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Peers and Perspectives

1rem

, where we delve into some of the social factors that create and widen healthcare disparities.

This Pride month, Contagion Community is highlighting the healthcare needs and disparities unique to the LQBTQ+ community. Joining us for June’s podcast are Steven Wolfe, DO, MPH, and Stuart A Fisk, CRNP, of the Allegheny Health Network (AHN).

Fisk and Wolfe work with LGBTQ people who are living with 

. In this episode, they delve into the intersectionality of the disease, emphasizing that HIV prevention and treatment is especially needed for transgender people of color.

Wolfe and Fisk both identify as gay men, and thus have a personal as well as professional stake in ensuring LGBTQ+ people have access to comprehensive healthcare.

“We need more physicians, like myself, out there who really understand what the community’s needs are,” Wolfe said.

Asked about the current state of the HIV epidemic, Wolfe said, “62% of people who are trans and Black have HIV…I think we’re going in the right direction, but I think that we need a lot more work when we’re thinking about the minority populations.”

Fisk added that 25-30% of people newly diagnosed with HIV are being diagnosed at the end stages of the disease. “We do not test people routinely for HIV,” he said. “To have the biomedical ability to end a pandemic as tragic as this one, and not do it because we’re failing to give people a $2 test, is really a bad thing.”

 is another HIV preventative measure that is vastly underutilized. Wolfe cited study data suggesting 96% of transgender women were aware of PrEP, “but the reality of it is only 32% of transgender women were actually using PrEP to prevent HIV. That’s a huge gap.”

Fisk pointed out that similar disparities exist for injection drug users, who are at high risk of getting HIV but are “rarely if ever” offered PrEP. “People of color in general who have risk of HIV acquisition are typically not being offered PrEP or do not take PrEP.”

“The problem is that HIV carries the stigma of the populations that it most impacts,” Fisk said, noting that our society’s criminalization of queerness, homelessness, and injection drug usage exacerbates HIV disease disparities. “The HIV pandemic has always been as much a social and political pandemic as it’s been a medical pandemic. Until we deal with those political and social issues that create risk, we will not see the end to this pandemic.”

Fisk has been working with marginalized people since the beginning of his nursing career, which he says has helped him become a better healthcare provider and a better human.

Wolfe noted that caring for people living with HIV is often not only about providing healthcare, but also mitigating the stigma these patients may have experienced throughout their lives. “The HIV pandemic has always been as much a social and political pandemic as it’s been a medical pandemic. Until we deal with those political and social issues that create risk, we will not see the end to this pandemic.”

The experts emphasized that HIV and LGBTQ+ healthcare should not be seen as specialized care. “This is care that should be integrated with regular primary care,” Fisk said, with Wolfe adding, “A transgender person should not have to go to an endocrinologist to get their hormones.”

Allegheny Health Network’s Positive Health Clinic has 3 different locations in the Pittsburgh area of western Pennsylvania. You can find out more by calling 

Missed Episode 4 of Contagion Community? 

Listen in on the conversation and feel free to offer your feedback on this episode, interest in participating in the podcast, or suggest ideas for future episodes. Please email your correspondence to Nina Cosdon: 

Joined by Steven Wolfe, DO, MPH, and Stuart A Fisk, CRNP, of the Allegheny Health Network, we discuss the populations most at risk of HIV infection, as well as advice for making healthcare spaces more inclusive and accessible for LGBTQ+ people.

"A Social and Political Pandemic”: HIV Disparities in LGBTQ+ People

Traditional healthcare systems can be inhospitable to people who use drugs. The Montefiore-NYHRE Clinic is an alternative academic medical center that promotes the holistic health and dignity of marginalized people who use drugs.

Today, associate editor Nina Cosdon interviews Brianna Norton, DO, MPH, an assistant professor in the Montefiore Einstein Department of Medicine (General Internal Medicine) and the medical director of New York Harm Reduction Editors (NYHRE).

Norton founded the Montefiore-NYHRE Clinic, which cares for people struggling with substance use disorders.

