ICMR will continue restricted Hydroxychloroquine use despite critical US study: Official
The Indian Council of Medical Research (ICMR) will continue with the restricted use of anti-malaria drug hydroxychloroquine (HCQ) to treat critical coronavirus disease (Covid-19) patients even though a US study has found it did not benefit a group of patients admitted in health centres, according to an official.
“We are generating our own data, and will take a decision according to our own results. The study to check its therapeutic use will take about 2-2.5 months to complete which should provide us the evidence against or for it. It will be too premature to say anything at this stage even though we are closely looking at all the data coming from other countries,” said the official in ICMR who did not wish to be identified.
In the US study made public on April 16, researchers analysed medical records of 368 hospitalised patients with the coronavirus infection at Veterans Health Administration medical centres. About 28% of these patients, who were given HCQ plus usual care, died. On the other hand, 11% of the patients, who got routine care alone, succumbed to the infection. The drug made no difference in the need for a breathing machine either, according to the study.
However, Switzerland-based drug maker Novartis announced a few days ago that it had reached an agreement with the US FDA to carry out a Phase III trial assessing HCQ as a treatment for hospitalised Covid-19 patients, for which it will be recruiting about 440 patients in at least a dozen sites in the US.
In India, the central drugs controller, towards the end of March, had approved the use of HCQ under the “restricted use” category, primarily for the studies that ICMR wanted to carry out.
ICMR has said that it is conducting a two-arm study on the prophylactic (prevention) and therapeutic (treatment) effects of HCQ against Covid-19.
As prophylactic, the drug has been recommended for asymptomatic health care workers involved in the care of suspected or confirmed cases of Covid-19. As therapeutic medicine, it is being given to critically ill Covid-19 patients in the intensive care unit (ICU) to see if their dependency on oxygen support is reduced.
In India, around 2% of Covid-19 cases need critical care in ICU, according to the health ministry.
In prophylactic cases, the drug is recommended to be taken under strict medical supervision, considering all contraindications.
The dosage given to people in India is 400mg, twice a day, for one day, and subsequently 400ml once a week. The course is recommended for seven weeks for prophylactics. In treatment purposes, it is being given in combination with the antibiotic azithromycin.
“In positive patients, the medicine has shown to reduce the viral load, and our aim is to see whether it will prevent infection or not,” Raman R Gangakhedkar, chief, epidemiology and communicable disease, ICMR, said earlier.
While results from the treatment cohort will still take time, the initial data collected from reactions found in health care workers showed two primary complains -- abdominal pain in about 10% of those who took the medicine and nausea in about 6% of them.
“If the results aren’t satisfactory, the drug will be withdrawn, like it was previously done with HIV/AIDS antiviral drugs such as lopinavir and ritonavir that did not show much benefit,” the ICMR official added.