LaTese Briggs, Ph.D. and Allison Thrower
In recent news on the HIV/AIDS front, the FDA is reviewing the possibility of marketing certain HIV drugs as a preventative measure
for individuals who are healthy but at-risk for infection. However, research that was viewed optimistically
over a year ago is coming under fire
by the AIDS Healthcare Foundation (AHF) as the group petitioned against FDA approval due to questions of efficacy, high costs, side effects and patients’ lack of commitment to the regimen. Whether or not the petition sticks, the real-world, widespread use of this treatment ultimately comes down to the payers.
In reality, they won’t pay for it. Why would they pay for a preventative method that only reduces the risk of infection by 40-50% and can lead to other health problems? This is especially true considering there is a perfectly viable prevention method that works more than 90% of the time – condoms (the AHF’s preferred preventive measure).
In that sense, the AHF has a point to its accusations. The 40-50% risk reduction is highly contingent upon adherence, which is critical in the treatment of HIV. HIV-positive patients who do not adhere to antiretroviral (ARV) schedules are at high risk for the development of drug resistance, which is also sexually transmissible. Now if those who need ARVs to keep them alive have adherence problems, it’s unlikely to expect it from HIV-negative individuals whose lives aren’t dependent on taking these drugs, also known as Pre-exposure Prophylaxis (PreP). There is an accountability issue here. How do we enforce to people that, if they don’t take PreP as scheduled, they can both contract HIV and greatly increase the risk of becoming resistant to a number of key HIV drugs? As the question seems to have no workable answer, therapeutic options may be limited. Also, as aforementioned, certain resistance mutations can be sexually transmitted, which adds to the public health risk. Furthermore, administration of PreP will require consistent monitoring to A) make certain that patients are taking the drug to avoid the development of drug resistance and B) keep an eye on kidney toxicity associated with tenofovir (one of the nucleoside reverse-transcriptase inhibitors [NRTIs] in Truvada). Physicians are trying to eventually move away from using NRTIs because of the toxicity profiles associated with long-term exposure. So while treatments are very effective, the related safety risks add another plausible argument to oppose PreP from a patient, physician or payer perspective.
All in all, even if Truvada is approved, the payers will shut down any real commercial opportunities because they will refuse to cover it. There may be special exceptions, such as use in serodiscordant couples, but for the most part this will be something that people will likely have to pay for out of pocket.