So the US FDA has finally approved Truvada as an HIV Pre-Exposure Prophylactic (or PrEp if you fancy acronyms). I am not sure what to make of this, to be honest. The proposition here is to prescribe a chemotherapeutic to perfectly healthy people so they can protect themselves against HIV, at a cost of 13900 US$ per annum. What other protections are available? Use condoms. If you've sex with someone who's HIV positive and you want to have unsafe sex, make sure they're on HAART. If they are, the additional protection daily chemotherapy would offer to perfectly health people is close to non-existent and certainly not worth the cost paid. If you live in a society with high HIV prevalence, the odds are that it's a developing country. Your healthcare system should likely not even consider paying for such a prevention strategy, it's simply not cost effective, considering competing health needs in your society.
The drug was tested mostly on folks in high-risk groups who engage in somewhat unusual high-risk behaviour such as having plenty of unprotected sex with folks they do not know or folks they know to be HIV infected (the press release says nothing about the question of whether the latter group included folks who were known by their risk-taking participants to be on HAART), sex workers, etc. So, if you happen to belong to a group of people who engage in high-risk sexual behavior, you likely are disciplined enough to take daily chemotherapeutic drugs to compensate for your risk-taking. Really? This explains probably a 42% efficacy when compared to the placebo control. Adherence might have been a bit of an issue there... That might also explain why the FDA requires Gilead to keep track of everyone who's (supposedly ) taking Truvada and gets infected anyway. Drug resistance seems a serious concern. Little seems to be known about pregnancy and Truvada, so that's being tested while the drug is being marketed. - Who knows, there might be a market in this high-risk segment of the population, even though it seems unreasonable to me that someone who enjoys such thrills should go on chemotherapy while healthy. Might they might not better wait until they're infected? Equally, in societies where the prevalence of HIV is very high (say, Sub-Saharan Africa), is the proposition to hook large numbers of perfectly health people on these heavy hitting drugs, 'just in case'?
As I said, I'm not sure what to make of this, but I am surprised about the logic of prescribing chemotherapy to healthy individuals as a 'just in case' strategy. Good for the shareholders of Gilead, the maker of Truvada though. You're making money off 'treating' the healthy... To be fair, it is anything but unusual that healthy people are being subjected to treatment in prevention efforts. Just think of flu vaccines, Hep B vaccination and so on and so forth. However, in the case under consideration the proposition is lifelong chemotherapy. That has quite a different ring and quality to it. We should take our time to discuss the pro's and con's of such a prevention strategy carefully, instead of diving headlong into it.
