Revised advisory on the use of Hydroxychloroquine (HCQ) as prophylaxis for SARS-CoV-2 infection

Abstract: भारतीय आयुर्विज्ञान अनुसंधान पर्रषद स्वास््य अनुसंधान र्वभाग, स्वास््य और पर्रवार कल्याण मंत्रालय, भारत सरकार Date: 22/05/2020 Revised advisory on the use of Hydroxychloroquine (HCQ) as prophylaxis for SARS-CoV-2 infection (in supersession of previous advisory dated 23rd March, 2020) 1. Background The Joint Monitoring Group under the Chairmanship of DGHS and including representatives from AIIMS, ICMR, NCDC, NDMA, WHO and experts drawn from Central Government hospitals reviewed the prophylactic use of Hydroxychloroquine (HCQ) in the context of expanding it to healthcare and other front line workers deployed in non-COVID and COVID areas, respectively. The National Task force (NTF) for COVID-19 constituted by Indian Council of Medical Research also reviewed the use of HCQ for prophylaxis of SARS-CoV-2 infection for high risk population based on the emerging evidence on its safety and efficacy. The NTF reviewed the data on in-vitro testing of HCQ for antiviral efficacy against SARS-CoV-2, safety profile of HCQ reported to the pharmacovigilance program of India, and data on the use of HCQ for the prophylaxis of SARS-CoV-2 infection among health care workers (HCWs) and reported its findings as detailed below: 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 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. 1.3  Studies on prophylaxis of SARS-CoV-2 infection A retrospective case-control analysis at ICMR has found that there is a significant doseresponse relationship between the number of prophylactic doses taken and frequency of Page 1 of 4   2. occurrence of SARS-CoV-2 infection in symptomatic healthcare workers who were tested for SARS-CoV-2 infection. Another investigation from 3 central government hospitals in New Delhi indicates that amongst healthcare workers involved in COVID-19 care, those on HCQ prophylaxis were less likely to develop SARS-CoV-2 infection, compared to those who were not on it. The benefit was less pronounced in healthcare workers caring for a general patient population. An observational prospective study of 334 healthcare workers at AIIMS, out of which 248 took HCQ prophylaxis (median 6 weeks of follow up) in New Delhi also showed that those taking HCQ prophylaxis had lower incidence of SARS-CoV-2 infection than those not taking it. Eligibility criteria for HCQ prophylaxis The Advisory earlier issued (dated 23rd March, 2020; available at: https://www.mohfw.gov.in/pdf/AdvisoryontheuseofHydroxychloroquinasprophylaxisforSARSC oV2infection.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..