WHO ad­vises doc­tors not to use Gilead’s remde­sivir for Covid-19

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THE World Health Or­ga­ni­za­tion ( WHO) rec­om­mended against us­ing Gilead Sciences Inc.’s remde­sivir to treat hos­pi­tal­ized Covid- 19 pa­tients less than a month af­ter US reg­u­la­tors granted the drug a speedy ap­proval.

“There is cur­rently no ev­i­dence that it im­proves sur­vival or the need for ven­ti­la­tion,” a panel of WHO­con­vened ex­perts de­vel­op­ing Covid- 19 treat­ment guide­lines said in THEBMJ med­i­cal jour­nal.

The rec­om­men­da­tion is a blow to Gilead’s drug, which was one of the first thought to of­fer a mean­ing­ful ben­e­fit in treat­ment of coron­avirus pa­tients af­ter a study showed it re­duced their re­cov­ery time. The an­tivi­ral has been used widely to treat Covid and was among the drugs Pres­i­dent Don­ald Trump re­ceived when he was di­ag­nosed with the dis­ease in early Oc­to­ber.

The ex­perts made the rec­om­men­da­tion af­ter the re­sults of a global trial spon­sored by the WHO, called Sol­i­dar­ity, found last month that remde­sivir didn’t re­duce deaths. They also re­viewed data from three other tri­als and said the drug “has no mean­ing­ful ef­fect” on the time it took pa­tients to clin­i­cally im­prove.

The US Food and Drug Ad­min­is­tra­tion ( FDA) ap­proved the drug a week later, bas­ing its de­ci­sion on a trial run by the Na­tional In­sti­tutes of Health that showed remde­sivir re­duced hos­pi­tal­ized pa­tients’ re­cov­ery time by five days.

Gilead has ques­tioned the re­sults of WHO’S trial and said the agency still has not re­leased key data to al­low the com­pany or oth­ers to eval­u­ate the reli­a­bil­ity of the in­terim re­sults.

Mul­ti­ple stud­ies pub­lished in peer- re­viewed jour­nals have showed remde­sivir, also known by its brand name, Vek­lury, is ben­e­fi­cial against the virus, par­tic­u­larly in im­prov­ing re­cov­ery time, “which can free up lim­ited hospi­tal re­sources,” Gilead said in a news statement on Thurs­day.

“We are dis­ap­pointed the WHO guide­lines ap­pear to ig­nore this ev­i­dence at a time when cases are dra­mat­i­cally in­creas­ing around the world and doc­tors are re­ly­ing on Vek­lury as the first and only ap­proved an­tivi­ral treat­ment for pa­tients with Covid- 19 in ap­prox­i­mately 50 coun­tries,” ac­cord­ing to the statement.

De­spite the dis­cor­dance with the WHO, the FDA said in its re­view of remde­sivir that “there were no is­sues iden­ti­fied that would ben­e­fit from dis­cus­sion” by a panel of out­side ad­vis­ers. FDA typ­i­cally con­venes such a panel be­fore de­cid­ing whether to ap­prove a drug in sit­u­a­tions where there are ques­tions aris­ing from clin­i­cal trial data.

‘Rel­a­tively high cost’

THE FDA orig­i­nally granted emer­gency use au­tho­riza­tion to remde­sivir in May. Gilead re­quested full FDA ap­proval in Au­gust. The Euro­pean Com­mis­sion granted the drug con­di­tional au­tho­riza­tion in July based on the US- led clin­i­cal trial.

Other coun­tries have also ap­proved remde­sivir as a treat­ment for Covid. Ja­pan’s chief Cab­i­net sec­re­tary, Kat­sunobu Kato, said Fri­day there’s no need for the na­tion, which gave its nod in May, to re­view remde­sivir’s ap­proval at this time. Zhong Nan­shan, a Chi­nese ex­pert on in­fec­tious dis­ease, said at a con­fer­ence in Zhuhai that remde­sivir isn’t“en­tirely use­less,”cit­ing short­ened hospi­tal stays among mild pa­tients in the US.

The WHO ex­perts wrote in The BMJ that their find­ings shouldn’t be in­ter­preted to mean that remde­sivir is in­ef­fec­tive, but that “there is no ev­i­dence based on cur­rently avail­able data that it does im­prove pa­tient- im­por­tant out­comes.”

The lim­ited ev­i­dence for us­ing the drug was weighed along­side the “rel­a­tively high cost and re­source im­pli­ca­tions as­so­ci­ated with remde­sivir,” which is given in­tra­venously, they said in a news re­lease.

The FDA was ear­lier crit­i­cized for hastily au­tho­riz­ing an an­ti­malar­ial drug, hy­drox­y­chloro­quine, to treat Covid- 19. Trump re­peat­edly touted the drug early in the pan­demic, though med­i­cal ev­i­dence was lack­ing to sup­port his claims. The FDA then re­voked its au­tho­riza­tion af­ter hy­drox­y­chloro­quine was shown not to com­bat the virus and was linked to harm­ful side ef­fects.

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