I have received press credentials for the 2025 BIO CEO and Investors Conference

 I have received media credentials to attend and cover the 2025 BIO CEO and Investors Conference, February 10-11 in New York City. I will be on hand, and if you are interested in live, independent coverage, I need charge no expenses.

Thanks for your consideration, and Happy Holidays.

One article I am proposing as coverage from this conference has to do with bone marrow transplants for breast cancer. This therapy (along with high dose chemotherapy) was considered experimental when I was in law school, and was the subject of bitter litigation. 

So fast-forward to the present, and what happened? Survival rates for breast cancer have increased markedly, especially with those women who have genetically-driven forms of the disease. Is the gain in survival associated with more use of bone marrow transplants for breast cancer?

 No. High dose chemotherapy with bone marrow transplant is not routinely used for patients with breast cancer; instead, the benefit has come about partially because the biopharma industry has developed several targeted therapies addressing genetically-associated forms of the disease. 

Is it possible that the managed care companies were right?

Small But Mighty: Three Breast Cancer Nonprofits Alleviating Financial Toxicity Experienced by Cancer Patients

 By John Otrompke

                The eleventh annual Dancing For The Survivors event was held tomorrow, Friday, October 13, at The Mint in Lathrup Village, Michigan.

“One of our dancers is Lisa McCall, a breast cancer survivor who was the dance choreographer for Aretha Franklin,” said Molly MacDonald, founder and CEO of The Pink Fund, based in Southfield, Michigan. The goal was to raise $300,000 from the event, she said.

The Pink Fund’s work alleviating the financial toxicities suffered by breast cancer patients was also highlighted this month by the Detroit People Mover, in partnership with Priority Waste Management. It was the light rail train’s first public service announcement.

“The Pink Fund is totally unique; they provide financial assistance for 90 days for people going through breast cancer, not for your co-pay or your insurance deductible, but for life bills like your car note, mortgage and electric bill,” said Heidi Floyd, patient advocate, influencer, and breast cancer patient sand survivor, who recently joined the Board of Directors. The Pink Fund is based in Detroit, but operates in all 50 states, she said.

“In the US, health care is not just provided just because you exist here; you have to get your own, so people have to make decisions about what to pay that month. Can I afford radiation treatment or do I have to keep the water on for my family? Three months’ worth of someone paying your mortgage could be a life changer,” she explained.

Floyd, who was first diagnosed with ER-positive, stage 3B breast cancer 18 years ago,  knows the realities of the financial costs of breast cancer from first-hand experience.

“I was a young mom. There’s a list of things not supposed to do. I wish I had known, because it would have changed everything for my family generationally. We did all the wrong things. We had a college fund for the kids; we didn’t have credit cards. When We started getting bills to the tune of hundreds of thousands of dollars after insurance, we got every credit card we could and maxed them out, without knowing we could go to the cancer center and negotiate, or call the mortgage company.

“Many people say, I didn’t think I needed financial assistance. I thought I had decent insurance, but I didn’t think about how I’d have to pay for the car to get to the cancer center, and $50 for parking, as well as child care. This month, I won’t pay the gas bill; next month, I won’t pay the electric,” she added.

“To me, the most amazing thing if that when you’re in the middle of a serious medical issue, you immediately realize where the gaps are in the system. There are some people who it’s inherent in their nature to say, I’m just going to do what I need to survive, and then they immediately try to do what they can to help other people. Molly is not going to repair the financial toxicity in the entire system; that would be a Sisyphean challenge. But she’s going to do what she can with what she has. That’s what weaves this tapestry together,” Floyd explained.

                                                Avoiding the Financial Toxicity of Cancer

“When you’ve been through cancer treatment, a long trail of side effects follow you quite a while,” said The Pink Fund’s MacDonald, who also sits on the board of directors of the National Breast Cancer Coalition.

 “In 2013, two doctors, Yusuf Zafar and Amy Abernathy, did a study in which they coined the term financial toxicity, which is less known than the physical toxicities of cancer treatment, but it’s becoming quite a hot topic as it effects patients regardless of the time in making their decisions. The most egregious example is that, according to our work, 41% of breast cancer patients will skip or stop treatment to return to work.”

Like Floyd, MacDonald knows first-hand about the financial toxicity of cancer treatment. Diagnosed in 2005 with ductal carcinoma in situ (stage 0), she had 23 surgeries and 6 weeks of radiation, followed by five years of aromatase inhibitors. In 2006, she founded The Pink Fund with her husband.

