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Introduction   

To understand how Pre-exposure prophylaxis (PrEP) works in preventing Human Immunodeficiency Virus (HIV), it is important that we have some background information on HIV and how it affects the human body. HIV is a virus that attacks the human immune system, making it susceptible to opportunistic infections.  

There are two classifications of HIV, and these are HIV -1, which is the most commonly diagnosed infection globally; and HIV-2, which is rare and predominantly occurs in West Africa. If left untreated, HIV can lead to what is known as acquired immunodeficiency syndrome (AIDS) [4][6].  

It is crucial for nurses to understand what PrEP is, types of PrEP, indications for use, and patient education topics to advocate for patients at high risk. 

Statistical Evidence 

Despite advances in medicine, HIV continues to be a persistent public health concern in the United States (US) and worldwide, therefore is still considered an epidemic. As of 2022, there are 39 million people living with HIV globally [7]. According to the World Health Organization (WHO), HIV has claimed over 40 million lives worldwide [12]. In the US, there are approximately 1.2 million people who are currently living with HIV. Of those, 13% do not know that they carry the virus [1] [3].  

Furthermore, in 2021, there were an estimated 32,000 new HIV infections in the US. Of those 86% of infections were among all men. From those newly reported HIV infections, the highest subpopulation was among gay, bisexual, and male-to-male sexual contacts who accounted for 22, 400 (70%), followed by 7,100 heterosexual infections (22%) and 2, 500 (8%) infections among drug users [3][9].  

Studies have shown that HIV has a disproportionate impact on racial and ethnic minorities. As of 2021, the most affected racial and ethnic group are the black/African Americans who accounted for 40% (14, 383), followed by the Hispanic/Latinos who accounted for 29% [3].  

Geographic location and identity also play a role in the rate of HIV infections. The regions that are most affected are the metropolitan cities with over 500, 000 or more people and the southern part of the US has the highest number of people living with HIV [9].  

There is no cure for HIV-AIDS, but recent estimates indicate that the rate of HIV infections has reduced by 12% from 2017 to 2021 because of the use of Pre-exposure prophylaxis (PrEP) drugs [3].  

Risk Factors and Causes 

HIV can occur in three stages in the human body, which are acute HIV infection, chronic HIV infection, and AIDS (late stage).  

During the acute HIV stage, most people develop flu-like symptoms which last between 2 – 4 weeks. It is during this stage that the HIV virus levels are high in the blood [9]. As a result, this causes the HIV virus to spread rapidly in the body and intrudes into the immune system by attacking the CD4 T lymphocytes (CD4 cells). The CD4 cells are the white blood cells that help the body fight infections [6].  

The late stage is when the HIV infection is most severe because the body can no longer fight opportunistic infections due to a weakened immune system and an increase in viral load. Therefore, the acute and last HIV phase increases one’s risk of contracting the virus due to increased levels in the blood [6]. Also, a recent diagnosis with a sexually transmitted infection (STI) in the past 6 months is a risk factor of acquiring HIV [1].  

The two most common ways in which HIV is spread are through unprotected sex (anal or vaginal) and sharing of needles by use of illicit drugs. HIV can be found in the bloodstream, saliva, vaginal fluid, and breast milk of those who are infected [13]. Risk factors can be attributed to substance use and engagement in unsafe behaviors from having sexual intercourse with a partner that is infected with HIV. Also, alcohol and drug use can hinder people from having protected sex [13].  

Other risk factors include perinatal infections (mother-to-child transmission) and sexually transmitted diseases (STIs), blood transfusions, transplant tissue, and accidental needle sticks [13]. 

Prevention Strategies 

Ending the HIV epidemic in the U.S (EHE) is a collaborative initiative amongst several federal agencies and organizations whose goal is to reduce the rate of HIV infections to 75% by 2025, and 90% by 2023 (CDC, 2023) [2]. One of the main strategies is through the implementation of PrEP drugs. PrEP has been proven to reduce HIV infections by 99% from sex and 74% from injection transmission when combined with sex education, linkage to care, and evidence-based practice interventions (LGBQT and POC empowerment) [6].  

Treatments 

HIV is usually treated using highly active antiretroviral drugs (HAART), a potent combination of antiretroviral drugs. HAART assists by slowing the progression of the virus [5]. Pharmacotherapy for HIV/AIDS-related illnesses has led to new drug discoveries such as Pre-exposure prophylaxis (PrEP), that are currently being used to combat the HIV/AIDS epidemic.  

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What is Pre-exposure Prophylaxis (PREP)?  

