By Arushi Sinha
SAN FRANCISCO -- November 6, 2008 -- Patients with chronic hepatitis B virus (HBV) infection who are treated with telbivudine appear to maintain suppression of the virus for as long as 3 years of treatment, according to results of the GLOBE study.
The findings, from a study conducted in China, France, Switzerland, Taiwan, Spain, and Germany, were presented here on November 2 at the Liver Meeting 2008, the 59th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD).
Investigator Ed Gane, MD, Middlemore Hospital, Auckland, New Zealand, and colleagues examined the use of the oral agent telbivudine in patients treated for 3 years.
"We were looking at patients to see if they undergo serological response," Dr. Gane explained on behalf of the study group.
The study enrolled 87 patients who were hepatitis B e antigen (HBeAg) positive and had completed 3 years of continuous telbivudine treatment. These patients exhibited HBeAg seroconversion and had undetectable HBV DNA (<300 copies/mL) levels at week 104.
Results show that after 3 years of telbivudine therapy, all of the patients had maintained their HBeAg status. In addition, 93.1% of 87 patients maintained their seroconversion and 88% maintained alanine aminotransferase (ALT) normalisation.
Also, 90.8% of patients had both HBeAg seroconversion as well as serum levels <103 copies/mL after 3 years. In 9.2% of patients, HBV DNA ranged between 103 and 105 copies/mL at 3 years. Among this subgroup, seroconversion was maintained in 7 of the 8 patients.
Based on these findings, the authors concluded that continued telbivudine treatment has clinical efficacy. They also found that long-term telbivudine treatment can result in HBeAg seroconversion, which is the goal of treatment for patients with chronic HBV. Therefore, the researchers suggested that such patients may be considered candidates for discontinuation of treatment.
"Once patients undergo seroconversion, they continue to resist [the virus]. While a small proportion will get a return, the majority will have undetectable levels in the blood," Dr. Gane said. "If they continue telbivudine treatment long term, the risk of loss of response is low."
[Presentation title: Continued Telbivudine Treatment Results in High Rates of Maintained Response in HBeAg-Positive Patients at 3 Years. Abstract 942]
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