For US HCPs Only
Dr. Edgar Turner Overton is a Regional Medical Director at ViiV Healthcare and also serves as Volunteer Medical Faculty at the School of Medicine, Division of Infectious Diseases at the University of Alabama at Birmingham (UAB).
2022 marks 10 years since the first FDA approval of an HIV pre-exposure prophylaxis medicine (more commonly known as “PrEP”). The introduction of PrEP was heralded as a key strategy that could substantially reduce the rate of HIV transmissions and help turn the tide of the HIV epidemic. However, despite that potential and the impact that it has had in some communities, PrEP remains significantly underutilized — especially among communities most affected by HIV.1 Recent findings presented at the International AIDS Conference in Montreal demonstrated that the lowest rates of PrEP utilization are in the South, where HIV rates are highest, and particularly among people of color.2
As we look forward to the next decade of HIV prevention and achieving the goals of preventing HIV transmission, it is essential that we act now to reimagine the future of PrEP in the United States. As healthcare providers, we are the front lines of addressing the HIV epidemic and will have a key role to play in making sure new tools to prevent HIV reach the communities we serve. We must partner with community stakeholders to ensure that our approach to HIV prevention is person-centered and provides people with knowledge to make informed choices about their health.
1. Avoid a one-size-fits-all approach
Before recently joining ViiV Healthcare, I worked as an infectious disease specialist in Missouri and Alabama, in the heart of the US HIV epidemic, for over 20 years. With the initial approval of PrEP as an oral tablet in 2012, community interest in this new HIV prevention tool was evident. My team and I were excited to provide people with access to an effective HIV prevention option by launching the first PrEP clinic in Alabama. We created a place where they could easily access PrEP and work with specialized healthcare professionals who were dedicated to their care. By ensuring the community had better access to PrEP, we were able to empower people to prevent transmissions in an entirely new way.
We found success, but also ran into challenges — many of which persist to this day. Some of my patients struggled with the routine of a daily pill, saying that their busy schedule got in the way. Others raised concerns about the stigma they felt with having to carry a bottle of pills. It was an important reminder that no single medicine will work for everyone in all circumstances. Both daily oral and long-acting prevention medicines are going to be key to helping to reduce new HIV cases in the US. It’s crucial that people have options that can help meet the unique needs of their lives.
This desire for expanding PrEP options served as an important motivating factor to my participation as an investigator in the clinical trials of long-acting cabotegravir for PrEP. APRETUDE (cabotegravir), which was approved by the FDA last year, is the first and only long-acting injectable PrEP option indicated to reduce the risk of sexually acquired HIV-1 infection in at-risk adults and adolescents weighing at least 35 kg. Individuals must have a negative HIV-1 test prior to initiation (with or without an oral lead-in with oral cabotegravir). It is given as few as six times per year (after the two initiation injection doses given consecutively one month apart), in comparison to the 365 days of administration of oral PrEP. With the availability of APRETUDE as an every-two-month injection, people have an additional important PrEP option. Having multiple PrEP options allows patients and their providers to choose the approach that is best for their lives.
It’s important to know that APRETUDE has a Boxed Warning for the risk of drug resistance with the use of APRETUDE for HIV-1 PrEP in undiagnosed HIV-1 infection. Individuals must be tested for HIV-1 infection prior to initiating APRETUDE or oral cabotegravir, and with each subsequent injection of APRETUDE, using a test approved or cleared by the FDA for the diagnosis of acute or primary HIV-1 infection. Drug-resistant HIV-1 variants have been identified with the use of APRETUDE for HIV-1 PrEP by individuals with undiagnosed HIV-1 infection. APRETUDE should not be initiated unless negative HIV-1 infection status is confirmed. Individuals who become infected with HIV-1 while receiving APRETUDE for PrEP must transition to a complete HIV-1 treatment regimen.
APRETUDE is contraindicated in people with unknown or positive HIV-1 status as well as people who have had a previous hypersensitivity reaction to cabotegravir. Use of APRETUDE is also contraindicated in people receiving certain medicines that may significantly decrease plasma concentrations of cabotegravir. The full Important Safety Information for APRETUDE can be found below for further details.
To learn more about APRETUDE, visit APRETUDEHCP.com.
2. Meet people where they are
In Alabama, the majority of new HIV cases are identified in Black individuals, yet our PrEP clinic served only a modest number of Black clients.3 Despite shouldering the burden of the US HIV epidemic (Black and Latinx Americans represent 74% of new HIV cases), these groups have not shared in the uptake of PrEP (69% of PrEP users are white, 13% Latinx, and 11% Black).4,1 These issues extend to women as well, with providers failing to routinely discuss HIV risk and prevention with female patients.5 Recent reports indicate that only 20-30% of women are even aware of PrEP.6 If we are to truly make progress in addressing HIV, it’s essential that our efforts include all of the communities at risk for HIV. As healthcare professionals, we must make it a priority to connect these communities to PrEP by meeting them where they are, with information and choices to fit their lives.
