Trial Outcomes & Findings for Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed-Dose Combination for 12 Weeks in Subjects With Chronic Genotype 1 or 4 HCV and HIV-1 Co-infection (NCT NCT02073656)
NCT ID: NCT02073656
Last Updated: 2018-11-16
Results Overview
SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ; ie, 25 IU/mL) at 12 weeks after stopping study treatment.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
335 participants
Primary outcome timeframe
Posttreatment Week 12
Results posted on
2018-11-16
Participant Flow
Participants were enrolled at study sites in the United States (including Puerto Rico), Canada, and New Zealand. The first participant was screened on 24 February 2014. The last study visit occurred on 01 December 2015.
429 participants were screened.
Participant milestones
| Measure |
LDV/SOF 12 Weeks
Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet once daily for up to 12 weeks.
Participants who experienced confirmed post-treatment virologic failure (relapse) at or before Posttreatment Week 24 were eligible to be enrolled in the Retreatment Substudy to receive LDV/SOF (90/400 mg) FDC tablet once daily + ribavirin (RBV) tablets (1000-1200 mg daily based on weight) for 24 weeks.
|
|---|---|
|
Primary Study
STARTED
|
335
|
|
Primary Study
COMPLETED
|
327
|
|
Primary Study
NOT COMPLETED
|
8
|
|
Retreatment Substudy
STARTED
|
9
|
|
Retreatment Substudy
COMPLETED
|
9
|
|
Retreatment Substudy
NOT COMPLETED
|
0
|
Reasons for withdrawal
| Measure |
LDV/SOF 12 Weeks
Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet once daily for up to 12 weeks.
Participants who experienced confirmed post-treatment virologic failure (relapse) at or before Posttreatment Week 24 were eligible to be enrolled in the Retreatment Substudy to receive LDV/SOF (90/400 mg) FDC tablet once daily + ribavirin (RBV) tablets (1000-1200 mg daily based on weight) for 24 weeks.
|
|---|---|
|
Primary Study
Lost to Follow-up
|
6
|
|
Primary Study
Death
|
1
|
|
Primary Study
Withdrew Consent
|
1
|
Baseline Characteristics
Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed-Dose Combination for 12 Weeks in Subjects With Chronic Genotype 1 or 4 HCV and HIV-1 Co-infection
Baseline characteristics by cohort
| Measure |
LDV/SOF 12 Weeks
n=335 Participants
Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet once daily for up to 12 weeks.
|
|---|---|
|
Age, Continuous
|
52 years
STANDARD_DEVIATION 8.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
59 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
276 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
56 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
276 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
115 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
203 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
6 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian/ Alaska Native
|
2 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
6 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Disclosed
|
3 participants
n=5 Participants
|
|
Region of Enrollment
New Zealand
|
9 participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
26 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
290 participants
n=5 Participants
|
|
Region of Enrollment
Puerto Rico
|
10 participants
n=5 Participants
|
|
HCV Genotype
Genotype 1a
|
250 participants
n=5 Participants
|
|
HCV Genotype
Genotype 1b
|
77 participants
n=5 Participants
|
|
HCV Genotype
Genotype 4
|
8 participants
n=5 Participants
|
|
Cirrhosis Status
No
|
268 participants
n=5 Participants
|
|
Cirrhosis Status
Yes
|
67 participants
n=5 Participants
|
|
IL28b Status
CC
|
81 participants
n=5 Participants
|
|
IL28b Status
CT
|
185 participants
n=5 Participants
|
|
IL28b Status
TT
|
69 participants
n=5 Participants
|
|
Baseline HCV RNA
|
6.7 log10 IU/mL
STANDARD_DEVIATION 0.64 • n=5 Participants
|
|
Baseline HCV RNA Category
< 800,000 IU/mL
|
36 participants
n=5 Participants
|
|
Baseline HCV RNA Category
≥ 800,000 IU/mL
|
299 participants
n=5 Participants
|
|
Baseline Serum Creatinine
|
1.00 mg/dL
STANDARD_DEVIATION 0.210 • n=5 Participants
|
|
Estimated Glomerular Filtration Rate Using the Cockcroft-Gault Equation
|
101.6 mL/min
STANDARD_DEVIATION 30.78 • n=5 Participants
|
|
Baseline CD4 Count
|
662 cells/uL
STANDARD_DEVIATION 293.8 • n=5 Participants
|
|
Prior HCV Treatment
Treatment-Naive
|
150 participants
n=5 Participants
|
|
Prior HCV Treatment
Treatment-Experienced with DAA+Peg-IFN+RBV
|
53 participants
n=5 Participants
|
|
Prior HCV Treatment
Treatment-Experienced with Peg-IFN+RBV
|
113 participants
n=5 Participants
|
|
Prior HCV Treatment
Treatment-Experienced with DAA+RBV
|
14 participants
n=5 Participants
|
|
Prior HCV Treatment
Treatment-Experienced with Other
|
5 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Posttreatment Week 12Population: Full Analysis Set: participants who enrolled and received at least 1 dose of study drug.
SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ; ie, 25 IU/mL) at 12 weeks after stopping study treatment.
Outcome measures
| Measure |
LDV/SOF 12 Weeks
n=335 Participants
Primary Study: LDV/SOF (90/400 mg) FDC tablet once daily for up to 12 weeks.
|
|---|---|
|
Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
|
96.1 percentage of participants
Interval 93.5 to 97.9
|
PRIMARY outcome
Timeframe: Up to 12 weeksPopulation: Safety Analysis Set: participants who enrolled and received at least 1 dose of study drug.
Outcome measures
| Measure |
LDV/SOF 12 Weeks
n=335 Participants
Primary Study: LDV/SOF (90/400 mg) FDC tablet once daily for up to 12 weeks.
|
|---|---|
|
Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Posttreatment Weeks 4 and 24Population: Full Analysis Set
SVR4 and SVR 24 were defined as HCV RNA \< LLOQ at 4 and 24 weeks after stopping study treatment, respectively.
Outcome measures
| Measure |
LDV/SOF 12 Weeks
n=335 Participants
Primary Study: LDV/SOF (90/400 mg) FDC tablet once daily for up to 12 weeks.
|
|---|---|
|
Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
SVR4
|
96.7 percentage of participants
Interval 94.2 to 98.3
|
|
Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
SVR24
|
96.1 percentage of participants
Interval 93.5 to 97.9
|
SECONDARY outcome
Timeframe: Weeks 1, 2, 4, 6, 8, 10, and 12Population: Participants in the Full Analysis Set with available data were analyzed.
Outcome measures
| Measure |
LDV/SOF 12 Weeks
n=335 Participants
Primary Study: LDV/SOF (90/400 mg) FDC tablet once daily for up to 12 weeks.
|
|---|---|
|
Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 6, 8, 10, and 12
Week 1 (N = 335)
|
29.3 percentage of participants
Interval 24.4 to 34.4
|
|
Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 6, 8, 10, and 12
Week 2 (N = 335)
|
81.2 percentage of participants
Interval 76.6 to 85.2
|
|
Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 6, 8, 10, and 12
Week 4 (N = 335)
|
98.8 percentage of participants
Interval 97.0 to 99.7
|
|
Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 6, 8, 10, and 12
Week 6 (N = 335)
|
99.1 percentage of participants
Interval 97.4 to 99.8
|
|
Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 6, 8, 10, and 12
Week 8 (N = 334)
|
99.4 percentage of participants
Interval 97.9 to 99.9
|
|
Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 6, 8, 10, and 12
Week 10 (N = 332)
|
100.0 percentage of participants
Interval 98.9 to 100.0
|
|
Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 6, 8, 10, and 12
Week 12 (N = 332)
|
100.0 percentage of participants
Interval 98.9 to 100.0
|
SECONDARY outcome
Timeframe: Baseline; Weeks 1, 2, 4, 6, and 8Population: Participants in the Full Analysis Set with available data were analyzed.
Outcome measures
| Measure |
LDV/SOF 12 Weeks
n=335 Participants
Primary Study: LDV/SOF (90/400 mg) FDC tablet once daily for up to 12 weeks.
|
|---|---|
|
Change From Baseline in HCV RNA at Weeks 1, 2, 4, 6, and 8
Change at Week 2 (N = 334)
|
-5.21 log10 IU/mL
Standard Deviation 0.654
|
|
Change From Baseline in HCV RNA at Weeks 1, 2, 4, 6, and 8
Change at Week 4 (N = 335)
|
-5.30 log10 IU/mL
Standard Deviation 0.743
|
|
Change From Baseline in HCV RNA at Weeks 1, 2, 4, 6, and 8
Change at Week 1 (N = 331)
|
-4.68 log10 IU/mL
Standard Deviation 0.674
|
|
Change From Baseline in HCV RNA at Weeks 1, 2, 4, 6, and 8
Change at Week 6 (N = 334)
|
-5.30 log10 IU/mL
Standard Deviation 0.772
|
|
Change From Baseline in HCV RNA at Weeks 1, 2, 4, 6, and 8
Change at Week 8 (N = 333)
|
-5.33 log10 IU/mL
Standard Deviation 0.645
|
SECONDARY outcome
Timeframe: Up to Posttreatment Week 24Population: Participants in the Full Analysis Set with available data were analyzed.
