Proven clinical efficacy of Russia’s first drug for

treatment of hepatitis C

June 6-7 in St. Petersburg hosted the fifth international conference "White Nights of Hepatology", organized by the European Association for the Study of the Liver (EASL). One of the sponsors of the event was an innovative Russian biopharmaceutical company BIOCAD.

Each year, the conference brings together hundreds of high-quality domestic and foreign experts. This year, the main discussion was around the latest developments and prospects in the use of antiviral drugs for the treatment of chronic viral hepatitis.

At the conference, June 7, with the support of the satellite symposium held BIOCAD "new drug pegylated interferon alpha in the treatment of chronic hepatitis C infection." The leading Russian specialists, hepatologists highlighted the effectiveness of antiviral therapy for chronic hepatitis C with the first Russian original drug pegylated interferon alpha "Algeron". 

"Preliminary results of a multicenter, randomized comparative study of the efficacy and safety of drugs" Algeron "(tsepeginterferon alfa-2b) and" PegIntron "(peginterferon alfa-2b) suggests that the use of domestic peginterferon plus ribavirin at a dose of 800-1400 mg / day . in the treatment of chronic hepatitis C in previously untreated patients is highly efficient in achieving RVR (rapid virologic response) EVR (early virologic response), biochemical response, the answer at the end of therapy. "Algeron" has an acceptable safety profile. When evaluating the severity and frequency of adverse events can be stated that in general they are comparable with those using imported drug "PegIntron," — said in its report on the symposium Olga O. Znoiko, Professor of Infectious Diseases and Epidemiology SEI HPE "Moscow State Medical and Dental University, AI Evdokimov, "Russian Ministry of Health.

The report Svetlana Kizhlo, head of one of the infectious department of St. Petersburg GOOSE "St. Petersburg Center for Prevention and Control of AIDS and infectious diseases," emphasized the use of modern methods of predicting the effectiveness of treatment in this study, including genetic analysis of nucleotide substitutions in the gene for the cytokine IL -28B, localized to human chromosome 19. Results of the study of the genetic polymorphism in great demand due to poor knowledge of Russian prognostic marker in patients.

According to the World Health Organization, hepatitis C virus in the world are infected with some 170 million people. Each year, this figure increased by 4.3 million According to official figures in Russia with chronic hepatitis C affects about 1.8 million people, and according to experts, taking into account the asymptomatic course of the disease — up to 5 million is projected to have a peak incidence in 2018 — 2020 . Until recently there were only two drugs pegylated interferon alpha, which are included in the standard treatment for this disease.

Developing and bringing to market of domestic drug pegylated interferon alpha can significantly increase the availability of modern effective treatment of chronic hepatitis C patients for Russian and save lives.

During the period 2011-2013. BIOCAD company held a large-scale clinical trial of the drug "Algeron" on the basis of relevant institutions in Moscow, St. Petersburg, Smolensk and Kazan. According to the results, to the 12th week of therapy early virologic response (EVR) in the intent-to-treat analysis was achieved in 94% of patients receiving "Algeron" as a dose of 1.5 mcg / kg / week., And 2, 0 mcg / kg / week., while in the comparison group, host of "PegIntron", the figure was 88%. These PCR studies of HCV RNA at the end of therapy (end-of-treatment response, EOT) were assessed in patients with genotype 2 or 3 chronic hepatitis C after 24 weeks infected with genotype 1 — after 48 weeks under standard mode Therapy of chronic hepatitis C, depending on genotype. In total, the EOT of patients receiving "Algeron" in a dose of 1.5 mg / kg was registered in 84% of the cases in the group of patients treated with "Algeron" in a dose of 2.0 mg / kg — 88% in the group comparison ("PegIntron") — 76% (no statistically significant differences between groups).

At the end of therapy with "Algeron" in patients with genotype 2 or 3 hepatitis C virus achieving virologic response rate was as follows: in the first group — 91.7%, in the second — 91.3%, while in the comparison group ("PegIntron") — 81.8% of cases. Infected genotype 1 EOT (end-of-treatment response) observed in 76.9% of cases in group 1, in 85.2% of cases in group 2 and in 71.4% — the comparison group (P> 0.05 ).

Thus, "Algeron" in its effectiveness in suppressing viral replication of hepatitis C is not inferior to a recognized standard treatment HCV-infection — drug peginterferon alpha "PegIntron." Innovative drug pegylated interferon alpha will be available in July 2013. The drug will be manufactured at the production site of BIOCAD in Petrovo Far, Moscow region.

About Us

BIOCAD — an innovative biopharmaceutical company full-service leader in the number of clinical research among domestic manufacturers. Using the best of advanced science and management, BIOCAD creating an entirely new possibilities for the treatment of diseases and improve the quality of life for patients. The development of original and reproduced drug is in its own research centers of the company. All products are manufactured strictly according to international standards of GMP. BIOCAD produces drugs and substance of the following areas: gynecology / urology, oncology / hematology, autoimmune and infectious diseases. Total staff numbers more than 650 people, about 130 of whom are scientists of the research laboratories. In 2012, revenues amounted to 3,000,000,000 rubles. BIOCAD has a wide network of subsidiaries in foreign countries: Ukraine, Belarus, Brazil, China, India and the United States. www.biocad.ru www.algeron.ru

Earlier this on CBS:http://sdelanounas.ru/blogs/31970/ 

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