Efficacy of Hydroxy Confirmed in 3,451 Italian patients – 30% mortality reduction

EXCLUSIVE INTERVIEW: Efficacy of hydroxychloroquine confirmed in 3451 Italian patients. Mortality reduction of 30%.

PETER D’ANGELO for FRANCE SOIR

An Italian study carried out on a group of more than 3,000 patients hospitalized for Covid-19 concluded that “the use of hydroxycholoroquine is associated with a 30% reduction in mortality”.

The research mobilized the main Italian hospitals, from north to south, including the university polyclinic “Agostino Gemelli”, where Roberto Cauda is the Director of the Infectology Department. “Our structure provided data for this retrospective multicentric study. It must be said that the clinical results on mortality reduction are consistent and in line with the other hospitals involved, there is a significant difference with the group treated with hydroxychloroquine” – and concludes – “but it is necessary that by the fall, a serious meta-analysis of all published studies on hydroxychloroquine be carried out”.

Currently, treatment is still blocked by European health regulatory agencies. To better understand how the research was carried out, we interviewed the head of the study, Licia Iacoviello, Director of the Centre for Epidemiology and Preventive Medicine at the University of Insubria, Varese, and Director of the Department of Epidemiology and Prevention at IRCCS Neuromed.

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MSDS: How many patients are involved in your study?

LI: Our study (COVID-19 RISK and CORIST Collaboration Treatments) was conducted on a cohort of 3,451 patients admitted to 33 clinical centers across Italy. It is a retrospective observational study.

FS: What are the structures involved in the collection of clinical data on patients?

LI: The study involved 33 structures, among the most recognized and important in Italy: Gemelli, Humanitas, San Matteo di Pavia, San Donato, San Gerardo di Monza, Spallanzani, Cotugno di Napoli, Miulli di Acquaviva delle Fonti, Monzino. University of Naples Federico II, Catania, Palermo, Cagliari, Chieti.

FS: This is a study involving Italian hospital structures, from North to South. What conclusions did you reach?

LI: We found a 30% reduction in the risk of death in patients receiving hydroxychloroquine. The inverse association of hydroxychloroquine with hospital mortality was particularly evident in patients who had  high levels of C-reactive protein on entry.

FS: What do you mean by “they had high levels of C-reactive protein on entry”?

LI: C-reactive protein is a marker for inflammation. Having a high level of C-reactive protein at the hospital entrance means that the Sars Covid II infection caused a significant inflammatory response. We believe that HCQ acts on this very component of the disease rather than inhibiting viral replication.

MSDS: What were the mortality rates in the hydroxychloroquine and control groups?

LI: The mortality rate for patients receiving hydroxychloroquine was 8.9/1,000 patients/day, the mortality rate for those not receiving hydroxychloroquine was 15.7/1,000 patients/day. Treatment began on the first day of admission at most clinical centres at a dose of 400 mg once daily for an average duration of 10 days. 76% of patients were on HCQ therapy.

MSDS: Did the drug have any statistically significant adverse effects?

LI: Our study did not collect information on adverse effects. However, previously published studies from the various centres participating in our study did not show any significant cardiovascular clinical events, although there was an increase in QT ECG. (sources: https://linkinghub.elsevier.com/retrieve/pii/S0167527320322233 and https://www.ahajournals.org/doi/10.1161/CIRCULATIONAHA.120.048476)

MSDS: Is the increased heart rate (QT) seen on the electrocardiogram a serious adverse event or can it be of variable magnitude?

LI: Exposure to a drug capable of inducing QT prolongation does not always result in delayed ventricular repolarization, and the occurrence of serious complications in patients with long-standing QT prolongation appears to be rare.

MSDS: Are there any common medications we use every day that can prolong the QT interval?

LI: There are other commonly used medications that can prolong the QT interval, among the most well known antipsychotics, such as haloperidol, macrolide antibiotics such as erythromycin and clarithromycin, or quinolones such as moxifloxacin.

MSDS: Could hydroxychloroquine have a significant impact on the treatment of Covid19?

LI: Our study is being reviewed in the European Journal of Internal Medicine. Its results may make an important contribution to the debate on the use of HCQ in COVID19.

In an emergency situation such as a pandemic, the “gold standard” of intervention studies cannot be used, and even randomized clinical trials (RCTs) cannot be done under the best conditions.

Therefore, all data from both retrospective and RCTs should be taken into account, provided they are conducted appropriately. We believe that HCQ administered early after the diagnosis of Covid-19 at low doses of 400 mg per day can be an effective and safe, inexpensive and easy-to-use drug, and not only in Italy.

MSDS: The major European medical agencies have blocked the use of hydroxychloroquine. There are currently many publications supporting the efficacy and safety of hydroxychloroquine. What is the outlook for the autumn?

LI: Other European studies already published have shown the effectiveness of HCQ treatment in reducing the risk of mortality. In particular, a study conducted in France on more than 3,100 patients with COVID-19 showed that HCQ treatment reduced the risk of hospitalization and death. A study conducted in Portugal suggests that HCQ treatment protects against SarCOV2 infection.

Today’s debate is hampered by the difficulty for positive studies to be published.

In the fall, when these studies become available, we will have a clearer and more balanced picture of the effectiveness of HCQ, which could lead to the reopening of the prescription of the drug in low doses and in special situations.

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Original article

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