Viekira Pak or Mavyret Treatment for Patient With Chronic Kidney Disease and Hepatitis C

The objective of arm 1 of this study is to evaluate the effect of paritaprevir/ritonavir,
ombitasvir, dasabuvir (referred to as Viekira Pak) ± ribavirin for adults with advanced CKD
with an estimated glomerular filtration rate (eGFR) less than 45ml/min that are infected with
hepatitis C virus (HCV) genotype 1 and to determine the effect of treatment on traditional
and novel markers of kidney function and cardiovascular disease risk in patients with
advanced CKD. During the course of this prospective, single arm treatment trial, we will
measure currently accepted markers of kidney function and novel biomarkers of CKD progression
to determine if they improve with eradication of HCV.

The objective of arm 2 is to evaluate Glecaprevir / Pibrentasvir (referred to as Mavyret) for
adults with advanced CKD with an estimated glomerular filtration rate (eGFR) less than
45ml/min that are infected with hepatitis C virus (HCV) genotype 1 and to determine the
effect of treatment on traditional and novel markers of kidney function and cardiovascular
disease risk in patients with advanced CKD. During the course of this prospective, single arm
treatment trial, we will measure currently accepted markers of kidney function and novel
biomarkers of CKD progression to determine if they improve with eradication of HCV.

Inclusion Criteria:

1. Male or female ≥ 18 year of age

2. HCV genotype 1 ≥ 1000 IU/mL

3. 6. Estimated glomerular filtration rate 15-45mL/min/1.73m2 as estimated by CKD-Epi
equation

Exclusion Criteria:

1. Pregnant or lactating females

2. Uncontrolled depression or psychiatric disease

3. History or presence of any form of cancer within 3 years of enrollment

4. Experiencing life-threatening cryoglobulinemic vasculitis requiring initiation of
rituximab, steroids or plasmapheresis.

5. Uncontrolled cardiovascular or pulmonary disease

6. Experiencing symptoms attributed to uremia

7. Anticipated need to begin renal replacement therapy in the next 6 months

8. History of kidney transplant