Virologic failure was defined as: * On-treatment virologic failure: * 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: * Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA \< LLOQ at last on-treatment visit.
Outcome measures
| Measure |
LDV/SOF 12 Weeks
n=335 Participants
Primary Study: LDV/SOF (90/400 mg) FDC tablet once daily for up to 12 weeks.
|
|---|---|
|
Percentage of Participants With Virologic Failure
On-Treatment Virologic Failure (N = 335)
|
0.6 percentage of participants
|
|
Percentage of Participants With Virologic Failure
Virologic Relapse (N = 333)
|
3.0 percentage of participants
|
SECONDARY outcome
Timeframe: Weeks 4, 8, and 12Population: Participants in the Safety Analysis Set with available data were analyzed.
Outcome measures
| Measure |
LDV/SOF 12 Weeks
n=335 Participants
Primary Study: LDV/SOF (90/400 mg) FDC tablet once daily for up to 12 weeks.
|
|---|---|
|
Percentage of Participants That Maintain HIV-1 RNA < 50 Copies/mL While on HCV Treatment
Week 4 (N = 335)
|
98.5 percentage of participants
|
|
Percentage of Participants That Maintain HIV-1 RNA < 50 Copies/mL While on HCV Treatment
Week 8 (N = 334)
|
98.2 percentage of participants
|
|
Percentage of Participants That Maintain HIV-1 RNA < 50 Copies/mL While on HCV Treatment
Week 12 (N = 334)
|
97.9 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline; Week 12, Posttreatment Weeks 12 and 24Population: Participants in the Safety Analysis Set with available data were analyzed.
Outcome measures
| Measure |
LDV/SOF 12 Weeks
n=335 Participants
Primary Study: LDV/SOF (90/400 mg) FDC tablet once daily for up to 12 weeks.
|
|---|---|
|
Change From Baseline in Serum Creatinine at the End of Treatment (Week 12) and at Posttreatment Weeks 12 and 24
Change at Week 12 (N = 320)
|
0.05 mg/dL
Standard Deviation 0.111
|
|
Change From Baseline in Serum Creatinine at the End of Treatment (Week 12) and at Posttreatment Weeks 12 and 24
Change at Posttreatment Week 12 (N = 325)
|
0.03 mg/dL
Standard Deviation 0.143
|
|
Change From Baseline in Serum Creatinine at the End of Treatment (Week 12) and at Posttreatment Weeks 12 and 24
Change at Posttreatment Week 24 (N = 313)
|
-0.02 mg/dL
Standard Deviation 0.134
|
SECONDARY outcome
Timeframe: Posttreatment Weeks 4, 12, and 24 of Retreatment SubstudyPopulation: Participants in the Full Analysis Set who entered the Retreatment Substudy were analyzed.
SVR4, SVR12, and SVR 24 were defined as HCV RNA \< LLOQ at 4, 12, and 24 weeks after stopping study treatment, respectively.
Outcome measures
| Measure |
LDV/SOF 12 Weeks
n=9 Participants
Primary Study: LDV/SOF (90/400 mg) FDC tablet once daily for up to 12 weeks.
|
|---|---|
|
For Participants in the Retreatment Substudy, Percentage of Participants With SVR at 4, 12, and 24 Weeks After Discontinuation of Therapy (SVR4, SVR12, and SVR24)
SVR4
|
88.9 percentage of participants
Interval 51.8 to 99.7
|
|
For Participants in the Retreatment Substudy, Percentage of Participants With SVR at 4, 12, and 24 Weeks After Discontinuation of Therapy (SVR4, SVR12, and SVR24)
SVR12
|
88.9 percentage of participants
Interval 51.8 to 99.7
|
|
For Participants in the Retreatment Substudy, Percentage of Participants With SVR at 4, 12, and 24 Weeks After Discontinuation of Therapy (SVR4, SVR12, and SVR24)
SVR24
|
88.9 percentage of participants
Interval 51.8 to 99.7
|
SECONDARY outcome
Timeframe: Weeks 2, 4, 8, 12, 16, 20, and 24 of the Retreatment SubstudyPopulation: Participants in the Full Analysis Set who entered the Retreatment Substudy were analyzed.
