These revised guidelines have now recommended the prophylactic use of HCQ for all asymptomatic healthcare providers (HCP) involved in containment and treatment of COVID19 and asymptomatic healthcare workers working in non-COVID hospitals/non-COVID areas of COVID hospitals/blocks, as well as asymptomatic frontline workers, such as surveillance workers deployed in containment zones and paramilitary/police personnel involved in COVID-19 related activities, asymptomatic household contacts of laboratory confirmed cases.
Following points must be considered :
1. ICMR says that " Based on the available evidence, it has been opined that HCQ is relatively safe, when certain contraindications are avoided, and has SOME beneficial effect as a prophylactic option. "
the term "Some" beneficial effect seems to be very subjective. We cannot take big clinical decisions on the basis of so called some beneficial effect
2. It seems they have not talked about/or might have skipped data obtained from big negative clinical studies on HCQ
3. in section 1.2 of studies supporting HCQ use they have mentioned about the adverse effects observed with the use of HCQ. In one safety study done on 1323 health care providers , some adverse effects were mentioned along with their percentage incidence, e.g. nausea (8.9%), abdominal pain (7.3%), vomiting (1.5%), hypoglycemia (1.7%) and cardio-vascular effects (1.9%). also they talked about 7 serious individual case safety reports with prolongation of QT interval on ECG in 3 cases.
1323 is a very less number compared to millions HCP working in INDIA. Secondly, if we consider the incidence of serious cardio-vascular effects to 1 percent ( which was 1.9% in this study) , even then prophylaxis in millions of HCP can lead thousands of fatal side effects (Consider the likelihood of Non-corona morbidity and mortality against that which is assigned to Corona). Hypoglycemia is another concern which can exacerbate cardiac problems and could be detrimental in diabetic subjects. I suppose the safety data must be collected more efficiently and in maximum number of HCQ users
4. They have mentioned the need of ECG in one of the sections but how many HCP will actually follow that remains a controversial question. Following C/I have also been mentioned for sensitizing HCP on the safe use of HCQ:
"The drug is contraindicated in persons with known case of: 1. Retinopathy, 2. Hypersensitivity to HCQ or 4-aminoquinoline compounds 3. G6PD deficiency 4. Pre-existing cardiomyopathy and cardiac rhythm disorders"
it is very difficult to screen all HCP for G6PD deficiency, the status of which is not known in many. Along with this, it is not easy screen all HCP for retinopathy or heart disorders.
5. Results of the studies (which the mentioned as good results) on which these recommendations are based, are not available in public domain as of now (hope to access them soon online).
6. It seems that they have not followed the level of evidence strategy or evidence based medicine principles
7. In the end they have also mentioned an umbrella statement which we should never forget
" Note: It is reiterated that the intake of above medicine should not instill a sense of false security "
Kindly give your inputs
Detailed document for ICMR Recommendations can be obtained from the following link:
https://www.mohfw.gov.in/pdf/RevisedadvisoryontheuseofhydroxychloroquineasprophylaxisforSARSCOVID19infection.pdf
I think the issue should be studies very well before recommending any action as regards this drug. First, it should be studied to determine if this drug has a positive effect on curing the COVID-19 patients. Then, side effects of the drug should be determined to make sure that the to-be-gained benefits justify the to-be-caused harm. Thirdly, it should be decided on which of these patients, this drug can be used.
I wouldnt tough it, as far as I am aware from what I have read there is 0 benefit to HCQ treatment and only potential risks for the user that are well known by doctors. This is a nonsensical recommendation. In a hospital at least patients can get care if they begin having issues with QT prolongation but an healthcare worker at home for the evening would not and can be potentially fatal to staff.
Even though many trials are overall small with there n values they dont even show a positive trend we can work towards with bigger studies. This is a ridiculous and dangerous tact by them
There is no proven benefit and there are proven though uncommon side effects.
Hence, this revised recommendation should have been released after collecting and publishing evidence
Some my colleagues and me have used the HQC as prevention during COVID19, even there wasn't proven or evidence for its benefits. None of us are infected in these weeks. We can explained the benefits of HQC, but we didn't have side effects.
So the best approach is an informed choice as dr Edmond puts it.
