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Study Shows Entecavir Suppressed Viral Levels of Hepatitis B for Four Years

BOSTON, Nov. 2 /PRNewswire-FirstCall/ -- Bristol-Myers Squibb Company (NYSE: BMY) today announced data from a four-year cohort (ETV-022/901, n=146), which showed that 91 percent (98/108) of patients treated with BARACLUDE(R) (entecavir) suppressed the amount of hepatitis B virus in the blood, or viral load, to undetectable levels(1) at week 192. Suppression of viral load to undetectable levels is a measure of antiviral treatment response; maintenance of viral load suppression is an important goal of chronic hepatitis B treatment. The results are being presented at the 58th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD).

Patients in this cohort were nucleoside naive e-antigen (HBeAg)-positive patients with chronic hepatitis B infection. HBeAg is a viral protein identified as a marker of active replication of the hepatitis B virus. Patients in this cohort were initially treated with BARACLUDE 0.5 mg in study ETV-022 and continued treatment with BARACLUDE 1 mg by enrolling in study ETV- 901 with a less than or equal to 35 day treatment gap.

Resistance monitoring in this cohort identified one patient with genotypic resistance to BARACLUDE at week 139 who had a virologic breakthrough at week 148.

"The data indicate that BARACLUDE maintained viral suppression through four years of treatment in this patient population," said Hugo Cheinquer, M.D., Universidade Federal Do Rio Grande Do Sul, Porto Alegre, Brazil. "That a majority of BARACLUDE patients had undetectable viral load at four years with one patient developing resistance is very encouraging news for physicians who treat this chronic disease."

Safety events in this cohort were consistent with prior experience. Five deaths were reported in this cohort; no deaths were attributed to BARACLUDE(R) (entecavir). Twelve percent of patients experienced a serious adverse event. The most common adverse events occurring in greater than or equal to 10 percent of patients were: upper respiratory tract infection (31 percent), headache (21 percent), cough (17 percent), diarrhea (16 percent), influenza (17 percent), nasopharyngitis (16 percent), pyrexia (12 percent) and upper abdominal pain (10 percent).

About the Nucleoside-Naive HBeAg-Positive Four-Year BARACLUDE Cohort (n=146)

This four-year cohort evaluated long-term efficacy and safety of BARACLUDE in nucleoside-naive chronic HBeAg-positive patients who received four years of continued BARACLUDE treatment. The four-year cohort consisted of 146 patients who met the following criteria:

  • Enrolled in study ETV-022, which compared the efficacy and safety of BARACLUDE 0.5 mg versus lamivudine 100 mg in nucleoside-naive chronic HBeAg-positive patients
  • Enrolled in study ETV-901, which evaluated the efficacy and safety of BARACLUDE 1 mg, after a treatment gap of less than or equal to 35 days
  • Some patients initially received combination of BARACLUDE 1 mg and lamivudine 100 mg for a mean of 26 weeks in study ETV-901. The mean duration of BARACLUDE 1 mg monotherapy was 194 weeks The analysis cohort was defined regardless of treatment response at the end of dosing in study ETV-022 or viral load, HBV serology, or ALT measurements at the start of dosing in study ETV-901. Serologic testing was conducted by a central laboratory in study ETV-022 and by local laboratories in study ETV-901.
Resistance was comprehensively monitored in the BARACLUDE clinical program. Patients with HBV DNA levels of greater than or equal to 300 copies/mL at weeks 48, 96, 144, 192, or at the end of dosing were genotyped and a phenotype was determined for all novel emerging substitutions. All patients experiencing a virologic breakthrough (greater than or equal to 1 log(10) increase from nadir) were phenotyped even if they did not have emerging substitutions. Study Results
  • At week 192 of BARACLUDE(R) (entecavir) treatment, 91 percent (n=98/108) of nucleoside-naive chronic HBeAg-positive patients in this cohort achieved undetectable viral load (HBV DNA During years three and four, an additional 41 percent (n=39/96) of patients lost HBeAg and 16 percent (n=15/96) of patients achieved HBeAg seroconversion.
  • Resistance monitoring in this cohort identified one patient with genotypic resistance to BARACLUDE who later experienced virologic breakthrough.
  • Safety events were consistent with previous experience. Additional cumulative safety results of patients reported in this four-year cohort:
  • Ninety percent of patients had any adverse event.
  • Grade 3-4 adverse events were reported in 13 percent of patients.
  • There were no discontinuations due to adverse events in this cohort.
  • Less than one percent of patients experienced on-treatment ALT flares during the fourth year.

Source: Bristol-Myers Squibb Company

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