Entecavir (Baraclude) Maintains HBV Suppression through 4 Years in Nucleoside-naive HBeAg Positive Patients

Several new antiviral compounds have been approved for the treatment of chronic hepatitis B, including the nucleoside analog entecavir (Baraclude), offering more choices for treatment-naive patients and for those who have developed resistance to lamivudine (Epivir-HBV),

Results of the current study, presented at the 58th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD 2007) in Boston (November 2-6, 2007), demonstrated that 91% of patients treated with entecavir achieved undetectable HBV viral load at week 192. Undetectable viral load is a measure of antiviral treatment response, and maintenance of viral suppression is an important goal of chronic hepatitis B treatment.

Participants in this 4-year cohort study had chronic HBV infection, were hepatitis B "e" antigen (HBeAg) positive, and had not previously been treated with nucleosides. HBeAg is a viral protein identified as a marker of active replication of HBV. Patients were initially treated with 0.5 mg entecavir in study ETV-022 and continued treatment with 1 mg entecavir by enrolling in study ETV-901 with a treatment gap of 35 days or less.

Results

• At week 192, 91% of patients (98 of 108) achieved undetectable HBV viral load (HBV DNA < 300 copies/mL).

• 86% of patients (96 of 112) achieved ALT normalization (ALT <1 times the upper limit of normal [ULN]).

• During years 3 and 4, an additional 41% of patients (39 of 96) lost HBeAg and 16% (15 of 96) achieved HBeAg seroconversion.

• Resistance monitoring identified 1 patient with genotypic resistance to entecavir who later experienced viral breakthrough.

• Adverse events were consistent with previous experience.

• Additional cumulative safety results of patients reported in this 4-year cohort:

- 90% of patients had no adverse events.

- Grade 3-4 adverse events were reported in 13%.

- There were no discontinuations due to adverse events.

- Less than 1% experienced on-treatment ALT flares during the fourth year.

Based on these results, the researchers concluded, "At Week 192, 91% of patients who received entecavir treatment during 4 years achieved undetectable HBV DNA and 86% had ALT normalization, with patients continuing to experience HBeAg loss and HBeAg seroconversion during Years 3 and 4. The safety profile was consistent with previously reported experience."

"The data indicate that Baraclude maintained viral suppression through 4 years of treatment in this patient population," said study co-author Hugo Cheinquer, MD, of Universidad Federal Do Rio Grande Do Sul, Porto Alegre, Brazil. "That a majority of Baraclude patients had undetectable viral load at 4 years with 1 patient developing resistance is very encouraging news for physicians who treat this chronic disease."

Division of Digestive Disease, UCLA School Of Medicine, Los Angeles, CA; National Cheng Kung University Medical College, Tainan, Taiwan; Tri-Service General Hospital, Taipei, Taiwan; Kangnam St. Mary's Hospital, Soeul, South Korea; California Pacific Medical Center, San Francisco, CA; Universidad Federal Do Rio Grande Do Sul, Porto Alegre, Brazil; Department of Gastroenterology, University of São Paulo School of Medicine, Sao Paulo, Brazil; Bristol-Myers Squibb Pharmaceutical Research Institute, Wallingford, CT.

11/06/07

Reference
S Han, T Chang, Y Chao, and others. Four-Year Entecavir Treatment in Nucleoside-Naive HBeAg(+) Patients: Results from Studies ETV-022 and -901 58th Annual Meeting of the American Association for the Study of Liver Diseases. Boston, MA. November 2-6, 2007. Abstract 938.