FDA Approves Abacavir for HIV-1 Infection

Date: December 18, 1998
Source: Food and Drug Administration (FDA)

FDA approved today abacavir (trade name Ziagen) for the treatment of Human Immunodeficiency Virus-1 (HIV-1) in adults and children. The following can be used to answer questions:

Ziagen, an oral medication taken twice daily, is one of a class of medicines called nucleoside analogue reverse transcriptase inhibitors (NRTIs) and is taken in combination with other anti-HIV medications. This combination of medicines helps to lower the amount of HIV found in the blood.

This new drug offers another choice for the treatment of HIV, a virus that mutates quickly and may become resistant to current treatment. Ziagen, available in tablet and liquid form is approved for adults and pediatric patients older than three months of age.

A potentially fatal hypersensitivity, or allergic reaction, has been associated with the use of Ziagen in at least 5 percent of patients. Symptoms of this reaction may include skin rash, fever, nausea, abdominal pain and severe tiredness.

A written list of the hypersensitivity symptoms is printed on a warning card and is provided along with a Medication Guide to patients by pharmacists. Anyone who experiences a hypersensitivity reaction must stop taking the medicine and call their health care provider immediately. Ziagen should not be taken again after a reaction occurs because more severe symptoms will arise within hours and may include life-threatening low blood pressure or death.

An abacavir hypersensitivity reaction registry has been established -- physicians should register patients developing symptoms of hypersensitivity by calling 1-800-270-0425.

All NRTIs can cause lactic acidosis-- a fatal metabolic disturbance that causes an abnormal buildup of lactic acid-- symptoms may include an enlarged liver.

Additional reported side effects of abacavir include nausea, vomiting, fatigue, headache, diarrhea and loss of appetite.

Accelerated approval of Ziagen was based on analyses of surrogate markers in three controlled studies of up to 24 weeks in duration. At present there are no results from controlled trials with Ziagen evaluating long-term suppression of HIV infection or AIDS.

Ziagen is manufactured and marketed by GlaxoWellcome Inc. Of Research Triangle Park, N.C.

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