PI Perspective #24

April 1998     View PDF

Indinavir in Women

Little is known about the effects of hormones on the metabolism, potential effectiveness or side effects of drugs in women. A small study looking at the effects of the menstrual cycle on indinavir (Crixivan) levels in the blood found dramatic differences in time to peak level and time to optimal therapeutic levels based on the various phases of the menstrual cycle over the course of a month. While the amount of indinavir in the blood appeared to change throughout the hormone cycle, it still remained broadly within the ranges observed in earlier studies that primarily included men. These monthly fluctuations need to be further studied to determine their implications on the durability of the regimen, resistance, dosing and possible long-term toxicity. Fortunately, there are several other studies looking at the use of antiretroviral therapy specifically in women, either in development or enrolling, that may have the opportunity to address these questions.