Trial Outcomes & Findings for Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed-Dose Combination in Adults With Chronic HCV and HBV Coinfection (NCT NCT02613871)
NCT ID: NCT02613871
Last Updated: 2020-03-06
Results Overview
SVR12 was defined as HCV RNA \< the lower limit of quantification (LLOQ; 15 IU/mL) at 12 weeks after stopping study treatment.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
111 participants
Primary outcome timeframe
Posttreatment Week 12
Results posted on
2020-03-06
Participant Flow
Participants were enrolled at study sites in Taiwan. The first participant was screened on 22 December 2015. The last study visit occurred on 07 November 2018.
135 participants were screened.
Participant milestones
| Measure |
LDV/SOF FDC
Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet orally once daily for 12 weeks.
|
|---|---|
|
Overall Study
STARTED
|
111
|
|
Overall Study
COMPLETED
|
108
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
LDV/SOF FDC
Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet orally once daily for 12 weeks.
|
|---|---|
|
Overall Study
Death
|
2
|
|
Overall Study
Withdrew Consent
|
1
|
Baseline Characteristics
Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed-Dose Combination in Adults With Chronic HCV and HBV Coinfection
Baseline characteristics by cohort
| Measure |
LDV/SOF FDC
n=111 Participants
LDV/SOF (90/400 mg) FDC tablet orally once daily for 12 weeks.
|
|---|---|
|
Age, Continuous
|
55 years
STANDARD_DEVIATION 9.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
69 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
42 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
111 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Not Hispanic or Latino
|
99 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Not Permitted
|
12 Participants
n=5 Participants
|
|
IL28b Status
CC
|
85 Participants
n=5 Participants
|
|
IL28b Status
CT
|
26 Participants
n=5 Participants
|
|
HCV RNA
|
5.9 log10 IU/mL
STANDARD_DEVIATION 0.73 • n=5 Participants
|
|
HCV RNA Category
< 800,000 IU/mL
|
44 Participants
n=5 Participants
|
|
HCV RNA Category
≥ 800,000 IU/mL
|
67 Participants
n=5 Participants
|
|
Cirrhosis status
Absence
|
93 Participants
n=5 Participants
|
|
Cirrhosis status
Presence
|
18 Participants
n=5 Participants
|
|
Fibroscan Score
|
9.3 kPa
STANDARD_DEVIATION 7.05 • n=5 Participants
|
|
Hepatitis B Virus (HBV) DNA
|
2.1 log10 IU/mL
STANDARD_DEVIATION 0.92 • n=5 Participants
|
|
Plasma HBV DNA
|
9423.1 IU/mL
STANDARD_DEVIATION 69641.90 • n=5 Participants
|
|
HBsAg
|
578.6 IU/mL
STANDARD_DEVIATION 1113.56 • n=5 Participants
|
|
Serum Lysyl Oxidase-Like 2 (LOXL-2) Level
|
98 pg/mL
STANDARD_DEVIATION 64.4 • n=5 Participants
|
|
HCV Genotype
Genotype 1
|
1 Participants
n=5 Participants
|
|
HCV Genotype
Genotype 1a
|
3 Participants
n=5 Participants
|
|
HCV Genotype
Genotype 1b
|
64 Participants
n=5 Participants
|
|
HCV Genotype
Genotype 2
|
43 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Posttreatment Week 12Population: Full Analysis Set included all participants who were enrolled and received at least 1 dose of study drug.
SVR12 was defined as HCV RNA \< the lower limit of quantification (LLOQ; 15 IU/mL) at 12 weeks after stopping study treatment.
Outcome measures
| Measure |
LDV/SOF FDC
n=111 Participants
LDV/SOF (90/400 mg) FDC tablet orally once daily for 12 weeks.
|
|---|---|
|
Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
Genotype 1
|
100.0 percentage of participants
Interval 94.7 to 100.0
|
|
Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
Genotype 2
|
100.0 percentage of participants
Interval 91.8 to 100.0
|
|
Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
Total
|
100.0 percentage of participants
Interval 96.7 to 100.0
|
PRIMARY outcome
Timeframe: First dose date up to 12 weeksPopulation: Safety Analysis Set included participants who received at least 1 dose of study drug.