During our study of APRETUDE, we purposefully took a multipronged effort to ensure communities that were disproportionately impacted by HIV would be included in research.4 This included using on-the-ground outreach, community events, and influencers. Many of our study participants, especially those within Black and transgender communities, felt empowered by participating in a clinical trial that was representative of themselves. Today, these trials are regarded as some of the most diverse and comprehensive HIV prevention trial programs to date.7 These types of targeted efforts, which purposefully reach communities with a high incidence of HIV, will be necessary to ensure PrEP reaches those who need it most in the coming decade.
3. Destigmatize sexual health
In addition to bringing PrEP to communities with a high need for HIV prevention services, healthcare providers play a pivotal role in reducing the taboo of talking about sex with our patients. Discomfort with frank conversations about sex only creates more barriers to PrEP — it’s time we break them down. Sex is a natural part of life, and without it, none of us would be here! We have a responsibility to educate our patients about sexual health, and as HCPs, we should take the first step. Instead of feeling uncomfortable about sex, let’s be open and discuss it with our patients. Honest dialogue can build connections, shed light on important health issues, and provide more patients safe spaces for comprehensive medical care.
To the next decade
We’ve reached a key transition in the US HIV epidemic. What we do now will determine the course of the next decade and whether we can truly capitalize on the potential of highly effective HIV prevention medications. With APRETUDE offering administration as an every-other-month injection, HCPs have the first-ever opportunity to offer choices in the route of administration for PrEP. We must commit to having open and honest conversations with all our patients about their sexual health, diversifying our clinic programs, and dismantling the barriers that make it hard for people to get access to these medicines.
APRETUDE (cabotegravir) 200 mg/mL extended-release injectable suspension
APRETUDE is indicated in at-risk adults and adolescents weighing at least 35 kg for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection. Individuals must have a negative HIV-1 test prior to initiating APRETUDE (with or without an oral lead-in with oral cabotegravir) for HIV-1 PrEP.
IMPORTANT SAFETY INFORMATION
BOXED WARNING: RISK OF DRUG RESISTANCE WITH USE OF APRETUDE FOR HIV-1 PRE-EXPOSURE PROPHYLAXIS (PrEP) IN UNDIAGNOSED EARLY HIV-1 INFECTION
Individuals must be tested for HIV-1 infection prior to initiating APRETUDE or oral cabotegravir, and with each subsequent injection of APRETUDE, using a test approved or cleared by the FDA for the diagnosis of acute or primary HIV-1 infection. Drug-resistant HIV-1 variants have been identified with use of APRETUDE by individuals with undiagnosed HIV-1 infection. Do not initiate APRETUDE for HIV-1 PrEP unless negative infection status is confirmed. Individuals who become infected with HIV-1 while receiving APRETUDE for PrEP must transition to a complete HIV-1 treatment regimen.
- Do not use APRETUDE in individuals:
- with unknown or positive HIV-1 status
- with previous hypersensitivity reaction to cabotegravir
- receiving carbamazepine, oxcarbazepine, phenobarbital, phenytoin, rifampin, and rifapentine
WARNINGS AND PRECAUTIONS
Comprehensive Management to Reduce the Risk of HIV-1 Infection:
- Use APRETUDE as part of a comprehensive prevention strategy, including adherence to the administration schedule and safer sex practices, including condoms, to reduce the risk of sexually transmitted infections (STIs). APRETUDE is not always effective in preventing HIV-1 acquisition. Risk for HIV-1 acquisition includes, but is not limited to, condomless sex, past or current STIs, self-identified HIV risk, having sexual partners of unknown HIV-1 viremic status, or sexual activity in a high prevalence area or network. Inform, counsel, and support individuals on the use of other prevention measures (e.g., consistent and correct condom use; knowledge of partner[s] HIV-1 status, including viral suppression status; regular testing for STIs)
- Use APRETUDE only in individuals confirmed to be HIV-1 negative. HIV-1 resistance substitutions may emerge in individuals with undiagnosed HIV-1 infection who are taking only APRETUDE, because APRETUDE alone does not constitute a complete regimen for HIV-1 treatment. Prior to initiating APRETUDE, ask seronegative individuals about recent (in past month) potential exposure events and evaluate for current or recent signs or symptoms consistent with acute HIV-1 infection (e.g., fever, fatigue, myalgia, skin rash). If recent (<1 month) exposures to HIV-1 are suspected or clinical symptoms consistent with acute HIV-1 infection are present, use a test approved or cleared by the FDA as an aid in the diagnosis of acute HIV-1 infection
- When using APRETUDE, HIV-1 testing should be repeated prior to each injection and upon diagnosis of any other STIs
