Scientists got the clinical trials results of the drug FABI256 aimed to treat chronic viral hepatitis B and D. The study involved 560 patients. 480 people achieved a SVR (sustained virological response) at the end of therapy and after 3 months after treatment the virus was not detected in the blood. According to medical practice, this is a complete cure. The effectiveness of the drug achieves 85%, which indicates a real breakthrough in the field of treatment of hepatitis B.
In the first stage of a clinical treatment 60 people with chronic hepatitis B and a delta agent (D) took part. 560 patients participated in the second stage. According to the WHO, 7% of people suffering from hepatitis B virus also have hepatitis D virus. Today these diseases are incurable: the aggressive behavior of the virus leads to the fact that in a few years 60-80% of patients have developing cirrhosis and liver cancer.
Researchers from the Walter Institute and Elsa explained the principle of the new drug: the active substances block the penetration of viruses into liver cells. Consequently, the life cycle of the virus is broken and the process of the disease can be controlled. The drug shows high antiviral activity and impeccable safety profile. At the moment, the results of the program are widely discussed in medical and scientific circles.
Clinical research data
All participants in the experiment did not receive any specific treatment before. Each patient took in the first and 29th day KI dose of FABI256 at the rate of 2 mg / kg. The results were convincing as a sustained virological response was achieved in 97.4% and 100% of patients at week 80 and 12 after the start of therapy. Weakly marked side effects were observed in 11.4% of participants in testing.
Lifelong treatment using traditional methods
Treatment of hepatitis B with an innovative drug can reduce the level of surface antigen (HBsAg), if it is used as a mono drug. Moreover, at a recent meeting in Melbourne, Australia, Victoria the researchers said that its effectiveness is not reduced in combination therapy. Traditional treatment using nucleoside / nucleotide antivirals such as tenofovir alafenamide (Vemlidy), tenofovir disoproxil fumarate (Viread) and entecavir (Baraclude) suppresses HBV replication for a long time, but usually does not come to cure.
Suppression of the virus occurs in almost all patients, but requires lifelong treatment. At the moment, scientists have not come to a common opinion whether to stop antiviral therapy in such patients. The main reason for the controversy is that the virological relapse in patients suffering from chronic hepatitis B who stopped treatment was well documented.
Most often, relapses occur in people with negative HBeAg at the beginning of the course, with reported rates of relapse up to 70% 36 months after discontinuing therapy. Due to the end of treatment, liver decompensation, jaundice and death were described in patients suffering cirrhosis of the liver. Unfortunately, patients are forced to abandon antiviral therapy because of huge financial costs.
The immune response of patients with chronic hepatitis B is unstable and is established only in a small number of patients. Although HBV DNA is effectively inhibited by nucleotide (t) ide analogues (NA). This applies, as a rule, to HBeAg-negative patients who receive lifelong treatment based on NUCs. In most cases discontinuation of NUCs therapy leads to relapse.
About the dangers of hepatitis B
The source of dangerous infection is not only the patient, but also the person in whose blood there are specific immunoglobulins (the causative agent and antibodies), while there are no symptoms of the disease (the carrier of the infection).
Main symptoms of hepatitis B virus:
- pain and constant heaviness in the right side;
• regular gagging;
• elevated body temperature;
• involuntary bruising on the body without mechanical damage;
• pain in the joints and muscles;
• diarrhea / constipation;
• loss of appetite;
• feeling of constriction in the epigastric (epigastric) region;
• yellow skin tone.
According to the latest data, in Russia and the CIS countries the number of cases reaches 15%. By the legislation and the danger to the health of citizens it is considered as an epidemic. The result of chronic hepatitis B is liver or intestinal cancer. Therefore, the creation of an effective new medicine to defeat the virus is truly a challenge to all of humanity.
Active replication of the virus leads to metastasis and the development of new tumors. During the research, scientists found that where there was no active copying of their own cells, decreases the possibility of the development of a secondary tumor in the liver. Presumably, this suggests that metastases fibrosis can be protected.
Work on a safe drug with a minimum list of side effects, but the maximum therapeutic effect can last 15-20 years. It took a little less time to create the FABI256. By the standards of the final development cycle, scientists have already reached the finish line.
According to an anonymous source, after completion of the trial were made the following conclusions. Therapy with the use of a new drug will allow to cure hepatitis B with high efficiency in comparison with existing means. Up to 85% of patients received a SVR (sustained viral response) during the first 6-month course of treatment. Scientists also performed clinical tests on how FABI256 is combined with antiretroviral drugs used to treat HIV infection.