Research results — Meravir

Research results

Innovative anti-HBV and HDV treatment Meravir was approved by FDA (Food and Drug Administration) in 2017. Food and Drug Administration recognized it as a safe and efficient treatment. Meravir underwent all the stages of preclinical and clinical human trials which are documented.

Backstory of treatment creation   

The search for anti-HBV and HDV treatment started back in 1995 when the epidemic of a dangerous disease hit the world. It causes severe complications —  fibrosis, cirrhosis,

hepatocellular carcinoma and etc. – in 40-60% of cases. But the scientists focused on exploration of the virus and development of a treatment only in 2013.  

Biopharmacologist explored the virus’s effect on the body and the principles of its distribution in the body for several years at Australian company called Panacea infarm founded by Walter and Eliza Hall Institute (Melbourne). It was revealed that HBV’s ribonucleic acid (RNA) sends out signals provoking accumulation of RNA molecular structure and replication of the virus. Active ingredients of Meravir destroy this chain and cease replication within infected cells.

Development of anti-HBV treatment was successful due to casual discovery  of American scientist who wee trying to create anti-cancer treatment. (Birinapant). They found out that the active ingredients of the treatment were able to destroy DNA of HBV, but the treatment couldn’t be used to cure oncological diseases. Unsuccessful development of American colleagues boosted the breakthrough in medicine and development of unique formula of Meravir. CSL Behring leading specialists were invited to participate in the project and made a scientific discovery.

Preclinical trials   

Preclinical trials were conducted on animals, in this case, on laboratory rodent. The scientists were astonished by the results: hundreds of rodents fully cured of HBV. Sustained virological response  was achieved in almost 90% of cases. The virus wasn’t revealed in their blood even in 3 months after they had stopped receiving therapy. It was decided to start clinical human trials immediately.

The first stage of clinical human trials

The first team of volunteers was gathered in 2015, it consisted of 60 persons. The patients were aware of all the testing assets and signed a consent to participate in the experiment. Clinical trials were held in specialized medical institutions allowing to provide medical assistance in situations of extreme urgency.

50 out of 60 patients tolerated different doses of treatment injections of which were they received. As a result, dependence of the effect on the dosage was revealed.  If a patient receives 10 mg of an active ingredient, amount of HBV’s DNA starts decreasing during the twelfth week in 10 out of 12 patients. If the dose is decreased, only 7 out of 40 patients  

Amount of HBV DNA kept decreasing actively in patients who continued to take 10 mg of FABI256 (codename Meravir) during the 24 weeks of treatment. According to the scientists, decrease of number of replications in blood prevents development of hepatocellular carcinoma and hepatic cirrhosis.

Patients’ condition was monitored during the clinical trial, the results of ultrasound scan, blood and urinary tests were collected in patients’ charts. It was concluded that FABI256 can destroy a virus if proper dosage is used and it is taken for a long time (up to 12 months).   

30 of test persons also had HDV in addition to HBV. One group of participants received only FABI256, another one received it together with peginterferon alfa. Both groups tolerated the treatments well, but combination therapy didn’t turn out to be more effective than Meravir monotherapy.

The second stage of clinical human trials

The second stage of clinical human trials was held in 2016, all of its 560 participants were patients without prior HBV or HDV therapy.

This time, another principle was used to calculate the dose: each participant took 2 mg/kg of FABI256 daily. The patients were divided into several groups. Sustained virological response was achieved during the twelfth week in 97,4 % and 100 % cases in two groups.

11,4 % of test persons experienced mild side effects: headache, muscle weakness, skin rash, nausea, aerocolia.

Summing up the final results, the researchers revealed that 480 patients (85% of the total number of participants) managed to cure of HBV. 65% of patients with stage 2-4 fibrosis and hepatic cirrhosis cured of HBV. Earlier, these patients were considered incurable.

A patient was considered to be cured of a disease only in cause of absence of HBV DNA in patient’s blood in three months after the patient had stopped receiving therapy.