Hepatitis C, Chronic
Conditions
Brief summary
This study is an open-label, multi-center trial to evaluate the novel 2-drug regimen of uprifosbuvir (MK-3682) 450 mg and ruzasvir (MK-8408) 60 mg in participants with chronic hepatitis C virus (HCV) genotype (GT)1, GT2, GT3, GT4, GT5, or GT6 infection. The impact of the study treatment regimen on the percentage of participants with undetectable HCV ribonucleic acid \[RNA\] 12 weeks after completing study treatment (SVR12) will be evaluated.
Interventions
DRUGUprifosbuvir 450 mg
450 mg administered as 3 x 150 mg oral tablets
DRUGRuzasvir 60 mg
60 mg administered as 6 x 10 mg oral capsules
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Has hepatitis C virus (HCV) ribonucleic acid (RNA) at the time of screening * Has documented chronic HCV genotype (GT)1, GT2, GT3, GT4, GT5, or GT6 with no evidence of non-typeable or mixed GT infection * Is otherwise healthy as determined by the medical history, physical examination, electrocardiogram (ECG), and clinical laboratory measurements performed at the time of screening * Has absence of cirrhosis or has compensated cirrhosis * Is HCV treatment-naïve or has experienced virologic failure after completing a prior interferon-containing regimen * Is of non-childbearing potential or agrees to avoid becoming pregnant or impregnating a partner beginning at least 2 weeks prior to administration of the initial dose of study drug and for 14 days after the last dose of study drug * For human immunodeficiency virus (HIV) co-infected participants: is not currently on antiretroviral therapy (ART) and has no plans to initiate ART treatment while participating in this study Or has well-controlled HIV on ART
Exclusion criteria
* Is mentally or legally incapacitated, has significant emotional problems (at screening or expected during the study) or has a history of a clinically significant psychiatric disorder that would interfere with the study procedures. * Has evidence of decompensated liver disease manifested by the presence of or history of ascites, esophageal or gastric variceal bleeding, hepatic encephalopathy or other signs or symptoms of advanced liver disease * Is Child-Pugh Class B or C or has a Pugh-Turcotte (CPT) score \>6 if cirrhotic * Is co-infected with Hepatitis B Virus * Has a history of opportunistic infection in the preceding 6 months prior to screening if co-infected with HIV * Has a history of malignancy ≤5 years prior to study start (except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer or carcinoma in situ) or is under evaluation for other active or suspected malignancy * Has cirrhosis and liver imaging within 6 months prior to study start showing evidence of hepatocellular carcinoma (HCC) or is under evaluation for HCC * Is taking any medications or herbal supplements restricted by the study entry criteria in the period from ≤2 weeks prior to study start through 2 weeks after the last dose of study drug * Has clinically-relevant drug or alcohol abuse within 12 months of study start * Has participated in any clinical study of an investigational product within 30 days prior to the first dose of study drug * Is female and is pregnant or breastfeeding, or expecting to conceive or donate eggs from at least 2 weeks prior to study start and 14 days after the last dose of study drug * Is male and is expecting to donate sperm from at least 2 weeks prior to Day 1 until 14 days after the last dose of study drug * Has or has had any of the following: organ transplants (including hematopoietic stem cell transplants) other than cornea and hair; poor venous access; history of gastric surgery; or history of malabsorption disorders * Has any cardiac abnormalities/dysfunction including but not limited to: unstable angina; unstable congestive heart failure; or unstable arrhythmia * Has a history of a medical/surgical condition that resulted in hospitalization within 3 months prior to study start, other than for minor elective procedures * Has any medical condition requiring, or likely to require, chronic systemic administration of corticosteroids, tumor necrosis factor (TNF) antagonists, or other immunosuppressant drugs during the study * Has evidence of history of chronic hepatitis not caused by HCV
