Trial Outcomes & Findings for Efficacy and Safety of Sofosbuvir/Velpatasvir ± Ribavirin for 12 Weeks in Adults With Chronic HCV Infection and Decompensated Cirrhosis (NCT NCT02996682)
NCT ID: NCT02996682
Last Updated: 2019-02-26
Results Overview
SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
102 participants
Primary outcome timeframe
Posttreatment Week 12
Results posted on
2019-02-26
Participant Flow
Participants were enrolled at study sites in Japan. The first participant was screened on 26 December 2016. The last study visit occurred on 08 May 2018.
155 participants were screened.
Participant milestones
| Measure |
SOF/VEL
Sofosbuvir/velpatasvir (SOF/VEL) (400/100 mg) fixed-dose combination (FDC) tablet once daily for 12 weeks
|
SOF/VEL + RBV
SOF/VEL (400/100 mg) FDC tablet once daily + ribavirin (RBV) capsules (600, 800, or 1,000 mg daily based on weight and CPT class) for 12 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
51
|
51
|
|
Overall Study
COMPLETED
|
51
|
48
|
|
Overall Study
NOT COMPLETED
|
0
|
3
|
Reasons for withdrawal
| Measure |
SOF/VEL
Sofosbuvir/velpatasvir (SOF/VEL) (400/100 mg) fixed-dose combination (FDC) tablet once daily for 12 weeks
|
SOF/VEL + RBV
SOF/VEL (400/100 mg) FDC tablet once daily + ribavirin (RBV) capsules (600, 800, or 1,000 mg daily based on weight and CPT class) for 12 weeks
|
|---|---|---|
|
Overall Study
Death
|
0
|
3
|
Baseline Characteristics
Efficacy and Safety of Sofosbuvir/Velpatasvir ± Ribavirin for 12 Weeks in Adults With Chronic HCV Infection and Decompensated Cirrhosis
Baseline characteristics by cohort
| Measure |
SOF/VEL
n=51 Participants
SOF/VEL (400/100 mg) FDC tablet once daily for 12 weeks
|
SOF/VEL + RBV
n=51 Participants
SOF/VEL (400/100 mg) FDC tablet once daily + RBV capsules (600, 800, or 1,000 mg daily based on weight and CPT class) for 12 weeks
|
Total
n=102 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66 Years
STANDARD_DEVIATION 9.6 • n=5 Participants
|
66 Years
STANDARD_DEVIATION 9.6 • n=7 Participants
|
66 Years
STANDARD_DEVIATION 9.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
51 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
102 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
51 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
102 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
HCV genotype
Genotype 1
|
41 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
|
HCV genotype
Genotype 2
|
9 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
HCV genotype
Genotype 3
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
HCV genotype
Missing
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
IL28b Status
CC
|
33 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
|
IL28b Status
CT
|
16 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
IL28b Status
TT
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
HCV RNA (log10 international units per milliliter [IU/mL])
|
5.7 log10 IU/mL
STANDARD_DEVIATION 0.70 • n=5 Participants
|
5.8 log10 IU/mL
STANDARD_DEVIATION 0.55 • n=7 Participants
|
5.8 log10 IU/mL
STANDARD_DEVIATION 0.63 • n=5 Participants
|
|
HCV RNA Category
< 800,000 IU/mL
|
30 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
HCV RNA Category
≥ 800,000 IU/mL
|
21 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Model for End Stage Liver Disease (MELD) Score Category
< 10 MELD Score
|
10 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Model for End Stage Liver Disease (MELD) Score Category
10-15 MELD Score
|
36 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
|
Model for End Stage Liver Disease (MELD) Score Category
16-20 MELD Score
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Model for End Stage Liver Disease (MELD) Score Category
21-25 MELD Score
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Model for End Stage Liver Disease (MELD) Score Category
> 25 MELD Score
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Child-Pugh-Turcotte (CPT) Class
CPT A [5-6]
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Child-Pugh-Turcotte (CPT) Class
CPT B [7-9]
|
40 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
79 Participants
n=5 Participants
|
|
Child-Pugh-Turcotte (CPT) Class
CPT C [10-15]
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Posttreatment Week 12Population: Full Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug.
SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.
