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US warns monkeypox could mutate to resist antiviral drug


WASHINGTON: U.S. health officials are warning against overusing the only drug available to treat monkeypox, saying even a small mutation in the virus can cause the drug to lose its effectiveness. use.
The Food and Drug Administration updated its guidance this week for Tpoxxhas been prescribed to tens of thousands of patients infected with the virus.
In an online update, FDA Officials warn that a single molecular change to monkeypox “could have a major impact on the antiviral activity of Tpoxx.” As the virus is constantly evolving to overcome obstacles to infection, including drugs, regulators insist that doctors should be “cautious” in prescribing drugs.
The call to scale back Tpoxx use follows weeks of criticism from HIV advocates and other patient groups, who have called for Biden managed to make antiviral drugs more widely available. Tpoxx is approved for the related smallpox virus, and its use against monkeypox is considered experimental and tightly controlled by federal officials.
Doctors who want to prescribe medicine must submit a prescription to Centers for Disease Control and Prevention, document the patient’s needs and agree to monitor their results and any side effects. Officials shipped 37,000 courses of medication to doctors.
Tpoxx works by targeting a unique protein found in monkeypox, smallpox, and similar viruses. The FDA said this week that numerous laboratory, animal and human reports suggest multiple ways in which smallpox in monkeys can develop resistance to the therapy.
The update comes as federal officials on Thursday expressed cautious optimism about the trajectory of the outbreak, noting that new cases have fallen about 50% since their peak in August. .
In one The White House meeting, CDC Director, Dr. Rochelle Walensky attributed the decline in vaccinations, access to education and individuals’ reductions in behaviors associated with contagion. The majority of cases in the US are in men who have sex with men, although officials stress that the virus can infect anyone.
Dr. Anthony Fauci, the nation’s top infectious disease official, noted that drug resistance is always a risk when using antiviral drugs.
“That’s why we’re uncomfortable when you only have a single drug,” Fauci told reporters. He added that a recently released study of Tpoxx supported by national health institutes will monitor for markers of mutations that can lead to drug resistance. The study is expected to enroll more than 500 patients across 60 US sites.
Last month, the Biden administration invoked rare emergency powers to prolong the nation’s limited supply of monkeypox vaccine. And last week, a separate statement promoted the use of experimental tests for the virus.
But no changes were made to allow emergency use of Tpoxx, prompting complaints from groups representing gay and bisexual people.
The US government’s national stockpile contains more than 1.7 million Tpoxx keys, originally manufactured for use in a potential bioterrorism attack.
The FDA approved the drug in 2018 under an “animal rule,” which allows for approval based on animal data when human testing is unethical or unfeasible. Smallpox was declared eliminated by the World Health Organization in 1980, ruling out the possibility of human studies.
Although this drug has been approved for smallpox, its effectiveness has been measured in monkeys infected with smallpox, which is considered a reasonably predictive marker of the effect of smallpox. season for humans. Animals receiving Tpoxx survived at a higher rate than animals receiving placebo. But FDA officials have warned that the animal results must be confirmed in human testing.
“Without human trials, we don’t know if Tpoxx would benefit people with monkeypox,” FDA commissioner Dr. Robert Califf told Senate lawmakers at the hearing. this week.
The CDC reported last week that 3.5% of patients monitored through their Tpoxx program reported side effects, mainly headaches and nausea.
The agency has only received back about 200 forms from physicians documenting a patient’s initial symptoms and outcomes, representing less than 1% of the doses shipped since the start of the outbreak.





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