CLINICAL TRIAL

sofosbuvir/velpatasvir for Hepatitis

Waitlist Available · 18+ · All Sexes · Pittsburgh, PA

This study is evaluating whether hearts from donors with hepatitis C may be safe for transplantation into recipients.

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About the trial for Hepatitis

Eligible Conditions
Hepatitis C · Cardiac Transplant · Hepatitis · Hepatitis A

Treatment Groups

This trial involves 2 different treatments. Sofosbuvir/velpatasvir is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Experimental Group 1
sofosbuvir/velpatasvir
DRUG
Experimental Group 2
sofosbuvir/velpatasvir
DRUG

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Velpatasvir
FDA approved

Side Effect Profile for Single Arm Intervention

Single Arm Intervention
Show all side effects
GI distress
18%
Altered Mental Status
9%
Suicidal Ideation
9%
Fatigue
9%
Scabies
9%
Visual Hallucination
9%
Seizure
9%
This histogram enumerates side effects from a completed 2019 Phase 4 trial (NCT03235154) in the Single Arm Intervention ARM group. Side effects include: GI distress with 18%, Altered Mental Status with 9%, Suicidal Ideation with 9%, Fatigue with 9%, Scabies with 9%.

Eligibility

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
End stage heart failure
Age ≥ 18 and <71 years
No obvious contraindication to liver transplant
Able to travel to UPMC for routine post-transplant visits and study visits for a minimum of 12 months after transplantation
Be willing to use a contraceptive method for a year after transplant
HCV NAT negative or positive
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 5 years
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 5 years.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether sofosbuvir/velpatasvir will improve 2 primary outcomes and 5 secondary outcomes in patients with Hepatitis. Measurement will happen over the course of 1 year.

HCV free at 1 year
1 YEAR
Proportion of participants in each experimental group who are free of HCV at 1 year following transplantation
Incidence of allograft rejection
5 YEARS
Incidence of graft loss
5 YEARS
Transmission rate of HCV from HCVAb+/NAT- donors to HCVAb- recipients
5 YEARS
Adverse Events
5 YEARS
Rate of adverse events due to sofosbuvir/velpatasvir (Epclusa) in patients in each experimental group
All-cause mortality
5 YEARS
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Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is hepatitis?

The World Health Organization classifies hepatitis as one of more than 100 diseases transmitted by blood-sucking insects, such as mosquitoes and phlebotomine sandflies, collectively known as the'vector diseases'.\n

Anonymous Patient Answer

What causes hepatitis?

Hepatitis is a contagious disease and infections occurring before the development of the chronic form can result in remission, whereas those occurring later are likely to be chronic in nature. Hepatitis B virus may be especially associated with chronic infections. Risk factors for progression to chronicity include the degree and severity of viral antigenicity, the presence of antigens in the blood, and the presence of antigens in the gut.

Anonymous Patient Answer

Can hepatitis be cured?

Hepatitis is not a curable disease. The cure rate of standard management is low. It depends the cause of chronic hepatitis, the severity and the age of the patient. However, patients with hepatitis A can be cured, while hepatitis B, hepatitis C, and HBV hepatitis are mostly incurable.

Anonymous Patient Answer

What are the signs of hepatitis?

Most people with hepatitis feel tired. Others feel weak, fatigued and have headaches. Complications, including inflammation of the brain, include loss of appetite and shortness of breath. Hepatitis can cause fatty liver, which is associated with jaundice (abnormal yellowing of the skin and the whites of the eyes). Other complications can include cirrhosis or cancer of the liver. The liver normally clears the products of liver illness, but after long-term heavy liver infections, a scar may be formed. This scar, known as fibrosis, may eventually lead to liver cancer or liver failure.

Anonymous Patient Answer

How many people get hepatitis a year in the United States?

The estimated number of new U.S. hepatitis infections in 2006 was 15 million with an estimated incidence rate of 6.4/10,000/year for hepatitis A; 4.9/10,000/year for hepatitis B; and 3.9/10,000/year for hepatitis C. The estimates for hepatitis E and hepatitis G were 4.3/10,000/year and 4.1/10,000/year, respectively.

Anonymous Patient Answer

What are common treatments for hepatitis?

Most treatment strategies are directed towards the patient's symptoms. If an underlying cause is discovered, various treatment options may be considered. These include vaccination, medications to treat or prevent viral hepatitis, liver function tests for screening in case a hepatitis is a contributing factor, or transplantation if the condition proves fatal or is refractory.

Anonymous Patient Answer

Does hepatitis run in families?

We identified a strong risk of HCC development in familial cases. This indicates a high level of familial risk for HCC, and therefore of familial risk for other diseases predisposing to HCC. Further research is warranted for other cancers in these families.

Anonymous Patient Answer

Have there been any new discoveries for treating hepatitis?

A new drug, telbivudine, has been approved by the US Food & Drug Authority for treating hepatitis B virus-related liver diseases. A more recent development is peginterferon and ribavirin which are effective in treating chronic hepatitis C, but are still more efficacious when used together with other medications in treating hepatitis C and C virus-related liver diseases.

Anonymous Patient Answer

Is sofosbuvir/velpatasvir typically used in combination with any other treatments?

A single prior NS5A assay result is unlikely to influence subsequent decisions on treatment, but if a patient receives two sofosbuvir/velpatasvir doses from 4 weeks apart, both viral assays should be required to determine the effectiveness of sofosbuvir/velpatasvir. Further clinical and virologic testing should be considered in patients with cirrhosis or a serum creatinine >2 mg/dL.

Anonymous Patient Answer

Has sofosbuvir/velpatasvir proven to be more effective than a placebo?

This was a randomized clinical trial assessing the relative effectiveness and safety of sofosbuvir/velpatasvir and a comparison to placebo in HCV treatment-naïve patients in 24 weeks to treatment end for a variety of adverse covariates including liver fibrosis. Relative to placebo there was no evidence of increased risk of SAE, including worsening of cirrhosis which were both significantly lower in patients treated with sofosbuvir/velpatasvir.

Anonymous Patient Answer

What are the latest developments in sofosbuvir/velpatasvir for therapeutic use?

Sofosbuvir/velpatasvir was shown to be safe and effective in treatment-naive and previously treated patients with HCV genotype 1. More patients in both groups (80%) had a sustained response compared with the placebo group (65%). There are limited long-term data on safety and efficacy in patients with cirrhosis and/or compensated cirrhosis.

Anonymous Patient Answer

What does sofosbuvir/velpatasvir usually treat?

This evidence suggests that people treated with sofosbuvir/velpatasvir might benefit from some or all of the same considerations that may be applied to other DAAs such as glecapreant and daclatasvir. The use of NS3/4A protease inhibitors prior to the adoption of sofosbuvir/velpatasvir may have shielded it from the emergence of sofosbuvir-resistant variants. However, the use of the same NS3/4A inhibitors post-sofosbuvir does not preclude the development of resistance to sofosbuvir/velpatasvir.

Anonymous Patient Answer
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