Important note: Information in this article was accurate in 1995. The state of the art may have changed since the publication date.
The Associated Press - 21 Nov 1995
Kim I. Mills, The Associated Press
When the two drugs are paired, 3TC appears to boost immune systems and lower the amount of HIV in the blood for at least six months, says Glaxo Wellcome Inc. of Research Triangle Park, N.C., which makes both drugs.
The combination therapy appears to work best in patients who have never tried AZT alone, prompting an FDA advisory panel to recommend earlier this month that it be offered as an initial therapy. Monday's action makes the 3TC combination patients' first new choice for initial treatment since AZT hit the market in 1987.
Glaxo's wholesale price for the combined drug therapy will be $12.67 to $13.96 per daily dose. This would total $4,600 to $5,100 a year, said Glaxo. Pharmacies and patients can expect to pay more. Sold under the trade name Epivir and also known as lamivudine, 3TC should be available in pharmacies next week.
It is the fifth member of a family of acquired immune deficiency syndrome drugs that fight the disease by incapacitating a protein important in the virus' reproduction.
The FDA's action was based on data from four clinical trials enrolling about 1,000 HIV-infected adults who received either the combined 3TC-AZT therapy, 3TC alone, AZT alone or AZT and ddC. The latter drug, ddC, was approved for use against AIDS, but, unlike 3TC, was not approved for initial therapy.
The trials showed that patients treated with the combination of 3TC and AZT sustained a higher increase of CD4 cells--a reflection of immune-system strength--than patients on the other three regimens. On average, CD4 cell counts in patients on the combination of 3TC and AZT increased by 30 to 50 cells.
"The real significance of this combination lies in its potent and sustained antiviral effect, and its boost to the immune system," said Dr. Joseph J. Eron Jr., assistant professor of medicine at the University of North Carolina, Chapel Hill, School of Medicine.
The 3TC-AZT approval was the latest example of the FDA's accelerated review of drugs for human immunodeficiency virus infection. The review took 4-1/2 months.
Numerous questions remain about the 3TC combination. There are some suggestions that when patients develop resistance to 3TC, they also may not respond to alternatives, such as the drugs ddl and ddC.
"I am very uncomfortable giving this regimen in a widespread way," Dr. Douglas Mayers of Walter Reed Army Institute of Research in Washington said earlier this month.
Copyright 1995/The Associated Press. Reproduced with permission. Reproduction of this article (other than one copy for personal reference) must be cleared through the Permissions Desk, The Associated Press, 50 Rockefeller Plaza, New York, NY 10020.
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Copyright © 1995 - Associated Press. Reproduction of this article (other than one copy for personal reference) must be cleared through the AP Permissions Desk.
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