Hepatitis C Virus Infection
Conditions
Brief summary
The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of the treatment with sofosbuvir velpatasvir (SOF/VEL) fixed-dose combination (FDC) with ribavirin (RBV) for 12 weeks in participants with chronic hepatitis C virus (HCV) infection and Child-Pugh-Turcotte (CPT) Class C cirrhosis.
Interventions
DRUGSOF/VEL
400/100 mg FDC tablet administered orally once daily
DRUGRBV
Tablets administered orally at 600 mg, if well tolerated then up to a maximum total daily dose of 1000 to 1200 mg (based on weight) divided twice 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: * A body mass index (BMI) of ≥ 18 kg/m\^2 * Chronic HCV infection (≥ 6 months) as documented by either prior medical history or liver biopsy * Quantifiable HCV RNA at screening * Individuals may be non-transplanted or with recurrent HCV post-liver transplant. * If listed for liver transplant, then the projected date of transplant must be ≥12 weeks after Day1 of treatment * If post-liver transplant, then Day1 must be ≥ 6 months from date of transplant * CPT score of 10 to 12, inclusive, as determined at screening * Liver imaging within 6 months of Day 1 to exclude hepatocellular carcinoma (HCC) * If treatment-experienced, the most recent HCV treatment must have been completed at least 8 weeks prior to Screening * Females of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test on Day 1 prior to randomization * Males and females of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception * Females must agree to refrain from egg donation and in vitro fertilization during treatment until at least 30 days after the last dose of SOF/VEL or 6 months after the last dose of RBV, whichever occurs last * Lactating females must agree to discontinue nursing before the study drugs are administered * Males must agree to refrain from sperm donation from the date of screening until at least 7 months after the last dose of RBV or 30 days after the last dose of SOF/VEL, whichever occurs last * 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 medical or psychiatric illness or individual is currently under evaluation for a potentially clinically significant illness * Gastrointestinal disorder or post-operative condition that could interfere with the absorption of the study drug * Difficulty with blood collection and/or poor venous access for the purposes of phlebotomy * Significant pulmonary disease, significant cardiac disease or porphyria * Malignancy within the 5 years prior to screening, with the exception of specific cancers that have been cured by surgical resection (basal cell skin cancer, etc.). Adults under evaluation for possible malignancy are not eligible * Significant drug allergy (such as anaphylaxis or hepatotoxicity) * Any history of organ transplant other than liver or kidney * Chronic liver disease of a non-HCV etiology * Inability to exclude HCC by imaging within 6 months of Day 1 * Alpha-fetoprotein (AFP) \> 50 unless negative imaging for hepatic masses within the last 6 months or during screening * Active spontaneous bacterial peritonitis at screening * Infection requiring systemic antibiotics at the time of screening * Evidence of fibrosing cholestatic hepatitis at screening * Life threatening serious adverse event (SAE) during screening * Active variceal bleeding within 6 months of screening * Prior placement of a portosystemic shunt (such as TIPS) * ECG with clinically significant abnormalities * Laboratory parameters with clinically significant abnormalities * Hepatitis B surface antigen positive at screening * Infection with human immunodeficiency virus (HIV) * Clinically-relevant alcohol or drug abuse within 12 months of screening. A positive drug screen will exclude individuals unless it can be explained by a prescribed medication; the diagnosis and prescription must be approved by the Investigator * Prior exposure to any HCV Non-structural Protein 5A (NS5A) inhibitor * Current use of corticosteroids at any dose \>10 mg