PrEP is a prescribed medication that is recommended to prevent the transmission of HIV in anyone who is at risk of acquiring the HIV infection when exposed [6].  

It is worth noting that PrEP prevents the transmission of HIV but not STIs or other viruses. Currently, there is no cure for HIV. However, studies have shown the use of PrEP along with improved testing and treatment is effective in reducing HIV when used as prescribed [6].  

Also, clinical guidelines support the use of PrEP when incorporated as part of a comprehensive prevention program which should include safe sexual practices and adherence to treatment. Emphasis must be placed on those using PrEP on adherence to therapy [5].  

Types of PrEP Medications 

There are three types of PrEP medications that are currently approved for use by the Food and Drug Administration (FDA): Truvada®: Emtricitabine/tenofovir disoproxil fumarate (F/TDF) Descovy®: Emtricitabine/tenofovir and aladenamide (F/TAF) and Apretude®: (Carbotegrovir) long-acting injection (HIV) [10] [11] [12].  

Indications of Use for PrEP 

• F/TDF and Carbotegrovir are indicated to reduce the transmission of HIV-1 infections in at-risk adults and adolescents who weigh at least 35kgs (77lbs) [1] [5]. 

• F/TAF is indicated to reduce the transmission of HIV-1 infections in at-risk adults and adolescents who weigh at least 35kgs (77lbs), except for transgender women who were assigned male sex at birth [5].  

• One must be HIV – 1 negative prior to starting PrEP [1] [5].  

Oral medications 

Truvada® (F/TDF) and Descovy® (F/TAF) are fixed-dose oral combination drugs. Although the two medications have some similarities, it is important to differentiate what they are [11] [12]. 

F/TDF was the first FDA-approved PrEP drug and is the most prescribed drug. Both F/TDF and F/TAF medications are available in pill form and must be taken once daily with or without food.  

The kidneys excrete F/TDF and, therefore can cause damage in those with renal impairment which is also linked to loss of bone mineral density. This makes F/TDF more favorable in patients who have osteoporosis and renal impairment.  

F/TDF was found to be safe for use in pregnant women [11] [12].  

Common side effects – Include fatigue, headache, nausea, and abdominal discomfort also known as ‘Start up Syndrome” which usually lasts for the first month of taking the medication. Increased weight gain and Low-Density Lipoprotein (LDL) seen in F/TAF compared to F/TDF.  

Severe side-effects – Clinicians must monitor for the development of the following potential severe or life-threatening effects: 

• Lactic acidosis: Not easily identifiable. Signs to look out for include weakness or tiredness, unusual muscle pain, difficulty breathing, stomach pain, nausea, and vomiting.  

• Immune reconstitution: flare-up of infections such as tuberculosis or autoimmune disorders and autoimmune Hepatitis.  

• Hepatomegaly with steatosis: jaundice, fever, and pain in right abdominal quadrant.  

• Renal impairment and bone problems (susceptible to bone fractures): more at risk with F/TDF.  

• FDA black box warnings: Severe Hepatitis B exacerbation.  

Injectable PrEP Medication 

• Apretude® (Cabotegravir): First FDA-approved long-acting intramuscular injectable PrEP.  

• The first two doses need to be administered one month apart.  

• Cabotegravir is recommended to be administered in the ventrogluteal or upper outer quadrant of the dorsogluteal muscle.  

• Cabotegravir is a good alternative for patients who have trouble taking pills or are concerned about the stigma of taking pills. 

Side effects – Include stomach pain, nausea, vomiting, loss of appetite, diarrhea, irritation at injection site, flatus, and tiredness.  

Severe Side Effects – Include hepatotoxicity, Depressive disorder, mood swings, insomnia, suicidal ideation, muscle pain, fatigue.  

Mechanism of Action 

PrEP helps to stop HIV from acting as a catalyst by helping the body to produce antibodies that can block the enzyme needed by the HIV-1 virus to replicate and spread throughout the body [5].  

Contraindications  

• Unknown HIV-1 status or HIV-1 positive status [5]. 

• Acute Hepatitis B and Hepatitis C infections.  

• Drug-to-drug interactions.  

• Previous hypersensitivity with Cabotegravir. 

• F/TDF is contraindicated for transgender women who were assigned male sex at birth [1]. 

• Oral PrEP: Creatinine clearance (CrCL) < 60/ ml per minute for F/TDF and CrCl < 30ml/min for F/TDF for patients with ESRD who are not receiving dialysis [5].  

