation 0.13

Secondary

Mean Change From Baseline in INR Value

Mean change from baseline in international normalized ratio (INR) value at day 2

Time frame: Treatment phase - Day 2

Population: Participants who received intervention

Arm	Measure	Value (MEAN)	Dispersion
GS-5734 100mg Given Intravenously Daily for 5 Days	Mean Change From Baseline in INR Value	0.01 Ratio	Standard Deviation 0.08
Normal Saline Given Intravenously Daily for 5 Days	Mean Change From Baseline in INR Value	-0.01 Ratio	Standard Deviation 0.14

Secondary

Mean Change From Baseline in INR Value

Mean change from baseline in international normalized ratio (INR) value at day 3

Time frame: Treatment phase - Day 3

Population: Participants who received intervention

Arm	Measure	Value (MEAN)	Dispersion
GS-5734 100mg Given Intravenously Daily for 5 Days	Mean Change From Baseline in INR Value	0.03 Ratio	Standard Deviation 0.07
Normal Saline Given Intravenously Daily for 5 Days	Mean Change From Baseline in INR Value	-0.03 Ratio	Standard Deviation 0.14

Secondary

Mean Change From Baseline in INR Value

Mean change from baseline in international normalized ratio (INR) value at day 4

Time frame: Treatment phase - Day 4

Population: Participants who received intervention

Arm	Measure	Value (MEAN)	Dispersion
GS-5734 100mg Given Intravenously Daily for 5 Days	Mean Change From Baseline in INR Value	1.04 Ratio	Standard Deviation 4.16
Normal Saline Given Intravenously Daily for 5 Days	Mean Change From Baseline in INR Value	-0.06 Ratio	Standard Deviation 0.15

Secondary

Mean Change From Baseline in INR Value

Mean change from baseline in international normalized ratio (INR) value at day 5

Time frame: Treatment phase - Day 5

Population: Participants who received intervention

Arm	Measure	Value (MEAN)	Dispersion
GS-5734 100mg Given Intravenously Daily for 5 Days	Mean Change From Baseline in INR Value	0.13 Ratio	Standard Deviation 0.07
Normal Saline Given Intravenously Daily for 5 Days	Mean Change From Baseline in INR Value	-0.05 Ratio	Standard Deviation 0.16

Secondary

Mean Change From Baseline in INR Value

Mean change from baseline in international normalized ratio (INR) value at day 8

Time frame: Treatment phase - Day 8

Population: Participants who received intervention

Arm	Measure	Value (MEAN)	Dispersion
GS-5734 100mg Given Intravenously Daily for 5 Days	Mean Change From Baseline in INR Value	0.12 Ratio	Standard Deviation 0.16
Normal Saline Given Intravenously Daily for 5 Days	Mean Change From Baseline in INR Value	-0.05 Ratio	Standard Deviation 0.15

Secondary

Mean Change From Baseline in INR Value

Mean change from baseline in international normalized ratio (INR) value at day 11

Time frame: Treatment phase - Day 11

Population: Participants who received intervention

Arm	Measure	Value (MEAN)	Dispersion
GS-5734 100mg Given Intravenously Daily for 5 Days	Mean Change From Baseline in INR Value	0.05 Ratio	Standard Deviation 0.18
Normal Saline Given Intravenously Daily for 5 Days	Mean Change From Baseline in INR Value	-0.03 Ratio	Standard Deviation 0.14

Secondary

Mean Change From Baseline in INR Value

Mean change from baseline in international normalized ratio (INR) value at day 16

Time frame: Treatment phase - Day 16

Population: Participants who received intervention and had lab value available at baseline and treatment/follow-up day/week. One subject had missing lab value.

Arm	Measure	Value (MEAN)	Dispersion
GS-5734 100mg Given Intravenously Daily for 5 Days	Mean Change From Baseline in INR Value	0.05 Ratio	Standard Deviation 0.19
Normal Saline Given Intravenously Daily for 5 Days	Mean Change From Baseline in INR Value	-0.05 Ratio	Standard Deviation 0.13

Secondary

Mean Change From Baseline in INR Value

Mean change from baseline in international normalized ratio (INR) value at day 24

Time frame: Treatment phase - Day 24

Population: Participants who received intervention

Arm	Measure	Value (MEAN)	Dispersion
GS-5734 100mg Given Intravenously Daily for 5 Days	Mean Change From Baseline in INR Value	0.06 Ratio	Standard Deviation 0.22
Normal Saline Given Intravenously Daily for 5 Days	Mean Change From Baseline in INR Value	-0.04 Ratio	Standard Deviation 0.15

Secondary

Mean Change From Baseline in INR Value

Mean change from baseline in international normalized ratio (INR) value at day 28

Time frame: Treatment phase - Day 28

Population: Participants who received intervention

Arm	Measure	Value (MEAN)	Dispersion
GS-5734 100mg Given Intravenously Daily for 5 Days	Mean Change From Baseline in INR Value	0.01 Ratio	Standard Deviation 0.21
Normal Saline Given Intravenously Daily for 5 Days	Mean Change From Baseline in INR Value	-0.03 Ratio	Standard Deviation 0.19

Secondary

Mean Change From Baseline in INR Value

Mean change from baseline in international normalized ratio (INR) value at week 8

Time frame: Follow-up phase - Week 8

Population: Participants who received intervention

Arm	Measure	Value (MEAN)	Dispersion
GS-5734 100mg Given Intravenously Daily for 5 Days	Mean Change From Baseline in INR Value	-0.01 Ratio	Standard Deviation 0.24
Normal Saline Given Intravenously Daily for 5 Days	Mean Change From Baseline in INR Value	-0.18 Ratio	Standard Deviation 0.21

Secondary

Mean Change From Baseline in INR Value

Mean change from baseline in international normalized ratio (INR) value at week 12

Time frame: Follow-up phase - Week 12

Population: Participants who received intervention

Arm	Measure	Value (MEAN)	Dispersion
GS-5734 100mg Given Intravenously Daily for 5 Days	Mean Change From Baseline in INR Value	0.04 Ratio	Standard Deviation 0.2
Normal Saline Given Intravenously Daily for 5 Days	Mean Change From Baseline in INR Value	-0.06 Ratio	Standard Deviation 0.27

Secondary

Mean Change From Baseline in INR Value

Mean change from baseline in international normalized ratio (INR) value at week 16

Time frame: Follow-up phase - Week 16

Population: Participants who received intervention and had lab value available at baseline and treatment/follow-up day/week. One subject had missing lab value.

Arm	Measure	Value (MEAN)	Dispersion
GS-5734 100mg Given Intravenously Daily for 5 Days	Mean Change From Baseline in INR Value	0.09 Ratio	Standard Deviation 0.2
Normal Saline Given Intravenously Daily for 5 Days	Mean Change From Baseline in INR Value	-0.05 Ratio	Standard Deviation 0.24

Secondary

Mean Change From Baseline in INR Value

Mean change from baseline in international normalized ratio (INR) value at week 20

Time frame: Follow-up phase - Week 20

Population: Participants who received intervention

Arm	Measure	Value (MEAN)	Dispersion
GS-5734 100mg Given Intravenously Daily for 5 Days	Mean Change From Baseline in INR Value	-0.05 Ratio	Standard Deviation 0.3
Normal Saline Given Intravenously Daily for 5 Days	Mean Change From Baseline in INR Value	-0.16 Ratio	Standard Deviation 0.26

Secondary

Mean Change From Baseline in INR Value

Mean change from baseline in international normalized ratio (INR) value at week 24

Time frame: Follow-up phase - Week 24

Population: Participants who received intervention and had lab value available at baseline and treatment/follow-up day/week. One subject had missing lab value.

Arm	Measure	Value (MEAN)	Dispersion
GS-5734 100mg Given Intravenously Daily for 5 Days	Mean Change From Baseline in INR Value	-0.1 Ratio	Standard Deviation 0.31
Normal Saline Given Intravenously Daily for 5 Days	Mean Change From Baseline in INR Value	-0.28 Ratio	Standard Deviation 0.2

Secondary

Mean Change From Baseline in PT Value

Mean change from baseline in prothrombin time (PT) value at day 4

Time frame: Treatment phase - Day 4

Population: Participants who received intervention

Arm	Measure	Value (MEAN)	Dispersion
GS-5734 100mg Given Intravenously Daily for 5 Days	Mean Change From Baseline in PT Value	6.27 Seconds	Standard Deviation 23.42
Normal Saline Given Intravenously Daily for 5 Days	Mean Change From Baseline in PT Value	-0.24 Seconds	Standard Deviation 0.5

Secondary

Mean Change From Baseline in PT Value

Mean change from baseline in prothrombin time (PT) value at week 12

Time frame: Follow-up phase - Week 12

Population: Participants who received intervention

Arm	Measure	Value (MEAN)	Dispersion
GS-5734 100mg Given Intravenously Daily for 5 Days	Mean Change From Baseline in PT Value	-0.22 Seconds	Standard Deviation 0.74
Normal Saline Given Intravenously Daily for 5 Days	Mean Change From Baseline in PT Value	0.06 Seconds	Standard Deviation 0.59

Secondary

Mean Change From Baseline in PT Value

Mean change from baseline in prothrombin time (PT) value at week 16

Time frame: Follow-up phase - Week 16

Population: Participants who received intervention and had lab value available at baseline and treatment/follow-up day/week. One subject had missing lab value.

Arm	Measure	Value (MEAN)	Dispersion
GS-5734 100mg Given Intravenously Daily for 5 Days	Mean Change From Baseline in PT Value	-0.17 Seconds	Standard Deviation 0.59
Normal Saline Given Intravenously Daily for 5 Days	Mean Change From Baseline in PT Value	-0.03 Seconds	Standard Deviation 0.54

Secondary

Mean Change From Baseline in PT Value

Mean change from baseline in prothrombin time (PT) value at week 20

Time frame: Follow-up phase - Week 20

Population: Participants who received intervention

Arm	Measure	Value (MEAN)	Dispersion
GS-5734 100mg Given Intravenously Daily for 5 Days	Mean Change From Baseline in PT Value	-0.25 Seconds	Standard Deviation 0.7
Normal Saline Given Intravenously Daily for 5 Days	Mean Change From Baseline in PT Value	0.26 Seconds	Standard Deviation 0.81

Secondary

Mean Change From Baseline in PT Value

Mean change from baseline in prothrombin time (PT) value at week 24

Time frame: Follow-up phase - Week 24

Population: Participants who received intervention

Arm	Measure	Value (MEAN)	Dispersion
GS-5734 100mg Given Intravenously Daily for 5 Days	Mean Change From Baseline in PT Value	-0.41 Seconds	Standard Deviation 0.9
Normal Saline Given Intravenously Daily for 5 Days	Mean Change From Baseline in PT Value	-0.23 Seconds	Standard Deviation 0.6

Secondary

Mean Change From Baseline in PT Value

Mean change from baseline in prothrombin time (PT) value at day 28

Time frame: Treatment phase - Day 28

Population: Participants who received intervention

Arm	Measure	Value (MEAN)	Dispersion
GS-5734 100mg Given Intravenously Daily for 5 Days	Mean Change From Baseline in PT Value	-0.34 Seconds	Standard Deviation 0.75
Normal Saline Given Intravenously Daily for 5 Days	Mean Change From Baseline in PT Value	0.11 Seconds	Standard Deviation 0.61

Secondary

Mean Change From Baseline in PT Value

Mean change from baseline in prothrombin time (PT) value at day 5

Time frame: Treatment phase - Day 5

Population: Participants who received intervention

Arm	Measure	Value (MEAN)	Dispersion
GS-5734 100mg Given Intravenously Daily for 5 Days	Mean Change From Baseline in PT Value	1.28 Seconds	Standard Deviation 0.6
Normal Saline Given Intravenously Daily for 5 Days	Mean Change From Baseline in PT Value	-0.13 Seconds	Standard Deviation 0.6

Secondary

Mean Change From Baseline in PT Value

Mean change from baseline in prothrombin time (PT) value at day 8

Time frame: Treatment phase - Day 8

Population: Participants who received intervention

Arm	Measure	Value (MEAN)	Dispersion
GS-5734 100mg Given Intravenously Daily for 5 Days	Mean Change From Baseline in PT Value	0.86 Seconds	Standard Deviation 0.76
Normal Saline Given Intravenously Daily for 5 Days	Mean Change From Baseline in PT Value	-0.11 Seconds	Standard Deviation 0.65

Secondary

Mean Change From Baseline in PT Value

Mean change from baseline in prothrombin time (PT) value at day 11

Time frame: Treatment phase - Day 11

Population: Participants who received intervention

Arm	Measure	Value (MEAN)	Dispersion
GS-5734 100mg Given Intravenously Daily for 5 Days	Mean Change From Baseline in PT Value	-0.08 Seconds	Standard Deviation 0.56
Normal Saline Given Intravenously Daily for 5 Days	Mean Change From Baseline in PT Value	0.04 Seconds	Standard Deviation 0.71

Secondary

Mean Change From Baseline in PT Value

Mean change from baseline in prothrombin time (PT) value at day 16

Time frame: Treatment phase - Day 16

Population: Participants who received intervention and had lab value available at baseline and treatment/follow-up day/week. One subject had missing lab value.