Outcome measures
| Measure |
LDV/SOF FDC
n=111 Participants
LDV/SOF (90/400 mg) FDC tablet orally once daily for 12 weeks.
|
|---|---|
|
Percentage of Participants With Any Adverse Event Leading to Permanent Discontinuation of Study Drug
|
0.0 percentage of participants
|
SECONDARY outcome
Timeframe: Posttreatment Week 4Population: Participants in Full Analysis Set were analyzed.
SVR4 was defined as HCV RNA \< LLOQ (15 IU/mL) at 4 weeks after stopping study treatment.
Outcome measures
| Measure |
LDV/SOF FDC
n=111 Participants
LDV/SOF (90/400 mg) FDC tablet orally once daily for 12 weeks.
|
|---|---|
|
Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4)
|
100.0 percentage of participants
Interval 96.7 to 100.0
|
SECONDARY outcome
Timeframe: Weeks 1, 2, 4, 8, and 12Population: Participants in Full Analysis Set were analyzed.
LLOQ = 15 IU/mL
Outcome measures
| Measure |
LDV/SOF FDC
n=111 Participants
LDV/SOF (90/400 mg) FDC tablet orally once daily for 12 weeks.
|
|---|---|
|
Percentage of Participants With HCV RNA < LLOQ While on Treatment
Week 1
|
33.3 percentage of participants
Interval 24.7 to 42.9
|
|
Percentage of Participants With HCV RNA < LLOQ While on Treatment
Week 2
|
82.0 percentage of participants
Interval 73.6 to 88.6
|
|
Percentage of Participants With HCV RNA < LLOQ While on Treatment
Week 4
|
100.0 percentage of participants
Interval 96.7 to 100.0
|
|
Percentage of Participants With HCV RNA < LLOQ While on Treatment
Week 8
|
100.0 percentage of participants
Interval 96.7 to 100.0
|
|
Percentage of Participants With HCV RNA < LLOQ While on Treatment
Week 12
|
100.0 percentage of participants
Interval 96.7 to 100.0
|
SECONDARY outcome
Timeframe: Posttreatment Weeks 24, 36, 48, 60, 72, 84, 96, and 108Population: Participants in Full Analysis Set with available data were analyzed.
LLOQ = 15 IU/mL
Outcome measures
| Measure |
LDV/SOF FDC
n=111 Participants
LDV/SOF (90/400 mg) FDC tablet orally once daily for 12 weeks.
|
|---|---|
|
Percentage of Participants With HCV RNA < LLOQ at Posttreatment Weeks 24, 36, 48, 60, 72, 84, 96, and 108
Posttreatment Week 24
|
100 percentage of participants
Interval 96.7 to 100.0
|
|
Percentage of Participants With HCV RNA < LLOQ at Posttreatment Weeks 24, 36, 48, 60, 72, 84, 96, and 108
Posttreatment Week 36
|
100 percentage of participants
Interval 96.7 to 100.0
|
|
Percentage of Participants With HCV RNA < LLOQ at Posttreatment Weeks 24, 36, 48, 60, 72, 84, 96, and 108
Posttreatment Week 48
|
100 percentage of participants
Interval 96.7 to 100.0
|
|
Percentage of Participants With HCV RNA < LLOQ at Posttreatment Weeks 24, 36, 48, 60, 72, 84, 96, and 108
Posttreatment Week 60
|
100 percentage of participants
Interval 96.7 to 100.0
|
|
Percentage of Participants With HCV RNA < LLOQ at Posttreatment Weeks 24, 36, 48, 60, 72, 84, 96, and 108
Posttreatment Week 72
|
100 percentage of participants
Interval 96.7 to 100.0
|
|
Percentage of Participants With HCV RNA < LLOQ at Posttreatment Weeks 24, 36, 48, 60, 72, 84, 96, and 108
Posttreatment Week 84
|
100 percentage of participants
Interval 96.7 to 100.0
|
|
Percentage of Participants With HCV RNA < LLOQ at Posttreatment Weeks 24, 36, 48, 60, 72, 84, 96, and 108
Posttreatment Week 96
|
100 percentage of participants
Interval 96.6 to 100.0
|
|
Percentage of Participants With HCV RNA < LLOQ at Posttreatment Weeks 24, 36, 48, 60, 72, 84, 96, and 108
Posttreatment Week 108
|
100 percentage of participants
Interval 96.6 to 100.0
|
SECONDARY outcome
Timeframe: Weeks 1, 2, 4, 8, and 12Population: Participants in Full Analysis Set were analyzed.
