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

NCT02946034 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: 2016P001822
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Chronic Kidney Disease; Chronic Hepatitis C

Keywords

CKD; HCV

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (2)

• Number of Patients Who Suffered Adverse Events Related to Study Drug (Safety and Tolerability)

  12 weeks

• Number of Patients Who Had Sustained Virologic Response at 12-weeks (SVR12) Post-treatment (Efficacy of Treatment)

  24 weeks

Study Arms (1)

Viekira Pak ± ribavirin or Mavyret

EXPERIMENTAL

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

Drug: Viekira Pak ± ribavirin; Drug: Mavyret

Interventions

Viekira Pak ± ribavirin DRUG

12 weeks treatment with AbbVie Viekira Pak ± ribavirin

Also known as: AbbVie 3D regimen

Viekira Pak ± ribavirin or Mavyret

Mavyret DRUG

8 or 12 weeks treatment with AbbVie Mavyret

Viekira Pak ± ribavirin or Mavyret

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female ≥ 18 year of age
• HCV genotype 1 ≥ 1000 IU/mL
• \. Estimated glomerular filtration rate 15-45mL/min/1.73m2 as estimated by CKD-Epi equation

You may not qualify if:

• Pregnant or lactating females
• Uncontrolled depression or psychiatric disease
• History or presence of any form of cancer within 3 years of enrollment
• Experiencing life-threatening cryoglobulinemic vasculitis requiring initiation of rituximab, steroids or plasmapheresis.
• Uncontrolled cardiovascular or pulmonary disease
• Experiencing symptoms attributed to uremia
• Anticipated need to begin renal replacement therapy in the next 6 months
• History of kidney transplant

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• AbbVie: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Hepatitis C, Chronic

Interventions

glecaprevir and pibrentasvir

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hepatitis C; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases

Limitations and Caveats

Our study has several limitations. Our pilot trial was limited by the small number of patients enrolled. Additionally, two subjects were lost to follow-up, decreasing the power of our analysis comparing pre- and post-treatment kidney function and biomarkers. Thus, the analysis presented is descriptive in nature. The analysis is limited by the absence of a control group.

Results Point of Contact

• Title: Dr. Raymond Chung
• Organization: Massachusetts General Hospital

Chung.Raymond@mgh.harvard.edu

617-726-5925

Study Officials

• Raymond T Chung, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Hepatology, Massachusetts General Hospital

Model Details: This a single-arm study. Initially, Viekira Pak was available through Abbvie. However, once Mavyret became available, it supplanted Viekira Pak as the study medication.

Study Record Dates

• First Submitted: October 21, 2016
• First Posted: October 26, 2016
• Study Start: February 1, 2017
• Primary Completion: September 16, 2020
• Study Completion: September 16, 2020
• Last Updated: November 5, 2021
• Results First Posted: November 5, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will share

Locations

US (1)