Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed-Dose Combination ± Ribavirin for the Treatment of HCV (ION-3)
Study Details
Study Description
Brief Summary
This study is to evaluate the safety, tolerability, and antiviral efficacy of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) with or without ribavirin (RBV) administered for 8 or 12 weeks in treatment-naive participants with chronic genotype 1 HCV infection.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 3 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: LDV/SOF 8 Week Participants will receive LDV/SOF FDC for 8 weeks. |
Drug: LDV/SOF
LDV 90 mg/SOF 400 mg FDC tablet administered orally once daily
Other Names:
|
Experimental: LDV/SOF+RBV 8 Week Participants will receive LDV/SOF FDC plus RBV for 8 weeks. |
Drug: LDV/SOF
LDV 90 mg/SOF 400 mg FDC tablet administered orally once daily
Other Names:
Drug: RBV
Ribavirin (RBV) tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)
|
Experimental: LDV/SOF 12 Week Participants will receive LDV/SOF FDC for 12 weeks. |
Drug: LDV/SOF
LDV 90 mg/SOF 400 mg FDC tablet administered orally once daily
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12) [Posttreatment Week 12]
SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 25 IU/mL) 12 weeks following the last dose of study drug.
- Incidence of Adverse Events Leading to Permanent Discontinuation From Any Study Drug [Up to 12 weeks]
The percentage of participants who experienced an adverse event leading to permanent discontinuation from any study drug was summarized.
Secondary Outcome Measures
- Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) [Posttreatment Weeks 4 and 24]
SVR4 and SVR24 were defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively.
- Percentage of Participants With HCV RNA < LLOQ at Week 2 [Week 2]
- Percentage of Participants With HCV RNA < LLOQ at Week 4 [Week 4]
- Percentage of Participants With HCV RNA < LLOQ at Week 8 [Week 8]
- Change From Baseline in HCV RNA at Week 2 [Baseline; Week 2]
- Change From Baseline in HCV RNA at Week 4 [Baseline; Week 4]
- Change From Baseline in HCV RNA at Week 8 [Baseline; Week 8]
- Percentage of Participants Experiencing Virologic Failure [Baseline to posttreatment Week 24]
Virologic failure was defined as on-treatment virologic failure or virologic relapse. On-Treatment Virologic Failure was defined as Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment) Virologic relapse was defined as confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Age > 18, with chronic genotype 1 HCV infection
-
HCV treatment-naive
-
HCV RNA > 10,000 IU/mL at screening
-
Screening laboratory values within defined thresholds
-
Use of two effective contraception methods if female of childbearing potential or sexually active male
Exclusion Criteria:
-
Pregnant or nursing female or male with pregnant female partner
-
Presence of cirrhosis
-
Coinfection with HIV or hepatitis B virus (HBV)
-
Current or prior history of clinical hepatic decompensation
-
Chronic use of systemic immunosuppressive agents
-
History of clinically significant illness or any other medical disorder that may interfere with subject treatment, assessment or compliance with the protocol
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Birmingham | Alabama | United States | ||
2 | La Jolla | California | United States | ||
3 | Los Angeles | California | United States | ||
4 | Palo Alto | California | United States | ||
5 | Sacramento | California | United States | ||
6 | San Diego | California | United States | ||
7 | San Francisco | California | United States | ||
8 | Aurora | Colorado | United States | ||
9 | Englewood | Colorado | United States | ||
10 | Washington | District of Columbia | United States | ||
11 | Gainesville | Florida | United States | ||
12 | Jacksonville | Florida | United States | ||
13 | Miami | Florida | United States | ||
