New Guideline: ICMR expands use of Hydroxychloroquine, adds ECG as prerequisite, Details
New Delhi: Expanding the use of anti-malarial drug hydroxychloroquine as a preventive treatment against coronavirus, the ICMR has issued new set of guidelines that also call for proper electrocardiogram (ECG) monitoring before and in certain conditions while the prescription of the HCQ. The guidelines clearly iterate that the intake of above medicine should not instil a sense of false security.
The Indian Council of Medical Research (ICMR) has issued revised guidelines for use of hydroxychloroquine (HCQ), the malaria drug, as a preventive medication for asymptomatic healthcare workers in non-Covid-19 hospitals, frontline staff on surveillance duty in containment zones and paramilitary/police personnel involved in coronavirus infection-related activities.
"The Joint Monitoring Group and the NTF have recommended prophylactic use of HCQ in 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 and all asymptomatic healthcare workers involved in containment and treatment of Covid-19 and working in non-Covid hospitals/non-Covid areas of Covid hospitals/blocks," the ICMR said, here on Saturday.
The ICMR revised the guidelines to expand use of this anti-malarial drug as a preventive treatment against coronavirus.
Stating that HCQ is relatively safe, when certain contra-indications are avoided, the ICMR said it had some beneficial effect as a prophylactic option. However, the drug should be given under strict medical supervision with informed consent and only on the prescription of a registered medical practitioner, it said.
The ICMR said electrocardiogram (ECG) shall be done before prescribing HCQ prophylaxis and in case any new cardiovascular symptom it would be mandatory, the advisory said.
The drug should not be recommended for prophylaxis in children under 15 years of age and in pregnancy and lactation, it said. Following are the full details of the revised guidelines
1.1 In-vitro study
At NIV, Pune, the report of the in-vitro testing of HCQ for antiviral efficacy showed reduction of infectivity /log reduction in viral RNA copy of SARs-CoV2.
1.2 Safety Profile of HCQ
The data on the assessment of HCQ prophylaxis among 1323 HCWs indicated mild adverse effects such as nausea (8.9%), abdominal pain (7.3%), vomiting (1.5%), hypoglycemia (1.7%) and cardio-vascular effects (1.9%). However, as per the data from the Pharmacovigilance program of India, there have been 214 reported instances of adverse drug reactions associated with prophylactic HCQ use. Of these, 7 were serious individual case safety reports with prolongation of QT interval on ECG in 3 cases.
2. Eligibility criteria for HCQ prophylaxis
The Advisory earlier issued (dated 23rd March 2020; available at: https://www.mohfw.gov.in/pdf/AdvisoryontheuseofHydroxychloroquinasprophylaxisforSARSCoV2infection.pdf), provided placing the high-risk population (asymptomatic Healthcare Workers involved in the care of suspected or confirmed cases of COVID-19 and asymptomatic household contacts of laboratory-confirmed cases of COVID-19) under chemoprophylaxis with HCQ.
In light of all of the above, the Joint Monitoring Group and NTF have now recommended the prophylactic use of HCQ in the following categories:
1. All asymptomatic healthcare workers involved in containment and treatment of COVID19 and asymptomatic healthcare workers working in non-COVID hospitals/non-COVID areas of COVID hospitals/blocks
2. Asymptomatic frontline workers, such as surveillance workers deployed in containment zones and paramilitary/police personnel involved in COVID-19 related activities.
3. Asymptomatic household contacts of laboratory-confirmed cases
3. Exclusion/contraindications
• 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
• The drug is not recommended for prophylaxis in children under 15 years of age and in pregnancy and lactation.
Rarely the drug causes cardiovascular side effects such as cardiomyopathy and rhythm (heart rate) disorders. In that situation the drug needs to be discontinued. The drug can rarely cause visual disturbance including blurring of vision which is usually self- limiting and improves on discontinuation of the drug. For the above cited reasons the drug has to be given under strict medical supervision with an informed consent
4. Dosage
1 • Asymptomatic household contacts of laboratory confirmed cases- Dosage -400 mg twice a day on Day 1, followed by 400 mg once weekly for next 3 weeks; to be taken with meals
2 • All asymptomatic healthcare workers involved in containment and treatment of COVID-19 and asymptomatic healthcare workers working in nonCOVID hospitals/non-COVID areas of COVID hospitals/blocks- DOSAGE- 400 mg twice a day on Day 1, followed by 400 mg once weekly for next 7 weeks; to be taken with meals
• Asymptomatic frontline workers, such as surveillance workers deployed in containment zones and paramilitary/police personnel involved in COVID-19 related activities -DOSAGE- 400 mg twice a day on Day 1, followed by 400 mg once weekly for next 7 weeks; to be taken with meals
5. Use of HCQ prophylaxis beyond 8 weeks [in categories 4 (2) above]
In clinical practice HCQ is commonly prescribed in a daily dose of 200mg to 400mg for treatment of diseases such as Rheumatoid Arthritis and Systemic Lupus Erythematosus for prolonged treatment periods with good tolerance. With available evidence for its safety and beneficial effect as a prophylactic drug against SARS-COV-2 during the earlier recommended 8 weeks period, the experts further recommended for its use beyond 8 weeks on weekly dosage with strict monitoring of clinical and ECG parameters which would also ensure that the therapy is given under supervision.
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.
You can read the full advisory by clicking on the following link
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