Outcome measures
| Measure |
LDV/SOF 12 Weeks
n=9 Participants
Primary Study: LDV/SOF (90/400 mg) FDC tablet once daily for up to 12 weeks.
|
|---|---|
|
For Participants in the Retreatment Substudy, Percentage of Participants With HCV RNA < LLOQ at Retreatment Weeks 2, 4, 8, 12, 16, 20, and 24
Week 2 Retreatment
|
88.9 percentage of participants
Interval 51.8 to 99.7
|
|
For Participants in the Retreatment Substudy, Percentage of Participants With HCV RNA < LLOQ at Retreatment Weeks 2, 4, 8, 12, 16, 20, and 24
Week 4 Retreatment
|
100.0 percentage of participants
Interval 66.4 to 100.0
|
|
For Participants in the Retreatment Substudy, Percentage of Participants With HCV RNA < LLOQ at Retreatment Weeks 2, 4, 8, 12, 16, 20, and 24
Week 8 Retreatment
|
100.0 percentage of participants
Interval 66.4 to 100.0
|
|
For Participants in the Retreatment Substudy, Percentage of Participants With HCV RNA < LLOQ at Retreatment Weeks 2, 4, 8, 12, 16, 20, and 24
Week 12 Retreatment
|
100.0 percentage of participants
Interval 66.4 to 100.0
|
|
For Participants in the Retreatment Substudy, Percentage of Participants With HCV RNA < LLOQ at Retreatment Weeks 2, 4, 8, 12, 16, 20, and 24
Week 16 Retreatment
|
100.0 percentage of participants
Interval 66.4 to 100.0
|
|
For Participants in the Retreatment Substudy, Percentage of Participants With HCV RNA < LLOQ at Retreatment Weeks 2, 4, 8, 12, 16, 20, and 24
Week 20 Retreatment
|
100.0 percentage of participants
Interval 66.4 to 100.0
|
|
For Participants in the Retreatment Substudy, Percentage of Participants With HCV RNA < LLOQ at Retreatment Weeks 2, 4, 8, 12, 16, 20, and 24
Week 24 Retreatment
|
100.0 percentage of participants
Interval 66.4 to 100.0
|
SECONDARY outcome
Timeframe: Baseline; Weeks 2, 4, and 8 of Retreatment SubstudyPopulation: Participants in the Full Analysis Set who entered the Retreatment Substudy were analyzed.
Outcome measures
| Measure |
LDV/SOF 12 Weeks
n=9 Participants
Primary Study: LDV/SOF (90/400 mg) FDC tablet once daily for up to 12 weeks.
|
|---|---|
|
For Participants in the Retreatment Substudy, Change From Baseline in HCV RNA at Retreatment Weeks 2, 4, and 8
Change at Week 2 Retreatment
|
-5.01 log10 IU/mL
Standard Deviation 0.775
|
|
For Participants in the Retreatment Substudy, Change From Baseline in HCV RNA at Retreatment Weeks 2, 4, and 8
Change at Week 4 Retreatment
|
-5.04 log10 IU/mL
Standard Deviation 0.802
|
|
For Participants in the Retreatment Substudy, Change From Baseline in HCV RNA at Retreatment Weeks 2, 4, and 8
Change at Week 8 Retreatment
|
-5.04 log10 IU/mL
Standard Deviation 0.802
|
SECONDARY outcome
Timeframe: Up to Posttreatment Week 24 of Retreatment SubstudyPopulation: Participants in the Full Analysis Set who entered the Retreatment Substudy were analyzed.
Virologic failure was defined as: * On-treatment virologic failure: * 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: * Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA \< LLOQ at last on-treatment visit.
