Race, Sex and Pregnancy
A Round-Up of News in Special Populations
Men, Women, and Race
The GRACE study is the first pharmaceutical company trial to focus on enrolling women so that differences from men can be seen. Early 24-week results (halfway through the study) were reported in this study which compares gender differences in the efficacy, safety, and tolerability of Prezista (darunavir) in combination with other HIV medications. Of the 203 women reaching 24 weeks, about half (51%) had less than 50 viral load. (People in the study were treatment experienced, and could therefore be expected to have less of a treatment response.) Almost one out of four women dropped out of the study before 24 weeks, but few of them did so because of virological failure (inadequate suppression of viral load). Less than one percent of the women experienced virological failure. Adverse events led to study discontinuation in 7.8% of the women. About 1 in 3 of the women experienced an adverse event grades 2-4 (considered problematic) that was potentially related to the medications they were taking. Side effects occurring in more than five percent of the women included nausea (6%), diarrhea (6%), elevated AST (a type of liver enzyme, 6%), elevated total cholesterol (12%), elevated LDL cholesterol (6%), and hyperglycemia (elevated levels of blood sugar, 16%). Almost 17% of the women experienced a serious adverse event, the most common being pneumonia (4.4%).
The CASTLE study comparing Reyataz/Norvir to Kaletra (which contains Norvir in it) reported that women on Kaletra experienced more nausea than men did (14% vs. 5%), but less diarrhea (9% vs. 12%). Increases in triglyceride levels were higher in the men on Kaletra than the women who were taking it, 64 vs. 34 mg/dL. In another study, women also experienced less diarrhea than men. In the ARTEMIS study of darunavir/Norvir, 26% of the women had diarrhea compared to 37% of the men. The women, however, had more vomiting -- 11% of them had this side effect compared to 4% of the men.
A third study also found a greater increase in triglyceride in men than in women -- 58.7 vs. 36.3 in the M05-730 study of Kaletra once a day vs. twice a day. There was a non-significant trend toward greater diarrhea in men than in women, 17.1% vs. 11.1%.
The study also found that diarrhea was higher in whites than in non-whites (17.8% vs. 9.7%, the difference was statistically significant). The CASTLE study found that diarrhea while taking Kaletra was highest in whites (14%) and lowest in blacks (5%), and that blacks had zero increase in cholesterol levels. ARTEMIS found that rash was greater in Latinos (14%) than in other groups (5-7%).
A look at drug levels found that the entry inhibitor vicriviroc, currently in development, does not lower blood concentration of birth control pills, but did if it was taken with Norvir, and this suggests the need for additional or alternate contraception. Reyataz when taken with Norvir once a day causes a drop in blood levels in the third trimester of pregnancy, and this suggests a need for a change in dosing.
The Women's Interagency HIV Study (WIHS, pronounced "wise") reported that the use of progestin-only hormonal birth control was by itself associated with increased insulin resistance and decreased HDL cholesterol in both HIV-positive and HIV-negative women at risk for infection. Insulin resistance is associated with diabetes and lower levels of HDL cholesterol and is associated with heart disease.
Kaletra was shown to have no evidence of birth defects risk compared to women without HIV. There was a non-significant trend between Kaletra used during the first trimester of pregnancy and premature delivery and low birth rate. The results were based on the international Antiretroviral Pregnancy Registry.
One study looked at the development of drug resistance in 135 women taking HIV medications for the first time during their pregnancy who stopped taking their therapy immediately after delivery. Most (57.3%) used Viracept with Combivir, more than a fourth (26.7%) used Viramune with Combivir, and the rest (16%) used Kaletra with Combivir.
Ten percent of the women (13 of the 135) had developed drug resistance. Five of these women (38.4% of the 13) had drug resistant mutations in their virus before going on medications and developed new mutations during therapy. Of the rest, four developed resistance to the Viramune class of drugs (non-nukes), two had resistance only to the nucleoside analog class of drugs (Combivir and others), one had both nuke and protease inhibitor mutations, and one had resistance only to the protease inhibitor drug class.
There was also news about women's desire for children. One study found that HIV-positive women knew little about the risk of mother-to-child transmission of the virus and overestimated their risk of passing on the infection. Another study found that positive women feel a strong difference between their attitudes and that of society in regard to pregnancy and childbearing. Nearly six out of 10 said they felt pressured to avoid pregnancy.
Research led by Dawn Averitt Bridge of the U.S., herself a positive woman with two HIV-negative children (visit www.thewellproject.com) reported communication problems between women and their doctors. The research found that nearly half of the HIV-positive women who had thought about having a baby or had been previously pregnant were not asked about their current or future pregnancy plans.
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