AEGiS-PRn: FDA Gives Accelerated Approval to New Therapy for Treatment of HIV Infection

Important note: Information in this article was accurate in 1995. The state of the art may have changed since the publication date.

FDA Gives Accelerated Approval to New Therapy for Treatment of HIV Infection

PR Newswire - November 20, 1995 .

RESEARCH TRIANGLE PARK, N.C., Nov. 20 /PRNewswire/ -- The anti-HIV drug Epivir(TM) brand lamivudine, formerly known as 3TC(TM), was released for marketing late on Friday, November 17, by the Food and Drug Administration. Epivir is indicated for use in combination with Retrovir(R) brand zidovudine (AZT) for the treatment of patients with AIDS and HIV infection.

The agency's action clears the way for availability of this combination which has been shown in clinical trials to increase the number of the body's CD4 cells. However, there are no data on the potential effect of Epivir on clinical outcomes of the disease, such as death or the occurrence of opportunistic infections. Adverse events most frequently associated with this combination in adults in clinical trials included headache (35%), nausea (33%), malaise and fatigue (27%), nasal signs and symptoms (20%), diarrhea (18%), neuropathy (12%), low white blood cells (7.2%) and anemia (2.9%). Some of these events required discontinuation of therapy. In addition, pancreatitis was observed in 15% of pediatric patients in clinical trials, especially in children who had received prior nucleoside analogue therapy.

Epivir in combination with Retrovir was reviewed under the FDA's accelerated approval regulations. These regulations permit early commercial release of a drug to treat a serious or potentially life-threatening disease based on its effects in clinical trials on laboratory markers of the disease, such as CD4 cell counts. The clearance of Epivir with Retrovir marks the first time under accelerated approval regulations that a combination HIV therapy has been indicated as a treatment option for HIV-infected adults who have not previously received treatment. Epivir is expected to be available in pharmacies within the next week.

FDA's action was based on data from four clinical trials enrolling approximately 1,000 HIV-infected adults who received either the combined therapy with Epivir and Retrovir, Epivir as a single therapy, Retrovir as a single therapy, or Retrovir and ddC in combination.

The trials showed that patients treated with the combination of Epivir and Retrovir sustained 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 Epivir and Retrovir increased by 30 to 50 cells above the levels at the start of the 24-week trials.

"Epivir in combination with Retrovir marks the beginning of the realization of the synergistic effects of combination therapy," said Joseph J. Eron, Jr., MD, assistant professor of medicine at the University of North Carolina, Chapel Hill, School of Medicine and primary investigator of the U.S. study of the combination in previously untreated patients. "The real significance of this combination lies in its potent and sustained antiviral effect, and its boost to the immune system."

All of the clinical studies of Epivir and Retrovir evaluated the effects of the combination on laboratory markers of HIV infection and AIDS. Studies to assess its effect on clinical endpoints such as progression to opportunistic infections or death are underway.

Epivir was discovered by BioChem Pharma (Nasdaq: BCHXF) of Laval, Quebec, Canada. BioChem Pharma licensed the rights to develop Epivir to Glaxo (NYSE: GLX)(now Glaxo Wellcome) in 1990. Both Epivir and Retrovir are manufactured and marketed by Glaxo Wellcome Inc.

NOTE TO EDITORS: For full prescribing information, please contact Kym White at Ogilvy Adams & Rinehart, 212-880-5235/

CONTACT: Ramona Jones for Glaxo Wellcome, 919-248-2839/ 09:01 EST

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