THE VIRGINIAN-PILOT
Copyright (c) 1995, Landmark Communications, Inc.
DATE: Tuesday, November 21, 1995 TAG: 9511210277
SECTION: FRONT PAGE: A1 EDITION: FINAL
SOURCE: BY MARIE JOYCE, STAFF WRITER
LENGTH: Medium: 77 lines
The Food and Drug Administration approved the first new AIDS treatment in nearly a decade Monday.
The FDA authorized the drug 3TC for use in combination with AZT. The new combination may transform standard treatment for the fatal disease, which has become the leading cause of death for Americans between 25 and 44, said a local doctor who participated in the trial.
When paired with AZT, 3TC appears to strengthen the patient's immune system and lower the body's level of HIV, the virus that causes AIDS, for at least six months.
``This is the best combination we've ever had'' to fight the virus, said Edward C. Oldfield III, director of Eastern Virginia Medical School's Infectious Diseases Division. About 75 patients at EVMS' Center for the Comprehensive Care of Immune Deficiency received the drug through a nationwide clinical trial.
Oldfield said he and his colleagues were very impressed with the drug, which goes under the generic name lamivudine and will be marketed under the brand name Epivir.
``Many people suggest that this is going to be the most commonly used regimen'' for AIDS patients. The drug is made by Glaxo Wellcome Inc. of Research Triangle, N.C., which also manufactures AZT.
A Glaxo Wellcome spokeswoman said the company will begin shipping to wholesalers today, so the drug should be available to patients by the end of this week or the beginning of next.
The drug isn't cheap. The wholesale price will be $3.11 per 150-milligram tablet. Patients take two tablets a day, so the annual cost will be more than $2,270. Combined with the cost of AZT and other drugs typically used to treat AIDS-related conditions, a patient's annual pharmaceutical bill could easily be more than double that.
The drug, when combined with the older drug AZT, apparently works by taking advantage of one of HIV's greatest survival skills, its ability to adapt at lightning speed.
HIV reproduces and mutates rapidly, creating 500 million genetic mutations each day in each patient. This enables the virus to adjust to any weapon that science has so far thrown at it. AZT, for instance, works for only about eight months.
The new drug, 3TC, acts as a sort of decoy. After a month of treatment, the HIV produces offspring immune to 3TC. But the genetic change that protects it from 3TC also seems to make it particularly susceptible to AZT.
And the drug appears to have no unpleasant side effects, said Oldfield.
The FDA's action was based on 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, another approved AIDS treatment.
Patients treated with the AZT-3TC combination experienced the greatest increase in the number of CD4 cells - the immune system cells attacked by the virus.
Monday's action makes the 3TC combination patients' first new choice for initial treatment since AZT hit the market in 1987. All other AIDS drugs sold to date are supposed to be used after AZT fails.
The 3TC-AZT approval was the latest example of the FDA's accelerated review of drugs for HIV infection. The review took 4 1/2 months.
Numerous questions remain about the 3TC combination. It will take some time to determine whether the combination improves long-term survival. There's also some concern that when patients develop resistance to 3TC, they also may not respond to other alternatives, such as the drugs ddI and ddC.
``I am very uncomfortable giving this regimen in a widespread way'' because of all the questions, Dr. Douglas Mayers of the Walter Reed Army Institute of Research in Washington told The Associated Press this month.
The eastern region of Virginia, which includes Hampton Roads and the Eastern Shore, has the highest AIDS rate in the state, according to state Health Department statistics, 35.9 cases per 100,000 people. As of June 30, more than 2,000 people in South Hampton Roads were infected with HIV. MEMO: The Associated Press contributed to this report.
KEYWORDS: AIDS by CNB