“Being diagnosed at a time of job transition left me unemployed and unemployable while in treatment. I was already negotiating with my health care provider to cover deductible, which it took me 3 years to pay off. My credit report really tanked. My home did go into foreclosure. My mother was had dementia at the time was not sure who I was, but she knew this person Molly had cancer, and she asked how she could help. I told her about the house, and she gave me $20,000 to pull it out of foreclosure. I ended up in line at the food bank. Fortunately, people brought foods while I was in treatment,” she explained.

So MacDonald started The Pink Fund, to address the issue of financial toxicity by paying non-medical bills in women and men in active treatment who have experienced a loss of household income. “You have to be at or below 50% of the federal poverty level, and we pay patient’s creditors, we don’t pay the patient,” noted MacDonald. “We pay between $3,000 to $6,000 per qualified, fully supported application, which amounts to about 57% of our income for housing every year,” she said.

The Pink Fund also covers health insurance premiums, COBRA, car payments and insurance and transportation, as well as utilities for 3 months. “If think of life like a Jenga tower, when your life starts to sway, and eventually it’s going to collapse, we’re not going to fix it, but we’re coming around providing financial scaffolding around you to stabilize you, so you can take a breath and figure out what your long-time financial strategy is,” MacDonald said.

      Supporting Moms and Children

                Like MacDonald, Audrey Guth was a successful businesswoman when she was diagnosed with breast cancer. “When I was diagnosed 15 years ago, I was the owner of a nanny agency. My first cancer was thyroid. I thought I would get over it without sharing my information with very many people. A few years later I was diagnosed with estrogen receptor-positive breast cancer. I didn’t know anyone who had breast cancer, but it was a totally different ball game, because it was life threatening. After the first surgery, I was told there was nothing left to do, but the margins weren’t clear, so it took 2 more surgeries to be able to remove all the physical cancer. Then I went through radiation,” said Guth, who today is the Founder and Volunteer Executive Director of Nankind, a charitable organization that transforms the cancer experience for families with free childcare and vital support programs, based in in Toronto.

                Like Floyd and MacDonald, Guth’s experience with cancer taught her about financial toxicity. “When I was diagnosed, I recognized that there is a gap in the health care system, where mothers had to make a choice between their own career and the care of their children. No mother is going to tell you they’d choose themselves over their children, so a lot of these moms were going without treatment,” said Guth, who has turned over her nanny for-profit agency to her daughter.

Today, Guth provides not only her network of highly screened and trained Volunteer Angels to parents with cancer and their children, but grief counselling as well. “Moms no longer here, so what do we do, abandon these children? So I went to hire a specialist in grief and bereavement, called a thanatologist, and asked her to create a treatment. During that time I learned grief is not just death, but a loss of normalcy. If children don’t grieve in an age-appropriate way, it can have long-term psycho-social impacts. For example, 80% of people in prisons have unresolved grief issues, as do drug abusers, those who engage in self-harming or have eating disorders,” explained Guth. “They also have a 50% higher incidence of mental health disorders. So we built the Nankind Program for Children. Every week for four hours, our Volunteer Angels engage with children and teach them coping strategies and mechanisms,” she said.

“One of the things we do that no one else offers is intense bereavement support, such as what to say to kids at a funeral. When you say, ‘They’re in a better place,’ that’s like saying to the kid they’d rather be there than with you,” Guth said.

Nankind provides support to over 150 families each year,  to mothers, fathers, and primary caregivers with all types of cancer, not just breast cancer Guth noted. “As of today, we have provided over 40,000 prepared meals to 2,000 families and empowered 3,500 children with the tools to build lifelong emotional resilience,” she added.

Providing Translation and Navigation Services to the Uninsured

                Dora Arias narrowly avoided the effects of financial toxicity when she was diagnosed with stage 0 estrogen receptor-positive breast cancer in 2003. “I always had very lumpy breasts, and always went to my annual gynecological appointments. The doctor said, ‘Why don’t you start screening earlier, because it’s going to be very hard for you to determine what’s good and bad.’ At age 37, my mammogram was clear, and the following year I almost cancelled my appointment. Because I was under 40, my insurance would not cover it, and I was not sick. My husband was like, ‘No, don’t be crazy. If we have to pay out of pocket, we’ll pay out of pocket,’” explained Arias, founder and executive director of Curémonos (which means ‘healing together’ in Spanish’ in Mountainside, New Jersey.

