Method for predicting the outcome of hepatitis b infection

C - Chemistry – Metallurgy – 12 – N

Patent

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Details

C12N 5/20 (2006.01) C07K 16/08 (2006.01) G01N 33/576 (2006.01) G01N 33/577 (2006.01)

Patent

CA 2250076

The present invention is concerned with prognosis of the development of Hepatitis B infection. The method according to the invention may also be used to monitor antiviral therapy with, for example, antiviral compounds like alpha- interferon. The present invention is based on the finding that the presence of specific biomolecules able to form complexes with HBeAg is a prognostic marker for the further development of an <u>acute</u> Hepatitis B infection. It has been found that based on the presence or absence of said specific biomolecules or complexes of said biomolecules and HBeAg during the acute phase of infection it can be predicted whether patients will recover and clear the virus after acute infection or will develop a chronic infection. The present invention therefore involves the use of an assay for the detection of circulating complexes comprising specific biomolecules bound to HBeAg in a method for predicting the course of infection in patients with an acute HBV infection. The present invention provides a new method for the prognosis of the development of Hepatitis B infection which can also be used to monitor therapy with antiviral agents and to indicate what the effect of such therapy is.

La présente invention concerne le pronostic du développement de l'hépatite B. Le procédé de l'invention convient également au suivi d'une thérapie antivirale à base par exemple de composés antiviraux tels que l'interféron .alpha.. L'invention repose sur la découverte que la présence de biomolécules aptes à former des complexes avec le HBeAg constitue un indicateur de pronostic du développement ultérieure de la phase aiguë de l'hépatite B. On a découvert la présence ou l'absence de ces biomolécules spécifiques ou de complexes de ces biomolécules et de HBeAg pendant la phase aiguë de la maladie, permet de prévoir si le patient guérira et se débarrassera du virus après la phase aiguë ou s'il développera une infection chronique. La présente invention fait donc intervenir un dosage permettant de détecter des complexes circulants comprenant les biomolécules spécifiques liées au HBeAg, et ce, en utilisant un procédé permettant de prévoir l'évolution de la maladie chez des patients atteints d'hépatite B en phase aiguë. L'invention concerne également un procédé de pronostic du développement de l'hépatite B qui convient également au suivi d'une thérapie à base d'agents antiviraux et qui permet d'indiquer l'effet produit par une telle thérapie.

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