Hepatitis C Virus Infection
Conditions
Brief summary
The primary objective of this study is to evaluate the efficacy, safety, and tolerability of treatment with sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) for 12 weeks in participants with chronic hepatitis C virus (HCV) infection.
Interventions
DRUGSOF/VEL
400/100 mg FDC tablet administered orally once daily
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: * HCV RNA ≥ 10\^4 IU/mL at screening * Chronic HCV infection (≥ 6 months) documented by prior medical history or liver biopsy Key
Exclusion criteria
* Any other chronic liver disease * Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV) * Clinical hepatic decompensation * Prior exposure to SOF or other nucleotide analogue HCV NS5B inhibitor or any HCV NS5A inhibitor Note: Other protocol defined Inclusion/
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) at 12 weeks after stopping study treatment. |
| Percentage of Participants Who Permanently Discontinued Study Drug Due to an Adverse Event | Up to 12 weeks | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With HCV RNA < LLOQ on Treatment at Week 1 | Week 1 | — |
| Percentage of Participants With HCV RNA < LLOQ on Treatment at Week 2 | Week 2 | — |
| Percentage of Participants With HCV RNA < LLOQ on Treatment at Week 4 | Week 4 | — |
| Percentage of Participants With HCV RNA < LLOQ on Treatment at Week 8 | Week 8 | — |
| Percentage of Participants With HCV RNA < LLOQ on Treatment at Week 12 | Week 12 | — |
| Percentage of Participants With HCV RNA < LLOQ 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. |
| Change From Baseline in HCV RNA at Week 2 | Baseline (Day 1); Week 2 | — |
| Change From Baseline in HCV RNA at Week 4 | Baseline (Day 1); Week 4 | — |
| Change From Baseline in HCV RNA at Week 8 | Baseline (Day 1); Week 8 | — |
| Change From Baseline in HCV RNA at Week 12 | Baseline (Day 1); Week 12 | — |
| Percentage of Participants With Virologic Failure | Up to Posttreatment Week 24 | 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) |
| Change From Baseline in HCV RNA at Week 1 | Baseline (Day 1); Week 1 | — |
| Percentage of Participants With HCV RNA < LLOQ at 24 Weeks After Discontinuation of Therapy (SVR24) | Posttreatment Week 24 | SVR24 was defined as HCV RNA \< LLOQ at 24 weeks after stopping study treatment. |
Countries
Russia, Sweden
Participant flow
Recruitment details
Participants were enrolled at study sites in the Russian Federation and Sweden. The first participant was screened on 04 April 2016 and the last study visit occurred on 13 September 2017.
Pre-assignment details
122 participants were screened.
Participants by arm
| Arm | Count |
|---|---|
| SOF/VEL SOF/VEL (400/100 mg) FDC tablet administered orally once daily for 12 weeks, with or without food | 119 |
| Total | 119 |
Baseline characteristics
| Characteristic | SOF/VEL |
|---|---|
| Age, Continuous | 44 years STANDARD_DEVIATION 11.1 |
| HCV RNA | 6.1 log10 IU/mL STANDARD_DEVIATION 0.54 |
| HCV RNA Category < 800,000 IU/mL | 38 Participants |
| HCV RNA Category ≥ 800,000 IU/mL | 81 Participants |
| IL28b Status CC | 29 Participants |
| IL28b Status CT | 72 Participants |
| IL28b Status TT | 18 Participants |
| Race/Ethnicity, Customized Asian | 2 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 0 Participants |
| Race/Ethnicity, Customized Not Hispanic or Latino | 119 Participants |
| Race/Ethnicity, Customized White | 117 Participants |
| Region of Enrollment Russia | 103 Participants |
| Region of Enrollment Sweden | 16 Participants |
| Sex: Female, Male Female | 59 Participants |
| Sex: Female, Male Male | 60 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 119 |
| other Total, other adverse events | 29 / 119 |
| serious Total, serious adverse events | 4 / 119 |
Outcome results
Primary
Percentage of Participants Who Permanently Discontinued Study Drug Due to an Adverse Event
Time frame: Up to 12 weeks
Population: Safety analysis Set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SOF/VEL | Percentage of Participants Who Permanently Discontinued 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) at 12 weeks after stopping study treatment.