Norton describes NYHRE as “a drop-in center, a syringe service program, and an overdose prevention center.” The clinic is located in East Harlem, but also has vans throughout the Bronx. “We reduced the barriers to access to healthcare by embedding a clinic within the community-based organization,” Norton explained.

“The focus,” Norton says, “is on the dignity and health of people who use drugs and sex workers.” NYHRE serves patients who are typically marginalized by society, and even by healthcare workers, with the goal of giving them a safe space to get the care they need from physicians they can feel comfortable trusting.

Norton said that some of the barriers her patients face are logistical, and stem from 

. Many normalcies of traditional American healthcare systems, like strict appointment times or copays, are impenetrable for marginalized populations. Norton says, “On top of the social determinants of health, there is a tremendous amount of stigma in the traditional healthcare system when it comes to people who use drugs.”

The Montefiore-NYHRE Clinic seeks to alleviate some of these challenges by seeing their patients as equal human beings, as people not defined by their substance use. “There’s this stigma that if you’re using drugs, you don’t care about your whole body,” Norton said, “and it’s just not true.”

“If you combine syringe service programs with substance use disorder treatment, which is what we’re doing, you can actually reduce HIV and Hep C by two-thirds.”

Norton also discussed the importance of addressing the reason the patient came into the office, rather than focusing on getting the person to stop using drugs. The Montefiore-NYHRE Clinic focuses on keeping people safe until they are ready to enter substance use disorder treatment. Norton emphasized, “I always say, you cannot get someone into treatment if they are not alive.”

“The whole philosophy of Osteopathic Medicine is seeing the patient as a whole, rather than in individual parts…It’s an asset in my practice today, because I’m open to a spectrum of treatments.”

Some of the specialized services the clinic provides are pre-exposure prophylaxis (PrEP), post-exposure prophylaxis (PEP), and HepC, HIV, and opioid use treatment.

The long-term goal is to offer wholistic care that makes patients feel safe seeing and trusting a doctor, so that as they age and require medical attention beyond what the clinic can provide, they will feel comfortable navigating traditional healthcare systems.

“What we’re saying is if you’re currently not going to stop using drugs at this very moment, let’s just give you the tools to use in a way that is safer, than can reduce harm…This is not a new concept, it’s just that people stigmatize the concept when it’s related to drug use.”

Missed Episode 2 of Contagion Community? 

People who use drugs face obstacles, like homelessness and stigma, that hinder their access to healthcare. Dr. Brianna Norton opened the Montefiore-NYHRE Clinic, a first-of its kind academic medical center, to serve marginalized people holistically and respectfully. 

“We Treat People With Dignity”: An Alternative Healthcare Clinic for People Who Use Drugs

New findings explore how HSV-1 infection influences tau phosphorylation via the cGAS-STING-TBK1 pathway, offering potential therapeutic avenues for Alzheimer's treatment.

Herpes Virus Contribution to Alzheimer’s 

In a retrospective cohort study, a health system found this form of prophylaxis led to substantial reductions in 2 of 3 sexually transmitted infections (STIs) in a mostly male population.

Doxycycline Postexposure Prophylaxis Prevents STIs Amongst Those Using HIV PrEP

During its 2 phase 3 clinical trials, the twice-yearly prophylaxis injection was found to be highly efficacious in preventing infection. 

Gilead Submits FDA New Drug Application for Lenacapavir for HIV Prevention

Sexual transmission was confirmed for nine of the 22 viruses studied, including Ebola, Zika, and mpox, making it a key factor in ongoing disease spread.

Viral Persistence in Semen and Its Implications for Disease Transmission

This comes after Japan recently announced it will donate over 3 million doses of the mpox vaccine, LC16m8 to a country in Africa.

World Health Organization Adds New Mpox Vaccine to Emergency Use Listing

The Gilead capsid inhibitor has been shown to have less adverse events compared to another PrEP, and the company plans to begin regulatory filings for approval before the end of this year.

