Prioritizing Culturally Competent Care, Advocacy, and Access in HIV

Editors note: This article was originally published on October 22, 2022. This version has been expanded and was republished as the cover story of the February 2023 issue of Drug Topics.

When asked about the “hot” topics in HIV this year, Marwan Haddad, MD, MPH, medical director of the Center for Key Populations at Community Health Center Inc in Middletown, Connecticut, turned not only toward what was new in HIV medicine, “but also [to] what fires we as a medical community needed to put out.”

During a symposium on HIV clinical science¹ presented at IDWeek 2022, held October 19-23, 2022, in Washington, DC, Haddad focused on 2 of the 4 pillars of the federal Ending the HIV Epidemic Initiative: treatment to reach sustained viral suppression, and prevention, including pre-exposure prophylaxis (PrEP) and syringe services programs.

“To truly end HIV as an epidemic…we must examine the context in which we as medical and public health communities are trying to implement these initiatives,” Haddad explained. In a study published earlier this year—on which Haddad was one of the authors—investigators outlined 10 principles for expanding and improving health care access and delivery in order for health care providers to “truly be able to end the HIV epidemic.”

These principles include ensuring access to health care for all—including care for those with mental health and substance use disorders—addressing social determinants of health, delivering health care to patients where they are, and funding innovative care models, repealing HIV criminalization laws, and growing a diverse, culturally competent HIV workforce, among others.

Health Inequity in HIV

According to the Joint United Nations Programme on HIV and AIDS (UNAIDS), a total of 38.4 million individuals across the globe were living with HIV in 2021.² Newly diagnosed infections accounted for 1.5 million of those cases and, a recent UNAIDS report cautioned, if current trends continue, 1.2 million individuals will be newly infected with HIV in 2025, a number that is “3 times more than the 2025 target of 370,000 new infections.”³

In the United States, data from HIV.gov⁴ demonstrate that HIV disproportionately affects certain populations, namely, racial and/or ethnic minorities and gay, bisexual, and other men who have sex with men. According to Haddad, Black and Hispanic individuals accounted for 42% and 27%, respectively, of new HIV diagnoses in 2020; these same individuals account for only 14% and 17% of PrEP users, respectively. “We must not lose sight of the health inequities that have existed in the HIV epidemic, highlighted further by the COVID-19 pandemic and the monkeypox (mpox) outbreak,” Haddad said. “These inequities apply to every aspect of HIV treatment and prevention.”

And, he added, “we must continue to look at treatment, prevention, and implementation through an equity lens in order for us to begin to close these gaps in disparities.”

When evaluated by region, these data come together to paint an additional picture: The US South—a region with well-documented health disparities such as high rates of chronic disease, high maternal mortality, poor health outcomes, and other factors related to social determinants of health^5,6—accounted for 51% or 15,661 HIV diagnoses made in 2020.⁷ The real number, though, is potentially higher; the CDC noted that data from 2020 should be “interpreted with caution” because of the impact that the COVID-19 pandemic had on access to HIV testing and other care-related services.⁷

HIV in Other Contexts

For health care providers, evaluating the HIV crisis through the lens of multiple syndemics—the interaction between multiple health threats, frequently exacerbated by societal circumstances—means looking at HIV in the context of other pressing health care issues like sexually transmitted infections, the opioid epidemic and injection drug use crisis, viral hepatitis, COVID-19, and mpox. Failing to do so, Haddad said, will only lead to inadequate responses.

For example, many initial studies showed no increased risk of severe COVID-19 outcomes in people living with HIV. However, the results of a study published in September 2021 indicated that there is an increased risk for severe disease progression—even in patients with controlled HIV. Whether this is due to the presence of increased comorbidities in this patient population or due to social determinants of health, these new data have potential long-term impacts. Currently the CDC recommends a 3-dose primary COVID-19 vaccine series for people living with HIV who are not on antiretroviral therapy or who have advanced HIV; but, Haddad said, these findings raise the question of whether all people with HIV should get this 3-dose series. “The CDC recommendation for now is, not at this time,” he said.

There is also no significant research on how long COVID-19 will impact this patient population.

