Pre-Exposure Prophylaxis—Ethical, Effective?

Katie Nelson

I do not yet have a formal project plan yet, but I plan to focus my work on current research in pre-exposure prophylaxis for HIV. The precedent for work on PREP is the administration of nevirapine in HIV+ pregnant mothers to prevent MTCT during childbirth. Tests on non-human primates have suggested the potential efficacy in prophylactic tenofovir (a nucleotide analog reverse transcriptase inhibitor that blocks HIV reverse TRNA, thereby inhibiting viral replication) for preventing the contraction of Simian Immunodeficiency Virus (SIV is the monkey equivalent of HIV). Trials are currently being conducted in high-risk populations such as Thai sex workers and American men who have sex with men to see if tenofovir can work in much the same way anti-malarial drugs do, to prevent viral replication rather than exposure in the first place.

These trials are wrought with ethical issues, as the predicted psychological response to a perceived panacea for HIV may result in risk compensation, meaning that people will be more likely to engage in high risk behavior if they believe the pill will cure all. However, simian studies have indicated that tenofovir may not be 100% effective, could potentially have toxic side-effects, and the effects may wear off over time and repeated exposures. Additional ethical issues are concentrated primarily on the sample statistic being studied. There have already been protests against Gilead, the pharmaceutical company that manufactures tenofovir, over the perception that they are using sex workers, an underserved population, for their testing without proper compensation or risk analysis. In essence, this research is mostly unprecedented, and there are a large number of unknowns about both the drug and the disease that make these trials fraught with challenges.

There exists the argument that in testing these high risk populations, the drug companies are essentially encouraging the furtherance of these behaviors. To counter these claims, the scientists conducting the trials make sure to include extensive sexual and drug counseling prior to the start of the trials in the hopes of encouraging exposure prevention. Yet the obvious discontinuity between the goals of the drug company (to test their product) and the human rights standards that urge for the greatest benefit to the participant in the study (presumably not being exposed to HIV in the first place) make this a sticky ethical area.

If, however, tenofovir is proven to be effective as a prophylactic treatment against HIV transmission, it could truly revolutionize the fight against the disease. NRTIs can be manufactured cheaply, and a prophylactic pill could simply be taken every day before engaging in risky behavior (although there are concerns that people who decline to protect themselves by such simple means as wearing a condom or using a clean needle would reject this safety measure as well) to cripple the spread of the HIV epidemic.

In terms of my own involvement in this issue, I plan to continue my research into this field. I plan to interview several scientists involved in this issue, learn more about ongoing clinical trials, particularly internationally, and to write my research paper on the ethical implications of this research.