HCVPREVENT-HCVNCT05653232
Prophylaxis With Direct-acting Antivirals for Kidney Transplantation From HCV-Infected Donors to Uninfected Recipients
A study testing Prophylaxis (P2W) and Transmit and Treat (T&T) in people with HCV, run by Johns Hopkins University at 9 sites in United States.
Trial summary
This study is being done to find out the best time to start medication for Hepatitis C Virus (HCV) in HCV-negative recipients of HCV-positive (HCV D+/R-) kidney transplants. Participants will be randomized into one of two groups: Arm 1 - Prophylaxis: This group will start the HCV medication before transplant and will… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HCV
- What is being tested?
- Prophylaxis (P2W) and Transmit and Treat (T&T)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 9 sitesUnited States
- Study dates
- 19 Apr 2023to Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant meets the standard criteria for KT at local center.
- Participant is able to understand and provide informed consent.
- Participant is ≥ 18 years old.
Who cannot join
- Participant has active HCV infection (detectable HCV RNA) at time of screening.
- Participant has cirrhosis or advanced liver fibrosis.
- Participant's aspartate aminotransferase (AST) or ALT > 2.5 times the upper limit of normal (ULN), within 60 days of screen.
- Participant has human immunodeficiency virus infection (HIV), or active hepatitis B (HBV) infection.
- Participant is unable to safely substitute or discontinue a medication that is contraindicated with the study medication.
- Past or current medical problems, which may pose additional risks from participation in the study, interfere with the participant's ability to comply with study, or impact the quality of the data obtained from the study.
- Participant is pregnant or breastfeeding.
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
United States9 sites, 7 recruiting
- Recruiting
Johns Hopkins University
Baltimore, Maryland, 21205
Christine Durand, MD, 410-955-5684, cdurand2@jhmi.edu
Christine Durand, MD
- Recruiting
University of California San Diego
La Jolla, California, 92037
Saima Aslam, MD, saslam@ucsd.edu
Saima Aslam, MD
- Recruiting
Loma Linda University Health
Loma Linda, California, 92408
Mina Rakoski, MD, mrakoski@llu.edu
Mina Rakoski, MD
- Terminated
University of Wisconsin, Madison
Madison, Wisconsin, 53792
- Recruiting
NYU Langone Health
New York, New York, 10016
Aprajita Mattoo, MD, Aprajita.Matoo@nyulangone.org
Aprajita Mattoo, MD
- Recruiting
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Susan Lerner, MD, Susan.Lerner@mountsinai.org
Susan Lerner, MD
- Recruiting
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
Fernanda Silveira, MD, silvfd@upmc.edu
Fernanda Silveira, MD
- Recruiting
Virginia Commonwealth University
Richmond, Virginia, 23298
Gaurav Gupta, MD, gaurav.gupta@vcuhealth.org
Gaurav Gupta, MD
- Active, not recruiting
University of Utah Medical Center
Salt Lake City, Utah, 84132
About this study
Official title: Prophylaxis With Direct-acting Antivirals for Kidney Transplantation From Hepatitis C Virus-Infected Donors to Uninfected Recipients: a Randomized Controlled Trial
This study is being done to find out the best time to start medication for Hepatitis C Virus (HCV) in HCV-negative recipients of HCV-positive (HCV D+/R-) kidney transplants. Participants will be randomized into one of two groups:
Arm 1 - Prophylaxis: This group will start the HCV medication before transplant and will take a shorter course of HCV medication for 2 weeks.
Arm 2 - Transmit and Treat: This group will start the HCV medication after transplant and will take the full course (12 weeks) of HCV medication.
Read the detailed description
In the past, HCV-positive (HCV+) kidneys were not given to HCV-negative recipients. But over the last few years, medications have been created that cure HCV in nearly 100% of patients. HCV+ transplants to HCV-negative recipients have become increasingly common now that HCV can be cured.
There are two approaches to giving HCV medication to recipients of these transplants. The first is a prophylaxis approach. With prophylaxis, HCV medication is started before transplant and continued for a shorter course after transplant. The second is a transmit-and-treat approach. With transmit-and-treat, HCV medication is started after transplant and continued for the full, recommended course. Both approaches have successfully cured HCV in HCV-negative recipients of HCV+ organs.
This research will use a study drug called sofosbuvir/velpatasvir (SOF/VEL). It contains two drugs for treating HCV in one pill. We will compare giving SOF/VEL for 2 weeks starting pre-transplant (prophylaxis) to giving SOF/VEL for 12 weeks starting no later than 14 days post-transplant (transmit-and-treat).
SOF/VEL belongs to a group of medications called direct-acting antiviral agents (DAAs). These drugs prevent HCV from multiplying and spreading in the human body. SOF/VEL are already approved and used for 12 weeks to treat HCV infection. The use of SOF/VEL for 2 weeks in preventing HCV infection has not been studied. The FDA is allowing SOF/VEL to be used in this study.
