FDA Approves First Combination Drug for AIDS

Date: September 29, 1997
Source: Food and Drug Administration (FDA)

On Friday, Sept. 26, FDA approved a combination of AZT (zidovudine) and 3TC (lamivudine) for treating AIDS and HIV infection. Combining these two drugs, which are commonly prescribed with one another, into one tablet could decrease the number of pills people with HIV have to take daily. The following can be used to answer questions:

Combivir, as the new drug is called, given twice a day provides an alternative regimen to 150 mg 3TC twice a day plus AZT 600 mg per day in divided doses. This drug form reduces pill intake for these two drugs to two per day instead of up to eight.

AZT and 3TC are members of the nucleoside analogue class of drug compounds, and both interfere with the replication of HIV, the virus that causes AIDS. These drugs are frequently part of the "drug cocktails" used to attack the virus in people with HIV.

Adverse events continue to be those associated with nucleoside analogue drugs: nausea, diarrhea, anemia, low white blood cells, pancreatitis and neuropathy.

AZT has been available for people with AIDS since 1987; 3TC was approved in 1995 for use in combination with AZT.

All three drugs are manufactured and marketed by Glaxo Wellcome of Research Triangle, N.C.

Food and Drug Administration U.S. Department of Health and Human Services Public Health Service 5600 Fishers Lane Rockville, MD 20857

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