What is Heptovir (Lamivudine)?
Heptovir (lamivudine) is a nucleoside and nucleotide reverse transcriptase inhibitor (NRTI) anti-viral drug indicated for the treatment of patients with chronic hepatitis B virus (HBV) infection and evidence of HBV viral replication. Due to its high rate of drug resistance in HBV, the drug should only be used if another antiviral HBV drug with less potential for resistance cannot be used.
Heptovir is effective in chronic HBV infection in increasing HBeAg seroconversion, reducing hepatic necro-inflammation (and reducing serum liver enzymes), and/or suppression of HBV DNA counts.
Dosage and administration
Dosage of Heptovir should be reduced for patients with impaired renal function (creatinine clearance <= 50 mL/min), due to risk of increased serum Heptovir concentrations.
Heptovir side effects
Patients using this medication may experience adverse effects.
These include, but are not limited to:
- stomach ache, nausea, vomiting
For an exhaustive list of side effects, consult the medication monograph.
As an NRTI, Heptovir is active against HIV infection. However, this drug contains a lower dose than is indicated for treating HIV and is often used as monotherapy, and both factors can cause HIV resistance. As such, patients should be tested for HIV infection prior to initiation of Heptovir therapy.
Patients who discontinue HBV anti-virals, including Heptovir, may experience severe acute exacerbations of hepatitis. As such, laboratory and clinical liver parameters should be closely monitored following discontinuation of Heptovir, for a period of at least several months. Resumption of HBV anti-viral therapy may be indicated.
Therapy with Heptovir should be initiated and monitored by a physician with experience in managing chronic HBV infections. Chronic HBV infection can follow a highly variable and unpredictable course, and clinical decisions to initiate or discontinue Heptovir therapy may be complicated.
Heptovir has not been proven to reduce the risk of transmission of HBV to others, so patients should be advised to observe standard universal precautions.
Heptovir has not been proven safe in patients with decompensated liver disease. Severe and even fatal cases of hepatomegaly with steatosis and lactic acidosis have been reported with NRTI use, including lamivudine, in the treatment of HIV infection, particularly in women and the obese. Reports of similar reactions have been seen in patients receiving lamivudine for HBV infection. As such, due caution should be used when using Heptovir in patients with risk factors for hepatic disease, other than HBV infection. Any clinical indications of hepatoxicity or lactic acidosis should prompt consideration of discontinuation of Heptovir.
Pregnancy and lactation
Safety of Heptovir has not been established in pregnancy; use should only be considered if potential benefits outweigh the risks. However, the Antiretroviral Pregnancy Registry has received reports of women (n>11,000) who were exposed to lamivudine in pregnancy, the vast majority of them for HIV treatment, and the incidence of birth defects was no higher than baseline. If treatment is discontinued for pregnancy, patients should be monitored for acute exacerbation of HBV infection. It is not known if this medication can prevent vertical transmission in pregnant women. Any women who are exposed to Heptovir during pregnancy should be reported to the Antiretroviral Pregnancy Registry. Mothers taking Heptovir should not breastfeed, due to high levels of excretion in the breast milk.
The product monograph for Heptovir should be consulted for a complete list of potential drug reactions.
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