Hepatitis C Virus Infection
Conditions
Brief summary
The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of treatment with sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) for 12 weeks in adults with chronic hepatitis C virus (HCV) infection.
Interventions
DRUGSOF/VEL
400/100 mg FDC tablet(s) 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: * Willing and able to provide written informed consent * HCV RNA detected at screening * Chronic HCV infection (≥ 6 months) documented by medical history or liver biopsy * Classification as treatment naïve or treatment experienced. Approximately 20% may be treatment-experienced. * Cirrhosis determination (approximately 20% may have cirrhosis) * Females of childbearing potential must have a negative urine pregnancy test at Screening and on Day 1 prior to enrollment. * Male individuals and female individuals of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception as described in the study protocol * Lactating females must agree to discontinue nursing before the study drug is administered * Adults must be able to comply with the dosing instructions for study drug administration and able to complete the study schedule of assessments Key
Exclusion criteria
* Current or prior history of any of the following: * Clinically-significant illness (other than HCV) or any other major medical disorder that may interfere with individual's treatment, assessment or compliance with the protocol * Clinical hepatic decompensation (ie, ascites, encephalopathy or variceal hemorrhage) * Liver transplantation * Hepatocellular carcinoma (HCC) (as determined by appropriate imaging at screening for those with cirrhosis) or current malignancy for which the patient is receiving treatment or which may interfere with individual's treatment, assessment or compliance with the protocol. * Screening laboratory parameters outside of defined threshold * Prior exposure to HCV NS5A inhibitor * Pregnant or nursing female * Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV) * Use of any prohibited concomitant medications as described in study protocol * Known hypersensitivity to VEL, SOF, or formulation excipients 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; 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 Virologic Failure | Up to Posttreatment Week 12 | 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. |
Countries
India
Participant flow
Recruitment details
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.
Pre-assignment details
170 participants were screened.
Participants by arm
| Arm | Count |
|---|---|
| SOF/VEL 12 Weeks SOL/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks | 129 |
| Total | 129 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Enrolled but Not Treated | 1 |
| Overall Study | Lost to Follow-up | 5 |
| Overall Study | Withdrew Consent | 1 |
Baseline characteristics
| Characteristic | SOF/VEL 12 Weeks |
|---|---|
| Age, Continuous | 43 years STANDARD_DEVIATION 14 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 128 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| HCV Genotype Genotype 1 | 28 Participants |
| HCV Genotype Genotype 3 | 90 Participants |
| HCV Genotype Genotype 4 | 7 Participants |
| HCV Genotype Genotype 6 | 1 Participants |
| HCV Genotype Indeterminate | 3 Participants |
| HCV RNA | 5.9 log10 IU/mL STANDARD_DEVIATION 0.96 |
| HCV RNA Category < 800,000 IU/mL | 55 Participants |
| HCV RNA Category ≥ 800,000 IU/mL | 74 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 129 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Sex: Female, Male Female | 53 Participants |
| Sex: Female, Male Male | 76 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 129 |
| other Total, other adverse events | 0 / 129 |
| serious Total, serious adverse events | 1 / 129 |
Outcome results
Primary
Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
Time frame: Up to Week 12
Population: Safety Analysis Set included all participants who took at least 1 dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SOF/VEL 12 Weeks | 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 12 Weeks | Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) | 93.0 percentage of participants |
Comparison: The SVR12 rate was compared to the pre-specified performance goal of 85% by using a two-sided exact one-sample binomial test at the 0.05 significance level.p-value: 0.0092-sided exact 1-sample binomial test
Secondary
Percentage of Participants With Virologic Failure
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.
Time frame: Up to Posttreatment Week 12
Population: Participants in the Full Analysis Set were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SOF/VEL 12 Weeks | Percentage of Participants With Virologic Failure | 2.3 percentage of participants |