Outcome measures
| Measure |
LDV/SOF FDC
n=111 Participants
LDV/SOF (90/400 mg) FDC tablet orally once daily for 12 weeks.
|
|---|---|
|
HCV RNA Change From Baseline While on Treatment
Change at Week 1
|
-4.14 log10 IU/mL
Standard Deviation 0.551
|
|
HCV RNA Change From Baseline While on Treatment
Change at Week 2
|
-4.63 log10 IU/mL
Standard Deviation 0.702
|
|
HCV RNA Change From Baseline While on Treatment
Change at Week 4
|
-4.73 log10 IU/mL
Standard Deviation 0.727
|
|
HCV RNA Change From Baseline While on Treatment
Change at Week 8
|
-4.73 log10 IU/mL
Standard Deviation 0.727
|
|
HCV RNA Change From Baseline While on Treatment
Change at Week 12
|
-4.73 log10 IU/mL
Standard Deviation 0.727
|
SECONDARY outcome
Timeframe: First dose date up to Posttreatment Week 12Population: Participants in Full Analysis Set were analyzed.
Virologic failure was defined as : * Breakthrough (confirmed HCV RNA ≥ LLOQ \[15 IU/mL\] 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), or * Relapse (HCV RNA ≥ LLOQ during the post-treatment period having achieved HCV RNA \< LLOQ at end of treatment, confirmed with 2 consecutive values or last available post-treatment measurement)
Outcome measures
| Measure |
LDV/SOF FDC
n=111 Participants
LDV/SOF (90/400 mg) FDC tablet orally once daily for 12 weeks.
|
|---|---|
|
Percentage of Participants With Virologic Failure
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Weeks 1, 2, 4, 8, and 12Population: Participants in Full Analysis Set with available data were analyzed.
Outcome measures
| Measure |
LDV/SOF FDC
n=111 Participants
LDV/SOF (90/400 mg) FDC tablet orally once daily for 12 weeks.
|
|---|---|
|
Plasma HBV DNA Change From Baseline While on Treatment
Change at Week 1
|
-0.06 log10 IU/mL
Standard Deviation 0.237
|
|
Plasma HBV DNA Change From Baseline While on Treatment
Change at Week 2
|
0.08 log10 IU/mL
Standard Deviation 0.366
|
|
Plasma HBV DNA Change From Baseline While on Treatment
Change at Week 4
|
0.37 log10 IU/mL
Standard Deviation 0.705
|
|
Plasma HBV DNA Change From Baseline While on Treatment
Change at Week 8
|
0.51 log10 IU/mL
Standard Deviation 0.906
|
|
Plasma HBV DNA Change From Baseline While on Treatment
Change at Week 12
|
0.24 log10 IU/mL
Standard Deviation 0.746
|
SECONDARY outcome
Timeframe: Posttreatment Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, and 108Population: Participants in Full Analysis Set with available data were analyzed.
