The purpose of this study was to evaluate the efficacy of 8 and 12 weeks of treatment with a fixed dose combination (FDC) of elbasvir (EBR) 50 mg + grazoprevir (GZR) 100 mg (i.e., MK-5172A) as assessed by the percentage of participants with hepatitis C virus (HCV) genotype (GT) 4 infection that achieve sustained virologic response (HCV ribonucleic acid \[RNA\] \< Lower Limit of Quantification \[LLOQ\]) 12 weeks after the end of study therapy (SVR12). This study also evaluated the safety and tolerability of EBR/GZR.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
117
One FDC tablet taken once daily by mouth for 8 or 12 weeks depending upon randomization.
CHU Amiens-Picardie - Hopital Sud ( Site 0217)
Amiens, France
CHU Jean Minjoz ( Site 0213)
Besançon, France
CHU Henri Mondor ( Site 0206)
Créteil, France
CHU de Grenoble - Hopital Michallon ( Site 0208)
Genoble, France
CHU Dupuytren ( Site 0209)
Limoges, France
Hopital Saint Eloi ( Site 0207)
Montpellier, France
C.H.U. de Nice Hopital de l Archet 2 ( Site 0215)
Nice, France
Centre Hospitalier Regional du Orleans ( Site 0212)
Orléans, France
Hopital Beaujon ( Site 0201)
Paris, France
Hopital Cochin ( Site 0211)
Paris, France
...and 3 more locations
Percentage of Participants Achieving Sustained Virologic Response 12 Weeks After End of Treatment (SVR12)
The percentage of participants to achieve SVR12 was determined for each arm (SVR12 was defined as HCV ribonucleic acid \[RNA\] \< lower limit of quantification \[LLOQ\] at 12 weeks after the end of all study therapy). Plasma HCV RNA was measured using the COBAS™ AmpliPrep/COBAS™ TaqMan HCV Test, v2.0®, which has a LLOQ of 15 IU/mL.
Time frame: 12 weeks after completing study treatment (Arm 1: Week 20 / Arm 2: Week 24)
Number of Participants With ≥ 1 Adverse Events (AEs)
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.
Time frame: Up to 14 weeks
Number of Participants Who Discontinued From Study Treatment Due to an AE
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.
Time frame: Up to Study Week 12
Percentage of Participants Achieving Sustained Virologic Response 24 Weeks After End of Treatment (SVR24)
The percentage of participants to achieve SVR24 was determined for each arm (SVR24 was defined as HCV RNA \< LLOQ at 24 weeks after the end of all study therapy). Plasma HCV RNA was measured using the COBAS™ AmpliPrep/COBAS™ TaqMan HCV Test, v2.0®, which has a LLOQ of 15 IU/mL.
Time frame: 24 weeks after completing study treatment (Arm 1: Week 32 / Arm 2: Week 36)
Prevalence of Baseline NS3 Resistance-Associated Substitutions (RASs) to EBR or GZR
Blood samples for viral resistance assays were collected at Baseline (Day 1) and analyzed for substitutions in the NS3 gene region. Results are pooled for all participants with baseline sequencing data available, and the number of participants with RASs is reported according HCV genotype. Resistance-associated substitutions are defined as amino acid substitutions that confer reduced susceptibility to a direct-acting antiviral (DAA) and may contribute to virologic failure. The prevalence of baseline substitutions in participants infected with HCV GT4 subtypes was assessed by evaluating amino acid substitutions in NS3.
Time frame: Day 1
Prevalence of Baseline NS5A RASs to EBR or GZR
Blood samples for viral resistance assays were collected at Baseline (Day 1) and analyzed for substitutions in the NS5A gene region. Results are pooled for all participants with baseline sequencing data available, and the number of participants with RASs is reported according HCV genotype. Resistance-associated substitutions are defined as amino acid substitutions that confer reduced susceptibility to a DAA and may contribute to virologic failure. The prevalence of baseline substitutions in participants infected with HCV GT4 subtypes was assessed by evaluating amino acid substitutions in NS5A.
Time frame: Day 1
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