Trial Outcomes & Findings for Study to Investigate the Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed-Dose Combination for 12 Weeks in Adults With Chronic HCV Infection and Compensated Cirrhosis (NCT NCT04112303)
NCT ID: NCT04112303
Last Updated: 2022-04-20
Results Overview
SVR12 was defined as hepatitis C virus ribonucleic acid (HCV RNA) \< LLOQ (i.e., 15 IU/mL) at 12 weeks after stopping study treatment.
COMPLETED
PHASE3
37 participants
Posttreatment Week 12
2022-04-20
Participant Flow
Participants were enrolled at study sites in Japan. The first participant was screened on 16 October 2019. The last study visit occurred on 25 June 2021.
41 participants were screened.
Participant milestones
| Measure |
SOF/VEL
Participants received sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) (400/100 mg) tablet orally once daily for up to 12 weeks.
|
|---|---|
|
Overall Study
STARTED
|
37
|
|
Overall Study
COMPLETED
|
36
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
SOF/VEL
Participants received sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) (400/100 mg) tablet orally once daily for up to 12 weeks.
|
|---|---|
|
Overall Study
Death
|
1
|
Baseline Characteristics
Study to Investigate the Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed-Dose Combination for 12 Weeks in Adults With Chronic HCV Infection and Compensated Cirrhosis
Baseline characteristics by cohort
| Measure |
SOF/VEL
n=37 Participants
Participants received SOF/VEL FDC (400/100 mg) tablet orally once daily for up to 12 weeks.
|
|---|---|
|
Age, Continuous
|
65 years
STANDARD_DEVIATION 11.4 • n=99 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
37 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
|
37 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
|
|
Region of Enrollment
Japan
|
37 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 hepatitis C virus ribonucleic acid (HCV RNA) \< LLOQ (i.e., 15 IU/mL) at 12 weeks after stopping study treatment.
Outcome measures
| Measure |
SOF/VEL
n=37 Participants
Participants received SOF/VEL FDC (400/100 mg) tablet orally once daily for up to 12 weeks.
|
|---|---|
|
Percentage of Participants With Sustained Virologic Response (SVR) < Lower Limit of Quantification (LLOQ) 12 Weeks After Discontinuation of Treatment (SVR12)
|
100.0 percentage of participants
Interval 90.5 to 100.0
|
PRIMARY outcome
Timeframe: First dose date up to Week 12.1Population: Participants in the Safety Analysis Set were analyzed.
TEAEs were defined as any AEs with an onset date on or after the study drug start and no later than 30 days after permanent discontinuation of study drug and/or any AEs leading to premature discontinuation of the study drug.
Outcome measures
| Measure |
SOF/VEL
n=37 Participants
Participants received SOF/VEL FDC (400/100 mg) tablet orally once daily for up to 12 weeks.
|
|---|---|
|
Percentage of Participants Who Experienced Any Treatment-Emergent Adverse Event (TEAE) Leading to Discontinuation of Study Drug
|
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) at 4 weeks after stopping study treatment.
Outcome measures
| Measure |
SOF/VEL
n=37 Participants
Participants received SOF/VEL FDC (400/100 mg) tablet orally once daily for up to 12 weeks.
|
|---|---|
|
Percentage of Participants With HCV RNA < LLOQ at 4 Weeks After Discontinuation of Treatment (SVR4)
|
100.0 percentage of participants
Interval 90.5 to 100.0
|
SECONDARY outcome
Timeframe: Posttreatment Week 24Population: Participants in the Full Analysis Set were analyzed.
SVR24 was defined as HCV RNA \< LLOQ (i.e.15 IU/mL) at 24 weeks after stopping study treatment.
Outcome measures
| Measure |
SOF/VEL
n=37 Participants
Participants received SOF/VEL FDC (400/100 mg) tablet orally once daily for up to 12 weeks.
|
|---|---|
|
Percentage of Participants With HCV RNA < LLOQ at 24 Weeks After Discontinuation of Treatment (SVR24)
|
100.0 percentage of participants
Interval 90.5 to 100.0
|
SECONDARY outcome
Timeframe: First dose date up to posttreatment Week 24Population: Participants in the Full Analysis Set 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 IL/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 end of treatment.
Outcome measures
| Measure |
SOF/VEL
n=37 Participants
Participants received SOF/VEL FDC (400/100 mg) tablet orally once daily for up to 12 weeks.
|
|---|---|
|
Percentage of Participants With Virologic Failure
|
0 percentage of participants
|
Adverse Events
SOF/VEL
Serious adverse events
| Measure |
SOF/VEL
n=37 participants at risk
Participants received sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) (400/100 mg) tablet orally once daily for up to 12 weeks.
|
|---|---|
|
Injury, poisoning and procedural complications
Patella fracture
|
2.7%
1/37 • All-Cause Mortality: Enrollment to Posttreatment Week 24; Adverse Events: First dose date up to Week 12.1 plus 30 days
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
Other adverse events
| Measure |
SOF/VEL
n=37 participants at risk
Participants received sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) (400/100 mg) tablet orally once daily for up to 12 weeks.
|
|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
5.4%
2/37 • All-Cause Mortality: Enrollment to Posttreatment Week 24; Adverse Events: First dose date up to Week 12.1 plus 30 days
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Nervous system disorders
Headache
|
8.1%
3/37 • All-Cause Mortality: Enrollment to Posttreatment Week 24; Adverse Events: First dose date up to Week 12.1 plus 30 days
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
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