Arm	Measure	Value (MEAN)	Dispersion
GS-5734 100mg Given Intravenously Daily for 5 Days	Mean Change From Baseline in PT Value	-0.13 Seconds	Standard Deviation 0.84
Normal Saline Given Intravenously Daily for 5 Days	Mean Change From Baseline in PT Value	-0.17 Seconds	Standard Deviation 0.56

Secondary

Mean Change From Baseline in PT Value

Mean change from baseline in prothrombin time (PT) value at day 24

Time frame: Treatment phase - Day 24

Population: Participants who received intervention

Arm	Measure	Value (MEAN)	Dispersion
GS-5734 100mg Given Intravenously Daily for 5 Days	Mean Change From Baseline in PT Value	-0.1 Seconds	Standard Deviation 0.78
Normal Saline Given Intravenously Daily for 5 Days	Mean Change From Baseline in PT Value	-0.07 Seconds	Standard Deviation 0.58

Secondary

Mean Change From Baseline in PT Value

Mean change from baseline in prothrombin time (PT) value at day 1

Time frame: Treatment phase - Day 1

Population: Participants who received intervention

Arm	Measure	Value (MEAN)	Dispersion
GS-5734 100mg Given Intravenously Daily for 5 Days	Mean Change From Baseline in PT Value	-0.13 Seconds	Standard Deviation 0.51
Normal Saline Given Intravenously Daily for 5 Days	Mean Change From Baseline in PT Value	0.22 Seconds	Standard Deviation 0.41

Secondary

Mean Change From Baseline in PT Value

Mean change from baseline in prothrombin time (PT) value at week 8

Time frame: Follow-up phase - Week 8

Population: Participants who received intervention

Arm	Measure	Value (MEAN)	Dispersion
GS-5734 100mg Given Intravenously Daily for 5 Days	Mean Change From Baseline in PT Value	-0.26 Seconds	Standard Deviation 0.59
Normal Saline Given Intravenously Daily for 5 Days	Mean Change From Baseline in PT Value	-0.27 Seconds	Standard Deviation 0.57

Secondary

Mean Change From Baseline in PT Value

Mean change from baseline in prothrombin time (PT) value at day 2

Time frame: Treatment phase - Day 2

Population: Participants who received intervention

Arm	Measure	Value (MEAN)	Dispersion
GS-5734 100mg Given Intravenously Daily for 5 Days	Mean Change From Baseline in PT Value	0.09 Seconds	Standard Deviation 0.71
Normal Saline Given Intravenously Daily for 5 Days	Mean Change From Baseline in PT Value	0.13 Seconds	Standard Deviation 0.51

Secondary

Mean Change From Baseline in PT Value

Mean change from baseline in prothrombin time (PT) value at day 3

Time frame: Treatment phase - Day 3

Population: Participants who received intervention

Arm	Measure	Value (MEAN)	Dispersion
GS-5734 100mg Given Intravenously Daily for 5 Days	Mean Change From Baseline in PT Value	0.28 Seconds	Standard Deviation 0.62
Normal Saline Given Intravenously Daily for 5 Days	Mean Change From Baseline in PT Value	-0.01 Seconds	Standard Deviation 0.62

Secondary

Number of Participants With Increase in Grade From Baseline for ALT Value

Number of participants with increase in grade from baseline in alanine transaminase (ALT) Value at day 28. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). ALT grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), & grade 4 (\> 10 x ULN)

Time frame: Treatment phase - Day 28

Population: Participants who received intervention

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Number of Participants With Increase in Grade From Baseline for ALT Value	0 Participants
Normal Saline Given Intravenously Daily for 5 Days	Number of Participants With Increase in Grade From Baseline for ALT Value	0 Participants

Secondary

Number of Participants With Increase in Grade From Baseline for ALT Value

Number of participants with increase in grade from baseline in alanine transaminase (ALT) Value at week 12. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). ALT grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), & grade 4 (\> 10 x ULN)

Time frame: Follow-up phase - Week 12

Population: Participants who received intervention

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Number of Participants With Increase in Grade From Baseline for ALT Value	1 Participants
Normal Saline Given Intravenously Daily for 5 Days	Number of Participants With Increase in Grade From Baseline for ALT Value	0 Participants

Secondary

Number of Participants With Increase in Grade From Baseline for ALT Value

Number of participants with increase in grade from baseline in alanine transaminase (ALT) Value at week 16. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). ALT grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), & grade 4 (\> 10 x ULN)

Time frame: Follow-up phase - Week 16

Population: Participants who received intervention

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Number of Participants With Increase in Grade From Baseline for ALT Value	1 Participants
Normal Saline Given Intravenously Daily for 5 Days	Number of Participants With Increase in Grade From Baseline for ALT Value	0 Participants

Secondary

Number of Participants With Increase in Grade From Baseline for ALT Value

Number of participants with increase in grade from baseline in alanine transaminase (ALT) Value at week 20. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). ALT grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), & grade 4 (\> 10 x ULN)

Time frame: Follow-up phase - Week 20

Population: Participants who received intervention

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Number of Participants With Increase in Grade From Baseline for ALT Value	0 Participants
Normal Saline Given Intravenously Daily for 5 Days	Number of Participants With Increase in Grade From Baseline for ALT Value	0 Participants

Secondary

Number of Participants With Increase in Grade From Baseline for ALT Value

Number of participants with increase in grade from baseline in alanine transaminase (ALT) value at week 24. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). ALT grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), & grade 4 (\> 10 x ULN)

Time frame: Follow-up phase - Week 24

Population: Participants who received intervention and had lab value available at baseline and treatment/follow-up day/week. One subject had missing lab value.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Number of Participants With Increase in Grade From Baseline for ALT Value	1 Participants
Normal Saline Given Intravenously Daily for 5 Days	Number of Participants With Increase in Grade From Baseline for ALT Value	1 Participants

Secondary

Number of Participants With Increase in Grade From Baseline for ALT Value

Number of participants with increase in grade from baseline in alanine transaminase (ALT) value at day 1. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (AE) \[DAIDS AE grading table\] version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). ALT grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), & grade 4 (\> 10 x ULN)

Time frame: Treatment phase - Day 1

Population: Participants who received intervention

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Number of Participants With Increase in Grade From Baseline for ALT Value	1 Participants
Normal Saline Given Intravenously Daily for 5 Days	Number of Participants With Increase in Grade From Baseline for ALT Value	0 Participants

Secondary

Number of Participants With Increase in Grade From Baseline for ALT Value

Number of participants with increase in grade from baseline in alanine transaminase (ALT) Value at day 2. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). ALT grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), & grade 4 (\> 10 x ULN)

Time frame: Treatment phase - Day 2

Population: Participants who received intervention

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Number of Participants With Increase in Grade From Baseline for ALT Value	1 Participants
Normal Saline Given Intravenously Daily for 5 Days	Number of Participants With Increase in Grade From Baseline for ALT Value	0 Participants

Secondary

Number of Participants With Increase in Grade From Baseline for ALT Value

Number of participants with increase in grade from baseline in alanine transaminase (ALT) Value at day 3. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). ALT grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), & grade 4 (\> 10 x ULN)

Time frame: Treatment phase - Day 3

Population: Participants who received intervention

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Number of Participants With Increase in Grade From Baseline for ALT Value	1 Participants
Normal Saline Given Intravenously Daily for 5 Days	Number of Participants With Increase in Grade From Baseline for ALT Value	0 Participants

Secondary

Number of Participants With Increase in Grade From Baseline for ALT Value

Number of participants with increase in grade from baseline in alanine transaminase (ALT) Value at day 4. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). ALT grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), & grade 4 (\> 10 x ULN)

Time frame: Treatment phase - Day 4

Population: Participants who received intervention

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Number of Participants With Increase in Grade From Baseline for ALT Value	1 Participants
Normal Saline Given Intravenously Daily for 5 Days	Number of Participants With Increase in Grade From Baseline for ALT Value	3 Participants

Secondary

Number of Participants With Increase in Grade From Baseline for ALT Value

Number of participants with increase in grade from baseline in alanine transaminase (ALT) Value at day 5. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). ALT grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), & grade 4 (\> 10 x ULN)

Time frame: Treatment phase - Day 5

Population: Participants who received intervention

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Number of Participants With Increase in Grade From Baseline for ALT Value	2 Participants
Normal Saline Given Intravenously Daily for 5 Days	Number of Participants With Increase in Grade From Baseline for ALT Value	2 Participants

Secondary

Number of Participants With Increase in Grade From Baseline for ALT Value

Number of participants with increase in grade from baseline in alanine transaminase (ALT) Value at day 8. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). ALT grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), & grade 4 (\> 10 x ULN)

Time frame: Treatment phase - Day 8

Population: Participants who received intervention

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Number of Participants With Increase in Grade From Baseline for ALT Value	5 Participants
Normal Saline Given Intravenously Daily for 5 Days	Number of Participants With Increase in Grade From Baseline for ALT Value	0 Participants

Secondary

Number of Participants With Increase in Grade From Baseline for ALT Value

Number of participants with increase in grade from baseline in alanine transaminase (ALT) Value at day 11. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). ALT grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), & grade 4 (\> 10 x ULN)

Time frame: Treatment phase - Day 11

Population: Participants who received intervention

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Number of Participants With Increase in Grade From Baseline for ALT Value	3 Participants
Normal Saline Given Intravenously Daily for 5 Days	Number of Participants With Increase in Grade From Baseline for ALT Value	0 Participants

Secondary

Number of Participants With Increase in Grade From Baseline for ALT Value

Number of participants with increase in grade from baseline in alanine transaminase (ALT) Value at day 16. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). ALT grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), & grade 4 (\> 10 x ULN)

Time frame: Treatment phase - Day 16

Population: Participants who received intervention and had lab value available at baseline and treatment/follow-up day/week. One subject had missing lab value.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Number of Participants With Increase in Grade From Baseline for ALT Value	1 Participants
Normal Saline Given Intravenously Daily for 5 Days	Number of Participants With Increase in Grade From Baseline for ALT Value	0 Participants

Secondary

Number of Participants With Increase in Grade From Baseline for ALT Value

Number of participants with increase in grade from baseline in alanine transaminase (ALT) Value at day 24. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). ALT grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), & grade 4 (\> 10 x ULN)

Time frame: Treatment phase - Day 24

Population: Participants who received intervention

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Number of Participants With Increase in Grade From Baseline for ALT Value	1 Participants
Normal Saline Given Intravenously Daily for 5 Days	Number of Participants With Increase in Grade From Baseline for ALT Value	0 Participants

Secondary

Number of Participants With Increase in Grade From Baseline for ALT Value

Number of participants with increase in grade from baseline in alanine transaminase (ALT) Value at week 8. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). ALT grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), & grade 4 (\> 10 x ULN)

Time frame: Follow-up phase - Week 8

Population: Participants who received intervention

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Number of Participants With Increase in Grade From Baseline for ALT Value	0 Participants
Normal Saline Given Intravenously Daily for 5 Days	Number of Participants With Increase in Grade From Baseline for ALT Value	0 Participants

Secondary

Number of Participants With Increase in Grade From Baseline for aPTT Value

Number of participants with increase in grade from baseline in activated partial thromboplastin time (aPTT) value at week 16. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). aPTT grade ranges include grade 1 (1.1 - 1.66 x ULN), grade 2 (1.67 - 2.33 x ULN), grade 3 (2.34 - 3.00 x ULN), & grade 4 (\> 3.00 x ULN)

Time frame: Follow-up phase - Week 16

Population: Participants who received intervention and had lab value available at baseline and treatment/follow-up day/week. Two subjects had missing lab value.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Number of Participants With Increase in Grade From Baseline for aPTT Value	1 Participants
Normal Saline Given Intravenously Daily for 5 Days	Number of Participants With Increase in Grade From Baseline for aPTT Value	2 Participants

Secondary

Number of Participants With Increase in Grade From Baseline for aPTT Value

Number of participants with increase in grade from baseline in activated partial thromboplastin time (aPTT) value at day 1. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). aPTT grade ranges include grade 1 (1.1 - 1.66 x ULN), grade 2 (1.67 - 2.33 x ULN), grade 3 (2.34 - 3.00 x ULN), & grade 4 (\> 3.00 x ULN)

Time frame: Treatment phase - Day 1

Population: Participants who received intervention and had lab value available at baseline and treatment/follow-up day/week. One subject had missing lab value.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Number of Participants With Increase in Grade From Baseline for aPTT Value	1 Participants
Normal Saline Given Intravenously Daily for 5 Days	Number of Participants With Increase in Grade From Baseline for aPTT Value	0 Participants

Secondary

Number of Participants With Increase in Grade From Baseline for aPTT Value

Number of participants with increase in grade from baseline in activated partial thromboplastin time (aPTT) value at day 2. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). aPTT grade ranges include grade 1 (1.1 - 1.66 x ULN), grade 2 (1.67 - 2.33 x ULN), grade 3 (2.34 - 3.00 x ULN), & grade 4 (\> 3.00 x ULN)

