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Sample Paper

The paper below reflects the output of an assignment from a graduate level Advanced Pharmacology class assignment. The guidelines allowed for my choice of topics and required the topic to cover the use of Healthy People 2030 at Health.gov as a guide.

Healthy People 2030: Reduce the Number of New HIV Infections with PrEP

 

Erica Rucci

Department of Nursing: University of South Carolina Upstate

NURS720: Advanced Applied Pharmacology

Dr. Tammy Gilliam

December 4, 2022

 

 

Abstract

Since the acquired immunodeficiency syndrome (AIDS) epidemic began in the United States in 1981, scientists and researchers had the challenge to create safe, affordable prescription drugs to treat and prevent human immunodeficiency virus (HIV). The first prescription medications were costly and had several adverse effects. Finally, in 2012 The Food and Drug Administration (FDA) approved a prescription medication that was affordable and safe called pre-exposure prophylaxis (PrEP). Research continues to show that increasing access and awareness of (PrEP) can help reduce the number of HIV infections.  This paper reflects on the journey scientists and physicians have taken to get to the possibility of reducing HIV up to 99% with PrEP.  Research from the Centers for Disease Control and Prevention (CDC), the FDA, peer reviewed articles, and journals tells us that access and awareness need to be increased so that PrEP is more widely available.

Keywords: HIV, PrEP, access, awareness, reduce

 

 

Reduce the Number of New HIV Infections

According to research from the Office of Disease Prevention and Health Promotion, (n.d.) 37,000 persons aged 13 years and over were newly infected with HIV in 2017.  They also state that people with HIV who take their medication as prescribed and get the virus under control can live long, healthy lives and have effectively no risk of transmitting HIV to a sexual partner (Office of Disease Prevention and Health Promotion, n.d.).  The key to reducing the number of new human immunodeficiency virus (HIV) infections include early diagnosis, rapid treatment, and prevention. Research shows that increasing access and awareness of pre-exposure prophylaxis (PrEP) can help reduce the number of HIV infections.
 

In 1981 the first official report of what will be knows as acquired immunodeficiency disease (AIDS) was reported in the United States (Centers for Disease Control and Prevention, 2022). That was the start of what is known as the AIDS pandemic.  Since then, it has been established that HIV is transmitted by sexual contact, contaminated needles and before guidelines were put into place blood transfusions. HIV is a virus that attacks cells that help the body fight infection, making a person more vulnerable to other infections and diseases (HIV.gov, 2022).  If left untreated, HIV can lead to the disease called AIDS, which is the last stage of infection that occurs when the body’s immune system is badly damaged because of the virus (HIV.gov, 2022). 
 

By the early 1990s, HIV was the No. 1 cause of death among Americans ages 25 to 44 (Watson, 2022).  Since 1981 when the AIDS pandemic started scientists and researchers were trying to find a cure for this disease that was taking over healthy young people.  In 1987 the antiviral drug Retrovir was introduced to treat HIV (Watson, 2022).  Retrovir had drawbacks, it did not work well on its own and it cause liver problems and deadly low blood cell counts (Watson, 2022).  At the time it was the most expensive prescription drug in history, with a one-year price tag of $16,500 in today’s dollars (Watson, 2022).  In 1995 The Food and Drug Administration (FDA) approved Saquinavir, the first in a different anti-HIV (antiretroviral) drug class called protease inhibitors (Watson, 2022).  A year later another class of antiretrovirals, called non-nucleoside reverse transcriptase inhibitor (NNRTI), included nevirapine (Viramune). These drugs paved the way to a new era of combination therapy for HIV/AIDS (Watson, 2022). 
 

Finally, there was a combination of prescription drugs called highly active antiretroviral therapy (HAART) that greatly lengthened the life span of people with AIDS (Watson, 2022).  HAAT required taking multiple pills a day, each one having their own side effects.  This drove many people to quit their HIV therapy (Watson, 2022). Prescription drugs are not successful if patients cannot take them due to cost, or unwanted side effects. Unfortunately, none of these therapies cured HIV or prevented HIV from being passed on to sexual partners.  That changed in 2012 when the FDA approved Truvada for a PrEP indication, for people who do not have HIV, to prevent them from getting it when they have sex or inject a substance (U.S Food and Drug Administration, 2019).    Of course, being aware of your own status as well as any partners is key in keeping healthy and obtaining early treatment.  
 

PrEP works by preventing HIV from replicating in the body. It acts as a catalyst that helps the body produce antibodies, which help diseases causing germs and viruses. Used correctly, PrEP eliminates the risk of contracting the virus after exposure. PrEP, taken the right way, is quite effective against HIV contact. It prevents HIV infections 99% of the time.  Before starting the PrEP medication, you need to have an HIV test. ) If the patient has HIV, taking the tablet increases the likelihood of developing drug resistance).  Before taking PrEP medication, patients are required to get input from a healthcare professional. (Washington Health Institute, 2021).
 

