Is there any evidence to back up the US president’s position?
Q. Is the drug that US President Donald Trump taking to reduce his risk of getting the coronavirus used in Ireland?
A. The drug hydroxychloroquine is used here as an antimalarial medicine. It is also used to treat conditions like lupus – an autoimmune disease – and arthritis, where it can help combat inflammation.
Q. It has been in the news now since March as a possible treatment for the coronavirus. Is there evidence for Mr Trump’s decision?
A. No. The main area of research in hospitals around the world, including in Ireland, is its role in treating patients who are very sick with the virus. Mr Trump has been taking it for two weeks on a prophylactic, or preventative, basis.
Q. What is the evidence from clinical trials on patients with the virus so far?
A. It was hyped as a potential game-changer but study findings so far are disappointing. The ‘British Medical Journal’ reported recently on a French trial which concluded that hydroxychloroquine does not significantly reduce admission to intensive care or improve survival rates in patients hospitalised with pneumonia due to the virus. It found 89pc of those who received hydroxychloroquine survived after 21 days, compared with 91pc in the control group. Trials are ongoing and there have been more promising reports on using hydroxychloroquine, the antibiotic azithromycin and zinc supplements, but the study must be peer reviewed.
Q. Are there risks associated with use of the drug outside of the conditions it is licensed to treat? What is the view of doctors and other experts here?
A. Due to the publicity about the drug there have been several circulars about it since early March. On March 30, the HSE issued advice to pharmacy contractors about its conservation because of its potential as an antiviral.
But last month the European Medicines Agency issued a public health statement saying recent studies have shown “serious, in some cases fatal, heart rhythm problems with chloroquine and hydroxychloroquine, particularly when taken at high doses or in combination with the antibiotic azithromycin”.
Doctors here have warned against following Mr Trump’s example. Dr Colm Henry, clinical adviser to the HSE, said yesterday: “The current advice from us in this country from the expert advisory group – in line with other countries – is that more research is needed before we demonstrate this is of any benefit either in prevention or treatment of Covid-19.”
Q. Is there any advice from the company which makes the drug?
A. Sanofi, the pharmaceutical firm, recently warned Irish doctors to take caution in any decision to prescribe the drug to treat Covid19 patients, especially in patients at risk of irregular heartbeat.
It said that hydroxychloroquine “has no marketing authorisation for the management of Covid-19 anywhere in the world...prescription of hydroxychloroquine for this purpose, outside the context of a clinical trial, is off-label”.
It said that so far “there is insufficient clinical evidence to draw any conclusion over the clinical efficacy and safety of hydroxychloroquine in the management of Covid-19, whether it is used as a single agent or in combination with any other medicines”.
The US Food and Drug Administration said it could have serious side-effects and needs to be taken under medical supervision.