Clinical recommendations for prescribing PrEP  

The following recommendations were issued by the CDC for the prevention of HIV using PrEP [1][5].  

• Providers must inform their adult and adolescent clients that are sexually active about PrEP.  

• Documented HIV-test results taken within a week of starting PrEP medications and periodically while on the medication. The HIV- 1 test must be confirmed through a blood serum test, approved FDA Point of Care test and antigen-antibody fingerstick test.  

• The patient must have no signs or symptoms of acute HIV infection. 

Drug-to-drug interactions 

• F/TDF affects the absorption of the following antiretrovirals: Didanosine, atazanavir, lopinavir/ritonavir. When used with Nonsteroidal anti-inflammatory (NDAIDS) drugs can cause nephrotoxicity [5][11]. 

• F/TAF and cabotegravir are both known to interfere with: Anticonvulsants i.e., carbamazepine, oxcarbazepine, phenobarbital, phenytoin, antimycobacterial i.e., Rifampin and rifabutin [9] [10].  

• F/TAF is decreased when used with Antiretrovirals: Ritonavir and tipranavir [10] 

• Cabotegravir interferes with Methadone by decreasing its levels in the body [5].  

Required Testing and Monitoring 

• Per CDC PrEP guidelines, it is required that health providers have documented HIV negative test results taken within a week prior to initiating PrEP. Thereafter, it is recommended that an HIV test is done every three months while on oral PrEP therapy and every two months for those prescribed the injection [5][9].  

• Testing of STI’s i.e., syphilis, gonorrhea & chlamydia prior to initiating PrEP.  

• Assess for kidney function i.e., creatinine every six months for those aged 50 or > and with creatinine clearance of < 60ml/min [5].  

• Hepatitis B serology testing screening prior to and whilst on F/TDF or F/TD.  

• Assess for symptoms of acute HIV infections.  

• Monitor lipid profile for patients on F/TAF 

• Monitor liver enzymes: indication for acute or chronic viral hepatitis infection [1] [5].  

Effectiveness 

PrEP is safe and highly effective when taken consistently with a prescribed regimen. PrEP is effective in preventing HIV infections from sex by 99% and 74% among drug users. No reports on significant health effects in those who have taken PrEP for up to 5 years and are HIV negative [6].  

Common misconceptions 

Two main misconceptions: PrEP is only used in gay men and the use of PrEP encourages risky sexual behaviors [5].  

Patient Education:  

Comprehensive prevention strategies such as counseling, safer sex practices and adherence to medication must be incorporated with the use of PrEP.  

• HIV transmission education should be reviewed with patients regularly and must include assessment of high-risk behaviors and appropriate interventions such as regular testing of HIV-1 status.  

• Encourage patients to disclose HIV status to sex and needle-sharing partners. Also, they should know their partner’s HIV status.  

• Educate patients on how to monitor for signs and symptoms of hypersensitivity i.e., muscle pain and fatigue.  

• Encourage regular follow-up visits every 3 months.  

• Educate patients to recognize and report the important symptoms: change in condition. Instruct patients not to stop taking the medication without consulting their provider.  

• Instruct patients to take the medication as scheduled.  

• Instruct patients to medication in its original container /blister pack.  

• Educate patients that PrEP does not prevent the spread of STIs.  

• If patients on dialysis teach them to take medication after dialysis treatment.  

Core drug knowledge 

• PrEP has proven to be safe and effective in preventing transmission of HIV-1 infections and has become part of the  

• F/TAF is not recommended in transgender women or individuals at risk with receptive vaginal sex.  

• Adherence to PrEP regimen is the most important factor in maintaining efficacy.  

• Risk assessment and baseline labs must be obtained prior to initiating PrEP. 

• Renal function should be monitored every 6 to 12 months in patients taking F/TDF or F/TAF based on age and CrCl levels.  

• PrEP medications should not be stopped without a patient consulting provider. This should include a repeat HIV test and documentation for discontinuing medication [5]. 

 Cost-Reducing Programs: 

• The Affordable Care Act allows for all insurance health plans to provide PrEP for free.  

• A program known as Ready, Set, PrEP provides free PrEP medications to those who qualify.  

• Drug manufacturing assistant programs such as ViiVconnect aids with PrEP injections for those who qualify.  

Conclusion

PrEP has become part of a worldwide comprehensive program that is aimed at eliminating the HIV epidemic. The benefits of PrEP can be achieved through identifying those at risk for acquiring HIV, counseling on medication adherence, encouraging safer sex practices and through regular testing and monitoring for HIV using the recommended guidelines.  

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