Phase 3
Completed N=237
Safety and Efficacy of Grazoprevir (MK-5172) + Elbasvir (MK-8742) in Participants With Chronic Hepatitis C and Chronic Kidney Disease (MK-5172-052)
Source: ClinicalTrials.gov NCT02092350 ↗Enrolled (actual)
237
Serious AEs
22.9%
Results posted
Apr 2016
Primary outcomePrimary: Percentage of Participants With Sustained Virologic Response 12 Weeks After Completing Study Therapy (SVR12) — 99.1; 98.0 Percentage of participants — p=0.001
◆ Published Evidence
Highly cited
666citations · ~61 / year
Grazoprevir plus elbasvir in treatment-naive and treatment-experienced patients with hepatitis C virus genotype 1 infection and stage 4-5 chronic kidney disease (the C-SURFER study): a combination phase 3 study.
Summary
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%.
Linked Publications (5)
-
Grazoprevir plus elbasvir in treatment-naive and treatment-experienced patients with hepatitis C virus genotype 1 infection and stage 4-5 chronic kidney disease (the C-SURFER study): a combination phase 3 study.
-
Elbasvir plus grazoprevir in patients with hepatitis C virus infection and stage 4-5 chronic kidney disease: clinical, virological, and health-related quality-of-life outcomes from a phase 3, multicentre, randomised, double-blind, placebo-controlled trial.
-
Pharmacokinetics of elbasvir and grazoprevir in subjects with end-stage renal disease or severe renal impairment.
-
Concomitant proton pump inhibitor use does not reduce the efficacy of elbasvir/grazoprevir: A pooled analysis of 1,322 patients with hepatitis C infection.
-
Interventions for dialysis patients with hepatitis C virus (HCV) infection.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Sustained Virologic Response 12 Weeks After Completing Study Therapy (SVR12) |
99.1; 98.0 | 0.001 sig |
| PRIMARY Number of Participants Experiencing an Adverse Event (AE) During the Initial Treatment and 14-day Follow-up Periods |
93; 96 | — |
| PRIMARY Number of Participants Discontinuing Study Drug Due to AEs During the Initial Treatment Period |
0; 5 | — |
| SECONDARY Percentage of Participants With Sustained Virologic Response 24 Weeks After Completing Study Therapy (SVR24) |
97.4; 98.0 | — |
| SECONDARY Percentage of Participants With Sustained Virologic Response 4 Weeks After Completing Study Therapy (SVR4) |
100.00; 99.0 | — |
Eligibility Criteria
Inclusion Criteria
- Documented chronic (at least 6 months) HCV GT 1 infection (with no evidence of mixed genotypes or genotype that cannot be assigned a type)
- Evidence or no evidence of liver cirrhosis based on one of the following:
- Liver biopsy performed within 24 months of Day 1 (if participant is cirrhotic then there is no time restriction on biopsy)
- Fibroscan performed within 12 months of Day 1 of this study
- Fibrosure™ (Fibrotest™) plus aspartate aminotransferase to platelet Ratio Index [APRI] obtained during the screening period)
- Has HCV status that is one of the following:
- Treatment naïve
- Prior interferon or pegylated interferon with or without ribavarin failures (null responder, partial responder, or relapser)
- Intolerant to prior interferon or pegylated intereferon with or without ribavarin regimen
- Chronic kidney disease (defined as glomerular filtration rate [eGFR] <=29) non-dialysis dependent or on hemodialysis for at least 3 months, including individuals awaiting kidney transplant and those with failed kidney transplants but no longer on immunosuppressant therapy)
- Female participant of reproductive potential must agree to remain abstinent or use (or have their partner use) 2 acceptable methods of contraception from at least 2 weeks prior to Day 1 through 14 days after the last dose of study drugs, or longer if dictated by local regulations
Exclusion Criteria
- Evidence of decompensated liver disease
- On peritoneal dialysis for management of kidney disease
- Co-infection with hepatitis B virus or human immunodeficiency virus (HIV)
- History of malignancy <=5 years prior to signing informed consent
- Clinical diagnosis of substance abuse
- Pregnant, breast-feeding, expecting to conceive or donate eggs, or donate sperm from Day 1 through 14 days after the last study dose, or longer if dictated by local regulations
- Organ transplant (including hematopoietic stem cell transplant) other than kidney, cornea, and hair
- Conditions requiring, or likely to require, chronic systemic administration of corticosteroids during the course of the trial
- Uncontrolled or poorly controlled hypertension
- Significant cardiovascular disorder (e.g. myocardial infarction or unstable angina) or cardiovascular procedure within 3 months prior to signing informed consent
- New or worsening signs or symptoms of congestive heart failure within 3 months of signing informed consent
- Severe active peripheral vascular disease
- Recent (within 3 months prior to signing informed consent) episode or recurrence of stroke, transient ischemic attack (TIA) or neurological disorder, including but not limited to seizures
- Evidence or history of chronic hepatitis not caused by HCV
Data sourced from ClinicalTrials.gov (NCT02092350) and the linked publication. 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.