Trial Outcomes & Findings for Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks in Adults With Chronic Hepatitis C Virus (HCV) Infection (NCT NCT03074331)
NCT ID: NCT03074331
Last Updated: 2019-03-19
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.
COMPLETED
PHASE3
130 participants
Posttreatment Week 12
2019-03-19
Participant Flow
Participants were enrolled at study sites in India. The first participant was screened on 23 March 2017. The last study visit occurred on 07 February 2018.
170 participants were screened.
Participant milestones
| Measure |
SOF/VEL 12 Weeks
Sofosbuvir/velpatasvir (SOL/VEL) (400/100 mg) fixed-dose combination (FDC) tablet orally once daily for 12 weeks
|
|---|---|
|
Overall Study
STARTED
|
130
|
|
Overall Study
COMPLETED
|
123
|
|
Overall Study
NOT COMPLETED
|
7
|
Reasons for withdrawal
| Measure |
SOF/VEL 12 Weeks
Sofosbuvir/velpatasvir (SOL/VEL) (400/100 mg) fixed-dose combination (FDC) tablet orally once daily for 12 weeks
|
|---|---|
|
Overall Study
Enrolled but Not Treated
|
1
|
|
Overall Study
Lost to Follow-up
|
5
|
|
Overall Study
Withdrew Consent
|
1
|
Baseline Characteristics
Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks in Adults With Chronic Hepatitis C Virus (HCV) Infection
Baseline characteristics by cohort
| Measure |
SOF/VEL 12 Weeks
n=129 Participants
SOL/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks
|
|---|---|
|
Age, Continuous
|
43 years
STANDARD_DEVIATION 14.0 • n=99 Participants
|
|
Sex: Female, Male
Female
|
53 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
76 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
128 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
129 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
HCV Genotype
Genotype 1
|
28 Participants
n=99 Participants
|
|
HCV Genotype
Genotype 3
|
90 Participants
n=99 Participants
|
|
HCV Genotype
Genotype 4
|
7 Participants
n=99 Participants
|
|
HCV Genotype
Genotype 6
|
1 Participants
n=99 Participants
|
|
HCV Genotype
Indeterminate
|
3 Participants
n=99 Participants
|
|
HCV RNA
|
5.9 log10 IU/mL
STANDARD_DEVIATION 0.96 • n=99 Participants
|
|
HCV RNA Category
< 800,000 IU/mL
|
55 Participants
n=99 Participants
|
|
HCV RNA Category
≥ 800,000 IU/mL
|
74 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Posttreatment Week 12Population: Full Analysis Set included all enrolled participants who took 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 12 Weeks
n=129 Participants
SOL/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks
|
|---|---|
|
Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
|
93.0 percentage of participants
Interval 87.2 to 96.8
|
PRIMARY outcome
Timeframe: Up to Week 12Population: Safety Analysis Set included all participants who took at least 1 dose of study drug.
Outcome measures
| Measure |
SOF/VEL 12 Weeks
n=129 Participants
SOL/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks
|
|---|---|
|
Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Up to Posttreatment Week 12Population: Participants in the Full Analysis Set were analyzed.
Virologic failure was defined as the following: * On Treatment Virologic Failure: HCV RNA persistently ≥ LLOQ through 12 weeks of treatment (nonresponse), or * Relapse: HCV RNA ≥ LLOQ at Posttreatment Week 12 having achieved HCV RNA \< LLOQ at end of treatment.
Outcome measures
| Measure |
SOF/VEL 12 Weeks
n=129 Participants
SOL/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks
|
|---|---|
|
Percentage of Participants With Virologic Failure
|
2.3 percentage of participants
|
Adverse Events
SOF/VEL 12 Weeks
Serious adverse events
| Measure |
SOF/VEL 12 Weeks
n=129 participants at risk
SOL/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks
|
|---|---|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.78%
1/129 • Adverse Events: Up to 12 plus 30 days; All-Cause Mortality: Up to Posttreatment Week 12
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
Other adverse events
Adverse event data not reported
Additional Information
Gilead Clinical Study Information Center
Gilead Sciences
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