of prednisone/day (or equivalent dose of corticosteroid) * Use of any prohibited concomitant medications * Use of granulocyte macrophage colony-stimulating factor (GM-CSF), epoetin alfa or other hematopoietic stimulating agents within 2 weeks of screening * Male with pregnant female partner * History of clinically significant hemoglobinopathy (eg, sickle cell disease, thalassemia) * Contraindications to RBV therapy * Known hypersensitivity to VEL, RBV, SOF, the metabolites, or formulation excipients * Participation in a clinical study with an investigational drug or biologic within 3 months prior to Day 1 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 Study Drug (SOF/VEL or RBV) Due to an Adverse Event | First dose date up to Week 12 | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Sustained Virologic Response 4 Weeks After Discontinuation of Therapy (SVR4) | Posttreatment Week 4 | SVR4 was defined as HCV RNA \< LLOQ 4 weeks after stopping study treatment. |
| Percentage of Participants With HCV RNA < LLOQ While on Study Treatment | Weeks 2, 4, 8, and 12 | — |
| Percentage of Participants With No Change, Improved, and Worsened Child-Pugh-Turcotte (CPT) Class | Baseline to Posttreatment Week 24 | CPT is a chronic liver disease classification system. Classes include CPT Class A, CPT Class B, and CPT Class C, in order of greater disease severity. Participants with improved CPT class was defined as having Class C at Baseline and Class B or A at Posttreatment Week 24 or Class B at Baseline and Class A at Posttreatment Week 24. Participants with worsened CPT class was defined as having Class A at Baseline and Class B or C at Posttreatment Week 24 or Class B at Baseline and Class C at Posttreatment Week 24. Participants with no change CPT class was defined as having CPT Class same between Baseline and Posttreatment Week 24. |
| Absolute HCV RNA Level Through Week 12 | Baseline; Weeks 2, 4, 8, and 12 | — |
| Change From Baseline in HCV RNA | Baseline; Weeks 2, 4, 8, and 12 | — |
| Number of Participants With Virologic Failure | Baseline up to Posttreatment Week 24 | 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 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 |
| Percentage of Participants With a Decrease, No Change, or Increase in Model for End Stage Liver Disease (MELD) Score | Baseline to Posttreatment Week 24 | MELD score is a chronic liver disease severity scoring system. Scores can range from 6 to 40, with higher scores indicating greater disease severity. No change was assigned for differences (posttreatment visits minus baseline score) of -1, 0 or 1; Decrease was assigned for differences that were less than or equal to -2; and Increase was assigned for values that were greater than or equal to 2. |
| Percentage of Participants With Sustained Virologic Response 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
France, United States
Participant flow
Recruitment details
Participants were enrolled at study sites in the United States and France. The first participant was screened on 23 January 2017. The last study visit occurred on 12 December 2018.
Pre-assignment details
73 participants were screened.
Participants by arm
| Arm | Count |
|---|---|
| SOF/VEL+ RBV SOF/VEL (400/100 mg) FDC tablet once daily + RBV tablet (600-1200 mg based on weight) divided twice daily for 12 weeks in participants with HCV infection and CPT Class C cirrhosis | 32 |
| Total | 32 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 8 |
| Overall Study | Withdrew Consent | 1 |
Baseline characteristics
| Characteristic | SOF/VEL+ RBV |
|---|---|
| Age, Continuous | 55 years STANDARD_DEVIATION 7 |
| Child-Pugh-Turcotte Class CPT B [7-9] | 9 Participants |
| Child-Pugh-Turcotte Class CPT C [10-15] | 23 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 7 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 19 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 6 Participants |
| HCV RNA | 5.2 log10 IU/mL STANDARD_DEVIATION 1.19 |
