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FDA approves first AI device to detect colon lesions

The US FDA announced its first-ever approval of an artificial intelligence device to help find colon lesions during colonoscopy.

The GI Genius (Cosmo Artificial Intelligence) identifies areas of the colon where a colorectal polyp or tumor might be located. Clinicians then follow up with a closer examination and possible treatment.

The GI Genius consists of both hardware and software designed to work with an endoscope. It uses machine learning to recognize possible polyps during a colonoscopy. It marks these areas with green squares on the video generated by the endoscope’s camera and emits a short, low-volume sound. Clinicians decide if a lesion is truly present and whether to sample or remove such a lesion.

The device does not diagnose the lesions or recommend treatments and is not intended to take the place of laboratory sampling

The FDA based its approval on a trial in which 700 people 40-80 years of age underwent colonoscopies for colorectal cancer screening, surveillance, follow-up from positive results of a fecal occult blood test, or gastrointestinal symptoms of possible colon cancer.

Of these participants, 263 were being screened or surveilled every 3 years or more. The researchers randomly divided them into a group of 136 who underwent white-light standard colonoscopy with the GI Genius, and 127 who underwent white-light standard colonoscopy without the GI Genius.

Using the GI Genius, clinicians identified adenomas or carcinomas that were later confirmed through lab results in 55.1% of patients. Without the GI Genius, the clinicians identified such lesions in 42.0% of patients.

The patients examined with the GI Genius received more biopsies, including slightly more that were not adenomas. But the biopsies did not lead to any adverse events such as perforations, infections, bleeding, or further biopsies.

Source: FDA

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Reactive Infectious Mucocutaneous Eruption associated with COVID-19

Formerly known as Mycoplasma-induced rash and mucositis, RIME has arisen as the preferred terminology to include mucocutaneous eruptions that are caused by other infectious agents. RIME secondary to SARS-CoV-2 infection, details its resolution with systemic steroids, and notes the potential for recurrence with subsequent milder symptoms, as has been previously reported. The combination of anosmia and ageusia, multiple positive SARS-CoV-2 PCR tests, and no other identified contemporaneous infections (the elevated Mycoplasma pneumoniae IgG titer with low IgM titer and negative nasopharyngeal PCR likely indicated prior exposure) suggests SARS-CoV-2 as the infectious trigger. The sparse cutaneous involvement and lack of dusky targetoid lesions also distinguish RIME from Stevens-Johnson syndrome and erythema multiforme (which has been described in association with SARS-CoV-2 infection).

Furthermore, RIME can be distinguished from the newly described multisystem inflammatory syndrome in children, which is associated with Kawasaki disease–like features, including mucocutaneous involvement, systemic symptoms, and dramatically elevated systemic inflammatory markers.

Initial Presentation 3 Days After Onset of Mucocutaneous Symptoms and 1 Week After Initial Anosmia and Ageusia

Source: JAMA

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Volanesorsen shows promise in Multifactorial Chylomicronemia

Volanesorsen significantly reduces triglyceride levels in patients with multifactorial chylomicronemia syndrome and may reduce acute pancreatitis events in these patients, according to results of the COMPASS trial.

In an earlier study, the researchers found that lowering hepatic apolipoprotein C-III (APOC3) synthesis with the antisense oligonucleotide volanesorsen effectively lowered triglycerides in patients with familial chylomicronemia syndrome.

The COMPASS phase-3 study explored the safety and efficacy of volanesorsen in patients with multifactorial chylomicronemia syndrome, also known as multifactorial severe hypertriglyceridemia.

COMPASS included 113 patients with multifactorial severe hypertriglyceridemia or familial chylomicronemia syndrome, who had a BMI of 45 kg/m2 or less and fasting plasma triglyceride of 500 mg/dL or higher.

By random assignment, 76 patients received subcutaneous volanesorsen (300 mg) once a week for 26 weeks and 38 received a matched volume of placebo. After 13 weeks of treatment, dosing was changed to 300 mg of volanesorsen or placebo every two weeks, except in patients who had completed at least five months of treatment.

The efficacy of treatment was independent of the type of genetic variants impairing lipoprotein lipase activity, which is a new finding that reinforces the notion that volanesorsen operates via lipoprotein lipase-independent mechanisms – eg, by inhibiting the production of triglyceride-rich lipoproteins.

Source: Lancet Diabetes and Endocrinology

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New HIV vaccine shows great results in phase 1 trial

The International AIDS Vaccine Initiative (IAVI) and Scripps Research have recently announced the results of an important Phase I clinical trial. The researchers tested a new vaccine approach designed to prevent HIV infections by stimulating the production of rare immune cells. These cells are needed to create the right antibodies to fight HIV.

The trial saw 48 participants divided into a low-dose group or a high-dose group. They received either the vaccine candidate or a placebo in two doses two months apart. Of those who received the vaccine, 97 percent had developed the right immune cells to respond to an HIV infection.

“This study demonstrates proof of principle for a new vaccine concept for HIV, a concept that could be applied to other pathogens, as well,” Dr William Schief, a professor and immunologist at Scripps Research and executive director of vaccine design at IAVI’s Neutralizing Antibody Center (NAC), whose laboratory developed the vaccine, said in a statement. “With our many collaborators on the study team, we showed that vaccines can be designed to stimulate rare immune cells with specific properties, and this targeted stimulation can be very efficient in humans. We believe this approach will be key to making an HIV vaccine and possibly important for making vaccines against other pathogens.”

