NEWS STORIES IN THIS ISSUE:

COVID-19 NEWS: Johns Hopkins Medicine Study Shows Vaccine Likely Protects People with HIV 
Johns Hopkins Medicine Documents Stroke Risk in Cardiac Assist Device
CBD Products May Help People with Epilepsy Better Tolerate Anti-Seizure Medications


COVID-19 NEWS: JOHNS HOPKINS MEDICINE STUDY SHOWS VACCINE LIKELY PROTECTS PEOPLE WITH HIV

A Johns Hopkins Medicine research team has shown that people living with the human immunodeficiency virus (HIV) are likely to be protected against SARS-CoV-2, the virus that causes COVID-19, if they are fully vaccinated.

This finding contrasts with earlier institute studies that evaluated the immune response after vaccination for two other patient populations not represented in the original COVID-19 vaccine clinical trials: organ transplant recipients and patients with rheumatic and musculoskeletal diseases. In those investigations, both groups showed lower-than-normal antibody levels to the virus after two doses, and only after a third shot were transplant recipients able to mount an effective defense.

The study of patients living with HIV was published July 22, 2021, in the journal Clinical Infectious Diseases.

“Previous research has suggested a suboptimal response to COVID-19 vaccines in people living with HIV; however, these studies did not fully characterize and define that response, both for cellular [where the immune system directly attacks infected cells] and humoral [where the immune system circulates virus-fighting antibodies] immunity,” says study senior author Joel Blankson, M.D., Ph.D., professor of medicine at the Johns Hopkins University School of Medicine. “What we found with the widely used Pfizer/BioNTech vaccine was just the opposite, as it induces robust immune responses in people living with HIV comparable to those seen in healthy people.”

To reach this finding, Blankson and his colleagues obtained blood between seven and 17 days after the second Pfizer/BioNTech vaccine dose from 12 people living with HIV (seven women and five men) and 17 healthy study participants (seven women and 10 men). None of these individuals had evidence of prior SARS-CoV-2 infection. All of the people living with HIV were on antiretroviral therapy and had a median CD4+ T lymphocyte count of 913 cells per microliter (a healthy adult has a CD4+ T cell count between 500 to 1,200 cells per microliter, while people with untreated HIV may have counts lower than 200 cells per microliter). CD4+ T lymphocytes are immune system cells, also known as helper T cells, because they assist another type of immune cell, the B lymphocyte (B cell), in responding to surface proteins — antigens — on viruses such as SARS-CoV-2. Activated by the CD4+ T cells, immature B cells become either plasma cells that produce antibodies to mark infected cells for disposal from the body or memory cells that “remember” the antigen’s biochemical structure for a faster response to future infections. Therefore, a CD4+ T cell count can serve as a measure of how well the immune system responds to a vaccine and yields humoral immunity.

To evaluate the humoral immunity induced by Pfizer/BioNTech vaccine in people living with HIV, the researchers used tests to detect the presence and measure the levels of antibodies against the protein making up the spikes that protrude from the surface of the SARS-CoV-2 virus. The Pfizer/BioNTech and Moderna messenger RNA (mRNA) vaccines provide genetic instructions to a vaccinated person’s immune system to recognize the spike protein and start production of antibodies against SARS-CoV-2.

“We found that there was no significant difference in either the vaccine-produced CD4+ T cell responses or the titers [levels] of SARS-CoV-2 spike binding antibodies for healthy participants and those living with HIV,” says Blankson. “This indicates that people living with HIV can be adequately protected against SARS-CoV-2, with proper vaccination.”

Blankson says that further research is needed to determine if people living with HIV and with lower CD4+ T cell counts get the same robust humoral and cellular responses to SARS-CoV-2 vaccines as the participants in this study.

Blankson is available for interviews.

 

JOHNS HOPKINS MEDICINE DOCUMENTS STROKE RISK IN CARDIAC ASSIST DEVICE

According to the American Heart Association (AHA), about 10 percent of the more than 6 million Americans living with heart failure have the advanced form of the disease — where conventional heart therapies and symptom management strategies are no longer effective. As the number of patients with this condition increases, so has the use of left ventricular assist devices (LVADs), mechanical pumps that take over the work of the left ventricle (chamber of the heart that pumps blood throughout the body) until a heart transplant can be performed. However, one in five patients using these devices have strokes.

In an effort to enhance patient safety and high-value health care, Johns Hopkins Medicine researchers recently compared two types of LVADs to determine the incidence of stroke associated with their use. They found that one of the devices presents a greater stroke risk for patients than the other.

Sung-Min Cho, D.O., M.H.S., assistant professor of neurology at the Johns Hopkins University School of Medicine, and colleagues looked at the number of strokes that occurred after patients were implanted with the Medtronic Heartware Ventricular Assist Device (HVAD) and the Abbott HeartMate3. Patient data for the study came from the Society of Thoracic Surgeons database known as Intermacs (for Interagency Registry for Mechanically Assisted Circulatory Support). The data documented 6,205 patients — 3,129 who received the HVAD and 3,076 given the HeartMate3.

