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Open Access Review

Clinical development of monoclonal antibody-based drugs in HIV and HCV diseases

Michela Flego*, Alessandro Ascione, Maurizio Cianfriglia and Stefano Vella

Author Affiliations

Department of Therapeutic Research and Medicines Evaluation, Istituto Superiore di Sanità, Viale Regina Elena 299, 00161 Rome, Italy

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BMC Medicine 2013, 11:4  doi:10.1186/1741-7015-11-4

Published: 4 January 2013

Abstract

Today there are many licensed antiviral drugs, but the emergence of drug resistant strains sometimes invalidates the effects of the current therapies used in the treatment of infectious diseases. Compared to conventional antiviral drugs, monoclonal antibodies (mAbs) used as pharmacological molecules have particular physical characteristics and modes of action, and, therefore, they should be considered as a distinct therapeutic class. Despite being historically validated, antibodies may represent a novel tool for combatting infectious diseases. The current high cost of mAbs' production, storage and administration (by injection only) and the consequent obstacles to development are outweighed by mAbs' clinical advantages. These are related to a low toxicity combined with high specificity and versatility, which allows a specific antibody to mediate various biological effects, ranging from the virus neutralization mechanisms to the modulation of immune responses.

This review briefly summarizes the recent technological advances in the field of immunoglobulin research, and the current status of mAb-based drugs in clinical trials for HIV and HCV diseases. For each clinical trial the available data are reported and the emerging conceptual problems of the employed mAbs are highlighted.

This overview helps to give a clear picture of the efficacy and challenges of the mAbs in the field of these two infectious diseases which have such a global impact.

Keywords:
monoclonal antibodies; mAb-mediated antiviral mechanisms; anti-infectious biological agents; antiviral mAb based therapy; anti-HIV drugs; anti-HCV drugs; clinical studies