Time frame: Treatment phase - Day 2

Population: Participants who received intervention and had lab value available at baseline and treatment/follow-up day/week. One subject had missing lab value.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Number of Participants With Increase in Grade From Baseline for aPTT Value	0 Participants
Normal Saline Given Intravenously Daily for 5 Days	Number of Participants With Increase in Grade From Baseline for aPTT Value	0 Participants

Secondary

Number of Participants With Increase in Grade From Baseline for aPTT Value

Number of participants with increase in grade from baseline in activated partial thromboplastin time (aPTT) value at day 3. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). aPTT grade ranges include grade 1 (1.1 - 1.66 x ULN), grade 2 (1.67 - 2.33 x ULN), grade 3 (2.34 - 3.00 x ULN), & grade 4 (\> 3.00 x ULN)

Time frame: Treatment phase - Day 3

Population: Participants who received intervention and had lab value available at baseline and treatment/follow-up day/week. One subject had missing lab value.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Number of Participants With Increase in Grade From Baseline for aPTT Value	1 Participants
Normal Saline Given Intravenously Daily for 5 Days	Number of Participants With Increase in Grade From Baseline for aPTT Value	1 Participants

Secondary

Number of Participants With Increase in Grade From Baseline for aPTT Value

Number of participants with increase in grade from baseline in activated partial thromboplastin time (aPTT) value at day 4. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). aPTT grade ranges include grade 1 (1.1 - 1.66 x ULN), grade 2 (1.67 - 2.33 x ULN), grade 3 (2.34 - 3.00 x ULN), & grade 4 (\> 3.00 x ULN)

Time frame: Treatment phase - Day 4

Population: Participants who received intervention and had lab value available at baseline and treatment/follow-up day/week. One subject had missing lab value.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Number of Participants With Increase in Grade From Baseline for aPTT Value	5 Participants
Normal Saline Given Intravenously Daily for 5 Days	Number of Participants With Increase in Grade From Baseline for aPTT Value	0 Participants

Secondary

Number of Participants With Increase in Grade From Baseline for aPTT Value

Number of participants with increase in grade from baseline in activated partial thromboplastin time (aPTT) value at day 5. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). aPTT grade ranges include grade 1 (1.1 - 1.66 x ULN), grade 2 (1.67 - 2.33 x ULN), grade 3 (2.34 - 3.00 x ULN), & grade 4 (\> 3.00 x ULN)

Time frame: Treatment phase - Day 5

Population: Participants who received intervention and had lab value available at baseline and treatment/follow-up day/week. One subject had missing lab value.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Number of Participants With Increase in Grade From Baseline for aPTT Value	2 Participants
Normal Saline Given Intravenously Daily for 5 Days	Number of Participants With Increase in Grade From Baseline for aPTT Value	0 Participants

Secondary

Number of Participants With Increase in Grade From Baseline for aPTT Value

Number of participants with increase in grade from baseline in activated partial thromboplastin time (aPTT) value at day 8. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). aPTT grade ranges include grade 1 (1.1 - 1.66 x ULN), grade 2 (1.67 - 2.33 x ULN), grade 3 (2.34 - 3.00 x ULN), & grade 4 (\> 3.00 x ULN)

Time frame: Treatment phase - Day 8

Population: Participants who received intervention and had lab value available at baseline and treatment/follow-up day/week. One subject had missing lab value.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Number of Participants With Increase in Grade From Baseline for aPTT Value	2 Participants
Normal Saline Given Intravenously Daily for 5 Days	Number of Participants With Increase in Grade From Baseline for aPTT Value	0 Participants

Secondary

Number of Participants With Increase in Grade From Baseline for aPTT Value

Number of participants with increase in grade from baseline in activated partial thromboplastin time (aPTT) value at day 11. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). aPTT grade ranges include grade 1 (1.1 - 1.66 x ULN), grade 2 (1.67 - 2.33 x ULN), grade 3 (2.34 - 3.00 x ULN), & grade 4 (\> 3.00 x ULN)

Time frame: Treatment phase - Day 11

Population: Participants who received intervention and had lab value available at baseline and treatment/follow-up day/week. One subject had missing lab value.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Number of Participants With Increase in Grade From Baseline for aPTT Value	0 Participants
Normal Saline Given Intravenously Daily for 5 Days	Number of Participants With Increase in Grade From Baseline for aPTT Value	0 Participants

Secondary

Number of Participants With Increase in Grade From Baseline for aPTT Value

Number of participants with increase in grade from baseline in activated partial thromboplastin time (aPTT) value at day 16. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). aPTT grade ranges include grade 1 (1.1 - 1.66 x ULN), grade 2 (1.67 - 2.33 x ULN), grade 3 (2.34 - 3.00 x ULN), & grade 4 (\> 3.00 x ULN)

Time frame: Treatment phase - Day 16

Population: Participants who received intervention and had lab value available at baseline and treatment/follow-up day/week. Three subjects had missing lab value.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Number of Participants With Increase in Grade From Baseline for aPTT Value	1 Participants
Normal Saline Given Intravenously Daily for 5 Days	Number of Participants With Increase in Grade From Baseline for aPTT Value	0 Participants

Secondary

Number of Participants With Increase in Grade From Baseline for aPTT Value

Number of participants with increase in grade from baseline in activated partial thromboplastin time (aPTT) value at day 24. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). aPTT grade ranges include grade 1 (1.1 - 1.66 x ULN), grade 2 (1.67 - 2.33 x ULN), grade 3 (2.34 - 3.00 x ULN), & grade 4 (\> 3.00 x ULN)

Time frame: Treatment phase - Day 24

Population: Participants who received intervention and had lab value available at baseline and treatment/follow-up day/week. One subject had missing lab value.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Number of Participants With Increase in Grade From Baseline for aPTT Value	1 Participants
Normal Saline Given Intravenously Daily for 5 Days	Number of Participants With Increase in Grade From Baseline for aPTT Value	1 Participants

Secondary

Number of Participants With Increase in Grade From Baseline for aPTT Value

Number of participants with increase in grade from baseline in activated partial thromboplastin time (aPTT) value at day 28. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). aPTT grade ranges include grade 1 (1.1 - 1.66 x ULN), grade 2 (1.67 - 2.33 x ULN), grade 3 (2.34 - 3.00 x ULN), & grade 4 (\> 3.00 x ULN)

Time frame: Treatment phase - Day 28

Population: Participants who received intervention and had lab value available at baseline and treatment/follow-up day/week. Two subjects had missing lab value.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Number of Participants With Increase in Grade From Baseline for aPTT Value	0 Participants
Normal Saline Given Intravenously Daily for 5 Days	Number of Participants With Increase in Grade From Baseline for aPTT Value	0 Participants

Secondary

Number of Participants With Increase in Grade From Baseline for aPTT Value

Number of participants with increase in grade from baseline in activated partial thromboplastin time (aPTT) value at week 8. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). aPTT grade ranges include grade 1 (1.1 - 1.66 x ULN), grade 2 (1.67 - 2.33 x ULN), grade 3 (2.34 - 3.00 x ULN), & grade 4 (\> 3.00 x ULN)

Time frame: Follow-up phase - Week 8

Population: Participants who received intervention and had lab value available at baseline and treatment/follow-up day/week. Two subjects had missing lab value.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Number of Participants With Increase in Grade From Baseline for aPTT Value	1 Participants
Normal Saline Given Intravenously Daily for 5 Days	Number of Participants With Increase in Grade From Baseline for aPTT Value	1 Participants

Secondary

Number of Participants With Increase in Grade From Baseline for aPTT Value

Number of participants with increase in grade from baseline in activated partial thromboplastin time (aPTT) value at week 12. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). aPTT grade ranges include grade 1 (1.1 - 1.66 x ULN), grade 2 (1.67 - 2.33 x ULN), grade 3 (2.34 - 3.00 x ULN), & grade 4 (\> 3.00 x ULN)

Time frame: Follow-up phase - Week 12

Population: Participants who received intervention and had lab value available at baseline and treatment/follow-up day/week. One subject had missing lab value.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Number of Participants With Increase in Grade From Baseline for aPTT Value	1 Participants
Normal Saline Given Intravenously Daily for 5 Days	Number of Participants With Increase in Grade From Baseline for aPTT Value	1 Participants

Secondary

Number of Participants With Increase in Grade From Baseline for aPTT Value

Number of participants with increase in grade from baseline in activated partial thromboplastin time (aPTT) value at week 20. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). aPTT grade ranges include grade 1 (1.1 - 1.66 x ULN), grade 2 (1.67 - 2.33 x ULN), grade 3 (2.34 - 3.00 x ULN), & grade 4 (\> 3.00 x ULN)

Time frame: Follow-up phase - Week 20

Population: Participants who received intervention and had lab value available at baseline and treatment/follow-up day/week. One subject had missing lab value.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Number of Participants With Increase in Grade From Baseline for aPTT Value	1 Participants
Normal Saline Given Intravenously Daily for 5 Days	Number of Participants With Increase in Grade From Baseline for aPTT Value	2 Participants

Secondary

Number of Participants With Increase in Grade From Baseline for aPTT Value

Number of participants with increase in grade from baseline in activated partial thromboplastin time (aPTT) value at week 24. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). aPTT grade ranges include grade 1 (1.1 - 1.66 x ULN), grade 2 (1.67 - 2.33 x ULN), grade 3 (2.34 - 3.00 x ULN), & grade 4 (\> 3.00 x ULN)

Time frame: Follow-up phase - Week 24

Population: Participants who received intervention and had lab value available at baseline and treatment/follow-up day/week. Two subjects had missing lab value.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Number of Participants With Increase in Grade From Baseline for aPTT Value	0 Participants
Normal Saline Given Intravenously Daily for 5 Days	Number of Participants With Increase in Grade From Baseline for aPTT Value	1 Participants

Secondary

Number of Participants With Increase in Grade From Baseline for AST Value

Number of participants with increase in grade from baseline in aspartate transaminase (AST) Value at day 1. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). AST grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), & grade 4 (\> 10 x ULN)

Time frame: Treatment phase - Day 1

Population: Participants who received intervention

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Number of Participants With Increase in Grade From Baseline for AST Value	0 Participants
Normal Saline Given Intravenously Daily for 5 Days	Number of Participants With Increase in Grade From Baseline for AST Value	0 Participants

Secondary

Number of Participants With Increase in Grade From Baseline for AST Value

Number of participants with increase in grade from baseline in aspartate transaminase (AST) Value at week 24. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). AST grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), & grade 4 (\> 10 x ULN)

Time frame: Follow-up phase - Week 24

Population: Participants who received intervention and had lab value available at baseline and treatment/follow-up day/week. One subject had missing lab value.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Number of Participants With Increase in Grade From Baseline for AST Value	1 Participants
Normal Saline Given Intravenously Daily for 5 Days	Number of Participants With Increase in Grade From Baseline for AST Value	1 Participants

Secondary

Number of Participants With Increase in Grade From Baseline for AST Value

Number of participants with increase in grade from baseline in aspartate transaminase (AST) value at week 20. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). AST grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), & grade 4 (\> 10 x ULN)

Time frame: Follow-up phase - Week 20

Population: Participants who received intervention

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Number of Participants With Increase in Grade From Baseline for AST Value	1 Participants
Normal Saline Given Intravenously Daily for 5 Days	Number of Participants With Increase in Grade From Baseline for AST Value	0 Participants

Secondary

Number of Participants With Increase in Grade From Baseline for AST Value

Number of participants with increase in grade from baseline in aspartate transaminase (AST) Value at week 16. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). AST grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), & grade 4 (\> 10 x ULN)

Time frame: Follow-up phase - Week 16

Population: Participants who received intervention

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Number of Participants With Increase in Grade From Baseline for AST Value	2 Participants
Normal Saline Given Intravenously Daily for 5 Days	Number of Participants With Increase in Grade From Baseline for AST Value	0 Participants

Secondary

Number of Participants With Increase in Grade From Baseline for AST Value

Number of participants with increase in grade from baseline in aspartate transaminase (AST) Value at week 12. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). AST grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), & grade 4 (\> 10 x ULN)

Time frame: Follow-up phase - Week 12

Population: Participants who received intervention

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Number of Participants With Increase in Grade From Baseline for AST Value	1 Participants
Normal Saline Given Intravenously Daily for 5 Days	Number of Participants With Increase in Grade From Baseline for AST Value	0 Participants

Secondary

Number of Participants With Increase in Grade From Baseline for AST Value

Number of participants with increase in grade from baseline in aspartate transaminase (AST) Value at week 8. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). AST grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), & grade 4 (\> 10 x ULN)

Time frame: Follow-up phase - Week 8

Population: Participants who received intervention

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Number of Participants With Increase in Grade From Baseline for AST Value	0 Participants
Normal Saline Given Intravenously Daily for 5 Days	Number of Participants With Increase in Grade From Baseline for AST Value	1 Participants

Secondary

Number of Participants With Increase in Grade From Baseline for AST Value

Number of participants with increase in grade from baseline in aspartate transaminase (AST) Value at day 28. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). AST grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), & grade 4 (\> 10 x ULN)