| HCV RNA Category < 800,000 IU/mL | 23 Participants |
| HCV RNA Category ≥ 800,000 IU/mL | 9 Participants |
| IL28B CC | 15 Participants |
| IL28B CT | 14 Participants |
| IL28B TT | 3 Participants |
| Model for End Stage Liver Disease (MELD) Score Category 10-15 MELD Score | 13 Participants |
| Model for End Stage Liver Disease (MELD) Score Category 16-20 MELD Score | 17 Participants |
| Model for End Stage Liver Disease (MELD) Score Category 21-25 MELD Score | 2 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 1 Participants |
| Race/Ethnicity, Customized Black or African American Native | 6 Participants |
| Race/Ethnicity, Customized Not Permitted | 6 Participants |
| Race/Ethnicity, Customized Other | 1 Participants |
| Race/Ethnicity, Customized White | 18 Participants |
| Region of Enrollment France | 6 participants |
| Region of Enrollment United States | 26 participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 8 / 32 |
| other Total, other adverse events | 27 / 32 |
| serious Total, serious adverse events | 17 / 32 |
Outcome results
Primary
Percentage of Participants Who Permanently Discontinued Study Drug (SOF/VEL or RBV) Due to an Adverse Event
Time frame: First dose date up to Week 12
Population: The Safety Analysis Set included all participants who took at least 1 dose of study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SOF/VEL+ RBV (Total) | Percentage of Participants Who Permanently Discontinued Study Drug (SOF/VEL or RBV) Due to an Adverse Event | Discontinuation of SOF/VEL | 6.3 percentage of participants |
| SOF/VEL+ RBV (Total) | Percentage of Participants Who Permanently Discontinued Study Drug (SOF/VEL or RBV) Due to an Adverse Event | Discontinuation of RBV | 21.9 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: The Full Analysis Set included all enrolled participants who took at least 1 dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SOF/VEL+ RBV (Total) | Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) | 78.1 percentage of participants |
| SOF/VEL+ RBV (GT-1) | Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) | 72.2 percentage of participants |
| SOF/VEL+ RBV (GT-2) | Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) | 80.0 percentage of participants |
| SOF/VEL+ RBV (GT-3) | Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) | 85.7 percentage of participants |
Secondary
Absolute HCV RNA Level Through Week 12
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+ RBV (Total) | Absolute HCV RNA Level Through Week 12 | Week 8 | 1.15 log10 IU/mL | Standard Deviation 0 |
| SOF/VEL+ RBV (Total) | Absolute HCV RNA Level Through Week 12 | Week 2 | 1.46 log10 IU/mL | Standard Deviation 0.392 |
| SOF/VEL+ RBV (Total) | Absolute HCV RNA Level Through Week 12 | Week 12 | 1.15 log10 IU/mL | Standard Deviation 0 |
| SOF/VEL+ RBV (Total) | Absolute HCV RNA Level Through Week 12 | Week 4 | 1.15 log10 IU/mL | Standard Deviation 0 |
| SOF/VEL+ RBV (Total) | Absolute HCV RNA Level Through Week 12 | Baseline | 5.17 log10 IU/mL | Standard Deviation 1.187 |
| SOF/VEL+ RBV (GT-1) | Absolute HCV RNA Level Through Week 12 | Week 4 | 1.15 log10 IU/mL | Standard Deviation 0 |
| SOF/VEL+ RBV (GT-1) | Absolute HCV RNA Level Through Week 12 | Week 8 | 1.15 log10 IU/mL | Standard Deviation 0 |
| SOF/VEL+ RBV (GT-1) | Absolute HCV RNA Level Through Week 12 | Week 12 | 1.15 log10 IU/mL | Standard Deviation 0 |
| SOF/VEL+ RBV (GT-1) | Absolute HCV RNA Level Through Week 12 | Week 2 | 1.47 log10 IU/mL | Standard Deviation 0.387 |
| SOF/VEL+ RBV (GT-1) | Absolute HCV RNA Level Through Week 12 | Baseline | 5.46 log10 IU/mL | Standard Deviation 0.537 |
| SOF/VEL+ RBV (GT-2) | Absolute HCV RNA Level Through Week 12 | Week 4 | 1.15 log10 IU/mL | Standard Deviation 0 |
| SOF/VEL+ RBV (GT-2) | Absolute HCV RNA Level Through Week 12 | Baseline | 6.01 log10 IU/mL | Standard Deviation 0.502 |
| SOF/VEL+ RBV (GT-2) | Absolute HCV RNA Level Through Week 12 | Week 2 | 1.63 log10 IU/mL | Standard Deviation 0.15 |
