safety and efficacy of grazoprevir (mk-5172) + elbasvir (mk-8742) in participants with chronic hepatitis c and chronic kidney disease (mk-5172-052)

Conditions: Hepatitis C Virus

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%.


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