Reposted from the blog I Need Politics
By John Tyburski
Part 1 in a Series of 2
In mid-May the U.S. Centers for Disease Control and Prevention (CDC) announced that it began recommending daily medication with a pill called Truvada to prevent Human Immunodeficiency Virus (HIV) infection among individuals at high risk of experiencing exposure to the virus. Truvada is a combination of two antiviral drugs, emtricitabine (Emtriva) and tenofovir disoproxil fumarate (Viread), and is manufactured and sold by Gilead Sciences Inc. of Foster City, California. Truvada is a pharmaceutical treatment and pre-exposure prophylaxis (PrEP) for HIV and was first approved by the U.S. Food and Drug Administration (FDA) in 2004. The FDA approved Truvada for use as PrEP in 2012. The cost of an annual regimen of Truvada is approximately $15,000 in the U.S., and fewer than 10,000 people currently take Truvada as PrEP. In 2013, worldwide sales of Truvada generated approximately $3.1 billion for Gilead. The decision by the CDC to endorse PrEP received mixed reviews, and some raised concerns that the decision sends the message that traditional preventive strategies against contracting HIV can be put aside. Moreover, the endorsement will increase domestic sales of Truvada, perhaps even at a cost to taxpayers via subsidized health care under the Affordable Care Act. It is worth asking who benefits the most from this decision. Will Gilead’s Truvada sales revenue increase as a result of endorsement by the CDC? Surely it will, and I propose that we have a conflict of interest driving health policy here.
The FDA stipulated that Truvada was to be prescribed in a PrEP capacity as part of a comprehensive prevention strategy that includes safe sex practices, counseling for risk reduction, and regular testing for HIV. It is not intended to replace any existing prevention strategies in either those at risk of contracting HIV from sexual practices or those at risk through injection drug use. The CDC maintains a PrEP information page that describes the criteria for establishing who is at high or substantial risk of getting HIV. I shall not go into these criteria, but I will just mention that the most important stipulation is that to be prescribed Truvada, one must test negative for HIV and continue to do so at regular intervals. Two groups of people who may wish to consider PrEP come to my mind: those who are in a sexual relationship with a partner who has HIV, and those who care for patients with HIV or Acquired Immune Deficiency Syndrome (AIDS), the manifestation disease of HIV after management with antiviral drugs ceases to be effective.
Truvada may also make sense for people who just want to have unprotected sex with multiple partners, but targeting this potential user group is a bit contentious. Michael Weinstein, president of AIDS Healthcare Foundation (AHF) in Los Angeles, California, has been an outspoken critic of the decision by the CDC to endorse the use of PrEP. He believes that the CDC abandoned good science and good public health practice, as the plugging of PrEP may have the unintended consequence of decreasing condom use. If anyone has a solid insight into this potential outcome, it is surely Weinstein. The AHF provides care to over 300,000 patients with HIV. Weinstein warns that this decision may not just bump up the transmission numbers a bit but lead to a catastrophic setback in HIV management and prevention in this country.
There are some other things to consider besides unintended declines in the practice of traditional HIV prevention approaches. For one, there are the side effects. The CDC makes them sound like minor discomforts in a small number of Truvada takers. However, individuals have reported some fairly substantial and unpleasant side effects. In addition, while the FDA cited two large, randomized, double-blind, placebo-controlled clinical studies in support of approving Truvada for PrEP, the risk reduction was a modest 42 percent compared with placebo in one study, an encouraging 75 percent in the other, and yet efficacy is strongly linked to adherence to the daily medication regimen. Finally, we need to examine and contemplate how Truvada costs will be covered now that the CDC endorses its use. Will Gilead provide the pills at reduced cost to lower income users, or will PrEP only be for the well-insured or wealthy? More importantly, does endorsement of a pricey retail pharmaceutical by the federal government create a conflict of interest? It should be no surprise that Gilead stock has been doing well recently.
Alas, these areas of concern will take time to dig into and analyze properly, and I plan to do so. My bnext piece will review the science behind Truvada to determine whether the data support the CDC’s decision. I will also look more closely at the cost of this drug, who is going to pay for it, and who is going to benefit most. Right now, I am leaning toward a boon for Gilead and a bust for those at high risk for HIV infection and taxpayers in general, but this is largely speculation at this point.