14 | Orlando | Florida | United States | ||
15 | Wellington | Florida | United States | ||
16 | Atlanta | Georgia | United States | ||
17 | Decatur | Georgia | United States | ||
18 | Marietta | Georgia | United States | ||
19 | Chicago | Illinois | United States | ||
20 | Indianapolis | Indiana | United States | ||
21 | Bowling Green | Kentucky | United States | ||
22 | Baton Rouge | Louisiana | United States | ||
23 | Baltimore | Maryland | United States | ||
24 | Lutherville | Maryland | United States | ||
25 | Boston | Massachusetts | United States | ||
26 | Novi | Michigan | United States | ||
27 | Kansas City | Missouri | United States | ||
28 | Saint Louis | Missouri | United States | ||
29 | Albuquerque | New Jersey | United States | ||
30 | Berlin | New Jersey | United States | ||
31 | Hillsborough | New Jersey | United States | ||
32 | Santa Fe | New Mexico | United States | ||
33 | Binghamton | New York | United States | ||
34 | Manhasset | New York | United States | ||
35 | New York | New York | United States | ||
36 | Chapel Hill | North Carolina | United States | ||
37 | Fayetteville | North Carolina | United States | ||
38 | Statesville | North Carolina | United States | ||
39 | Winston-Salem | North Carolina | United States | ||
40 | Philadelphia | Pennsylvania | United States | ||
41 | Providence | Rhode Island | United States | ||
42 | Germantown | Tennessee | United States | ||
43 | Nashville | Tennessee | United States | ||
44 | Arlington | Texas | United States | ||
45 | Houston | Texas | United States | ||
46 | San Antonio | Texas | United States | ||
47 | Fairfax | Virginia | United States | ||
48 | Falls Church | Virginia | United States | ||
49 | Newport News | Virginia | United States | ||
50 | Norfolk | Virginia | United States | ||
51 | Richmond | Virginia | United States | ||
52 | Seattle | Washington | United States |
Sponsors and Collaborators
- Gilead Sciences
Investigators
- Study Director: Robert H. Hyland, DPhil, Gilead Sciences
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- GS-US-337-0108
Study Results
Participant Flow
Recruitment Details | Participants were enrolled at a total of 59 study sites in the United States. The first participant was screened on 06 May 2013. The last participant observation occurred on 07 March 2014. |
---|---|
Pre-assignment Detail | 831 participants were screened. |
Arm/Group Title | LDV/SOF 8 Week | LDV/SOF+RBV 8 Week | LDV/SOF 12 Week |
---|---|---|---|
Arm/Group Description | Ledipasvir (LDV) 90 mg/sofosbuvir (SOF) 400 mg fixed-dose combination (FDC) tablet once daily for 8 weeks | LDV 90 mg/SOF 400 mg FDC tablet once daily plus ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 8 weeks | LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks |
Period Title: Overall Study | |||
STARTED | 215 | 216 | 216 |
COMPLETED | 202 | 200 | 204 |
NOT COMPLETED | 13 | 16 | 12 |
Baseline Characteristics
Arm/Group Title | LDV/SOF 8 Week | LDV/SOF+RBV 8 Week | LDV/SOF 12 Week | Total |
---|---|---|---|---|
Arm/Group Description | LDV 90 mg/SOF 400 mg FDC tablet once daily for 8 weeks | LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks | LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks | Total of all reporting groups |
Overall Participants | 215 | 216 | 216 | 647 |
Age (years) [Mean (Standard Deviation) ] | ||||
Mean (Standard Deviation) [years] |
53
(10.2)
|
51
(11.7)
|
53
(10.6)
|
52
(10.9)
|
Sex: Female, Male (Count of Participants) | ||||
Female |
85
39.5%
|
99
45.8%
|
88
40.7%
|
272
42%
|
Male |
130
60.5%
|
117
54.2%
|
128
59.3%
|
375
58%
|
Race/Ethnicity, Customized (participants) [Number] | ||||
Black or African American |
45
20.9%
|
36
16.7%
|
42
19.4%
|
123
19%
|
White |
164
76.3%
|
176
81.5%
|
167
77.3%
|
507
78.4%
|
Asian |
5
2.3%
|
2
0.9%
|
3
1.4%
|
10
1.5%
|
American Indian/Alaska Native |
0
0%
|
1
0.5%
|
0
0%
|
1
0.2%
|
Hawaiian or Pacific Islander |
