AIFA Suspends Authorization to Use Hydroxychloroquine to Treat COVID-19 Outside Clinical Trials
From the beginning of the COVID-19 emergency, AIFA and its Technical-Scientific Commission (CTS) have been constantly engaged in a process of continuous updating of scientific evidence, and have prepared cards that gradually make the addresses explicit. therapeutics within which it is possible to foresee a controlled and safe use of the drugs used in this emergency.
In particular, in the absence of a specific therapeutic indication for COVID-19, hydroxychloroquine was made available to the NHS taking into account preliminary scientific evidence on COVID patients and in the face of a toxicity profile that appeared consolidated on the basis of uses authorized clinicians for the chronic treatment of rheumatic diseases. The Agency's position was therefore to foresee its use, at the dosages and for the times indicated in the sheets, in the context of an accurate assessment of the risk / benefit ratio in the individual cases, carefully considering the concomitant pathologies (long QT syndrome , major arrhythmias, liver or kidney failure, electrolyte disturbances), pharmacological associations (especially for drugs that increase QT) and a history of favism (G6PD deficiency).
At present, however, new clinical evidence relating to the use of hydroxychloroquine in subjects with SARS-CoV-2 infection (albeit deriving from observational studies or clinical trials of not high methodological quality) indicate an increased risk for adverse reactions in the face of little or no benefit.
For this reason, pending obtaining more solid evidence from clinical trials in progress in Italy and in other countries (with particular reference to randomized ones), AIFA suspends the authorization to use hydroxychloroquine for the treatment of SARS-CoV-2, outside clinical trials, both in the hospital and in the home setting. Such use is consequently excluded from reimbursement. It is also reiterated that the Agency has never authorized the use of hydroxychloroquine for preventive purposes.
The possible continuation of already started treatments is entrusted to the evaluation of the attending physician.
The AIFA form relating to the use of hydroxychloroquine in the therapy of adult patients with COVID-19 will be promptly updated.
Finally, it should be noted that, on the basis of the evidence currently available, there are no concrete elements that can change the assessment of the risk / benefit ratio for the indications already authorized (rheumatoid arthritis in the active and chronic phase and discoid and disseminated lupus erythematosus). Patients with rheumatic diseases treated with hydroxychloroquine can therefore continue therapy according to the indications of the attending physician.
As already stated, the Agency and the CTS are engaged in a process of continuous updating of the information relating to the efficacy and safety tests which will gradually become available.