                “It came back, and the doctor recommended a mastectomy because I had calcifications spread throughout my breast. There was a 99% chance of a cure and no radiation, whereas even if I had a lumpectomy, my breast was going to be disfigured. I was scared, because I was very young, I was active, and I was working in the city for JP Morgan. I learned that it’s not vanity, it’s the fact that you’re having an amputation, and losing part of your body. He recommended plastic surgery right away,” she added.

                In 2009, Arias founded Curémonos, which has provided translation services as well as patient navigation, education, and support, connecting more than 5,000 women (most of whom are uninsured) to resources within and outside the hospital. Today Arias provides the service on a purely voluntary basis.

                “All of these people have been through a horrible situation. Instead of dwelling on that, saying, ‘Why me?’, they contemplate why anyone else should have to go through it,” said Heidi Floyd. “The world is awash with people who want to influence without actually making an impact. These women are the opposite of that. The world has enough people telling you what kind of makeup to buy, how to put it on, and what clothes you should wear. These women aren’t seeking adulation or attention, but they should have all of it,” she added.

 

© 2023 John Otrompke

FDA’s Approval of IND Application Allows Kyverna Therapeutics to Explore Role of CARs in Lupus, and Possibly Other Immune-Moderated Diseases

 By John Otrompke

                Immunology company Kyverna Therapeutics, Inc., will be exploring a new role for CAR T-cells in treating lupus nephritis, after the company received approval on Nov. 11 from the FDA for its investigational new drug application to begin trying its agent, KYV-101, in humans.

“CAR Ts are very effective depleters of B-cells, which in lupus nephritis are abnormally located in nephrotic tissues,” explained chief medical officer James Chung, MD PhD. The Emeryville, California, company plans to begin a phase 1 / 2 trial next year, and should have clinical data within 6 months, he added.

“This is sort of a ‘Goldilocks’ moment, because the agent has efficacy on B-cells, and on the other hand, it also has a great safety profile. These lupus nephritis patients can live 20 or 30 years, so we can’t give them the level of side effects you see in oncology patients,” noted CEO Peter Maag, PhD, who was hired by the company in October. (Maag had previously served as the CEO of Brisbane, California-based CareDx, Inc., a personalized medicine company in the transplant medicine space).

The announcement comes on the heels of an article published in October in Nature Medicine, which described the success of the therapy in treating five patients. (“Anti-CD19 CAR T cell therapy for refractory systemic lupus erythematosus,” Mackensen A, Müller F, Mougiakakos D, et al. Nat Med. 2022 Oct;28(10):2124-2132. doi: 10.1038/s41591-022-02017-5. Epub 2022 Sep 15. Erratum in: Nat Med. 2022 Nov 3;: PMID: 36109639).

“Seventeen months out, they still have no need for additional immune suppression. If that’s true in five patients, the discovery might amount to a paradigm shift, achieved by pushing the immune system’s reset button through the deep depletion of B-cells,” added Maag.

Lupus occurs mostly in young women with about 65% of cases occurring in those between the ages of 16 and 55. Approximately 40% of adults will develop lupus nephritis, 60% of whom will fail standard of care and approved treatments, said Chung, and up to 40% of those with diffuse disease will ultimately develop kidney failure, requiring dialysis or a kidney transplant to stay alive.

The treatment, an anti-CD19 chimeric antigen receptor T-cell (CAR T) construct for which Kyverna has obtained exclusive, global licensing from the NIH to use in both autologous and allogeneic CAR T-cell therapies, will be tested first in open label clinical trials, Maag said.

“The FDA and other health agencies have accepted objective endpoints for lupus nephritis, such as serum creatinine, which is a measure of renal function,” Chung noted.

While multiple gene signatures have been identified in lupus patients, KYV-101 does not target them; instead, the company hopes to target a broader population of lupus patients through depletion of B cells.

“There are a number of diseases in which B-cell depletion might be relevant; there is some evidence in multiple sclerosis, for example,” said Maag, adding that the company is in talks with the FDA regarding such an application.

The Clinical Imperative of Personalized Medicine Makes Broader Reimbursement for Genetic Diagnostics Assured

 A Discussion of Several Panels at the 16^th Annual Meeting of the Personalized Medicine Coalition

by John Otrompke

                Although reimbursement coverage is now available for select use cases for molecular diagnostics, these use cases have been demonstrated to be too narrow. Almost 10% of colorectal cancer patients treated at Mayo Clinic Cancer Centers for the two years before the pandemic had actionable germline genetic variants that would not have been identified by contemporaneous guidelines from medical societies such as the National Comprehensive Cancer Network (NCCN), or the 20-gene sequencing panel based on those guidelines, according to a recent article. (Uson P, Riegert-Johnson D, Boardman L, et al. Germline Cancer Susceptibility Gene Testing in Unselected Patients With Colorectal Adenocarcinoma: A Multicenter Prospective Study, Clinical Gastroenterology and Hepatology 2022;20:e508–e528).