0
0%
|
1
0.5%
|
0
0%
|
1
0.2%
|
Other |
1
0.5%
|
0
0%
|
3
1.4%
|
4
0.6%
|
Not Disclosed |
0
0%
|
0
0%
|
1
0.5%
|
1
0.2%
|
Race/Ethnicity, Customized (participants) [Number] | ||||
Hispanic or Latino |
13
6%
|
12
5.6%
|
14
6.5%
|
39
6%
|
Not Hispanic or Latino |
200
93%
|
204
94.4%
|
202
93.5%
|
606
93.7%
|
Not Disclosed |
2
0.9%
|
0
0%
|
0
0%
|
2
0.3%
|
HCV RNA (log10 IU/mL) [Mean (Standard Deviation) ] | ||||
Mean (Standard Deviation) [log10 IU/mL] |
6.5
(0.76)
|
6.4
(0.69)
|
6.4
(0.76)
|
6.5
(0.74)
|
HCV RNA Category (participants) [Number] | ||||
< 800,000 IU/mL |
34
15.8%
|
45
20.8%
|
44
20.4%
|
123
19%
|
≥ 800,000 IU/mL |
181
84.2%
|
171
79.2%
|
172
79.6%
|
524
81%
|
HCV Genotype (participants) [Number] | ||||
Genotype 1 (no confirmed subtype) |
1
0.5%
|
0
0%
|
0
0%
|
1
0.2%
|
Genotype 1a |
171
79.5%
|
172
79.6%
|
172
79.6%
|
515
79.6%
|
Genotype 1b |
43
20%
|
44
20.4%
|
44
20.4%
|
131
20.2%
|
IL28b Status (participants) [Number] | ||||
CC |
56
26%
|
60
27.8%
|
56
25.9%
|
172
26.6%
|
CT |
120
55.8%
|
128
59.3%
|
124
57.4%
|
372
57.5%
|
TT |
39
18.1%
|
28
13%
|
36
16.7%
|
103
15.9%
|
Outcome Measures
Title | Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12) |
---|---|
Description | SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 25 IU/mL) 12 weeks following the last dose of study drug. |
Time Frame | Posttreatment Week 12 |
Outcome Measure Data
Analysis Population Description |
---|
Full Analysis Set: participants were randomized and received at least one dose of study medication. |
Arm/Group Title | LDV/SOF 8 Week | LDV/SOF+RBV 8 Week | LDV/SOF 12 Week |
---|---|---|---|
Arm/Group Description | LDV 90 mg/SOF 400 mg FDC tablet once daily for 8 weeks | LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks | LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks |
Measure Participants | 215 | 216 | 216 |
Number [percentage of participants] |
94.0
43.7%
|
93.1
43.1%
|
96.3
44.6%
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | LDV/SOF 8 Week |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | <0.001 |
Comments | The p-value for the comparison of the LDV/SOF 8 week group against the adjusted historical null rate (60%) was based on a 2-sided 1-sample binomial test. | |
Method | Binomial test | |
Comments |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | LDV/SOF+RBV 8 Week |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | <0.001 |
Comments | The p-value for the comparison of the LDV/SOF+RBV 8 week group against the adjusted historical null rate (60%) was based on a 2-sided 1-sample binomial test. | |
Method | Binomial test | |
Comments |
Statistical Analysis 3
Statistical Analysis Overview | Comparison Group Selection | LDV/SOF 12 Week |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | <0.001 |
Comments | The p-value for the comparison of the LDV/SOF 12 week group against the adjusted historical null rate (60%) was based on a 2-sided 1-sample binomial test. | |
Method | Binomial test | |
Comments |
Statistical Analysis 4
Statistical Analysis Overview | Comparison Group Selection | LDV/SOF+RBV 8 Week, LDV/SOF 12 Week |
---|---|---|
Comments | ||
Type of Statistical Test | Non-Inferiority or Equivalence | |
Comments | Noninferiority would be demonstrated if the lower bound of the confidence interval (CI) for the difference between groups was greater than -12%. | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -3.2 | |
Confidence Interval |
(2-Sided) 97.5% -8.3 to 1.8 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Difference in proportions between treatment groups and associated confidence interval (CI) were calculated based on stratum-adjusted Mantel-Haenszel proportions. |
Statistical Analysis 5
Statistical Analysis Overview | Comparison Group Selection | LDV/SOF 8 Week, LDV/SOF 12 Week |
---|---|---|
Comments | ||
Type of Statistical Test | Non-Inferiority or Equivalence | |
