Epivir-HBV and placebo were associated with similar side effects during the study period. In conjunction with the earlier New England Journal report of Lai et al. The optimum duration of treatment with Epivir-HBV, the durability of HBeAg seroconversions occurring during treatment, and the relationship of initial treatment response to outcomes such as hepatocellular carcinoma and decompensated cirrhosis are not known. The reappearance of assay-detectable HBV DNA during lamivudine treatment was observed in approximately one third of patients after initial response. Post-treatment exacerbations of hepatitis B have occurred.
Most events appear to be self-limiting.
Fatalities have been reported in some cases. The causal relationship to discontinuation of lamivudine treatment is unknown. Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported rarely with the use of nucleoside analogues alone or in combination, including lamivudine and other antiretrovirals. If treatment with Epivir-HBV is prescribed for chronic hepatitis B for a patient with unrecognized or untreated HIV infection, rapid emergence of HIV resistance is likely because of subtherapeutic dose and inappropriate monotherapy. Any question regarding a medical diagnosis, treatment, referral, drug availability or pricing should be directed to either a licensed physician or to the product's manufacturer.