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving Sustained Virologic Response 12 Weeks After Completing Study Therapy (SVR12) | Week 24 (12 weeks after completing study therapy) | The percentage of participants in each arm achieving SVR12 was determined. SVR12 was defined as HCV ribonucleic acid (RNA) levels in plasma \< lower limit of quantification (LLOQ) 12 weeks after completing study treatment. Plasma levels of HCV RNA were measured with the COBAS™ AmpliPrep/COBAS™ Taqman™ HCV Test, v2.0 ® assay, which has a LLOQ of 15 IU/mL. |
| Percentage of Participants With ≥1 Adverse Events (AEs) | Up to Week 14 (up to 2 weeks after completing study therapy) | The percentage of participants experiencing an AE during the treatment period and first 2 weeks of follow-up was determined. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. |
| Percentage of Participants Withdrawing From Study Therapy Due to an AE | Up to Week 12 | The percentage of participants discontinuing from study therapy during the treatment period was determined. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. |
| Percentage of Participants With ≥1 Events of Clinical Interest (ECIs) | Up to Week 14 (up to 2 weeks after completing study therapy) | The percentage of participants with ECIs was determined. ECIs were defined as the following: 1) an overdose of study drug; 2) first instance of alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>500 IU/L; 3) first instance of ALT or AST \>3x nadir and \>3x upper limit of normal (ULN); 4) first instance of estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73 m\^2; or 4) first instance of serum creatinine \>1.3x ULN and elevated from baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Virologic Failure (VF) | 12 weeks after the end of all study therapy (24 weeks) | The percentage of participants in each arm experiencing VF was determined. VF was defined as: 1) non-response (HCV RNA detected at end of treatment without HCV RNA \< LLOQ while on treatment); 2) rebound (\>1 log 10 IU/mL increase in HCV RNA from nadir while on treatment); 3) virologic breakthrough (HCV RNA ≥LLOQ after being \<LLOQ on treatment); or 4) relapse (HCV RNA ≥LLOQ after end of all study therapy after being undetectable at end of treatment); virologic failure could occur either on-treatment or relapse post-treatment. For VF, participants with GT1 infection were separated into GT1a or GT1b infection |
| Percentage of Participants With Baseline Resistance-Associated Substitutions (RAS) Achieving SVR12 | 12 weeks after the end of all study therapy (24 weeks) | The percentage of participants in each arm with baseline RAS achieving SVR12 was determined. Analysis of RAS in NS5A or NS5B at baseline was determined. SVR12 was defined as HCV RNA levels in plasma \< LLOQ 24 weeks after completing study treatment. Plasma levels of HCV RNA were measured with the COBAS™ AmpliPrep/COBAS™ Taqman™ HCV Test, v2.0 ® assay, which has a LLOQ of 15 IU/mL. |
| Percentage of Participants Achieving Sustained Virologic Response 24 Weeks After Completing Study Therapy (SVR24) | Week 36 (24 weeks after completing study therapy) | The percentage of participants in each arm achieving SVR24 was determined. SVR24 was defined as HCV RNA levels in plasma \< LLOQ 24 weeks after completing study treatment. Plasma levels of HCV RNA were measured with the COBAS™ AmpliPrep/COBAS™ Taqman™ HCV Test, v2.0 ® assay, which has a LLOQ of 15 IU/mL. For SVR24, participants with GT1 infection were separated into GT1a or GT1b infection. |
Participant flow
Recruitment details
Adult participants with hepatitis C virus (HCV) genotype (GT) 1, 2, 3, 4, or 6 infection were enrolled at 5 study centers in the United States. Participants with HCV GT5 infection were initially intended for inclusion but none were enrolled.
