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Definitions for SARS-CoV-2 Variant of Interest & Variant of Concern

WHO has working definitions for SARS-CoV-2 Variant of Interest (VOI) and Variant of Concern (VOC).

A SARS-CoV-2 VOI is a SARS-CoV-2 variant with genetic changes that are predicted or known to affect virus characteristics such as transmissibility, disease severity, immune escape, diagnostic or therapeutic escape; and that has been identified as causing significant community transmission or multiple COVID-19 clusters, in multiple countries with increasing relative prevalence alongside increasing number of cases over time, or other apparent epidemiological impacts to suggest an emerging risk to global public health.

A SARS-CoV-2 VOC is a SARS-CoV-2 variant that meets the definition of a VOI (see above) and, through a comparative assessment, has been demonstrated to be associated with one or more of the following changes at a degree of global public health significance, increase in transmissibility or detrimental change in COVID-19 epidemiology; OR increase in virulence or change in clinical disease presentation; OR decrease in effectiveness of public health and social measures or available diagnostics, vaccines, therapeutics.

Source: WHO

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Omicron: A variant of concern

WHO designated the variant B.1.1.529 a variant of concern, named Omicron, on the advice of WHO’s Technical Advisory Group on Virus Evolution (TAG-VE). It is not yet clear whether Omicron is more transmissible compared to other variants, including Delta. The number of people testing positive has risen in areas of South Africa affected by this variant, but epidemiologic studies are underway. It is not yet clear whether infection with Omicron causes more severe disease compared to infections with other variants, including Delta. Preliminary data suggests that there are increasing rates of hospitalization in South Africa, but this may be due to increasing overall numbers of people becoming infected, rather than a result of specific infection with Omicron. there may be an increased risk of reinfection with Omicron as compared to other variants of concern, but information is limited. The widely used PCR tests continue to detect infection, including infection with Omicron, as we have seen with other variants as well.

Source: WHO

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The case of the ‘Esperanza patient’ whose HIV infection vanished naturally

Researchers have reported that a woman living with HIV in Argentina is now the second person whose immune system rid itself of the virus. She was diagnosed with HIV-1 in 2013. Researchers found that she might potentially be an “elite controller” of the virus, showing no signs of active HIV infection in the 8 years since her diagnosis.

The Esperanza patient is just the second person reported to have possibly staved off the virus naturally- ultimately erasing any signs of active HIV without the assistance of medical therapies like stem cell transplants. The first was a woman from California, Loreen Willenberg, who is now 67 years old. She was diagnosed with HIV in 1992, and her immune system apparently performed the same function of naturally eliminating HIV.

Source: Healthline

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FDA approves Vosoritide for children with Achondroplasia

The US FDA has approved vosoritide (Voxzogo) daily injection for the treatment of children with achondroplasia. Indicated to increase linear growth in pediatric patients aged ≥5 years who have achondroplasia with open epiphyses.

Route: SC Inj.

MOA: Analog of C-type natriuretic peptide (CNP); this peptide binds to natriuretic-peptide receptor B (NPR B), which induces synthesis of cGMP molecules, which, in turn, inhibits the MAPK pathway.

Adverse Effects: Injection site erythema (75%), Injection site swelling (62%), Vomiting (27%), Injection site urticaria (25%), Arthralgia (15%), Decreased blood pressure (13%), Gastroenteritis (13%)

Source: Medscape

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FDA approves ropeginterferon for adults with polycythemia vera

The U.S. FDA approved Besremi (ropeginterferon alfa-2b-njft) injection to treat adults with polycythemia vera, a blood disease that causes the overproduction of red blood cells. The excess cells thicken the blood, slowing blood flow and increasing the chance of blood clots.

Besremi has a longer half-life than do other pegylated interferon-alfas, allowing for dosing every 2 weeks instead of weekly.

Besremi can cause liver enzyme elevations, low levels of white blood cells, low levels of platelets, joint pain, fatigue, itching, upper airway infection, muscle pain and flu-like illness. Side effects may also include urinary tract infection, depression and transient ischemic attacks. May cause or worsen neuropsychiatric, autoimmune, ischemic and infectious diseases.

Source: FDA

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FDA approves mobocertinib for NSCLC with EGFR exon 20 insertion mutations

The US FDA has granted an accelerated approval to mobocertinib for the treatment of patients with locally advanced or metastatic nonsmall cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations. The drug is limited to use in patients whose disease has progressed on or after platinum-based chemotherapy and who have had the EGFR exon20 insertion mutation detected on an FDA-approved test. Mobocertinib is the first oral tyrosine kinase inhibitor (TKI) specifically designed to target these mutations, which are less common than the more predominant EGFR mutations in this lung cancer. The most common adverse reactions (> 20%) were diarrhea, rash, nausea, stomatitis, vomiting, decreased appetite, paronychia, fatigue, dry skin, and musculoskeletal pain, according to the company. The prescribing information includes a boxed warning for QTc prolongation and Torsades de Pointes, and warnings and precautions for interstitial lung disease/pneumonitis, cardiac toxicity, and diarrhea.

Source: Medscape

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Novel diabetic foot ulcer cream shows promise in phase 3 trial

ON101 (Fespixon, Oneness Biotech), a first-in-class, macrophage-regulating, wound-healing cream for diabetic foot ulcers has shown benefit over absorbent dressings in a phase 3 trial, with another trial ongoing. The published trial showed that foot ulcers treated with ON101 cream were almost three times more likely to be completely healed at 16 weeks than those treated with standard care with an absorbent dressing (Aquacel Hydrofiber, ConvaTec) (odds ratio, 2.84; P < .001).

Source: Medscape

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Subcutaneous Inj. vedolizumab appears to be effective maintenance therapy in IBD-UC

Subcutaneous vedolizumab appears to be an effective and safe maintenance therapy for some patients with moderate to severe active Crohn’s disease, according to results of a phase-3 trial. Vedolizumab, the first gut-selective biologic for the treatment of inflammatory bowel disease, now offers IV and SC routes of administration for maintenance therapy.

Source: Journal of Crohn’s and Colitis

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FDA approves first vagus nerve stimulation system for stroke rehab

The US FDA has approved the Vivistim System (MicroTransponder), a first-of-its kind vagus nerve stimulation (VNS) system intended to treat moderate-to-severe upper extremity motor deficits associated with chronic ischemic stroke. The Vivistim® System stimulates the vagus nerve while the patient is undergoing a rehabilitative movement, which tells the brain to “pay attention” to that movement. This simultaneous pairing of a specific movement with vagus nerve stimulation (VNS) strengthens motor circuits associated with the physical movement. Consistently pairing VNS with specific neural circuits helps rebuild those circuits and the brain relearns the commands to enable the muscles to perform specific tasks and can strengthen those muscles as well. This simultaneous pairing of muscle movement with VNS strengthens the neural circuits in the brain. Over time, a patient may regain upper limb function.

Source: MicroTransponder

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Dapagliflozin might reduce the risk for ventricular arrhythmias in HFrEF

The addition of dapagliflozin to standard therapy reduced the relative risk for the primary composite endpoint of any serious ventricular arrhythmia, resuscitated cardiac arrest, or sudden death by 21%. Dapagliflozin and other SGLT2 inhibitors have favorable effects on adverse cardiac remodeling, which contributes to sudden death and ventricular arrhythmia. They’ve also been shown to reduce cardiac chamber size, left ventricular hypertrophy, and N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels over time, consistent with a reduction in in myocardial wall stress.

Source: Medscape