sofosbuvir/velpatasvir for Hepatitis

Phase-Based Estimates
1
Effectiveness
2
Safety
UPMC, Pittsburgh, PA
Hepatitis+3 More
sofosbuvir/velpatasvir - Drug
Eligibility
18+
All Sexes
Eligible conditions
Hepatitis

Study Summary

This study is evaluating whether liver transplants from hepatitis C positive donors may be safe and effective for hepatitis C negative recipients.

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Eligible Conditions

  • Hepatitis
  • Hepatitis C
  • Hepatitis A
  • Transplantation, Liver

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

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.

1 year
HCV free at 1 year
5 years
Adverse events
All-cause mortality
Incidence of allograft rejection
Incidence of graft loss
Transmission rate of HCV from HCVAb+/NAT- donors to HCVAb- recipients
Waitlist time after enrollment

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Side Effects for

Single Arm Intervention
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%.

Trial Design

2 Treatment Groups

No Control Group
HCV seropositive viremic (HCV Ab+/NAT+) donor

This trial requires 73 total participants across 2 different 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.

HCV seropositive viremic (HCV Ab+/NAT+) donor
Drug
Post-operative day 1, liver recipients will be treated with 12-week oral course of sofosbuvir/ velpatasvir (Epclusa®), a fixed-dose combination of a nucleotide analogue HCV NS5B polymerase inhibitor (sofosbuvir - 400mg) and a NS5A inhibitor (velpatasvir - 100mg).
HCV seropositive non-viremic (HCV Ab+/NAT-) donor
Drug
Liver recipients will be monitored for HCV for one year following transplant. When HCV RNA is detected, the transmission-triggered treatment phase will be initiated. Recipients will be treated with 12-week oral course of sofosbuvir/velpatasvir (Epclusa®), a fixed-dose combination of a nucleotide analogue HCV NS5B polymerase inhibitor (sofosbuvir - 400mg) and a NS5A inhibitor (velpatasvir - 100mg).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Velpatasvir
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 5 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 5 years for reporting.

Closest Location

UPMC - Pittsburgh, PA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 7 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
No available living liver donor Listed for an isolated liver transplant at UPMC
Have panel reactive antibody level of <98%
Able to travel to UPMC for routine post-transplant visits and study visits for a minimum of 12 months after transplantation
Able to provide informed consent
Be willing to use a contraceptive method for a year after transplant
Patients with end-stage liver disease listed for liver transplantation at UPMC.
Age ≥ 18

Patient Q&A Section

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

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

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Hepatitis A is the most common cause of acute infectious hepatitis among young Americans. The rate has declined over the past 10 years, although considerable variation by state exists. Hepatitis B infection increases with age and is acquired almost exclusively by contact with the blood of an infected person. Risk factors for HCV infection vary by age and have shifted over time. However, vaccination for HCV remains an important means of preventing HCV infection and acquiring the disease.

Unverified Answer

What are the signs of hepatitis?

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As with any other gastrointestinal disorder, signs of hepatitis can manifest as vomiting, loss of appetite, and weakness. Hepatitis symptoms can also include weight loss or loss of bladder control. Symptoms of hepatitis can be differentiated from common gastrointestinal issues by a history of traveling, alcohol use, or a history of medical issues. Patients diagnosed with hepatitis should be tested for the herpes viruses. The presence of these viral infections can be confirmed using immunofluorescence and molecular testing.

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What are common treatments for hepatitis?

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Specific management guidelines are recommended on the basis of hepatitis a (HA) prevalence data. There are no specific recommendations for hepatitis b (HBV) management in general. There are strong indications of a role for a multidisciplinary approach to HBV management to optimize outcome. Specific guidelines exist for hepatitis c infection (HCV) management including both antiviral therapies and medical interventions. Specific treatment guidelines are needed for a variety of other hepatitis infections, such as hepatitis D.

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Can hepatitis be cured?

