Community Research and Development Information Service - CORDIS

FP6

VIRGIL — Result In Brief

Project ID: 503359
Funded under: FP6-LIFESCIHEALTH
Country: France

Novel antiviral drugs with low resistance incidences

Antiviral drugs dramatically lose their efficiency due to resistance incidences during treatment. European scientists established a network for the comprehensive study of these setbacks for effective control and development of next generation drugs.
Novel antiviral drugs with low resistance incidences
Antiviral drug resistance is a major issue in the fight against contagious diseases, like influenza and hepatitis. The impact of antiviral resistance can be massive and fatal, since it can void about 50 % of the efficacy of a major first-line antiviral drug. Therefore, there is currently a quest in progress involving drug development of low or very low incidence of antiviral resistance.

The primary aim of the EU-funded project ‘European vigilance network for the management of antiviral drug resistance’ (Virgil) was the integration of existing clinical, technological and research networks in a comprehensive and collaborative manner. This network targeted the creation of a common multicentre platform for clinical studies, focusing on viral hepatitis.

More than 20 patients with viral hepatitis were selected and participated in the project. Data on their progress before, during and after the antiviral treatment were collected and classified according to their resistant features.

Virgil partners successfully accomplished all the objectives of the project, generating a central database at the information technology (IT) centre in Munich. The first international electronic system for data collection on viral hepatitis resistance called eCase Report Form (eCRF) was successfully developed, evaluated and implemented in the database. Therefore, data from different countries can be collected, whilst more than 1 000 patients have already been registered.

Currently, Virgil focuses on hepatitis B virus (HBV) infection due to the availability of already used drugs with proven development of resistance. However, the eCRF system will soon be able to host hepatitis C virus (HCV) resistance incidents.

The first large scale clinical evaluation of the antiviral compounds tenofovir and entecavir was performed, for the treatment of hepatitis B in real life patients. This very important study proved that those two drugs are both safe and effective. Nevertheless, both compounds were detected with certain limitations, highlighting a route for further investigation.

A mathematical model established by the Virgil consortium also estimated the social impact of antiviral resistance in mortality, morbidity and cost. The results were striking, showing a very high mortality of 40 % (in 20 years) due to hepatitis B-related diseases. The early application of a drug treatment with a very low resistance possibility can drastically reduce mortality by 90%.

An online doctor consultation system (VirDoc) was established in order to facilitate physicians to deal with chronic hepatitis B patients with antiviral resistance. Due to technical and human difficulties this system did not work as expected; therefore, specific efforts are required to make it friendlier to physicians.

virgil successfully achieved the establishment of a comprehensive, effective and highly interactive network for monitoring, preventing and finally combating antiviral drug resistance. The capabilities of the network are continuously improving, expanding and integrating new partners with new expertise. Therefore, it constitutes a valuable tool for researchers, scientists, physicians, and public health officers towards an efficient protection against viruses.

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