Mpox has also disproportionally impacted those living with HIV. A Morbidity and Mortality Weekly Report report from September 2022 indicated that 38% of nearly 2000 patients across 8 US jurisdictions were people living with HIV; 63% were Black and 41% were Hispanic, indicative of yet another health care disparity. Vaccination against mpox, Haddad added, is also critical for this population: A study out of Chicago showed that among 90 breakthrough infections, only 2 occurred 2 weeks after the second vaccine, “underscoring the importance that all our patients at risk for Monkeypox exposure get both their vaccine shots.”

“The LGBT community response to the [mpox] outbreak needs to be highlighted and commended and underscores that we must always include the voices of those affected at the tables and in the rooms where decisions are being made, period,” Haddad added.

Substance Use Disorder in the Spotlight

Substance use disorder, the opioid epidemic, and the injection drug use crisis also impact HIV care. “We will continue to see clusters and outbreaks of HIV injection secondary to injection drug use if we are not increasing access to substance use care, including mental health services and medication for opioid use disorders, like methadone, buprenorphine, and naltrexone,” Haddad said, adding that there will be increases in other infectious diseases, such as viral hepatitis and endocarditis secondary to injection drug use, if health care inequities persist. “We must provide innovative ways to provide, expand, and deliver these services, especially in rural areas,” he said. “We need everyone involved, working collaboratively, and embracing harm reduction as a model.”

Everyone, in this case, includes everyone: Primary care providers, infectious disease clinicians, and pharmacists must work together to maximize their impact in treating this crisis, according to Haddad. Since the 2015 HIV cluster in Scott County, Indiana, similar outbreaks have been identified in Massachusetts, Washington state, Kentucky, and Ohio. In West Virginia, these clusters can be traced to the closure of syringe services programs in 2018; HIV cases have been identified in 29 of 55 counties across the state, with injection drug use as the “predominant mode of transmission,” according to Haddad.

Engaging With Advocacy

Regardless of personal beliefs, Haddad implored attendees to use their voices to oppose the laws, regulations, and policies being passed that interfere with medical decision-making that should lie with patients, their families, and their health care providers. “Wherever you stand personally on these issues, we must not stand quiet,” he said. “We know that those who will be most harmed by this interference are those individuals and communities already experiencing health disparities.”

These policy decisions can be linked directly with poor health outcomes. States with the highest rates of HIV infections and lowest rates of PrEP uptake correlate directly with states that have fewer pro-LGBTQ+ policies, more anti-transgender policies and regulations against youth participation in sports, more restrictions on LGBTQ+ curriculum in schools, and more HIV criminalization laws.

“Our patients in every state are affected psychologically and emotionally by these culture wars,” said Haddad, “which will lead to increased stigma and discrimination in all states, which will result in more HIV infections, worsening mental health, higher rates of suicidal ideation, and worse health outcomes.”

New Therapies on the Horizon

Long-acting injectable medications represent a new era in HIV treatment that Haddad is optimistic about. Cabotegravir/rilpivirine (CAB/RPV), for example, is a complete injectable regimen approved in February 2022 that is administered to patients every 2 months. Additional research demonstrated that CAB/RPV can be administered without oral lead-in and 1 study evaluated whether a CAP/RPV regimen could be initiated in patients not currently virologically suppressed—important, Haddad noted, “for patients who cannot tolerate oral medications at all or who are experiencing housing instability or homelessness.”

Although this medication is promising, Haddad raised some system-level challenges associated with its use. Within his practice, Haddad and his colleagues needed to rethink their team-based approach and workflows for prescribing, procuring coverage, receiving and storing medications, training, and administering injections. “This is where some innovative methods can be adopted to increase access and address some of these issues,” he explained. “Can we look at community pharmacists administering the injections since pharmacies are usually more accessible to patients than many of our clinics, particularly in rural areas?”

In December 2022, the FDA approved lenacapavir (Sunlenca) for the treatment of HIV in heavily treatment-experienced, multidrug-resistant adults with HIV. This first-in-class treatment is administered twice yearly; its approval was described as an “important milestone” on the path to ending the HIV epidemic.⁸

Researchers are also investigating the ways in which broadly neutralizing antibodies (bNAbs) might change HIV therapy. In late October 2022, ViiV Healthcare announced positive findings from a phase 2 proof-of-concept study of N6LS (VH3810109), a novel and investigational bNAb, in adults with HIV.⁹ Results, presented at the 30th HIV Glasgow Conference in Glasgow, Scotland, showed that a single infusion of N6LS “demonstrated strong antiviral efficacy” across 2 dosing levels (40 mg/kg and ~4 mg/kg [280 mg]) while being well tolerated by study participants.⁹