| SOF/VEL+ RBV (GT-2) | Absolute HCV RNA Level Through Week 12 | Week 8 | 1.15 log10 IU/mL | Standard Deviation 0 |
| SOF/VEL+ RBV (GT-2) | Absolute HCV RNA Level Through Week 12 | Week 12 | 1.15 log10 IU/mL | Standard Deviation 0 |
| SOF/VEL+ RBV (GT-3) | Absolute HCV RNA Level Through Week 12 | Week 8 | 1.15 log10 IU/mL | Standard Deviation 0 |
| SOF/VEL+ RBV (GT-3) | Absolute HCV RNA Level Through Week 12 | Week 2 | 1.43 log10 IU/mL | Standard Deviation 0.526 |
| SOF/VEL+ RBV (GT-3) | Absolute HCV RNA Level Through Week 12 | Baseline | 4.84 log10 IU/mL | Standard Deviation 1.058 |
| SOF/VEL+ RBV (GT-3) | Absolute HCV RNA Level Through Week 12 | Week 4 | 1.15 log10 IU/mL | Standard Deviation 0 |
| SOF/VEL+ RBV (GT-3) | Absolute HCV RNA Level Through Week 12 | Week 12 | 1.15 log10 IU/mL | Standard Deviation 0 |
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+ RBV (Total) | Change From Baseline in HCV RNA | Change at Week 8 | -4.00 log10 IU/mL | Standard Deviation 1.217 |
| SOF/VEL+ RBV (Total) | Change From Baseline in HCV RNA | Change at Week 12 | -4.00 log10 IU/mL | Standard Deviation 1.217 |
| SOF/VEL+ RBV (Total) | Change From Baseline in HCV RNA | Change at Week 4 | -3.99 log10 IU/mL | Standard Deviation 1.238 |
| SOF/VEL+ RBV (Total) | Change From Baseline in HCV RNA | Change at Week 2 | -3.72 log10 IU/mL | Standard Deviation 1.092 |
| SOF/VEL+ RBV (GT-1) | Change From Baseline in HCV RNA | Change at Week 4 | -4.39 log10 IU/mL | Standard Deviation 0.52 |
| SOF/VEL+ RBV (GT-1) | Change From Baseline in HCV RNA | Change at Week 12 | -4.39 log10 IU/mL | Standard Deviation 0.52 |
| SOF/VEL+ RBV (GT-1) | Change From Baseline in HCV RNA | Change at Week 2 | -4.06 log10 IU/mL | Standard Deviation 0.531 |
| SOF/VEL+ RBV (GT-1) | Change From Baseline in HCV RNA | Change at Week 8 | -4.39 log10 IU/mL | Standard Deviation 0.52 |
| SOF/VEL+ RBV (GT-2) | Change From Baseline in HCV RNA | Change at Week 4 | -4.88 log10 IU/mL | Standard Deviation 0.395 |
| SOF/VEL+ RBV (GT-2) | Change From Baseline in HCV RNA | Change at Week 8 | -4.72 log10 IU/mL | Standard Deviation 0.445 |
| SOF/VEL+ RBV (GT-2) | Change From Baseline in HCV RNA | Change at Week 12 | -4.72 log10 IU/mL | Standard Deviation 0.445 |
| SOF/VEL+ RBV (GT-2) | Change From Baseline in HCV RNA | Change at Week 2 | -4.50 log10 IU/mL | Standard Deviation 0.366 |
| SOF/VEL+ RBV (GT-3) | Change From Baseline in HCV RNA | Change at Week 2 | -3.41 log10 IU/mL | Standard Deviation 0.665 |
| SOF/VEL+ RBV (GT-3) | Change From Baseline in HCV RNA | Change at Week 4 | -3.70 log10 IU/mL | Standard Deviation 1.058 |
| SOF/VEL+ RBV (GT-3) | Change From Baseline in HCV RNA | Change at Week 12 | -3.70 log10 IU/mL | Standard Deviation 1.058 |
| SOF/VEL+ RBV (GT-3) | Change From Baseline in HCV RNA | Change at Week 8 | -3.70 log10 IU/mL | Standard Deviation 1.058 |
Secondary
Number of Participants With Virologic Failure
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 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: Baseline up to Posttreatment Week 24
Population: Participants in the Full Analysis Set were analyzed.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SOF/VEL+ RBV (Total) | Number of Participants With Virologic Failure | 0 Participants |
| SOF/VEL+ RBV (GT-1) | Number of Participants With Virologic Failure | 0 Participants |
| SOF/VEL+ RBV (GT-2) | Number of Participants With Virologic Failure | 1 Participants |
| SOF/VEL+ RBV (GT-3) | Number of Participants With Virologic Failure | 1 Participants |
Secondary
Percentage of Participants With a Decrease, No Change, or Increase in Model for End Stage Liver Disease (MELD) Score
MELD score is a chronic liver disease severity scoring system. Scores can range from 6 to 40, with higher scores indicating greater disease severity. No change was assigned for differences (posttreatment visits minus baseline score) of -1, 0 or 1; Decrease was assigned for differences that were less than or equal to -2; and Increase was assigned for values that were greater than or equal to 2.