Early diagnosis plays a big role in reducing the number of HIV infections, the Center for Disease Control (CDC) emphasizes the need of increasing testing in non-traditional settings such as jails, emergency departments, and street-based services (n.d). 16% of South Carolinians with HIV are unaware of their status this means that they are not getting the HIV care they need. They also state that 710 new HIV infections occurred in South Carolina (Centers for Disease Control and Prevention, n.d.). All patients between 13 and 75 years of age should be routinely screened for HIV (Huyng & Kahwaji, 2022).  The standard of care test for diagnosing HIV in a clinical setting is the serum test, known as the HIV fourth-generation test, a combination antibody (Ab) and antigen (Ag) test (Huyng & Kahwaji, 2022).  Increasing access to the use of HIV self-tests and integrating STI and viral hepatitis screening into HIV testing services will help to increase diagnosis of HIV (Centers for Disease Control and Prevention, n.d.).  
 

Early diagnosis can lead to rapid treatment and the ability to make partners aware of the potential exposure.  In looking at data from Centers for Disease and Control and Prevention (n.d.), 71% of South Carolinians with diagnosed HIV are virally suppressed.  This allows them to live a long and healthy life and have effectively no risk of sexually transmitting HIV (Centers for Disease and Control and Prevention, n.d.).  Ideas on how to increase rapid treatment are expanding telemedicine and developing networks to rapidly link persons with recently diagnosed HIV to care services Centers for Disease and Control and Prevention (n.d.). 
 

In the United States, 15% of HIV positive patients who are unaware of their status account for up to 40% of new HIV transmissions (Huyng & Kahwaji, 2022).  As discussed preciously, early diagnosis and rapid treatment can reduce HIV transmission and lower the viral load to prevent the spread to other potential partners.  Another way to decrease new infections of HIV is PrEP.  As of January 2019, the FDA has approved three medications as PrEP for HIV. Truvada (tenofovir disoproxil fumarate 300 mg/emtricitabine 200 mg) preferred as an oral daily regimen, Descovy (tenofovir alafenamide 25 mg/emtricitabine 200 mg) as an alternative oral regimen for cisgender, MSM, and transgender women, and Apretude (Long-acting injectable cabotegravir 600 mg) (Department of Health, 2022).  Because PrEP is effective preventive care, the Affordable Care Act (ACA) requires most health plans to cover it at no cost to the patient (Gerencher, 2022).  There is also Copay assistance such as the Truvada copay card, a Descovy copay card, and GoodRX has a generic option: emtricitabine/tenofovir, that will help a person pay less than $30 for a 30-day supply (Gerencher, 2022). Providers should make their patients aware of cost differences, Publix offers emtricitabine-tenofovir Pressair with GoodRX for $32.70, while CVS and Walgreen charge more than $500.00 for 30 tablets (Gerencher, 2022).
 

Questions about PrEP are how well does it work, what are the side effects, and what does it cost?  In a peer reviewed article from Desai et al., (2017) it is clear from the evidence available that oral FTC-TDF PrEP is highly effective in reducing the risk of HIV acquisition across different types of sexual exposure, genders, dosing schedules, and different country contexts and epidemics. The Centers for Disease Control and Prevention (2022) states PrEP is safe, but some people experience side effects like diarrhea, nausea, headache, fatigue, and stomach pain. These side effects usually go away over time. Unlike the Retrovir which was highly expensive, PrEP is more attainable. Most health insurance plans, including Medicaid, cover the cost of PrEP without co-pays. This includes the medication, medical appointments and lab tests associated with PrEP (Department of Health, 2022). There are also options for people who do not have health insurance or prescription drug coverage.  For people without access to health insurance or prescription drug coverage, a number of options for financial assistance are available.  Advancing Access, Patient Advocate Foundation Co-pay Relief, and Ready, Set, PrEP are some sites people can visit to gain more information about paying for PrEP, some of which offer PrEP for free (S.C. Department of Health and Environmental Control, 2019).
 

 It has been established that PrEP reduces the risk of getting HIV from sex by about 99% when taken as prescribed (Centers for Disease Control and Prevention, 2022). Finding an affordable, safe, easy to administer HIV drug is not the problem anymore, the issue is spreading awareness and access to PrEP.  A study led by researchers at the Johns Hopkins Bloomberg School of Public Health (2020) found that just under 20 percent of HIV-uninfected patients visiting Baltimore sexual health clinics were aware of pre-exposure prophylaxis medication (PrEP). There are companies out there who are helping to help greatly reduce if not eliminate HIV in the United States. Ready, Set, PrEP makes free daily oral PrEP medications available nationwide, and is a key component of efforts to end HIV in the United States (HIV.gov, 2022).   “Together we can reduce the number of new HIV transmissions in the United States by 75% by 2025 and by at least 90% by 2030” (HIV.gov, 2022).
 

