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Initiation of lamivudine treatment should only be considered when the use of an alternative antiviral agent with a higher genetic barrier to resistance is not available or appropriate.
During initiation and maintenance of treatment patients should be monitored regularly by a physician experienced in the management of chronic hepatitis B.
If 3TC-HBV is discontinued or there is a loss of efficacy, some patients may experience clinical or laboratory evidence of recurrent hepatitis. Exacerbation of hepatitis has primarily been detected by serum ALT elevations, in addition to the re-emergence of HBV DNA. See Table 1 in Actions for more information regarding frequency of post treatment ALT elevations. Most events appear to have been self-limited. Fatalities are very rare and the causal relationship to discontinuation of 3TC-HBV treatment is unknown.
If 3TC-HBV is discontinued, patients should be periodically monitored both clinically and by assessment of serum liver function tests (ALT and bilirubin levels), for at least four months for evidence of recurrent hepatitis; patients should then be followed as clinically indicated. For patients who develop evidence of recurrent hepatitis post-treatment, there are insufficient data on the benefits of re-initiation of 3TC-HBV treatment.
In patients with moderate to severe renal impairment serum lamivudine concentrations (AUC) are increased due to decreased renal clearance, therefore the dose should be reduced for patients with a creatinine clearance of less than 50 mL/minute. 3TC-HBV is not suitable for patients who require doses below 100 mg (see Dosage & Administration).
Transplantation recipients and patients with advanced liver disease are at greater risk from active viral replication. Due to marginal liver function in these patients, hepatitis reactivation at discontinuation of 3TC-HBV or loss of efficacy during treatment may induce severe and even fatal decompensation. It is recommended that these patients are monitored for parameters associated with hepatitis B, for liver and renal function, and for antiviral response during treatment. If treatment is discontinued for any reason, it is recommended that these patients are monitored for at least 6 months post cessation of treatment. Patients experiencing signs of hepatic insufficiency during or post-treatment should be monitored frequently, as appropriate.
There are limited data on the use of 3TC-HBV in patients receiving concurrent immunosuppressive regimes, including cancer chemotherapy.
In HBeAg positive or negative patients, the development of YMDD (tyrosine-methionine-aspartate-aspartate) mutant HBV may result in a diminished therapeutic response to lamivudine, indicated by a rise in HBV DNA and ALT from previous on-treatment levels. In order to reduce the risk of resistance in patients receiving lamivudine monotherapy, a switch to or addition of an alternative agent without cross-resistance to lamivudine should be considered if serum HBV DNA remains detectable at or beyond 24 weeks of treatment (see Clinical studies under Actions).
For the treatment of patients who are co-infected with HIV and are currently receiving or are planning to receive an antiretroviral treatment regimen including lamivudine, the dose of lamivudine usually prescribed for HIV infection should be maintained.
There is limited information available on maternal-foetal transmission of hepatitis B virus in pregnant women receiving treatment with 3TC-HBV. The standard recommended procedures for hepatitis B virus immunisation in infants should be followed.
Patients should be advised that therapy with 3TC-HBV has not been proven to reduce the risk of transmission of hepatitis B virus to others and therefore, appropriate precautions should still be taken.
Effects on Ability to Drive and Use Machines: There have been no studies to investigate the effect of 3TC-HBV on driving performance or the ability to operate machinery. Further, a detrimental effect on such activities would not be predicted from the pharmacology of the drug.
