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

Mass General Brigham

Status and phase: Completed; Phase 4

Conditions: Chronic Kidney Disease; Chronic Hepatitis C

Treatments: Drug: Viekira Pak ± ribavirin; Drug: Mavyret

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02946034

2016P001822

Details and patient eligibility

About

Open-label experimental trial of 12 weeks of Viekira Pak treatment ± ribavirin or Mavyret for adults with chronic kidney disease and hepatitis C.

Full description

The objective of this study is to evaluate the effect of paritaprevir/ritonavir, ombitasvir, dasabuvir (referred to as Viekira Pak) ± ribavirin or 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.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Viekira Pak ± ribavirin or Mavyret

Experimental group

Description:

12 week therapy with Viekira Pak ± ribavirin 8 or 12 week therapy with Mavyret

Treatment:

Drug: Mavyret

Drug: Viekira Pak ± ribavirin