{"id":734,"date":"2021-12-03T05:07:38","date_gmt":"2021-12-03T05:07:38","guid":{"rendered":"https:\/\/aanewshop.com\/index.php\/2021\/12\/03\/mercks-covid-19-pill-may-soon-be-here-how-well-will-it-work\/"},"modified":"2021-12-03T05:07:38","modified_gmt":"2021-12-03T05:07:38","slug":"mercks-covid-19-pill-may-soon-be-here-how-well-will-it-work","status":"publish","type":"post","link":"https:\/\/aanewshop.com\/index.php\/2021\/12\/03\/mercks-covid-19-pill-may-soon-be-here-how-well-will-it-work\/","title":{"rendered":"Merck\u2019s COVID-19 pill may soon be here. How well will it work?"},"content":{"rendered":"<p> [ad_1]<br \/>\n<\/p>\n<div data-component=\"video-embed\">\n<p>Hopes for an easy pill that could combat COVID-19 before people land in the hospital have dimmed a bit. New data about an antiviral pill made by Merck with its partner Ridgeback Pharmaceuticals show it\u2019s not as stellar as first believed. And the drug has drawbacks that could outweigh its potential to fight the coronavirus and keep people out of the hospital.<\/p>\n<p>The U.S. Food and Drug Administration is now weighing whether to grant emergency use authorization for the drug, called molnupiravir, after the agency\u2019s advisory panel narrowly voted to recommend it on November 30. The drug was <a href=\"https:\/\/www.gov.uk\/government\/news\/first-oral-antiviral-for-covid-19-lagevrio-molnupiravir-approved-by-mhra\">authorized for use in the United Kingdom<\/a> on November 4. \u00a0If the FDA follows suit, it could wind up being just a stopgap: Some advisers already have urged the agency to be ready to withdraw that authorization as soon as something better comes along.<\/p>\n<p><a href=\"https:\/\/www.sciencenews.org\/article\/coronavirus-covid-19-why-early-treatment-drugs\">Finding an early treatment hasn\u2019t been easy<\/a>, so many experts initially hailed the development of molnupiravir as a potential game changer for the pandemic: A pill that could be given to people early in the infection might help keep health care systems from being overwhelmed, and spare people at high risk from the most severe complications (<em>SN: 7\/27\/21<\/em>). <\/p>\n<p>In a clinical trial, the drug showed <a href=\"https:\/\/www.sciencenews.org\/article\/coronavirus-covid-antiviral-pill-merck-molnupiravir-hospitalization-death\">early signs of preventing hospitalization and death<\/a> from COVID-19 in people at high risk of severe disease (<em>SN: 10\/1\/21<\/em>). In fact, the results were so promising \u2014 a 48 percent reduction in the relative risk of hospitalization or death \u2014 that the trial was stopped so that the drug might potentially reach the public earlier.<\/p>\n<section class=\"newsletter-signup__wrapper___DVd9U\">\n<picture><source srcset=\"https:\/\/www.sciencenews.org\/wp-content\/themes\/sciencenews\/client\/src\/images\/cta-module@1x.jpg 1x,&#10;&#9;&#9;&#9;&#9;https:\/\/www.sciencenews.org\/wp-content\/themes\/sciencenews\/client\/src\/images\/cta-module@2x.jpg 2x\" media=\"(min-width: 768px)\"><source srcset=\"https:\/\/www.sciencenews.org\/wp-content\/themes\/sciencenews\/client\/src\/images\/cta-module-sm@1x.jpg 1x,&#10;&#9;&#9;&#9;&#9;https:\/\/www.sciencenews.org\/wp-content\/themes\/sciencenews\/client\/src\/images\/cta-module-sm@2x.jpg 2x\"><img decoding=\"async\" class=\"newsletter-signup__background___3SW2w\" src=\"https:\/\/www.sciencenews.org\/wp-content\/themes\/sciencenews\/client\/src\/images\/cta-module-sm@2x.jpg\" alt=\"\"\/><br \/>\n<\/source><\/source><\/picture>\n<div class=\"newsletter-signup__container___N89vM\" data-component=\"newsletter-signup\">\n<div class=\"text\">\n<h3 class=\"newsletter-signup__heading___1dxzt\">\n\t\t\t\tSign Up For the Latest from <em>Science News<\/em>\t\t\t<\/h3>\n<div class=\"newsletter-signup__message___zLR0I\">\n<p>Headlines and summaries of the latest <em>Science News<\/em> articles, delivered to your inbox<\/p>\n<\/p><\/div>\n<\/p><\/div>\n<div class=\"newsletter-signup__form-wrapper___fEuHP\">\n<div class=\"newsletter-signup__thankyou___3LtPI\" role=\"alert\">\n<p>Thank you for signing up!<\/p>\n<\/p><\/div>\n<div class=\"newsletter-signup__error___1tzT6\" role=\"alert\">\n<p>There was a problem signing you up.<\/p>\n<\/p><\/div>\n<\/p><\/div>\n<\/p><\/div>\n<\/section>\n<p>But on November 26, Merck announced in a news release that when all the available data from the trial was in, the<a href=\"https:\/\/www.merck.com\/news\/merck-and-ridgeback-biotherapeutics-provide-update-on-results-from-move-out-study-of-molnupiravir-an-investigational-oral-antiviral-medicine-in-at-risk-adults-with-mild-to-moderate-covid-19\/\"> reduction in relative risk fell to 30 percent<\/a> against hospitalization and death compared with a placebo. The shift stemmed from an unexplained decrease in severe disease among people in the placebo group in the last part of the trial.<\/p>\n<p>In data collected from May 7 through August 5, 53 of 377 people (or 14.1 percent) in the placebo group were hospitalized and eight died (2.1 percent). In the molnupiravir group, 28 of 385 people (7.3 percent) were hospitalized and none died.