Hepatitis C Virus Infection
Conditions
Brief summary
The primary objectives of this study are to determine the efficacy, safety, and tolerability of treatment with sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) fixed-dose combination (FDC) for 12 weeks in participants with chronic hepatitis C virus (HCV) infection with or without cirrhosis, who did not achieve sustained viral response (SVR) after receiving prior treatment in a Gilead-sponsored HCV treatment study of direct-acting antiviral (DAA)-containing regimens.
Interventions
DRUGSOF/VEL/VOX
400/100/100 mg FDC tablet administered orally once daily with food
Sponsors
Gilead Sciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Chronically HCV-infected males and non-pregnant/non-lactating females aged 18 years or older who did not achieve sustained virologic response (SVR) in a prior Gilead-sponsored HCV treatment study Note: Other protocol defined Inclusion/
Exclusion criteria
may apply.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) | Posttreatment Week 12 | SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment. |
| Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event | Up to Week 12 | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4) | Posttreatment Week 4 | SVR4 was defined as HCV RNA \< LLOQ at 4 weeks after stopping study treatment. |
| Percentage of Participants With HCV RNA < LLOQ On Treatment | Weeks 2, 4, 8, and 12 | — |
| Percentage of Participants With Virologic Failure | Up to Posttreatment Week 12 | Virologic failure was defined as: * On-treatment virologic failure: * Breakthrough (confirmed HCV RNA ≥ LLOQ after 2 consecutive HCV RNA \< LLOQ), 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 |
| Change From Baseline in HCV RNA | Baseline; Weeks 2, 4, 8, and 12 | — |
Countries
Australia, Canada, France, Germany, New Zealand, United Kingdom, United States
Participant flow
Recruitment details
Participants were enrolled at study sites in North America, Europe, New Zealand, and Australia. The first participant was screened on 25 April 2017. The last study visit occurred on 19 March 2018.
Pre-assignment details
38 participants were screened.
Participants by arm
| Arm | Count |
|---|---|
| SOF/VEL/VOX SOF/VEL/VOX (400/100/100 mg) FDC tablet once daily for 12 weeks | 31 |
| Total | 31 |
Baseline characteristics
| Characteristic | SOF/VEL/VOX |
|---|---|
| Age, Continuous | 60 years STANDARD_DEVIATION 7.1 |
| Cirrhosis Status No | 16 Participants |
| Cirrhosis Status Yes | 15 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 29 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| HCV Genotype Genotype 1 | 19 Participants |
| HCV Genotype Genotype 2 | 2 Participants |
| HCV Genotype Genotype 3 | 8 Participants |
| HCV Genotype Genotype 4 | 1 Participants |
| HCV Genotype Genotype 5 | 1 Participants |
| HCV RNA Category < 800,000 IU/mL | 6 Participants |
| HCV RNA Category ≥ 800,000 IU/mL | 25 Participants |
| HCV RNA (log10 IU/mL) | 6.5 log10 IU/mL STANDARD_DEVIATION 0.56 |
| IL28b Status CC | 3 Participants |
| IL28b Status CT | 21 Participants |
| IL28b Status TT | 7 Participants |
| Race/Ethnicity, Customized Race Black or African American | 5 Participants |
| Race/Ethnicity, Customized Race Not Disclosed | 1 Participants |
| Race/Ethnicity, Customized Race White | 25 Participants |
| Region of Enrollment Australia | 2 Participants |
| Region of Enrollment Canada | 2 Participants |
| Region of Enrollment France | 1 Participants |
| Region of Enrollment Germany | 2 Participants |
| Region of Enrollment New Zealand | 3 Participants |
| Region of Enrollment United Kingdom | 1 Participants |
| Region of Enrollment United States | 20 Participants |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 31 |
| other Total, other adverse events | 17 / 31 |
| serious Total, serious adverse events | 1 / 31 |
Outcome results
Primary
Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
Time frame: Up to Week 12
Population: Participants in the Safety Analysis Set were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SOF/VEL/VOX | Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event | 0 percentage of participants |
Primary
Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.
Time frame: Posttreatment Week 12
Population: Full Analysis Set included all enrolled participants who took at least 1 dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SOF/VEL/VOX | Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) | 100.0 percentage of participants |
Secondary
Change From Baseline in HCV RNA
Time frame: Baseline; Weeks 2, 4, 8, and 12
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SOF/VEL/VOX | Change From Baseline in HCV RNA | Change at Week 4 | -5.34 log10 IU/mL | Standard Deviation 0.571 |
| SOF/VEL/VOX | Change From Baseline in HCV RNA | Change at Week 2 | -5.16 log10 IU/mL | Standard Deviation 0.56 |
| SOF/VEL/VOX | Change From Baseline in HCV RNA | Change at Week 8 | -5.34 log10 IU/mL | Standard Deviation 0.563 |
| SOF/VEL/VOX | Change From Baseline in HCV RNA | Change at Week 12 | -5.34 log10 IU/mL | Standard Deviation 0.563 |
Secondary
Percentage of Participants With HCV RNA < LLOQ On Treatment
Time frame: Weeks 2, 4, 8, and 12
Population: Participants in the Full Analysis Set were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SOF/VEL/VOX | Percentage of Participants With HCV RNA < LLOQ On Treatment | Week 12 | 100.0 percentage of participants |
| SOF/VEL/VOX | Percentage of Participants With HCV RNA < LLOQ On Treatment | Week 2 | 51.6 percentage of participants |
| SOF/VEL/VOX | Percentage of Participants With HCV RNA < LLOQ On Treatment | Week 4 | 96.8 percentage of participants |
| SOF/VEL/VOX | Percentage of Participants With HCV RNA < LLOQ On Treatment | Week 8 | 100.0 percentage of participants |
Secondary
Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4)
SVR4 was defined as HCV RNA \< LLOQ at 4 weeks after stopping study treatment.
Time frame: Posttreatment Week 4
Population: Participants in the Full Analysis Set were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SOF/VEL/VOX | Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4) | 100.0 percentage of participants |
Secondary
Percentage of Participants With Virologic Failure
Virologic failure was defined as: * On-treatment virologic failure: * Breakthrough (confirmed HCV RNA ≥ LLOQ after 2 consecutive HCV RNA \< LLOQ), 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
Time frame: Up to Posttreatment Week 12
Population: Participants in the Full Analysis Set were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SOF/VEL/VOX | Percentage of Participants With Virologic Failure | 0 percentage of participants |