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OPED: New hope for people with HIV

A new study holds promise for people living with HIV who have limited therapy options or rely on complex drug regimens

A new international study led by a researcher from New York-Presbyterian Queens, published in The New England Journal of Medicine on May 11, demonstrated the effectiveness of an investigational long-acting, first-in-class therapy for people with multi-drug resistant HIV – signaling the potential for a radically simplified drug treatment and improved compliance among patients living with HIV.

In the randomized controlled, double-blind trial known as “CAPELLA, injections beneath the skin of an investigational HIV agent called lenacapavir significantly suppressed the viral level in patients with HIV who were currently on a failing antiretroviral treatment regimen. Importantly, viral suppression remained high for six months.

If approved, the new therapy has the potential to be a game-changer in several ways, according to the study’s lead author, Dr. Sorana Segal-Maurer, director of the Dr. James J. Rahal, Jr. Division of Infectious Diseases at NewYork-Presbyterian Queens and a professor of clinical medicine at Weill Cornell Medicine.

The encouraging results of the study offer hope for people living with HIV who have limited therapy options, as well as those who are reliant on complex drug regimens,” Dr. Segal-Maurer said. “Lenacapavir has the potential to be used as either a long-acting pill or a subcutaneous injection every six months, which anyone can be taught to do. I cannot even find the words to share what that means to all our patients, but especially those with limited or no treatment options, or whose unique circumstances make it difficult to engage in care.” 

However, she stressed, that patients still need to be highly adherent to the rest of their antiretroviral medications that make up their complete regimen.

Lenacapavir, from Gilead Sciences, is an investigational antiretroviral medicine called a capsid inhibitor that targets the cone-shaped shell of the virus and proteins important to viral reproduction. Previous research showed that lenacapavir interrupts multiple stages in the viral life cycle, helping to suppress the virus.

New York-Presbyterian Queens was one of 42 investigational sites for lenacapavir around the world.

Despite significant advances in antiretroviral treatments that have helped many people with HIV suppress the virus, there are still patients with treatment failures due to viral resistance or unacceptable side effects,” Segal-Maurer added. “These patients no longer have viral suppression and require treatment options that can be complex and difficult to adhere to, leading to further drug resistance. These challenges underscore the importance of new treatment options for people living with multi-drug resistant HIV infection.”

The phase II/III CAPELLA trial included 72 people living with HIV with a median age of 52, 75 percent of whom were men. Individuals were eligible for the study if they were age 12 and older, were currently on a failing drug regimen, and had developed resistance to at least two drugs from four main classes of antiretroviral medications (46 percent of patients in the study had resistance to all four major classes of antiretroviral medications). Half of the trial participants were randomized to receive oral lenacapavir or a placebo along with their existing medication regimen for 14 days.

The remaining 36 participants started taking lenacapavir pills at the beginning of the trial on top of a regimen of HIV medications designed to maximize effectiveness for these heavily treatment-experienced people. After 14 days on the oral drug, they, too, switched to the subcutaneous injections.

At the end of the lead-in period, 88 percent of participants receiving lenacapavir saw a significant drop in their viral level, compared with just 17 percent of those on the placebo. Trial participants randomized to receive lenacapavir also experienced an increase in white blood cells called CD4 T cells, critical to fighting the infection. Overall, the percentage of people with profoundly low CD4 T cells decreased from 24 percent to 0 percent. No one dropped out of the study as a result of drug-related side effects, according to Dr. Segal-Maurer.

The significance of the trial’s findings is profound. We’ve come a long way,” said Segal-Maurer, who has witnessed the evolution of HIV treatment over the decades, starting at the beginning of the AIDS epidemic. “I was in medical school in the early to mid-eighties when the average lifespan between diagnosis and death was anywhere from weeks to months. We’ve gone from many pills multiple times a day to one pill a day to possibly even less. Now we’re in a place where if a patient can engage in care and take their medicine, they have an excellent chance for improved outcomes and a long lifespan.”