Participants by arm
| Arm | Count |
|---|---|
| GT1: Uprifosbuvir 450 mg + Ruzasvir 60 mg Participants with HCV GT1 infection took uprifosbuvir 450 mg ruzasvir 60 mg once daily for 12 weeks. Study drug was taken after an overnight fast and at least 1 hour before a meal. | 69 |
| GT2: Uprifosbuvir 450 mg + Ruzasvir 60 mg Participants with HCV GT2 infection took uprifosbuvir 450 mg ruzasvir 60 mg once daily for 12 weeks. Study drug was taken after an overnight fast and at least 1 hour before a meal. | 29 |
| GT3: Uprifosbuvir 450 mg + Ruzasvir 60 mg Participants with HCV GT3 infection took uprifosbuvir 450 mg ruzasvir 60 mg once daily for 12 weeks. Study drug was taken after an overnight fast and at least 1 hour before a meal. | 39 |
| GT4: Uprifosbuvir 450 mg + Ruzasvir 60 mg Participants with HCV GT4 infection took uprifosbuvir 450 mg ruzasvir 60 mg once daily for 12 weeks. Study drug was taken after an overnight fast and at least 1 hour before a meal. | 20 |
| GT6: Uprifosbuvir 450 mg + Ruzasvir 60 mg Participants with HCV GT6 infection took uprifosbuvir 450 mg ruzasvir 60 mg once daily for 12 weeks. Study drug was taken after an overnight fast and at least 1 hour before a meal. | 3 |
| Total | 160 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 0 | 1 | 0 |
| Overall Study | Death | 0 | 0 | 1 | 0 | 0 |
| Overall Study | Lost to Follow-up | 2 | 0 | 4 | 0 | 0 |
| Overall Study | Protocol Violation | 0 | 1 | 0 | 0 | 0 |
| Overall Study | Study terminated prior to completion | 2 | 0 | 5 | 0 | 1 |
Baseline characteristics
| Characteristic | GT1: Uprifosbuvir 450 mg + Ruzasvir 60 mg | Total | GT6: Uprifosbuvir 450 mg + Ruzasvir 60 mg | GT4: Uprifosbuvir 450 mg + Ruzasvir 60 mg | GT3: Uprifosbuvir 450 mg + Ruzasvir 60 mg | GT2: Uprifosbuvir 450 mg + Ruzasvir 60 mg |
|---|---|---|---|---|---|---|
| Age, Continuous | 49.8 Years STANDARD_DEVIATION 10.7 | 51.9 Years STANDARD_DEVIATION 10.3 | 61.3 Years STANDARD_DEVIATION 1.5 | 56.5 Years STANDARD_DEVIATION 8.5 | 48.7 Years STANDARD_DEVIATION 10.3 | 57.2 Years STANDARD_DEVIATION 6.8 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 3 Participants | 3 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 7 Participants | 0 Participants | 1 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 64 Participants | 149 Participants | 0 Participants | 19 Participants | 39 Participants | 27 Participants |
| Sex: Female, Male Female | 33 Participants | 67 Participants | 1 Participants | 5 Participants | 18 Participants | 10 Participants |
| Sex: Female, Male Male | 36 Participants | 93 Participants | 2 Participants | 15 Participants | 21 Participants | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 69 | 0 / 29 | 1 / 39 | 0 / 20 | 0 / 3 |
| other Total, other adverse events | 25 / 69 | 8 / 29 | 13 / 39 | 6 / 20 | 2 / 3 |
| serious Total, serious adverse events | 4 / 69 | 0 / 29 | 1 / 39 | 2 / 20 | 0 / 3 |
Outcome results
Primary
Percentage of Participants Achieving Sustained Virologic Response 12 Weeks After Completing Study Therapy (SVR12)
The percentage of participants in each arm achieving SVR12 was determined. SVR12 was defined as HCV ribonucleic acid (RNA) levels in plasma \< lower limit of quantification (LLOQ) 12 weeks after completing study treatment. Plasma levels of HCV RNA were measured with the COBAS™ AmpliPrep/COBAS™ Taqman™ HCV Test, v2.0 ® assay, which has a LLOQ of 15 IU/mL.