- Conditions
- HCV
- Being tested
- Prophylaxis (P2W), Transmit and Treat (T&T)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prophylaxis (P2W)Other
For participants enrolled in P2W arm, the initial dose of SOF/VEL will be administered to the recipient when called to the operating room for transplant (typically 1-3 hours prior to the start of surgery). Post-transplant, SOF/VEL will be continued daily for 13 days post-KT (a total of 14 doses administered).
Transmit and Treat (T&T)Other
For participants enrolled in T\&T arm, SOF/VEL will begin between post-KT day 0 and post-KT day 14. Participants will be clinically-prescribed DAAs once viremia is detected, and participant's insurance will be petitioned to obtain treatment as soon as possible. If insurance-provided DAAs are approved before post-KT day 14, participant will begin 12 weeks of study-provided SOF/VEL on date of insurance-provided DAAs approval. If insurance-provided DAAs are not approved by post-KT day 14, study-provided SOF/VEL will begin on post-KT day 14 and continue for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Prophylaxis (P2W) | Experimental | Prophylaxis is one dose of sofosbuvir/velpatasvir (SOF/VEL) pre-HCV D+/R- kidney transplant (KT), continued for 2 weeks. Receives: Other: Prophylaxis (P2W) |
| Transmit and Treat (T&T) | Experimental | T\&T is study-supplied SOF/VEL for 12 weeks starting on post-HCV D+/R- kidney transplant day participant's insurance approves standard of care DAAs, or post-KT day 14, whichever comes first. Receives: Other: Transmit and Treat (T&T) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite event of HCV-related or HCV treatment-related death, fibrosing cholestatic hepatitis, or HCV relapse
Proportion of events in each arm.
Measured: Within 26 weeks of transplant
Number of participants with liver injury
Measured with a longitudinal model of Alanine aminotransferase (ALT).
Measured: The first 28 days post-transplant
Secondary outcomes (11)
Participant survival
Time to event (death)
Measured: At 6 months and 1 year post-transplant
Graft survival
Time to event (graft loss)
Measured: At 6 months and 1 year post-transplant
HCV plasma RNA
Based on local testing
Measured: At week 26 post-transplant
Graft rejection
Cumulative incidence of rejection
Measured: At 6 months and 1 year post-transplant
Prevalence of donor specific antibody (DSA)
Proportion of participants with a de novo donor-specific human leukocyte antigen (HLA) antibody as measured and reported by local sites' lab
Measured: At 4 weeks and 6 months post-transplant, and with any episode of clinically suspected or proven rejection.
Graft function - eGFR <60
Proportion of participants with glomerular filtration rate (eGFR) by Chronic Kidney Disease Epidemiology Collaboration equation (CKD-EPI) < 60 mL/min/1.73 m2
Measured: Months 3, 6, 9, and 12 post-transplant
Graft function - mean eGFR
Mean calculated eGFR by CKD-EPI
Measured: Months 3, 6, 9, and 12 post-transplant
Graft function - eGFR slope
The slope of eGFR by CKD-EPI, over time based on serum creatinine
Measured: Months 3, 6, 9, and 12 post-transplant
Development of HCV resistance-associated variants (RAVs)
Proportion of participants with RAVs as measured and reported by local sites' lab
Measured: With any HCV viremia after P2W or T&T through end of follow up (at least 6 months, up to 3 years post-transplant)
Incidence and severity of bacterial, fungal, viral, and opportunistic infections
Cumulative incidence of infections
Measured: From transplant through end of follow up (at least 6 months, up to 3 years post-transplant)
Incidence of surgical and vascular complications
Number of surgical and vascular complications
Measured: During the first year post-transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2022
- Study start19 Apr 2023
- Primary completionSep 2027 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HCVStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christine Durand, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05653232
- Sponsor's protocol ID
- IRB00316833
- Other IDs
- U01AI157931
- Acronym
- PREVENT-HCV
- Status last verified
- Sep 2026
- First submitted
- 6 Dec 2022
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prophylaxis With Direct-acting Antivirals for Kidney Transplantation From Hepatitis C Virus-Infected Donors to Uninfected Recipients: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05653232
- Acronym / sponsor ID
- PREVENT-HCV / IRB00316833
- Conditions
- HCV
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- 19 Apr 2023 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 16 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is being done to find out the best time to start medication for Hepatitis C Virus (HCV) in HCV-negative recipients of HCV-positive (HCV D+/R-) kidney transplants. Participants will be randomized into one of two groups:
Arm 1 - Prophylaxis: This group will start the HCV medication before transplant and will take a shorter course of HCV medication for 2 weeks.
Arm 2 - Transmit and Treat: This group will start the HCV medication after transplant and will take the full course (12 weeks) of HCV medication.
Detailed description
In the past, HCV-positive (HCV+) kidneys were not given to HCV-negative recipients. But over the last few years, medications have been created that cure HCV in nearly 100% of patients. HCV+ transplants to HCV-negative recipients have become increasingly common now that HCV can be cured.
