"This action is important in that it recognizes that Epivir^TM has a significant impact on survival and delaying the progression of HIV infection."

-Richard S. Kent, M.D.

This quote refers to the FDA accelerated approval of Epivir^TM used in combination with Retrovir^TM to treat patients with AIDS and the HIV infection. This is important because the FDA regulations only permit early commercial release of a drug to treat a serious or potentially life-threatening diseases based on its effects in clinical trials on lab markers. An example of a laboratory marker is the CD4 cell counts (discussed later). This is the first time under the accelerated approval regulations that a combination HIV therapy has been indicated as a treatment option for HIV infected adults.

In different studies, Epivir^TM has proven to be effective in reducing the risk of death and disease progression. This combination treatment increases a patient’s CD4 cells by more than any other treatment. On average, their CD4 cell counts went up between 30 to 50 cells above the level at the beginning of the 24-week study. This increase is a direct reflection on the immune system strength.

This combination of Epivir and Retrovir inhibits HIV reverse transcriptase via viral DNA chain termination. It is safe for people of all ages, which is reflected in the many studies conducted. Although there is no evidence of harm to the fetus, pregnant women are advised to only take Epivir^TM(also called Lamivudine) if the potential benefits outweigh the risks. This caution is posted because Lamivudine can be transferred to the fetus through the placenta.

There are some possible side effects. Among those are headaches, fatigue, fever/chills, nausea, diarrhea, and nasal signs and symptoms.

It is advised that Epivir^TM be taken in dosages of 300 mg daily which is two 150 mg tablets. Each tablet costs $3.11; annually costing $2270. Retrovir^TM is to be used in combination with Epivir.^TM Retrovir^TM is 500 mg daily in five 100-mg capsules. Each capsule costs $1.29; annually costing $2354. Therefore, used in combination would cost $12.67 per day or $4600 per year. Epivir^TM comes in both tablets and oral solution.

Epivir^TM and Retrovir^TM are manufactured and marketed by Glaxo Wellcome Inc.