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February 19, 2008

Trends Examined in Women’s HIV/AIDS Therapy

Older Drugs Make a Comeback among Women

A form of highly active antiretroviral therapy (HAART) that was waning in popularity is now coming back into favor among women and their providers, according to a study by researchers at the Johns Hopkins Bloomberg School of Public Health. Protease inhibitor-based HAART, which was supplanted by new and supposedly superior NNRTI-based HAART in the late 1990s, has experienced a recent upswing. The study appeared in the January 15, 2008, issue of Clinical Infectious Diseases.

“Several years ago, protease inhibitors (PIs) got a bad rap, because NNRTIs were supposed to be so much better,” said Elizabeth Golub, PhD, MPH, the study’s lead author. But when two of the existing three NNRTIs were discovered to have especially harmful side effects for women, the PI-based regimens gradually came back into favor. One of the NNRTIs, nevirapine, has been found to cause severe liver disease if initiated in women with healthier immune systems (CD4+ cell counts greater than 250). Another NNRTI, efavirenz, is suspected of causing birth defects. “Neither is desirable for use among the majority of HIV-infected women,” said Golub, assistant scientist in the Department of Epidemiology. Published reports have suggested that protease inhibitors are linked to diabetes and heart disease, although research on these associations (particularly in women) are ongoing.

The study also concluded that those women who initiated HAART with PI-based regimens had more effectively increased their CD4+ cell counts at the 2-year mark than had those women using two other forms of HAART, which included NNRTI-based therapy and triple-NRTI-based therapy. “The whole goal of [highly active antiretroviral] therapy is to get your CD4+ count up,” said Golub, and from this perspective, PI-based regimens have fared better over time. To reach this conclusion, the study compared 1- and 2-year absolute CD4+ cell counts among HAART initiators.

Another finding of the study is that before the year 2002, initial regimens adapted by women were determined primarily by CD4+ cell count and HIV viral load, but that from 2002 to 2005, trends in initial regimens were more determined by sociodemographic considerations such as race, ethnicity and medical coverage. The study also determined that initial regimens did not affect whether or not women switched their regimens.

Regarding the frequency with which HIV-infected women switch among the various HAART regimens, Golub said, “Most antiretrovirals have their toxicities—some are worse for some people, while others are worse for other people—and patients switch regimens until they find something that works for them and is tolerable in terms of side effects.”

Prior studies on HIV treatment effectiveness have been conducted predominantly on males, while this study was conducted solely among women, participants in the Women’s Interagency HIV Study (WIHS), the largest nationwide cohort study of HIV-infected and at-risk women. “HIV progression is not necessarily the same in women as it is in men,” said Golub. This study may demonstrate that the initiation of HAART among women is keeping pace with the availability of information about the adverse effects of different regimens, as well as the effectiveness of various regimens, as they specifically pertain to women.

“Patterns, Predictors, and Consequences of Initial Regimen Type among HIV-Infected Women Receiving Highly Active Antiretroviral Therapy” was written by Elizabeth T. Golub, PhD, MPH, Lorie Benning, MS, Anjali Sharma, MD, Monica Gandhi, MD, Mardge H. Cohen, MD, Mary Young, MD and Stephen J. Gange, PhD.

Public Affairs media contact: Tim Parsons at 410-955-6878 or