Articles: sars-cov-2.
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The newly described SARS-CoV-2 respiratory virus is now righteously presenting as an ominous threat, based on the speed with which it originated a zoonosis from bats; advancing at a similar rate, the virus has placed mankind before a pandemic, with an infection toll of some 431 million, and a lethality of 5,9 million (as of February 25, 2022). The size of the harm that this agent can unleash against us is appallingly wide, from brain ischemia to foot chilblain, passing by heart massive infarction. ⋯ This will have to be avoided, and surveillance of society on psychological terms will be one tenet. Needless to say, the role of the enteric tract in these issues is growing higher, and it will be narrated to seal the matters with the last (not the least) touch of glue.
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Review
Drug Repurposing and Observational Studies: The Case of Antivirals for the Treatment of COVID-19.
Remdesivir and molnupiravir were the only 2 repurposed antivirals that were approved for emergency use during the COVID-19 pandemic. Both drugs received their emergency use authorization on the basis of a single industry-funded phase 3 trial, which was launched after evidence of in vitro activity against SARS-CoV-2. In contrast, for tenofovir disoproxil fumarate (TDF), little in vitro evidence was generated, no randomized trials for early treatment were done, and the drug was not considered for authorization. ⋯ Observational data in favor of TDF was systematically dismissed, even though no viable alternative explanations were proposed for the lower risk for severe COVID-19 among TDF users. Lessons learned from the TDF example during the first 2 years of the COVID-19 pandemic are described, and the use of observational clinical data to guide decisions about the launch of randomized trials during the next public health emergency is proposed. The goal is that gatekeepers of randomized trials make better use of the available observational evidence for the repurposing of drugs without commercial value.