What side effects are associated with this type of intervention?

Common treatments for Hepatitis C, such as the direct-acting antivirals Sofosbuvir and Ledipasvir, are generally well-tolerated. The most frequently reported side effects include headache, fatigue, nausea, and insomnia. Serious adverse events are rare but can include anemia and depression. Patients should also be aware of potential drug interactions, especially with medications that affect gastric pH or are P-glycoprotein inducers.

What prior FDA approvals exist?

The FDA has approved several direct-acting antivirals (DAAs) for the treatment of Hepatitis C, significantly improving cure rates and tolerability. Key approvals include Sofosbuvir (Sovaldi) and Ledipasvir-Sofosbuvir (Harvoni), which target the NS5B polymerase and NS5A protein, respectively. Other notable combinations include Sofosbuvir-Velpatasvir (Epclusa) and Glecaprevir-Pibrentasvir (Mavyret), which are effective across multiple HCV genotypes. These DAAs have largely replaced older interferon-based therapies due to their higher efficacy and better safety profiles.

What other types of research exist?

Promising alternatives to Sofosbuvir and Ledipasvir for Hepatitis C treatment include: <ol> <li>Elbasvir-Grazoprevir: Effective in preventing chronic HCV infection in transplant recipients and maintaining good kidney allograft function.</li> <li></li> </ol> Glecaprevir-Pibrentasvir: Demonstrated high sustained virologic response (SVR) rates and well-tolerated with mild adverse effects. 3. Sofosbuvir-Velpatasvir: Used successfully in various DAA regimens with shorter treatment durations. These alternatives offer effective treatment options with different mechanisms of action and have shown promising results in clinical trials.

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Anti-viral

Preemptive Mavyret Therapy for Hepatitis C in Organ Transplant Recipients

Phase 4

Recruiting

Led By Bashar A Aqel

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Drug Has Already Been Approved

Summary

This trial is testing if using two medicines together can stop Hepatitis C from spreading to people who get an organ transplant from a donor with Hepatitis C. The goal is to protect the new organ recipient from getting infected by the virus.

Who is the study for?

This trial is for kidney, heart, lung, or pancreas transplant patients without chronic hepatitis C. Participants must be willing to accept a graft from a donor with hepatitis C and understand the risks of acquiring HCV infection. Those with chronic liver disease, pregnant women, or individuals with HIV or chronic hepatitis B cannot join.

What is being tested?

The study tests the effectiveness of Mavyret in preventing the transmission of Hepatitis C from an infected donor to a recipient who does not have Hepatitis C during organ transplantation.

What are the potential side effects?

Mavyret may cause side effects such as headache, fatigue, nausea and insomnia. It can also lead to temporary increases in certain liver enzymes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Graft and patient survival

Rate of prevention of HCV viremia in recipients of HCV viremic solid organs

Side effects data

From 2020 Phase 4 trial • 10 Patients • NCT02946034

30%

fatigue

10%

Hypertensive emergency

10%

anemia

10%

Cryoglobulinemic glomerulonephritis

10%

Heart block

10%

muscle pain in leg

10%

cryoglobulinemia

10%

slow ventricular response

10%

high potassium

10%

Seizure

10%

Fall / loss of consciousness

10%

Abdominal pain

10%

Stroke

100%

80%

60%

40%

20%

Study treatment Arm

Viekira Pak ± Ribavirin or Mavyret

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Arm 1: Pre-emptive Treatment ArmExperimental Treatment1 Intervention

Single arm study were all recipients of HCV viremic organs will receive combination therapy.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Mavyret

2018

Completed Phase 4

~110

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Direct-acting antivirals (DAAs) like Sofosbuvir and Ledipasvir are commonly used to treat Hepatitis C by targeting specific proteins essential for the virus's replication. Sofosbuvir inhibits the NS5B RNA polymerase, crucial for viral RNA synthesis, while Ledipasvir targets the NS5A protein, involved in viral replication and assembly. These targeted actions result in high cure rates and fewer side effects, making the treatment more tolerable and effective for patients, thereby significantly improving their outcomes.

Hepatitis C virus infection.Ledipasvir-sofosbuvir: interferon-/ribavirin-free regimen for chronic hepatitis C virus infection.