Trial Outcomes & Findings for QUICKly Eradicate Hepatitis C in Patients Undergoing REnal Transplant With 4 Weeks of Glecaprevir/Pibrentasvir (NCT NCT04515797)

NCT ID: NCT04515797

Last Updated: 2024-12-03

Results Overview

Negative HCV RNA by blood testing at 12 weeks after the last dose of G/P

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 2 participants
• Primary outcome timeframe: 12 weeks post last dose of treatment with G/P
• Results posted on: 2024-12-03

Participant Flow

18 HCV negative subjects were agreed to receive kidney transplant from HCV RNA-positive donors, resulting in 2 subjects enrolled (transplanting with an HCV RNA positive kidney). Recruitment began in May 2021 and ended in August 2023 when enrollment was closed prior to study completion.

Participant milestones

Measure	Treatment With Direct Acting Antiviral for HCV 4 week treatment period with glecaprevir and pibrentasvir (G/P) initiated within 24 hours of transplant Glecaprevir and Pibrentasvir: 4 weeks of treatment starting within 24 hrs of kidney transplant
Overall Study STARTED	2
Overall Study COMPLETED	2
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

QUICKly Eradicate Hepatitis C in Patients Undergoing REnal Transplant With 4 Weeks of Glecaprevir/Pibrentasvir

Baseline characteristics by cohort

Measure	Treatment With Direct Acting Antiviral for HCV n=2 Participants 4 week treatment period with glecaprevir and pibrentasvir (G/P) initiated within 24 hours of transplant Glecaprevir and Pibrentasvir: 4 weeks of treatment starting within 24 hrs of kidney transplant
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	2 participants n=5 Participants
Adults receiving kidney transplant from HCV RNA positive donor	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks post last dose of treatment with G/P

Population: Subjects receiving at least 1 dose of G/P after receipt of donor HCV RNA positive kidney transplant

Negative HCV RNA by blood testing at 12 weeks after the last dose of G/P

Outcome measures

Measure	Treatment With Direct Acting Antiviral for HCV n=2 Participants 4 week treatment period with glecaprevir and pibrentasvir (G/P) initiated within 24 hours of transplant Glecaprevir and Pibrentasvir: 4 weeks of treatment starting within 24 hrs of kidney transplant
Number of Participants With Undetectable Blood HCV RNA Level	2 Participants

SECONDARY outcome

Timeframe: 1 Year Study Period

Population: Subjects receiving HCV RNA positive kidney transplant and initiating treatment with DAA experience protocol related adverse events

Serious and non-serious adverse events attributed to study drug and/or HCV-viremia

Outcome measures

Measure	Treatment With Direct Acting Antiviral for HCV n=2 Participants 4 week treatment period with glecaprevir and pibrentasvir (G/P) initiated within 24 hours of transplant Glecaprevir and Pibrentasvir: 4 weeks of treatment starting within 24 hrs of kidney transplant
Adverse Events	0 Participants

SECONDARY outcome

Timeframe: Measured at Week 2 and Week 4 of Treatment;

Population: Subjects receiving HCV RNA positive kidney transplant and initiating treatment with DAA with a negative HCV viral load at the 2 week and 4 week treatment mark of the full 4 week treatment period. For both participants, the measured HCV RNA was 0 copies/mL (no copies present in the sample/undetectable HCV RNA).

Assessment of HCV RNA viral load at on-treatment visits, measured at both week 2 and week 4 on treatment. The viral loads measured at Week 2 and 4 are averaged together and reported in copies per mL

Outcome measures

Measure	Treatment With Direct Acting Antiviral for HCV n=2 Participants 4 week treatment period with glecaprevir and pibrentasvir (G/P) initiated within 24 hours of transplant Glecaprevir and Pibrentasvir: 4 weeks of treatment starting within 24 hrs of kidney transplant
HCV RNA Viral Load	0 copies per mL Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: 1 Year Study Period

Population: Data not collected

Post-transplant allograft function measured by mean eGFR over study period

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 Year Study Period

Population: Reportable outcome events in patients who 4 weeks of study treatment with glecaprevir/pibrentasvir

The rate of clinical safety outcomes: death, graft failure, acute allograft rejection, delayed graft functions, ALT elevations > 5x ULN related to study treatment with glecaprevir/Pibrentasvir

Outcome measures

Measure	Treatment With Direct Acting Antiviral for HCV n=2 Participants 4 week treatment period with glecaprevir and pibrentasvir (G/P) initiated within 24 hours of transplant Glecaprevir and Pibrentasvir: 4 weeks of treatment starting within 24 hrs of kidney transplant
Rate of Death, Graft Failure, Acute Allograft Rejection, Delayed Graft Function, ALT Elevation	0 reported outcome events Interval 0.0 to 0.0

Adverse Events

Treatment With Direct Acting Antiviral for HCV

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Raymond Chung

Massachusetts General Hospital

Phone: 6177247562

Email: Chung.Raymond@mgh.harvard.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place