This study will evaluate the safety and efficacy of combination treatment with grazoprevir (MK-5172) + elbasvir (MK-8742) for cirrhotic and non-cirrhotic participants with chronic Genotype 1 (GT1) hepatitis C virus (HCV) infection and chronic kidney disease (CKD). The primary study hypothesis is that the proportion of HCV GT1-infected CKD participants within the Immediate Treatment and Intensive Pharmacokinetics (PK) groups achieving a sustained viral response 12 weeks after the end of all study treatment (SVR12) will be \>45%.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
237
Grazoprevir 100 mg tablet
Elbasvir 50 mg tablet
Placebo tablet matched to grazoprevir
Placebo tablet matched to elbasvir
Percentage of Participants With Sustained Virologic Response 12 Weeks After Completing Study Therapy (SVR12)
SVR12 was defined as hepatitis C virus (HCV) ribonucleic acid (RNA) lower than the limit of quantification (LLoQ) 12 weeks after completing study therapy. HCV RNA was measured using the COBAS™ AmpliPrep/COBAS™ Taqman™ HCV Test, v2.0®, which has a LLoQ of 15 IU/mL.
Time frame: Week 24 (Immediate Treatment + Intensive PK) or Week 40 (Deferred Treatment)
Number of Participants Experiencing an Adverse Event (AE) During the Initial Treatment and 14-day Follow-up Periods
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. This analysis includes the Immediate Treatment + Intensive PK group and the placebo treatment period for the Deferred Treatment group.
Time frame: Up to Week 14
Number of Participants Discontinuing Study Drug Due to AEs During the Initial Treatment Period
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. This analysis includes the Immediate Treatment + Intensive PK group and the placebo treatment period for the Deferred Treatment group.
Time frame: Up to Week 12
Percentage of Participants With Sustained Virologic Response 24 Weeks After Completing Study Therapy (SVR24)
SVR24 was defined as HCV RNA \<LLoQ 24 weeks after completing study therapy. HCV RNA was measured using the COBAS™ AmpliPrep/COBAS™ Taqman™ HCV Test, v2.0®, which has a LLoQ of 15 IU/mL.
Time frame: Week 36 (Immediate Treatment + Intensive PK) or Week 52 (Deferred Treatment)
Percentage of Participants With Sustained Virologic Response 4 Weeks After Completing Study Therapy (SVR4)
SVR4 was defined as HCV RNA \<LLoQ 4 weeks after completing study therapy. HCV RNA was measured using the COBAS™ AmpliPrep/COBAS™ Taqman™ HCV Test, v2.0®, which has a LLoQ of 15 IU/mL.
Time frame: Week 16 (Immediate Treatment + Intensive PK) or Week 32 (Deferred Treatment)
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