                Next generation sequencing was performed on the 361 patients using the 84-gene Multi-Cancer Panel from Invitae Corp. (NVTA, San Francisco). Researchers found incrementally actionable variants in 9.4% patients that would not have been identified by the 20-gfene panel from the same company.

“We collaborated with the Mayo Clinic, and the study showed that family history and age are imperfect predictors of whether you have Lynch syndrome, so we ought to test every patient,” explained Robert Nussbaum, MD, CMO at Invitae, a co-author on the article.

The company also recently launched its personal care monitoring service, which measures minimal residual disease in the form of cell-free DNA. “Does the patient need adjuvant treatment? Will they relapse, and if so, when?” added Nussbaum, who also spoke on a panel about diagnostics at this year’s annual Personalized Medicine Conference at Dana Point, California, in May. Some payors are reimbursing for the diagnostic test, Nussbaum said.

Reimbursement for genetic diagnostics is likely to grow in the future as researchers develop more evidence about the clinical and economic benefits that such testing can provide. If genetic diagnostics are not reimbursed consistently, drugmakers may have a harder time marketing genetically guided therapeutics.

“Even in the primary care setting, virtually every patient should be assessed for hereditary risk factors,” noted Lisa Alderson, CEO and founder of Genome Medical, Inc., in South San Francisco, CA. “While 7% of the population has a single-gene variant that impacts their health, a much larger percentage, approximately 17%, have moderate risk variants that may influence treatment or preventive options.” Fully 85% of people have genetic factors that impact their response to prescribed drugs and could change dosing or therapeutic selection, particularly in the areas of pain management, oncology, and mental and behavioral health, added Alderson, who also spoke at a session at the PMC conference on precision medicine in differently-structured health systems.

“We have a full-time team of leading molecular geneticists, genetics counsellors and a pharmacist, as well as a contract network of specialists and primary care doctors whom we bring into specific patient’s cases as needed. We see patients directly and also support providers in appropriately utilizing genomics. We are simplifying the process of finding patients with need through our patient assessment and clinical support tools. Physicians just point patients to our platform, which identifies those who meet NCCN guidelines for oncology testing and hereditary cancer risk assessment,” she added.

“Genome Medical is a covered benefit for approximately 170 million people, including all beneficiaries of United Healthcare, CIGNA, and most of the Blues,” said Alderson. “Many payors are bringing Genome Medical in network to better support this complex area of medicine. Today, we have both underutilization and overutilization of genetic testing in the market. The majority of patients meeting guidelines are not identified and when testing is ordered, up to 25 percent of the time, it is the wrong test. We also support clinical decision making to ensure action is taken on the results.

“Take colon cancer as an example. If somebody is at an elevated risk for cancer because of their genetic make-up, that changes the standard of care for cancer screening. The standard of care is for the average patient to have their first colonoscopy at age 45, but if they are at higher risk, the first colonoscopy may take place when they are in their 30s. If they have a colonoscopy earlier, the cost is quite low compared to that of treatment, because removing polyps means you can prevent colon cancer from forming,” she explained.

“There is a pretty steep lag between when you demonstrate clinical utility and when you have broad-based adoption, but we’re trying to build a future model in which providers order genomics earlier and particularly for complex cases. There is a gap in knowledge which is creating a gap in clinical care, but by reducing underutilization and overutilization, we show a very immediate return-on-investment, a 5-times ROI,” Alderson said.

Speeding the Time to Clinical Acceptance

Colon cancer is far from the only example of a disease state in which genetic science is changing medicine and saving lives. “Sepsis accounts for half of all hospital deaths in the US. As it is a time-critical disease, earlier detection or prediction can help save lives. Currently, there is no single biomarker that can accurately predict sepsis. However, research has shown that the combination of a few in vitro diagnostic tests can significantly improve the prediction of sepsis,” said Okan Ekinci, MD, global head of marketing and innovation for Roche Diagnostics Information Solution in Basel, Switzerland. A recent study suggested that a combination of five biomarkers improved sepsis prediction in children compared with C-reactive protein alone, added Ekinci, who also spoke at the PMC conference panel on diagnostic tools.  (Rautiainen L, Cirko A, Pavare J, et al. Biomarker combinations in predicting sepsis in hospitalized children with fever. BMC Pediatrics [2022] 22:272).

