Clinical

Telbivudine better than lamivudine for chronic hepatitis B

Last Updated: 2009-03-17 8:00:19 -0400 (Reuters Health)

NEW YORK (Reuters Health) - As a treatment for chronic hepatitis B, telbivudine produces a better therapeutic response than does lamivudine in both HBeAg-positive and -negative patients, according to 2-year follow-up data from the GLOBE trial.

When it became available in 1998, lamivudine revolutionized the treatment of chronic hepatitis B, note Dr. Yun-Fan Liaw, from Chang Gung University College of Medicine, Taipei, Taiwan, and colleagues. The current findings, however, suggest that the newer agent telbivudine has now displaced lamivudine as the treatment of choice.

The GLOBE trial included 921 HBeAg-positive and 446 HBeAg-negative patients who were randomized to receive telbivudine or lamivudine once daily for 104 weeks. Therapeutic response, the main outcome, was defined as a hepatitis B virus DNA level < 5 log10 copies/mL and HBeAg loss or normalization of the alanine aminotransferase level.

In HBeAg-positive patients, the treatment response rate was higher with telbivudine than with lamivudine: 63% vs. 48% (p < 0.001), according to the report in the February issue of Gastroenterology. In HBeAg-negative patients, the corresponding rates were 78% and 66% (p = 0.007).

Compared with lamivudine, treatment with telbivudine in the HBeAg-positive group was associated with higher rates of nondetectable viremia and HBeAg loss and with lower rates of viral resistance. In the HBeAg-negative group, telbivudine use also increased the odds of nondetectable viremia and was tied to less viral resistance.

In general, the two drugs had comparable side effect profiles, although telbivudine was more often linked to grade 3/4 increases in creatine kinase levels: 12.9% vs. 4.1% (p < 0.001).

Despite these findings, however, the future of telbivudine as a long-term treatment for chronic hepatitis B is uncertain, Dr. Robert J. Fontana, from the University of Michigan Medical Center, Ann Arbor, comments in a related editorial.

"The rising incidence of telbivudine-resistant hepatitis B virus will likely limit its long-term utility in the management of chronic hepatitis B virus," he writes. "Additional drugs that target other steps in the hepatitis B virus replication cycle or host immune response are needed."

Gastroenterology 2009;136:389-403,486-495.