Outcome measures
| Measure |
LDV/SOF 12 Weeks
n=9 Participants
Primary Study: LDV/SOF (90/400 mg) FDC tablet once daily for up to 12 weeks.
|
|---|---|
|
For Participants in the Retreatment Substudy, Percentage of Participants With Virologic Failure
Virologic Relapse
|
11.1 percentage of participants
|
|
For Participants in the Retreatment Substudy, Percentage of Participants With Virologic Failure
On-Treatment Virologic Failure
|
0 percentage of participants
|
Adverse Events
LDV/SOF 12 Weeks (Primary Study)
Serious events: 8 serious events
Other events: 179 other events
Deaths: 0 deaths
LDV/SOF+RBV 24 Weeks (Retreatment)
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
LDV/SOF 12 Weeks (Primary Study)
n=335 participants at risk
LDV/SOF (90/400 mg) FDC tablet once daily for up to 12 weeks.
|
LDV/SOF+RBV 24 Weeks (Retreatment)
n=9 participants at risk
Participants who experienced confirmed post-treatment virologic failure (relapse) at or before Posttreatment Week 24 during the Primary Study were eligible to be enrolled in the Retreatment Substudy to receive LDV/SOF (90/400 mg) FDC tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks.
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
0.30%
1/335 • LDV/SOF 12 Weeks: Up to 12 weeks plus 30 days; LDV/SOF+RBV 24 Weeks: Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/9 • LDV/SOF 12 Weeks: Up to 12 weeks plus 30 days; LDV/SOF+RBV 24 Weeks: Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Ileus
|
0.30%
1/335 • LDV/SOF 12 Weeks: Up to 12 weeks plus 30 days; LDV/SOF+RBV 24 Weeks: Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/9 • LDV/SOF 12 Weeks: Up to 12 weeks plus 30 days; LDV/SOF+RBV 24 Weeks: Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Hepatobiliary disorders
Portal vein thrombosis
|
0.60%
2/335 • LDV/SOF 12 Weeks: Up to 12 weeks plus 30 days; LDV/SOF+RBV 24 Weeks: Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/9 • LDV/SOF 12 Weeks: Up to 12 weeks plus 30 days; LDV/SOF+RBV 24 Weeks: Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Infections and infestations
Clostridium difficile colitis
|
0.30%
1/335 • LDV/SOF 12 Weeks: Up to 12 weeks plus 30 days; LDV/SOF+RBV 24 Weeks: Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/9 • LDV/SOF 12 Weeks: Up to 12 weeks plus 30 days; LDV/SOF+RBV 24 Weeks: Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Infections and infestations
Peritonitis bacterial
|
0.30%
1/335 • LDV/SOF 12 Weeks: Up to 12 weeks plus 30 days; LDV/SOF+RBV 24 Weeks: Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/9 • LDV/SOF 12 Weeks: Up to 12 weeks plus 30 days; LDV/SOF+RBV 24 Weeks: Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Infections and infestations
Respiratory tract infection
|
0.30%
1/335 • LDV/SOF 12 Weeks: Up to 12 weeks plus 30 days; LDV/SOF+RBV 24 Weeks: Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/9 • LDV/SOF 12 Weeks: Up to 12 weeks plus 30 days; LDV/SOF+RBV 24 Weeks: Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Infections and infestations
Sepsis
|
0.30%
1/335 • LDV/SOF 12 Weeks: Up to 12 weeks plus 30 days; LDV/SOF+RBV 24 Weeks: Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/9 • LDV/SOF 12 Weeks: Up to 12 weeks plus 30 days; LDV/SOF+RBV 24 Weeks: Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.30%
1/335 • LDV/SOF 12 Weeks: Up to 12 weeks plus 30 days; LDV/SOF+RBV 24 Weeks: Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/9 • LDV/SOF 12 Weeks: Up to 12 weeks plus 30 days; LDV/SOF+RBV 24 Weeks: Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatocellular carcinoma
|
0.60%
2/335 • LDV/SOF 12 Weeks: Up to 12 weeks plus 30 days; LDV/SOF+RBV 24 Weeks: Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/9 • LDV/SOF 12 Weeks: Up to 12 weeks plus 30 days; LDV/SOF+RBV 24 Weeks: Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Psychiatric disorders
Substance abuse
|
0.30%
1/335 • LDV/SOF 12 Weeks: Up to 12 weeks plus 30 days; LDV/SOF+RBV 24 Weeks: Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/9 • LDV/SOF 12 Weeks: Up to 12 weeks plus 30 days; LDV/SOF+RBV 24 Weeks: Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Renal and urinary disorders
Azotaemia
|
0.30%
1/335 • LDV/SOF 12 Weeks: Up to 12 weeks plus 30 days; LDV/SOF+RBV 24 Weeks: Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/9 • LDV/SOF 12 Weeks: Up to 12 weeks plus 30 days; LDV/SOF+RBV 24 Weeks: Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.30%
1/335 • LDV/SOF 12 Weeks: Up to 12 weeks plus 30 days; LDV/SOF+RBV 24 Weeks: Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/9 • LDV/SOF 12 Weeks: Up to 12 weeks plus 30 days; LDV/SOF+RBV 24 Weeks: Up to 24 weeks plus 30 days
Safety Analysis Set
|
Other adverse events
| Measure |
LDV/SOF 12 Weeks (Primary Study)
n=335 participants at risk
LDV/SOF (90/400 mg) FDC tablet once daily for up to 12 weeks.