<\/p>\n<p>But an FDA analysis of subsequent data showed that from August 6 through October 2, 15 of the 322 people (4.7 percent) in the placebo group were hospitalized and one died (less than 1 percent). Of the 324 people who got molnupiravir during that time period, 20 (6.2 percent) were hospitalized and one died (less than 1 percent), making molnupiravir appear to produce worse outcomes than placebo.<\/p>\n<p>Overall, among the 709 people in the molnupiravir group, there were 48 hospitalizations and one death compared with 68 hospitalizations and nine deaths among the 699 people who got a placebo, dropping the effectiveness from the initial 48 percent to 30 percent.<\/p>\n<h3>Split support<\/h3>\n<p>Taking that lower-than-expected efficacy into account, the FDA\u2019s antimicrobial drugs <a href=\"https:\/\/www.fda.gov\/advisory-committees\/advisory-committee-calendar\/november-30-2021-antimicrobial-drugs-advisory-committee-meeting-announcement-11302021-11302021#event-materials\">advisory committee<\/a> came to a <a href=\"https:\/\/www.fda.gov\/advisory-committees\/advisory-committee-calendar\/november-30-2021-antimicrobial-drugs-advisory-committee-meeting-announcement-11302021-11302021#event-materials\">split 13\u201310 decision<\/a> about whether the antiviral drug should be granted emergency use authorization, with experts on each side of the vote often agreeing with points made by the opposing side. The debate and vote reflected a storm of uncertainty about the drug\u2019s efficacy and who should use it \u2014 the list of people who would not be eligible is far longer than those most experts would give the drug to. The panel also queried whether the drug could lead to even more dangerous versions of the coronavirus, whether it can cause growth delays in children or mutations in human DNA, and other unanswered questions.<\/p>\n<aside class=\"wp-block-sciencenews-inline-related-post alignleft\">\n<h4>\n<a href=\"https:\/\/www.sciencenews.org\/editors-picks\/2019-novel-coronavirus-outbreak\">See all our coverage of the coronavirus outbreak<\/a><br \/>\n<\/h4>\n<\/aside>\n<p>Virologist John Coffin of Tufts University in Boston said during the FDA meeting that he\u2019s dreamed of a small molecule drug that could effectively treat viral infections. \u201cI\u2019m not sure [molnupiravir] is the one we\u2019ve been waiting for, but it\u2019s all we\u2019ve got at the moment.\u201d He voted in favor of the drug but was among those urging the FDA to reconsider if better options become available.<\/p>\n<p>Something better might already be on the horizon if an antiviral pill made by Pfizer lives up to its early promise of an 89 percent decrease in hospitalization and death compared with placebo if taken within three days of symptom onset. That drug works differently than molnupiravir and may not have the same safety concerns.<\/p>\n<p>Another early treatment, lab-made <a href=\"https:\/\/www.sciencenews.org\/article\/covid-19-coronavirus-antibodies-lab-treatment-immune-system\">monoclonal antibodies, is already authorized<\/a> for use in nonhospitalized COVID-19 patients  (<em>SN: 9\/22\/20<\/em>). But that treatment has to be given intravenously, requiring a trip to an infusion center. Many people don\u2019t have ready access to such a facility. Some new variants of the coronavirus can also evade some of these antibodies.<\/p>\n<h3>Drug drawbacks<\/h3>\n<p>Among the worries about authorizing molnupiravir is the possibility that the antiviral could spur evolution of more dangerous versions of the coronavirus. The antiviral pill works by making mutations in viral RNA so that viruses are rendered noninfectious and eventually stop replicating. Such mutations happen throughout the virus\u2019s genetic instruction book, or genome.<\/p>\n<p>Some of those mutations could land in the spike protein, which helps the coronavirus break into cells, or other proteins and make the virus more transmissible or more evasive to vaccines. That\u2019s especially a fear if people don\u2019t finish the full five-day course of the drug needed to render the virus inoperable, leading potentially to highly mutated new forms of the virus that could infect others.\u00a0<\/p>\n<p>\u201cThe potential for this drug to drive some very challenging variants into the public is of major, major concern,\u201d said James Hildreth, an immunologist and president of Meharry Medical College in Nashville.<\/p>\n<p>Merck representatives said that possibility is unlikely, because after five days of taking even a half dose of the drug, infectious viruses were no longer detectable among study participants tested. In one study, the company found seven patients who had changes in the coronavirus\u2019s spike protein after taking molnupiravir, but there was no evidence that the viruses spread to other people or affected the patient\u2019s health (none were hospitalized or died).