QUICKly Eradicate Hepatitis C in Patients Undergoing REnal Transplant With 4 Weeks of Glecaprevir/Pibrentasvir (QUICK-CURE)

This is a single center study characterizing the experience of administration of 4 weeks of pan-genotypic DAA therapy in kidney transplantation to prevent the transmission of hepatitis C virus infection from an HCV-positive donor kidney to an HCV-negative recipient.

Study Overview

• Status: Completed
• Conditions: Hepatitis C; Kidney Disease, Chronic; Kidney Failure
• Intervention / Treatment: Drug: Glecaprevir and Pibrentasvir

Detailed Description

The goal of this study is to determine if the administration of glecaprevir and pibrentasvir (G/P) for 4 weeks beginning in the immediate peri-transplant period prevents establishment of HCV infection in HCV negative recipients receiving transplanted kidneys from HCV RNA positive donors.

• Study Type: Interventional
• Enrollment (Actual): 2
• 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

Description

Inclusion Criteria (Recipient)

1. Met MGH Transplant Center criteria and already listed for kidney transplant with stage 5 CKD / ESRD (eGFR <15 ml/min/1.73m2 or on renal replacement therapy)
2. Must agree to birth control. Women must agree to use birth control in accordance with Mycophenolate Risk Evaluation and Mitigation Strategy and at least one barrier method
3. No evidence of clinically significant liver disease at the time of transplant readiness as determined by the clinical team
4. Able to sign informed consent

Inclusion Criteria (Deceased Donor)

1. Detectable HCV NAT test
2. KDPI score is less than ≤ 0.850
3. Traditional Donor Selection Criteria Met - acceptable for transplantation per usual evaluation

Exclusion Criteria (Recipient)

1. Pregnant or nursing (lactating) women
2. HBV positivity (Ag or DNA)
3. Any contra-indication to kidney transplantation per MGH transplant center protocol
4. Any signs or symptoms of clinically significant chronic liver disease per transplant center physician
5. Inability to discontinue any medication with a known drug-drug interaction as listed in the G/P package insert

Exclusion Criteria (Deceased Donor)

1. Confirmed HIV
2. Confirmed HBV positive (surface antigen or HBV DNA positive)
3. Any standard contra-indication to donation noted in donor (significant malignancy, unusual infection, kidney anatomical damage or significant pathology)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment with Direct Acting Antiviral for HCV; 4 week treatment period with glecaprevir and pibrentasvir (G/P) within 24 hours of transplant	Drug: Glecaprevir and Pibrentasvir; 4 weeks of treatment starting within 24 hrs of kidney transplant; Other Names: Mavyret; Direct Acting Antiviral HCV Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SVR12	Sustained virologic response 12 weeks after completing G/P	12 weeks post-treatment (16 weeks post-transplant)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Events	Serious and non-serious adverse events attributed to study drug and/or HCV-viremia	1 Year Study Period
HCV RNA Viral Load	Assessment of HCV RNA viral load at on-treatment visits	Weeks 2 and 4 of Treatment
Allograft Function	Post-transplant allograft function measured by mean eGFR over study period	1 Year Study Period
Rate of Death, Graft Failure, Acute Allograft Rejection, Delayed graft function, ALT elevation	The rate of clinical safety outcomes: death, graft failure, acute allograft rejection, delayed graft functions, ALT elevations > 5x ULN	1 Year Study Period

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Investigators: Principal Investigator: Nahel Elias, MD, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2021
• Primary Completion (Actual): August 31, 2023
• Study Completion (Actual): August 31, 2023

Study Registration Dates

• First Submitted: August 13, 2020
• First Submitted That Met QC Criteria: August 13, 2020
• First Posted (Actual): August 17, 2020

Study Record Updates

• Last Update Posted (Estimated): October 9, 2023
• Last Update Submitted That Met QC Criteria: October 6, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: HCV; Hepatitis C; Kidney Failure; Kidney Transplant
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Urologic Diseases; Disease Attributes; Liver Diseases; Flaviviridae Infections; Hepatitis, Viral, Human; Enterovirus Infections; Picornaviridae Infections; Chronic Disease; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Renal Insufficiency, Chronic; Hepatitis; Hepatitis A; Hepatitis C; Renal Insufficiency; Anti-Infective Agents; Antiviral Agents
• Other Study ID Numbers: 2020P002523

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.: Yes