Time frame: Posttreatment Week 12
Population: Full Analysis Set: participants who received at least 1 dose of study drug
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SOF/VEL | Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) | 99.2 percentage of participants |
Secondary
Change From Baseline in HCV RNA at Week 1
Time frame: Baseline (Day 1); Week 1
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SOF/VEL | Change From Baseline in HCV RNA at Week 1 | -4.17 log10 IU/mL | Standard Deviation 0.502 |
Secondary
Change From Baseline in HCV RNA at Week 12
Time frame: Baseline (Day 1); Week 12
Population: Full Analysis Set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SOF/VEL | Change From Baseline in HCV RNA at Week 12 | -4.93 log10 IU/mL | Standard Deviation 0.544 |
Secondary
Change From Baseline in HCV RNA at Week 2
Time frame: Baseline (Day 1); Week 2
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SOF/VEL | Change From Baseline in HCV RNA at Week 2 | -4.70 log10 IU/mL | Standard Deviation 0.525 |
Secondary
Change From Baseline in HCV RNA at Week 4
Time frame: Baseline (Day 1); Week 4
Population: Full Analysis Set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SOF/VEL | Change From Baseline in HCV RNA at Week 4 | -4.90 log10 IU/mL | Standard Deviation 0.54 |
Secondary
Change From Baseline in HCV RNA at Week 8
Time frame: Baseline (Day 1); Week 8
Population: Full Analysis Set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SOF/VEL | Change From Baseline in HCV RNA at Week 8 | -4.93 log10 IU/mL | Standard Deviation 0.544 |
Secondary
Percentage of Participants With HCV RNA < LLOQ at 24 Weeks After Discontinuation of Therapy (SVR24)
SVR24 was defined as HCV RNA \< LLOQ at 24 weeks after stopping study treatment.
Time frame: Posttreatment Week 24
Population: Full Analysis Set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SOF/VEL | Percentage of Participants With HCV RNA < LLOQ at 24 Weeks After Discontinuation of Therapy (SVR24) | 99.2 percentage of participants |
Secondary
Percentage of Participants With HCV RNA < LLOQ 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: Full Analysis Set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SOF/VEL | Percentage of Participants With HCV RNA < LLOQ at 4 Weeks After Discontinuation of Therapy (SVR4) | 100.0 percentage of participants |
Secondary
Percentage of Participants With HCV RNA < LLOQ on Treatment at Week 1
Time frame: Week 1
Population: Full Analysis Set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SOF/VEL | Percentage of Participants With HCV RNA < LLOQ on Treatment at Week 1 | 21.0 percentage of participants |
Secondary
Percentage of Participants With HCV RNA < LLOQ on Treatment at Week 12
Time frame: Week 12
Population: Full Analysis Set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SOF/VEL | Percentage of Participants With HCV RNA < LLOQ on Treatment at Week 12 | 100.0 percentage of participants |
Secondary
Percentage of Participants With HCV RNA < LLOQ on Treatment at Week 2
Time frame: Week 2
Population: Full Analysis Set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SOF/VEL | Percentage of Participants With HCV RNA < LLOQ on Treatment at Week 2 | 64.7 percentage of participants |
Secondary
Percentage of Participants With HCV RNA < LLOQ on Treatment at Week 4
Time frame: Week 4
Population: Full analysis set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SOF/VEL | Percentage of Participants With HCV RNA < LLOQ on Treatment at Week 4 | 96.6 percentage of participants |
Secondary
Percentage of Participants With HCV RNA < LLOQ on Treatment at Week 8
Time frame: Week 8
Population: Full Analysis Set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SOF/VEL | Percentage of Participants With HCV RNA < LLOQ on Treatment at Week 8 | 100.0 percentage of participants |
Secondary
Percentage of Participants With Virologic Failure
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)
Time frame: Up to Posttreatment Week 24
Population: Full Analysis Set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SOF/VEL | Percentage of Participants With Virologic Failure | 0.8 percentage of participants |