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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
160
450 mg administered as 3 x 150 mg oral tablets
60 mg administered as 6 x 10 mg oral capsules
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)
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)
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
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)
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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)
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)
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)