Outcome measures
| Measure |
LDV/SOF FDC
n=111 Participants
LDV/SOF (90/400 mg) FDC tablet orally once daily for 12 weeks.
|
|---|---|
|
Plasma HBV DNA Change From Baseline at Posttreatment Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, and 108
Change at Posttreatment Week 84
|
0.50 log10 IU/mL
Standard Deviation 1.008
|
|
Plasma HBV DNA Change From Baseline at Posttreatment Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, and 108
Change at Posttreatment Week 96
|
0.41 log10 IU/mL
Standard Deviation 0.963
|
|
Plasma HBV DNA Change From Baseline at Posttreatment Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, and 108
Change at Posttreatment Week 4
|
0.49 log10 IU/mL
Standard Deviation 0.727
|
|
Plasma HBV DNA Change From Baseline at Posttreatment Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, and 108
Change at Posttreatment Week 12
|
0.66 log10 IU/mL
Standard Deviation 0.955
|
|
Plasma HBV DNA Change From Baseline at Posttreatment Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, and 108
Change at Posttreatment Week 24
|
0.56 log10 IU/mL
Standard Deviation 1.036
|
|
Plasma HBV DNA Change From Baseline at Posttreatment Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, and 108
Change at Posttreatment Week 36
|
0.67 log10 IU/mL
Standard Deviation 1.190
|
|
Plasma HBV DNA Change From Baseline at Posttreatment Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, and 108
Change at Posttreatment Week 48
|
0.68 log10 IU/mL
Standard Deviation 1.269
|
|
Plasma HBV DNA Change From Baseline at Posttreatment Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, and 108
Change at Posttreatment Week 60
|
0.70 log10 IU/mL
Standard Deviation 1.399
|
|
Plasma HBV DNA Change From Baseline at Posttreatment Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, and 108
Change at Posttreatment Week 72
|
0.55 log10 IU/mL
Standard Deviation 1.131
|
|
Plasma HBV DNA Change From Baseline at Posttreatment Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, and 108
Change at Posttreatment Week 108
|
0.38 log10 IU/mL
Standard Deviation 0.923
|
SECONDARY outcome
Timeframe: Weeks 1, 2, 4, 8, and 12Population: Participants in Full Analysis Set with available data were analyzed.
Outcome measures
| Measure |
LDV/SOF FDC
n=111 Participants
LDV/SOF (90/400 mg) FDC tablet orally once daily for 12 weeks.
|
|---|---|
|
HBsAg Level Change From Baseline While on Treatment
Change at Week 1
|
-0.14 log10 IU/mL
Standard Deviation 0.184
|
|
HBsAg Level Change From Baseline While on Treatment
Change at Week 2
|
-0.18 log10 IU/mL
Standard Deviation 0.181
|
|
HBsAg Level Change From Baseline While on Treatment
Change at Week 4
|
-0.25 log10 IU/mL
Standard Deviation 0.185
|
|
HBsAg Level Change From Baseline While on Treatment
Change at Week 8
|
-0.41 log10 IU/mL
Standard Deviation 0.234
|
|
HBsAg Level Change From Baseline While on Treatment
Change at Week 12
|
-0.47 log10 IU/mL
Standard Deviation 0.266
|
SECONDARY outcome
Timeframe: Posttreatment Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, and 108Population: Participants in Full Analysis Set with available data were analyzed.
Outcome measures
| Measure |
LDV/SOF FDC
n=111 Participants
LDV/SOF (90/400 mg) FDC tablet orally once daily for 12 weeks.
