CDC: Avoid Condoms That Are Lubricated With Nonoxynol-9

OB/GYN News, Sept 15, 2000 by Kathryn Demott

Sexually active individuals should be warned against using the microbicide nonoxynol-9 by itself to prevent HIV transmission and, if given a choice, they should use condoms without the spermicide instead of ones lubricated with it, the Centers for Disease Control and Prevention, Atlanta, has advised.

That's the warning in a "Dear Colleague" letter written by Dr. Helene D. Gayle, director of the National Center for HIV STD, and TB Prevention at the CDC, and sent to health care providers nationwide.

Officials at the CDC and the Joint United Nations Program on HIV/AIDS (UNAIDS) plan to spend the next few months reviewing public health recommendations on the use of nonoxynol-9 as a result of preliminary findings from a triple-blind study released at the 13th International AIDS Conference in Durban, South Africa, in July

In that study, 990 prostitutes in four African and two Asian cities received COL-1492 (Advantage-S), a gel containing 52.5 mg of nonoxynol-9 per dose, or a placebo gel (Replens). After nearly 800 person-years of use, 59 women in the nonoxynol-9 group (15%) were HIV positive, compared with 41 in the placebo group (10%), a significant difference.

Women in both groups were HIV negative at baseline and were counseled to use condoms along with the gel.

Those in the nonoxynol-9 group developed more vaginal lesions, which were believed to be caused by the irritating microbicide and to have facilitated HIV transmission. Prostitutes in the study had an average of 75 sexual encounters a month, and some applied the gel up to 20 times a day.

It's not clear whether the risk of HIV transmission would be affected by more occasional use of the spermicide or by use under other circumstances, such as during anal sex.

"I don't know of any direct data" in humans looking specifically at the HIV transmission risk when condoms are lubricated with nonoxynol-9, Dr. Robert Janssen, director of the division of HIV/AIDS prevention at the CDC, said in an interview.

While the amount of nonoxynol-9 used as a lubricant in condoms is much less than that found to be harmful in the study, "the problem is that the study showed harm," he said.

Among the prostitutes, there seemed to be a dose-related response. At some point, the use of nonoxynol-9 was not only of no benefit, it became harmful. "The question is: Where in the spectrum [of use] does it begin to increase the risk for HIV transmission," and what are the factors that contribute to that increase? he added.

Dr. Janssen said that he expects to have revised public health recommendations drawn up by late fall or early winter.

Until then, clinicians involved in sexual risk counseling are advised to stop recommending nonoxynol-9 for the prevention of HIV transmission.

The CDC has never recommended nonoxynol-9 alone for HIV prevention, emphasizing instead the "consistent and correct use of condoms, with or without spermicide," according to the letter.

Under the interim recommendations, individuals should still be advised to use condoms. However, it should be explained that if given a choice, condoms without nonoxynol-9 may be a better option for HIV prevention.

And if people are not able to choose, a condom lubricated with nonoxynol-9 is clearly better than using no condom at all," Dr. Gayle said in the letter.

Nonoxynol-9 May Raise Infection Risk

INCLINE VILLAGE, NEV. -- Use of the vaginal spermicide nonoxynol-9 with intercourse results in disturbances of vaginal flora and pH that may predispose to genitourinary tract infections, Dorothy L. Patton, Ph.D., reported at the annual meeting of the Infectious Diseases Society for Obstetrics and Gynecology.

She studied 21 healthy young women who applied a 100-mg insert of nonoxynol-9 twice daily for 3 days, a period in which they had intercourse twice using nonspermicidal condoms. Subjects' vaginal epithelium was serially assessed colposcopically, histologically and by culture out to 8 days postintercourse.

Use of nonoxynol-9 was associated with increased vaginal erythema, a rise in vaginal pH, a significant increase in vaginal E. coli, and a large decline in lactobacillus concentration. These changes were transient. Return to normal was noted within 1 week following intercourse using nonoxynol-9, according to Dr. Patton, who is professor of ob.gyn. at the University of Washington, Seattle.

In an earlier study no changes in vaginal flora were noted in volunteers who used nonoxynol-9 alone, without intercourse, she said at the meeting, also sponsored by the American College of Obstetricians and Gynecologists.

Nonoxynol-9 is the only commercially available spermicide on the U.S. market.

Bruce Jancin