Scientists and researchers have come a long way since the AIDS pandemic in 1981, with safer, more affordable prescription drugs. People have the option of taking one pill a day, verses a cocktail of expensive medications with adverse side effects.   PrEP is covered by most insurance companies, and there are many resources available to help to pay for this much need prophylactic medication. PrEP puts people that do not have HIV in control of their own health and wellness. Early testing and rapid treatment are key in helping people live healthy longer lives and reduce the spread of HIV. In 2019, PrEP changed the world by providing a prevention strategy for people who do not have HIV. By increasing access and awareness of pre-exposure prophylaxis (PrEP) the number of HIV infections will continue to decrease.

 

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References

Centers for Disease Control and Prevention. (2022). HIV and AIDS timeline. npin.cdc.gov. https://npin.cdc.gov/pages/hiv-and-aids-timeline#1980

Centers for Disease Control and Prevention. (n.d.). HIV prevention to end HIV epidemic in the United States South Carolina. CDC.gov. https://www.cdc.gov/hiv/pdf/policies/profiles/cdc-hiv-south-carolina-PrEP.pdf

Centers for Disease Control and Prevention. (2022). PrEP effectiveness. CDC.gov. https://www.cdc.gov/hiv/basics/prep/prep-effectiveness.html

Department of Health. (2022). Preventing HIV by taking one pill once a day: Pre-exposure prophylaxis (PrEP). health.ny.gov. https://www.health.ny.gov/diseases/aids/general/prep/faqs.htm#:~:text=On%2DDemand%20PrEP%3A%20On%2D,their%20last%20possible%20sexual%20exposure.

Desai, M., Field, N., Grant, R., & McCormack, S. (2017). State of the art review: Recent advances in PrEP for HIV. NCBI. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6020995/

Gerencher, K. (2022). 5 Ways to Save on PrEP Costs (With or Without Insurance) Kristen Gerencher, MSOT Christina Aungst, PharmD Written by Kriste. goodrx.com. https://www.goodrx.com/truvada/truvada-hiv-prep-cost-generic-how-to-save

HIV.gov. (2022). Ready, set, PrEP expands access to HIV prevention medications. hiv.gov. https://www.hiv.gov/federal-response/ending-the-hiv-epidemic/prep-program

HIV.gov. (2022). What are HIV and AIDS? hiv.gov. https://www.hiv.gov/hiv-basics/overview/about-hiv-and-aids/what-are-hiv-and-aids#:~:text=A%20person%20with%20HIV%20is,and%201%2C600%20cells%2Fmm3.)

Huyng, K., & Kahwaji, C. (2022). HIV Testing. NCBI. https://www.ncbi.nlm.nih.gov/books/NBK482145/

Johns Hopkins Bloomberg School of Public Health. (2022). Study finds low awareness of PrEP, the highly effective medication that protects individuals from HIV publichealth.jhu.edu. https://publichealth.jhu.edu/2021/study-finds-low-awareness-of-prep-the-highly-effective-medication-that-protects-individuals-from-hiv

Office of Disease Prevention and Health Promotion. (n.d.). Reduce the number of new HIV infections — HIV‑01. Health.gov. https://health.gov/healthypeople/objectives-and-data/browse-objectives/sexually-transmitted-infections/reduce-number-new-hiv-infections-hiv-01

S.C. Department of Health and Environmental Control. (2019). What is PrEP? SCDHEC. https://scdhec.gov/infectious-diseases/hiv-std-viral-hepatitis/pre-exposure-prophylaxis-prep

U.S Food and Drug Administration. (2019). FDA In Brief: FDA continues to encourage ongoing education about the benefits and risks associated with PrEP, including additional steps to help reduce the risk of getting HIV. fda.gov. https://www.fda.gov/news-events/fda-brief/fda-brief-fda-continues-encourage-ongoing-education-about-benefits-and-risks-associated-prep

Washington Health Institute. (2021). What is PrEP and how does it work? dc-whi.org. https://dc-whi.org/what-is-prep-and-how-does-it-work/#:~:text=How%20Does%20PrEP%20Help%20Patients,by%20the%20virus%20to%20replicate.

Watson, S. (2022). The History of HIV Treatment: Antiretroviral Therapy and More. WebMD. https://www.webmd.com/hiv-aids/hiv-treatment-history

© 2023 by Erica Rucci, BSN, RN

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