The results were presented at the International AIDS Society HIV Research for Prevention (HIVR4P) virtual conference in February. The team has been looking to stimulate the body to create broadly neutralizing antibodies or bnABs, specialized blood proteins that can attach themselves to the spikes on the surface of HIV. This is an immune response that can neutralize diverse strains of the virus.

“We and others postulated many years ago that in order to induce bnAbs, you must start the process by triggering the right B cells — cells that have special properties giving them potential to develop into bnAb-secreting cells,” Schief explained. “In this trial, the targeted cells were only about one in a million of all naïve B cells. To get the right antibody response, we first need to prime the right B cells. The data from this trial affirms the ability of the vaccine immunogen to do this.”

Source: IAVI.org

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HCC risk reduced by aspirin in chronic viral hepatitis

HCC is the fourth-leading cause of cancer mortality worldwide, and is driven mostly by viral hepatitis B (HBV) and viral hepatitis C (HCV) infection. The risk of hepatocellular carcinoma (HCC) was reduced by 31% compared with no aspirin use, and liver-related mortality dropped by 27%, as long as aspirin use continued. The analysis showed that in aspirin users, the 10-year cumulative incidence of HCC was 4% compared with 8.3% in nonusers. After multivariable adjustment, aspirin users had a risk of HCC that was 31% lower compared with nonusers (adjusted subhazard ratio, 0.69; 95% confidence interval.

Source: New England Journal of Medicine

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Chronic adverse events likely common after Anti-PD-1 therapy for Melanoma

Chronic immune-related adverse events (irAEs) associated with anti-programmed cell death-1 (PD-1) therapy for melanoma were more common than previously thought in a retrospective multicenter study.

As reported in JAMA Oncology, Dr. Johnson and colleagues analyzed data on 387 melanoma patients treated at eight academic medical centers between 2015-2020. The median age was 63, 61% were men, and all received adjuvant anti-PD-1 for stage III-IV melanomas.

Sixty-nine percent of patients had any acute irAE, defined as arising during anti-PD-1 treatment, including 19.5% with grades 3-5 events. One patient had neurotoxicity and one had fatal myocarditis.

Chronic irAEs – those that persisted beyond 12 weeks after anti-PD-1 discontinuation – developed in 43.2% of patients; most (96.4%) were grade 1 or 2 and only 14% had resolved by the last available follow-up.

Source: Medscape

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Adjuvant Nivolumab in Resected Esophageal or Gastroesophageal Junction Cancer

When esophageal or gastroesophageal-junction cancer remains a threat after chemoradiotherapy and surgery because of residual pathological disease, treatment with the checkpoint inhibitor nivolumab doubles disease-free survival, according to the results of the large international CheckMate 577 trial.

The treatment, also used for kidney, liver, lung and a host of other cancers, is designed to block the cancer’s defense mechanism against the immune system. It costs about $165,000, sells under the brand name Opdivo.

Source: The New England Journal of Medicine

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BRCA1 & BRCA 2 mutations raise risk for Endometrial Cancer also

Women with a BRCA1 or BRCA2 mutation have an increased risk for endometrial cancer (EC), and the greatest risk is for the rare subgroup of serous-like and p53-abnormal endometrial cancers in BRCA1 mutation carriers, according to a Dutch study.

BRCA1 and BRCA2 mutation carriers had a significant two- to three-fold increase in EC risk, with the highest risk increases found for two EC subgroups with “unfavorable” clinical outcomes: serous-like histology (8-10 fold) and p53-abnormal EC (11-12 fold), the researchers report in the Journal of the National Cancer Institute.

Source: Journal of the National Cancer Institute.

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Quadruple medical therapy for Heart Failure

Quadruple therapy with an angiotensin receptor–neprilsyin inhibitor (ARNI), evidence-based β-blocker, mineralocorticoid receptor antagonist (MRA), and sodium glucose cotransporter 2 inhibitor (SGLT2i) may reduce risk of death by 73% over 2 years in patients with heart failure (HF) with reduced ejection fraction (HFrEF).

Simultaneous or Rapid Sequence Initiation of Comprehensive Disease-Modifying Medical Therapy (CDMMT) for Heart Failure:

Source: JAMA

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Higher calorie refeeding effective in teens with anorexia nervosa

Researchers examined data on adolescents (mean age 16.4 years) hospitalized with anorexia nervosa who were randomized to higher-calorie refeeding (n=60) or lower-calorie refeeding (n=51). Patients started higher-calorie refeeding (2,000 kcals/day, increasing by 200 kcals per day) or lower-calorie refeeding (1,400 kcals/day, increasing by 200 kcals every other day) within 24 hours of admission.

The primary endpoints were clinical remission at one year, defined by reaching a weight of at least 95% of median body mass index (BMI) based on U.S. Centers for Disease Control and Prevention growth charts, and psychological recovery, defined by achieving a global score within one standard deviation of community norms on the Eating Disorder Examination Questionnaire (EDE-Q).

Source: Reuters