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news.Bristol-Myers Squibb has presented 96-week clinical trial data from two phase III studies demonstrating that Baraclude led to a significant difference in viral load suppression to undetectable levels compared to lamivudine in two chronic hepatitis B patient types.
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The results, which were presented at Digestive Disease Week, show that, after up to 96 weeks of treatment, 94% of nucleoside-naive HBeAg-negative chronic hepatitis B patients treated with Baraclude (entecavir) experienced an undetectable viral load, defined as HBV DNA less than 300 copies per milliliter of blood (mL), compared to 77% of patients treated with lamivudine.
This difference was statistically significant based on a cumulative analysis of all patients. In addition, no evidence of Baraclude resistance was identified in these patients.
Additional 96-week study data evaluated the use of Baraclude compared to continued lamivudine in lamivudine-refractory, HBeAg-positive chronic hepatitis B patients. After up to 96 weeks of treatment, 30% of patients who were switched to Baraclude treatment achieved an undetectable viral load, compared to less than 1% of patients who continued lamivudine treatment.
Viral rebound due to Baraclude resistance occurred in 9% of patients through week 96 and required the prior presence of LVD-resistance substitutions.