The Medicines Agency restricts tests on hydroxychloroquine

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Despite having a complicated name, between study and study and with various controversies in between, we have burned the term hydroxychloroquine . This Monday the Spanish Agency of Medicines and Health Products (AEMPS) published new measures around the trials on this drug, after the comings and goings of official organizations in the last month.

Thus, after publishing The Lancet a study that indicated that not only did not show benefits but that it increased mortality, the WHO decided in late May to temporarily suspend the trials. On June 3, the WHO decided to resume them, a day before The Lancet retracted it, unable to answer for the veracity of the data of several authors. That same June 3, The New England published the results of an investigation of hydroxychloroquine as a post-exposure preventive treatment (after having contact with infected patients): it is not effective .

On June 17, the WHO stopped the hydroxychloroquine treatment group in the Solidarity trial as it did not reduce mortality in patients hospitalized for Covid-19 when compared to the reference treatment. Recruitment for the Recovery trial (studying hydroxychloroquine in the UK) has also been definitively discontinued, concluding that hydroxychloroquine does not provide clinical benefit in hospitalized patients with coronavirus.

With all these results, the AEMPS has decided to implement measures for the 20 clinical trials currently in Spain , authorized in 107 hospital centers, which include hydroxychloroquine in one of its treatment arms: nine of them are for pre-exposure prophylaxis ( see if it is effective in protecting healthy individuals and preventing them from becoming infected); five evaluate the efficacy of treatment for hospitalized patients at different stages of disease severity; and the remaining six analyze the efficacy of the drug in patients with mild disease (of these, two also investigate post-exposure prophylaxis).

For those who have not started recruiting, the Aemps suspends its initiation and asks the promoters to justify that the population they are going to include in the trial differs from that included in the Recovery and Solidarity trials. "If the population is similar, it is expected that these trials do not provide significant differences to what we already know about the efficacy of hydroxychloroquine, so they should not start recruitment. If the population or the treatment differs, but there are other studies While they have started recruiting, the recommendation is to join the studies that are already active, "says the agency.

For trials that have already started recruitment targeting moderate and severe hospitalized patients and in post-exposure prophylaxis, the Aemps suspends recruitment and requests that they provide a justification that the population to be included differs from that included in the aforementioned trials. Recovery and Solidarity. "If there are no differences, recruitment in the hydroxychloroquine arms should be permanently suspended," adds Aemps. For pre-exposure prophylaxis studies and mild patients, the Aemps suggests continuing clinical trials "so as to allow additional evidence to be generated in order to make data-driven decisions."

"The problem is that the doses used in Recovery and Solidarity are very high, which is dangerous in the face of possible adverse effects. In 10 days in Recovery 9.6 grams of hydroxychloroquine were administered, while here in Spain 2.4 grams were administered in 5 days. The Jama magazine warned more than a month and a half ago that a double dose of chloroquine produced an increase in mortality. I would be careful not to stop these studies, I would keep the trials with lower doses than those used by Recovery "explains Jesús Sierra, head of the Hospital Pharmacy section of the Hospital de Jerez and coordinator of the Spanish Registry of Pharmacotherapy Results (Rerfar) versus Covid-19 of the Spanish Society of Hospital Pharmacy (SEFH).

"In these prophylaxis studies, the differences in the aggressiveness of the disease have not been measured. In other words, we know that they are infected the same despite using hydroxychloroquine, that is, it does not prevent, but we do not know if they become sicker or milder. Serious. This drug doesn't seem to be very effective. Even my feeling is that it could work more for its immunomodulatory profile (to modify the immune system) than for the retroviral one (to treat virus infections), "says Sierra.

To its experimental use in several Chinese hospitals in full outbreak and other controversies due to the limitations of some trials, hydroxychloroquine had its 15 minutes of fame thanks to the fact that Donald Trump defended it. Precisely this may have been the downfall of this drug. "The Lancet study has done a lot of damage to hydroxychloroquine, although it has been withdrawn due to not being able to verify the data, the damage has been done. I think the drug could have been very damaging also if Trump supported it, somehow a good result would have Validated what he defended, although he also proposed to inject bleach ... ", Elucubra Sierra.

The truth is that in any case the suspension, stresses the AEMPS, is not due to safety issues, but to the lack of clinical benefit "in hospitalized patients and for use in post-exposure prophylaxis." Hence, the Spanish body recommends its subscribed use "only in the setting of clinical trials that allow knowledge to be generated in those patients where the evidence is not, at the moment, so robust." And it should be remembered that, despite the fear that may have been generated by some adverse results when mixing this drug with other drugs, hydroxychloroquine is safe in the indications for which it is authorized , such as the treatment of malaria, lupus or rheumatoid arthritis.

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