Telbivudine

Telbivudine is used to treat chronic hepatitis B in adults who show evidence of viral replication and who also have either persistently raised serum aminotransferases (ALT or AST) or histologically active disease. Some points need to be considered before starting Telbivudine. This use is based on virologic, serologic, biochemical and histologic responses in adults with HBeAg positive and HBeAg negative chronic hepatitis B and compensated liver disease, who had not been treated with a nucleoside before. For HBeAg-positive patients, Telbivudine should only be started when HBV DNA is less than 9 log10 copies per mL and ALT is greater than or equal to 2x Upper Limit of Normal (ULN) before treatment. For HBeAg-negative patients, it should only be started when HBV DNA is less than 7 log10 copies per mL before treatment. The response during treatment should guide whether therapy continues. Telbivudine has not been evaluated in patients co-infected with HIV, HCV or HDV, nor in liver transplant recipients or patients with decompensated liver disease. It has also not been studied in well-controlled trials in patients with established nucleoside analog reverse transcriptase inhibitor-resistant hepatitis B virus infection, but it is expected to be cross-resistant to lamivudine. The safety and efficacy of Telbivudine have not been evaluated in Black/African American or Hispanic patients.