N/A
Completed N=2,435
Durability of Virologic Response and/or Viral Resistance Patterns in Participants With Chronic Hepatitis C Who Have Been Previously Treated With Grazoprevir (MK-5172) (MK-5172-017)
Source: ClinicalTrials.gov NCT01667081 ↗Enrolled (actual)
2,435
Serious AEs
4.3%
Results posted
Jun 2022
Primary outcomePrimary: Time to Viral Relapse — NA; NA Months
Summary
This is a three-year (except for participants with chronic kidney disease [CKD] or cirrhosis) multicenter study to follow participants who received at least one dose of grazoprevir (MK-5172) in a previous study to determine whether they remain hepatitis C virus (HCV)-Ribonucleic acid (RNA) negative over time, and to determine if they have developed antiviral resistance. The study will also evaluate long-term adverse events in this population. Participants from MK-5172-052 (NCT02092350) with CKD or cirrhosis will be followed for five years.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Viral Relapse |
NA; NA | — |
| PRIMARY Persistence of Treatment-Emergent Nonstructural Protein (NS)3 and NS5A Resistance-associated Substitutions (RASs) in Participants With HCV Genotype (GT) 1a Infections |
22; 25; 18; 11; 10; 25 | — |
| PRIMARY Persistence of Treatment-Emergent NS3 and NS5A RASs in Participants With HCV Genotype 1b Infections |
4; 7; 2; 3; 2; 7 | — |
| PRIMARY Persistence of Treatment-Emergent NS3 and NS5A RASs in Participants With Genotype 4 Infections |
2; 4; 2; 1; 3; 1 | — |
| PRIMARY Number of Participants Who Experienced a Drug-Related Adverse Event (AE) During the Long-Term Follow-Up |
1; 1 | — |
| PRIMARY Number of Participants Who Experienced a Drug-Related Serious Adverse Event (SAE) During the Long-Term Follow-Up |
1; 1 | — |
| PRIMARY Number of Participants Who Experienced an Event of Clinical Interest (ECI) During the Long-Term Follow-Up |
98; 4 | — |
Eligibility Criteria
Inclusion Criteria
- Previously participated in a HCV treatment protocol that included grazoprevir in the treatment regimen
- Must enroll in the present study within three months of the last study visit of their previous protocol in which they received a grazoprevir-containing regimen
- For Amendment 03: Adult participants must have received a grazoprevir-containing regimen in a prior trial and have been identified as having failed therapy in that study
- For Amendment 04: Pediatric participants must have received at least 1 dose of a grazoprevir-containing regimen and experienced virologic failure with 1 or more associated treatment-emergent RASs at Follow-up Week 12 in MK-5172-079 (NCT03379506)
Exclusion Criteria
- Has received HCV therapy after completion of the protocol-defined grazoprevir treatment trial regimen and before or after entry into this follow-up study
- For Amendment 03: Has failed therapy due to re-infection, defined as an HCV RNA sample with a different genotype than the baseline genotype in the prior treatment study, or an HCV RNA sample determined to be reinfection by phylogenetic analysis with comparison to the baseline sequence in the prior treatment study
- For Amendment 03: Has failed therapy and received retreatment with HCV therapy, except in the case where they were re-treated in a Merck-sponsored protocol
Data sourced from ClinicalTrials.gov (NCT01667081). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.