The FDA has now approved the use of Truvada, the combination of tenofovir and emticitabine, as a prophylaxis based on the outcome of two large clinical trials that have found that it reduces the rate of infection among both men who have sex with men and heterosexuals (note that women who have sex with women aren’t listed, not because they don’t exist, but because they are a very low risk group).

Of course there are some caveats to the approval, namely that it includes some specific labeling and directions:

The approval comes with some caveats, mainly to prevent the development of genetic resistance to the drug combination:

• The FDA is changing Truvada’s boxed warning to ensure that both doctors and potential users know that the drug must only be used for PrEP by people who are confirmed to be HIV-negative before the drug is started.
• Those using the drug combination must be tested for HIV and shown to be negative at least every 3 months during use.
• The combination is also subject to a Risk Evaluation and Mitigation Strategy (REMS), whose central component is a training and education program to assist prescribers in counseling users or potential users.
• And the manufacturer, Gilead Sciences, of Foster City, Calif., is required to collect viral isolates from individuals who acquire HIV while taking Truvada and to evaluate these isolates for the presence of resistance.
• The company is also required to collect data on outcomes for women who become pregnant while taking Truvada for PrEP.
• Gilead has also been told to conduct a trial to evaluate drug adherence and its relationship to adverse events, risk of acquiring HIV, and development of resistance among those who become HIV-positive.

Resistance to HIV drugs often arises when fewer than three different drugs are taken for treatment. The concern with PrEP is that some people may catch HIV, continue taking Truvada rather than a complete three-drug regimen, and develop resistance.

This is also a good reminder that any and all medication that is designed to treat an infection MUST ALWAYS be used properly. It makes me angry when I hear about people not finishing a course of antibiotics. The fact that the above mandates are even necessary shows the sad state of the United States. Really what it comes down to is the rampant lack of understanding of evolution. If you don’t kill every single pathogen you’re treating, then those who survived the treatment will reproduce and what ever allowed them to survive will allow their progeny to better survive that drug for the next person.

Just like with the anti-vaxers, I don’t care if your stupidity get’s you killed, but I don’t want to you put the next person who may have a legitimate contraindication to that treatment or prophylaxis at risk…

Okay, now that I’ve got that out of my system, you should read the rest of the article, this is just awesome!