Comments | Noninferiority would be demonstrated if the lower bound of the CI for the difference between groups was greater than -12%. | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -2.3 | |
Confidence Interval |
(2-Sided) 97.5% -7.2 to 2.5 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Difference in proportions between treatment groups and associated confidence interval (CI) were calculated based on stratum-adjusted Mantel-Haenszel proportions. |
Statistical Analysis 6
Statistical Analysis Overview | Comparison Group Selection | LDV/SOF 8 Week, LDV/SOF+RBV 8 Week |
---|---|---|
Comments | ||
Type of Statistical Test | Non-Inferiority or Equivalence | |
Comments | Noninferiority would be demonstrated if the lower bound of the CI for the difference between groups was greater than -12%. | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 0.9 | |
Confidence Interval |
(2-Sided) 95% -3.9 to 5.7 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Difference in proportions between treatment groups and associated confidence interval (CI) were calculated based on stratum-adjusted Mantel-Haenszel proportions. |
Title | Incidence of Adverse Events Leading to Permanent Discontinuation From Any Study Drug |
---|---|
Description | The percentage of participants who experienced an adverse event leading to permanent discontinuation from any study drug was summarized. |
Time Frame | Up to 12 weeks |
Outcome Measure Data
Analysis Population Description |
---|
Safety Analysis Set |
Arm/Group Title | LDV/SOF 8 Week | LDV/SOF+RBV 8 Week | LDV/SOF 12 Week |
---|---|---|---|
Arm/Group Description | LDV 90 mg/SOF 400 mg FDC tablet once daily for 8 weeks | LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks | LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks |
Measure Participants | 215 | 216 | 216 |
Number [percentage of participants] |
0
0%
|
0.9
0.4%
|
0.9
0.4%
|
Title | Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) |
---|---|
Description | SVR4 and SVR24 were defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively. |
Time Frame | Posttreatment Weeks 4 and 24 |
Outcome Measure Data
Analysis Population Description |
---|
Full Analysis Set |
Arm/Group Title | LDV/SOF 8 Week | LDV/SOF+RBV 8 Week | LDV/SOF 12 Week |
---|---|---|---|
Arm/Group Description | LDV 90 mg/SOF 400 mg FDC tablet once daily for 8 weeks | LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks | LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks |
Measure Participants | 215 | 216 | 216 |
SVR4 |
96.3
44.8%
|
94.9
43.9%
|
96.3
44.6%
|
SVR24 |
94.0
43.7%
|
93.1
43.1%
|
96.3
44.6%
|
Title | Percentage of Participants With HCV RNA < LLOQ at Week 2 |
---|---|
Description | |
Time Frame | Week 2 |
Outcome Measure Data
Analysis Population Description |
---|
Participants in the Full Analysis Set with Available Data were analyzed. |
Arm/Group Title | LDV/SOF 8 Week | LDV/SOF+RBV 8 Week | LDV/SOF 12 Week |
---|---|---|---|
Arm/Group Description | LDV 90 mg/SOF 400 mg FDC tablet once daily for 8 weeks | LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks | LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks |
Measure Participants | 215 | 214 | 216 |
Number [percentage of participants] |
88.4
41.1%
|
91.1
42.2%
|
91.2
42.2%
|
Title | Percentage of Participants With HCV RNA < LLOQ at Week 4 |
---|---|
Description | |
Time Frame | Week 4 |
Outcome Measure Data
Analysis Population Description |
---|
Participants in the Full Analysis Set with Available Data were analyzed. |
Arm/Group Title | LDV/SOF 8 Week | LDV/SOF+RBV 8 Week | LDV/SOF 12 Week |
---|---|---|---|
Arm/Group Description | LDV 90 mg/SOF 400 mg FDC tablet once daily for 8 weeks | LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks | LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks |
Measure Participants | 216 | 213 | 216 |
Number [percentage of participants] |
100.0
46.5%
|
99.1
45.9%
|
