Trial Outcomes & Findings for Study to Investigate the Efficacy and Safety of Sofosbuvir/Velpatasvir (SOF/VEL) Fixed-Dose Combination (FDC) and Sofosbuvir/Velpatasvir/Voxilaprevir (SOF/VEL/VOX ) FDC for 12 Weeks in Adults With Chronic Hepatitis C Virus (HCV) Infection (NCT NCT04211909)
NCT ID: NCT04211909
Last Updated: 2021-10-27
Results Overview
SVR12 was defined as HCV RNA \< LLOQ (i.e., 15 IU/mL) at 12 weeks after stopping study treatment.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
87 participants
Primary outcome timeframe
Posttreatment Week 12
Results posted on
2021-10-27
Participant Flow
Participants were enrolled at study sites in South Korea. The first participant was screened on 03 January 2020. The last study visit occurred on 12 November 2020.
96 participants were screened.
Participant milestones
| Measure |
SOF/VEL
Participants with chronic hepatitis C virus (HCV) infection (genotype 1 or 2), who were treatment-naive or treatment-experienced with interferon (IFN)-based treatments received sofosbuvir/velpatasvir (SOF/VEL) (400/100 mg) fixed-dose combination (FDC) tablet orally once daily for 12 weeks.
|
SOF/VEL/VOX
Participants with chronic HCV infection (genotype 1 or 2), who were treatment-experienced with nonstructural protein 5A (NS5A) direct-acting antiviral (DAA)-based treatments of at least a 4 weeks duration received sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) (400/100/100 mg) FDC tablet orally once daily for 12 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
54
|
33
|
|
Overall Study
COMPLETED
|
54
|
33
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study to Investigate the Efficacy and Safety of Sofosbuvir/Velpatasvir (SOF/VEL) Fixed-Dose Combination (FDC) and Sofosbuvir/Velpatasvir/Voxilaprevir (SOF/VEL/VOX ) FDC for 12 Weeks in Adults With Chronic Hepatitis C Virus (HCV) Infection
Baseline characteristics by cohort
| Measure |
SOF/VEL
n=54 Participants
Participants with chronic HCV infection (genotype 1 or 2), who were treatment-naive or treatment-experienced with IFN-based treatments received SOF/VEL 400/100 mg FDC tablet orally once daily for 12 weeks.
|
SOF/VEL/VOX
n=33 Participants
Participants with chronic HCV infection (genotype 1 or 2), who were treatment-experienced with NS5A DAA-based treatments of at least a 4 weeks duration received SOF/VEL/VOX 400/100/100 mg FDC tablet orally once daily for 12 weeks.
|
Total
n=87 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
34 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
20 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
40 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
|
54 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
87 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
|
|
Race/Ethnicity, Customized
Ethnicity · Not Hispanic or Latino
|
53 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
86 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Not Permitted
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Interleukin-28B gene (IL28b) Status
CC
|
41 participants
n=5 Participants
|
23 participants
n=7 Participants
|
64 participants
n=5 Participants
|
|
Interleukin-28B gene (IL28b) Status
CT
|
13 participants
n=5 Participants
|
9 participants
n=7 Participants
|
22 participants
n=5 Participants
|
|
Interleukin-28B gene (IL28b) Status
TT
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Interleukin-28B gene (IL28b) Status
Missing
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
HCV RNA Category
< 800,000 IU/mL
|
24 participants
n=5 Participants
|
3 participants
n=7 Participants
|
27 participants
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
|
|
Genotype
Genotype 1
|
27 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
|
Genotype
Genotype 2
|
27 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Posttreatment Week 12Population: Full Analysis Set included all enrolled participants who took at least 1 dose of study drug and had detectable HCV RNA at baseline.
SVR12 was defined as HCV RNA \< LLOQ (i.e., 15 IU/mL) at 12 weeks after stopping study treatment.
Outcome measures
| Measure |
SOF/VEL
n=53 Participants
Participants with chronic HCV infection (genotype 1 or 2), who were treatment-naive or treatment-experienced with IFN-based treatments received SOF/VEL 400/100 mg FDC tablet orally once daily for 12 weeks.
|
SOF/VEL/VOX
n=33 Participants
Participants with chronic HCV infection (genotype 1 or 2), who were treatment-experienced with NS5A DAA-based treatments of at least a 4 weeks duration received SOF/VEL/VOX 400/100/100 mg FDC tablet orally once daily for 12 weeks.
|
|---|---|---|
|
Percentage of Participants With Sustained Virologic Response (SVR) < Lower Limit of Quantification (LLOQ) 12 Weeks After Discontinuation of Study Treatment
|
98.1 percentage of participants
Interval 89.9 to 100.0
|
100 percentage of participants
Interval 89.4 to 100.0
|
PRIMARY outcome
Timeframe: First dose date up to 12 weeks plus 30 daysPopulation: Safety Analysis Set included all participants who took at least 1 dose of the study drug.
