Compared with HIV-negative women, HIV-positive women are at a higher risk of developing lesions on their cervix. In HIV-positive women, these lesions are more likely to become cancerous and spread. Moreover, even after these lesions have been scraped or burnt off, they can quickly recurr. Researchers in the United States recently released the results of a study examining the effectiveness of the anti-cancer cream 5-FU (5-fluorouracil) in preventing the reappearance of cervical lesions. Their results are promising.

Study details

Researchers recruited 101 women whose cervical lesions had been removed. Fifty women were randomly assigned to receive five per cent 5-FU cream at a dose of 2.0 grams every two weeks for six months. These women used an applicator to place the cream on their cervix. The cream was not applied during menstrual periods or at "other times of bleeding." The women also avoided having sexual intercourse 48 hours after each application. The remaining 51 women were not given 5-FU. Both groups of women were monitored regularly for the reappearance of cervical lesions.

The researchers did not calculate the subjects' age and CD4+ cell counts on the basis of averages. Rather, they calculated the mid-points for these characteristics, meaning that 50 per cent of subjects had a value below this point, while the other 50 per cent had a value above this point. This mid-point is called the median. The median values were as follows:

• Age - 32 years
• CD4+ count - 326 cells

Viral load values were not given. Only four women were taking anti-HIV therapy that included a protease inhibitor.

Results - new lesions

Of the 101 subjects, 38 per cent had new lesions. The breakdown by group was as follows:

• 5-FU - 28 per cent (14 of 50 subjects)
• Observation only - 47 per cent (24 of 51 subjects)

Moreover, some subjects were at increased risk of developing lesions that were likely to become cancerous:

• 5-FU - 8 per cent
• Observation - 31 per cent

This difference between the two groups was statistically significant.

Recurrence of cervical lesions were affected by CD4+ counts in the following ways:

• 46 per cent of women who had fewer than 200 CD4+ cells developed new lesions.
• 33 per cent of women who had at least 200 CD4+ cells developed new lesions.

Results - survival

Ten of the 101 women died, six while they were in the study. The breakdown of deaths occurred in the following groups:

• 5-FU - 7 subjects
• Observation - 3 subjects

None of the subjects died from cervical cancer.

Results - side effects

There were no cases of severe toxicity associated with the use of 5-FU. Ten women receiving 5-FU and five women who did not get the drug reported at least one episode of the following symptoms:

• Bleeding
• Irritation
• Discharge

All in all, the results from this study represent an exciting advance for HIV-positive women who are at risk of developing cervical lesions.

REFERENCE

1. Maiman M, Watts DH, Andersen J, et al. Vaginal 5-fluorouracil for high-grade cervical dysplasia in human immunodeficiency virus infection: a randomized trial. Obstetrics and Gynecology 1999;94:954-961.

Copyright © 2000 - TreatmentUpdate. Reproduced with permission. Reproduction of this article (other than one copy for personal reference) must be cleared through the Editor, The Canadian AIDS Treatment Information Exchange, 555 Richmond St. West, Suite 505, Box 1104, Toronto, ON, M5V 3B1 • Phone: 416-203-7122 • Toll Free: 1-800-263-1638 • Fax: 416-203-8284  http://www.catie.ca