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Epivir in combination with other antiretroviral agents is indicated for the treatment of HIV infection. Epivir should be used with caution in pediatric patients with a history of prior antiretroviral nucleoside exposure, a history of pancreatitis, or other significant risk factors for the development of pancreatitis. Patients with HIV or coinfected with HIV and hepatitis B should only receive the recommended HIV dosage of Epivir (300mg/day) and not Epivir-HBV (100mg/day). Epivir has not been adequately studied for treatment of chronic hepatitis B in coinfected patients. Clinical and laboratory exacerbations of hepatitis B have occurred after discontinuation of lamivudine and may be severe in patients with decompensated liver disease.

Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues alone or in combination, including abacavir, lamivudine and other antiretrovirals.

Redistribution/accumulation of body fat has been observed in patients receiving antiretroviral therapy. The causal relationship, mechanism and long-term consequences of these events are currently unknown.

The most common side effects with Ziagen are nausea, vomiting, tiredness, headache, diarrhea and loss of appetite. The most common side effects with Epivir are headache, upset stomach, tiredness, and nasal signs and symptoms.

The recommended dose of Ziagen is 300mg twice a day. The recommended dose of Epivir is 150mg twice a day or 300mg once a day. Recombinant laboratory strains of HIV-1 (HXB2) containing multiple reverse transcriptase mutations conferring abacavir resistance exhibited cross-resistance to lamivudine, didanosine, and zalcitabine in vitro.

GlaxoSmithKline is one of the world's leading research-base
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Contact: Elaine Salewske
esalewske@pcipr.com
312-558-1770
Public Communications Inc.
16-Sep-2003