ENTECAVIR (Baraclude)- Newest drug for hepatitis-B viral infection:
A London New drugs group publication- February-2007
Entecavir is a guanosine analogue with marked activity against HBV DNA polymerase.
The European Medicines Evaluation Agency (EMEA) has granted marketing authorisation for Entecavir (Baraclude) for the treatment of chronic hepatitis B virus (HBV) infection in adults with compensated liver disease and evidence of active viral replication, persistently elevated serum ALT levels and histological evidence of active inflammation and/or fibrosis.
The Scottish Medicines Consortium approved the use of Entecavir for the treatment of chronic hepatitis B virus infection, in adults with liver disease and evidence of active viral replication, persistently elevated alanine aminotransferase levels and evidence of active inflammation and or fibrosis.
Phase III trials in nucleoside-naive patients with both HBeAg-positive and -negative chronic hepatitis B have been carried out.
In nucleoside-naive patients with HBeAg-positive and HBeAg-negative chronic hepatitis B, the use of entecavir was associated with significantly higher rates of histologic, virologic and biochemical improvements compared with lamivudine. This appears to be due to its potent suppression of HBV replication, as seen by the higher number of patients with undetectable levels of HBV DNA (less than 300 copies/ml) after 48 weeks.
The higher rates of histologic improvement seen with Entecavir suggest that long-term use could result in a reduced risk of end-stage liver disease and heptatocellular carcinoma. Entecavir was tolerated as well as lamivudine, though long-term safety needs to be determined. ALT flares were less frequent in the entecavir group, and those that did occur where associated with lowered HBV DNA levels.
A phase III trial of Entecavir in lamivudine-refractory patients with HBeAg-positive chronic hepatitis B showed that Entecavir treatment was associated with superior responses across histologic, virologic, serologic and biochemical endpoints. Entecavir strongly suppressed HBV DNA levels compared with lamivudine. The higher seroconversion rates in the Entecavir group suggests that longer term treatment will result in a higher proportion of patients achieving HBeAg seroconversion and resolution of chronic hepatitis.
Resistance to Entecavir was not seen in any trial of nucleoside naive patients after 96 weeks of treatment. In lamivudine refractory patients, resistance to Entecavir occurred in 15% of patients after 3 years of follow up.
In all trials ALT flares were seen in both Entecavir- and lamivudine treated patients, though more were linked with lamivudine use. The majority of the flares seen with entecavir were not associated with hepatic decompensation or rising HBV DNA levels.
Other adverse events did not differ significantly between the groups.
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