On Monday, the FDA approved the first pill created to prevent the transmission of HIV infections to those who are at high risk of exposure to the disease. The medication, Truvada, is already used with other anti-retroviral drugs to treat HIV-positive patients. Their recent approval means that the FDA now recommends Truvada as part of a comprehensive HIV prevention plan. Patients still should, of course, practice safe sex (use condoms, avoid having sex with high-risk partners before getting tested for HIV, etc.), get tested regularly, and participate in risk reduction counseling.
The FDA’s approval was based upon the results of several clinical studies of Truvada. The studies found that participants who followed a daily regimen and maintained high levels of the drug in their blood achieved protection rates at nearly 90%. Heterosexual couples in which one partner was infected and who routinely practiced safe sex also found their risk of infection reduced by 75%. The FDA’s approval is contingent on the further investigation of possible drug resistance in those who are infected with HIV while taking Truvada. This could happen if individuals do not take the drug correctly, and public health specialists worry that this may cause the development of HIV strains that are resistant to Truvada.
Gilead, the company which produces Truvada, will also be required to collect further data on women who become pregnant while taking the drug because safety risks to the fetus remain unknown. The lack of research on the pill’s effects on women is hardly surprising.
Biomedical research has a long history of completely ignoring women and, instead, focusing entirely on male subjects. One reason for this is that by the time women were considered important enough to be worthy of comprehensive healthcare (though some people are still behind the times on that one), scientists had long since adopted the incorrect belief that women’s bodies functioned in the “normal” (read: male) way, just with different reproductive organs. But those organs were seen as a weakness and, as such, scientists also refrained from testing on women in order to avoid the potential liabilities of prenatal exposure and to protect a woman’s potential fetus. After they caught on to gender differences, the gender ratio in biomedical studies still didn’t even out because they thought that the hormonal changes associated with women’s monthly cycles would negatively affect the studies rather than actually providing helpful information about the 50% of the population that would be taking their products. These conceptions of men as “normal” and women as “abnormal” are, unfortunately, still quite prevalent. They continue to crop up, even in research on the development of a new drug to combat HIV.
Of course, this is not to detract from the importance of this amazing medical achievement. Serious kudos to the scientists who created this pill! They are saving so many lives.
Images Courtesy of Jeff Beall and blogs.kqed.org.