An Analysis on HIV Transmission and PrEP Accessibility

 Introduction

Six years ago, the pharmaceutical company Gilead produced Pre-Exposure Prophylaxis (PrEP), a daily use HIV-prevention pill that provides over 99% protection from transmission (https://prepfacts.org/prep/the-basics/). Since PrEP was released under the brand name Truvada in 2012, there has been an approximate increase in wholesale price by 45% (Luthra, S., & Gorman, A.). While there have been several medications introduced to also provide transmission reduction, only Gilead's remains FDA approved. With AIDS no longer being a death sentence, HIV has not been regarded as intensely as in previous decades. However, with seemingly incredible  disparate infection rates, and the highest percentage of the infected population becoming infected by the age of 25, one must wonder how this is happening. This paper will look to understand the mechanisms behind this increasing disparity, why the cost of PrEP has increased, and what can be done to combat the increasing rate of HIV among the United State's youth. This paper will conclude with a brief overview of current initiatives to address this epidemic, with a particular interest in New York State.

Brief History on HIV

HIV and AIDS as an epidemic have served as a sociopolitical epidemic of study for the last few decades. It served for many as a reminder of the pitfalls of what can occur when health crises become politicized. The first individuals who started showing symptoms of AIDS that were reported on in the United States were gay men. At this time, they were experiencing symptoms of  pneumonia and Kaposi's Sarcoma (KS), a rare form of cancer indicative of AIDS, that was dubbed to be known as both the gay man's pneumonia and gay cancer in the public sphere of the time. Just the next year, AIDS (Acquired Immune Deficiency Syndrome) would be used for the first time in a CDC publishing. At this time it was defined as A disease at least moderately predictive of a defect in cell-mediated immunity, occurring in a person with no known cause for diminished resistance to that disease HIV/AIDS 2018).

The political climate is one that had directly impacted how we have viewed those who become infected with HIV. First, HIV transmission primarily impacted LGBT+ individuals, a target base that became centralized to the argument against governmental assistance. Further, the highest risks of obtaining HIV is via needle injection. For injecting drug users (IDU), their basis for assistance was fought by what researchers have coined as addictophobia.

The central basing of othering was what allowed this epidemic to occur so long. Even though the epidemic was a huge issue facing the United States just a few decades previous, it has been widely disregarded as of current. While HIV is no longer killing individuals the way it had previously, transmission among certain groups has increased vastly and has become a new, changing crisis of its own.

Possible Explanations for Disparity

        At around the same historical moment of the AIDS crisis was the push towards abstinence-only education. This political move came into the picture with the passing of the Adolescent Family Life Act of 1982, amending current laws to include the provision of abstinence only educational services under the category of necessary services (Specter & Arlen 1997). In 1996, the Welfare Reform Legislation was proposed by Bill Clinton to be amended for continuation of this policy. When in debate, it was overwhelmingly accepted  and touted for its bipartisan holding. Abstinence-only education funding was then included among other financially incentivized healthy behavior motivators by the State. It was directed under the title of teenage pregnancy prevention and provided block grants through appropriations to Maternal and Child Health (O'Campo 422-423). There were several ways in which funding was distributed to individuals for abstinence education. One such funding that is particularly interesting to the current STI infectious climate was targeted through Title V, which stated that abstinence-only funding would go to states with regard for the proportion of the amount of low-income students they had (Foulkes 11). Foulkes further analyzed the low-income schools affected, and it was noted that minority groups were consistently targeted by policy implications of tying welfare and low income to funding through a channel of abstinence only.  Beyond just the targeting of inner city schools with lack of information, these programs actually frequently would provide students with entirely incorrect information regarding STIs, pregnancy, and sexual risk factors. With abstinence only showing no changes in amount of sexual activity or age at which sexual activity begins among youth, the government was creating a direct knowledge deficit among certain communities.

        Because of this, disparate educational aspects may have led to and should be considered when looking at disparate health outcomes in this case for African American youth. According to African-American health advocates, the sentiment of protection not being worthwhile becomes ingrained young African-American women and men who find themselves in poverty, with little hope of doing better economically, may believe they have no real reason to take preventive measures to protect themselves from HIV (Foulkes 19). These feelings of economic hope and worthwhileness are not just internal struggles but an actual health disparity, particularly for those who lie at the intersections. While gay men overall are the most effected by HIV and AIDS, gay African American men alone make up 38% of all new diagnoses for HIV (HIV/AIDS 2018). It is vital to consider this information that is indicative of the importance of looking at individuals falling in the intersections of these identities.

PrEP, Gilead, Criticisms of Current System

Currently, there is only one company that holds the patent for Pre-Exposure Prophylaxis, an Antiretroviral medication that makes HIV transmission over 99% preventable with daily usage (insert Gilead thing here). This company is Gilead Sciences, a Californian-based pharmaceutical company that has PrEP patented under the name Truvada. This drug was released publicly back in 2012, and has had many positive effects among states with high PrEP usage. According to independent research done on Gilead, within the ten states most utilizing Truvada within the United States, the estimated number of HIV diagnoses was decreased by approximately 4.7 percent. With this noted, it should also be noted that the number of HIV diagnoses was increased by 0.9 percent in the ten states with the lowest usage of Truvada (Press Releases).

This company has been criticized heavily by many activist groups, one of which being ACT UP, for their holding of the patent and aggressively increasing the price so that it cannot become accessible. As of current, their estimates are that Truvada would cost Gilead approximately $6 to create a month's supply, however without insurance the cost for a one month prescription would run upwards of $1,500 (slate article citation). Beyond the excessive cost being pushed onto the consumer, there is also the criticism that most of the funding that was put towards creating and testing pre-exposure prophylaxis was federally provided. Of the agencies responsible for funding researching included large backing from the National Institute of Health and the Centers for Disease Control (CDC) and Prevention (Slate). In the HIV Prevention Research & Development Funding Trends released by AVAC (AIDS Vaccines Advocacy Coalition), it is noted that the public funding for HIV transmission reduction and PrEP research was vastly outweighing that of what was provided by private companies. Given that most of the funding was provided by taxpayer money, Gilead's holding and vast price increase has been considered both unjust and unethical by many.

