Initiate only if pretreatment HBV DNA and ALT levels are known. HBV DNA should be <9 log
10 copies/mL and ALT should be 2X ULN in HBeAg-positive patients prior to therapy. HBV DNA should be <7 log copies/mL in HBeAg-negative patients prior to therapy. Institute alternate 10
therapy in patients with incomplete viral suppression (HBV DNA 300 copies/mL) after 24 weeks of treatment or if patients test positive for HBV DNA at any time after initial response. Female gender, obesity, and prolonged nucleoside exposure may be risk factors for developing lactic acidosis and hepatomegaly with steatosis; d/c therapy if lactic acidosis or hepatotoxicity develops. Caution with known risk factors for liver disease. Myopathy/myositis and peripheral neuropathy reported; interrupt therapy if suspected and d/c if confirmed. Rhabdomyolysis and uncomplicated myalgia reported. Caution in elderly.
Fatigue, creatinine kinase increase, headache, cough, diarrhea, abdominal pain, nausea, pharyngolaryngeal pain, arthralgia, pyrexia, rash, lactic acidosis, severe hepatomegaly with steatosis, back pain, dizziness.
See Contraindications. Drugs that alter renal function may alter plasma concentrations.
Category B, not for use in nursing.
Thymidine nucleoside analogue; inhibits HBV DNA polymerase (reverse transcriptase) by competing with the natural substrate thymidine 5'-triphosphate and causing DNA chain termination after incorporation into viral DNA.
with varying degrees of renal function resulted in different pharmacokinetic parameters.
Distribution: Plasma protein binding (3.3%). Elimination: (600mg single dose) Urine (42%), T 1/2 =40-49 hrs.
Assess for renal/hepatic impairment, use in women, obesity, nucleoside exposure duration, risk factors for liver disease, pregnancy/nursing status, and possible drug interactions. Obtain HBV DNA and ALT levels prior to therapy.
Monitor hepatic function periodically and for several months after d/c. Monitor for exacerbation of
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