|
|---|---|
|
HBsAg Level Change From Baseline at Posttreatment Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, and 108
Change at Posttreatment Week 4
|
-0.16 log10 IU/mL
Standard Deviation 0.347
|
|
HBsAg Level Change From Baseline at Posttreatment Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, and 108
Change at Posttreatment Week 12
|
-0.01 log10 IU/mL
Standard Deviation 0.338
|
|
HBsAg Level Change From Baseline at Posttreatment Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, and 108
Change at Posttreatment Week 24
|
-0.02 log10 IU/mL
Standard Deviation 0.405
|
|
HBsAg Level Change From Baseline at Posttreatment Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, and 108
Change at Posttreatment Week 36
|
-0.07 log10 IU/mL
Standard Deviation 0.484
|
|
HBsAg Level Change From Baseline at Posttreatment Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, and 108
Change at Posttreatment Week 48
|
-0.10 log10 IU/mL
Standard Deviation 0.526
|
|
HBsAg Level Change From Baseline at Posttreatment Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, and 108
Change at Posttreatment Week 60
|
-0.16 log10 IU/mL
Standard Deviation 0.664
|
|
HBsAg Level Change From Baseline at Posttreatment Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, and 108
Change at Posttreatment Week 72
|
-0.20 log10 IU/mL
Standard Deviation 0.619
|
|
HBsAg Level Change From Baseline at Posttreatment Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, and 108
Change at Posttreatment Week 84
|
-0.25 log10 IU/mL
Standard Deviation 0.608
|
|
HBsAg Level Change From Baseline at Posttreatment Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, and 108
Change at Posttreatment Week 96
|
-0.32 log10 IU/mL
Standard Deviation 0.618
|
|
HBsAg Level Change From Baseline at Posttreatment Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, and 108
Change at Posttreatment Week 108
|
-0.37 log10 IU/mL
Standard Deviation 0.658
|
SECONDARY outcome
Timeframe: Weeks 1, 2, 4, 8, and 12Population: Participants in Full Analysis Set with available data were analyzed.
Outcome measures
| Measure |
LDV/SOF FDC
n=111 Participants
LDV/SOF (90/400 mg) FDC tablet orally once daily for 12 weeks.
|
|---|---|
|
Serum LOXL-2 Level Change From Baseline While on Treatment
Change at Week 1
|
-2 pg/mL
Standard Deviation 29.4
|
|
Serum LOXL-2 Level Change From Baseline While on Treatment
Change at Week 2
|
-6 pg/mL
Standard Deviation 26.9
|
|
Serum LOXL-2 Level Change From Baseline While on Treatment
Change at Week 4
|
-15 pg/mL
Standard Deviation 27.8
|
|
Serum LOXL-2 Level Change From Baseline While on Treatment
Change at Week 8
|
-22 pg/mL
Standard Deviation 36.6
|
|
Serum LOXL-2 Level Change From Baseline While on Treatment
Change at Week 12
|
-27 pg/mL
Standard Deviation 36.0
|
SECONDARY outcome
Timeframe: Posttreatment Weeks 4, 12, and 36Population: Participants in Full Analysis Set were analyzed.
Outcome measures
| Measure |
LDV/SOF FDC
n=111 Participants
LDV/SOF (90/400 mg) FDC tablet orally once daily for 12 weeks.
|
|---|---|
|
Serum LOXL-2 Level Change From Baseline at Posttreatment Weeks 4, 12, and 36
Change at Posttreatment Week 4
|
-30 pg/mL
Standard Deviation 45.0
|
|
Serum LOXL-2 Level Change From Baseline at Posttreatment Weeks 4, 12, and 36
Change at Posttreatment Week 12
|
-32 pg/mL
Standard Deviation 51.8
|
|
Serum LOXL-2 Level Change From Baseline at Posttreatment Weeks 4, 12, and 36
Change at Posttreatment Week 36
|
-41 pg/mL
Standard Deviation 53.0
|
SECONDARY outcome
Timeframe: First dose date up to Posttreatment Week 108Population: Participants in Full Analysis Set were analyzed.
Outcome measures
| Measure |
LDV/SOF FDC
n=111 Participants
LDV/SOF (90/400 mg) FDC tablet orally once daily for 12 weeks.
|
|---|---|
|
Percentage of Participants That Required HBV Therapy During the Study
|
7.2 percentage of participants
|
SECONDARY outcome
Timeframe: Posttreatment Weeks 12, 60, and 108Population: Participants in Full Analysis Set with available data were analyzed.
