Debates raged at the 19th International AIDS Conference was held Washington, DC from July 22 to 27, on the latest news in HIV prevention and treatment research. The conference was the first held in the United States since 1990 due to the lifting of the ban on HIV travel in 2010. The choice of location was appropriate as DC has the highest rates of HIV in the country.
One major debate at the conference was related to the FDA’s approval of Truvada as a medication to prevent acquiring HIV. Pre-exposure prophylaxis (PrEP) has ignited a storm of debate weighing benefits, costs, and harms to patients. The intent of PrEP is to serve as a combination prevention therapy that includes medication and other proven preventatives such as condom use and reducing the number of sexual partners. Gilead explains on its site that Truvada is meant to be used in combination with condoms. The arguments in favor of PrEP are focused on the promise of the treatment approach and those against PrEP highlight the potential harms of medication non-adherence and treatment resistance.
From examining the larger context, it does not appear that PrEP will provide a meaningful public health contribution to the fight against AIDS. First, there is the question of affected patients access to any medication. Today, only a fraction of those infected with HIV have access to anti-retroviral treatment. The World Health Organization (WHO) has achieved strides and people on ART have increased to 47% overall in low and middle income countries. However, that still means some 14 million are without any anti-retroviral coverage.
Even in the United States, universal access is complex, with evident racial and income disparities to treatment. The Complicating this situation is the reality that a large proportion of those infected do not know their status. The Centers for Disease Control, which is responsible for surveillance and preventative strategies estimates that 20% of the 1.2 million persons infected do not know their status.
Most likely those who transmit HIV are those who are unaware of their because the CDC notes that at least 95% of those infected with HIV (known cases) do not transmit HIV in a given year. How will PrEP adequately target those 5%, who are most likely to transmit HIV? The CDC is addressing this question by publishing interim guidance on using PrEP with the highest risk group, men who have sex with men. The guidance outlines the intensive supports that surround the use of the preventative treatment, which means that PrEP will be even more expensive than the $1,200 price tag for the medication.
The FDA has approved its safety and efficacy in controlled trials, which means this medication is ready to face the test of the marketplace. Whether physicians and public health officials can make use of this preventative medication for their patients remains to be seen.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
