Nov 29, 2024 | Featured, HIV AIDS, Research
People with HIV are now living healthier, longer lives thanks to advances in antiretroviral therapy, but they can still have chronic diseases like diabetes and hypertension. Eventually, they might need organ replacements, like kidneys, but this group of people has been at a disadvantage.
Patients with HIV have been known to receive lower priority on waitlists given the shortage of organs and misconceptions about the patients’ ability to receive them. But what if we could increase the pool of available organs by allowing the use of organs from donors with HIV for recipients with HIV?
A new milestone was achieved in a first-of-its-kind study in the United States in which Mount Sinai was a major player. The HOPE study, published in The New England Journal of Medicine, showed that not only are kidney transplants from HIV+ donors safe and effective, they are just as much so as transplants from HIV- donors.
“It had been illegal, by federal law, to use HIV+ organs,” says Sander Florman, MD, Director of the Recanati/Miller Transplantation Institute at Mount Sinai and an author of the paper. “Prior to the HOPE Act signed by then-President Obama, organs with HIV had to be discarded. But if we can show it is safe to use organs from people with HIV, why not use them, so that HIV+ people can get transplanted quicker?”
“Eventually, the goal of this study is to move HIV-to-HIV kidney transplants out of just research and into a standard of care,” says Meenakshi Rana, MD, Associate Professor of Medicine (Infectious Diseases), Icahn School of Medicine at Mount Sinai, and an author of the paper. “This has larger implications not just for people with HIV, but for everyone who’s on a waitlist—if a person with HIV can receive an organ faster from a donor with HIV, then everyone on the list also moves up.”
Drs. Florman and Rana discuss the importance of the HOPE study, how it could destigmatize organ transplants for people with HIV, and future impacts.
What’s the history of organ transplantation for people who are HIV+?
In the past, people with HIV were considered not medically suitable for organ transplants. It was thought that the immune-suppressing drugs required to prevent organ rejection might cause the HIV to develop into AIDS, says Dr. Florman.
In the late 1990s, Mount Sinai showed that it was possible to do a living liver donation to a patient with HIV. “It was extremely controversial,” says Dr. Florman. “At the time, nobody was doing HIV transplants. And second of all, very few centers in the country were doing living-donor liver transplants.”
Sandy Florman, MD, Director of the Recanati/Miller Transplantation Institute at Mount Sinai (left) and Meenakshi Rana, MD, Associate Professor of Medicine, Infectious Diseases (right).
In regulations dating to 1988, it was made illegal to transplant or even study organs from donors with HIV. In 2013, President Obama signed the HIV Organ Policy Equity (HOPE) Act, which lifted the research ban.
On November 26, 2024, the U.S. Department of Health and Human Services announced a final rule stating kidney and liver transplants involving donors and recipients with HIV no longer need to be done under the auspices of a clinical trial. The decision was motivated by evidence from studies enabled by the HOPE Act that showed such procedures were safe and effective.
In the 2000s, Mount Sinai participated in another trial that showed it was possible to transplant kidneys from donors without HIV to recipients with HIV—a trial that was the predecessor to the HOPE study.
However, people with HIV faced more than just medical skepticism—they also faced social stigma.
Having an undetectable load, or simply being undetectable, means HIV levels in a person are so low that they cannot transmit the virus to another person sexually. This is typically achieved through antiretroviral therapy.
“Even with the advent of the medications, where your HIV can be well controlled and you could live a normal life, there is stigma among some medical professionals about getting a needlestick or getting splashed in the eye with blood,” says Dr. Florman. “The reality is that part of the criteria for doing these transplants is that the candidates need to have well-controlled HIV, even undetectable viral load. And so the risk of getting HIV from a needlestick or a splash is actually very low, although not zero.”
What were the HOPE study results?
The HOPE study transplanted 198 kidneys into recipients with HIV. Half of those kidneys were from donors with HIV and the other half from donors without. Mount Sinai was the largest enroller of the trial, transplanting 55 patients.
- There was no significant difference in outcomes between both groups, including overall survival at one year and three years, survival without graft loss at one year and three years, and rejection at one year.
- Adverse events, infections, and complications were similar between both groups, and any HIV-related infection events were able to be treated.
What impacts could this study have?
“Even though we’ve had previous findings that people with HIV could receive transplants, historically, people with HIV have had longer wait times in terms of access to an organ, and higher mortality rates,” says Dr. Rana. “So one of the huge implications of this study is that it could really reduce the wait time of access to organ transplantation for people with HIV, and that’s really important for reducing disparities in transplant.”
That goal is one step closer to becoming reality. On November 26, 2024, the U.S. Department of Health and Human Services announced a final rule stating that after a decade of studies enabled by the HOPE Act, kidney and liver transplants between donors and recipients with HIV are now permitted, and no longer have to be done as clinical trials.
This announcement will hopefully encourage organ procurement organizations (OPOs) to be more inclusive of donors with HIV. “Some OPOs have been good and pursued donors with HIV. Others have not been interested for a variety of reasons. Hopefully, as more HIV patients are able to access transplants, these OPOs would follow the demand and seek more donors with HIV,” says Dr. Florman.
