-- ETV-027 compared 0.5 mg of BARACLUDE vs. 100 mg of lamivudine in nucleoside-naive chronic HBeAg-negative chronic hepatitis B patients. -- Rollover study ETV-901 was established as an open-label, follow-up protocol for patients in phase II and III studies of BARACLUDE. -- Due to ongoing blinding of study ETV-027, most patients retreated in ETV-901 initially received a combination of 1 mg of BARACLUDE plus 100 mg of lamivudine, and were subsequently switched to 1 mg of BARACLUDE monotherapy.
The analysis cohort was defined regardless of treatment response at the end of dosing in study ETV-027, and independent of virologic or ALT measurements at the start of dosing in study ETV-901. During off-treatment follow-up, the majority of patients had recurrent levels of hepatitis B virus in the blood (viremia) and increases in ALT.
Data Results At the end of dosing for study ETV-027: -- 94 percent (n=93/99) of the re-treatment cohort had undetectable viral load -- 78 percent (n=77/99) had ALT normalization At entry into ETV-901: -- Four percent (n=4/99) of patients had undetectable viral load -- Eight percent (n=8/97) of patients had ALT normalization Following re-treatment in study ETV-901: -- 93 percent (n=82/88) of patients had undetectable viral load (HBV DNA <300 copies/mL) by week 48 of re-treatment with BARACLUDE -- 83 percent (n=79/95) of patients had ALT normalization (ALT less than or equal to 1 times the upper limit of normal) by week 48 of re- treatment BARACLUDE Adverse events in study ETV-027/901 re-treatment cohort: -- 67 percent (n=66/99) of patients experienced an adverse event. The most common adverse events occurring in greater than ten percent of patients were abdominal pain, fa
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