Further Data Finds Lenacapavir to Be Safe and Tolerable for PrEP Use 

Gilead announced that its twice-yearly injectable HIV capsid inhibitor, lenacapavir, was found to be safe and tolerable for participants in a PrEP study.

Findings from the ongoing PURPOSE 2 trial demonstrated no significant or new safety concerns identified, and lenacapavir was generally well-tolerated. Aside from injection site reactions (ISRs), the most common adverse events (AEs) observed were rectal chlamydia infection (lenacapavir: 13.2%; emtricitabine and tenofovir disoproxil (Truvada): 11.8%), oropharyngeal gonococcal infection (lenacapavir: 13.0%; Truvada: 10.9%) and rectal gonococcal infection (lenacapavir: 10.7%; Truvada: 9.1%).

, Jared Baeten, MD, PhD, is the senior vice president of clinical development and virology discusses how lenacapavir could influence HIV prevention guidelines and improve accessibility, particularly for those who prefer infrequent dosing.

For HIV prevention, we need options that can fit really well into people's lives and will operate across all of that multifaceted diversity, because new HIV infections are occurring around the world in many different contexts. The Purpose results are the basis of multiple regulatory filings all around the world. We’re working to kick off those filings by the end of this year and beyond," Baeten said.


PURPOSE 2 is a phase 3, double-blind, multicenter, randomized study evaluating the safety and efficacy of twice-yearly subcutaneous lenacapavir for PrEP vs bHIV and once-daily oral Truvada in 3,273 cisgender gay, bisexual, and other men, transgender women, transgender men, and gender nonbinary individuals aged 16 years or older who have sex with partners assigned male at birth. The trial spanned 88 sites in Argentina, Brazil, Mexico, Peru, South Africa, Thailand and the United States and participants were randomized in a 2:1 ratio to lenacapavir and Truvada, respectively. Because effective PrEP options already exist, there is broad consensus in the PrEP field that a placebo group would be unethical; thus, the trial used bHIV as the primary comparator and Truvada as a secondary comparator.

Serious AEs were reported in 3.3% of participants in the lenacapavir group, compared to 4.0% in the Truvada group. Frequency of AEs was consistent between study groups.

“These data reinforce that twice-yearly lenacapavir could be a highly effective and potentially game-changing HIV prevention choice that we have long hoped for in our efforts to end the HIV epidemic,” said Colleen Kelley, MD, MPH, Professor of Medicine at Emory University and a PURPOSE 2 Principal Investigator. “PURPOSE 2 was intentionally designed to reflect the lives and locations of many people who are disproportionately affected by HIV around the world by focusing on gender, racial, ethnic and geographic diversity.”

Lenacapavir is injected into the subcutaneous layer of fat in the abdomen to form a drug depot, which should get smaller and resolve, or reduce in size substantially, prior to the next lenacapavir injection. The drug depot may be palpable as a bump or nodule but is usually not visible. A total of 15,239 lenacapavir and placebo injections were administered during the trial. The most commonly reported ISRs were subcutaneous nodules (lenacapavir: 63.4%; placebo: 39.2%), injection site pain (lenacapavir: 56.4%; placebo: 53.4%) and erythema (lenacapavir: 17.3%; placebo: 19.4%). Twenty-nine people (<1%) across both groups discontinued due to ISRs. ISR incidence, including nodules, decreased with subsequent injections.

 last month that lenacapavir was more efficacious in preventing HIV infection than a daily PrEP pill, emtricitabine and tenofovir disoproxil.

Early data was shared from the PURPOSE 2 phase 3 clinical trial. The investigators reported there were 2 confirmed cases of HIV among 2,180 participants in the lenacapavir group (incidence 0.10 per 100 person-years); thus demonstrating a 99.9% prevention rate amongst participants. The results demonstrated superiority of twice-yearly lenacapavir over bHIV (incidence 2.37 per 100 person-years), with 96% relative risk reduction (incidence rate ratio 0.04, p<0.0001). 

