Transplanting Hepatitis C Positive Organs

Mass General Brigham

Status and phase: Enrolling; Phase 4

Conditions: Hepatitis C; Awaiting Organ Transplant

Treatments: Other: Monitoring; Drug: Sofosbuvir/velpatasvir

Study type: Interventional

Funder types: Other

Identifiers

NCT03086044

2016-P001170

Details and patient eligibility

About

This is an open-label, pilot safety and efficacy trial for adults who are active on the heart, lung, or kidney transplantation lists and are eligible to receive an organ from an increased risk donor who has evidence of active or prior hepatitis C infection (HCV).

Full description

This is an open label pilot study transplanting organs from Hepatitis C positive donors into HCV uninfected recipients at Brigham and Women's Hospital. Heart, lung and kidney transplant participants will be stratified into two different study arms depending on whether the donor of the organ was HCV nucleic acid amplifications technology (NAT) positive or negative. In the NAT positive arm, the recipients will receive a course of direct acting antivirals (DAA) to begin on the day of transplant. If the donor was HCV antibody (Ab) positive and NAT negative, the recipients will receive close monitoring with serial HCV viral loads (VL) and will only begin treatment with DAA if they develop HCV viremia.

Enrollment: 148 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Men and women who are age ≥ 18 years
• Active on either the cardiac, lung, or kidney transplant waiting list
• Willing and able to provide written informed consent to receive organs from an increased risk donor with a known transmissible infection

Exclusion criteria

• Hepatitis B NAT or viral load positive
• Evidence of cirrhosis or clinically significant liver disease

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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148 participants in 2 patient groups

HCV NAT Positive Donor

Experimental group

Description:

Intervention: 2 week treatment course with a direct acting antiviral, sofosbuvir 400mg / velpatasvir 100mg daily Participants who receive allografts from a donor who is HCV NAT positive will receive treatment with a direct acting antiviral, sofosbuvir 400mg / velpatasvir 100mg daily, beginning on the day of transplant.

Treatment:

Drug: Sofosbuvir/velpatasvir

HCV NAT Negative, HCV Ab Positive Donor

Experimental group

Description:

Intervention: HCV viral load monitoring Participants who receive allografts from a donor who is HCV Ab positive and NAT negative will have close serial HCV viral load monitoring and will be treated with a direct acting antiviral, 400mg / velpatasvir 100mg daily, for 6 weeks if HCV viremia develops.

Treatment:

Drug: Sofosbuvir/velpatasvir

Other: Monitoring