RE: Recognition awareness5 Jul 2020 10:56
The W.H.O. suspends two drug studies, including one on hydroxychloroquine, over possible safety issues.
The World Health Organization on Saturday formally suspended its evaluation of two high-profile drug candidates in clinical trials designed to identify treatments effective against the coronavirus.
The W.H.O. formally adopted the recommendations of a steering committee and dropped the antimalarial drug hydroxychloroquine from its Solidarity trial, as well as the drug combination lopinavir/ritonavir, first developed as an antiviral against H.I.V., the virus that causes AIDS.
Hydroxychloroquine was promoted by the Trump administration as a preventive and treatment for Covid-19, the illness caused by the coronavirus. But neither hydroxychloroquine nor lopinavir/ritonavir has shown benefits in hospitalized Covid-19 patients. In clinical trials, both drugs have failed to reduce deaths among those with severe symptoms.
And though neither drug appeared to increase the risk of death, the W.H.O. report cited possible safety issues associated with both treatments.
A similar clinical trial of hydroxychloroquine, led by the National Institutes of Health, was halted in June, based on recent evidence of the drug’s lackluster performance. Just days prior, the Swiss drugmaker Novartis had discontinued its own hydroxychloroquine clinical trial after it was unable to enroll the 440 participants it needed.
The F.D.A. has also revoked emergency use authorization of hydroxychloroquine to treat hospitalized Covid-19 patients, and now cautions against using the drug, which has been linked to reports of serious heart rhythm problems, blood and lymph system disorders and other side effects.
The W.H.O.’s decision applies only to its studies involving patients hospitalized with Covid-19, leaving open the possibility for further evaluation of hydroxychloroquine and lopinavir/ritonavir in infected patients who have not yet been admitted to the hospital, or as a treatment to prevent those exposed to the coronavirus from getting sick. In the United States, clinical trials studying both drugs continue.
The Solidarity trial is also continuing its explorations of two other treatment strategies: one involving remdesivir, an antiviral that has been shown to speed recovery in patients hospitalized with Covid-19, and a second that combines lopinavir/ritonavir with interferon beta-1a, which decreases inflammation.