Additionally, the study could expand awareness among patients with HIV and providers that access to life-saving transplantation is more a possibility than ever, says Dr. Rana.
Does this mean people with HIV should consider becoming donors?
“I would definitely want to encourage people with HIV to become donors,” says Dr. Rana. “This would help destigmatize what it means to be a person living with HIV.”
“The patients we helped transplant have always been very grateful, especially because other centers often wouldn’t offer them the procedure,” says Dr. Florman. “But I was surprised that people with HIV who don’t need transplants are grateful that they can now be organ donors. Because now they feel a sense of pride in the idea that they, too, can be organ donors and help save other lives.”
Nov 25, 2024 | Featured, Your Health
True or false: Lung cancer only affects those who have smoked a long time. The answer: False.
The actual connection between smoking and lung cancer is one of three key takeaways about lung cancer from the experts at Mount Sinai.
- Smoking is the leading cause of lung cancer, but not the only cause. Smoking is responsible for about 80 to 90 percent of lung cancer cases. But a growing number of nonsmokers are being diagnosed with lung cancer. The risk of lung cancer increases with the number of cigarettes smoked and how long someone has smoked. For non-smokers, a family history, secondhand smoke and exposure to chemicals like radon and asbestos can increase the risk of lung cancer.
- Lung cancer is the leading cause of cancer deaths. Lung cancer is the leading cause of cancer-related deaths worldwide, and is the deadliest type of cancer for both men and women.
- Early diagnosis is important. Lung cancer is often diagnosed at advanced stages, when treatment options are limited. Early diagnosis can make a big difference in survival rates.
The symptoms of lung cancer are the same whether or not you have smoked. Some people have general symptoms of not feeling well or feeling tired all the time, according to the Centers for Disease Control and Prevention. Some people cough frequently, cough up blood, or have chest pain, wheezing, or shortness of breath. These symptoms can happen with other illnesses. If you have any of these symptoms, talk to your doctor, who can help find the cause.
Here are more important updates on lung cancer prevention and treatment from the Center of Excellence for Thoracic Oncology, led by co-directors Fred R. Hirsch, MD, PhD, and Andrew J Kaufman, MD, and the entire team at Mount Sinai Health System have vast experience researching, detecting, and treating lung cancers.
These experts note a number of important developments in the field, including improved cure rates thanks to early detection of lung cancer through low-dose computed tomography (CT) scans and by raising awareness of lung cancer risk in “never smokers.” Artificial intelligence (AI) technology is helping to find lung cancer earlier and more accurately, while a recent study points to disparities in lung cancer testing.
Cure Rate From Early Detection
Research led by Claudia Henschke, MD, PhD, Professor of Diagnostic, Molecular and Interventional Radiology and Director of the Early Lung and Cardiac Action Program (ELCAP) at the Icahn School of Medicine at Mount Sinai, indicates that early detection works. In a multi-decade study (1992-2022) involving more than 31,000 people, those who detected lung cancer early through low-dose CT scans had an 81 percent survival rate after 20 years. The average five-year survival rate for all lung cancer patients is 28 percent, according to the American Cancer Society. However, only 23 percent of lung cancers are diagnosed at an early stage.
“Early detection is crucial in the fight against lung cancer,” said Dr. Henschke. “Our research shows that annual low-dose CT screening significantly increases survival rates by identifying cancers at their most treatable stages. We encourage individuals, especially those at higher risk, to take advantage of these screening opportunities.”
Lung Cancer in Never Smokers
According to the American Cancer Society, up to 20 percent of lung cancer cases occur in people who have never smoked. This fact helps us understand that lung cancer can affect anyone, not just smokers. Factors like exposure to secondhand smoke, radon, air pollution, asbestos, or a family history of lung cancer may increase your risk of lung cancer. Researchers estimate that second-hand smoke contributes to about 7,300 and radon to about 2,900 of these cases. Mount Sinai offers a program that allows individuals 40 and older to be screened even if they have little to no smoking history.
“Lung cancer is often associated with smoking, but it’s important to recognize that it can develop in people who have never smoked or have smoked very little—fewer than 100 cigarettes in their lifetime,” said Raja Flores, MD, Chair of Thoracic Surgery at the Mount Sinai Health System. “In fact, about 10-20 percent of lung cancers in the United States occur in individuals who have never smoked. Lung Cancer Awareness Month is an important time to highlight that many factors beyond smoking influence an individual’s lifetime risk for lung cancer. We need education about exposure and subsequent access to testing to improve early detection in all populations, regardless of smoking history.”
Using Artificial Intelligence (AI) in Screening
Icahn Mount Sinai is advancing the use of AI technology to find lung cancer earlier and more accurately. Recently developed by the I-ELCAP team, the Open Source Automated Image Reading System (AIRS) will analyze CT scans to spot nodules that might be missed by the human eye and assess a patient’s risk for lung cancer based on their medical history and other factors. Designed as a future “rule out” tool for annual repeat and follow-up low-dose CT scans, AIRS is expected to cut radiologists’ reading time by approximately 85 percent.