Time frame: Baseline to Posttreatment Week 24
Population: Participants in the Full Analysis Set who achieved SVR24 with available data were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SOF/VEL+ RBV (Total) | Percentage of Participants With a Decrease, No Change, or Increase in Model for End Stage Liver Disease (MELD) Score | Decrease (Improvement) | 52.6 percentage of participants |
| SOF/VEL+ RBV (Total) | Percentage of Participants With a Decrease, No Change, or Increase in Model for End Stage Liver Disease (MELD) Score | No Change | 21.1 percentage of participants |
| SOF/VEL+ RBV (Total) | Percentage of Participants With a Decrease, No Change, or Increase in Model for End Stage Liver Disease (MELD) Score | Increase (Worsening) | 26.3 percentage of participants |
Secondary
Percentage of Participants With HCV RNA < LLOQ While on Study Treatment
Time frame: Weeks 2, 4, 8, and 12
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SOF/VEL+ RBV (Total) | Percentage of Participants With HCV RNA < LLOQ While on Study Treatment | Week 2 | 43.8 Percentage of participants |
| SOF/VEL+ RBV (Total) | Percentage of Participants With HCV RNA < LLOQ While on Study Treatment | Week 4 | 96.6 Percentage of participants |
| SOF/VEL+ RBV (Total) | Percentage of Participants With HCV RNA < LLOQ While on Study Treatment | Week 8 | 100.0 Percentage of participants |
| SOF/VEL+ RBV (Total) | Percentage of Participants With HCV RNA < LLOQ While on Study Treatment | Week 12 | 100.0 Percentage of participants |
| SOF/VEL+ RBV (GT-1) | Percentage of Participants With HCV RNA < LLOQ While on Study Treatment | Week 4 | 100.0 Percentage of participants |
| SOF/VEL+ RBV (GT-1) | Percentage of Participants With HCV RNA < LLOQ While on Study Treatment | Week 8 | 100.0 Percentage of participants |
| SOF/VEL+ RBV (GT-1) | Percentage of Participants With HCV RNA < LLOQ While on Study Treatment | Week 12 | 100.0 Percentage of participants |
| SOF/VEL+ RBV (GT-1) | Percentage of Participants With HCV RNA < LLOQ While on Study Treatment | Week 2 | 38.9 Percentage of participants |
| SOF/VEL+ RBV (GT-2) | Percentage of Participants With HCV RNA < LLOQ While on Study Treatment | Week 8 | 100.0 Percentage of participants |
| SOF/VEL+ RBV (GT-2) | Percentage of Participants With HCV RNA < LLOQ While on Study Treatment | Week 4 | 75.0 Percentage of participants |
| SOF/VEL+ RBV (GT-2) | Percentage of Participants With HCV RNA < LLOQ While on Study Treatment | Week 12 | 100.0 Percentage of participants |
| SOF/VEL+ RBV (GT-2) | Percentage of Participants With HCV RNA < LLOQ While on Study Treatment | Week 2 | 0 Percentage of participants |
| SOF/VEL+ RBV (GT-3) | Percentage of Participants With HCV RNA < LLOQ While on Study Treatment | Week 12 | 100.0 Percentage of participants |
| SOF/VEL+ RBV (GT-3) | Percentage of Participants With HCV RNA < LLOQ While on Study Treatment | Week 4 | 100.0 Percentage of participants |
| SOF/VEL+ RBV (GT-3) | Percentage of Participants With HCV RNA < LLOQ While on Study Treatment | Week 2 | 71.4 Percentage of participants |
| SOF/VEL+ RBV (GT-3) | Percentage of Participants With HCV RNA < LLOQ While on Study Treatment | Week 8 | 100.0 Percentage of participants |
Secondary