A version of this op-ed can be found on the New York-Presbyterian Queens “Health Matters” website.

Dr. Sorana Segal-Maurer is a paid consultant for Gilead Sciences and director of Dr. James J. Rahal, Jr., Infectious Diseases Division at New York-Presbyterian Queens, and professor of clinical medicine at Weill Cornell Medicine. She is the site principal investigator for a number of studies evaluating new investigational HIV antiretroviral therapies.

Meng helps secure $3 million for new labor and delivery wing at Elmhurst Hospital

U.S. Rep. Grace Meng and representatives from the office of U.S. Rep. Alexandria Ocasio-Cortez visited Elmhurst Hospital to celebrate $3 million in federal funding secured for a new Labor and Delivery unit on the hospital’s fifth floor.

In honor of Women’s Health Month in May, Meng led a “wall-breaking” ceremony before touring the current Labor and Delivery unity to see where the future renovations will take place.

Federal funding for the initiative — which will support the hospital’s goal of improving health indicators for pregnant women and decreasing maternal and infant mortality rates — was made available under the Community Project Funding Program and through the offices of Senators Kirsten Gillibrand and Chuck Schumer.

Black and Native American women in the U.S. are three times more likely to die than white women from pregnancy-related causes, and black babies are twice as likely to die than white babies, according to the Center for Disease Control and Prevention. While 700 pregnancy deaths occur per year, two-thirds of them are considered to be preventable.

Rep. Grace Meng and representatives from the office of Rep. Alexandria Ocasio-Cortez visited Elmhurst Hospital to celebrate $3 million in federal funding secured for a new Labor and Delivery unit on the hospital’s fifth floor.

In New York City, black women have an eight times greater risk of pregnancy-related death than white women. They were also three times more likely than their white counterparts to experience severe maternal morbidity, which can include blood clots, kidney failure, stroke or heart attack.

Meng said she was proud to deliver the federal funds to the local hospital, enabling expanded access and care to families. Construction of the new hospital wing is scheduled for spring and summer 2022

“Elmhurst plays a critical role in the health and wellbeing of our communities, and I cannot wait until the renovation is completed,” Meng said. “All families deserve a modern, safe, and equitable maternal health care experience, and investments like this are needed to ensure that the hospital can continue to provide efficient, high-quality and state of the art services that local residents need and deserve. It is also crucial to meet the growing needs of the area. When the COVID-19 crisis began, NYC Health + Hospitals in Elmhurst was in the heart of the epicenter, and this project is an example of how we must build back better and stronger as we work to recover from the pandemic. I’m excited for this renovation to begin, and look forward to the upgrades benefiting Queens families for decades to come.”

Meng also took part in a patient baby shower co-sponsored by MetroPlusHealth, which included educational presentations on prenatal care, breastfeeding, safe sleep, nutrition, and the hospital’s doula program. Community-based organizations CommonPoint Queens and the Queens Museum also joined in the baby shower events. Following presentations, patients had the opportunity to win prizes by answering trivia questions related to well-baby care.

NYC Health + Hospitals/Elmhurst CEO Helen Arteaga-Landaverde said that she is beyond ecstatic and grateful to lawmakers who will help see the project through to its completion..

“Our expectant mothers and newborns will greatly benefit from these investments in infrastructure and improving patient care and patient satisfaction at our facility,” Arteaga-Landaverde said. “We look forward to working closely with our federal legislators to ensure that Elmhurst has the resources it needs to meet the growing healthcare demands of our community.”

City’s New Top Doctor gives COVID briefing

Dr. Ashwin Vasan has taken over as the city’s top doctor at the two-year mark of the ongoing pandemic.

Officially taking the reins from Dr. Dave Chokshi on March 16, Vasan held his first briefing last week in Queens alongside President and CEO of NYC Health + Hospitals, Dr. Mitchell Katz and Director of NYC Test and Trace Corps, Dr. Ted Long.

