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AIDS Treatment Data Network
(ATDN) 3TC - a new anti-HIV drug?

December 1, 1994
Treatment Review #15; December 1994

3TC, also known as lamivudine, is an antiretroviral that works in the same way as AZT, ddI, ddC and d4T. Researchers studying the drug reported in November of this year that the combination of 3TC and AZT was effective in improving laboratory tests of the immune system. Further trials of the drug to study its clinical benefits will begin next year, the company said.

In two separate studies, HIV+ participants were given either AZT, or AZT in combination with 3TC. After 24 weeks, tests showed that study participants taking the combination therapy had an increased number of T cells and lower levels of virus in the blood. The people taking AZT alone either showed less improvement or got worse, according to their laboratory tests. These studies did not examine progression to illness, disease or death, but measured HIV's effects in the blood. People receiving the combination experienced an average gain of 85 T4 cells after eight weeks on study and maintained an increase of 80 T4 cells through week 24. At week 48, an increase of 49 T4 cells persisted. People receiving only AZT had their T4 cell counts drop by an average of seven at week 24. When switched to the combination treatment, these people showed an average increase of 40 T4 cells by week 48.

3TC is in Phase III trials in Europe and the Far East as a treatment for hepatitis B. Phase III trials are planned for the US, Canada and Japan in late 1994 and 1995. Side-effects seen in trials are fatigue and headaches. The company that makes the drug will file for approval of 3TC in the first half of 1995. The company expects to report results from two United States trials comparing AZT, 3TC and the two drugs in combination in late January. With the release of this information, the company's stock surged. Many analysts reacted skeptically, stating, "Popular press overreacts," and pointing out that three other AIDS drugs for use with AZT have already been approved.

The data behind the report is based on six months of treatment and six months of follow-up. It is not know how well 3TC in combination with AZT would do if taken for a longer time. Currently, 3TC is in a clinical trial for children and adolescents in combination with AZT and ddI at the National Cancer Institute. If you would like more information about this trial, call The Network. 3TC is also available through an expanded access program from the drug company for both children and adults. Children can take the drug in syrup form. Adults take pills. Doctors can call (800) 248-9757 for more information.