Abstract

AIDS: The Food and Drug Administration (FDA) used accelerated approval regulations to approve the use of Glaxo-Wellcome's lamivudine (Epivir/3TC) in combination with AZT. The FDA guidelines used for approval, including viral load and CD4 count benefits, are explained. The guidelines warn that 3TC should be used with extreme caution in pediatric patients who are at risk of developing pancreatitis. Glaxo Wellcome has been commended for testing the drug on children beyond the FDA requirements. Cross resistance to ddI and ddC is a concern if AZT is used after 3TC treatment. Despite controversy at the Antiviral Drugs Advisory Committee meeting, the FDA did not indicate any specific T-cell range for the 3TC/AZT combination therapy. The price of 3TC to wholesalers is $3.11 per 150 mg tablet. Glaxo-Wellcome will provide reimbursement assistance to patients who have no other means of purchasing the drug.