Time frame: Week 24 (12 weeks after completing study therapy)
Population: All participants who received ≥1 dose of study treatment, have data available, who do not have protocol deviations that could substantially affect the results of the endpoint, and who did not discontinue from the study for non-treatment-related reasons, are included.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GT1: Uprifosbuvir 450 mg + Ruzasvir 60 mg | Percentage of Participants Achieving Sustained Virologic Response 12 Weeks After Completing Study Therapy (SVR12) | 97.1 Percentage of Participants |
| GT2: Uprifosbuvir 450 mg + Ruzasvir 60 mg | Percentage of Participants Achieving Sustained Virologic Response 12 Weeks After Completing Study Therapy (SVR12) | 100.0 Percentage of Participants |
| GT3: Uprifosbuvir 450 mg + Ruzasvir 60 mg | Percentage of Participants Achieving Sustained Virologic Response 12 Weeks After Completing Study Therapy (SVR12) | 76.9 Percentage of Participants |
| GT4: Uprifosbuvir 450 mg + Ruzasvir 60 mg | Percentage of Participants Achieving Sustained Virologic Response 12 Weeks After Completing Study Therapy (SVR12) | 90.0 Percentage of Participants |
| GT6: Uprifosbuvir 450 mg + Ruzasvir 60 mg | Percentage of Participants Achieving Sustained Virologic Response 12 Weeks After Completing Study Therapy (SVR12) | 66.7 Percentage of Participants |
Primary
Percentage of Participants With ≥1 Adverse Events (AEs)
The percentage of participants experiencing an AE during the treatment period and first 2 weeks of follow-up was determined. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Time frame: Up to Week 14 (up to 2 weeks after completing study therapy)
Population: All participants who received ≥1 dose of study drug are included.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GT1: Uprifosbuvir 450 mg + Ruzasvir 60 mg | Percentage of Participants With ≥1 Adverse Events (AEs) | 52.2 Percentage of Participants |
| GT2: Uprifosbuvir 450 mg + Ruzasvir 60 mg | Percentage of Participants With ≥1 Adverse Events (AEs) | 44.8 Percentage of Participants |
| GT3: Uprifosbuvir 450 mg + Ruzasvir 60 mg | Percentage of Participants With ≥1 Adverse Events (AEs) | 43.6 Percentage of Participants |
| GT4: Uprifosbuvir 450 mg + Ruzasvir 60 mg | Percentage of Participants With ≥1 Adverse Events (AEs) | 55.0 Percentage of Participants |
| GT6: Uprifosbuvir 450 mg + Ruzasvir 60 mg | Percentage of Participants With ≥1 Adverse Events (AEs) | 66.7 Percentage of Participants |
Primary
Percentage of Participants With ≥1 Events of Clinical Interest (ECIs)
The percentage of participants with ECIs was determined. ECIs were defined as the following: 1) an overdose of study drug; 2) first instance of alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>500 IU/L; 3) first instance of ALT or AST \>3x nadir and \>3x upper limit of normal (ULN); 4) first instance of estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73 m\^2; or 4) first instance of serum creatinine \>1.3x ULN and elevated from baseline.