Time frame: Treatment phase - Day 28

Population: Participants who received intervention

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Number of Participants With Increase in Grade From Baseline for AST Value	0 Participants
Normal Saline Given Intravenously Daily for 5 Days	Number of Participants With Increase in Grade From Baseline for AST Value	0 Participants

Secondary

Number of Participants With Increase in Grade From Baseline for AST Value

Number of participants with increase in grade from baseline in aspartate transaminase (AST) value at day 24. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). AST grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), & grade 4 (\> 10 x ULN)

Time frame: Treatment phase - Day 24

Population: Participants who received intervention

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Number of Participants With Increase in Grade From Baseline for AST Value	0 Participants
Normal Saline Given Intravenously Daily for 5 Days	Number of Participants With Increase in Grade From Baseline for AST Value	0 Participants

Secondary

Number of Participants With Increase in Grade From Baseline for AST Value

Number of participants with increase in grade from baseline in aspartate transaminase (AST) Value at day 16. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). AST grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), & grade 4 (\> 10 x ULN)

Time frame: Treatment phase - Day 16

Population: Participants who received intervention and had lab value available at baseline and treatment/follow-up day/week. One subject had missing lab value.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Number of Participants With Increase in Grade From Baseline for AST Value	0 Participants
Normal Saline Given Intravenously Daily for 5 Days	Number of Participants With Increase in Grade From Baseline for AST Value	0 Participants

Secondary

Number of Participants With Increase in Grade From Baseline for AST Value

Number of participants with increase in grade from baseline in aspartate transaminase (AST) value at day 11. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). AST grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), & grade 4 (\> 10 x ULN)

Time frame: Treatment phase - Day 11

Population: Participants who received intervention

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Number of Participants With Increase in Grade From Baseline for AST Value	0 Participants
Normal Saline Given Intravenously Daily for 5 Days	Number of Participants With Increase in Grade From Baseline for AST Value	0 Participants

Secondary

Number of Participants With Increase in Grade From Baseline for AST Value

Number of participants with increase in grade from baseline in aspartate transaminase (AST) Value at day 8. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). AST grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), & grade 4 (\> 10 x ULN)

Time frame: Treatment phase - Day 8

Population: Participants who received intervention

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Number of Participants With Increase in Grade From Baseline for AST Value	3 Participants
Normal Saline Given Intravenously Daily for 5 Days	Number of Participants With Increase in Grade From Baseline for AST Value	0 Participants

Secondary

Number of Participants With Increase in Grade From Baseline for AST Value

Number of participants with increase in grade from baseline in aspartate transaminase (AST) Value at day 5. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). AST grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), & grade 4 (\> 10 x ULN)

Time frame: Treatment phase - Day 5

Population: Participants who received intervention

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Number of Participants With Increase in Grade From Baseline for AST Value	1 Participants
Normal Saline Given Intravenously Daily for 5 Days	Number of Participants With Increase in Grade From Baseline for AST Value	1 Participants

Secondary

Number of Participants With Increase in Grade From Baseline for AST Value

Number of participants with increase in grade from baseline in aspartate transaminase (AST) value at day 4. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). AST grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), & grade 4 (\> 10 x ULN)

Time frame: Treatment phase - Day 4

Population: Participants who received intervention

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Number of Participants With Increase in Grade From Baseline for AST Value	1 Participants
Normal Saline Given Intravenously Daily for 5 Days	Number of Participants With Increase in Grade From Baseline for AST Value	1 Participants

Secondary

Number of Participants With Increase in Grade From Baseline for AST Value

Number of participants with increase in grade from baseline in aspartate transaminase (AST) value at day 3. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). AST grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), & grade 4 (\> 10 x ULN)

Time frame: Treatment phase - Day 3

Population: Participants who received intervention

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Number of Participants With Increase in Grade From Baseline for AST Value	1 Participants
Normal Saline Given Intravenously Daily for 5 Days	Number of Participants With Increase in Grade From Baseline for AST Value	4 Participants

Secondary

Number of Participants With Increase in Grade From Baseline for AST Value

Number of participants with increase in grade from baseline in aspartate transaminase (AST) Value at day 2. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). AST grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), & grade 4 (\> 10 x ULN)

Time frame: Treatment phase - Day 2

Population: Participants who received intervention

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Number of Participants With Increase in Grade From Baseline for AST Value	0 Participants
Normal Saline Given Intravenously Daily for 5 Days	Number of Participants With Increase in Grade From Baseline for AST Value	0 Participants

Secondary

Number of Participants With Increase in Grade From Baseline for PT Value

Number of participants with increase in grade from baseline in prothrombin time (PT) value at day 11. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). PT grade ranges include grade 1 (1.1 - 1.25 x ULN), grade 2 (1.26 - 1.50 x ULN), grade 3 (1.51 - 3.00 x ULN), & grade 4 (\> 3.00 x ULN)

Time frame: Treatment phase - Day 11

Population: Participants who received intervention

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Number of Participants With Increase in Grade From Baseline for PT Value	0 Participants
Normal Saline Given Intravenously Daily for 5 Days	Number of Participants With Increase in Grade From Baseline for PT Value	0 Participants

Secondary

Number of Participants With Increase in Grade From Baseline for PT Value

Number of participants increase in grade from baseline in prothrombin time (PT) value at week 24. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). PT grade ranges include grade 1 (1.1 - 1.25 x ULN), grade 2 (1.26 - 1.50 x ULN), grade 3 (1.51 - 3.00 x ULN), & grade 4 (\> 3.00 x ULN)

Time frame: Follow-up phase - Week 24

Population: Participants who received intervention

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Number of Participants With Increase in Grade From Baseline for PT Value	0 Participants
Normal Saline Given Intravenously Daily for 5 Days	Number of Participants With Increase in Grade From Baseline for PT Value	0 Participants

Secondary

Number of Participants With Increase in Grade From Baseline for PT Value

Number of participants increase in grade from baseline in prothrombin time (PT) value at week 20. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). PT grade ranges include grade 1 (1.1 - 1.25 x ULN), grade 2 (1.26 - 1.50 x ULN), grade 3 (1.51 - 3.00 x ULN), & grade 4 (\> 3.00 x ULN)

Time frame: Follow-up phase - Week 20

Population: Participants who received intervention

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Number of Participants With Increase in Grade From Baseline for PT Value	0 Participants
Normal Saline Given Intravenously Daily for 5 Days	Number of Participants With Increase in Grade From Baseline for PT Value	1 Participants

Secondary

Number of Participants With Increase in Grade From Baseline for PT Value

Number of participants increase in grade from baseline in prothrombin time (PT) value at week 16. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). PT grade ranges include grade 1 (1.1 - 1.25 x ULN), grade 2 (1.26 - 1.50 x ULN), grade 3 (1.51 - 3.00 x ULN), & grade 4 (\> 3.00 x ULN)

Time frame: Follow-up phase - Week 16

Population: Participants who received intervention

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Number of Participants With Increase in Grade From Baseline for PT Value	0 Participants
Normal Saline Given Intravenously Daily for 5 Days	Number of Participants With Increase in Grade From Baseline for PT Value	0 Participants

Secondary

Number of Participants With Increase in Grade From Baseline for PT Value

Number of participants increase in grade from baseline in prothrombin time (PT) value at week 12. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). PT grade ranges include grade 1 (1.1 - 1.25 x ULN), grade 2 (1.26 - 1.50 x ULN), grade 3 (1.51 - 3.00 x ULN), & grade 4 (\> 3.00 x ULN)

Time frame: Follow-up phase - Week 12

Population: Participants who received intervention

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Number of Participants With Increase in Grade From Baseline for PT Value	0 Participants
Normal Saline Given Intravenously Daily for 5 Days	Number of Participants With Increase in Grade From Baseline for PT Value	0 Participants

Secondary

Number of Participants With Increase in Grade From Baseline for PT Value

Number of participants increase in grade from baseline in prothrombin time (PT) value at week 8. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). PT grade ranges include grade 1 (1.1 - 1.25 x ULN), grade 2 (1.26 - 1.50 x ULN), grade 3 (1.51 - 3.00 x ULN), & grade 4 (\> 3.00 x ULN)

Time frame: Follow-up phase - Week 8

Population: Participants who received intervention

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Number of Participants With Increase in Grade From Baseline for PT Value	0 Participants
Normal Saline Given Intravenously Daily for 5 Days	Number of Participants With Increase in Grade From Baseline for PT Value	0 Participants

Secondary

Number of Participants With Increase in Grade From Baseline for PT Value

Number of participants increase in grade from baseline in prothrombin time (PT) value at day 28. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). PT grade ranges include grade 1 (1.1 - 1.25 x ULN), grade 2 (1.26 - 1.50 x ULN), grade 3 (1.51 - 3.00 x ULN), & grade 4 (\> 3.00 x ULN)

Time frame: Treatment phase - Day 28

Population: Participants who received intervention

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Number of Participants With Increase in Grade From Baseline for PT Value	0 Participants
Normal Saline Given Intravenously Daily for 5 Days	Number of Participants With Increase in Grade From Baseline for PT Value	0 Participants

Secondary

Number of Participants With Increase in Grade From Baseline for PT Value

Number of participants increase in grade from baseline in prothrombin time (PT) value at day 24. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). PT grade ranges include grade 1 (1.1 - 1.25 x ULN), grade 2 (1.26 - 1.50 x ULN), grade 3 (1.51 - 3.00 x ULN), & grade 4 (\> 3.00 x ULN)

Time frame: Treatment phase - Day 24

Population: Participants who received intervention

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Number of Participants With Increase in Grade From Baseline for PT Value	0 Participants
Normal Saline Given Intravenously Daily for 5 Days	Number of Participants With Increase in Grade From Baseline for PT Value	0 Participants

Secondary

Number of Participants With Increase in Grade From Baseline for PT Value

Number of participants with increase in grade from baseline in prothrombin time (PT) value at day 1. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). PT grade ranges include grade 1 (1.1 - 1.25 x ULN), grade 2 (1.26 - 1.50 x ULN), grade 3 (1.51 - 3.00 x ULN), & grade 4 (\> 3.00 x ULN)

Time frame: Treatment phase - Day 1

Population: Participants who received intervention

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Number of Participants With Increase in Grade From Baseline for PT Value	0 Participants
Normal Saline Given Intravenously Daily for 5 Days	Number of Participants With Increase in Grade From Baseline for PT Value	0 Participants

Secondary

Number of Participants With Increase in Grade From Baseline for PT Value

Number of participants with increase in grade from baseline in prothrombin time (PT) value at day 2. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). PT grade ranges include grade 1 (1.1 - 1.25 x ULN), grade 2 (1.26 - 1.50 x ULN), grade 3 (1.51 - 3.00 x ULN), & grade 4 (\> 3.00 x ULN)

Time frame: Treatment phase - Day 2

Population: Participants who received intervention

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Number of Participants With Increase in Grade From Baseline for PT Value	0 Participants
Normal Saline Given Intravenously Daily for 5 Days	Number of Participants With Increase in Grade From Baseline for PT Value	0 Participants

Secondary

Number of Participants With Increase in Grade From Baseline for PT Value

Number of participants with increase in grade from baseline in prothrombin time (PT) value at day 3. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). PT grade ranges include grade 1 (1.1 - 1.25 x ULN), grade 2 (1.26 - 1.50 x ULN), grade 3 (1.51 - 3.00 x ULN), & grade 4 (\> 3.00 x ULN)

Time frame: Treatment phase - Day 3

Population: Participants who received intervention

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Number of Participants With Increase in Grade From Baseline for PT Value	0 Participants
Normal Saline Given Intravenously Daily for 5 Days	Number of Participants With Increase in Grade From Baseline for PT Value	0 Participants

Secondary

Number of Participants With Increase in Grade From Baseline for PT Value

Number of participants with increase in grade from baseline in prothrombin time (PT) value at day 4. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). PT grade ranges include grade 1 (1.1 - 1.25 x ULN), grade 2 (1.26 - 1.50 x ULN), grade 3 (1.51 - 3.00 x ULN), & grade 4 (\> 3.00 x ULN)

Time frame: Treatment phase - Day 4

Population: Participants who received intervention

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Number of Participants With Increase in Grade From Baseline for PT Value	2 Participants
Normal Saline Given Intravenously Daily for 5 Days	Number of Participants With Increase in Grade From Baseline for PT Value	0 Participants

Secondary

Number of Participants With Increase in Grade From Baseline for PT Value

Number of participants with increase in grade from baseline in prothrombin time (PT) value at day 5. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). PT grade ranges include grade 1 (1.1 - 1.25 x ULN), grade 2 (1.26 - 1.50 x ULN), grade 3 (1.51 - 3.00 x ULN), & grade 4 (\> 3.00 x ULN)

Time frame: Treatment phase - Day 5

Population: Participants who received intervention

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Number of Participants With Increase in Grade From Baseline for PT Value	1 Participants
Normal Saline Given Intravenously Daily for 5 Days	Number of Participants With Increase in Grade From Baseline for PT Value	0 Participants