“Artificial intelligence is revolutionizing the way we approach lung cancer screening. By enhancing the analysis of CT scans, AI can help us detect growths earlier and more accurately than ever before,” said David F. Yankelevitz, MD, Director of the Lung Biopsy Service at Icahn Mount Sinai. “This technology is a tool not only to improve diagnostic precision but also to allow us to tailor screening protocols to individual patients, ultimately leading to better outcomes and survival rates.”
Disparities in Lung Cancer Testing
A recent Mount Sinai study found that people with lung cancer face significant differences in getting important tests based on their race and income. This study, led by Emanuela Taioli, MD, PhD, and her team at the Institute for Translational Epidemiology at Icahn Mount Sinai, identifies a serious concern in cancer care.
“The results of this study are important because they show that if we can fix these gaps in testing, more people will be able to get the treatments they need and improve their chances of survival,” said Dr. Taioli. “For doctors, this means they need to make sure that everyone has equal access to these important tests. For patients, especially those from lower-income or minority backgrounds, it means there’s a need for better access to treatments that can improve their health and improve their chances of survival.”
Accessing Care at Mount Sinai
Mount Sinai has broad experience with a variety of diagnostic tools and some of the most advanced treatment options in the New York City area. Here are a few of our locations across New York City and Long Island:
- Mount Sinai Brooklyn, 3201 Kings Highway, Brooklyn, NY
- Lung and Thoracic Cancer Services at The Mount Sinai Hospital, 1190 Fifth Avenue
For more information, please visit www.mountsinai.org/lungcancer
Updated on Nov 19, 2024 | Community, Diversity and Inclusion, Featured
Alexander Charney, MD, PhD
An essential part of achieving health equity is the fair collection of genomic data, ensuring that informed health care decisions can reflect the unique, diverse genomes of all cultures. Currently, there is a lack of diversity in genomic research data. This limits what we can uncover about health and potential treatments for our global population.
Expanding diversity among participants in genomic research can bridge these gaps, advancing our understanding of human genetics for all communities. One ambitious initiative that strives to diversify this data is the Mount Sinai Million Health Discoveries Program.
Mount Sinai Health System’s Health Equity Data Assessment (HEDA) team met with leaders of the program who expressed their challenge with identifying the ethnic identities of Mount Sinai patients participating in the program. HEDA was quickly able to assist in rectifying the data issue, which resulted in increasing the ethnic identities from 0.5 percent to 66 percent.
This assistance will have a significant impact on the program objectives. A hypothesis was formulated in the Measures and Outcomes section of the HEDA Hub. The HEDA team will track progress towards the program’s goal of reaching a million patients.
The Charles Bronfman Institute for Personalized Medicine at the Icahn School of Medicine at Mount Sinai leads this project and aims to sequence the genomes of one million Mount Sinai patients over the next five years. It seeks to integrate health and research data to drive discoveries that directly benefit a diverse patient population.
Lea K. Davis, PhD
Mount Sinai Million is poised to serve as a model for embedding genetics into routine clinical care. By leveraging data from one of the world’s most diverse patient populations within a massive New York City health system, this program seeks to deepen our understanding of the connections between genetics and disease.
In a recent conversation with Alexander Charney, MD, PhD, Director, The Charles Bronfman Institute for Personalized Medicine, and Associate Professor, Genetics and Genomic Sciences, Psychiatry, Neuroscience, Neurosurgery, and Artificial Intelligence and Human Health, Icahn Mount Sinai; and Lea K. Davis, PhD, Scientific Director of the Mount Sinai Million Health Discoveries Program, The Charles Bronfman Institute for Personalized Medicine, and Associate Professor of Medicine (Data-Driven and Digital Medicine), Icahn Mount Sinai, we gained further insight into this initiative.
Dr. Charney explains: “Our goal is to develop personalized treatments tailored not only to the disease but to the individual’s genetic makeup, which we know varies significantly across populations.”
“Equity is a core value of the scientific vision for the Mount Sinai Million,” says Dr. Davis. “We are thrilled to connect the program with HEDA and are looking forward to supporting equity-focused research through the development of this incredible resource.”
Reflecting on the broader impact, Dr. Charney says the initiative “isn’t just about collecting data; it’s about improving lives.” He envisions a health care system where genetic insights enable clinicians to make more informed, individualized decisions.
“With this kind of data,” he says, “we’re not just diagnosing based on symptoms—we’re diagnosing based on a person’s unique genetic and biological profile, which could mean a huge leap in effectiveness.”
With this forward-thinking approach, Dr. Charney and the Mount Sinai team are working toward a future where each person’s treatment is precise, effective, and, above all, personalized.
To enroll as a participant or to learn more about the Mount Sinai Million Health Discoveries Program, visit mountsinaimillion.org.