There are two approaches to giving HCV medication to recipients of these transplants. The first is a prophylaxis approach. With prophylaxis, HCV medication is started before transplant and continued for a shorter course after transplant. The second is a transmit-and-treat approach. With transmit-and-treat, HCV medication is started after transplant and continued for the full, recommended course. Both approaches have successfully cured HCV in HCV-negative recipients of HCV+ organs.
This research will use a study drug called sofosbuvir/velpatasvir (SOF/VEL). It contains two drugs for treating HCV in one pill. We will compare giving SOF/VEL for 2 weeks starting pre-transplant (prophylaxis) to giving SOF/VEL for 12 weeks starting no later than 14 days post-transplant (transmit-and-treat).
SOF/VEL belongs to a group of medications called direct-acting antiviral agents (DAAs). These drugs prevent HCV from multiplying and spreading in the human body. SOF/VEL are already approved and used for 12 weeks to treat HCV infection. The use of SOF/VEL for 2 weeks in preventing HCV infection has not been studied. The FDA is allowing SOF/VEL to be used in this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prophylaxis (P2W) | Experimental | Other: Prophylaxis (P2W)Prophylaxis is one dose of sofosbuvir/velpatasvir (SOF/VEL) pre-HCV D+/R- kidney transplant (KT), continued for 2 weeks. |
| Transmit and Treat (T&T) | Experimental | Other: Transmit and Treat (T&T)T\&T is study-supplied SOF/VEL for 12 weeks starting on post-HCV D+/R- kidney transplant day participant's insurance approves standard of care DAAs, or post-KT day 14, whichever comes first. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participant meets the standard criteria for KT at local center.
- Participant is able to understand and provide informed consent.
- Participant is ≥ 18 years old.
Key exclusion criteria (7 listed)
- Participant has active HCV infection (detectable HCV RNA) at time of screening.
- Participant has cirrhosis or advanced liver fibrosis.
- Participant's aspartate aminotransferase (AST) or ALT > 2.5 times the upper limit of normal (ULN), within 60 days of screen.
- Participant has human immunodeficiency virus infection (HIV), or active hepatitis B (HBV) infection.
- Participant is unable to safely substitute or discontinue a medication that is contraindicated with the study medication.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prophylaxis (P2W)For participants enrolled in P2W arm, the initial dose of SOF/VEL will be administered to the recipient when called to the operating room for transplant (typically 1-3 hours prior to the start of surgery). Post-transplant, SOF/VEL will be continued daily for 13 days post-KT (a total of 14 doses administered). | Other | Prophylaxis (P2W) |
| Transmit and Treat (T&T)For participants enrolled in T\&T arm, SOF/VEL will begin between post-KT day 0 and post-KT day 14. Participants will be clinically-prescribed DAAs once viremia is detected, and participant's insurance will be petitioned to obtain treatment as soon as possible. If insurance-provided DAAs are approved before post-KT day 14, participant will begin 12 weeks of study-provided SOF/VEL on date of insurance-provided DAAs approval. If insurance-provided DAAs are not approved by post-KT day 14, study-provided SOF/VEL will begin on post-KT day 14 and continue for 12 weeks. | Other | Transmit and Treat (T&T) |
Primary outcome
Composite event of HCV-related or HCV treatment-related death, fibrosing cholestatic hepatitis, or HCV relapse
Time frame: Within 26 weeks of transplant
Proportion of events in each arm.
Number of participants with liver injury
Time frame: The first 28 days post-transplant
Measured with a longitudinal model of Alanine aminotransferase (ALT).
11 secondary outcomes
Participant survival
Time frame: At 6 months and 1 year post-transplant
Graft survival
Time frame: At 6 months and 1 year post-transplant
HCV plasma RNA
Time frame: At week 26 post-transplant
Graft rejection
Time frame: At 6 months and 1 year post-transplant
Prevalence of donor specific antibody (DSA)
Time frame: At 4 weeks and 6 months post-transplant, and with any episode of clinically suspected or proven rejection.
Graft function - eGFR <60
Time frame: Months 3, 6, 9, and 12 post-transplant
Graft function - mean eGFR
Time frame: Months 3, 6, 9, and 12 post-transplant
Graft function - eGFR slope
Time frame: Months 3, 6, 9, and 12 post-transplant
Development of HCV resistance-associated variants (RAVs)
Time frame: With any HCV viremia after P2W or T&T through end of follow up (at least 6 months, up to 3 years post-transplant)
Incidence and severity of bacterial, fungal, viral, and opportunistic infections
Time frame: From transplant through end of follow up (at least 6 months, up to 3 years post-transplant)
Incidence of surgical and vascular complications
Time frame: During the first year post-transplant
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christine Durand, MD principal investigator
Johns Hopkins University
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prophylaxis (P2W) and Transmit and Treat (T&T) in people with HCV, run by Johns Hopkins University at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christine Durand, MD (410-955-5684, cdurand2@jhmi.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite event of HCV-related or HCV treatment-related death, fibrosing cholestatic hepatitis, or HCV relapse (time frame: Within 26 weeks of transplant). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026.