Secondary

Number of Participants With Increase in Grade From Baseline for PT Value

Number of participants with increase in grade from baseline in prothrombin time (PT) value at day 8. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). PT grade ranges include grade 1 (1.1 - 1.25 x ULN), grade 2 (1.26 - 1.50 x ULN), grade 3 (1.51 - 3.00 x ULN), & grade 4 (\> 3.00 x ULN)

Time frame: Treatment phase - Day 8

Population: Participants who received intervention

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Number of Participants With Increase in Grade From Baseline for PT Value	0 Participants
Normal Saline Given Intravenously Daily for 5 Days	Number of Participants With Increase in Grade From Baseline for PT Value	0 Participants

Secondary

Number of Participants With Increase in Grade From Baseline for PT Value

Number of participants with increase in grade from baseline in prothrombin time (PT) value at day 16. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). PT grade ranges include grade 1 (1.1 - 1.25 x ULN), grade 2 (1.26 - 1.50 x ULN), grade 3 (1.51 - 3.00 x ULN), & grade 4 (\> 3.00 x ULN)

Time frame: Treatment phase - Day 16

Population: Participants who received intervention and had lab value available at baseline and treatment/follow-up day/week. One subject had missing lab value.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Number of Participants With Increase in Grade From Baseline for PT Value	0 Participants
Normal Saline Given Intravenously Daily for 5 Days	Number of Participants With Increase in Grade From Baseline for PT Value	0 Participants

Secondary

Participants With Grade 1 ALT Level

Participants with grade 1 (1.25 - 2.5 x ULN) alanine transaminase (ALT) level at day 24

Time frame: Treatment phase - Day 24

Population: Participants who received intervention

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Participants With Grade 1 ALT Level	1 Participants
Normal Saline Given Intravenously Daily for 5 Days	Participants With Grade 1 ALT Level	0 Participants

Secondary

Participants With Grade 1 ALT Level

Participants with grade 1 (1.25 - 2.5 x ULN) alanine transaminase (ALT) level at day 28

Time frame: Treatment phase - Day 28

Population: Participants who received intervention

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Participants With Grade 1 ALT Level	0 Participants
Normal Saline Given Intravenously Daily for 5 Days	Participants With Grade 1 ALT Level	0 Participants

Secondary

Participants With Grade 1 ALT Level

Participants with grade 1 (1.25 - 2.5 x ULN) alanine transaminase (ALT) level at week 8

Time frame: Follow-up phase - Week 8

Population: Participants who received intervention

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Participants With Grade 1 ALT Level	0 Participants
Normal Saline Given Intravenously Daily for 5 Days	Participants With Grade 1 ALT Level	0 Participants

Secondary

Participants With Grade 1 ALT Level

Participants with grade 1 (1.25 - 2.5 x ULN) alanine transaminase (ALT) level at week 12

Time frame: Follow-up phase - Week 12

Population: Participants who received intervention

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Participants With Grade 1 ALT Level	1 Participants
Normal Saline Given Intravenously Daily for 5 Days	Participants With Grade 1 ALT Level	0 Participants

Secondary

Participants With Grade 1 ALT Level

Participants with grade 1 (1.25 - 2.5 x ULN) alanine transaminase (ALT) level at week 16

Time frame: Follow-up phase - Week 16

Population: Participants who received intervention

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Participants With Grade 1 ALT Level	0 Participants
Normal Saline Given Intravenously Daily for 5 Days	Participants With Grade 1 ALT Level	0 Participants

Secondary

Participants With Grade 1 ALT Level

Participants with grade 1 (1.25 - 2.5 x ULN) alanine transaminase (ALT) level at week 24

Time frame: Follow-up phase - Week 24

Population: Participants who received intervention and had lab value available at baseline and treatment/follow-up day/week. One subject had missing lab value.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Participants With Grade 1 ALT Level	1 Participants
Normal Saline Given Intravenously Daily for 5 Days	Participants With Grade 1 ALT Level	0 Participants

Secondary

Participants With Grade 1 ALT Level

Participants with grade 1 (1.25 - 2.5 x ULN) alanine transaminase (ALT) level at week 20

Time frame: Follow-up phase - Week 20

Population: Participants who received intervention

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Participants With Grade 1 ALT Level	0 Participants
Normal Saline Given Intravenously Daily for 5 Days	Participants With Grade 1 ALT Level	0 Participants

Secondary

Participants With Grade 1 ALT Level

Participants with grade 1 (1.25 - 2.5 x ULN) alanine transaminase (ALT) level at day 1

Time frame: Treatment phase - Day 1

Population: Participants who received intervention

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Participants With Grade 1 ALT Level	1 Participants
Normal Saline Given Intravenously Daily for 5 Days	Participants With Grade 1 ALT Level	0 Participants

Secondary

Participants With Grade 1 ALT Level

Participants with grade 1 (1.25 - 2.5 x ULN) alanine transaminase (ALT) level at day 2

Time frame: Treatment phase - Day 2

Population: Participants who received intervention

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Participants With Grade 1 ALT Level	1 Participants
Normal Saline Given Intravenously Daily for 5 Days	Participants With Grade 1 ALT Level	0 Participants

Secondary

Participants With Grade 1 ALT Level

Participants with grade 1 (1.25 - 2.5 x ULN) alanine transaminase (ALT) level at day 3

Time frame: Treatment phase - Day 3

Population: Participants who received intervention

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Participants With Grade 1 ALT Level	1 Participants
Normal Saline Given Intravenously Daily for 5 Days	Participants With Grade 1 ALT Level	5 Participants

Secondary

Participants With Grade 1 ALT Level

Participants with grade 1 (1.25 - 2.5 x ULN) alanine transaminase (ALT) level at day 4

Time frame: Treatment phase - Day 4

Population: Participants who received intervention

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Participants With Grade 1 ALT Level	1 Participants
Normal Saline Given Intravenously Daily for 5 Days	Participants With Grade 1 ALT Level	3 Participants

Secondary

Participants With Grade 1 ALT Level

Participants with grade 1 (1.25 - 2.5 x ULN) alanine transaminase (ALT) level at day 5

Time frame: Treatment phase - Day 5

Population: Participants who received intervention

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Participants With Grade 1 ALT Level	2 Participants
Normal Saline Given Intravenously Daily for 5 Days	Participants With Grade 1 ALT Level	2 Participants

Secondary

Participants With Grade 1 ALT Level

Participants with grade 1 (1.25 - 2.5 x ULN) alanine transaminase (ALT) level at day 8

Time frame: Treatment phase - Day 8

Population: Participants who received intervention

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Participants With Grade 1 ALT Level	4 Participants
Normal Saline Given Intravenously Daily for 5 Days	Participants With Grade 1 ALT Level	0 Participants

Secondary

Participants With Grade 1 ALT Level

Participants with grade 1 (1.25 - 2.5 x ULN) alanine transaminase (ALT) level at day 11

Time frame: Treatment phase - Day 11

Population: Participants who received intervention

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Participants With Grade 1 ALT Level	3 Participants
Normal Saline Given Intravenously Daily for 5 Days	Participants With Grade 1 ALT Level	0 Participants

Secondary

Participants With Grade 1 ALT Level

Participants with grade 1 (1.25 - 2.5 x ULN) alanine transaminase (ALT) level at day 16

Time frame: Treatment phase - Day 16

Population: Participants who received intervention and had lab value available at baseline and treatment/follow-up day/week. One subject had missing lab value.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Participants With Grade 1 ALT Level	1 Participants
Normal Saline Given Intravenously Daily for 5 Days	Participants With Grade 1 ALT Level	0 Participants

Secondary

Participants With Grade 1 AST Level

Participants with grade 1 (1.25 - 2.5 x ULN) aspartate transaminase (AST) level at week 8

Time frame: Follow-up phase - Week 8

Population: Participants who received intervention

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Participants With Grade 1 AST Level	0 Participants
Normal Saline Given Intravenously Daily for 5 Days	Participants With Grade 1 AST Level	1 Participants

Secondary

Participants With Grade 1 AST Level

Participants with grade 1 (1.25 - 2.5 x ULN) aspartate transaminase (AST) level at day 1

Time frame: Treatment phase - Day 1

Population: Participants who received intervention

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Participants With Grade 1 AST Level	0 Participants
Normal Saline Given Intravenously Daily for 5 Days	Participants With Grade 1 AST Level	0 Participants

Secondary

Participants With Grade 1 AST Level

Participants with grade 1 (1.25 - 2.5 x ULN) aspartate transaminase (AST) level at day 2

Time frame: Treatment phase - Day 2

Population: Participants who received intervention

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Participants With Grade 1 AST Level	0 Participants
Normal Saline Given Intravenously Daily for 5 Days	Participants With Grade 1 AST Level	0 Participants

Secondary

Participants With Grade 1 AST Level

Participants with grade 1 (1.25 - 2.5 x ULN) aspartate transaminase (AST) level at day 3

Time frame: Treatment phase - Day 3

Population: Participants who received intervention

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Participants With Grade 1 AST Level	1 Participants
Normal Saline Given Intravenously Daily for 5 Days	Participants With Grade 1 AST Level	4 Participants

Secondary

Participants With Grade 1 AST Level

Participants with grade 1 (1.25 - 2.5 x ULN) aspartate transaminase (AST) level at day 4

Time frame: Treatment phase - Day 4

Population: Participants who received intervention

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Participants With Grade 1 AST Level	1 Participants
Normal Saline Given Intravenously Daily for 5 Days	Participants With Grade 1 AST Level	1 Participants

Secondary

Participants With Grade 1 AST Level

Participants with grade 1 (1.25 - 2.5 x ULN) aspartate transaminase (AST) level at day 5

Time frame: Treatment phase - Day 5

Population: Participants who received intervention

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Participants With Grade 1 AST Level	1 Participants
Normal Saline Given Intravenously Daily for 5 Days	Participants With Grade 1 AST Level	1 Participants

Secondary

Participants With Grade 1 AST Level

Participants with grade 1 (1.25 - 2.5 x ULN) aspartate transaminase (AST) level at day 8

Time frame: Treatment phase - Day 8

Population: Participants who received intervention

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Participants With Grade 1 AST Level	3 Participants
Normal Saline Given Intravenously Daily for 5 Days	Participants With Grade 1 AST Level	0 Participants

Secondary

Participants With Grade 1 AST Level

Participants with grade 1 (1.25 - 2.5 x ULN) aspartate transaminase (AST) level at day 11

Time frame: Treatment phase - Day 11

Population: Participants who received intervention

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Participants With Grade 1 AST Level	0 Participants
Normal Saline Given Intravenously Daily for 5 Days	Participants With Grade 1 AST Level	0 Participants

Secondary

Participants With Grade 1 AST Level

Participants with grade 1 (1.25 - 2.5 x ULN) aspartate transaminase (AST) level at day 16

Time frame: Treatment phase - Day 16

Population: Participants who received intervention and had lab value available at baseline and treatment/follow-up day/week. One subject had missing lab value.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Participants With Grade 1 AST Level	0 Participants
Normal Saline Given Intravenously Daily for 5 Days	Participants With Grade 1 AST Level	0 Participants

Secondary

Participants With Grade 1 AST Level

Participants with grade 1 (1.25 - 2.5 x ULN) aspartate transaminase (AST) level at day 24

Time frame: Treatment phase - Day 24

Population: Participants who received intervention

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Participants With Grade 1 AST Level	0 Participants
Normal Saline Given Intravenously Daily for 5 Days	Participants With Grade 1 AST Level	0 Participants

Secondary

Participants With Grade 1 AST Level

Participants with grade 1 (1.25 - 2.5 x ULN) aspartate transaminase (AST) level at day 28

Time frame: Treatment phase - Day 28

Population: Participants who received intervention

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Participants With Grade 1 AST Level	0 Participants
Normal Saline Given Intravenously Daily for 5 Days	Participants With Grade 1 AST Level	0 Participants

Secondary

Participants With Grade 1 AST Level

Participants with grade 1 (1.25 - 2.5 x ULN) aspartate transaminase (AST) level at week 12

Time frame: Follow-up phase - Week 12

Population: Participants who received intervention

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Participants With Grade 1 AST Level	0 Participants
Normal Saline Given Intravenously Daily for 5 Days	Participants With Grade 1 AST Level	0 Participants

Secondary

Participants With Grade 1 AST Level

Participants with grade 1 (1.25 - 2.5 x ULN) aspartate transaminase (AST) level at week 16

Time frame: Follow-up phase - Week 16

Population: Participants who received intervention

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Participants With Grade 1 AST Level	0 Participants
Normal Saline Given Intravenously Daily for 5 Days	Participants With Grade 1 AST Level	0 Participants

Secondary

Participants With Grade 1 AST Level

Participants with grade 1 (1.25 - 2.5 x ULN) aspartate transaminase (AST) level at week 24

Time frame: Follow-up phase - Week 24

Population: Participants who received intervention

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Participants With Grade 1 AST Level	1 Participants
Normal Saline Given Intravenously Daily for 5 Days	Participants With Grade 1 AST Level	0 Participants

Secondary

Participants With Grade 1 AST Level

Participants with grade 1 (1.25 - 2.5 x ULN) aspartate transaminase (AST) level at week 28