There were 9 incident cases among 1,087 individuals in the Truvada group (incidence 0.93 per 100 person-years). Twice-yearly lenacapavir was 89% more effective than once-daily emtricitabine and tenofovir disoproxil (incidence rate ratio 0.11, p=0.00245).

Lenacapavir’s Access to Low and Middle Income Countries

Last week, Gilead announced that it had signed non-exclusive, royalty-free voluntary licensing agreements with 6 pharmaceutical companies to manufacture and supply high-quality, low-cost versions of lenacapavir for 120 primarily low and middle income countries, and is working on a strategy for broad, global access to lenacapavir for PrEP, if approved.

Based on the data from this trial and the Purpose 1 study, the company said it also plans to begin filing for regulatory approvals this year.
"Filings may have to involve approvals in the hands of regulators who are excited to interface on those approvals. If they happen, they are just one step toward what needs to occur, which is accessibility and equitable accessibility for people all around the world. Because we at Gilead, I think we share this with stakeholders and colleagues everywhere, would like nothing more than to end new infections for HIV, to end this epidemic everywhere, for everyone."


References
1. Gilead Presents Additional Efficacy, Safety and Demographic Data From PURPOSE 2 Trial at 5th HIV Research for Prevention Conference. Gilead press release. October 7, 2024. Accessed October 7, 2024.


https://www.gilead.com/news/news-details/2024/gilead-presents-additional-efficacy-safety-and-demographic-data-from-purpose-2-trial-at-5th-hiv-research-for-prevention-conference


2. Gilead’s Twice-Yearly Lenacapavir for HIV Prevention Reduced HIV Infections by 96% and Demonstrated Superiority to Daily Truvada® in Second Pivotal Phase 3 Trial. Gilead press release. September 12, 2024. Accessed September 12, 2024.


https://www.gilead.com/news-and-press/press-room/press-releases/2024/9/gileads-twiceyearly-lenacapavir-for-hiv-prevention-reduced-hiv-infections-by-96-and-demonstrated-superiority-to-daily-truvada-in-second-pivotal-ph


3. Gilead Signs Royalty-Free Voluntary Licensing Agreements with Six Generic Manufacturers to Increase Access to Lenacapavir for HIV Prevention in High-Incidence, Resource-Limited Countries. Gilead press release. September 12, 2024. Accessed September 12, 2024. October 2, 2024. Accessed October 7, 2024.



The therapy, lenacapavir, showed sustained virological suppression and safety over a 2-year period in this treatment-challenged patient population. 

Examining a Newer Combination Therapy for Heavily Treated HIV Patients

People with multi-drug resistant (MDR) HIV have limited antiretroviral therapy (ART) options, which can leave their disease management very challenging.

“The patients who meet this definition tend to be very well known to us,” Onyema Ogbuagu, MBBCh, FACP, FIDSA, director of HIV Clinical Trials program at Yale School of Medicine, said. “I provide HIV care, and we all know many of these patients tend to be people who have long [been] in HIV care—it is typically not the newly infected.”

He says that these patients may have been diagnosed with HIV as children and now are adults or maybe they are older adults who had HIV for decades, and their ART regimens are less effective in keeping their HIV viral loads suppressed.

“Someone gave a talk today at CROI, [and the person] said that people don't fail drugs, but drugs fail people,” Ogbuagu said.

It is within this context, that treatment for these patients with multidrug resistance need an additional therapy to keep their viral loads down and prevent them from becoming vulnerable to other opportunistic infections.

There is a newer therapy, lenacapavir (Sunlenca), which has shown some promising data in addressing MDR HIV and as a potential complement to existing ART regimen in these aforementioned patients. Lenacapavir is a first-in-class, investigational long-acting HIV capsid that was 

 in late 2022 and is indicated for adult patients living with HIV, whose infections cannot be successfully treated with other available treatments due to resistance, intolerance, or safety consideration.

