FDA Approves First Combination Drug for AIDS
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Accession Number
A00389
Author
US Department of Health and Human Services (HHS), Food and Drug Administration (FDA)
Source
FDA Talk Paper
Release Date
September 29, 1997
Major Descriptors
Drug administration
FDA approval
Lamivudine (3TC)
Nucleoside analogues
Zidovudine (AZT)
Topic
Drugs and Treatment
Text
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.
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Food and Drug Administration U.S. Department of Health and Human Services Public Health Service 5600 Fishers Lane Rockville, MD 20857
FDA Talk Papers are prepared by the Press Office to guide FDA personnel in responding with consistency and accuracy to questions from the public on subjects of current interest. Talk Papers are subject to change as more information becomes available.
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