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There are no clear scientific answers to whether hepatitis can be cured. There is little research on this subject and the conclusions of previous studies are inconsistent. Recent studies suggest that interferons, which suppress the growth of Hepatitis C, can cause a cure of hepatitis C with a higher rate of side effects. The evidence for the effectiveness of interferon therapies in suppressing the growth of hepatitis C has not yet been determined. There are still a number of unresolved challenges in the area of hepatitis C treatment, including the optimal dosage and duration of therapy, the best duration interval between treatment periods, the optimal length and route of administration of interferon, and the value of early and late treatment.

Unverified Answer

What is hepatitis?

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Hepatitis is a common infection and most commonly an infection of the liver which can cause nausea, vomiting, loss of appetite, lightheadedness, fatigue, abdominal pain and tiredness. More than 5% of US adults are chronically infected, and more than 1 million are infected with hepatitis B and C annually. hepatitis C is present in all parts of the world where hepatitis B is prevalent and affects about 2 million people. Because of the hepatitis epidemics in Asia it is likely that an even greater number of people are affected. Alcoholics are particularly susceptible to hepatitis. The risk for new infections is highest around the time of delivery (around 25% of the babies are affected).

Unverified Answer

What causes hepatitis?

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There is no single cause for chronic viral hepatitis. Chronic viral hepatitis is the result of multiple factors: genetics, immune system dysfunction, viral infection, and other environmental factors. These factors can vary widely by region, with different hepatitis B virus (HBV) and hepatitis C virus (HCV) strains having different risk profiles. HCV most often infects individuals who are infected with HBV. The diagnosis of chronic hepatitis C requires the detection of HCV DNA and antigen.\n

Unverified Answer

How does sofosbuvir/velpatasvir work?

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Results show that sofosbuvir/velpatasvir was significantly more effective than sofosbuvir/ledipasvir. The high response levels among subjects with suppressed viremia supports a potential role for sofosbuvir as a single tablet regimen.

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Does hepatitis run in families?

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Hereditary factors, even if present in only 3.6% of cases, constitute an important underlying cause of autoimmune hepatitis. Patients who have a family history of autoimmune hepatitis have more frequent, and possibly more severe, attacks. The clinical diagnosis of autoimmune hepatitis should not be delayed in these patients, particularly those who are young at onset (≤45 years) and have a significant degree of liver fibrosis.

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What is the average age someone gets hepatitis?

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The average age someone gets hepatitis B or hepatitis D has remained the same since 1998 (11 to 20 years old). The average age someone gets hepatitis A, however, has increased. Thus the average age at which people get hepatitis B and hepatitis D can vary from a young age to someone nearing adulthood. The average age someone gets hepatitis C, however, has increased since 1998. Most cases of hepatitis A are acquired before the age of 20. Thus the average age at which someone gets hepatitis A has decreased since 1998. The average age someone gets hepatitis C remains the same. Finally, the average age someone gets the hepatitis E has changed in recent years due to increased awareness and increased testing.

Unverified Answer

What is the latest research for hepatitis?

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The current review has revealed that there are two major sources of recent data on hepatitis research, namely, peer-reviewed, high-impact journals and journals that specialize in hepatology. The article identified a number of high-impact journals and journals that cover a variety of topics specific to hepatitis within their scope of expertise. The article also highlighted a few journals that provide a bibliography of articles related to HBV/hepatitis; these journals, as a group, will continue to serve as an important resource.

Unverified Answer

Have there been other clinical trials involving sofosbuvir/velpatasvir?

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The S_v_P_V trial is the first clinical trial published in Hepatology demonstrating the safety and effectiveness of sofosbuvir plus velpatasvir in the treatment of HBV.

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

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Both HCV treatment and IFN-γ-producing CD4(+) TILs were decreased in NSCLC patients after 3 months treatment. SOF/VP120 can be a safe and effective HCV treatment in NSCLC patients.

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