Type B viral hepatitis, chronic
Black Box Warning: Severe acute exacerbations of hepatitis may occur in patients who have discontinued anti-hepatitis B therapy, including telbivudine. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who discontinue anti-hepatitis B therapy. If appropriate, resumption of anti-hepatitis B therapy may be warranted.
Monitor AST/ALT, HBV envelope antigen, HBV surface antigen, and HBV DNA levels every 3 months for first year of therapy and annually thereafter during treatment.
Monitor HBV DNA levels at 24 weeks of treatment to ensure complete viral suppression has occurred (HBV DNA <300 copies/mL).
Monitor hepatic function closely for at least several months after stopping treatment for potential acute exacerbation of hepatitis B.
Perform non-invasive liver testing annually in patients without cirrhosis at baseline.
Common
Severe
Contraindication: Peginterferon alfa-2a - increased risk of peripheral neuropathy
Antimicrobial class: Antiviral agent, Thymidine nucleoside analog
Pregnancy category: B
Average serum half life: 40-49 hours
Precautions: Interrupt therapy if lactic acidosis, myopathy, peripheral neuropathy or pronounced hepatotoxicity is suspected. Oral solution contains 47 mg of sodium per 600-mg dose (30 mL).