Percentage of Participants With No Change, Improved, and Worsened Child-Pugh-Turcotte (CPT) Class
CPT is a chronic liver disease classification system. Classes include CPT Class A, CPT Class B, and CPT Class C, in order of greater disease severity. Participants with improved CPT class was defined as having Class C at Baseline and Class B or A at Posttreatment Week 24 or Class B at Baseline and Class A at Posttreatment Week 24. Participants with worsened CPT class was defined as having Class A at Baseline and Class B or C at Posttreatment Week 24 or Class B at Baseline and Class C at Posttreatment Week 24. Participants with no change CPT class was defined as having CPT Class same between Baseline and Posttreatment Week 24.
Time frame: Baseline to Posttreatment Week 24
Population: Participants in the Full Analysis Set who achieved SVR24 with available data were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SOF/VEL+ RBV (Total) | Percentage of Participants With No Change, Improved, and Worsened Child-Pugh-Turcotte (CPT) Class | Improved CPT Class | 42.1 Percentage of participants |
| SOF/VEL+ RBV (Total) | Percentage of Participants With No Change, Improved, and Worsened Child-Pugh-Turcotte (CPT) Class | Worsened CPT Class | 0 Percentage of participants |
| SOF/VEL+ RBV (Total) | Percentage of Participants With No Change, Improved, and Worsened Child-Pugh-Turcotte (CPT) Class | No Change CPT Class | 57.9 Percentage of participants |
Secondary
Percentage of Participants With Sustained Virologic Response 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: Participants in the Full Analysis Set were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SOF/VEL+ RBV (Total) | Percentage of Participants With Sustained Virologic Response 24 Weeks After Discontinuation of Therapy (SVR24) | 75.0 percentage of participants |
| SOF/VEL+ RBV (GT-1) | Percentage of Participants With Sustained Virologic Response 24 Weeks After Discontinuation of Therapy (SVR24) | 72.2 percentage of participants |
| SOF/VEL+ RBV (GT-2) | Percentage of Participants With Sustained Virologic Response 24 Weeks After Discontinuation of Therapy (SVR24) | 80.0 percentage of participants |
| SOF/VEL+ RBV (GT-3) | Percentage of Participants With Sustained Virologic Response 24 Weeks After Discontinuation of Therapy (SVR24) | 71.4 percentage of participants |
Secondary
Percentage of Participants With Sustained Virologic Response 4 Weeks After Discontinuation of Therapy (SVR4)
SVR4 was defined as HCV RNA \< LLOQ 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+ RBV (Total) | Percentage of Participants With Sustained Virologic Response 4 Weeks After Discontinuation of Therapy (SVR4) | 87.5 percentage of participants |
| SOF/VEL+ RBV (GT-1) | Percentage of Participants With Sustained Virologic Response 4 Weeks After Discontinuation of Therapy (SVR4) | 88.9 percentage of participants |
| SOF/VEL+ RBV (GT-2) | Percentage of Participants With Sustained Virologic Response 4 Weeks After Discontinuation of Therapy (SVR4) | 80.0 percentage of participants |
| SOF/VEL+ RBV (GT-3) | Percentage of Participants With Sustained Virologic Response 4 Weeks After Discontinuation of Therapy (SVR4) | 85.7 percentage of participants |