Time frame: Follow-up phase - Week 28

Population: Participants who received intervention and had lab value available at baseline and treatment/follow-up day/week. One subject had missing lab value.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Participants With Grade 1 AST Level	1 Participants
Normal Saline Given Intravenously Daily for 5 Days	Participants With Grade 1 AST Level	0 Participants

Secondary

Participants With Grade 2 ALT Level

Participants with grade 2 (2.6 - 5.0 x ULN) alanine transaminase (ALT) level at day 1

Time frame: Treatment phase - Day 1

Population: Participants who received intervention

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Participants With Grade 2 ALT Level	1 Participants
Normal Saline Given Intravenously Daily for 5 Days	Participants With Grade 2 ALT Level	0 Participants

Secondary

Participants With Grade 2 ALT Level

Participants with grade 2 (2.6 - 5.0 x ULN) alanine transaminase (ALT) level at day 16

Time frame: Treatment phase - Day 16

Population: Participants who received intervention and had lab value available at baseline and treatment/follow-up day/week. One subject had missing lab value.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Participants With Grade 2 ALT Level	1 Participants
Normal Saline Given Intravenously Daily for 5 Days	Participants With Grade 2 ALT Level	0 Participants

Secondary

Participants With Grade 2 ALT Level

Participants with grade 2 (2.6 - 5.0 x ULN) alanine transaminase (ALT) level at day 24

Time frame: Treatment phase - Day 24

Population: Participants who received intervention

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Participants With Grade 2 ALT Level	0 Participants
Normal Saline Given Intravenously Daily for 5 Days	Participants With Grade 2 ALT Level	0 Participants

Secondary

Participants With Grade 2 ALT Level

Participants with grade 2 (2.6 - 5.0 x ULN) alanine transaminase (ALT) level at day 28

Time frame: Treatment phase - Day 28

Population: Participants who received intervention

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Participants With Grade 2 ALT Level	0 Participants
Normal Saline Given Intravenously Daily for 5 Days	Participants With Grade 2 ALT Level	0 Participants

Secondary

Participants With Grade 2 ALT Level

Participants with grade 2 (2.6 - 5.0 x ULN) alanine transaminase (ALT) level at day 2

Time frame: Treatment phase - Day 2

Population: Participants who received intervention

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Participants With Grade 2 ALT Level	0 Participants
Normal Saline Given Intravenously Daily for 5 Days	Participants With Grade 2 ALT Level	0 Participants

Secondary

Participants With Grade 2 ALT Level

Participants with grade 2 (2.6 - 5.0 x ULN) alanine transaminase (ALT) level at week 8

Time frame: Follow-up phase - Week 8

Population: Participants who received intervention

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Participants With Grade 2 ALT Level	0 Participants
Normal Saline Given Intravenously Daily for 5 Days	Participants With Grade 2 ALT Level	0 Participants

Secondary

Participants With Grade 2 ALT Level

Participants with grade 2 (2.6 - 5.0 x ULN) alanine transaminase (ALT) level at week 12

Time frame: Follow-up phase - Week 12

Population: Participants who received intervention

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Participants With Grade 2 ALT Level	0 Participants
Normal Saline Given Intravenously Daily for 5 Days	Participants With Grade 2 ALT Level	0 Participants

Secondary

Participants With Grade 2 ALT Level

Participants with grade 2 (2.6 - 5.0 x ULN) alanine transaminase (ALT) level at week 16

Time frame: Follow-up phase - Week 16

Population: Participants who received intervention

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Participants With Grade 2 ALT Level	1 Participants
Normal Saline Given Intravenously Daily for 5 Days	Participants With Grade 2 ALT Level	0 Participants

Secondary

Participants With Grade 2 ALT Level

Participants with grade 2 (2.6 - 5.0 x ULN) alanine transaminase (ALT) level at week 20

Time frame: Follow-up phase - Week 20

Population: Participants who received intervention

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Participants With Grade 2 ALT Level	0 Participants
Normal Saline Given Intravenously Daily for 5 Days	Participants With Grade 2 ALT Level	0 Participants

Secondary

Participants With Grade 2 ALT Level

Participants with grade 2 (2.6 - 5.0 x ULN) alanine transaminase (ALT) level at week 24

Time frame: Follow-up phase - Week 24

Population: Participants who received intervention and had lab value available at baseline and treatment/follow-up day/week. One subject had missing lab value.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Participants With Grade 2 ALT Level	0 Participants
Normal Saline Given Intravenously Daily for 5 Days	Participants With Grade 2 ALT Level	0 Participants

Secondary

Participants With Grade 2 ALT Level

Participants with grade 2 (2.6 - 5.0 x ULN) alanine transaminase (ALT) level at day 11

Time frame: Treatment phase - Day 11

Population: Participants who received intervention

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Participants With Grade 2 ALT Level	0 Participants
Normal Saline Given Intravenously Daily for 5 Days	Participants With Grade 2 ALT Level	0 Participants

Secondary

Participants With Grade 2 ALT Level

Participants with grade 2 (2.6 - 5.0 x ULN) alanine transaminase (ALT) level at day 3

Time frame: Treatment phase - Day 3

Population: Participants who received intervention

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Participants With Grade 2 ALT Level	0 Participants
Normal Saline Given Intravenously Daily for 5 Days	Participants With Grade 2 ALT Level	0 Participants

Secondary

Participants With Grade 2 ALT Level

Participants with grade 2 (2.6 - 5.0 x ULN) alanine transaminase (ALT) level at day 4

Time frame: Treatment phase - Day 4

Population: Participants who received intervention

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Participants With Grade 2 ALT Level	0 Participants
Normal Saline Given Intravenously Daily for 5 Days	Participants With Grade 2 ALT Level	0 Participants

Secondary

Participants With Grade 2 ALT Level

Participants with grade 2 (2.6 - 5.0 x ULN) alanine transaminase (ALT) level at day 5

Time frame: Treatment phase - Day 5

Population: Participants who received intervention

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Participants With Grade 2 ALT Level	0 Participants
Normal Saline Given Intravenously Daily for 5 Days	Participants With Grade 2 ALT Level	0 Participants

Secondary

Participants With Grade 2 ALT Level

Participants with grade 2 (2.6 - 5.0 x ULN) alanine transaminase (ALT) level at day 8

Time frame: Treatment phase - Day 8

Population: Participants who received intervention

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Participants With Grade 2 ALT Level	0 Participants
Normal Saline Given Intravenously Daily for 5 Days	Participants With Grade 2 ALT Level	0 Participants

Secondary

Participants With Grade 2 AST Level

Participants with grade 2 (2.6 - 5.0 x ULN) aspartate transaminase (AST) level at day 11

Time frame: Treatment phase - Day 11

Population: Participants who received intervention

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Participants With Grade 2 AST Level	0 Participants
Normal Saline Given Intravenously Daily for 5 Days	Participants With Grade 2 AST Level	0 Participants

Secondary

Participants With Grade 2 AST Level

Participants with grade 2 (2.6 - 5.0 x ULN) aspartate transaminase (AST) level at day 5

Time frame: Treatment phase - Day 5

Population: Participants who received intervention

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Participants With Grade 2 AST Level	0 Participants
Normal Saline Given Intravenously Daily for 5 Days	Participants With Grade 2 AST Level	0 Participants

Secondary

Participants With Grade 2 AST Level

Participants with grade 2 (2.6 - 5.0 x ULN) aspartate transaminase (AST) level at week 8

Time frame: Follow-up phase - Week 8

Population: Participants who received intervention

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Participants With Grade 2 AST Level	0 Participants
Normal Saline Given Intravenously Daily for 5 Days	Participants With Grade 2 AST Level	0 Participants

Secondary

Participants With Grade 2 AST Level

Participants with grade 2 (2.6 - 5.0 x ULN) aspartate transaminase (AST) level at day 16

Time frame: Treatment phase - Day 16

Population: Participants who received intervention and had lab value available at baseline and treatment/follow-up day/week. One subject had missing lab value.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Participants With Grade 2 AST Level	0 Participants
Normal Saline Given Intravenously Daily for 5 Days	Participants With Grade 2 AST Level	0 Participants

Secondary

Participants With Grade 2 AST Level

Participants with grade 2 (2.6 - 5.0 x ULN) aspartate transaminase (AST) level at week 12

Time frame: Follow-up phase - Week 12

Population: Participants who received intervention

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Participants With Grade 2 AST Level	1 Participants
Normal Saline Given Intravenously Daily for 5 Days	Participants With Grade 2 AST Level	0 Participants

Secondary

Participants With Grade 2 AST Level

Participants with grade 2 (2.6 - 5.0 x ULN) aspartate transaminase (AST) level at week 16

Time frame: Follow-up phase - Week 16

Population: Participants who received intervention

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Participants With Grade 2 AST Level	2 Participants
Normal Saline Given Intravenously Daily for 5 Days	Participants With Grade 2 AST Level	0 Participants

Secondary

Participants With Grade 2 AST Level

Participants with grade 2 (2.6 - 5.0 x ULN) aspartate transaminase (AST) level at week 24

Time frame: Follow-up phase - Week 24

Population: Participants who received intervention

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Participants With Grade 2 AST Level	0 Participants
Normal Saline Given Intravenously Daily for 5 Days	Participants With Grade 2 AST Level	0 Participants

Secondary

Participants With Grade 2 AST Level

Participants with grade 2 (2.6 - 5.0 x ULN) aspartate transaminase (AST) level at day 24

Time frame: Treatment phase - Day 24

Population: Participants who received intervention

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Participants With Grade 2 AST Level	0 Participants
Normal Saline Given Intravenously Daily for 5 Days	Participants With Grade 2 AST Level	0 Participants

Secondary

Participants With Grade 2 AST Level

Participants with grade 2 (2.6 - 5.0 x ULN) aspartate transaminase (AST) level at week 28

Time frame: Follow-up phase - Week 28

Population: Participants who received intervention and had lab value available at baseline and treatment/follow-up day/week. One subject had missing lab value.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Participants With Grade 2 AST Level	0 Participants
Normal Saline Given Intravenously Daily for 5 Days	Participants With Grade 2 AST Level	0 Participants

Secondary

Participants With Grade 2 AST Level

Participants with grade 2 (2.6 - 5.0 x ULN) aspartate transaminase (AST) level at day 28

Time frame: Treatment phase - Day 28

Population: Participants who received intervention

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Participants With Grade 2 AST Level	0 Participants
Normal Saline Given Intravenously Daily for 5 Days	Participants With Grade 2 AST Level	0 Participants

Secondary

Participants With Grade 2 AST Level

Participants with grade 2 (2.6 - 5.0 x ULN) aspartate transaminase (AST) level at day 1

Time frame: Treatment phase - Day 1

Population: Participants who received intervention

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Participants With Grade 2 AST Level	0 Participants
Normal Saline Given Intravenously Daily for 5 Days	Participants With Grade 2 AST Level	0 Participants

Secondary

Participants With Grade 2 AST Level

Participants with grade 2 (2.6 - 5.0 x ULN) aspartate transaminase (AST) level at day 2

Time frame: Treatment phase - Day 2

Population: Participants who received intervention

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Participants With Grade 2 AST Level	0 Participants
Normal Saline Given Intravenously Daily for 5 Days	Participants With Grade 2 AST Level	0 Participants

Secondary

Participants With Grade 2 AST Level

Participants with grade 2 (2.6 - 5.0 x ULN) aspartate transaminase (AST) level at day 3

Time frame: Treatment phase - Day 3

Population: Participants who received intervention

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Participants With Grade 2 AST Level	0 Participants
Normal Saline Given Intravenously Daily for 5 Days	Participants With Grade 2 AST Level	0 Participants

Secondary

Participants With Grade 2 AST Level

Participants with grade 2 (2.6 - 5.0 x ULN) aspartate transaminase (AST) level at day 4

Time frame: Treatment phase - Day 4

Population: Participants who received intervention

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Participants With Grade 2 AST Level	0 Participants
Normal Saline Given Intravenously Daily for 5 Days	Participants With Grade 2 AST Level	0 Participants

Secondary

Participants With Grade 2 AST Level

Participants with grade 2 (2.6 - 5.0 x ULN) aspartate transaminase (AST) level at day 8

Time frame: Treatment phase - Day 8

Population: Participants who received intervention

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Participants With Grade 2 AST Level	0 Participants
Normal Saline Given Intravenously Daily for 5 Days	Participants With Grade 2 AST Level	0 Participants

Secondary

Participants With Grade 3 ALT Level

Participants with grade 3 (5.1 - 10.0 x ULN) alanine transaminase (ALT) level at day 2

Time frame: Treatment phase - Day 2

Population: Participants who received intervention

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Participants With Grade 3 ALT Level	0 Participants
Normal Saline Given Intravenously Daily for 5 Days	Participants With Grade 3 ALT Level	0 Participants

Secondary

Participants With Grade 3 ALT Level

Participants with grade 3 (5.1 - 10.0 x ULN) alanine transaminase (ALT) level at day 1

Time frame: Treatment phase - Day 1

Population: Participants who received intervention

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Participants With Grade 3 ALT Level	0 Participants
Normal Saline Given Intravenously Daily for 5 Days	Participants With Grade 3 ALT Level	0 Participants

