Generic AIDS Drug Effective - And Now?

Medical Authors and Editors: Barbara K. Hecht, Ph.D. and Frederick Hecht, M.D.

July 2, 2004 -- The first clinical trial of a generic combination of drugs for AIDS has demonstrated that the generic combination works as well as band name drugs. The trial will be reported in the July 3 issue of the English medical journal The Lancet.

The Lancet report has important implications for American foreign health policy. "This issue is important because the United States has refused to let the $15 billion that President Bush has committed to fighting AIDS in the third world be used for generic drugs, arguing that there is not enough proof they are effective," noted The New York Times.

The generic combination in the trial consisted of nevirapine, stavudine and lamivudine made by Cipla Ltd. of Mumbai, India. The brand names for these drugs are Viramune, Zerit and Epivir, respectively.

A Most Unusual Clinical Trial

The makers of generics normally do not need to carry out trials of their products. They need only prove that their drugs are chemically identical to brand-name drugs. So this clinical trial of generic drugs is most unusual.

The clinical trial was done in Yaounde, the capital of Cameroon in West Africa. Nearly all the patients were in the far advanced stages of AIDS. By the end of the trial, the generic combination pill had driven down the HIV virus to very low levels in 80% of patients. And most of the patients had increases in CD-4 cells, the cells that HIV attacks.