Lenacapavir is manufactured by Gilead, and at this week’s 

Conference on Retroviruses and Opportunistic Infections (CROI)

 in Denver, CO, new data was presented that demonstrated treatment benefits over a 2-year periodfrom the phase 2/3 CAPELLA trial evaluating the lenacapavir. Ogbuagu was at CROI, and is a principal investigator on the trial. 

CAPELLA is a double-blinded, placebo-controlled global multicenter study designed to evaluate the antiviral activity of lenacapavir when administered every 6 months as a subcutaneous injection in heavily treatment-experienced (HTE) people with MDR HIV infection. The eligible participants had resistance to ≥2 ARVs in ≥3 of the 4 main ARV classes (NRTI, NNRTI, PI, INSTI).

The optimized background regimen (OBR) participants were selected by individual clinicians, and other investigational drugs were permitted for the study.

The investigators wrote that the OBR overall susceptibility score was the sum of susceptibility scores for each OBR ARV; 0 (no susceptibility), 0.5 (partial susceptibility) and 1 (full susceptibility) and efficacy was assessed at Weeks 26, 52, and 104. Lenacapavir and OBR ARV resistance analyses were done at virologic failure (virologic rebound ≥50 copies/mL or <1 log10 decline vs baseline).

There were 72 patients enrolled, and of them, 12 (17%) had no fully active antiretrovirals in their OBR; 6 of 12 and 1 of 12 had 1 or 2 partially active (score 0.5 each) ARVs, respectively. The investigators report the median (range) number of OBR ARVs was 4 (2–6). Overall, OBR comprised NRTI (9 participants), INSTI (8), PI (7) or NNRTI (6); 5, 2, and 2 participants were on a CD4 post-attachment inhibitor (ibalizumab), CCR5 inhibitor (maraviroc), or attachment inhibitor (fostemsavir), respectively.

The trial was conducted over a 2-year period, and Ogbuagu says this was about looking at the modality of subcutaneous injections as it related to safety, but also the long-term efficacy of the therapy.

“We found even as far out as two years or the so called 104 [week] data, that about 82% of individuals—when we excluded those who are missing— were virologically suppressed…that's unheard of numbers for this kind of patient population,” Ogbuagu said. “We have other studies with other agents that have shown lower rates of treatment success with these kinds of patients.”

spoke to Ogbuagu during CROI about lenacapavir's mechanism of action, more insights around the CAPELLA study, and the value he sees in the addition of this HIV therapy.

Ogbuagu O, Ratanasuwan W, Avihingsanon A, et al. Lenacapavir Efficacy IN CAPELLA Patients With No Fully Active Agents In Optimized Background Regimen. Poster #630 presented at CROI 2024. March 3-6, 2023. Denver, CO.

Conferences

Examining a Newer Therapy for Heavily Treated HIV Patients

June 27 commemorates National HIV Testing Day, a day that encourages everyone to get tested for 

, know their status, and take the appropriate next steps.

 about everything from who should be tested for HIV to the obstacles hindering HIV eradication.

Belkind is the associate medical director of adolescent medicine at Callen-Lorde Community Health Center and is the clinical director of Health Outreach to Teens (HOTT), a health organization that primarily serves LGBTQ+ youth. Belkind is also a member of the National Hispanic Medical Association, American Academy of HIV Medicine, and the World Professional Association for Transgender Health.

“It’s really important for everybody to know their status,” says Belkind, “Approximately 16% of people that are living with HIV don’t know that they have it.” Historically underrepresented minorities average a higher rate of both HIV infections and unknown HIV infections. Belkind specifically noted that for the Hispanic/Latinx community, the risk of HIV is 3.5-4 times higher than for White people.

“The importance of testing is for us to find those people that are living with HIV before they get sick,” Belkind said. He pointed out that HIV testing is different from screening for other diseases, such as cancer, because identifying and treating people living with HIV is also the best way to prevent HIV infection.

We commonly hear “undetectable equals untransmissible,” or “U=U,” and this understanding of HIV is invaluable. People who test negative for HIV can have the assurance of knowing their status, while also discussing potential preventative options, such as 

“Regular HIV testing is an essential component for the sexual health for everyone,” says Belkind, “and this is regardless of sexual orientation, or race, or gender.” He pointed out that the US Centers for Disease Control and Prevention (CDC) recommends everyone over the age of 13 be tested at least once.

