The novel combined oral contraceptive, marketed as Nextstellis, contains 3 mg drospirenone (DRSP) and 14.2 mg of estetrol (E4) in tablet form. Estetrol is an estrogen that is naturally produced during pregnancy, but will now be produced from a plant source; it has not previously been used in oral contraceptives.
Source: FDA
For treatment of Chagas disease, benznidazole can be taken for a shorter period of time and at lower doses with similar efficacy to the current standard regimen and is much more tolerable, a new study suggests.
Chagas disease, caused by the protozoan Trypanosoma cruzi, is endemic in Latin America, where an estimated 5.7 million people are infected.
Benznidazole is a highly effective antiparasitic treatment for Chagas disease but side effects with the standard dose and long duration of treatment (300 mg daily for eight weeks) lead many patients to stop treatment.
The current study found that a reduced dose and shorter course of benznidazole is effective in patients with chronic indeterminate Chagas disease, with clearance of parasitemia and decrease in lytic antibody titers, with superior safety.
The BENDITA trial included 210 adults from Bolivia with chronic indeterminate Chagas disease, confirmed by serological testing and positive qualitative PCR results.
Source: Medscape
None of the 43 antibiotics currently in development as well as recently approved medicines are enough to combat the increasing emergence and spread of antimicrobial resistance, the World Health Organization cautioned.
Drug resistance is driven by the misuse and overuse of antibiotics and other antimicrobials, which encourages bacteria to evolve into “superbugs” and find new ways to beat the medicines. Previous studies have estimated AMR will kill tens of millions of people every year after 2050.
Out of the 43 antibiotics in development, the WHO said 26 drugs target the 13 most dangerous “superbugs”. But the health agency said most of these antibiotics are derivatives of existing classes, which could result in “rapid emergence of drug-resistance.”
Source: WHO
Remdesivir was the first drug approved by the FDA for treating the SARS-CoV-2 virus. It is indicated for treatment of COVID-19 disease in hospitalized adults and children aged 12 years and older who weigh at least 40 kg. The broad-spectrum antiviral is a nucleotide analog prodrug.
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Brazil’s P1 coronavirus variant, behind a deadly COVID-19 surge in the Latin American country that has raised international alarm, is mutating in ways that could make it better able to evade antibodies, according to scientists studying the virus. Studies have shown the P1 variant to be as much as 2.5 times more contagious than the original coronavirus and more resistant to antibodies.
Source: Medscape
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
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.
Source: JAMA
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.
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
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