Time frame: Up to Week 14 (up to 2 weeks after completing study therapy)
Population: All participants who received ≥1 dose of study drug are included.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GT1: Uprifosbuvir 450 mg + Ruzasvir 60 mg | Percentage of Participants With ≥1 Events of Clinical Interest (ECIs) | Overdose | 4.3 Percentage of Participants |
| GT1: Uprifosbuvir 450 mg + Ruzasvir 60 mg | Percentage of Participants With ≥1 Events of Clinical Interest (ECIs) | Non-overdose ECI | 2.8 Percentage of Participants |
| GT2: Uprifosbuvir 450 mg + Ruzasvir 60 mg | Percentage of Participants With ≥1 Events of Clinical Interest (ECIs) | Overdose | 3.4 Percentage of Participants |
| GT3: Uprifosbuvir 450 mg + Ruzasvir 60 mg | Percentage of Participants With ≥1 Events of Clinical Interest (ECIs) | Overdose | 5.1 Percentage of Participants |
| GT3: Uprifosbuvir 450 mg + Ruzasvir 60 mg | Percentage of Participants With ≥1 Events of Clinical Interest (ECIs) | Non-overdose ECI | 2.5 Percentage of Participants |
Primary
Percentage of Participants Withdrawing From Study Therapy Due to an AE
The percentage of participants discontinuing from study therapy during the treatment period was determined. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Time frame: Up to Week 12
Population: All participants who received ≥1 dose of study drug are included.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GT1: Uprifosbuvir 450 mg + Ruzasvir 60 mg | Percentage of Participants Withdrawing From Study Therapy Due to an AE | 0.0 Percentage of Participants |
| GT2: Uprifosbuvir 450 mg + Ruzasvir 60 mg | Percentage of Participants Withdrawing From Study Therapy Due to an AE | 3.4 Percentage of Participants |
| GT3: Uprifosbuvir 450 mg + Ruzasvir 60 mg | Percentage of Participants Withdrawing From Study Therapy Due to an AE | 0.0 Percentage of Participants |
| GT4: Uprifosbuvir 450 mg + Ruzasvir 60 mg | Percentage of Participants Withdrawing From Study Therapy Due to an AE | 5.0 Percentage of Participants |
| GT6: Uprifosbuvir 450 mg + Ruzasvir 60 mg | Percentage of Participants Withdrawing From Study Therapy Due to an AE | 0.0 Percentage of Participants |
Secondary
Percentage of Participants Achieving Sustained Virologic Response 24 Weeks After Completing Study Therapy (SVR24)
The percentage of participants in each arm achieving SVR24 was determined. SVR24 was defined as HCV RNA levels in plasma \< LLOQ 24 weeks after completing study treatment. Plasma levels of HCV RNA were measured with the COBAS™ AmpliPrep/COBAS™ Taqman™ HCV Test, v2.0 ® assay, which has a LLOQ of 15 IU/mL. For SVR24, participants with GT1 infection were separated into GT1a or GT1b infection.
Time frame: Week 36 (24 weeks after completing study therapy)
Population: All participants who received ≥1 dose of study treatment, have data available, who do not have protocol deviations that could substantially affect the results of the endpoint, and who did not discontinue from the study for non-treatment-related reasons, are included.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GT1: Uprifosbuvir 450 mg + Ruzasvir 60 mg | Percentage of Participants Achieving Sustained Virologic Response 24 Weeks After Completing Study Therapy (SVR24) | 96.2 Percentage of Participants |
| GT2: Uprifosbuvir 450 mg + Ruzasvir 60 mg | Percentage of Participants Achieving Sustained Virologic Response 24 Weeks After Completing Study Therapy (SVR24) | 100.0 Percentage of Participants |
| GT3: Uprifosbuvir 450 mg + Ruzasvir 60 mg | Percentage of Participants Achieving Sustained Virologic Response 24 Weeks After Completing Study Therapy (SVR24) | 75.0 Percentage of Participants |
| GT4: Uprifosbuvir 450 mg + Ruzasvir 60 mg | Percentage of Participants Achieving Sustained Virologic Response 24 Weeks After Completing Study Therapy (SVR24) | 90.0 Percentage of Participants |
| GT6: Uprifosbuvir 450 mg + Ruzasvir 60 mg | Percentage of Participants Achieving Sustained Virologic Response 24 Weeks After Completing Study Therapy (SVR24) | 66.7 Percentage of Participants |
| GT1b: Uprifosbuvir 450 mg + Ruzasvir 60 mg | Percentage of Participants Achieving Sustained Virologic Response 24 Weeks After Completing Study Therapy (SVR24) | 100.0 Percentage of Participants |
Secondary
Percentage of Participants With Baseline Resistance-Associated Substitutions (RAS) Achieving SVR12
The percentage of participants in each arm with baseline RAS achieving SVR12 was determined. Analysis of RAS in NS5A or NS5B at baseline was determined. SVR12 was defined as HCV RNA levels in plasma \< LLOQ 24 weeks after completing study treatment. Plasma levels of HCV RNA were measured with the COBAS™ AmpliPrep/COBAS™ Taqman™ HCV Test, v2.0 ® assay, which has a LLOQ of 15 IU/mL.
