Epivir (Heptovir)

Epivir (Heptovir) Information

Epivir is indicated for the treatment of patients with chronic hepatitis B and evidence of hepatitis B virus (HBV) replication. This indication is based on the analysis of histologic and serologic endpoints in patients with compensated chronic hepatitis B, which were mainly derived from studies of 1 year duration. Data beyond 1 year is limited. The safety and efficacy of lamivudine have not been established in patients with decompensated liver disease in placebo-controlled studies.

Epivir (Heptovir) Warnings

Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of antiretroviral nucleoside analogues alone or in combination, including lamivudine, in the treatment of HIV infection. A majority of these cases have been in women. Obesity and prolonged nucleoside exposure may be risk factors. Particular caution should be exercised when administering 3TC or Heptovir to any patient with known risk factors for liver disease (other than hepatitis B). However, cases have been reported in patients with no known risk factors. Treatment with lamivudine should be suspended in any patient who develops clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity. Pancreatitis has been reported in patients receiving 3TC (lamivudine), particularly in HIV-infected pediatric patients with prior nucleoside exposure. Contraindications exist with patients with known hypersensitivity to lamivudine or to any ingredient of the preparation. The safety and efficacy of lamivudine have not been established in patients with decompensated liver disease. The efficacy of Epivir has not been established in patients not responding to interferon therapy. Clinical significance of the development of YMDD mutant HBV DNA is not known. Optimum duration of therapy has not been established. Following discontinuation of Epivir in patients with chronic hepatitis B, some patients may experience clinical or laboratory evidence of recurrent hepatitis, which may have more severe consequences in patients with decompensated liver disease. If Epivir is discontinued, patients should be periodically monitored both clinically and by assessment of serum liver function tests (ALT and bilirubin levels), for at least 4 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 reinitiation of lamivudine treatment. Some chronic hepatitis B patients may be coinfected with HIV. The possibility of such coinfection should be considered prior to initiating lamivudine therapy. Chronic hepatitis B is a highly variable condition and during therapy it is possible the patient may experience rebound during therapy (i.e., viral load increase or increase in liver enzyme levels) or other discordant results (e.g., increased HBV DNA and improved liver histology). Patients should be advised that therapy of chronic hepatitis B with lamivudine has not been proven to reduce the risk of transmission of hepatitis B virus to others through sexual contact or blood contamination and, therefore, appropriate precautions should still be taken. There are no adequate and well-controlled studies in pregnant women. There are limited data on the use of lamivudine in pregnancy. There is no information available on maternal-fetal transmission of hepatitis B virus in pregnant women receiving treatment with lamivudine. The standard recommended procedures for hepatitis B virus immunization in infants should be followed. It is recommended that mothers taking lamivudine do not breast-feed to avoid potential adverse effects from lamivudine in nursing infants. Drug Interactions : The likelihood of metabolic interactions is low, due to limited metabolism and plasma protein binding and almost complete renal elimination of unchanged drug.

Epivir (Heptovir) Side Effects

The most common side effects of Epivir reported were malaise and fatigue, respiratory tract infections, headache, abdominal discomfort and pain, nausea, vomiting and diarrhea. In patients with HIV infection, cases of pancreatitis and peripheral neuropathy (or paresthesia) have been reported, although no relationship to treatment with lamivudine (3TC) has been clearly established. In patients with chronic hepatitis B, there was no observed difference in incidence of these events between placebo- and lamivudine-treated patients.

Epivir (Heptovir) Overdose

Limited data are available on the consequences of ingestion of acute overdoses in humans. No fatalities occurred, and the patients recovered. No specific signs or symptoms have been identified following such overdosage. Although no data are available, administration of activated charcoal may be used to aid in removal of unabsorbed drug. Since Epivir is dialyzable, continuous hemodialysis could be used in the treatment of overdose, although this has not been studied.

Epivir (Heptovir) Usage Guidelines

The recommended dose for adults and adolescents who are at least 16 years old is 100 mg once daily. Optimum duration of therapy has not been established. Discontinuation of Epivir may be considered in immunocompetent patients when HBeAg and/or HBsAg seroconversion occurs. There are limited data regarding the maintenance of seroconversion long-term after stopping treatment with lamivudine. If Epivir is discontinued, patients should be periodically monitored for evidence of recurrent hepatitis .

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