What side effects are associated with this type of intervention?

Common treatments for heart failure include ACE inhibitors, beta-blockers, diuretics, and aldosterone antagonists. ACE inhibitors can cause cough, elevated blood potassium levels, and low blood pressure. Beta-blockers may lead to fatigue, cold extremities, and bradycardia. Diuretics often result in electrolyte imbalances and dehydration. Aldosterone antagonists can cause hyperkalemia and renal dysfunction. Direct-acting antivirals like Sofosbuvir/Velpatasvir, primarily used for HCV, are generally well-tolerated but can have cardiovascular side effects such as bradycardia, especially when co-administered with other medications like amiodarone.

What prior FDA approvals exist?

FDA-approved treatments for heart failure include a variety of medications aimed at improving heart function and managing symptoms. These include ACE inhibitors (e.g., enalapril), angiotensin II receptor blockers (ARBs) (e.g., losartan), beta-blockers (e.g., metoprolol), and mineralocorticoid receptor antagonists (e.g., spironolactone). Additionally, newer classes of drugs such as angiotensin receptor-neprilysin inhibitors (ARNIs) like sacubitril/valsartan and SGLT2 inhibitors (e.g., dapagliflozin) have been approved for heart failure management. While these treatments do not directly relate to antiviral mechanisms like Sofosbuvir/Velpatasvir, they represent the current landscape of heart failure therapeutics.

What other types of research exist?

For heart failure patients considering treatment in 2024, promising novel alternatives to Sofosbuvir/Velpatasvir include Tenofovir Alafenamide (TAF) and Tenofovir Disoproxil Fumarate (TDF). Both have shown efficacy in treating chronic hepatitis B and may offer benefits in managing hepatitis C, especially in patients with comorbid conditions like heart failure. Additionally, Peginterferon (PegIFN) may be considered for select patients due to its cost-effectiveness and finite treatment duration.

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Direct-Acting Antiviral

Epclusa for Heart Transplant Recipients with Hepatitis C (TROJAN-C Trial)

Phase 2

Waitlist Available

Research Sponsored by Baylor Research Institute

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

Summary

This trial tests if using hearts from donors with Hepatitis C for transplants in patients without Hepatitis C is safe and effective by treating them with Epclusa®. It targets patients who urgently need a heart transplant. Epclusa® works by stopping the Hepatitis C virus from multiplying. Epclusa® has been shown to be effective in treating Hepatitis C virus (HCV) infections, including in transplant recipients.

Who is the study for?

This trial is for adults over 18 who need a heart transplant and don't have Hepatitis C. They must be willing to give consent, not have had any organ transplants before, and can't be pregnant or have severe kidney disease requiring dialysis. People with a history of HIV or certain levels of liver damage aren't eligible.

What is being tested?

The study tests the safety and effectiveness of using hearts from donors with Hepatitis C in recipients without the virus, treating them with Epclusa after transplantation to prevent infection.

What are the potential side effects?

Epclusa may cause headaches, fatigue, nausea, insomnia, and less commonly rash or depression. It's important for participants to report any side effects they experience during the trial.

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

Sustained virologic response after 12 weeks of treatment

Secondary study objectives

1-year post-transplant survival

Side effects data

From 2019 Phase 2 & 3 trial • 10 Patients • NCT02825212

40%

Increased fatigue

30%

nausea and abdominal pain

20%

Urinary frequency and/or dysuria

10%

Herpes Zoster

100%

80%

60%

40%

20%

Study treatment Arm

Pts With Hep C Virus Infection-Related Cryoglobulinemia

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: TreatmentExperimental Treatment1 Intervention

Epclusa® will be started within 14 days of quantifiable viremia and continued for 12 weeks. Within 24 hours prior to first-dose of treatment, HCV genotype will be sent from transplant recipient.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Epclusa

2016

Completed Phase 3

~30

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

Common treatments for heart failure include ACE inhibitors, which reduce blood pressure and decrease the heart's workload by inhibiting the conversion of angiotensin I to angiotensin II; beta-blockers, which slow the heart rate and reduce blood pressure by blocking the effects of adrenaline; diuretics, which help remove excess fluid from the body, reducing the strain on the heart; and aldosterone antagonists, which prevent sodium retention and reduce fluid buildup. These treatments are crucial for heart failure patients as they help improve heart function, reduce symptoms, and prevent hospitalizations, thereby enhancing the quality of life and survival rates.