Secondary

Participants With Grade 3 ALT Level

Participants with grade 3 (5.1 - 10.0 x ULN) alanine transaminase (ALT) level at day 11

Time frame: Treatment phase - Day 11

Population: Participants who received intervention

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Participants With Grade 3 ALT Level	0 Participants
Normal Saline Given Intravenously Daily for 5 Days	Participants With Grade 3 ALT Level	0 Participants

Secondary

Participants With Grade 3 ALT Level

Participants with grade 3 (5.1 - 10.0 x ULN) alanine transaminase (ALT) level at day 16

Time frame: Treatment phase - Day 16

Population: Participants who received intervention and had lab value available at baseline and treatment/follow-up day/week. One subject had missing lab value.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Participants With Grade 3 ALT Level	0 Participants
Normal Saline Given Intravenously Daily for 5 Days	Participants With Grade 3 ALT Level	0 Participants

Secondary

Participants With Grade 3 ALT Level

Participants with grade 3 (5.1 - 10.0 x ULN) alanine transaminase (ALT) level at day 24

Time frame: Treatment phase - Day 24

Population: Participants who received intervention

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Participants With Grade 3 ALT Level	0 Participants
Normal Saline Given Intravenously Daily for 5 Days	Participants With Grade 3 ALT Level	0 Participants

Secondary

Participants With Grade 3 ALT Level

Participants with grade 3 (5.1 - 10.0 x ULN) alanine transaminase (ALT) level at day 28

Time frame: Treatment phase - Day 28

Population: Participants who received intervention

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Participants With Grade 3 ALT Level	0 Participants
Normal Saline Given Intravenously Daily for 5 Days	Participants With Grade 3 ALT Level	0 Participants

Secondary

Participants With Grade 3 ALT Level

Participants with grade 3 (5.1 - 10.0 x ULN) alanine transaminase (ALT) level at week 8

Time frame: Follow-up phase - Week 8

Population: Participants who received intervention

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Participants With Grade 3 ALT Level	0 Participants
Normal Saline Given Intravenously Daily for 5 Days	Participants With Grade 3 ALT Level	0 Participants

Secondary

Participants With Grade 3 ALT Level

Participants with grade 3 (5.1 - 10.0 x ULN) alanine transaminase (ALT) level at week 12

Time frame: Follow-up phase - Week 12

Population: Participants who received intervention

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Participants With Grade 3 ALT Level	0 Participants
Normal Saline Given Intravenously Daily for 5 Days	Participants With Grade 3 ALT Level	0 Participants

Secondary

Participants With Grade 3 ALT Level

Participants with grade 3 (5.1 - 10.0 x ULN) alanine transaminase (ALT) level at week 16

Time frame: Follow-up phase - Week 16

Population: Participants who received intervention

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Participants With Grade 3 ALT Level	0 Participants
Normal Saline Given Intravenously Daily for 5 Days	Participants With Grade 3 ALT Level	0 Participants

Secondary

Participants With Grade 3 ALT Level

Participants with grade 3 (5.1 - 10.0 x ULN) alanine transaminase (ALT) level at week 20

Time frame: Follow-up phase - Week 20

Population: Participants who received intervention

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Participants With Grade 3 ALT Level	0 Participants
Normal Saline Given Intravenously Daily for 5 Days	Participants With Grade 3 ALT Level	0 Participants

Secondary

Participants With Grade 3 ALT Level

Participants with grade 3 (5.1 - 10.0 x ULN) alanine transaminase (ALT) level at week 24

Time frame: Follow-up phase - Week 24

Population: Participants who received intervention and had lab value available at baseline and treatment/follow-up day/week. One subject had missing lab value.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Participants With Grade 3 ALT Level	0 Participants
Normal Saline Given Intravenously Daily for 5 Days	Participants With Grade 3 ALT Level	0 Participants

Secondary

Participants With Grade 3 ALT Level

Participants with grade 3 (5.1 - 10.0 x ULN) alanine transaminase (ALT) level at day 8

Time frame: Treatment phase - Day 8

Population: Participants who received intervention

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Participants With Grade 3 ALT Level	0 Participants
Normal Saline Given Intravenously Daily for 5 Days	Participants With Grade 3 ALT Level	0 Participants

Secondary

Participants With Grade 3 ALT Level

Participants with grade 3 (5.1 - 10.0 x ULN) alanine transaminase (ALT) level at day 5

Time frame: Treatment phase - Day 5

Population: Participants who received intervention

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Participants With Grade 3 ALT Level	0 Participants
Normal Saline Given Intravenously Daily for 5 Days	Participants With Grade 3 ALT Level	0 Participants

Secondary

Participants With Grade 3 ALT Level

Participants with grade 3 (5.1 - 10.0 x ULN) alanine transaminase (ALT) level at day 4

Time frame: Treatment phase - Day 4

Population: Participants who received intervention

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Participants With Grade 3 ALT Level	0 Participants
Normal Saline Given Intravenously Daily for 5 Days	Participants With Grade 3 ALT Level	0 Participants

Secondary

Participants With Grade 3 ALT Level

Participants with grade 3 (5.1 - 10.0 x ULN) alanine transaminase (ALT) level at day 3

Time frame: Treatment phase - Day 3

Population: Participants who received intervention

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Participants With Grade 3 ALT Level	0 Participants
Normal Saline Given Intravenously Daily for 5 Days	Participants With Grade 3 ALT Level	0 Participants

Secondary

Participants With Grade 3 AST Level

Participants with grade 3 (5.1 - 10.0 x ULN) aspartate transaminase (AST) level at day 24

Time frame: Treatment phase - Day 24

Population: Participants who received intervention

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Participants With Grade 3 AST Level	0 Participants
Normal Saline Given Intravenously Daily for 5 Days	Participants With Grade 3 AST Level	0 Participants

Secondary

Participants With Grade 3 AST Level

Participants with grade 3 (5.1 - 10.0 x ULN) aspartate transaminase (AST) level at week 28

Time frame: Follow-up phase - Week 28

Population: Participants who received intervention and had lab value available at baseline and treatment/follow-up day/week. One subject had missing lab value.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Participants With Grade 3 AST Level	0 Participants
Normal Saline Given Intravenously Daily for 5 Days	Participants With Grade 3 AST Level	1 Participants

Secondary

Participants With Grade 3 AST Level

Participants with grade 3 (5.1 - 10.0 x ULN) aspartate transaminase (AST) level at day 28

Time frame: Treatment phase - Day 28

Population: Participants who received intervention

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Participants With Grade 3 AST Level	0 Participants
Normal Saline Given Intravenously Daily for 5 Days	Participants With Grade 3 AST Level	0 Participants

Secondary

Participants With Grade 3 AST Level

Participants with grade 3 (5.1 - 10.0 x ULN) aspartate transaminase (AST) level at week 24

Time frame: Follow-up phase - Week 24

Population: Participants who received intervention

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Participants With Grade 3 AST Level	0 Participants
Normal Saline Given Intravenously Daily for 5 Days	Participants With Grade 3 AST Level	0 Participants

Secondary

Participants With Grade 3 AST Level

Participants with grade 3 (5.1 - 10.0 x ULN) aspartate transaminase (AST) level at week 16

Time frame: Follow-up phase - Week 16

Population: Participants who received intervention

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Participants With Grade 3 AST Level	0 Participants
Normal Saline Given Intravenously Daily for 5 Days	Participants With Grade 3 AST Level	0 Participants

Secondary

Participants With Grade 3 AST Level

Participants with grade 3 (5.1 - 10.0 x ULN) aspartate transaminase (AST) level at week 12

Time frame: Follow-up phase - Week 12

Population: Participants who received intervention

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Participants With Grade 3 AST Level	0 Participants
Normal Saline Given Intravenously Daily for 5 Days	Participants With Grade 3 AST Level	0 Participants

Secondary

Participants With Grade 3 AST Level

Participants with grade 3 (5.1 - 10.0 x ULN) aspartate transaminase (AST) level at week 8

Time frame: Follow-up phase - Week 8

Population: Participants who received intervention

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Participants With Grade 3 AST Level	0 Participants
Normal Saline Given Intravenously Daily for 5 Days	Participants With Grade 3 AST Level	0 Participants

Secondary

Participants With Grade 3 AST Level

Participants with grade 3 (5.1 - 10.0 x ULN) aspartate transaminase (AST) level at day 1

Time frame: Treatment phase - Day 1

Population: Participants who received intervention

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Participants With Grade 3 AST Level	0 Participants
Normal Saline Given Intravenously Daily for 5 Days	Participants With Grade 3 AST Level	0 Participants

Secondary

Participants With Grade 3 AST Level

Participants with grade 3 (5.1 - 10.0 x ULN) aspartate transaminase (AST) level at day 2

Time frame: Treatment phase - Day 2

Population: Participants who received intervention

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Participants With Grade 3 AST Level	0 Participants
Normal Saline Given Intravenously Daily for 5 Days	Participants With Grade 3 AST Level	0 Participants

Secondary

Participants With Grade 3 AST Level

Participants with grade 3 (5.1 - 10.0 x ULN) aspartate transaminase (AST) level at day 3

Time frame: Treatment phase - Day 3

Population: Participants who received intervention

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Participants With Grade 3 AST Level	0 Participants
Normal Saline Given Intravenously Daily for 5 Days	Participants With Grade 3 AST Level	0 Participants

Secondary

Participants With Grade 3 AST Level

Participants with grade 3 (5.1 - 10.0 x ULN) aspartate transaminase (AST) level at day 4

Time frame: Treatment phase - Day 4

Population: Participants who received intervention

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Participants With Grade 3 AST Level	0 Participants
Normal Saline Given Intravenously Daily for 5 Days	Participants With Grade 3 AST Level	0 Participants

Secondary

Participants With Grade 3 AST Level

Participants with grade 3 (5.1 - 10.0 x ULN) aspartate transaminase (AST) level at day 5

Time frame: Treatment phase - Day 5

Population: Participants who received intervention

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Participants With Grade 3 AST Level	0 Participants
Normal Saline Given Intravenously Daily for 5 Days	Participants With Grade 3 AST Level	0 Participants

Secondary

Participants With Grade 3 AST Level

Participants with grade 3 (5.1 - 10.0 x ULN) aspartate transaminase (AST) level at day 8

Time frame: Treatment phase - Day 8

Population: Participants who received intervention

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Participants With Grade 3 AST Level	0 Participants
Normal Saline Given Intravenously Daily for 5 Days	Participants With Grade 3 AST Level	0 Participants

Secondary

Participants With Grade 3 AST Level

Participants with grade 3 (5.1 - 10.0 x ULN) aspartate transaminase (AST) level at day 11

Time frame: Treatment phase - Day 11

Population: Participants who received intervention

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Participants With Grade 3 AST Level	0 Participants
Normal Saline Given Intravenously Daily for 5 Days	Participants With Grade 3 AST Level	0 Participants

Secondary

Participants With Grade 3 AST Level

Participants with grade 3 (5.1 - 10.0 x ULN) aspartate transaminase (AST) level at day 16

Time frame: Treatment phase - Day 16

Population: Participants who received intervention and had lab value available at baseline and treatment/follow-up day/week. One subject had missing lab value.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Participants With Grade 3 AST Level	0 Participants
Normal Saline Given Intravenously Daily for 5 Days	Participants With Grade 3 AST Level	0 Participants

Secondary

Participants With Grade 4 ALT Level

Participants with grade 4 (\> 10 x ULN) alanine transaminase (ALT) level at day 28

Time frame: Treatment phase - Day 28

Population: Participants who received intervention

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Participants With Grade 4 ALT Level	0 Participants
Normal Saline Given Intravenously Daily for 5 Days	Participants With Grade 4 ALT Level	0 Participants

Secondary

Participants With Grade 4 ALT Level

Participants with grade 4 (\> 10 x ULN) alanine transaminase (ALT) level at day 1

Time frame: Treatment phase - Day 1

Population: Participants who received intervention

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Participants With Grade 4 ALT Level	0 Participants
Normal Saline Given Intravenously Daily for 5 Days	Participants With Grade 4 ALT Level	0 Participants

Secondary

Participants With Grade 4 ALT Level

Participants with grade 4 (\> 10 x ULN) alanine transaminase (ALT) level at day 2

Time frame: Treatment phase - Day 2

Population: Participants who received intervention

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Participants With Grade 4 ALT Level	0 Participants
Normal Saline Given Intravenously Daily for 5 Days	Participants With Grade 4 ALT Level	0 Participants

Secondary

Participants With Grade 4 ALT Level

Participants with grade 4 (\> 10 x ULN) alanine transaminase (ALT) level at day 3

Time frame: Treatment phase - Day 3

Population: Participants who received intervention

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Participants With Grade 4 ALT Level	0 Participants
Normal Saline Given Intravenously Daily for 5 Days	Participants With Grade 4 ALT Level	0 Participants

Secondary

Participants With Grade 4 ALT Level

Participants with grade 4 (\> 10 x ULN) alanine transaminase (ALT) level at day 4

Time frame: Treatment phase - Day 4

Population: Participants who received intervention

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Participants With Grade 4 ALT Level	0 Participants
Normal Saline Given Intravenously Daily for 5 Days	Participants With Grade 4 ALT Level	0 Participants

