Being Alive; August 1996
Ann M. Khalsa, MD

Women are finally being included in some clinical drug trials, such as combination therapy and protease inhibitor studies. To date (and the results are still preliminary), no major differences in women's responses to treatments have been found. This means that the results from the clinical drug trials, which still have studied mostly men, are applicable to women.

HPV and Dysplasia (Genital Warts and Cancer)

There was interesting data on anal HPV infection (human papilloma virus, the cause of most genital cancers) and anal dysplasia (pre-invasive cancer) in women. In one study from New York the rate of anal pap smear abnormalities (atypia or low grade dysplasia) in women was 27% (versus 6% in HIV-negative women). The risk factors for anal HPV infection or dysplasia included HIV positivity, less than 200 T-cells, history of cervical/vaginal/vulvar HPV or dysplasia, prostitution or smoking. Anal sex was not a risk factor (i.e., you don't have to have had anal sex to get anal HPV or dysplasia). Anal pap smears are currently recommended only for HIV+ women who have the above risk factors, not routinely for all HIV+ women.

Studies presented at the conference still showed approximately 3- to 8-fold increased rates of cervical HPV and dysplasia. There is still controversy over whether or not biannual colposcopy is needed (in addition to pap smears) on a routine basis or only for abnormal pap smears. The data from studies looking at this are still pending.

Mucosal Candidiasis

Vaginal and oral candida (yeast) infections continue to be problems for HIV+ women. Oral thrush was associated with lower CD4's (273 vs. 392), recent injection drug use, and cigarette smoking. One study showed 37% and 49% decreased rates of vaginal and oral candidiasis with fluconazole prophylaxis. Drug resistance was shown equally among those on fluconazole (3.7%) and those on placebo (4.3%), suggesting at least from this study, that possibly fluconazole prophylaxis is not a bad thing to do.

Contraception and Transmission Prevention

There was a major report on female-controlled contraception among heterosexual women. Data were presented showing increased acceptance of the female condom (87% would like to use it) versus the male condom (63%). Three female condoms are now available, Bikini Condoms (latex), Women's Choice (latex), and Reality (polyurethane.) The polyurethane Reality condom is stronger than latex and is impermeable to HIV, as well as HPV and CMV. It has an estimated 97% efficacy (similar to latex condoms). Cost, availability and comfort were not mentioned.

Vaginal microbicides (substances which kill infections) were also discussed. In addition to nonoxydol-9, a detergent type of microbicide, there are other classes of compounds being studied. These include lactobacillus, 3TC and ddI. As compared with 1994 when there were 21 agents in studies, there are now 35 agents being studied; however, only two are in advanced clinical trials. Thus, unfortunately, none of these agents will likely be available for several more years.

The shedding of HIV in cervical and vaginal fluids was shown to be increased with lower CD4 levels (50% with CD4's lower than 200), and genital ulcers or sexually transmitted diseases (STDs) (30-47% versus 20% without STDs). These studies suggest that there may be an increased risk of transmission from women to their partners at times when they have lower CD4 levels, STDs or genital ulcers.

Wasting In Women

There were also several studies on wasting in women, two of which show that women tend to lose relatively more fat than men. This was postulated to be due to declining levels of the female hormones estrogen and progesterone (the same hormones which make women "curvy" at puberty, due to fat depositions). This was in contrast to relatively more muscle loss in men, also due to low levels of the sex hormone testosterone (which makes men muscular at puberty).

Another study on wasting showed a 50% decrease in testosterone levels in women experiencing wasting. Presumably, dysregulation of both female and so-called male sex hormones in women (both men and women have both estrogen and testosterone normally) contribute to wasting in women. There was mention that an ACTG study is soon to begin, which will look at male-sex hormone replacement therapy (with nandrolone) in women. (Call USC, 213.343.8291, for details.)

A study on the use of megace in wasting in women reported that while women gained on average 6-8 lbs., the weight gain is not sustained when CD4's are less than 50. Amenorrhea was not reported. (Megace is a synthetic progesterone.) The weight gain was associated with improved appetite. Several other studies reported that decreased oral food intake is the most important determinant of weight loss.

Perinatal Transmission

This is the area receiving the most attention in women, with many studies in progress. Several studies confirmed the ACTG 076 finding of reduced transmission of HIV (down to 6-8%) with AZT treatment. The theoretical possibility of decreasing this rate down to 2% was also discussed. Note that this is still a goal, not yet a reality.

Maternal Viral Load and CD4 Levels

Numerous studies reported increased transmission with high maternal viral loads, or low CD4 counts. Treatment should be aimed at both reducing viral loads and raising CD4's as much as possible.

Both inflammation or prolonged rupture of the placental membranes (bag of waters) were shown to be associated with increased transmission. Also, prolonged duration of time from full cervical dilation to delivery was found to be associated with transmission, suggesting that delivery should be hastened if possible.

(Ann M. Khalsa, MD, is Asst. Director of Clinical Training at USC's Pacific AIDS Education Center.)

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