Reuters Health Information (2007-11-26): Entecavir therapy provides long-term benefit for chronic hepatitis B
Entecavir therapy provides long-term benefit for chronic hepatitis B
Last Updated: 2007-11-26 20:01:54 -0400 (Reuters Health)
NEW YORK (Reuters Health) - An extension of an earlier study shows that entecavir continues to better suppress virus compared with lamivudine after 2 years in nucleoside-naive patients with chronic e antigen-positive hepatitis B, according to a study in the November issue of Gastroenterology.
"Entecavir is now the best medication, by far, for long-term suppression of HBV infection, with a very favorable side-effect profile," lead author Dr. Robert. G. Gish of the California Pacific Medical Center, San Francisco told Reuters Health.
The double-blind, multicenter, controlled trial followed 709 patients with chronic HBV infection randomized to entecavir or lamivudine. Both groups had already received 48 weeks of either 0.5 mg of entecavir daily or 100 mg of lamivudine daily. The two groups were well matched at baseline for demographic and disease characteristics.
At the end of the first year, virologic responders were eligible to continue the blinded treatment for a total of 96 weeks.
By the end of year two, 74% patients treated with entecavir achieved HBV DNA levels below 300 copies/mL by polymerase chain reaction assay. Only 37% of those treated with lamivudine reached the same milestone.
The proportion of patients receiving entecavir who achieved normal ALT levels was 79%, compared with 68% of the lamivudine patients
None of the patients experienced virologic break-through due to entecavir resistance during the 96 weeks.
In an accompanying editorial, Dr. Emmet B. Keefe of the Stanford University School of Medicine commented that "entecavir continues to demonstrate a high genetic barrier to resistance in nucleoside-naive patients."
Gastroenterology 2007;133:1437-1444, 1718-1721.