That being said, certain individuals are at an inherently higher risk of contracting HIV, such as people who use intravenous drugs, people who participate in sex work, or men who have sex with men. Getting tested once in a lifetime does not eradicate the risk of HIV infection, and Belkind says people who are sexually active may want to incorporate HIV testing into routine health. These tests can be given by a primary care provider, or even bought over the counter to be taken at home.

The stigma that lingers around HIV has been “the biggest challenge,” says Belkind. “It’s HIV stigma, it’s 

 stigma, really.” Belkind pointed out there is an erroneous belief that a person who has HIV or even gets tested for HIV “did something wrong.” The best way to strip HIV of this dangerous stigma is for everyone to get tested, Belkind says, “If everybody gets tested, then nobody is singled out for being tested.”

HIV testing is for everyone, explains Dr. Uri Belkind, regardless of sexual orientation, race, or gender. 

Contagion Community

National HIV Testing Day: Empowering Everyone to Know Their Status and End the Stigma

Yasaswi Kislovskiy, MD, MSc was first drawn to obstetrics and gynecology out of a “real desire to work on gender equity and to reduce marginalization that communities experience all the time.”

“Reproductive infectious disease was a fantastic opportunity,” Kislovskiy said, explaining that the specialty combines public health, infectious disease, and antimicrobial stewardship, “and thinks about those issues from the lens of gender equity.”

Even today, women, pregnant people, and people with a uterus are excluded from health care considerations. Kislovskiy and her team at Allegheny Health Network advocate for people who experience marginalization, working to mitigate health disparities, especially related to 

“Historically, pregnant people have been excluded from major trials,” said Kislovskiy. “What we absolutely should do is study infections as they impact pregnant people and the baby, and ideally help reduce the complications that might happen.”

Kislovskiy emphasized that for people with a baby on the way, what should be an exciting time can be dampened by concerns over reproductive infectious disease.

“It can be a challenging and confusing time to deal with an infection while you’re also pregnant,” Kislovskiy said. “I think finding a healthcare provider that you feel like you can trust and help you navigate the data to help you make a decision that’s right for you is also really, really, important. Because there are a lot of therapies and tools out there to help you overcome whatever you’re experiencing.”

Yasaswi Kislovskiy, MD MSc, is a board-certified OB/Gyn. She is also certified with the American Academy of HIV Medicine and completed a fellowship in Reproductive Infectious Disease. Kislovskiy works with the 

 to care for people living with HIV, peripartum challenges, and severe gynecologic infections.

Yasaswi Kislovskiy, MD, MSc, specialized in reproductive infectious disease to advocate for gender equity in health care.

Reproductive Infectious Disease Spotlights Gender Inequity in Health Care 


This year marks the 10 year anniversary since the FDA approved emtricitabine-tenofovir (Truvada) for 

 thus sparking the beginning of a daily pill designed to prevent new HIV infections. This was seen as a breakthrough for trying to stem the tide of new infections.

PrEP continues to be a highly efficacious treatment strategy in HIV prevention. According to the Centers for Disease Control and Prevention (CDC), PrEP reduces the risk of getting HIV from sex by about 99% when taken as prescribed.

“All of us who have been doing this for so long were able to exhale a little bit as a way to get ahead of this pandemic, because we have not gotten far enough with the vaccine,” Emily Rymland, DNP FNP-C, AAHIVS-certified HIV specialist and director of Clinical Services at 

, said of the introduction of PrEP. “This is our alternative to a vaccine, which has been super exciting and wonderful.”

Along with the intended HIV prophylaxis element, PrEP may offer other peripheral benefits. The results from 

Taking into account the first PrEP pill was FDA approved in 2012, a clinician reflects on its significance and where the shortcomings of education and utility of it needs to be fortified.

Sexually Transmitted Diseases

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