|
LDV/SOF+RBV 24 Weeks (Retreatment)
n=9 participants at risk
Participants who experienced confirmed post-treatment virologic failure (relapse) at or before Posttreatment Week 24 during the Primary Study were eligible to be enrolled in the Retreatment Substudy to receive LDV/SOF (90/400 mg) FDC tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.60%
2/335 • LDV/SOF 12 Weeks: Up to 12 weeks plus 30 days; LDV/SOF+RBV 24 Weeks: Up to 24 weeks plus 30 days
Safety Analysis Set
|
33.3%
3/9 • LDV/SOF 12 Weeks: Up to 12 weeks plus 30 days; LDV/SOF+RBV 24 Weeks: Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Blood and lymphatic system disorders
Haemolytic anaemia
|
0.00%
0/335 • LDV/SOF 12 Weeks: Up to 12 weeks plus 30 days; LDV/SOF+RBV 24 Weeks: Up to 24 weeks plus 30 days
Safety Analysis Set
|
11.1%
1/9 • LDV/SOF 12 Weeks: Up to 12 weeks plus 30 days; LDV/SOF+RBV 24 Weeks: Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Eye disorders
Vision blurred
|
0.60%
2/335 • LDV/SOF 12 Weeks: Up to 12 weeks plus 30 days; LDV/SOF+RBV 24 Weeks: Up to 24 weeks plus 30 days
Safety Analysis Set
|
11.1%
1/9 • LDV/SOF 12 Weeks: Up to 12 weeks plus 30 days; LDV/SOF+RBV 24 Weeks: Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Diarrhoea
|
10.4%
35/335 • LDV/SOF 12 Weeks: Up to 12 weeks plus 30 days; LDV/SOF+RBV 24 Weeks: Up to 24 weeks plus 30 days
Safety Analysis Set
|
11.1%
1/9 • LDV/SOF 12 Weeks: Up to 12 weeks plus 30 days; LDV/SOF+RBV 24 Weeks: Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Nausea
|
9.9%
33/335 • LDV/SOF 12 Weeks: Up to 12 weeks plus 30 days; LDV/SOF+RBV 24 Weeks: Up to 24 weeks plus 30 days
Safety Analysis Set
|
11.1%
1/9 • LDV/SOF 12 Weeks: Up to 12 weeks plus 30 days; LDV/SOF+RBV 24 Weeks: Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Vomiting
|
4.2%
14/335 • LDV/SOF 12 Weeks: Up to 12 weeks plus 30 days; LDV/SOF+RBV 24 Weeks: Up to 24 weeks plus 30 days
Safety Analysis Set
|
11.1%
1/9 • LDV/SOF 12 Weeks: Up to 12 weeks plus 30 days; LDV/SOF+RBV 24 Weeks: Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
General disorders
Fatigue
|
21.2%
71/335 • LDV/SOF 12 Weeks: Up to 12 weeks plus 30 days; LDV/SOF+RBV 24 Weeks: Up to 24 weeks plus 30 days
Safety Analysis Set
|
66.7%
6/9 • LDV/SOF 12 Weeks: Up to 12 weeks plus 30 days; LDV/SOF+RBV 24 Weeks: Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
General disorders
Chest discomfort
|
0.00%
0/335 • LDV/SOF 12 Weeks: Up to 12 weeks plus 30 days; LDV/SOF+RBV 24 Weeks: Up to 24 weeks plus 30 days
Safety Analysis Set
|
11.1%
1/9 • LDV/SOF 12 Weeks: Up to 12 weeks plus 30 days; LDV/SOF+RBV 24 Weeks: Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
General disorders
Cyst
|
0.00%
0/335 • LDV/SOF 12 Weeks: Up to 12 weeks plus 30 days; LDV/SOF+RBV 24 Weeks: Up to 24 weeks plus 30 days
Safety Analysis Set
|
11.1%
1/9 • LDV/SOF 12 Weeks: Up to 12 weeks plus 30 days; LDV/SOF+RBV 24 Weeks: Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Infections and infestations
Upper respiratory tract infection
|
5.4%
18/335 • LDV/SOF 12 Weeks: Up to 12 weeks plus 30 days; LDV/SOF+RBV 24 Weeks: Up to 24 weeks plus 30 days
Safety Analysis Set
|