Outcome measures
| Measure |
SOF/VEL
n=54 Participants
Participants with chronic HCV infection (genotype 1 or 2), who were treatment-naive or treatment-experienced with IFN-based treatments received SOF/VEL 400/100 mg FDC tablet orally once daily for 12 weeks.
|
SOF/VEL/VOX
n=33 Participants
Participants with chronic HCV infection (genotype 1 or 2), who were treatment-experienced with NS5A DAA-based treatments of at least a 4 weeks duration received SOF/VEL/VOX 400/100/100 mg FDC tablet orally once daily for 12 weeks.
|
|---|---|---|
|
Percentage of Participants Who Permanently Discontinued the Study Drug Due to an Adverse Event
|
1.9 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Posttreatment Week 4Population: Participants in the Full Analysis Set were analyzed.
SVR4 was defined as HCV RNA \< LLOQ (i.e.15 IU/mL) 4 weeks after stopping study treatment.
Outcome measures
| Measure |
SOF/VEL
n=53 Participants
Participants with chronic HCV infection (genotype 1 or 2), who were treatment-naive or treatment-experienced with IFN-based treatments received SOF/VEL 400/100 mg FDC tablet orally once daily for 12 weeks.
|
SOF/VEL/VOX
n=33 Participants
Participants with chronic HCV infection (genotype 1 or 2), who were treatment-experienced with NS5A DAA-based treatments of at least a 4 weeks duration received SOF/VEL/VOX 400/100/100 mg FDC tablet orally once daily for 12 weeks.
|
|---|---|---|
|
Percentage of Participants With SVR < LLOQ 4 Weeks After Discontinuation of Study Treatment
|
98.1 percentage of participants
Interval 89.9 to 100.0
|
100 percentage of participants
Interval 89.4 to 100.0
|
SECONDARY outcome
Timeframe: Baseline up to Posttreatment Week 12Population: Participants in the Full Analysis Set were analyzed.
Virologic failure was defined as: On-treatment virologic failure: * Breakthrough (HCV RNA ≥ LLOQ after having previously had HCV RNA \< LLOQ, while on treatment, confirmed with 2 consecutive values), 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 |
SOF/VEL
n=53 Participants
Participants with chronic HCV infection (genotype 1 or 2), who were treatment-naive or treatment-experienced with IFN-based treatments received SOF/VEL 400/100 mg FDC tablet orally once daily for 12 weeks.
|
SOF/VEL/VOX
n=33 Participants
Participants with chronic HCV infection (genotype 1 or 2), who were treatment-experienced with NS5A DAA-based treatments of at least a 4 weeks duration received SOF/VEL/VOX 400/100/100 mg FDC tablet orally once daily for 12 weeks.
|
|---|---|---|
|
Percentage of Participants With Virologic Failure
|
1.9 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Week 2, Week 4, Week 8, Week 12Population: Participants in the Full Analysis Set were analyzed.
LLOQ was 15 IU/mL.
Outcome measures
| Measure |
SOF/VEL
n=53 Participants
Participants with chronic HCV infection (genotype 1 or 2), who were treatment-naive or treatment-experienced with IFN-based treatments received SOF/VEL 400/100 mg FDC tablet orally once daily for 12 weeks.
|
SOF/VEL/VOX
n=33 Participants
Participants with chronic HCV infection (genotype 1 or 2), who were treatment-experienced with NS5A DAA-based treatments of at least a 4 weeks duration received SOF/VEL/VOX 400/100/100 mg FDC tablet orally once daily for 12 weeks.
|
|---|---|---|
|
Percentage of Participants With HCV RNA < LLOQ on Treatment
Week 2
|
90.6 percentage of participants
|
69.7 percentage of participants
|
|
Percentage of Participants With HCV RNA < LLOQ on Treatment
Week 4
|
100.0 percentage of participants
|
100.0 percentage of participants
|
|
Percentage of Participants With HCV RNA < LLOQ on Treatment
Week 8
|
100.0 percentage of participants
|
100.0 percentage of participants
|
|
Percentage of Participants With HCV RNA < LLOQ on Treatment
Week 12
|
100.0 percentage of participants
|
100.0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 2, Week 4, Week 8, Week 12Population: Participants in the Full Analysis Set with available data were analyzed.
Outcome measures
| Measure |
SOF/VEL
n=53 Participants
Participants with chronic HCV infection (genotype 1 or 2), who were treatment-naive or treatment-experienced with IFN-based treatments received SOF/VEL 400/100 mg FDC tablet orally once daily for 12 weeks.
|
SOF/VEL/VOX
n=33 Participants
Participants with chronic HCV infection (genotype 1 or 2), who were treatment-experienced with NS5A DAA-based treatments of at least a 4 weeks duration received SOF/VEL/VOX 400/100/100 mg FDC tablet orally once daily for 12 weeks.