Outcome measures
| Measure |
SOF/VEL
n=51 Participants
SOF/VEL (400/100 mg) FDC tablet once daily for 12 weeks
|
SOF/VEL + RBV
n=51 Participants
SOF/VEL (400/100 mg) FDC tablet once daily + RBV capsules (600, 800, or 1,000 mg daily based on weight and CPT class) for 12 weeks
|
|---|---|---|
|
Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
|
92.2 Percentage of participants
Interval 81.1 to 97.8
|
92.2 Percentage of participants
Interval 81.1 to 97.8
|
PRIMARY outcome
Timeframe: Up to 12 weeksPopulation: Safety Analysis Set
Outcome measures
| Measure |
SOF/VEL
n=51 Participants
SOF/VEL (400/100 mg) FDC tablet once daily for 12 weeks
|
SOF/VEL + RBV
n=51 Participants
SOF/VEL (400/100 mg) FDC tablet once daily + RBV capsules (600, 800, or 1,000 mg daily based on weight and CPT class) for 12 weeks
|
|---|---|---|
|
Percentage of Participants Who Discontinued Treatment (SOF/VEL or RBV) Early Due to an Adverse Event
Discontinuation of SOF/VEL
|
0 Percentage of participants
|
3.9 Percentage of participants
|
|
Percentage of Participants Who Discontinued Treatment (SOF/VEL or RBV) Early Due to an Adverse Event
Discontinuation of RBV
|
NA Percentage of participants
RBV drug was not used an as intervention in this arm.
|
17.6 Percentage of participants
|
SECONDARY outcome
Timeframe: Posttreatment Week 4Population: Full Analysis Set
SVR4 was defined as HCV RNA \< LLOQ at 4 weeks after stopping study treatment.
Outcome measures
| Measure |
SOF/VEL
n=51 Participants
SOF/VEL (400/100 mg) FDC tablet once daily for 12 weeks
|
SOF/VEL + RBV
n=51 Participants
SOF/VEL (400/100 mg) FDC tablet once daily + RBV capsules (600, 800, or 1,000 mg daily based on weight and CPT class) for 12 weeks
|
|---|---|---|
|
Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4)
|
94.1 Percentage of participants
Interval 83.8 to 98.8
|
96.1 Percentage of participants
Interval 86.5 to 99.5
|
SECONDARY outcome
Timeframe: Posttreatment Week 24Population: Full Analysis Set
SVR24 was defined as HCV RNA \< LLOQ at 24 weeks after stopping study treatment.
Outcome measures
| Measure |
SOF/VEL
n=51 Participants
SOF/VEL (400/100 mg) FDC tablet once daily for 12 weeks
|
SOF/VEL + RBV
n=51 Participants
SOF/VEL (400/100 mg) FDC tablet once daily + RBV capsules (600, 800, or 1,000 mg daily based on weight and CPT class) for 12 weeks
|
|---|---|---|
|
Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24)
|
92.2 Percentage of participants
Interval 81.1 to 97.8
|
92.2 Percentage of participants
Interval 81.1 to 97.8
|
SECONDARY outcome
Timeframe: Up to 12 weeksPopulation: Participants in the Full Analysis Set with available data were analyzed.
Outcome measures
| Measure |
SOF/VEL
n=51 Participants
SOF/VEL (400/100 mg) FDC tablet once daily for 12 weeks
|
SOF/VEL + RBV
n=51 Participants
SOF/VEL (400/100 mg) FDC tablet once daily + RBV capsules (600, 800, or 1,000 mg daily based on weight and CPT class) for 12 weeks
|
|---|---|---|
|
Percentage of Participants Who Had HCV RNA < LLOQ by Visit While on Treatment
Week 2
|
45.1 Percentage of participants
|
51.0 Percentage of participants
|
|
Percentage of Participants Who Had HCV RNA < LLOQ by Visit While on Treatment
Week 4
|
96.1 Percentage of participants
|
90.2 Percentage of participants
|
|
Percentage of Participants Who Had HCV RNA < LLOQ by Visit While on Treatment
Week 8
|
100.0 Percentage of participants
|
96.1 Percentage of participants
|
|
Percentage of Participants Who Had HCV RNA < LLOQ by Visit While on Treatment
Week 12
|
100.0 Percentage of participants
|
100.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and up to 12 weeksPopulation: Participants in the Full Analysis Set with available data were analyzed.
Outcome measures
| Measure |
SOF/VEL
n=51 Participants
SOF/VEL (400/100 mg) FDC tablet once daily for 12 weeks
|
SOF/VEL + RBV
n=51 Participants
SOF/VEL (400/100 mg) FDC tablet once daily + RBV capsules (600, 800, or 1,000 mg daily based on weight and CPT class) for 12 weeks
|
|---|---|---|
|
Change From Baseline in HCV RNA
Change at Week 4
|
-4.55 log10 IU/mL
Standard Deviation 0.696
|
-4.65 log10 IU/mL
Standard Deviation 0.528
|
|
Change From Baseline in HCV RNA
Change at Week 8
|
-4.56 log10 IU/mL
Standard Deviation 0.705
|
-4.70 log10 IU/mL
Standard Deviation 0.554
|
|
Change From Baseline in HCV RNA
Change at Week 2
|
-4.14 log10 IU/mL
Standard Deviation 0.573
|
-4.33 log10 IU/mL
Standard Deviation 0.525
|
|
Change From Baseline in HCV RNA
Change at Week 12
|
-4.56 log10 IU/mL
Standard Deviation 0.705
|
-4.70 log10 IU/mL
Standard Deviation 0.554
|
SECONDARY outcome
Timeframe: Baseline to Posttreatment Week 24Population: Participants in the Full Analysis Set who achieved SVR24 with available data were analyzed.