- Additional HIV testing to determine HIV status is needed if an HIV-1 test indicates possible HIV-1 infection or if symptoms consistent with acute HIV-1 infection develop following an exposure event. If HIV-1 infection is confirmed, then transition the individual to a complete HIV-1 treatment
- Counsel HIV-1 uninfected individuals to strictly adhere to the recommended dosing and testing schedule for APRETUDE
Potential Risk of Resistance with APRETUDE:
- There is a potential risk of developing resistance to APRETUDE if an individual acquires HIV-1 either before, while taking, or following discontinuation of APRETUDE. To minimize this risk, it is essential to clinically reassess individuals for risk of HIV-1 acquisition and to test before each injection to confirm HIV-1–negative status. Individuals who are confirmed to have HIV-1 infection must transition to a complete HIV-1 treatment. If individuals at continuing risk of HIV-1 acquisition discontinue APRETUDE, alternative forms of PrEP should be considered and initiated within 2 months of the final injection of APRETUDE
Long-Acting Properties and Potential Associated Risks with APRETUDE:
- Residual concentrations of cabotegravir may remain in the systemic circulation of individuals for prolonged periods (up to 12 months or longer). Take the prolonged-release characteristics of cabotegravir into consideration and carefully select individuals who agree to the required every-2-month injection dosing schedule because non-adherence or missed doses could lead to HIV-1 acquisition and development of resistance
- Serious or severe hypersensitivity reactions have been reported in association with other integrase inhibitors and could occur with APRETUDE
- Discontinue APRETUDE immediately if signs or symptoms of hypersensitivity reactions develop. Clinical status, including liver transaminases, should be monitored and appropriate therapy initiated
- Hepatotoxicity has been reported in a limited number of individuals receiving cabotegravir with or without known pre-existing hepatic disease or identifiable risk factors
- Clinical and laboratory monitoring should be considered and APRETUDE should be discontinued if hepatotoxicity is suspected and individuals managed as clinically indicated
- Depressive disorders (including depression, depressed mood, major depression, persistent depressive disorder, suicidal ideation or attempt) have been reported with APRETUDE
- Promptly evaluate patients with depressive symptoms
Risk of Reduced Drug Concentration of APRETUDE Due to Drug Interactions:
- The concomitant use of APRETUDE and other drugs may result in reduced drug concentration of APRETUDE
- Refer to the full Prescribing Information for steps to prevent or manage these possible and known significant drug interactions, including dosing recommendations. Consider the potential for drug interactions prior to and during use of, and after discontinuation of APRETUDE; review concomitant medications during use of APRETUDE
The most common adverse reactions (incidence ≥1%, all grades) with APRETUDE were injection site reactions, diarrhea, headache, pyrexia, fatigue, sleep disorders, nausea, dizziness, flatulence, abdominal pain, vomiting, myalgia, rash, decreased appetite, somnolence, back pain, and upper respiratory tract infection.
- Refer to the full Prescribing Information for important drug interactions with APRETUDE
- Drugs that induce UGT1A1 may significantly decrease the plasma concentrations of cabotegravir
USE IN SPECIFIC POPULATIONS
- Lactation: Assess the benefit-risk of using APRETUDE to the infant while breastfeeding due to the potential for adverse reactions and residual concentrations in the systemic circulation for up to 12 months or longer after discontinuation
- Pediatrics: Not recommended in individuals weighing less than 35 kg
Please see full Prescribing Information, including Boxed Warning, for APRETUDE.
Trademarks are owned by or licensed to the ViiV Healthcare group of companies.
©2022 ViiV Healthcare or licensor.
CBTOGM220092 October 2022
Produced in USA.
1 Huang Y-lin A, Zhu W, Smith DK, Harris N, Hoover KW. HIV preexposure prophylaxis, by race and ethnicity — United States, 2014–2016. CDC MMWR Morbidity and Mortality Weekly Report. 2018;67(41):1147-1150. doi:10.15585/mmwr.mm6741a3
2 Sullivan P, et al. Trends in PrEP inequity by race and census region. AIDS 2022 Conference Programme. https://programme.aids2022.org/Abstract/Abstract/?abstractid=12943. Accessed August 23, 2022.
3 Alabama Department of Public Health (ADPH). Brief Facts on African-Americans and HIV in Alabama. https://www.alabamapublichealth.gov/hiv/assets/brieffactsonafricanamericansandhiv.pdf. Published February 5, 2019. Accessed August 23, 2022.
4 U.S. Statistics – Fast Facts. HIV.gov. https://www.hiv.gov/hiv-basics/overview/data-and-trends/statistics. Accessed September 20, 2021.
5 Hirschhorn LR, et al. Black Cisgender Women’s PrEP Knowledge, Attitudes, Preferences, and Experience in Chicago. J Acquir Immune Defic Syndr. August 15, 2020;84(5): 497-507. doi: 10.1097/QAI.0000000000002377.
6 Zhang C, et al. Suboptimal HIV Pre-exposure Prophylaxis Awareness and Willingness to Use Among Women Who Use Drugs in the United States: A Systematic Review and Meta-analysis. AIDS Behav. October 2019; 23(10):2641-2653. doi: 10.1007/s10461-019-02573-x.
7 Data on file, ViiV Healthcare.