11.1%
1/9 • LDV/SOF 12 Weeks: Up to 12 weeks plus 30 days; LDV/SOF+RBV 24 Weeks: Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/335 • LDV/SOF 12 Weeks: Up to 12 weeks plus 30 days; LDV/SOF+RBV 24 Weeks: Up to 24 weeks plus 30 days
Safety Analysis Set
|
11.1%
1/9 • LDV/SOF 12 Weeks: Up to 12 weeks plus 30 days; LDV/SOF+RBV 24 Weeks: Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Investigations
Blood uric acid increased
|
0.00%
0/335 • LDV/SOF 12 Weeks: Up to 12 weeks plus 30 days; LDV/SOF+RBV 24 Weeks: Up to 24 weeks plus 30 days
Safety Analysis Set
|
11.1%
1/9 • LDV/SOF 12 Weeks: Up to 12 weeks plus 30 days; LDV/SOF+RBV 24 Weeks: Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Metabolism and nutrition disorders
Decreased appetite
|
2.4%
8/335 • LDV/SOF 12 Weeks: Up to 12 weeks plus 30 days; LDV/SOF+RBV 24 Weeks: Up to 24 weeks plus 30 days
Safety Analysis Set
|
11.1%
1/9 • LDV/SOF 12 Weeks: Up to 12 weeks plus 30 days; LDV/SOF+RBV 24 Weeks: Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Metabolism and nutrition disorders
Increased appetite
|
0.30%
1/335 • LDV/SOF 12 Weeks: Up to 12 weeks plus 30 days; LDV/SOF+RBV 24 Weeks: Up to 24 weeks plus 30 days
Safety Analysis Set
|
11.1%
1/9 • LDV/SOF 12 Weeks: Up to 12 weeks plus 30 days; LDV/SOF+RBV 24 Weeks: Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Metabolism and nutrition disorders
Abnormal loss of weight
|
0.00%
0/335 • LDV/SOF 12 Weeks: Up to 12 weeks plus 30 days; LDV/SOF+RBV 24 Weeks: Up to 24 weeks plus 30 days
Safety Analysis Set
|
11.1%
1/9 • LDV/SOF 12 Weeks: Up to 12 weeks plus 30 days; LDV/SOF+RBV 24 Weeks: Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.9%
23/335 • LDV/SOF 12 Weeks: Up to 12 weeks plus 30 days; LDV/SOF+RBV 24 Weeks: Up to 24 weeks plus 30 days
Safety Analysis Set
|
22.2%
2/9 • LDV/SOF 12 Weeks: Up to 12 weeks plus 30 days; LDV/SOF+RBV 24 Weeks: Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.1%
7/335 • LDV/SOF 12 Weeks: Up to 12 weeks plus 30 days; LDV/SOF+RBV 24 Weeks: Up to 24 weeks plus 30 days
Safety Analysis Set
|
11.1%
1/9 • LDV/SOF 12 Weeks: Up to 12 weeks plus 30 days; LDV/SOF+RBV 24 Weeks: Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.90%
3/335 • LDV/SOF 12 Weeks: Up to 12 weeks plus 30 days; LDV/SOF+RBV 24 Weeks: Up to 24 weeks plus 30 days
Safety Analysis Set
|
11.1%
1/9 • LDV/SOF 12 Weeks: Up to 12 weeks plus 30 days; LDV/SOF+RBV 24 Weeks: Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Musculoskeletal and connective tissue disorders
Foot deformity
|
0.00%
0/335 • LDV/SOF 12 Weeks: Up to 12 weeks plus 30 days; LDV/SOF+RBV 24 Weeks: Up to 24 weeks plus 30 days
Safety Analysis Set
|
11.1%
1/9 • LDV/SOF 12 Weeks: Up to 12 weeks plus 30 days; LDV/SOF+RBV 24 Weeks: Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Nervous system disorders
Headache
|
24.5%
82/335 • LDV/SOF 12 Weeks: Up to 12 weeks plus 30 days; LDV/SOF+RBV 24 Weeks: Up to 24 weeks plus 30 days
Safety Analysis Set
|
11.1%
1/9 • LDV/SOF 12 Weeks: Up to 12 weeks plus 30 days; LDV/SOF+RBV 24 Weeks: Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Nervous system disorders
Dizziness
|
3.3%