In their study, first published online July 28, 2021, in the AHA journal Circulation, Cho and his team hypothesized beforehand that the two devices would carry similar stroke risks. However, with more than a year of data analyzed, the researchers instead determined that the HVAD had a higher rate of stroke than the HeartMate3.

“We found that 16% of patients with the HVAD experienced strokes, compared with 6% of those using the HeartMate3,” says Cho. 

The U.S. Food and Drug Administration released a statement June 3, 2021, alerting health care providers to no longer implant the HVAD. That same day, Medtronic announced that distribution and sale of the device would stop.

Cho says that his team plans to find the reasons behind the stroke risk seen in its study.

Hopefully, those observations will inform future device design, advanced heart failure management and device selection, and most of all, yield safer LVAD systems to support seriously ill patients,” he says.

Cho is available for interviews.

 

CBD PRODUCTS MAY HELP PEOPLE WITH EPILEPSY BETTER TOLERATE ANTI-SEIZURE MEDICATIONS

Artisanal (non-pharmaceutical) cannabidiol (CBD) products have become popular in recent years for their apparent therapeutic effects. CBD — a naturally occurring compound of the cannabis plant legally derived from hemp — is used widely as a naturopathic remedy for a number of health conditions, including epilepsy and seizure disorders. Now, Johns Hopkins Medicine researchers, in collaboration with the Realm of Caring Foundation and other institutions, have conducted an observational study with participant-reported data to better understand the impact these products may have on people with epilepsy.

They found that CBD may reduce the adverse effects associated with anti-seizure medications, and seems to improve other aspects of health and quality of life for patients.

The findings were first published online July 27, 2021, in the journal Epilepsy and Behavior.

“The potential of CBD products for the treatment of seizure disorders goes beyond seizure control alone,” says Ryan Vandrey, Ph.D., professor of psychiatry and behavioral sciences at the Johns Hopkins University School of Medicine. “In our study, we saw clinically significant improvements in anxiety, depression and sleep when patients with epilepsy initiated therapeutic use of artisanal CBD products.”

Epilepsy, one of the most common nervous system disorders affecting people of all ages, is a neurological condition characterized by recurrent seizures. Treatment for epilepsy includes anti-seizure medications and diet therapy, such as forms of the ketogenic diet. Surgery may be an alternative treatment, especially when medications or diet fail to control seizures, or if drug side effects — including dizziness, nausea, headache, fatigue, vertigo and blurred vision — are too difficult for a patient to tolerate.

Epidiolex, a pharmaceutical formulation of CBD is approved by the FDA to treat three types of rare seizure disorders (Dravet syndrome, Lennox-Gastaut syndrome and tuberous sclerosis complex), but is not approved for the many other types of epilepsy. As a result, patients with other forms of epilepsy often seek alternative forms of CBD, including those evaluated in the new study.

For their evaluation, the researchers analyzed data gathered between April 2016 and July 2020 from 418 participants — 230 women and 188 men — with 205 (49%) at least age 18 and 213 (51%) age 18 or younger. The participants included 71 adults with epilepsy who used artisanal CBD products for medicinal purposes and 209 who were caregivers of children or dependent adults to whom artisanal CBD products were given. The control group consisted of 29 adults with epilepsy who were considering the use of CBD products and 109 caregivers who were considering it for a dependent child or adult patient.

Participants completed a web-based survey that included questions regarding quality of life, anxiety and depression, and sleep. They were prompted via email to complete follow-up surveys at three-month intervals for 14 months.

Compared with the control group, artisanal CBD users reported lower epilepsy medication-related adverse effects (13% lower) and had greater psychological health satisfaction (21% greater) at the beginning of the study. They also reported lower anxiety (19% lower) and depression (17% lower).

Both adult and youth (18 years or younger) CBD users reported better quality sleep, compared with their peers in the control groups.

Caregivers of patients currently using CBD products reported significantly less burden and stress, compared with caregivers in the control group (13% less).

Importantly, 27 patients in the control group at the start of the study started using artisanal CBD products later in the study. After starting CBD, these patients reported significant improvements in physical and psychological health, as well as reductions in anxiety and depression.

Participants also were asked about possible adverse effects related to their CBD use. Among the 280 users, the majority (79%) did not report any adverse effects. The remaining reported negative factors such as drowsiness (11%), high or prohibitive product cost (4%), worsening of epilepsy symptoms (4%), concerns about legal issues (3%) and worries about problematic drug interactions (1%).

Vandrey says further research is needed to understand how these findings can best be applied to helping people with epilepsy. In the interim, he says, patients should consult with their physician before trying CBD products.

“Our hope is to do controlled clinical trials to better inform clinical decision making and identify specific formulations that are most beneficial to patients,” he says.

Along with the Realm of Caring Foundation, researchers from Kennedy Krieger Institute, the Medical University of South Carolina and the Canopy Growth Corporation also contributed to the new study.

Vandrey is available for interviews.

 

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