Study of Grazoprevir (MK-5172) + Elbasvir (MK-8742) + Ribavirin in Participants With Chronic Hepatitis C Who Failed Prior Direct-Acting Antiviral Therapy (MK-5172-048)
CompletedPhase 2Results postedLast updated 24 September 2018
What this trial tests
Phase 2 trial testing Grazoprevir (GZR) in Hepatitis C Virus in 79 participants. Completed in 4 May 2015.
18 and older, any sex, with Hepatitis C Virus. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percentage of Participants Achieving Sustained Virologic Response (SVR) at 12 Weeks After the End of All Study Therapy (SVR12)Primary· Up to 24 weeks
SVR12 is defined as participants having hepatitis C virus ribonucleic acid (HCV RNA) level lower than the limit of quantification (LLoQ, \<15 IU/mL in plasma), either target detected and unquantifiable or undetectable 12 weeks after the end of all study therapy.
Group
Value
95% CI
GZR 100 mg + EBR 50 mg + RBV for 12 Weeks
97.1
90.1 – 99.7
Percentage of Participants Experiencing Adverse EventsPrimary· Up to 40 weeks (from Day 1 [post-dose] through 24 [-12/+4] weeks following last dose of study drug)
Adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the Sponsor's product, whether or not considered related to the use of the product.
Group
Value
95% CI
GZR 100 mg + EBR 50 mg + RBV for 12 Weeks
79.7
69.2 – 88.0
Percentage of Participants Discontinuing Study Drug Due to an Adverse EventPrimary· Up to 12 weeks
Adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the Sponsor's product, whether or not considered related to the use of the product.
Group
Value
95% CI
GZR 100 mg + EBR 50 mg + RBV for 12 Weeks
1.3
0.0 – 6.9
Percentage of Participants Achieving SVR12 by Prior Direct-acting Antiviral (DAA) TherapySecondary· Up to 24 weeks
SVR12 is defined as participants having HCV RNA level lower than the LLoQ (\<15 IU/mL in plasma), either target detected and unquantifiable or undetectable 12 weeks after the end of all study therapy. Prior DAA therapy regimen included boceprevir, telaprevir, simeprevir, or sofosbuvir taken concomitantly with peginterferon and ribavirin. Below categories specify with our without resistance-associated variants (RAVs) of the hepatitis C virus.
Boceprevir with signature baseline RAVs, n=9
Group
Value
95% CI
GZR 100 mg + EBR 50 mg + RBV for 12 Weeks
88.9
51.8 – 99.7
Boceprevir without signature baseline RAVs, n=16
Group
Value
95% CI
GZR 100 mg + EBR 50 mg + RBV for 12 Weeks
100.0
79.4 – 100.0
Telaprevir with signature baseline RAVs, n=18
Group
Value
95% CI
GZR 100 mg + EBR 50 mg + RBV for 12 Weeks
94.4
72.7 – 99.9
Telaprevir without signature baseline RAVs, n=22
Group
Value
95% CI
GZR 100 mg + EBR 50 mg + RBV for 12 Weeks
100.0
84.6 – 100.0
Simeprevir with signature baseline RAVs, n=4
Group
Value
95% CI
GZR 100 mg + EBR 50 mg + RBV for 12 Weeks
100.0
39.8 – 100.0
Simeprevir without signature baseline RAVs, n=1
Group
Value
95% CI
GZR 100 mg + EBR 50 mg + RBV for 12 Weeks
100.0
2.5 – 100.0
Adverse events — posted to ClinicalTrials.gov
Time frame: Serious adverse events (SAEs): up to 40 weeks (including 24-week follow-up [-12/+4 weeks]); non-serious adverse events (NSAEs): Up to 14 weeks (including 2-week follow-up).
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
GZR 100 mg + EBR 50 mg + RBV for 12 Weeks
Serious: 6/79 (8%)
Deaths: —
Serious adverse events (6 terms)
Reaction
System
GZR 100 mg + EBR 50 mg + R…
Appendicitis
Infections and infestations
—
Pharyngitis bacterial
Infections and infestations
—
Urinary tract infection
Infections and infestations
—
Laryngeal squamous cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
In this study, participants with hepatitis C virus (HCV) genotype 1 (GT1) who failed prior direct-acting antiviral (DAA) therapy will receive Grazoprevir (MK-5172) + Elbasvir (MK-8742) + Ribavirin (RBV) to evaluate sustained virologic response (SVR) using this drug combination.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Merck Sharp & Dohme LLC
Last refreshed: 24 September 2018
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02105454.