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.
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.
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.
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.
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
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.
[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.
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.
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.
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.
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.
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.
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.
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).