FDA Approves Trizivir, 3-Drug Anti-HIV Combo

RESEARCH TRIANGLE PARK, NC—Trizivir, Glaxo-Wellcome’s new triple-drug anti-HIV combination, has received FDA approval. The agent is given as one tablet twice daily, with no food or water restrictions.

Trizivir combines lamivudine (Epivir, 3TC) 150 mg and zidovudine (Retrovir, AZT) 300 mg with abacavir (Ziagen) 300 mg. All three agents are nucleoside analogs. Epivir and Retrovir are already available in a two-drug combination product (Combivir).

Trizivir is indicated alone or in combination with other antiretroviral agents for the treatment of HIV infection and is intended only for patients whose regimen would otherwise include all three of the agents in the tablet. The indication is based on analyses of surrogate markers in controlled studies of up to 24 weeks’ duration.

Trizivir must not be used by patients who have previously experienced a hypersensitivity reaction to abacavir. These occur in approximately 5% of patients taking abacavir and can be life threatening.