In July 2012, the Food and Drug Administration (“FDA”) approved a combination of drugs, Emtricitabine and Tenofovir Disoproxil Fumarate (under the brand name “Truvada,” or more generally termed “Pre-Exposure Prophylaxis” or “PrEP”), for use both in treatment of those with HIV and prevention for those with high-risk exposure to HIV. Why be on this medication? Since condoms are far from fully effective when discussing HIV-prevention, some classify their Truvada use as an “insurance policy” for HIV-prevention. Though some (1, 2) have suggested that a cure to HIV is in sight, no cure or vaccine has been approved for human use, and as such, prevention is the only means by which to decrease incidence and prevalence of HIV infections.
So all news regarding HIV/AIDS in Minnesota is good news, correct? Not quite. New HIV infections rose 2 percent in 2014, and a greater proportion was found in younger, student-aged populations (almost half of the new infections occurred in populations between the ages of 13 and 34). Worse, in male populations (which had over 3 times the new infection incidence as compared to female populations) about four out of 10 new infections occurred in persons younger than 29. This rate has been exponentially increasing in Minnesota with data showing that new infections among men aged 13-24 quadrupled from 2001 to 2009.
Most concerning was that these new infections were concentrated in the Twin Cities seven-county metro area (representing 86 percent of new diagnoses). Since the Twin Cities area has more than 15 colleges and universities, this issue seems to be disproportionally impacting students in this area. Though the national average age of college students is around 25 years, the University of Minnesota has the highest percentage of students over 25 in the United States; further, the average age of graduate students centers around the low 30s [PDF].
So colleges and universities in the Seven-Counties Metro Area are aware of this trend and are addressing it, correct? Not quite.
Universities seem to be systematically ignoring recent breakthroughs in HIV-medication, with some universities articulating negative views of the treatment. Minnesota colleges provide confidential, peer HIV testing free of charge, which helps students take the next steps regarding their respective treatment and transmission. However, these steps minimally comport with recently updated CDC guidelines. Though educational institutions have promoted less risky sexual behaviors (even though these efforts have been found to be highly ineffectual and only stigmatize homosexual behaviors [1, 2, 3]), HIV testing, and condom usage as methods to mitigate transmission, universities have failed to incorporate PrEP usage in student populations in the discussion.
Example: University of Minnesota
The best example is the University of Minnesota, which represents the largest enrollment in Minnesota. For those students, access to PrEP is not available on student university health insurance [PDF], even though it is available on a separate insurance plan for professors [PDF] and university employees. This trend is not uncommon nationwide as the Affordable Care Act (ACA) exempted University Health Plans from the full requirements of the ACA. As a result, even treatments dictated by physicians as “medical necessities” are barred from coverage. Thus, though the University of Minnesota covers several forms of birth control that were comparable in price to Truvada (pre-ACA or upon their respective emergence into the pharmaceutical market), the University of Minnesota currently refuses to cover medical necessary treatments for those at high risk of contracting HIV.
Though MinnesotaCare allows state residents to access this medication, relying on state public assistance programs alone to provide this sort of care for students is shortsighted. First, this is forcing otherwise healthy students off student health insurance and forcing them on to public assistance programs. Second, this route fails to provide out-of-state residents with access to the drug; since 33 percent of matriculants to the U of M are considered out-of-state residents, this policy bars access to a large portion of the student body. Though private insurance generally covers the medication, full-time students with no income have no means by which to afford these options; private insurance is unaffordable to students (even with federal subsidies) because the cheapest exchange plans still require significant cost-sharing for benefits utilization via an annual deductible. All this adds up to one point: Colleges and universities are making coverage of Truvada a financial hardship.