11/335 • LDV/SOF 12 Weeks: Up to 12 weeks plus 30 days; LDV/SOF+RBV 24 Weeks: Up to 24 weeks plus 30 days
Safety Analysis Set
|
11.1%
1/9 • LDV/SOF 12 Weeks: Up to 12 weeks plus 30 days; LDV/SOF+RBV 24 Weeks: Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Psychiatric disorders
Irritability
|
3.0%
10/335 • LDV/SOF 12 Weeks: Up to 12 weeks plus 30 days; LDV/SOF+RBV 24 Weeks: Up to 24 weeks plus 30 days
Safety Analysis Set
|
11.1%
1/9 • LDV/SOF 12 Weeks: Up to 12 weeks plus 30 days; LDV/SOF+RBV 24 Weeks: Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Psychiatric disorders
Emotional disorder
|
0.00%
0/335 • LDV/SOF 12 Weeks: Up to 12 weeks plus 30 days; LDV/SOF+RBV 24 Weeks: Up to 24 weeks plus 30 days
Safety Analysis Set
|
11.1%
1/9 • LDV/SOF 12 Weeks: Up to 12 weeks plus 30 days; LDV/SOF+RBV 24 Weeks: Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.4%
8/335 • LDV/SOF 12 Weeks: Up to 12 weeks plus 30 days; LDV/SOF+RBV 24 Weeks: Up to 24 weeks plus 30 days
Safety Analysis Set
|
44.4%
4/9 • LDV/SOF 12 Weeks: Up to 12 weeks plus 30 days; LDV/SOF+RBV 24 Weeks: Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.30%
1/335 • LDV/SOF 12 Weeks: Up to 12 weeks plus 30 days; LDV/SOF+RBV 24 Weeks: Up to 24 weeks plus 30 days
Safety Analysis Set
|
11.1%
1/9 • LDV/SOF 12 Weeks: Up to 12 weeks plus 30 days; LDV/SOF+RBV 24 Weeks: Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/335 • LDV/SOF 12 Weeks: Up to 12 weeks plus 30 days; LDV/SOF+RBV 24 Weeks: Up to 24 weeks plus 30 days
Safety Analysis Set
|
11.1%
1/9 • LDV/SOF 12 Weeks: Up to 12 weeks plus 30 days; LDV/SOF+RBV 24 Weeks: Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Nasal dryness
|
0.00%
0/335 • LDV/SOF 12 Weeks: Up to 12 weeks plus 30 days; LDV/SOF+RBV 24 Weeks: Up to 24 weeks plus 30 days
Safety Analysis Set
|
11.1%
1/9 • LDV/SOF 12 Weeks: Up to 12 weeks plus 30 days; LDV/SOF+RBV 24 Weeks: Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.2%
4/335 • LDV/SOF 12 Weeks: Up to 12 weeks plus 30 days; LDV/SOF+RBV 24 Weeks: Up to 24 weeks plus 30 days
Safety Analysis Set
|
11.1%
1/9 • LDV/SOF 12 Weeks: Up to 12 weeks plus 30 days; LDV/SOF+RBV 24 Weeks: Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.60%
2/335 • LDV/SOF 12 Weeks: Up to 12 weeks plus 30 days; LDV/SOF+RBV 24 Weeks: Up to 24 weeks plus 30 days
Safety Analysis Set
|
11.1%
1/9 • LDV/SOF 12 Weeks: Up to 12 weeks plus 30 days; LDV/SOF+RBV 24 Weeks: Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
0.30%
1/335 • LDV/SOF 12 Weeks: Up to 12 weeks plus 30 days; LDV/SOF+RBV 24 Weeks: Up to 24 weeks plus 30 days
Safety Analysis Set
|
11.1%
1/9 • LDV/SOF 12 Weeks: Up to 12 weeks plus 30 days; LDV/SOF+RBV 24 Weeks: Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
0.00%
0/335 • LDV/SOF 12 Weeks: Up to 12 weeks plus 30 days; LDV/SOF+RBV 24 Weeks: Up to 24 weeks plus 30 days
Safety Analysis Set
|
11.1%
1/9 • LDV/SOF 12 Weeks: Up to 12 weeks plus 30 days; LDV/SOF+RBV 24 Weeks: Up to 24 weeks plus 30 days
Safety Analysis Set
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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
- Publication restrictions are in place
Restriction type: OTHER