Where We Are Failing/Our Disparities

        Going back to Gilead's numbers, what should be noted again is the increase in HIV among states with low numbers of Truvada usage. While there have been great strides among those who have had access to the drug, there is also an incredible disparity in HIV transmission overall. Among all groups of gay men, the most affected group by HIV and AIDS, gay and bisexual men who have sex with men (MSM) accounted for HIV diagnoses accordingly per race: African American MSM held the highest number accounting for 10,226 (38 percent) of all new diagnoses in 2016. For Latino men that number was 7,689 (29 percent). White men accounted for only 28 percent in comparison (meaning 7,392 diagnoses). Gay and bisexual men who have sex with men between the ages of 13 to 34 accounted for just over two-thirds (64%) of HIV diagnoses among all gay and bisexual men (HIV/AIDS 2018).

Discussion of What We're Doing

There are several entities that have provided avenues for critiquing the patenting and cost of PrEP. One of which doing work based out of New York is an organization called PrEP4All, which has become increasingly well-known for its slogan and hashtag #breakthepatent. The organizers have pointed to government officials to do what is within their legal ability and ethical necessity to ensure the interests of the public are held to higher importance than that of private entities. One call that the organization has put to the federal government is to push a march in under the Bayh-Dole Act of 1980, an act that allows intervention on the patent (Patents, Profits, and the American People). If the government did this, that would mean that they would have the ability to publicize the medication, meaning costs would decrease dramatically.

While the government does have the ability to do this, there has not been one instance of this occurring since its enactment (Patents, Profits, and the American People). This does not mean that there haven't been attempts to do so. In fact, there have been several. The National Institute of Health, one of the major funders of PrEP research listed above, had been petitioned six times for march-in actions previously, all of which with no avail (Patents, Profits, and the American People).

Another initiative local to New York was enacted by Governor Andrew Cuomo in 2014, and was most recently discussed for its progress thus far at the state-wide conference on HIV and AIDS earlier this month. On June 29th, 2014, Cuomo announced Ending the AIDS Epidemic in New York State, a program which detailed a three point plan for reducing the transmission rate of HIV within the state. The plan listed out the goal of reducing transmission rates to 750 individual infected per year by 2020, a number that was nearing 3,000 per year when the initiative was started.(Department of Health). If this was successful, this would be the first time transmission rates were on a decrease in New York State ever. The three points included: identifying undiagnosed individuals with HIV and assisting them in gaining access to treatment plans, maintain support and links to individuals who are HIV positive to health care options to attempt to minimize further viral transmission, and give avenues of access to PrEP to high risk HIV negative persons. The committee came up with the slogan U = U, meaning undetectable = untransmittable, to help spread the message of HIV treatment and what constituted contained viral load that was not transmittable (Department of Health).

 In the summit held this December, the committee reported on a progress summary that was completed earlier in the year in March. The summary included a synopsis of what had been enacted since the beginning of the initiative in 2014. Since that date, the state has spend over 20 million dollars on the three goal guidelines and has seen a 16% decrease in the number of HIV cases since 2014. One major point touted by the committee is the 600 percent increase in low-income individuals being given access to PrEP. What that increase becomes, however, is still not incredibly high. This would bring the overall users to just over 1,600 (Department of Health). 

Beyond this summary, Cuomo has also pledged nearly $1 million this October to continue support for organizations both working on reducing HIV transmission overall and assisting those living with HIV or AIDS, or with infected family members, showing a continuous effort to engage in HIV efforts.

Suggestions for a More Intersectional Approach

While the Summit reported some great strides towards HIV progress, it should also be noted that there are some interesting statistics to further look at. When looking at the differences among which racial groups in who received care within 30 days, the breakdown is as follows: Non-Hispanic, White (80%) > Asian/Pacific Islander (76%) > Hispanic (75%) > Non-Hispanic, Black and Multi Race (73%, respectively). Given that according to the National Civil Liberties Union reported that New York was in the top three states for taking abstinence-only funding. Given the disparities listed above, it should be noted how vital immediate care could be for gay African Americans with the current HIV transmission rate expected to reach 1/2 by 2020. While the transmission rates have decreased tremendously, we are still missing the educational component that empowers individuals to use and seek out preventative methods when regarding transmission. While PrEP access is needed, and needed in an affordable manner, we cannot overlook the direct attack on non-white communities that occurred under abstinence only. To provide the best access we can to our citizens, we must consider the purpose of the groups we are targeting, not just look at the decreasing rates overall. Yes, transmission is decreasing and care is more accessible, but for who, and how long is it taking? 

        The HIV/AIDS epidemic is one like no other. It directly showed the pitfalls of what can happen when a public health issue is made politicized. It continued its grasp through governmental propositioning of abstinence only education that was directly targeted to be heterosexual-focused, and directly impactive of non-white, low income communities. Now, we have options for combatting it and access to a drug that can make transmission over 99% protected against. While a drug may not be reparative in regard to fixing all of the problems at the crux of these two intersecting dilemmas, it can be a safeguard that has been so frequently disregarded for our high-risk communities. Given the politicalization of sex, sexual education, sexual health, and sexual identity within this country, maybe looking back and calling of the National Institute of Health to utilize its power for PrEP is not only a good option, but a dutiful obligation to a system failure.

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