BARACLUDE data show low resistance over 5 years in nucleoside-naive hepatitis B patients

More than 700 patients across six studies initiated therapy on BARACLUDE and were monitored for treatment response and resistance. The year five analysis expands upon previous analyses, adding in information on patients who received treatment with BARACLUDE during the fifth year of follow-up (n=108 for patients in nucleoside-naïve studies and n=33 for patients in lamivudine-refractory studies).

In this comprehensive analysis, all patients enrolled in Bristol-Myers Squibb clinical trials ETV-014, -015, -022, -027, -026 and -901 who experienced a virologic breakthrough1 or whose virus had not yet reached undetectable levels2 at weeks 48, 96, 144, 192, 240 or end of dosing, were sequenced to determine if any changes occurred in the genetic code of the virus that would result in resistance or loss of effectiveness of BARACLUDE.

Nucleoside-naïve patients in this analysis were initially treated with BARACLUDE 0.5 mg in studies ETV-022 and -027 and continued treatment with BARACLUDE 1 mg by enrolling in study ETV-901 with a treatment gap of less than or equal to 35 days. Lamivudine-refractory patients in this analysis initiated therapy on BARACLUDE 1 mg in studies ETV-014, -015, and -026 and continued treatment in study ETV-901 with a treatment gap of less than or equal to 35 days.

1 Virologic breakthrough is defined as a greater than or equal to 1 log increase in HBV DNA from nadir, as measured by the polymerase chain reaction or PCR assay.

2 Undetectable viral load is defined as HBV DNA levels less than 300 copies/mL, as measured by PCR assay.

Viral load reduction in chronic hepatitis B patients treated with BARACLUDE® (entecavir) in nucleoside-naïve and lamivudine-refractory studies was also evaluated.

Data Results

Results from these studies prior to this year five analysis were previously announced on April 14, 2007.

Nucleoside-naïve data

• The incidence of BARACLUDE resistance in patients in nucleoside-naïve studies over time is low, with a cumulative probability of genotypic BARACLUDE resistance of 1.2 percent through five years.
• No nucleoside-naive patient developed resistance (n=108) in year five.
• 93 percent of the nucleoside-naive patients taking BARACLUDE were able to achieve and maintain an undetectable viral load (HBV DNA < 300 copies/mL) through year five (n=108).

Lamivudine-refractory data