Secondary

Participants With Grade 4 ALT Level

Participants with grade 4 (\> 10 x ULN) alanine transaminase (ALT) level at day 5

Time frame: Treatment phase - Day 5

Population: Participants who received intervention

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Participants With Grade 4 ALT Level	0 Participants
Normal Saline Given Intravenously Daily for 5 Days	Participants With Grade 4 ALT Level	0 Participants

Secondary

Participants With Grade 4 ALT Level

Participants with grade 4 (\> 10 x ULN) alanine transaminase (ALT) level at day 8

Time frame: Treatment phase - Day 8

Population: Participants who received intervention

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Participants With Grade 4 ALT Level	0 Participants
Normal Saline Given Intravenously Daily for 5 Days	Participants With Grade 4 ALT Level	0 Participants

Secondary

Participants With Grade 4 ALT Level

Participants with grade 4 (\> 10 x ULN) alanine transaminase (ALT) level at day 11

Time frame: Treatment phase - Day 11

Population: Participants who received intervention

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Participants With Grade 4 ALT Level	0 Participants
Normal Saline Given Intravenously Daily for 5 Days	Participants With Grade 4 ALT Level	0 Participants

Secondary

Participants With Grade 4 ALT Level

Participants with grade 4 (\> 10 x ULN) alanine transaminase (ALT) level at day 16

Time frame: Treatment phase - Day 16

Population: Participants who received intervention and had lab value available at baseline and treatment/follow-up day/week. One subject had missing lab value.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Participants With Grade 4 ALT Level	0 Participants
Normal Saline Given Intravenously Daily for 5 Days	Participants With Grade 4 ALT Level	0 Participants

Secondary

Participants With Grade 4 ALT Level

Participants with grade 4 (\> 10 x ULN) alanine transaminase (ALT) level at day 24

Time frame: Treatment phase - Day 24

Population: Participants who received intervention

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Participants With Grade 4 ALT Level	0 Participants
Normal Saline Given Intravenously Daily for 5 Days	Participants With Grade 4 ALT Level	0 Participants

Secondary

Participants With Grade 4 ALT Level

Participants with grade 4 (\> 10 x ULN) alanine transaminase (ALT) level at week 8

Time frame: Follow-up phase - Week 8

Population: Participants who received intervention

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Participants With Grade 4 ALT Level	0 Participants
Normal Saline Given Intravenously Daily for 5 Days	Participants With Grade 4 ALT Level	0 Participants

Secondary

Participants With Grade 4 ALT Level

Participants with grade 4 (\> 10 x ULN) alanine aminotransferase (ALT) level at week 12

Time frame: Follow-up phase - Week 12

Population: Participants who received intervention

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Participants With Grade 4 ALT Level	0 Participants
Normal Saline Given Intravenously Daily for 5 Days	Participants With Grade 4 ALT Level	0 Participants

Secondary

Participants With Grade 4 ALT Level

Participants with grade 4 (\> 10 x ULN) alanine transaminase (ALT) level at week 16

Time frame: Follow-up phase - Week 16

Population: Participants who received intervention

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Participants With Grade 4 ALT Level	0 Participants
Normal Saline Given Intravenously Daily for 5 Days	Participants With Grade 4 ALT Level	0 Participants

Secondary

Participants With Grade 4 ALT Level

Participants with grade 4 (\> 10 x ULN) alanine transaminase (ALT) level at week 24

Time frame: Follow-up phase - Week 24

Population: Participants who received intervention and had lab value available at baseline and treatment/follow-up day/week. One subject had missing lab value.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Participants With Grade 4 ALT Level	0 Participants
Normal Saline Given Intravenously Daily for 5 Days	Participants With Grade 4 ALT Level	1 Participants

Secondary

Participants With Grade 4 ALT Level

Participants with grade 4 (\> 10 x ULN) alanine transaminase (ALT) level at week 20

Time frame: Follow-up phase - Week 20

Population: Participants who received intervention

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Participants With Grade 4 ALT Level	0 Participants
Normal Saline Given Intravenously Daily for 5 Days	Participants With Grade 4 ALT Level	0 Participants

Secondary

Participants With Grade 4 AST Level

Participants with grade 4 (\> 10 x ULN) aspartate transaminase (AST) level at day 2

Time frame: Treatment phase - Day 2

Population: Participants who received intervention

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Participants With Grade 4 AST Level	0 Participants
Normal Saline Given Intravenously Daily for 5 Days	Participants With Grade 4 AST Level	0 Participants

Secondary

Participants With Grade 4 AST Level

Proportion of grade 4 (\> 10 x ULN) aspartate transaminase (AST) level at week 12

Time frame: Follow-up phase - Week 12

Population: Participants who received intervention

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Participants With Grade 4 AST Level	0 Participants
Normal Saline Given Intravenously Daily for 5 Days	Participants With Grade 4 AST Level	0 Participants

Secondary

Participants With Grade 4 AST Level

Proportion of grade 4 (\> 10 x ULN) aspartate transaminase (AST) level at week 16

Time frame: Follow-up phase - Week 16

Population: Participants who received intervention

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Participants With Grade 4 AST Level	0 Participants
Normal Saline Given Intravenously Daily for 5 Days	Participants With Grade 4 AST Level	0 Participants

Secondary

Participants With Grade 4 AST Level

Participants with grade 4 (\> 10 x ULN) aspartate transaminase (AST) level at day 1

Time frame: Treatment phase - Day 1

Population: Participants who received intervention

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Participants With Grade 4 AST Level	0 Participants
Normal Saline Given Intravenously Daily for 5 Days	Participants With Grade 4 AST Level	0 Participants

Secondary

Participants With Grade 4 AST Level

Participants with grade 4 (\> 10 x ULN) aspartate transaminase (AST) level at week 28

Time frame: Follow-up phase - Week 28

Population: Participants who received intervention and had lab value available at baseline and treatment/follow-up day/week. One subject had missing lab value.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Participants With Grade 4 AST Level	0 Participants
Normal Saline Given Intravenously Daily for 5 Days	Participants With Grade 4 AST Level	0 Participants

Secondary

Participants With Grade 4 AST Level

Proportion of grade 4 (\> 10 x ULN) aspartate transaminase (AST) level at week 8

Time frame: Follow-up phase - Week 8

Population: Participants who received intervention

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Participants With Grade 4 AST Level	0 Participants
Normal Saline Given Intravenously Daily for 5 Days	Participants With Grade 4 AST Level	0 Participants

Secondary

Participants With Grade 4 AST Level

Proportion of grade 4 (\> 10 x ULN) aspartate transaminase (AST) level at day 28

Time frame: Treatment phase - Day 28

Population: Participants who received intervention

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Participants With Grade 4 AST Level	0 Participants
Normal Saline Given Intravenously Daily for 5 Days	Participants With Grade 4 AST Level	0 Participants

Secondary

Participants With Grade 4 AST Level

Proportion of grade 4 (\> 10 x ULN) aspartate transaminase (AST) level at day 24

Time frame: Treatment phase - Day 24

Population: Participants who received intervention

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Participants With Grade 4 AST Level	0 Participants
Normal Saline Given Intravenously Daily for 5 Days	Participants With Grade 4 AST Level	0 Participants

Secondary

Participants With Grade 4 AST Level

Participants with grade 4 (\> 10 x ULN) aspartate transaminase (AST) level at day 16

Time frame: Treatment phase - Day 16

Population: Participants who received intervention and had lab value available at baseline and treatment/follow-up day/week. One subject had missing lab value.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Participants With Grade 4 AST Level	0 Participants
Normal Saline Given Intravenously Daily for 5 Days	Participants With Grade 4 AST Level	0 Participants

Secondary

Participants With Grade 4 AST Level

Participants with grade 4 (\> 10 x ULN) aspartate transaminase (AST) level at day 11

Time frame: Treatment phase - Day 11

Population: Participants who received intervention

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Participants With Grade 4 AST Level	0 Participants
Normal Saline Given Intravenously Daily for 5 Days	Participants With Grade 4 AST Level	0 Participants

Secondary

Participants With Grade 4 AST Level

Participants with grade 4 (\> 10 x ULN) aspartate transaminase (AST) level at day 8

Time frame: Treatment phase - Day 8

Population: Participants who received intervention

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Participants With Grade 4 AST Level	0 Participants
Normal Saline Given Intravenously Daily for 5 Days	Participants With Grade 4 AST Level	0 Participants

Secondary

Participants With Grade 4 AST Level

Participants with grade 4 (\> 10 x ULN) aspartate transaminase (AST) level at day 5

Time frame: Treatment phase - Day 5

Population: Participants who received intervention

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Participants With Grade 4 AST Level	0 Participants
Normal Saline Given Intravenously Daily for 5 Days	Participants With Grade 4 AST Level	0 Participants

Secondary

Participants With Grade 4 AST Level

Proportion of grade 4 (\> 10 x ULN) aspartate transaminase (AST) level at week 24

Time frame: Follow-up phase - Week 24

Population: Participants who received intervention

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Participants With Grade 4 AST Level	0 Participants
Normal Saline Given Intravenously Daily for 5 Days	Participants With Grade 4 AST Level	0 Participants

Secondary

Participants With Grade 4 AST Level

Participants with grade 4 (\> 10 x ULN) aspartate transaminase (AST) level at day 4

Time frame: Treatment phase - Day 4

Population: Participants who received intervention

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Participants With Grade 4 AST Level	0 Participants
Normal Saline Given Intravenously Daily for 5 Days	Participants With Grade 4 AST Level	0 Participants

Secondary

Participants With Grade 4 AST Level

Participants with grade 4 (\> 10 x ULN) aspartate transaminase (AST) level at day 3

Time frame: Treatment phase - Day 3

Population: Participants who received intervention

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GS-5734 100mg Given Intravenously Daily for 5 Days	Participants With Grade 4 AST Level	0 Participants
Normal Saline Given Intravenously Daily for 5 Days	Participants With Grade 4 AST Level	0 Participants

Source: ClinicalTrials.gov · Data processed: Feb 15, 2026

GS-5734 to Assess the Antiviral Activity, Longer-Term Clearance of Ebola Virus, and Safety in Male Ebola Survivors With Evidence of Ebola Virus Persistence in Semen

Conditions

Keywords

Brief summary

Detailed description

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Participants by arm

Baseline characteristics

Adverse events

Outcome results

Mean Assay Negativity Rate (ANR) for Ebola Virus During the Follow-up Phase

Mean Assay Negativity Rate (ANR) for Ebola Virus During the Treatment Phase

Mean Assay Negativity Rate (ANR) for Ebola Virus During the Follow-up Phase

Mean Assay Negativity Rate (ANR) for Ebola Virus During the Follow-up Phase

Mean Assay Negativity Rate (ANR) for Ebola Virus During the Treatment Phase

Mean Assay Negativity Rate (ANR) for Ebola Virus During the Treatment Phase

Mean Change From Baseline in ALT Value

Mean Change From Baseline in ALT Value

Mean Change From Baseline in ALT Value

Mean Change From Baseline in ALT Value

Mean Change From Baseline in ALT Value

Mean Change From Baseline in ALT Value

Mean Change From Baseline in ALT Value

Mean Change From Baseline in ALT Value

Mean Change From Baseline in ALT Value

Mean Change From Baseline in ALT Value

Mean Change From Baseline in ALT Value

Mean Change From Baseline in ALT Value

Mean Change From Baseline in ALT Value

Mean Change From Baseline in ALT Value

Mean Change From Baseline in ALT Value at Day 11

Mean Change From Baseline in aPTT Value

Mean Change From Baseline in aPTT Value

Mean Change From Baseline in aPTT Value

Mean Change From Baseline in aPTT Value

Mean Change From Baseline in aPTT Value

Mean Change From Baseline in aPTT Value

Mean Change From Baseline in aPTT Value

Mean Change From Baseline in aPTT Value

Mean Change From Baseline in aPTT Value

Mean Change From Baseline in aPTT Value

Mean Change From Baseline in aPTT Value

Mean Change From Baseline in aPTT Value

Mean Change From Baseline in aPTT Value

Mean Change From Baseline in aPTT Value

Mean Change From Baseline in aPTT Value

Mean Change From Baseline in AST Value

Mean Change From Baseline in AST Value

Mean Change From Baseline in AST Value

Mean Change From Baseline in AST Value

Mean Change From Baseline in AST Value

Mean Change From Baseline in AST Value

Mean Change From Baseline in AST Value

Mean Change From Baseline in AST Value

Mean Change From Baseline in AST Value

Mean Change From Baseline in AST Value

Mean Change From Baseline in AST Value

Mean Change From Baseline in AST Value

Mean Change From Baseline in AST Value

Mean Change From Baseline in AST Value

Mean Change From Baseline in AST Value

Mean Change From Baseline in INR Value

Mean Change From Baseline in INR Value

Mean Change From Baseline in INR Value

Mean Change From Baseline in INR Value

Mean Change From Baseline in INR Value

Mean Change From Baseline in INR Value

Mean Change From Baseline in INR Value

Mean Change From Baseline in INR Value