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 transplanting kidneys from hepatitis C seropositive donors to hepatitis C seronegative recipients is safe and effective.

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Eligible Conditions

  • Hepatitis
  • Hepatitis C
  • Hepatitis A
  • Kidney Transplantation

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Compared to trials

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

Compared to 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 non-viremic (HCV Ab+/NAT-) donor

This trial requires 30 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 non-viremic (HCV Ab+/NAT-) donor
Drug
Kidney 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).
HCV seropositive viremic (HCV Ab+/NAT+) donor
Drug
Starting post-operative day 1, kidney 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
Sofosbuvir
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 9 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
/1.73 m 2 People who have chronic hemodialysis, peritoneal dialysis, or stage 5 chronic kidney disease (CKD) have a glomerular filtration rate of less than 15 ml/min/1.73 m². show original
The text suggests that a person should have a panel reactive antibody level of less than 98%. show original
This means that the person can travel to UPMC for routine post-transplant visits and study visits for a minimum of 12 months after transplantation. show original
This text is discussing patients who are in the late stages of renal disease and are on a list to receive a kidney transplant. show original
Age ≥ 18
There is no available living donor for an isolated kidney transplant at UPMC who has less than 60 months of accrued transplant waiting time and/or less than 60 months of dialysis time. show original
No obvious contraindication to kidney transplant
The ability to provide informed consent is a characteristic of being an autonomous individual show original
If you are willing to use a contraceptive method for a year after your transplant, we can schedule your surgery. show original

Patient Q&A Section

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

Can hepatitis be cured?

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At this time, there is no cure for acute or chronic hepatitis B nor the related chronic hepatitis delta, and treatment must focus on managing the infection. The goal of the treatment for chronic hepatitis B is to decrease the number of cases and their severity.

Unverified Answer

What causes hepatitis?

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The exact cause of hepatitis is unknown. More than one factor may cause it. This condition may be triggered by environmental or viral factors. It may also be genetic and present for life; and it may be associated with autoimmune disorders such as myasthenia gravis and type 1 diabetes mellitus. These factors may be involved in the onset of fatty liver disease.

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What are the signs of hepatitis?

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Pain in the upper right side of the abdomen, loss of appetite, nausea and headaches are all common symptoms of hepatitis. Complications of hepatitis that can affect the liver include kidney failure or kidney failure due to cirrhosis. Blood samples taken are the best way to test for certain signs of hepatitis.\n

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What are common treatments for hepatitis?

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Common treatments for hepatitis include medications, liver biopsies, hepatic blood flow tests, interferon therapies, immunotherapy, and vaccines. Hepatitis B is best treated with both interferon therapy and lamivudine. Hepatitis C is best treated with antiviral drugs like pegylated interferon and ribavirin. Autoimmune hepatitis may be treated with corticosteroids, rituximab, or in the case of severe manifestations, dialysis or liver transplantation.

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

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[Hepatitis A is a contagious disease transmitted through the oral-faecal-urinary route. Rates can be underestimated or incorrectly calculated in areas where there has been a high proportion of hepatitis A cases, high levels of seroprevalence, or in areas where screening is not used routinely. The annual incidence and incidence per 100,000 were 11.0 and 3.0 per 100,000 individuals per year, respectively.

Unverified Answer

What is hepatitis?

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Hepatitis is a condition of the liver that is characterized by swelling of the liver due to cell death caused by an infection, toxin, drug or autoimmune disease. The viral hepatitis forms of hepatitis are usually transient and the person will recover spontaneously. Symptoms of chronic infections tend to be fatigue and diarrhea. Hepatitis B and C are both often chronic and cause cirrhosis. Hepatitis B results in liver cancer, hepatitis C can cause liver cancer, both of which are often fatal. When a viral infection leads to acute hepatitis, the first symptoms may include discomfort and loss of appetite. When a chronic infection leads to hepatitis, the symptoms may be mild, or may include itchiness, muscle aches and joint pain.

Unverified Answer

Have there been other clinical trials involving sofosbuvir/velpatasvir?

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No clinical trial has been reported on sofosbuvir/velpatasvir treatment. It's not clear if other antiviral treatments are more effective or have less adverse events. The decision on the first-line antiviral treatment in HCC should consider the risks of adverse events as a patient's disease severity and baseline hepatic function.

Unverified Answer

Who should consider clinical trials for hepatitis?

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Findings from a recent study of the present study have two important implications: first, if the most efficacious hepatitis treatments cannot be reached through the approval of existing products, then the possibility of treatment access in the future could be adversely affected. Moreover, our results suggest that such treatments may have to be approved for use in more-severe disease states and thus will represent a broader burden to the healthcare system.

Unverified Answer

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

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Adding a PIs to antivirals is a common practice to control viral replication and prevent drug resistance. Considering the high rates of resistance and adverse events from the presence of PI-induced drug resistance, physicians should consider the addition of PIs to antiviral therapies during treatment.

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Does sofosbuvir/velpatasvir improve quality of life for those with hepatitis?

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Patients who received sofosbuvir/velpatasvir reported a statistically significant improvement in physical and mental QOL compared with placebo. Patient-reported improvements included physical functioning, general, and mental QOL.

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

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Single SRI therapy with sofosbuvir/velpatasvir was at least as effective as a placebo when the efficacy endpoints were defined as viral load <1000 Cop/mL or virological response <50% viral load at week 1. Data from a recent study does not indicate that sofosbuvir/velpatasvir is a better treatment than a placebo with regard to safety. Further trials are warranted as well as a meta-analysis on the role of sofosbuvir/velpatasvir in patients with HIV who are coinfected.

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What is sofosbuvir/velpatasvir?

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In patients treated for HCV and achieving SVR, the addition of SOF/VVL improves virologic outcomes for SVR in the real world. Clinical trials were registered with www.clinicaltrials.gov (NCT02446420 and NCT02557693; 1).

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