Remde­sivir has lit­tle ef­fect on Covid-19 mor­tal­ity: WHO

Gilead calls the find­ings pre­ma­ture; an­a­lysts do not see much im­pact on In­dian mak­ers of the drug

Business Standard - - FRONT PAGE - SOHINI DAS

Gilead’s remde­sivir has lit­tle or no im­pact on Covid-19 pa­tients’ length of hospi­tal stay, ini­ti­a­tion of ven­ti­la­tion, or chances of sur­vival, a clin­i­cal trial by the World Health Or­ga­ni­za­tion (WHO) has found.

The US biotech gi­ant, how­ever, ques­tioned the find­ings of the study, say­ing th­ese were pre­ma­ture and the data ap­peared in­con­sis­tent. Other stud­ies, the firm said, had val­i­dated the drug’s ben­e­fits.

Listed phar­ma­ceu­ti­cal com­pa­nies that man­u­fac­ture remde­sivir in In­dia — Cadila Health­care, Ci­pla, and Ju­bi­lant Life Sci­ences — seemed to defy the neg­a­tive news, as their shares ended the day in the green. Cadila Health­care’s stock was, in fact, up 3.4 per cent on the BSE. In­dian clin­i­cians in­di­cated that they would con­tinue to pre­scribe the drug. The an­tivi­ral med­i­ca­tion was one of the drugs used to treat US Pres­i­dent Don­ald Trump’s coro­n­avirus in­fec­tion.

The re­sults of the WHO’S Sol­i­dar­ity trial, con­ducted on 11,266 hos­pi­talised

Covid-19 pa­tients across 30 coun­tries, found that remde­sivir, along with other re­pur­posed drugs hy­drox­y­chloro­quine (rheuma­toid arthri­tis drug), lopinavir/ri­ton­avir (used in lep­rosy), and in­ter­feron, “ap­peared to have lit­tle

ef­fect on in-hospi­tal mor­tal­ity”.

Se­nior of­fi­cials in In­dian pharma firms that have li­cens­ing agree­ments with Gilead to make and sell remde­sivir said they did not ex­pect a ma­jor fall in de­mand for the drug as long as doc­tors con­tin­ued to pre­scribe it.

An­a­lysts, too, said that for big pharma firms like Ci­pla and Cadila Health­care, there would not be any ma­jor down­side on the stock prices. “Remde­sivir’s con­tri­bu­tion to their top lines is not very sig­nif­i­cant, and we do not ex­pect doc­tors to sud­denly stop pre­scrib­ing the drug be­cause one study found it is not very use­ful,” said Sapna Jhawar, vice pres­i­dent (re­search), Do­lat Cap­i­tal.

Ex­plain­ing the clin­i­cian’s ex­pe­ri­ence, Satya­naryana Mysore, head of depart­ment of in­ter­ven­tional pul­monology at Ma­ni­pal Hos­pi­tals, said meta-anal­y­sis did not nec­es­sar­ily cap­ture the true essence of a drug’s ef­fi­cacy or im­pact on the pa­tient. “As part of the task force of re­mote med­i­cal guid­ance to hos­pi­tals across Kar­nataka, I have seen the dif­fer­ence the drug made,” he said.

“Prior to July 15, when the drug was not avail­able here, mor­bidi­ties and the sever­ity of cases in gov­ern­ment hos­pi­tals were much higher. Remde­sivir def­i­nitely helped,” he said, adding tim­ing of ad­min­is­ter­ing the drug could make a dif­fer­ence. Gilead ex­pressed con­cern that the data from the open-la­bel global trial had not been un­der a rig­or­ous re­view. Open-la­bel trial ba­si­cally means that par­tic­i­pants, as well as the in­ves­ti­ga­tors, know which drug is given to them. The Us-based drug ma­jor and the in­no­va­tor of Vek­lury, or remde­sivir, said it was un­clear if any “con­clu­sive” find­ings could be drawn from the study re­sults.

“The emerg­ing data ap­pears in­con­sis­tent with more ro­bust ev­i­dence from mul­ti­ple ran­domised, con­trolled stud­ies pub­lished in peer-re­viewed jour­nals val­i­dat­ing the clin­i­cal ben­e­fit of Vek­lury,” the com­pany said.

The com­pany said they were con­cerned that the data from this trial had not un­der­gone the rig­or­ous re­view re­quired to al­low for con­struc­tive sci­en­tific dis­cus­sion, par­tic­u­larly given the lim­i­ta­tions of the trial de­sign. WHO, how­ever, de­fended the data. "It's a re­li­able re­sult, don't let any­body tell you oth­er­wise, be­cause they'll try to,” Richard Peto, an in­de­pen­dent statis­ti­cian hired by WHO to scru­ti­nise its Sol­i­dar­ity trial re­sults, said.

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