Though I agree with dr Andrei and frankly believe that such recommendations create a false sense of security.
https://www.researchgate.net/publication/340730632_Hydroxychloroquine_prophylaxis_for_COVID-19_contacts_in_India
Pranav Ish Yes
Some more controversy added to this in a recent article.
https://www.telegraphindia.com/india/coronavirus-pandemic-questions-cloud-study-on-hcq/cid/1777431?utm_source=twitter&utm_medium=social&utm_campaign=tt_daily_twit&__twitter_impression=true
This study is the latest data from India
http://www.ijmr.org.in/preprintarticle.asp?id=285520
Andrei G Dan
Concerning the study in the Lancet, there has just been an expression of concern published by the editors of the Lancet:
https://www.thelancet.com/journals/lanpub/article/PIIS0140-6736(20)31290-3/fulltext
And there is another expression of concern about another big data study carried out by the same team and published in New England Journal of Medicine (NEJM)
Article Expression of Concern: Mehra MR et al. Cardiovascular Diseas...
There have just been retraction for the two previously cited big data studies notably that in the Lancet about use of HCQ for Covid-19
https://www.thelancet.com/lancet/article/s0140673620313246?utm_campaign=tlcoronavirus20&utm_source=twitter&utm_medium=social
This recent RCT on prophylaxis of COVID with HCQS showed lack of efficacy of HCQS in preventing COVID 19
https://www.nejm.org/doi/full/10.1056/NEJMoa2016638
Preliminary analysis of RECOVERY trial showed no benefit of HCQS in terms of reducing mortality among COVID patients. They have decided to stop the further recruitment in HCQS arm.
https://www.pharmaceutical-journal.com/20208044.article?utm_campaign=2483_PJ_weekly_roundup&utm_medium=email&utm_source=Pharmaceutical%20Journal&firstPass=false
It is a mistake that the ICMR recommends the use of hydroxychloroquine for the prevention of COVID, and it is known that everyone knows in the medical field the risk of this treatment.
It was considered from the first that the use of hydroxychloroquine to prevent COVID is incorrect and it does not treat viruses, it is a risk to the heart and may increase deaths.
unfortunately, many doctors I know continue to take it weekly with no proven effect and thankfully no side effect yet even beyond the original 7 weeks recommendation
SOLIDARITY trial halts HCQ arm due to lack of efficacy
https://www.wionews.com/world/who-halts-hydroxychloroquine-trial-for-covid-19-over-lack-of-proven-benefit-306664
FDA also revoked emergency use authorization of HCQ due to lack of efficacy
https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-revokes-emergency-use-authorization-chloroquine-and
Indian council of medical research (ICMR)had expanded the number of laboratories that could conduct covid 19 tests only after an intervention made by union minister for home affairs amit shah ,reports the hundu.
As of 30 January ,when the first comfirmed case of covid 19 in India had come to light ,all the samples were sent only to the national institute of virology (NIV)which is located in pune.
Following ICMR'S inability to enable more testing facilities ,shah is said to have asked the ICMR to either include more facilities or else the responsibility to conduct to all India institute of medical sciences (Allms).
The instructions were reportedly given by the Hm in a meeting held in march which which was attended by director -General of the ICMR ,Pr Balram Bhargava .As an outcome of the same ,by march 17 ,the number of laboratories with the capability to test samlles for covid 19 had shot up to 72.
Following this,on 23 march,the ICMR had also issued guidelines allowing private laboratories to test for covid 19.meanwhile ,it should be noted that as of now,the number of laboratories with the capability to conduct testing for covid 19 has shot up to 220 as report by Tums of India.the government aims to elevate the elevate into 300 by the end of April.
A small letter to address the cardiac safety of widespread uncontrolled use of HCQ.
Article HCQ induced QT prolongation- Primum non nocere
Thankfully we found this toxicity rarely in our patients, though it was reported from various countries. Of course, underlying illness, dose , duration, etc can be a determinant for the same
It is ethically acceptable only in HCWs that have no contraindications and as long as there are no universally recognized valid alternatives.
It can risk cardiac arrhythmia so care has to be taken when administered to patients.
Doctors in Italy have been again authorized to prescribe hydroxychloroquine to COVID-19 patients since December; 40 Italian physicians claimed that hydroxychloroquine can stop disease progression in early-stage patients:
https://www.nature.com/articles/d43978-020-00035-w