Success stories such as those of Genome Medical and Invitae come as some payors express frustration with the lack of transparency regarding some diagnostic tools, such as smaller, locally-designed tests.

“It can take 14 to 17 years for a new test to get to widespread adoption, but hopefully we can get it under 10 years, and maybe as low as 7,” agreed Jill Hagenkord, MD, CMO at Optum Genomics in Eden Prairie, Minnesota. (Optum Genomics is currently part of United Healthcare).

To help reduce the time lag, Hagenkord is leading the roll-out of the Optum Evidence Engine, a service which connects developers of diagnostic tests with market access experts who can help design studies and communicate with investors.

“There is a lack of consistent regulatory oversight due the FDA’s exercise of its enforcement discretion, so that anything can go on the market, and does, without any clear criteria. It’s impossible to determine whether the tests do or don’t work at all. Nobody even knows how many tests are on the market, because we don’t have unique identifiers for them, which could make it easier for payors to distinguish between those that do and those that don’t work. So some payors decide that they’re either just going to pay for all laboratory-designed tests, or pay for none of them.” Those at the Optum Evidence Engine have finally begun to assign unique identifiers to the locally-designed tests within the past year, added Hagenkord, who spoke on a panel about reimbursement at this year’s annual PMC conference.

While there may be a significant time lag in personalized medicine between the demonstration of clinical utility and widespread adoption, it is undeniable that broader reimbursement for genetic testing is a fait accompli. Breast cancer is one important example of a clinical area where the clinical importance of personalized medicine has perhaps been longest-established.

“Anybody who has hormone receptor-positive breast cancer, and that’s 80% of breast cancers, is getting targeted therapy,” said Kevin Hughes, MD, director of cancer genetics at the University of South Carolina in Charleston.

Genetic testing for the approximately 13 gene signatures associated with breast cancer is almost always reimbursed, added Hughes, who is also a board member for the American Society of Breast Surgeons. “We’re trying to get the NCCN to change to guidelines to match ours, because they have a very complex set of criteria that ends up with about 50% of breast cancer patients testable,” he noted.

The author is a member of the Personalized Medicine Coalition

© 2022 John J. Otrompke, JD

All contents (c) 2022 John J. Otrompke

Time for an Epilepsy Moonshot Initiative? -Precision Medicine at AES

                         AES Poster Demonstrates the Increasing Relevance of a Genetic Diagnosis 

                                to the Treatment of Epileptic Children at a Center of Excellence

by John Otrompke

Genetic analysis led to a change in treatment for almost half of the children with epilepsy who received a consultation at Boston Children’s Hospital for whom a firm etiology was lacking, according to a poster presented on Dec. 5 at the 2021 annual meeting of the American Epilepsy Society in Chicago. Treatment was impacted in 45% of individuals, including 36% with an impact on anti-seizure medication choice.

In light of developing knowledge of the disease and emerging therapies, providers should routinely use genetic testing to evaluate children with epilepsy, according to abstract number 2.319, “Genetic Diagnosis in Pediatric Epilepsy Impacts Medical Management,” which was said to be the first study to report on the impact of a genetic diagnosis on the medical management of pediatric epilepsy in a clinical setting.

Pediatric epilepsy is unexplained in about two-thirds of cases, so a genetic diagnosis is especially important for children. Geneticists have determined that epilepsy is a highly variegated disease, with some studies reporting that up to 78% of patients with epilepsy of unknown cause having significant genetic variants.  

“There are over 500 genetic variants implicated in epilepsy, and they’re all very rare,” said Heather Olson, MD, attending physician at Boston Children’s Hospital, and assistant professor of neurology at Harvard Medical School, senior author on the poster. The poster found that in 10% of the patients, genetic testing had an influence on the discussion of participation in ongoing gene-specific clinical trials. 

In some forms, epilepsy is not only a severe, limiting condition, but can even be fatal. For example, some children with the BRAT-1 variant, which is thought to be related to mitochondrial homeostasis, die a few months after birth due to cardiopulmonary arrest.

Nevertheless, genetic testing remains controversial among insurers, with an ICER of around $15,000 per diagnosis.

                                                            About the Study

In the study, researchers examined course-of-treatment and other outcomes for 602 children with epilepsy who received next-generation genetic sequencing at Boston Children’s Hospital between 2012 and 2019. About one-quarter of the children who were tested received a genetic diagnosis. 