The CDC connects two major social factors (poverty and prevalence of HIV) to the disproportionate presence of HIV in younger communities, so mitigation strategies need to be focused on this age group in this area. Since Truvada is most effective when taken daily (and has a much lower efficacy if not done this way), these sorts of systemic barriers directly lead to impairment of patient health care for the most “at risk” individuals. Worse, though students could gain access to this drug through parental coverage until they are 26, two issues arise. First, as earlier noted, Minnesota students, based on their higher average age at matriculation, are aging out of their coverage. Second, even if students were not aging out of coverage, stigma regarding use of the drug has been mired in controversy, with some Minnesota physicians being accused of “slut shaming” patients on the medication. Despite the medical breakthrough in prevention, with drug (PrEP has been shown to reduce the risk of HIV infection in people who are at high risk by up to 92 percent) and strict physician criteria [PDF] regarding patient access to Truvada, the drug has been mired in controversy, with speculation that this pill is “a party drug” by terming those that take the drug, regardless of rationale, “Truvada whores.” This is despite the fact that studies have shown that there is no link between Truvada and increased sexual risks. While it is true that Truvada is not for all people who are at high risk of catching HIV, is it also true that these sorts of decisions should be made between a patient and a physician, and not be mandated by a university through barriers to pharmaceutical access.
Three rationales given
Three general rationales/misconceptions have been promoted for this lack of access. First, has been the cost of the regime. Ironically, the cost of an HIV-negative individual on Truvada is far less than the costs of antiretroviral treatment for HIV+ individuals; further, the cost of Truvada is far less than treatment or care for AIDS patients. Further, the University of Minnesota opted to cover far more costly “medically necessary” treatments for other conditions, and opted to cover far more expensive birth control treatments pre-ACA.
Second is the fear of drug resistance. Though these claims can come to fruition, the fear is minimal at best (one study showing that of 4,747 participants, only four showed evidence of the virus “mutating” over several years; of these four cases, no viral strains were fully drug resistant, and most simply showed minor changes). Generally, these fears seem to stem from the pandemic of the 1980s; they tend to further stigmatize usage of these sorts of medications.
Third, the medications have been lambasted socially as “unsafe” or “ineffective.” (1, 2) Truvada was approved by the FDA [PDF] to be distributed in connection with a Truvada Medication Guide with each prescription. Admittedly, the medication has a host of common side effects, like increased lactic acid in blood (lactic acidosis) or liver issues. Other health issues, such as renal changes, have been disproven. Further, the U.S. Public Health Service released physician guidelines in 2014 addressing both of these issues, through mandating blood tests every few months as the standard of care to ensure patient safety and drug efficacy of the treatment. Though less common side effects are present, health-care providers closely monitor patients for several months to ensure symptoms are not abnormal.
Two-pronged approach seems necessary
In response to the issues surrounding Truvada, a two-pronged approach seems necessary. First, colleges, like all other health insurance post-ACA, need to be mandated to cover Truvada for those at high risk of contracting HIV. Either the universities, some of which conduct internal appeals to deal with health appeal issues, could voluntarily pass these measures, or universities could be mandated to comply with these provisions. Second, general education concerning HIV treatment needs to be increased. Not only do existing programs in Minnesota need to be updated to educate the masses on the general safety and efficacy of this treatment, but existing programs also need to ensure that they do not endorse prejudicial attitudes toward those on the drug. Since the CDC asserts that prejudice and marginalization result in increased risk of HIV transmission, discussion and education to higher-risk communities, like programs in Chicago, would greatly benefit Minnesota.
Minnesota cannot rely on yesterday’s methods to combat today’s epidemic. As one commentator mentioned: “The bottom line: If we can get a critical mass of gay men on either Truvada or retrovirals, we could soon reach a tipping point in which this virus could be wiped out in a generation.”
If we, as a state, want to address the HIV-disparities occurring in younger populations, we need to require the Minnesota colleges and universities to cover this treatment for those who need it.
Thomas Hale-Kupiec is a law student who lives in the Twin Cities with his monogamous partner and his two cats. Truvada was deemed “medically necessary” in his circumstance, but University of Minnesota blocked his coverage.
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