The Evolution of the HIV Epidemic and the Role of Pharmacists: Where Are We 35 Years Later?

In June of 1981 an unspeakable new disease entered the public consciousness in the United States and it did so quickly and unexpectedly, leaving illness, tragedy, and death in its wake. The emergency departments, first in Los Angeles and then, one by one, in each of the major cities in the United States and eventually every state, would see their first cases of very rare opportunistic infections such as pneumocystis carinii pneumonia and Kaposi's sarcoma. Many of the first persons seen in the hospitals were gay men and Haitian immigrants who did not live more than a few weeks or months with the disease initially referred to as “gay-related immune deficiency” or “gay cancer” during those early years before its cause, human immunodeficiency virus (HIV), was identified and effective testing and therapies became available. With these first cases of what came to be known as acquired immunodeficiency syndrome (AIDS), a particularly harsh and complicated form of social and medical stigma was born and, sadly, is still a tragic companion of people living with HIV disease today.

In the late 1980s, azidothymidine (AZT), the first pharmaceutical therapy for HIV, was approved by the FDA and marketed under the brand name Retrovir. AZT was the first breakthrough in AIDS therapy, significantly reducing the replication of the virus and leading to clinical and immunologic improvements. Short-term success was realized; however, over the long term, AZT would prove ineffective as a single agent for many reasons. It is important to note that the first AIDS drug assistance program was created at this time, and implemented across the United States with the assistance of grant funding from the Robert Wood Johnson Foundation. This program was the immediate precursor to the most significant HIV/AIDS care and treatment law, the Ryan White Comprehensive AIDS Resources Emergency Act. Passed in 1990, this multilayered legislation became the safety net for thousands of people living with HIV and AIDS throughout the United States and its territories.

During the period from 1995 to 1996, the first effective combination therapy succeeded in clinical trials, introducing a new class of drugs called protease inhibitors. This new treatment (antiretroviral) paradigm of drugs was approved by the FDA, and the use of the term “cocktail” to describe combination therapies was rapidly adopted into the cultural lexicon. Mortality from AIDS was blunted, and the “Lazarus effect” was observed throughout the United States and the developed world. With this great success, however, came enormous treatment costs. Much larger appropriations directed to the Ryan White program were needed, and the amazing advocacy that evolved from the earliest days of the AIDS crisis had varying degrees of success in allocating funding at the state and federal levels.

Today, the World Health Organization estimates that there are 35 million people living with HIV/AIDS worldwide. According to the Centers for Disease Control, 1.2 million Americans are among those infected. In the United States, changes to the Ryan White law combined with the introduction of the Patient Protection and Affordable Care Act (ACA) are slowly closing the gaps into which individuals at the highest risk fall, with one big exception: the states where expansion of Medicaid did not occur.

Pharmacies, ranging from specialty to community and the well-known box stores, are on the front lines, as patient adherence to antiretroviral therapy (ART) is essential for curbing the epidemic. Although treatments have greatly improved in terms of efficacy, dosing, and reduction of adverse events, the disease remains complex and potentially deadly, if untreated. Knowledgeable pharmacists, physicians, and nurses are critical to ensuring positive outcomes for treating HIV, especially given the prevalence of complicated comorbidities, an aging population, and periodic treatment paradigm shifts. In addition, research has demonstrated that ART can also serve as a preventive measure, reducing the risk of transmission to virtually zero, with adherence.

Another challenge for patients, pharmacists, and clinical practitioners is HIV prevention. This past July, new guidelines were introduced recommending which individuals at high risk receive a very expensive daily oral pre-exposure prophylaxis (PrEP). Better and longer-lasting PrEP therapies are on the horizon, though, and hopefully a more reasonable price will be realized in both the developed and developing worlds.

In 2010, the White House Office of National AIDS Policy announced a new coordinated national strategy to combat HIV/AIDS, noting 4 areas where improvements are needed: awareness of status, linkage to care, engagement in care, and viral suppression.¹ This revised strategy is integrated with the implementation of the ACA, which opened the private insurance market to patients previously excluded because of preexisting conditions and expanded Medicaid eligibility. Expanded access to preventive care (ie, education, condoms, PrEP) and continuity of treatment is absolutely essential to the long-term prevention of new HIV cases.

Patients excluded from the private insurance market because of preexisting conditions (including HIV/AIDS) are now required to have coverage. Implementation of the ACA entered its second year last October, and the practical effect of expanded coverage for retail and independent pharmacies is becoming apparent. Previously marginalized patients are now able to receive complex drug regimens, and pharmacies find themselves ordering and stocking more expensive and specialized medications. The ACA did not take significant steps in acknowledging the role of pharmacists in the caregiving chain and the critical role they play in medication therapy management. A personal approach to treatment management, which includes monitoring for adherence, is a critical component of successful disease management, and thus, mandatory mail-order requirements should be eliminated from all plans covering persons with HIV disease.

An important structural change tied to the ACA is increased accountability for pharmacists, which is designed to cut overall costs and move the health care system toward an outcomes-based model for care. With regard to complex disease management, the role of pharmacists in improving the efficacy of drug therapies while reducing the overall cost of care has been proven through much research. One glaring omission for accountability with regard to the implementation of the ACA is that Medicare Part D providers are excluded from accountability. For the time being, pharmacy has been sidelined from this aspect of the ACA where it has the potential to have the largest impact. Regardless, pharmacists in retail settings are going to find themselves using their clinical skills more than they did prior to the ACA because of the increased number of insured people with complex diseases who now have access to care.

Medicaid expansion under the ACA has unfortunately been politicized. The ACA has been a target in recent presidential debates, with calls for a major overhaul or complete elimination, the latter being very unlikely under any circumstance.

For patients living with HIV/AIDS, access to care and ART is a matter of life and death. For example, the Ryan White Care Act provides assistance for half of people in the United States living with HIV/AIDS, with approximately 530,000 beneficiaries. Many national organizations, including one of the most well-known treatment and care providers, AIDS Healthcare Foundation, have expressed concern about gaps in coverage in states that refused Medicaid expansion under the ACA as well as concerns over insurance formulary restrictions. With more choices of ART than ever before, persons living with HIV will now be subject to stricter formulary management. In addition, the first-ever generic single-tablet regimens may be available in the near future.

Positive care outcomes are less likely when a patient goes undiagnosed, and the consequences of a patient’s nonadherence, whether involuntary or not, have a direct bearing on public health. Going off a drug regimen for 3 days or more can necessitate stoppage of therapies and additional resistance testing. If the virus develops resistance, more complex therapies may be required. The efficacy of current ART cannot be understated, but positive outcomes are dependent on strict adherence to regimens that can be very complex; thus the role of the pharmacist is crucial.

David W. Poole is director of legislative affairs for AIDS Healthcare Foundation. Konrad Brown is pharmacy literature researcher for AIDS Healthcare Foundation.

References

• Fact sheet: the national HIV/AIDS strategy: updated to 2020 [news release]. Washington, DC: The White House, Office of the Press Secretary; July 30 2015. www.whitehouse.gov/the-press-office/2015/07/30/fact-sheet-national-hivaids-strategy-updated-2020.
• Killelea A. Intersections of Ryan White and the Affordable Care Act (ACA). National Alliance of State and Territorial AIDS Directors. US Conference on AIDS; October 1, 2012.