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

Safety, Efficacy, and Changes in Traditional and Novel Biomarkers of Kidney Function in Patients With Hepatitis C and Advanced Chronic Kidney Disease Treated With Abbvie Viekira Pak or Mavyret Regimen

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

Study Overview

• Status: Completed
• Conditions: Chronic Kidney Disease; Chronic Hepatitis C
• Intervention / Treatment: Drug: Viekira Pak ± ribavirin; Drug: Mavyret

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Viekira Pak ± ribavirin or Mavyret; 12 week therapy with Viekira Pak ± ribavirin 8 or 12 week therapy with Mavyret	Drug: Viekira Pak ± ribavirin; 12 weeks treatment with AbbVie Viekira Pak ± ribavirin; Other Names: AbbVie 3D regimen; Drug: Mavyret; 8 or 12 weeks treatment with AbbVie Mavyret

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average Change in Urine Tumor Necrosis Factor (TNF)-Alpha From Baseline to Post-treatment	Measure of novel biomarkers of incident and progressive CKD and liver disease to determine if eradication of HCV infection changes the measures of chronic inflammation associated with progressive end-organ disease. To calculate the average change, the difference between baseline values and the average of 12-weeks post treatment and 40-weeks post treatment were found for each patient. These differences were then averaged, as shown below.	52 Weeks
Average Change in Urine Interleukin (IL)-6 From Baseline to Post-treatment	Measure of novel biomarkers of incident and progressive CKD and liver disease to determine if eradication of HCV infection changes the measures of chronic inflammation associated with progressive end-organ disease. To calculate the average change, the difference between baseline values and the average of 12-weeks post treatment and 40-weeks post treatment were found for each patient. These differences were then averaged, as shown below.	52 weeks
Average Change in Plasma Tumor Necrosis Factor (TNF)-Alpha From Baseline to Post-treatment	Measure of novel biomarkers of incident and progressive CKD and liver disease to determine if eradication of HCV infection changes the measures of chronic inflammation associated with progressive end-organ disease. To calculate the average change, the difference between baseline values and the average of 12-weeks post treatment and 40-weeks post treatment were found for each patient. These differences were then averaged, as shown below.	52 weeks
Average Change in Plasma Interferon Gamma-induced Protein 10 (IP-10) From Baseline to Post-treatment	Measure of novel biomarkers of incident and progressive CKD and liver disease to determine if eradication of HCV infection changes the measures of chronic inflammation associated with progressive end-organ disease. To calculate the average change, the difference between baseline values and the average of 12-weeks post treatment and 40-weeks post treatment were found for each patient. These differences were then averaged, as shown below.	52 Weeks 52 Weeks 52 weeks
Average Change in Plasma Interferon (IFN)-Gamma From Baseline to Post-treatment	Measure of novel biomarkers of incident and progressive CKD and liver disease to determine if eradication of HCV infection changes the measures of chronic inflammation associated with progressive end-organ disease. To calculate the average change, the difference between baseline values and the average of 12-weeks post treatment and 40-weeks post treatment were found for each patient. These differences were then averaged, as shown below.	52 weeks
Average Change in Plasma Interleukin (IL)-6 From Baseline to Post-treatment	Measure of novel biomarkers of incident and progressive CKD and liver disease to determine if eradication of HCV infection changes the measures of chronic inflammation associated with progressive end-organ disease. To calculate the average change, the difference between baseline values and the average of 12-weeks post treatment and 40-weeks post treatment were found for each patient. These differences were then averaged, as shown below.	52 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Patients Who Suffered Adverse Events Related to Study Drug (Safety and Tolerability)	Safety and tolerability of Viekira Pak treatment in CKD patients will be assessed by number of patients who suffered adverse events (serious or otherwise) deemed to be related to study drug.	12 weeks
Number of Patients Who Had Sustained Virologic Response at 12-weeks (SVR12) Post-treatment (Efficacy of Treatment)	Efficacy will be determined by negative HCV RNA viral load measured during the 12 week treatment period as well as 12 weeks after the last dose.	24 weeks

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: AbbVie

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 1, 2017
• Primary Completion (ACTUAL): September 16, 2020
• Study Completion (ACTUAL): September 16, 2020

Study Registration Dates

• First Submitted: October 21, 2016
• First Submitted That Met QC Criteria: October 25, 2016
• First Posted (ESTIMATE): October 26, 2016

Study Record Updates

• Last Update Posted (ACTUAL): November 5, 2021
• Last Update Submitted That Met QC Criteria: October 5, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: HCV; CKD
• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Urologic Diseases; Liver Diseases; Renal Insufficiency; Flaviviridae Infections; Hepatitis, Viral, Human; Enterovirus Infections; Picornaviridae Infections; Hepatitis, Chronic; Kidney Diseases; Renal Insufficiency, Chronic; Hepatitis; Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Antimetabolites; Ribavirin
• Other Study ID Numbers: 2016P001822

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Results data will be shared with the study sponsor and publication of data is anticipated.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No