MELD score is a chronic liver disease severity scoring system. Scores can range from 6 to 40, with higher scores indicating greater disease severity. "No change" was assigned for differences (posttreatment visits minus baseline score) of -1, 0 or 1; "Decrease" was assigned for differences that were less than or equal to -2; and "Increase" was assigned for values that were greater than or equal to 2.
Outcome measures
| Measure |
SOF/VEL
n=47 Participants
SOF/VEL (400/100 mg) FDC tablet once daily for 12 weeks
|
SOF/VEL + RBV
n=46 Participants
SOF/VEL (400/100 mg) FDC tablet once daily + RBV capsules (600, 800, or 1,000 mg daily based on weight and CPT class) for 12 weeks
|
|---|---|---|
|
Percentage of Participants With a Decrease, No Change, or Increase in Model for End Stage Liver Disease (MELD) Score
Decrease (Improvement)
|
38.3 Percentage of participants
|
21.7 Percentage of participants
|
|
Percentage of Participants With a Decrease, No Change, or Increase in Model for End Stage Liver Disease (MELD) Score
No Change
|
53.2 Percentage of participants
|
54.3 Percentage of participants
|
|
Percentage of Participants With a Decrease, No Change, or Increase in Model for End Stage Liver Disease (MELD) Score
Increase (Worsening)
|
8.5 Percentage of participants
|
23.9 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to Posttreatment Week 24Population: Participants in the Full Analysis Set who achieved SVR24 with available data were analyzed.
CPT is a chronic liver disease classification system. Classes include CPT Class A, CPT Class B, and CPT Class C, in order of greater disease severity. Participants with improved CPT class was defined as having Class C at Baseline and Class B or A at Posttreatment Week 24 or Class B at Baseline and Class A at Posttreatment Week 24. Participants with worsened CPT class was defined as having Class A at Baseline and Class B or C at Posttreatment Week 24 or Class B at Baseline and Class C at Posttreatment Week 24. CPT scores were calculated using prothrombin activation percentage for the coagulation parameter per Japan's standard.
Outcome measures
| Measure |
SOF/VEL
n=47 Participants
SOF/VEL (400/100 mg) FDC tablet once daily for 12 weeks
|
SOF/VEL + RBV
n=46 Participants
SOF/VEL (400/100 mg) FDC tablet once daily + RBV capsules (600, 800, or 1,000 mg daily based on weight and CPT class) for 12 weeks
|
|---|---|---|
|
Percentage of Participants With Improved and Worsened Child-Pugh-Turcotte (CPT) Class
Improved CPT Class
|
36.2 Percentage of participants
|
39.1 Percentage of participants
|
|
Percentage of Participants With Improved and Worsened Child-Pugh-Turcotte (CPT) Class
Worsened CPT Class
|
4.3 Percentage of participants
|
2.2 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to Posttreatment Week 24Population: Full Analysis Set
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), 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 |
SOF/VEL
n=51 Participants
SOF/VEL (400/100 mg) FDC tablet once daily for 12 weeks
|
SOF/VEL + RBV
n=51 Participants
SOF/VEL (400/100 mg) FDC tablet once daily + RBV capsules (600, 800, or 1,000 mg daily based on weight and CPT class) for 12 weeks
|
|---|---|---|
|
Percentage of Participants With Virologic Failure
|
7.8 Percentage of participants
|
3.9 Percentage of participants
|
Adverse Events
SOF/VEL
Serious events: 4 serious events
Other events: 14 other events
Deaths: 0 deaths
SOF/VEL + RBV
Serious events: 7 serious events
Other events: 34 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
SOF/VEL
n=51 participants at risk
SOF/VEL (400/100 mg) FDC tablet once daily for 12 weeks
|
SOF/VEL + RBV
n=51 participants at risk
SOF/VEL (400/100 mg) FDC tablet once daily + RBV capsules (600, 800, or 1,000 mg daily based on weight and CPT class) for 12 weeks
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/51 • Adverse Events: Up to 12 weeks plus 30 days; All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
2.0%
1/51 • Adverse Events: Up to 12 weeks plus 30 days; All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/51 • Adverse Events: Up to 12 weeks plus 30 days; All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
2.0%
1/51 • Adverse Events: Up to 12 weeks plus 30 days; All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Gastric varices haemorrhage
|
0.00%
0/51 • Adverse Events: Up to 12 weeks plus 30 days; All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
2.0%
1/51 • Adverse Events: Up to 12 weeks plus 30 days; All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Oesophageal varices haemorrhage
|
0.00%
0/51 • Adverse Events: Up to 12 weeks plus 30 days; All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
2.0%
1/51 • Adverse Events: Up to 12 weeks plus 30 days; All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Varices oesophageal