FibroScan is a non-invasive device that assesses the hardness (or stiffness) of the liver using the technique of transient elastography. FibroScan results range from 2.5 kPa to 75 kPa with higher scores indicating greater liver stiffness. Per protocol, cirrhosis status was determined as follows: * Presence of cirrhosis = FibroScan result of \> 12.5 kPa * Absence of cirrhosis = FibroScan result of ≤ 12.5 kPa
Outcome measures
| Measure |
LDV/SOF FDC
n=111 Participants
LDV/SOF (90/400 mg) FDC tablet orally once daily for 12 weeks.
|
|---|---|
|
Fibrosis Status as Assessed by Fibroscan Score at Posttreatment Weeks 12, 60, and 108
Posttreatment Week 12
|
8.0 kPa
Standard Deviation 7.01
|
|
Fibrosis Status as Assessed by Fibroscan Score at Posttreatment Weeks 12, 60, and 108
Posttreatment Week 60
|
7.2 kPa
Standard Deviation 4.99
|
|
Fibrosis Status as Assessed by Fibroscan Score at Posttreatment Weeks 12, 60, and 108
Posttreatment Week 108
|
7.1 kPa
Standard Deviation 4.79
|
SECONDARY outcome
Timeframe: First dose date up to Posttreatment Week 108Population: Participants in Full Analysis Set were analyzed.
Outcome measures
| Measure |
LDV/SOF FDC
n=111 Participants
LDV/SOF (90/400 mg) FDC tablet orally once daily for 12 weeks.
|
|---|---|
|
Percentage of Participants That Develop Hepatocellular Carcinoma (HCC) During the Study
|
0.0 percentage of participants
|
Adverse Events
LDV/SOF FDC
Serious events: 4 serious events
Other events: 24 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
LDV/SOF FDC
n=111 participants at risk
LDV/SOF (90/400 mg) FDC tablet orally once daily for 12 weeks.
|
|---|---|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.90%
1/111 • Adverse Events: First dose date up to 12 weeks plus 30 days; All-Cause Mortality: First dose date up to maximum 3 years
Safety Analysis Set included participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.90%
1/111 • Adverse Events: First dose date up to 12 weeks plus 30 days; All-Cause Mortality: First dose date up to maximum 3 years
Safety Analysis Set included participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.90%
1/111 • Adverse Events: First dose date up to 12 weeks plus 30 days; All-Cause Mortality: First dose date up to maximum 3 years
Safety Analysis Set included participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Optic neuritis
|
0.90%
1/111 • Adverse Events: First dose date up to 12 weeks plus 30 days; All-Cause Mortality: First dose date up to maximum 3 years
Safety Analysis Set included participants who received at least 1 dose of study drug.
|
Other adverse events
| Measure |
LDV/SOF FDC
n=111 participants at risk
LDV/SOF (90/400 mg) FDC tablet orally once daily for 12 weeks.
|
|---|---|
|
General disorders
Fatigue
|
7.2%
8/111 • Adverse Events: First dose date up to 12 weeks plus 30 days; All-Cause Mortality: First dose date up to maximum 3 years
Safety Analysis Set included participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
8.1%
9/111 • Adverse Events: First dose date up to 12 weeks plus 30 days; All-Cause Mortality: First dose date up to maximum 3 years
Safety Analysis Set included participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Headache
|
9.9%
11/111 • Adverse Events: First dose date up to 12 weeks plus 30 days; All-Cause Mortality: First dose date up to maximum 3 years
Safety Analysis Set included participants who received at least 1 dose of study drug.
|
Additional Information
Gilead Clinical Study Information Center
Gilead Sciences
Phone: 1-833-445-3230 (GILEAD-0)
Email: [email protected]
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