<\/p>\n<p>Molnupiravir might also create mutations in human DNA, researchers say. The drug is a nucleoside analog \u2014 an artificial RNA building block that can mimic the bases cytosine and uracil. Some enzymes in human cells might convert those RNA subunits to a DNA building block, which may lead to mutations in human DNA, especially in rapidly reproducing cells, such as blood cells. How likely that is is an open question.<\/p>\n<p>Lab tests with bacteria and cells grown in lab dishes suggested that the drug might cause such DNA mutations under certain circumstances. But tests in animals suggested that the risk of such mutations actually happening in the body is low. To reduce the chance of such mutations happening, people would be able to take molnupiravir for no more than five days. That should be long enough to eliminate the virus but short enough not to cause lasting harm.<\/p>\n<h3>Limited eligibility<\/h3>\n<p>Animal studies have also indicated that molnupiravir might interfere with bone growth, so the drug probably would not be given to pregnant women or to children or adolescents. For three months, researchers gave rats doses of the drug nine to 15 times higher than people would receive. Those young rats had trouble converting cartilage at growth plates \u2014 tissue at the end of long bones that determines the bone\u2019s future length and shape \u2014 into bone. But the problem wasn\u2019t seen if rats were dosed for one month or if they got a dose similar to what people would get.<\/p>\n<p>Such bone problems would not be an issue for adults, but more data are needed before giving the drug to kids or to pregnant women, experts say.<\/p>\n<p>It\u2019s also unclear whether the drug will help vaccinated people, or be effective against the delta variant. It\u2019s efficacy also varied depending on a patient\u2019s high-risk health condition. It was good at keeping people with obesity out of the hospital, but more people with diabetes ended up hospitalized while taking the drug than in the placebo group.<\/p>\n<h3>Filling a need<\/h3>\n<p>Still, there are no good remedies for people with mild to moderate COVID-19. Yet as of November 30, more than 82,000 people in the United States are being diagnosed with COVID-19 each day and more than 800 die. Those numbers are expected to increase as case counts surge in some parts of the country. The new <a href=\"https:\/\/www.sciencenews.org\/article\/omicron-coronavirus-variant-vaccines-mutations\">omicron variant might add fuel to that fire<\/a> if it proves more contagious than the currently dominant delta variant (<em>SN: 12\/1\/21<\/em>).<\/p>\n<p>So even with all of molnupiravir\u2019s drawbacks, federal regulators might decide a 30 percent reduction in hospitalizations and deaths is worth giving the drug temporary authorization.<\/p>\n<p>The drug might be helpful for \u201cthe right patient population, the right virus at the right time,\u201d said Lindsey Baden, an infectious diseases doctor at Brigham and Women\u2019s Hospital in Boston who chaired the FDA\u2019s advisory committee. \u201cTo me that at least suggests there are populations where there may be benefit.\u201d<\/p>\n<p>But more studies need to be done to address concerns about the drug, he said. \u201cIt\u2019s the absence of data that makes many of us uncomfortable.\u201d<\/p>\n<p>President Joe Biden said December 2 during remarks laying out a plan to combat the omicron variant that the government has secured a supply of the drugs and, if authorized, will distribute them similarly to vaccines.<\/p>\n<aside class=\"wp-block-sciencenews-inline-related-post\">\n<h4><a href=\"https:\/\/www.sciencenews.org\/article\/sign-up-for-e-mail-updates-on-the-coronavirus-outbreak\">Sign up for e-mail updates on the latest coronavirus news and research<\/a><\/h4>\n<\/aside><\/div>\n<p>[ad_2]<br \/>\n<br \/><a href=\"https:\/\/www.sciencenews.org\/article\/covid-pill-merck-molnupiravir-antiviral-fda\">Source link <\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>[ad_1] Hopes for an easy pill that could combat COVID-19 before people land in the hospital have dimmed a bit. New data about an antiviral pill made by Merck with its partner Ridgeback Pharmaceuticals show it\u2019s not as stellar as first believed. And the drug has drawbacks that could outweigh its potential to fight the [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[],"class_list":["post-734","post","type-post","status-publish","format-standard","hentry","category-science"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.0 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Merck\u2019s COVID-19 pill may soon be here. How well will it work? - AA News Shop<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.sciencenews.org\/article\/covid-pill-merck-molnupiravir-antiviral-fda\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Merck\u2019s COVID-19 pill may soon be here. How well will it work? - AA News Shop\" \/>\n<meta property=\"og:description\" content=\"[ad_1] Hopes for an easy pill that could combat COVID-19 before people land in the hospital have dimmed a bit. New data about an antiviral pill made by Merck with its partner Ridgeback Pharmaceuticals show it\u2019s not as stellar as first believed. 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