A number of hurdles in HIV, including preventative efforts, still need to be addressed.
Modern medicine has achieved significant strides since the onset of the HIV/AIDS epidemic, however, vaccinations and a cure for the virus remains out of reach. Eradicating HIV is challenging due to several factors, including economic and financial issues, health care literacy, and the feeling of stigmatization among those infected with the virus, according to the session HIV—Why it Won’t Go Away at the 2017 Asembia Specialty Pharmacy Summit.
There are also regional disparities across the nation, with infection and mortality rates highest in southern states. Furthermore, individuals in the South are less likely to be aware of their HIV-positive status, according to the panel. There have been several milestones achieved over the years in the HIV treatment landscape, such as the release of the first guidelines for the use of antiretroviral drugs in adults; new HIV tests that allow for quicker diagnosis; and the FDA approval of pre-exposure prophylaxis (PrEP) for HIV prevention.
“Milestones and strides in HIV are to be commended,” said Jeremy Zeller, senior director of Pharmacy Systems Development, AIDS Healthcare Foundation, during the session. “But there are challenges we face, particularly in prevention.”
The 3 major obstacles in fighting HIV are that too few individuals are even aware of their infection, largely due to misconceptions and fear that prevent them from finding out their status; many patients who are HIV-positive do not receiving ongoing treatment; and socioeconomic and equity disparities put African Americans and Latinos at a greater risk, the panelists noted. Approximately 1.2 million individuals in the United States are HIV-positive, of whom 1 in 8 are unaware of their status.
Worldwide, there are 36.7 million people with HIV, and 40% are unaware of their status, according to the panelists. There is a lack of education and communication in some communities and many individuals who engage in high-risk behavior do not believe they are at risk, and therefore do not get tested, according to Zeller.
There is also a misunderstanding surrounding the HIV testing process. Most think that HIV testing involves visiting a laboratory, with test results taking days or weeks to be processed. The current standard across most organizations is a simple oral swab test that produces results in 20 minutes. The AIDS Healthcare Foundation has standard finger prick test that takes 1 minute.
Fear also prevents individuals from knowing their status, according to Zeller. The stigma that still surrounds HIV produces a guilt factor, with many who fear others finding out they were tested or that they tested positive.
“The stigma is still alive and well with HIV,” Zeller said.
Additionally, patients may just simply fear receiving a positive diagnosis. In 2014, less than half of the US population underwent the testing process. The younger population, aged 18 to 24, has the lowest testing rate of 35%, as such, Zeller noted that this population should become a larger focus.
The best way to prevent HIV transmission is through effective treatment. In the United States, only 40% of patients with HIV receive regular medical care and 30% of patients are successfully controlling the virus through therapy, according to the panel. More recently, some cities have been stepped up efforts to combat HIV through what is commonly called rapid entry.
The approach involves getting individuals tested, linked to care, brought to a physician’s office, have lab work performed to confirm status, and then start treatment—all within 24 hours. The reasoning behind rapid entry is the sooner that a patient starts treatment, the sooner their viral loads are reduced, decreasing transmission, according to the panel. Furthermore, they noted that it keeps patients engaged right from the beginning and encourages them to follow through with all necessary steps.
Socioeconomic and equity disparities are another significant barrier, particularly with the Latino and the African American populations, according to the panel. These communities have an increased prevalence of HIV and STDs; higher rates of underdiagnosed and untreated STDs in general; poor access to health care due to lack of insurance; higher rates of incarceration; lower socioeconomic status and the ability to afford the basics of life; and discrimination, stigma, and homophobia that tends to run high, the panel noted.
Other challenges are complacency and limited resources allocated from HIV prevention and education, according to the panel. As research continues to progress, the question remains: why is it so difficult to develop a vaccine against HIV?
“Since the ‘80s, you’ve had various scientists jump up and say, ‘I’m right there, the vaccine is right around the corner,’ and then obstacle after obstacle [occurs],” Zeller said. “We’re still waiting.”
In 2012, the FDA approved PrEP for use in high-risk populations. When used properly, it has a 90% efficacy rate in preventing HIV transmission. However, education and support for high-risk populations remains a challenge, panelist Brandon Patchett noted.
“You can’t deny that the studies show that PrEP is very valuable and powerful,” Patchett, assistant director of pharmacy clinical services, AIDS Healthcare Foundation, said during the session. “But if it’s not used effectively, properly, and education is not substantial, PrEP can quickly turn from a valuable tool into a barrier, and almost a problem.”
In an Emory University PrEP study, investigators recruited 184 young black men who have sex with men (YBMSM). They found that approximately half (53%) of the patients even knew what PrEP was. Of the 184 YBMSM, only 116 were willing to start PrEP. By the end of the study, only 52 of 184 YBMSM remained active in the PrEP program.
Treatments have progressed since the 1980s, shifting from complicated and high burden treatments, to more options that require a daily single-tablet. To date, there are 41 HIV AVR agents over 5 main drug class types available. Unfortunately, nonadherence can be a significant barrier to prevention.
Current trends in new drug development seeks to improve adherence through longer-acting agents that would reduce dosing frequency and hopefully improve patient adherence, according to the panel. These investigational drugs are: cabotegravir, which is administered monthly and possibly quarterly; MK-8591, which shows promise for once weekly oral or parenteral administration every 6 months or 1 year; elsulfavirine, which is available in once-weekly oral and longer-acting injection formulations; and ibalizumab, which requires infusion dosing every other week.
Reducing the frequency in treatment could have the biggest impact when it comes to PrEP. In fact, a lot of the above-mentioned drugs are being examined for use in PrEP. Specialty pharmacies are also a piece in the puzzle of treatment success through therapy initiation and management. When a patient comes with a prescription, specialty pharmacists will do everything necessary to get that patient on therapy and be successful.
This means assisting with coordination of insurance benefits to ensure the medication is maximally covered for the patient by doing prior authorizations, identifying secondary payers to get additional coverage, and manufacturer assistance and co-pay programs, according to the panel. Overall, specialty pharmacists seek to decrease the patient’s financial burden long-term so it does not become a barrier to their adherence or treatment.
Additionally, pharmacists can customize the individual needs of patients to ease access to medications, by offering special packaging and medication delivery. It is critical for specialty pharmacists to provide education to patients after initiating treatment. Education is also critical after initiating treatment. Adherence has the biggest potential for therapeutic failure when it comes to HIV treatment, according to the panel. When specialty pharmacists work to maintain therapy, extensive patient consultation is critical.
Adherence tools, such as special packaging, pill trays, and timers, also help increase compliance. Effective adherence programs entail monthly outreach to patients to see how they are doing on the treatment, and identify patients at risk of nonadherence or falling out of care, according to the panel.
To eradicate HIV, there needs to be an increase in education and HIV awareness worldwide, according to the panel. Greater access to preventative tools to help control HIV transmission and more widespread testing to identify HIV-positive individuals would provide a major boost to achieving these goals.
HIV patients need to be linked to care and treated with antiretroviral therapy soon after their initial diagnosis. For those already living with HIV, regular care needs to be maintained and they need to achieve undetectable viral levels. Lastly, there needs to be a continued effort to conduct extensive research on additional treatments and preventative measures, the panel concluded.