“Patients with childhood epilepsy usually receive genetic testing at our hospital when no other cause has been identified,” explained Isabel Haviland, MD, lead author and postdoctoral research fellow at Boston Children’s.

Of the children who received an epilepsy gene assay with or without exome, 152 received a clinical diagnosis of genetic epilepsy, which had an impact on medical management in 110 or 72% of those patients. Of those 110 patients, the choice of anti-seizure medication was impacted in 36% of patients, while 10% were eligible for gene-specific clinical trials or investigational new drug use. Another 3% of the 110 patients were treated off-label.

Of the 152 patients who received a genetic diagnosis, care coordination was impacted in 48%, and vitamin treatment and/or metabolic treatment such as the ketogenic diet was ordered in 7%.

Additionally, genetic testing led to a change in diagnosis in some children. “For two children who initially had a diagnosis of primary mitochondrial disorder, it was found that their epilepsy was in fact due to a genetic cause,” explained Haviland.

One child was found to have a variant in gene PRRT2 and was switched to a different anti-seizure medication, eventually becoming seizure-free.

                               A Diagnosis of Genetic Epilepsy Frequently Determines Treatment

Due to the variegated nature of genetic epilepsy, genetic diagnoses in the children resulted in differential treatment in the form of vitamin supplements, dietary regimens, off-label treatment with already approved drugs, new or experimental treatment with small molecule drugs, or enrollment in gene therapy clinical trials. 

While outright cures are very rare, even something as simple as supplementing the child’s diet with vitamins may partially correct the problem and treat the epilepsy. “For example, vitamin B6 is important for brain development, but some genetic disorders affect its pathway in the brain,” said Haviland.

Another nutritional intervention sometimes used is the ketogenic diet. “This results in changes in not only ketones, but insulin, glucose, and free fatty acids; all of these metabolic changes may have a role in reducing seizure frequency,” she added, noting that initiating the ketogenic diet in a child requires hospitalization.

Some drugs are already approved for the treatment of genetic epilepsy, such as fenfluramine, which was approved in June of 2020 to treat Dravet syndrome, one of the first established epilepsies.

“We recently published a case report  about an individual who had been having monthly seizures, who had to go into the intensive care unit each time. Having now received an accurate genetic diagnosis of Dravet syndrome, the patient is now three years seizure free,” said Olson.

Then there are the genetic epilepsies for which off-label treatments can be used, such as epilepsy with a variant in GRIN2A, a gene involved in brain cell communication, which has been treated with memantine, a drug approved only for Alzheimer’s disease. There are also small molecule drugs under development for some genetic epilepsies. 

“But generally, the only way to cure genetic epilepsy is with a gene therapy that modifies and corrects the variant in the patient’s gene, such as an antisense oligonucleotide (ASO). An ASO is designed just for one child, but these are very few and far between,” explained Olson. 

HIV-Related Dementia Worsens in Patients with Depression and Peripheral Inflammation

 

by John Otrompke

Dementia which occurs in people with HIV can be distinguished from Alzheimer’s disease and warrants different treatment, according to a poster presented at this year’s annual meeting of the American Neurological Association, which took place virtually.

Markers for inflammation found in HIV patients are associated with cognitive decline, whereas amyloid markers were not, according to poster 368, “Peripheral Inflammation and Depressed Mood Independently Predict Neurocognitive Worsening Over.”

“HIV dementia is different from Alzheimer’s because it is one of the few treatable dementias. When patients go on anti-retroviral therapy and achieve suppression, they also get cognitive improvement,” explained Ronald Ellis, MD, PhD, professor at the University of California-San Diego, lead author on the poster.

The researchers measured cognitive decline over 12 years in 191 patients with HIV. Inflammation biomarkers such as interleukin-6, C-reactive protein, and soluble tumor necrosis factor type II were associated with greater neuro-cognitive decline (p=0.02), as was depressed mood at entry (p=0.0004). On the other hand, biomarkers like amyloid beta 42 and solid amyloid precursor proteins (sometimes thought to be associated with Alzheimer’s disease) were not associated with greater cognitive decline in HIV patients.

There are other differences as well, according to Ellis. “Although classic Alzheimer’s proceeds at a more rapid rate, people with HIV develop cognitive problems earlier.”

And while viral suppression is associated with cognitive improvement, it doesn’t restore cognition to normal, he explained. However, researchers have speculated that treatment intensification could actually reverse the decline, he added.

#ANA

#dementia