Time frame: 12 weeks after the end of all study therapy (24 weeks)
Population: All participants who received ≥1 dose of study treatment, and who do not have protocol deviations that could substantially affect the results of the endpoint, and who did not discontinue from the study for non-treatment-related reasons, and who had baseline sequencing data available, are included.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GT1: Uprifosbuvir 450 mg + Ruzasvir 60 mg | Percentage of Participants With Baseline Resistance-Associated Substitutions (RAS) Achieving SVR12 | 97.1 Percentage of Participants |
| GT2: Uprifosbuvir 450 mg + Ruzasvir 60 mg | Percentage of Participants With Baseline Resistance-Associated Substitutions (RAS) Achieving SVR12 | 100.0 Percentage of Participants |
| GT3: Uprifosbuvir 450 mg + Ruzasvir 60 mg | Percentage of Participants With Baseline Resistance-Associated Substitutions (RAS) Achieving SVR12 | 97.4 Percentage of Participants |
| GT4: Uprifosbuvir 450 mg + Ruzasvir 60 mg | Percentage of Participants With Baseline Resistance-Associated Substitutions (RAS) Achieving SVR12 | 94.7 Percentage of Participants |
| GT6: Uprifosbuvir 450 mg + Ruzasvir 60 mg | Percentage of Participants With Baseline Resistance-Associated Substitutions (RAS) Achieving SVR12 | 66.6 Percentage of Participants |
Secondary
Percentage of Participants With Virologic Failure (VF)
The percentage of participants in each arm experiencing VF was determined. VF was defined as: 1) non-response (HCV RNA detected at end of treatment without HCV RNA \< LLOQ while on treatment); 2) rebound (\>1 log 10 IU/mL increase in HCV RNA from nadir while on treatment); 3) virologic breakthrough (HCV RNA ≥LLOQ after being \<LLOQ on treatment); or 4) relapse (HCV RNA ≥LLOQ after end of all study therapy after being undetectable at end of treatment); virologic failure could occur either on-treatment or relapse post-treatment. For VF, participants with GT1 infection were separated into GT1a or GT1b infection
Time frame: 12 weeks after the end of all study therapy (24 weeks)
Population: All participants who received ≥1 dose of study treatment, have data available, who do not have protocol deviations that could substantially affect the results of the endpoint, and who did not discontinue from the study for non-treatment-related reasons, are included.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GT1: Uprifosbuvir 450 mg + Ruzasvir 60 mg | Percentage of Participants With Virologic Failure (VF) | 3.7 Percentage of Participants |
| GT2: Uprifosbuvir 450 mg + Ruzasvir 60 mg | Percentage of Participants With Virologic Failure (VF) | 0.0 Percentage of Participants |
| GT3: Uprifosbuvir 450 mg + Ruzasvir 60 mg | Percentage of Participants With Virologic Failure (VF) | 23.1 Percentage of Participants |
| GT4: Uprifosbuvir 450 mg + Ruzasvir 60 mg | Percentage of Participants With Virologic Failure (VF) | 5.0 Percentage of Participants |
| GT6: Uprifosbuvir 450 mg + Ruzasvir 60 mg | Percentage of Participants With Virologic Failure (VF) | 33.3 Percentage of Participants |
| GT1b: Uprifosbuvir 450 mg + Ruzasvir 60 mg | Percentage of Participants With Virologic Failure (VF) | 0.0 Percentage of Participants |