|
|---|---|---|
|
Change From Baseline in HCV RNA
Baseline
|
5.95 log10 IU/mL
Standard Deviation 0.866
|
6.48 log10 IU/mL
Standard Deviation 0.354
|
|
Change From Baseline in HCV RNA
Change at Week 2
|
-4.78 log10 IU/mL
Standard Deviation 0.857
|
-5.19 log10 IU/mL
Standard Deviation 0.545
|
|
Change From Baseline in HCV RNA
Change at Week 4
|
-4.81 log10 IU/mL
Standard Deviation 0.866
|
-5.33 log10 IU/mL
Standard Deviation 0.354
|
|
Change From Baseline in HCV RNA
Change at Week 8
|
-4.79 log10 IU/mL
Standard Deviation 0.867
|
-5.33 log10 IU/mL
Standard Deviation 0.354
|
|
Change From Baseline in HCV RNA
Change at Week 12
|
-4.79 log10 IU/mL
Standard Deviation 0.867
|
-5.33 log10 IU/mL
Standard Deviation 0.354
|
SECONDARY outcome
Timeframe: Baseline, Week 2, Week 4, Week 8, Week 12Population: Participants in the Full Analysis Set with available data were analyzed.
Number of participants with ALT normalization, defined as ALT \> upper limit of normal (ULN) (ULN = 43 U/L) at baseline and ALT ≤ ULN, at each visit was presented.
Outcome measures
| Measure |
SOF/VEL
n=53 Participants
Participants with chronic HCV infection (genotype 1 or 2), who were treatment-naive or treatment-experienced with IFN-based treatments received SOF/VEL 400/100 mg FDC tablet orally once daily for 12 weeks.
|
SOF/VEL/VOX
n=33 Participants
Participants with chronic HCV infection (genotype 1 or 2), who were treatment-experienced with NS5A DAA-based treatments of at least a 4 weeks duration received SOF/VEL/VOX 400/100/100 mg FDC tablet orally once daily for 12 weeks.
|
|---|---|---|
|
Number of Participants With Alanine Aminotransferase (ALT) Normalization
Baseline (ALT>ULN)
|
21 participants
|
16 participants
|
|
Number of Participants With Alanine Aminotransferase (ALT) Normalization
Week 2 (ALT≤ ULN)
|
21 participants
|
13 participants
|
|
Number of Participants With Alanine Aminotransferase (ALT) Normalization
Week 4 (ALT≤ ULN)
|
21 participants
|
13 participants
|
|
Number of Participants With Alanine Aminotransferase (ALT) Normalization
Week 8 (ALT≤ ULN)
|
19 participants
|
13 participants
|
|
Number of Participants With Alanine Aminotransferase (ALT) Normalization
Week 12 (ALT≤ ULN)
|
17 participants
|
13 participants
|
Adverse Events
SOF/VEL
Serious events: 3 serious events
Other events: 5 other events
Deaths: 0 deaths
SOF/VEL/VOX
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
SOF/VEL
n=54 participants at risk
Participants with chronic HCV infection (genotype 1 or 2), who were treatment-naive or treatment-experienced with IFN-based treatments received SOF/VEL 400/100 mg FDC tablet orally once daily for 12 weeks.
|
SOF/VEL/VOX
n=33 participants at risk
Participants with chronic HCV infection (genotype 1 or 2), who were treatment-experienced with NS5A-DAA based treatments of at least a 4 weeks duration received SOF/VEL/VOX 400/100/100 mg FDC tablet orally once daily for 12 weeks.
|
|---|---|---|
|
Gastrointestinal disorders
Haematochezia
|
1.9%
1/54 • From first dose date up to 12 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/33 • From first dose date up to 12 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
General disorders
Pyrexia
|
1.9%
1/54 • From first dose date up to 12 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/33 • From first dose date up to 12 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.00%
0/54 • From first dose date up to 12 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
3.0%
1/33 • From first dose date up to 12 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Nervous system disorders
Cerebral infarction
|
1.9%
1/54 • From first dose date up to 12 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/33 • From first dose date up to 12 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Erythema nodosum
|
1.9%
1/54 • From first dose date up to 12 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/33 • From first dose date up to 12 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
Other adverse events
| Measure |
SOF/VEL
n=54 participants at risk
Participants with chronic HCV infection (genotype 1 or 2), who were treatment-naive or treatment-experienced with IFN-based treatments received SOF/VEL 400/100 mg FDC tablet orally once daily for 12 weeks.
|
SOF/VEL/VOX
n=33 participants at risk
Participants with chronic HCV infection (genotype 1 or 2), who were treatment-experienced with NS5A-DAA based treatments of at least a 4 weeks duration received SOF/VEL/VOX 400/100/100 mg FDC tablet orally once daily for 12 weeks.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
3.7%
2/54 • From first dose date up to 12 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
9.1%
3/33 • From first dose date up to 12 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Nervous system disorders
Headache
|
7.4%
4/54 • From first dose date up to 12 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
9.1%
3/33 • From first dose date up to 12 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/54 • From first dose date up to 12 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
9.1%
3/33 • From first dose date up to 12 weeks plus 30 days
The Safety Analysis Set included all participants who took 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