Important note: Information in this article was accurate in 1998. The state of the art may have changed since the publication date.

Reuters NewMedia, Inc.; Thursday July 2, 7:32 pm EST
Mark Egan

Brokerage house Merrill Lynch Thursday cut its near-term rating on Gilead to neutral from accumulate, while keeping its long-term rating as accumulate. Gilead on Wednesday said it told a Geneva AIDS conference that its Preveon drug, when used with other drugs, showed a decrease in levels of HIV genetic material when tested in Phase II/III clinical trials.

Even so, analysts were more concerned about the effect of the drug's toxicity. "People were not impressed with their data at the Geneva AIDS conference," one analyst who asked not be named said. "There were questions of toxicity." In a June presentation at a HIV drug-resistance workshop in Lake Maggiore, Italy, Gilead said about one third of patients who took the drug for at least six to 12 months had elevated "kidney markers" -- amino acids shed by the kidney that are deemed a potential sign of toxicity.

Gilead said such side effects could be thwarted in early stages by reducing the dosage to alleviate any clinical problem.

So while the toxicity is reversible, physicians who prescribe the drug would have to take patients on and off the drug, resulting in lower sales than if Preveon was used on a consistent basis over time.

Jonas Alsenas, an analyst at Furman Selz, said the company raised more questions than it answered at the AIDS conference.

"There are more questions now than going in to the conference," Alsenas said. "Although it's possible those issues could be resolved, we felt there was much more risk involved with the story, and we downgraded the stock to a buy from a strong buy."

Gilead's Preveon (adefovir dipvoxil) is an experimental drug called a reverse transcriptase inhibitor. In previous studies the company has said that in a six-month period it was able to withstand attempts by the HIV virus to mutate and become resistant to the drug.

The drug is targeted at what is known as "salvage patients," those who have shown resistance to other available therapies. The hope was that many of those patients, who number about 100,000 and rising worldwide, would use Preveon as a long-term treatment.

"I think it is still reasonable to believe the U.S. Food and Drug Administration would approve the drug even with this toxicity profile just because these patients have no other alternative ... and once you take them off the drug the kidney toxicity reverses, so it's not like there's any permanent damage," Alsenas said.

Reuters NewMedia, Inc. Reston Town Center, 1750 Presidents Street, Suite 250, Reston, VA 22090

Copyright (c) 1998 Reuters Limited. All rights reserved. Republication or redistribution of Reuters content is expressly prohibited without the prior written consent of Reuters. Reuters shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.
980702
RE980706

Always watch for outdated information. This article first appeared in 1998. This material is designed to support, not replace, the relationship that exists between you and your doctor.

AEGiS presents published material, reprinted with permission and neither endorses nor opposes any material. All information contained on this website, including information relating to health conditions, products, and treatments, is for informational purposes only. It is often presented in summary or aggregate form. It is not meant to be a substitute for the advice provided by your own physician or other medical professionals. Always discuss treatment options with a doctor who specializes in treating HIV.

Copyright ©1980, 1998. AEGiS. All materials appearing on AEGiS are protected by copyright as a collective work or compilation under U.S. copyright and other laws and are the property of AEGiS, or the party credited as the provider of the content. .