Resumen de «possible» induced fulminant hepatic failure by a combined therapy of simeprevir and sofosbuvir

Pilar Taberner Bonastre, Cristina Sangrador Pelluz, Enrique Soler Company, F. J. Maiques Llácer

• Treatment of hepatitis C has recently undergone a dramatic change with the emergence of new drugs with high response rates exceeding 90% and good tolerability.

  The most common adverse reactions described for simeprevir and sofosbuvir are fatigue, headache and nausea. Fulminant hepatic failure, a serious adverse reaction whose actual incidence is unknown has been reported in some patients treated with simeprevir associated with peginterferon or sofosbuvir. Our aim was to establish the degree of causality attribution of fulminant hepatic failure in our patient to the antiviral treatment that she received at the time of its onset.

  We applied the algorithm of Roussel Uclaf Casuality Assesment Method determining a form of cholestatic hepatotoxicity and a total score of five points.

  This outcome established as «possible» the relationship between fulminant hepatic failure and the treatment with simeprevir, sofosbuvir and ribavirin. After linking as «possible» relationship between fulminant hepatic failure and the drugs, the adverse reaction was reported by the Pharmacy Service to the pharmacovigilance center of the Valencian Community via the yellow card system.

  The pharmacovigilance and the notification of adverse reactions acquire particular significance when its main declaration derives from voluntary reporting,they are potentially serious reactions and the drugs that trigger them are marketed promptly including a small sample in their pivotal trials