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Highlights provide a timely synopsis of selected interesting developments emerging in the last two weeks from the information universe covered by the PCORI Health Care Horizon Scanning System (HCHSS). Information covers currently emerging innovations in patient-centered care that may or may not be directly related to the Topics to Watch. The views presented here are solely those of ECRI Horizon Scanning and have not been vetted by other stakeholders.

The US Food and Drug Administration's (FDA’s) Vaccines and Related Biological Products Advisory Committee has voted unanimously to support development of annual vaccines to match future SARS-CoV-2 strains. Recent data show that the current bivalent boosters are significantly more effective than the previous monovalent boosters at protecting against severe Omicron infection and show promise against subvariants XBB and XBB.1.5 plus CH.1.1 and CA.3.1.

Post-COVID conditions continue to keep many out of work, but there are preliminary hopes of prevention through treatment with the mood stabilizer lithium (see Topics to Watch), the antiviral drug Paxlovid (nirmatrelvir and ritonavir), or the diabetes drug metformin.

These past two weeks saw fascinating early signs of the healthcare future. Electronic health records suggest 22 possible links between viral infections and brain diseases, such as Alzheimer’s disease, while a speech brain–computer interface implant has reportedly allowed a patient with amyotrophic lateral sclerosis (ALS, or Lou Gehrig’s disease) to communicate 62 words per minute.

New tools for modifying T cells, such as CRISPR (a genetic tool using clustered regularly interspaced short palindromic repeats) and synthetic biology, may make future CAR-T (chimeric antigen receptor T-cell) therapies less expensive and less dangerous, according to a recent news item in the journal Nature. The review charts progress made in treatment of solid tumors, particularly for gliomas. See Topics to Watch for a glioma treatment that is on the horizon.

Topics to Watch

ECRI Horizon Scanning has selected the topics below as those with potential for impact within the PCORI HCHSS’s focus areas in the United States within the next 3 years. All views presented are preliminary and based on readily available information at the time of writing. Because these topics are rapidly developing, we cannot guarantee the accuracy of this information after the date listed on this publication. In addition, all views expressed in the commentary section are solely those of ECRI Horizon Scanning and have not been vetted by other stakeholders. Topics are listed in alphabetical order.

Low-Dose Lithium to Treat Post-COVID Conditions

At a Glance

  • An unmet need exists for accessible, inexpensive treatments for post-COVID conditions (PCC), effects that often persist after acute SARS-CoV-2 infection.
  • Studies suggest that PCC symptoms may result from prolonged systemic inflammation and persistent reservoirs of SARS-CoV-2 in certain tissues. Lithium, a mood stabilizer and well-established treatment for bipolar disorder, may also be of benefit as a PCC treatment through anti-inflammatory mechanisms.
  • Data from a proof-of-concept study in patients hospitalized with COVID-19 suggest that low-dose lithium (10 mg/d) might lower the risk of developing PCC.
  • Based on these observations, the University of Buffalo is conducting a phase 2 randomized, placebo-controlled clinical trial to evaluate whether low-dose lithium reduces PCC-associated fatigue, cognitive impairment, anxiety, headache, pain, and sleep disturbances.
  • Based on the cost of standard-dose lithium used to treat bipolar disorder, a full course to treat PCC might be about $20.

For a description and commentary about this topic/issue, download this Innovation Brief.

Tovorafenib (DAY101) to Treat Relapsed or Progressing Pediatric Low-Grade Glioma

At a Glance

  • Pediatric low-grade glioma (pLGG) is a rare brain cancer that currently requires years of aggressive surgery, radiation, and chemotherapy to manage.
  • BRAF is a key protein of the mitogen-activated protein kinase (MAPK) cell signaling pathway, which regulates cell survival, proliferation, differentiation, and stress responses. Hyperactivating BRAF gene alterations are frequently seen in LGG.
  • Tovorafenib (DAY101) is an experimental oral inhibitor of all RAF isoforms that is being tested to treat relapsed or progressing pLGG in patients with BRAF alterations.
  • Topline data from the ongoing phase 2 FIREFLY-1 trial suggest that tovorafenib is well tolerated and elicits responses in children, adolescents, and young adults with pLGG when other BRAF inhibitors have been ineffective.
  • The developer plans to submit a new drug application (NDA) to the FDA in the first half of 2023, which will include additional follow-up data from the full study population.

For a description and commentary about this topic/issue, download this Innovation Brief.

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We welcome your comments on this Innovation Brief at [email protected].

Posted: February 15, 2023

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