100.0
46.3%
|
Title | Percentage of Participants With HCV RNA < LLOQ at Week 8 |
---|---|
Description | |
Time Frame | Week 8 |
Outcome Measure Data
Analysis Population Description |
---|
Participants in the Full Analysis Set with Available Data were analyzed. |
Arm/Group Title | LDV/SOF 8 Week | LDV/SOF+RBV 8 Week | LDV/SOF 12 Week |
---|---|---|---|
Arm/Group Description | LDV 90 mg/SOF 400 mg FDC tablet once daily for 8 weeks | LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks | LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks |
Measure Participants | 215 | 213 | 214 |
Number [percentage of participants] |
100.0
46.5%
|
100.0
46.3%
|
99.5
46.1%
|
Title | Change From Baseline in HCV RNA at Week 2 |
---|---|
Description | |
Time Frame | Baseline; Week 2 |
Outcome Measure Data
Analysis Population Description |
---|
Participants in the Full Analysis Set with Available Data were analyzed. |
Arm/Group Title | LDV/SOF 8 Week | LDV/SOF+RBV 8 Week | LDV/SOF 12 Week |
---|---|---|---|
Arm/Group Description | LDV 90 mg/SOF 400 mg FDC tablet once daily for 8 weeks | LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks | LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks |
Measure Participants | 215 | 212 | 212 |
Mean (Standard Deviation) [log10 IU/mL] |
-5.06
(0.752)
|
-5.01
(0.675)
|
-4.99
(0.750)
|
Title | Change From Baseline in HCV RNA at Week 4 |
---|---|
Description | |
Time Frame | Baseline; Week 4 |
Outcome Measure Data
Analysis Population Description |
---|
Participants in the Full Analysis Set with Available Data were analyzed. |
Arm/Group Title | LDV/SOF 8 Week | LDV/SOF+RBV 8 Week | LDV/SOF 12 Week |
---|---|---|---|
Arm/Group Description | LDV 90 mg/SOF 400 mg FDC tablet once daily for 8 weeks | LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks | LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks |
Measure Participants | 215 | 212 | 216 |
Mean (Standard Deviation) [log10 IU/mL] |
-5.12
(0.760)
|
-5.05
(0.682)
|
-5.05
(0.758)
|
Title | Change From Baseline in HCV RNA at Week 8 |
---|---|
Description | |
Time Frame | Baseline; Week 8 |
Outcome Measure Data
Analysis Population Description |
---|
Participants in the Full Analysis Set with Available Data were analyzed. |
Arm/Group Title | LDV/SOF 8 Week | LDV/SOF+RBV 8 Week | LDV/SOF 12 Week |
---|---|---|---|
Arm/Group Description | LDV 90 mg/SOF 400 mg FDC tablet once daily for 8 weeks | LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks | LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks |
Measure Participants | 215 | 213 | 213 |
Mean (Standard Deviation) [log10 IU/mL] |
-5.12
(0.760)
|
-5.05
(0.683)
|
-5.04
(0.761)
|
Title | Percentage of Participants Experiencing Virologic Failure |
---|---|
Description | Virologic failure was defined as on-treatment virologic failure or virologic relapse. On-Treatment Virologic Failure was defined as Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment) Virologic relapse was defined as confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit. |
Time Frame | Baseline to posttreatment Week 24 |
Outcome Measure Data
Analysis Population Description |
---|
Full Analysis Set |
Arm/Group Title | LDV/SOF 8 Week | LDV/SOF+RBV 8 Week | LDV/SOF 12 Week |
---|---|---|---|
Arm/Group Description | LDV 90 mg/SOF 400 mg FDC tablet once daily for 8 weeks | LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks | LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks |
Measure Participants | 215 | 216 | 216 |
On-treatment virologic failure |
0
0%
|
0
0%
|
0
0%
|
Virologic relapse |
5.1
2.4%
|
4.2
1.9%
|
1.4
0.6%
|
Adverse Events
Time Frame | Up to 12 weeks plus 30 days | |||||
---|---|---|---|---|---|---|
Adverse Event Reporting Description | Safety Analysis Set | |||||
Arm/Group Title | LDV/SOF 8 Week | LDV/SOF+RBV 8 Week | LDV/SOF 12 Week | |||
