U.S. WARNS ON SOME USE OF A FIGHTER AGAINST H.I.V.

By Lawrence K. Altman

The New York Times 5 Jan. '01

Federal health officials advised doctors yesterday not to prescribe a standard H.I.V. prevention drug to healthy health care workers stuck by needles.

The drug, nevirapine, can produce liver damage severe enough to require liver transplants, and has caused death in such use, the Centers for Disease Control and Prevention said in its weekly report.

But nevirapine should still be used for two other groups, the centers said. One is in treating people infected with H.I.V., the AIDS virus. The second is to prevent transmission of H.I.V. from mothers to their infants during childbirth.

The differing recommendations are based on the relative benefits and risks of nevirapine among the three groups and the low but real risk that health care workers will be infected with H.I.V. from injuries caused by contaminated needles.

Needle-stick injuries are common in American hospitals -- 236,000 a year, the General Accounting Office has estimated. But most do not lead to H.I.V. infections. Since AIDS was recognized in 1981, the disease control centers has documented that 56 health care workers were infected with H.I.V. chiefly through needle-stick injuries and that 138 other workers were possibly infected through occupational exposure.

The agency recommends a four-week course of anti-H.I.V. drugs for health care workers who have been stuck with needles believed to contain contaminated blood. But it recommends drugs other than nevirapine.

Dr. Helen Gayle who directs the agency's AIDS program, said many doctors had prescribed nevirapine for such use.

One reason was the influence of studies that found a single dose of nevirapine could prevent transmission of H.I.V. from mother to child. Another was that the drug, in theory, might act faster than others.

"Clearly there needs to be caution, particularly for healthy health care workers who could take other recommended regimens" to prevent H.I.V. infection, Dr. Gayle said in an interview.

There are no studies that show nevirapine is beneficial in preventing H.I.V. infection after needle sticks, said Dr. Julie L. Gerberding, an agency expert on infections acquired at hospitals.

The agency said it and the federal Food and Drug Administration had identified 22 cases of severe liver, skin and muscle damage related to nevirapine taken after possible exposure to H.I.V. from March 1997 through September 2000.

Such complications are highlighted in the information that the drug's manufacturer, Roxane Laboratories of Columbus, Ohio, includes in each package.

Roxane, a subsidiary of the Boehringer Ingelheim Corporation, makes and markets nevirapine under the trade name Viramune.

Administering the drug as an H.I.V. preventive after needle sticks is not an approved use of nevirapine, said Sheila Burke, a spokeswoman for Boehringer Ingelheim.

No serious adverse effects have been found in three large studies of nevirapine's use in reducing the risk of a mother transmitting H.I.V. to her newborn child during delivery, the disease control centers said. The benefit outweighs the risk, largely because the mother and child take only one pill, Dr. Gayle said.

The United Nations' AIDS program said it supported the agency's recommendation for using nevirapine to prevent mother-to-child transmission of H.I.V. and was working with Boehringer Ingelheim to start programs in developing countries.

Nevirapine is included in some combinations of anti-H.I.V. drugs for people infected with the virus, and patients should continue such therapy unless their doctors change it, Dr. Gayle said.

The agency does not recommend nevirapine to prevent H.I.V. infection among people recently exposed to the virus through unsafe sex, although some doctors have prescribed it as an experimental treatment, Dr. Gerberding said.