Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Phase II/III Randomized Clinical Trial to Study the Efficacy and Safety of the Combination Regimen of MK-5172 and MK-8742 in Subjects With Chronic Hepatitis C Virus Infection and Chronic Kidney Disease
Brief 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%.


Options:
A: 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
B: Inclusion Criteria:

* Chronic hepatitis C virus (HCV) infection
* Screening laboratory results indicating HCV genotype 1 - 6 (GT1 - 6) infection.
* Subject must be HCV treatment-naïve or have failed previous HCV treatment.
* Subjects with underlying chronic renal impairment (estimated glomerular filtration rate (eGFR) \< 30 mL/min/1.73 m2 as estimated by the MDRD method at screening, including those requiring dialysis).
* Non-cirrhotic subjects must have documented absence of cirrhosis and subjects with cirrhosis must have documented compensated cirrhosis.

Exclusion Criteria:

* History of severe, life-threatening or other significant sensitivity to any excipients of the study drug.
* Female who is pregnant, planning to become pregnant during the study, or breastfeeding; or male whose partner is pregnant or planning to become pregnant during the study.
* Recent (within 6 months prior to study drug administration) history of drug or alcohol abuse that could preclude adherence to the protocol in the opinion of the investigator.
* Positive test result at Screening for hepatitis B surface antigen (HBsAg) or anti-human immunodeficiency virus antibody (HIV Ab).
* HCV genotype performed during screening indicating co-infection with more than 1 HCV genotype; HCV GT3 infected, treatment-experienced subjects were excluded.
* Patients who failed a previous regimen containing protease inhibitor (PIs) and/or nonstructural protein 5A (NS5A) inhibitors.
C: Inclusion Criteria:

* HBV-positive patients

  * Chronic hepatitis B defined by a positive HBsAg ( surface antigen of the hepatitis B virus) for at least 6 months
  * Acute hepatitis B defined as a recent appearance (\<6 months) of detectable HBs Ag,
  * Chronic hepatitis B with serological remission HbsAg-negative , HB DNA-negative,
  * With or without association with acute or chronic hepatitis D.
* HCV-positive patients

  * Chronic hepatitis C defined by the positivity for anti-HCV antibodies for at least 6 months and positive HCV-RNA
  * Acute hepatitis C defined by the recent appearance of HCV RNA (less than 6 months) in patients with risk factors (with or without positive antibodies)
  * Patients with cured hepatitis C defined by long-term eradication, either spontaneous, a positive anti-HCV antibodies associated to a negative RNA at two collection - 6 months interval time; either treatment defined by negative viremia 3 month after end of treatment.

Exclusion Criteria:

* HIV co-infected patients are not eligible to the cohort.
* So-called vulnerable populations (minors, people under guardianship or protection, or a private individual under protection from making legal or administrative decisions)
* Treatment ongoing hepatitis C during or stopped since less than 3 months
* Patients end of life
* Woman whose pregnancy is known
D: Inclusion Criteria:

* Age 18-65 years old
* Creatinine clearance (Ccr) \< 15 ml/min/1.73 m2
* Anti-HCV (Abbott HCV EIA 3.0, Abbott Diagnostic, Chicago, IL) positive \> 6 months
* Detectable serum quantitative HCV-RNA (Cobas Taqman HCV test, version 2, Roche Diagnostics) with a dynamic range of 25-391000000 IU/ml

Exclusion Criteria:

* Receiving interferon-based therapy for chronic hepatitis C
* Severe anemia (hemoglobin \< 10 g/dL) or hemoglobinopathy
* Neutropenia (neutrophil count, \<1,500/mm3)
* Thrombocytopenia (platelet \<90,000/ mm3)
* Co-infection with HBV or HIV
* Chronic alcohol abuse (daily consumption \> 20 g/day)
* Autoimmune liver disease
* Decompensated liver disease (Child classification B or C)
* Neoplastic disease
* An organ transplant
* Immunosuppressive therapy
* Poorly controlled autoimmune diseases, pulmonary diseases, cardiac diseases, psychiatric diseases, neurological diseases, diabetes mellitus
* Evidence of drug abuse
* Unwilling to have contraception

Answer: A