Arm/Group Description | LDV 90 mg/SOF 400 mg FDC tablet once daily for 8 weeks | LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks | LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks | |||
All Cause Mortality |
||||||
LDV/SOF 8 Week | LDV/SOF+RBV 8 Week | LDV/SOF 12 Week | ||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | / (NaN) | / (NaN) | / (NaN) | |||
Serious Adverse Events |
||||||
LDV/SOF 8 Week | LDV/SOF+RBV 8 Week | LDV/SOF 12 Week | ||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 4/215 (1.9%) | 1/216 (0.5%) | 5/216 (2.3%) | |||
Gastrointestinal disorders | ||||||
Abdominal pain | 0/215 (0%) | 0/216 (0%) | 1/216 (0.5%) | |||
Colitis | 1/215 (0.5%) | 0/216 (0%) | 0/216 (0%) | |||
Lower gastrointestinal haemorrhage | 1/215 (0.5%) | 0/216 (0%) | 0/216 (0%) | |||
Hepatobiliary disorders | ||||||
Bile duct stone | 0/215 (0%) | 0/216 (0%) | 1/216 (0.5%) | |||
Jaundice | 0/215 (0%) | 0/216 (0%) | 1/216 (0.5%) | |||
Immune system disorders | ||||||
Anaphylactic reaction | 1/215 (0.5%) | 0/216 (0%) | 0/216 (0%) | |||
Injury, poisoning and procedural complications | ||||||
Road traffic accident | 0/215 (0%) | 0/216 (0%) | 1/216 (0.5%) | |||
Skeletal injury | 0/215 (0%) | 0/216 (0%) | 1/216 (0.5%) | |||
Metabolism and nutrition disorders | ||||||
Diabetes mellitus inadequate control | 1/215 (0.5%) | 0/216 (0%) | 0/216 (0%) | |||
Hypoglycaemia | 0/215 (0%) | 0/216 (0%) | 1/216 (0.5%) | |||
Musculoskeletal and connective tissue disorders | ||||||
Rhabdomyolysis | 0/215 (0%) | 0/216 (0%) | 1/216 (0.5%) | |||
Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||
Pituitary tumour | 0/215 (0%) | 1/216 (0.5%) | 0/216 (0%) | |||
Squamous cell carcinoma of lung | 0/215 (0%) | 0/216 (0%) | 1/216 (0.5%) | |||
Psychiatric disorders | ||||||
Mental status changes | 0/215 (0%) | 0/216 (0%) | 1/216 (0.5%) | |||
Respiratory, thoracic and mediastinal disorders | ||||||
Haemothorax 0 | 0/215 (0%) | 0/216 (0%) | 1/216 (0.5%) | |||
Respiratory failure | 0/215 (0%) | 0/216 (0%) | 1/216 (0.5%) | |||
Vascular disorders | ||||||
Hypertension | 1/215 (0.5%) | 0/216 (0%) | 0/216 (0%) | |||
Other (Not Including Serious) Adverse Events |
||||||
LDV/SOF 8 Week | LDV/SOF+RBV 8 Week | LDV/SOF 12 Week | ||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 146/215 (67.9%) | 166/216 (76.9%) | 150/216 (69.4%) | |||
Blood and lymphatic system disorders | ||||||
Anaemia | 2/215 (0.9%) | 17/216 (7.9%) | 2/216 (0.9%) | |||
Gastrointestinal disorders | ||||||
Nausea | 15/215 (7%) | 39/216 (18.1%) | 24/216 (11.1%) | |||
Diarrhoea | 15/215 (7%) | 13/216 (6%) | 9/216 (4.2%) | |||
Constipation | 9/215 (4.2%) | 12/216 (5.6%) | 8/216 (3.7%) | |||
General disorders | ||||||
Fatigue | 45/215 (20.9%) | 75/216 (34.7%) | 49/216 (22.7%) | |||
Irritability | 3/215 (1.4%) | 29/216 (13.4%) | 10/216 (4.6%) | |||
Musculoskeletal and connective tissue disorders | ||||||
Arthralgia | 9/215 (4.2%) | 12/216 (5.6%) | 16/216 (7.4%) | |||
Muscle spasms | 3/215 (1.4%) | 12/216 (5.6%) | 6/216 (2.8%) | |||
Nervous system disorders | ||||||
Headache | 30/215 (14%) | 54/216 (25%) | 33/216 (15.3%) | |||
Dizziness | 6/215 (2.8%) | 13/216 (6%) | 9/216 (4.2%) | |||
Psychiatric disorders | ||||||
Insomnia | 11/215 (5.1%) | 26/216 (12%) | 15/216 (6.9%) | |||
Respiratory, thoracic and mediastinal disorders | ||||||
Cough | 3/215 (1.4%) | 12/216 (5.6%) | 7/216 (3.2%) | |||
Dyspnoea | 0/215 (0%) | 11/216 (5.1%) | 1/216 (0.5%) | |||
Skin and subcutaneous tissue disorders | ||||||
Rash | 3/215 (1.4%) | 20/216 (9.3%) | 5/216 (2.3%) | |||
Pruritus | 2/215 (0.9%) | 16/216 (7.4%) | 5/216 (2.3%) |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met: The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or The study has been completed at all study sites for at least 2 years
Results Point of Contact
Name/Title | Clinical Trial Disclosures |
---|---|
Organization | Gilead Sciences, Inc. |
Phone | |
ClinicalTrialDisclosures@gilead.com |
- GS-US-337-0108