Data planned for presentation at the 56th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) demonstrated no virologic rebounds due to resistance through two years in nucleoside-naïve chronic Hepatitis B adult patients (with wild-type virus) treated with the Bristol-Myers Squibb oral antiviral agent Baraclude (entecavir). Additional study data planned for presentation at AASLD showed significant increase in viral load suppression to undetectable levels compared to lamivudine in nucleoside-naïve, chronic Hepatitis B e-antigen (HBeAg) positive patients treated up to 96 weeks with Baraclude as part of a large-scale Phase III clinical trial (Study ETV-022).
"Data showed that 80 per cent of patients taking Baraclude up to 96 weeks experienced cumulative confirmed viral load reductions to undetectable levels compared to 39 per cent of patients taking lamivudine in Study ETV-022. In patients treated for up to 96 weeks, treatment with Baraclude resulted in significant improvement compared to lamivudine as measured by reductions in viral load to undetectable levels and normalisation of alanine aminotransferase (ALT) levels," said Robert Gish, a study investigator and medical director of the California Pacific Medical Center's liver transplant programme in San Francisco.
Serious adverse events occurred in eight per cent of patients in both the Baraclude and lamivudine treatment arms.
Extended resistance monitoring for Baraclude in more than 650 nucleoside-naïve, HBeAg-positive and HBeAg-negative chronic Hepatitis B patients (with wild-type virus) showed no evidence of virologic rebound due to antiviral resistance to Baraclude following up to two years of treatment. Baraclude did not select for resistance substitutions that reduced sensitivity to Baraclude or that are generally associated with lamivudine resistance. In lamivudine-refractory patients treated with Baraclude for two years, virologic rebounds that could be attributed to Baraclude resistance were observed in 9 per cent (14/154) of patients. In all cases, patients who rebounded harboured specific resistance mutations attributed to previous lamivudine treatment, claims a company release.
Baraclude is a nucleoside analog, approved for marketing in the United States by the US Food and Drug Administration on March 29, 2005.
Baraclude is a prescription medicine used for chronic infection with Hepatitis B virus (HBV) in adults where the virus is multiplying and damaging the liver.