|
2.0%
1/51 • Adverse Events: Up to 12 weeks plus 30 days; All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/51 • Adverse Events: Up to 12 weeks plus 30 days; All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Bacterial sepsis
|
0.00%
0/51 • Adverse Events: Up to 12 weeks plus 30 days; All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
2.0%
1/51 • Adverse Events: Up to 12 weeks plus 30 days; All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/51 • Adverse Events: Up to 12 weeks plus 30 days; All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
3.9%
2/51 • Adverse Events: Up to 12 weeks plus 30 days; All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
2.0%
1/51 • Adverse Events: Up to 12 weeks plus 30 days; All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/51 • Adverse Events: Up to 12 weeks plus 30 days; All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal adenocarcinoma
|
2.0%
1/51 • Adverse Events: Up to 12 weeks plus 30 days; All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/51 • Adverse Events: Up to 12 weeks plus 30 days; All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Hepatic encephalopathy
|
2.0%
1/51 • Adverse Events: Up to 12 weeks plus 30 days; All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
3.9%
2/51 • Adverse Events: Up to 12 weeks plus 30 days; All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/51 • Adverse Events: Up to 12 weeks plus 30 days; All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
2.0%
1/51 • Adverse Events: Up to 12 weeks plus 30 days; All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
Other adverse events
| Measure |
SOF/VEL
n=51 participants at risk
SOF/VEL (400/100 mg) FDC tablet once daily for 12 weeks
|
SOF/VEL + RBV
n=51 participants at risk
SOF/VEL (400/100 mg) FDC tablet once daily + RBV capsules (600, 800, or 1,000 mg daily based on weight and CPT class) for 12 weeks
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/51 • Adverse Events: Up to 12 weeks plus 30 days; All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
37.3%
19/51 • Adverse Events: Up to 12 weeks plus 30 days; All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Haemolytic anaemia
|
0.00%
0/51 • Adverse Events: Up to 12 weeks plus 30 days; All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.9%
3/51 • Adverse Events: Up to 12 weeks plus 30 days; All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/51 • Adverse Events: Up to 12 weeks plus 30 days; All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.9%
3/51 • Adverse Events: Up to 12 weeks plus 30 days; All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/51 • Adverse Events: Up to 12 weeks plus 30 days; All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
13.7%
7/51 • Adverse Events: Up to 12 weeks plus 30 days; All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
General disorders
Oedema peripheral
|
5.9%
3/51 • Adverse Events: Up to 12 weeks plus 30 days; All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
3.9%
2/51 • Adverse Events: Up to 12 weeks plus 30 days; All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Nasopharyngitis
|
13.7%
7/51 • Adverse Events: Up to 12 weeks plus 30 days; All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.9%
3/51 • Adverse Events: Up to 12 weeks plus 30 days; All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Gastroenteritis
|
5.9%
3/51 • Adverse Events: Up to 12 weeks plus 30 days; All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/51 • Adverse Events: Up to 12 weeks plus 30 days; All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Contusion
|
2.0%
1/51 • Adverse Events: Up to 12 weeks plus 30 days; All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.9%
3/51 • Adverse Events: Up to 12 weeks plus 30 days; All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/51 • Adverse Events: Up to 12 weeks plus 30 days; All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
7.8%
4/51 • Adverse Events: Up to 12 weeks plus 30 days; All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Headache
|
2.0%
1/51 • Adverse Events: Up to 12 weeks plus 30 days; All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
7.8%
4/51 • Adverse Events: Up to 12 weeks plus 30 days; All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/51 • Adverse Events: Up to 12 weeks plus 30 days; All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
7.8%
4/51 • Adverse Events: Up to 12 weeks plus 30 days; All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
7.8%
4/51 • Adverse Events: Up to 12 weeks plus 30 days; All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
2.0%
1/51 • Adverse Events: Up to 12 weeks plus 30 days; All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all 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