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The clinical trials of the hepatitis B drug FABI256 with the participation of people have started

Statistics show that more than 1 million people worldwide dies from different hepatitis B effects. According to Rospotrebnadzor (Federal Service for Consumer Rights Protection and Human Welfare in Russian Federation), in 2017 over 14,000 cases of chronic hepatitis B were registered in Russia, 1.3 thousand people suffers from an acute condition of this disease. All that the contemporary pharmaceutical market can offer such patients today is medicines suppressing the virus but not destroying it. 

Australian scientists developed a new drug for treating hepatitis B. It should provide a direct effect on pathogenic cells, destroy them inside the liver, in such way defeating the chronic form of this disease. The preclinical trials ended in 2013 and turned out to be successful. Scientists began testing the innovative drug on humans. 

It is a significant step to confirm the drug’s safety and efficacy. Our editorial staff found out, according to the preliminary data, that the drug demonstrated the high efficacy level as a treatment method for hepatitis B. The exact release form of the product has not yet been determined. Perhaps, the form of pills.

According to WHO, 7% of patients with chronic hepatitis B also have hepatitis D cells in their blood. This diagnosis (co-infection) seriously complicates the course of the disease, increases the risk of liver cancer and mortality among such patients. The drug codenamed FABI256 completely blocks the RNA of pathogenic enzymes of hepatitis B and D cells and the virus in general.

The clinical trials are conducted on volunteers: 60 people

All trials are aimed at the assessment of the medication’s tolerability by a human body. The tests also specify the required dosage, monitor and record side effects, estimate the drug’s effectiveness. Undoubtedly, this phase of research must be taken very responsibly due to its danger. All tests are conducted under the strict supervision of trusted professionals and take place in specialized medical institutions with the necessary equipment and medical preparations to give a quick response in any unpredictable case.

The conducted research of the phase IIa demonstrated the great tolerability of the drug in different permissible doses in 50 patients with chronic hepatitis B. 

The dose-rate dependence was defined: on the 12th week of the clinical trial they decreased the dose >1 log10 DNA HBV among the 10/12 patients (75%) who previously were taking 10 mg of the tested medication. Other groups received decreased DNA HBV less commonly (7/40; 17%). The patients who were taking 10 mg of FABI256 demonstrated the low level of DNA HBV up to the 24th week of the treatment. 

All medical procedures are performed only after informing the patient about all nuances, risks, and benefits of the trial and getting his or her full consent. At the same time, individual medical dossiers are filled in thoroughly. Such dossiers contain the results of various analyzes – urinal tests, ultrasound, blood tests, etc.

This is a subject to the Declaration of Helsinki and ICH GCP. Theoretically, the drug can reduce the number of viruses in a body, up to their complete extraction in the bloodstream. According to scientists, the reduction of the viral load will prevent the development of cirrhosis and liver cancer.

Right now hepatitis B is an incurable disease because the virus gene quickly integrates into the human DNA chain. If the clinical efficacy of the studied drug is proven, it will be a real breakthrough in the treatment of viral hepatitis B. The antiretroviral treatment is considered the only method (mostly an auxiliary one) of curing hepatitis B. During the last 10 years, various drugs have been tested. One of them is a drug that was very promising and became the key to a breakthrough in the treatment of hepatitis B – Birinapant.

Thanks to the drug’s mechanism of action, the scientists managed to develop an innovative medication for treating hepatitis B.  

According to preliminary information, the treatment course will last from 6 to 12 months. However, there is no detailed information about the drug’s side effects so far. There are the references that the group of scientists who took part in the development of Sofosbuvir also have joined the research group that worked at FABI256. 

Apparently, their previous experience turned out to be useful during the process of the drug’s development. Let’s hope that the date of commencement of production and its cost will be released soon. It’s expected that the price will be quite high during the first years after the drug’s release.

At some points during the clinical trials, 30 patients with chronic hepatitis B were taking the drug FABI256 as a single medication for 24 weeks. Then they were taking this drug simultaneously with pegylated Interferon Alfa. As a result, the patients responded both to the medication as a monotherapy and in a combinatory treatment very well.