“Although it’s only my first week on the job, I understand how important regular communication is with all of you,” Vasan said to the press. “While the losses of the last two years have been profound, we’ve also developed tools in that period that are saving lives, including testing, prevention and new treatments, like antiviral pills.”

“It’s an honor to be the city’s doctor. Something you’ll hear me talk a lot about is the emotional toll that this pandemic has taken on all of us. We have all been through so much over these past two years and continuing uncertainty about the future of COVID can certainly add to the strain on New Yorkers mental health and well being,” Vasan said.

As of March 21, the city’s seven-day and 28-day average positivity rates are trending in the right direction with 1.66 percent and 1.89 percent rates, respectively.

Although he said New York City is currently in a “low-risk environment”, Vasan said he and his team at the city’s Department of Health and Mental Hygiene is monitoring the presence of the BA.2 subvariant of Omicron.

Dr. Celia Quinn said that ‘about 30 percent’ of cases in the city can be attributed to the subvariant, and that while it appears to be more transmissible than other strains of Omicron, it does not appear to cause more severe illness.

“I think the important thing to remember and to emphasize for New Yorkers is that currently, there’s no evidence that BA.2 causes more severe illness, increases risk of hospitalization, or that our current vaccines offer less protection against it,” Vasan said.

With just 55 percent of New Yorkers aged 65 or older who received their booster or additional dose, Vasan and his team stressed the importance of vaccines and reconnecting with health care providers.

As some mask mandates have been relaxed in city schools and other places, Vasan and Katz hesitated to say what it would take to lift a workplace vaccine mandate.

“People who have tried to predict what’s going to happen in the future for this pandemic have repeatedly found egg on their face, as they say, and I’m not going to do that here today,” he said.

Dr. Katz added, “Nobody has suggested that we should, you know, because polio levels are so low, we should say that schoolchildren shouldn’t be vaccinated for polio. I think vaccine mandates have a long and important history in public health.

“If you have childhood vaccinations, then everybody grows up to be vaccinated. So it turns out to be irrelevant, right? The point of childhood vaccinations is by doing it at childhood, you’re giving the person maximum benefit. And then they grow up as a whole cohort of people who are fully vaccinated.”

Don’t Forget the Purpose of Healthcare System

Americans should be deeply concerned about our “sick-care” health system. The system is designed to withhold the best medicines, medical devices, and operations until their health deteriorates, and then belatedly, rescue care is offered.
It’s a penny-wise, pound-foolish approach to clinical care that puts patients at risk. There’s a far better alternative.
A truly patient-centric healthcare system would assess patients’ risk for heart attacks, diabetes, and other serious conditions, and then devote resources to preemptively reduce that risk while improving their quality of life. The current system limits access to care in the name of short-term savings, and ironically increases long-term spending.
Nowhere is this clearer than our approach to prescription drugs.
Politicians can get guaranteed applause by promising to slash the cost of medicines.
And this political drumbeat is increasingly reflected in policy efforts, whether it is the executive branch attempting to link drug prices in our country to those of other nations that employ government price controls, congressional legislation that would give the federal government greater price-controlling powers over drugs in the Medicare program, or a greater reliance on institutions like the Institute for Clinical and Economic Review (ICER) that assigns a financial value to a person’s life in determining whether to grant patients access to innovative treatments.
We need to pursue a patient-risk framework that will accelerate the delivery of breakthrough treatments to those who need them most. Healthcare providers should use data analytics and clinical assessments to score the health risk for each patient and devote the necessary medical resources to reduce that risk.
Just consider how that’d change our approach to a disease like diabetes, which is particularly prevalent in minority communities. More than 16 percent of Blacks and nearly 15 percent of Hispanics live with the condition, compared to less than 12 percent of whites.
All told, it cost our country over $237 billion in direct medical costs in 2017. Of that, about $15 billion was spent on insulin, which helps patients keep the disease under control and live relatively normal lives.
A true healthcare system would conduct regular screenings for the roughly one in three Americans who are pre-diabetic and make it easy for patients to access medications.
Instead, our current sick-care system forces diabetes patients to pay a considerable share of insulin costs out of pocket. Many can’t afford it. Over 13 percent of diabetes patients have skipped medications or not filled prescriptions due to cost concerns.
As a result, they often suffer the worst complications. Lower limb amputations, which about 70,000 Americans with uncontrolled diabetes require each year, cost about $70,000 apiece.
In other words, we spend roughly $5 billion cutting off people’s feet and toes. That doesn’t begin to count the expenses associated with other complications, from kidney disease to blindness.
The old saying, “an ounce of prevention is worth a pound of cure,” really is true. According to the CDC, “effective blood sugar management can reduce the risk of eye disease, kidney disease, and nerve disease [resulting from uncontrolled diabetes] by 40 percent.”
If we don’t do more to predict patients’ health risks and then improve outcomes, then the trillions we invest in transportation, housing, energy, education, environment, and food have limited value.
At a time when historic progress is being made in treating diseases from cancer to Alzheimer’s, it makes little sense to focus narrowly on cutting drug costs rather than viewing healthcare spending holistically.