HIV vaccines are also a research priority, but study results thus far have been disappointing. On January 18, 2023, Johnson & Johnson announced it would conclude the phase 3 MOSAICO clinical trial (NCT03964415) of its investigational vaccine regimen containing a mosaic-based adenovirus serotype 26 vector (Ad26.Mos4.HIV) after an independent data safety monitoring board determined that the vaccine was safe but did not provide effective protection against HIV infection.^10,11

The Future of HIV Care

Outside the treatment pipeline, what does the future of HIV and infectious disease care hold? Providers across the health care spectrum must keep their focus on COVID-19 and long COVID, including treatment and prevention in those with HIV, as well as mpox vaccinations and treatments. Scaling up treatments for opioid and substance use disorders should also be high priority, particularly in light of the consequences of injection drug use.

“We need to advocate loudly and strongly as health care professionals that we must be able to practice and treat our patients without interference from the government and the courts,” Haddad said. “We must fight stigma and discrimination and focus on health equity. We must insist that we give a seat at the table, in rooms where decisions are being made, to people whose lives are affected by these decisions.”

References

1. Haddad M. What’s hot: HIV clinical science. Presented at: IDWeek 2022; October 19-23, 2022; Washington, DC. Session 21.
2. Global HIV & AIDS statistics — fact sheet. UNAIDS. Accessed January 20, 2023. https://www.unaids.org/en/resources/fact-sheet
3. In danger: UNAIDS global AIDS update 2022. Joint United Nations Programme on HIV/AIDS. Accessed January 20, 2023. https://www.unaids.org/sites/default/files/media_asset/2022-global-aids-update-summary_en.pdf
4. U.S. statistics. HIV.gov. Updated October 27, 2022. Accessed January 20, 2023. https://www.hiv.gov/hiv-basics/overview/data-and-trends/statistics
5. Artiga S, Damico A. Health and health coverage in the South: a data update. Kaiser Family Foundation. February 10, 2016. Accessed January 20, 2023. https://www.kff.org/racial-equity-and-health-policy/issue-brief/health-and-health-coverage-in-the-south-a-data-update/
6. Miller CE, Vasan RS. The southern rural health and mortality penalty: a review of regional health inequities in the United States. Soc Sci Med. 2021;268:113443. doi:10.1016/j.socscimed.2020.113443
7. HIV in the United States by region: HIV diagnoses. CDC. Reviewed October 24, 2022. Accessed January 23, 2022. https://www.cdc.gov/hiv/statistics/overview/diagnoses.html
8. Sunlenca (lenacapavir) receives FDA approval as a first-in-class, twice-yearly treatment option for people living with multi-drug resistant HIV. News release. Gilead Sciences. December 22, 2022. Accessed January 20, 2023. https://www.gilead.com/news-and-press/press-room/press-releases/2022/12/sunlenca-lenacapavir-receives-fda-approval-as-a-firstinclass-twiceyearly-treatment-option-for-people-living-with-multidrug-resistant-hiv
9. ViiV Healthcare presents positive proof-of-concept findings for N6LS, an investigational, broadly neutralising antibody (bNAb) offering a potential new approach for the treatment of HIV. News release. ViiV Healthcare. October 25, 2022. Accessed January 20, 2023. https://www.businesswire.com/news/home/20221021005483/en/ViiV-Healthcare-presents-positive-proof-of-concept-findings-for-N6LS-an-investigational-broadly-neutralising-antibody-bNAb-offering-a-potential-new-approach-for-the-treatment-of-HIV
10. Experimental HIV vaccine regimen safe but ineffective, study finds. News release. National Institutes of Health. January 18, 2023. Accessed January 20, 2023. https://www.nih.gov/news-events/news-releases/experimental-hiv-vaccine-regimen-safe-ineffective-study-finds
11. Janssen and global partners to discontinue phase 3 Mosaico HIV vaccine clinical trial. News release. Johnson & Johnson. January 18, 2023. Accessed January 20, 2023. https://www.jnj.com/janssen-and-global-partners-to-discontinue-phase-3-mosaico-hiv-vaccine-clinical-trial