Gary A. Puckrein is president and chief executive officer of the National Minority Quality Forum.

Staying healthy while traveling

The benefits of travel are enumerable, and I’m seeing many social media posts from friends and family who are venturing back onto planes and trains this summer. However, as anyone who has traveled in the past 10 years knows, travel has always had its downsides, even pre-pandemic.

What increases the risk of catching a virus or infection during air and train travel?
Surprisingly, it’s not what you may think. Most people tend to focus on the air quality. While it’s true that infections can be spread through air droplets, a plane’s air is actually filtered more than a movie theater’s or sporting event venue’s.
According to a study in 2007 by Charles Gerba, professor of environment microbiology at the University of Arizona, it’s the surfaces on the airplane that create the greatest risk of picking up bacteria and viruses. The surfaces that harbor the most microbial pathogens are tray tables, bathrooms, and seats – especially arm rests.
If you could avoid contact with your face after touching the surfaces on an airplane, you could significantly reduce transmission. However, it is almost impossible not to touch your face.
In medical school, during one lab, the professor put a powder that could only be seen with UV lighting on our books. At the end of class, the professor used an ultraviolet light and confirmed that everyone had touched their face at least once – and most of us repeatedly.

Preventing viruses and infections
The most reasonable approach is to carry antimicrobial wipes to clean the surfaces of the hand rests and tray tables. Wash your hands after using the bathroom. Use hand sanitizers before you eat. You might also put a napkin over the tray table to avoid touching the surface.
Fortunately, most infections are not life-threatening, but rather a short-term inconvenience.

Deep vein thrombosis (DVT) and pulmonary embolism (PE) risks
More serious is a DVT, which is also referred to as “economy class syndrome,” because it occurs most often when sitting for long periods of time in cramped spaces. The risk of a DVT is increased by as much as two to four times on long-haul flights.
DVTs are more likely for travelers who have other risk factors, such as obesity, heart failure, cancer, increased age or recent major surgery. A 2001 New England Journal of Medicine study found that flights greater than 3600 miles cause increased risk of a DVT and PE. This limits the risk to mostly international flights and those traveling from the east coast to Hawaii. Unfortunately, DVTs and PEs can be life-threatening, if untreated.

Prevention of DVTs
When on a flight of more than five hours, make sure you walk or move around every one to two hours. Hydration is also critical to decrease clot risk. Another easy solution is below the knee compression stockings, which have been shown to decrease risk dramatically.

What about the role of stress?
Travel increases stress for many. Acute stress tends to increase the risk of hypercoagulability, or clots, and thus the risk of cardiovascular disease.
Chronic stress may also cause people to be more susceptible to infection, including the common cold.
Biofeedback, which involves deep breathing and meditation, is a great way to reduce both chronic and acute stress while traveling.
Though there are no guarantees, take these precautions to minimize the risks of infection, DVT/PE and increased stress. Also, take it to heart the next time you hear the captain and flight attendants tell you to sit back, relax and enjoy the trip.

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