On March 21, US President Donald Trump expressed his enthusiasm on the efficacy of the drug combination hydroxychloroquine and azithromycin (an antibiotic) in the treatment of COVID-19.
“It may work, it may not work,” he said at a White House press briefing on March 20. A day later, though, Trump said in a tweet: HYDROXYCHLOROQUINE & AZITHROMYCIN, taken together, have a real chance to be one of the biggest game changers in the history of medicine. The FDA has moved mountains – Thank You!. Hopefully they will both be out in use immediately. People are dying, move fast and god bless everyone.”
On Monday, as stocks of hydroxychloroquine ran out at stores across India, the National Task Force for COVID-19 issued an advisory on the use of the drug as prophylaxis (for prevention) for SARS-CoV2. At a press briefing minutes after the document was released to the press, Dr Balram Bhargava, director general, ICMR, measured his words rather carefully, emphasizing the word “only” several times, in his statement on the issue.
“Hydroxychloroquine is recommended only... and I mean only...first, for healthcare workers treating a COVID patient. Second, it is recommended only for persons staying and caring for a household positive patient, then they can take hydroxychloroquine, only for prevention, only in these two circumstances,” he said.
“And for this, there’s enough stocks in the country,” he added.
Hydroxychloroquine is a drug used for the prevention and treatment of certain types of malaria. Specifically, it is used for chloroquine-sensitive malaria. Other uses of the drug include in the treatment of rheumatoid arthritis and lupus.
The government advisory on the subject said that the protocol was only for restricted use in emergency situations, and should not instill a sense of “false security” among healthcare workers. It further added that high-risk contacts of a positive case who are taking the medicine should remain in home quarantine while on the drug.
"It is found to be effective against coronavirus in laboratory studies and in-vivo studies. Its use in prophylaxis is dervied from available evidence of benefit as treatment and supported by pre-clinical data. The recommendations are based on these considerations as well as risk benefit consideration, under exceptional circumstances that call for the protection of high-risk individuals."
But experts have had a mixed response on the use of the drugs as preventive measure. Dr Anthony Fauci, leading infectious disease expert in the US, who is also the face of the US administration’s response to the pandemic, said on Friday, and then again on Saturday, that high quality research was needed on the drug, and as of now, only “anecdotal” reports were available.
In India, in a yet to be published—but accepted for publication—article titled, ‘Chloroquine or Hydroxychloroquine in the treatment of COVID-19 with or without Diabetes: A systematic search and a narrative review with a special reference to India and other developing countries’, the authors conclude that though evidence for chloroquine (anti-malaria) and HCQ is limited (based on the experimental data and only two small human trials), “considering the potentially favorable benefit-risk balance of chloroquine and HCQ in absence of any other valid treatment option, we believe that such treatment could be useful in the current context of pandemic COVID-19 outbreak.”
Dr Anoop Misra, one of the authors of the report, told THE WEEK that “prophylaxis of COVID-19 is an attractive concept, but there is no scientific evidence that it will work”. “However, in this war-like situation, such a step could be allowed till good research produces data. In other words, this approval should be conditional,” said Misra, chairman of Fortis Centre for Diabetes, Obesity and Cholesterol (C-DOC) and heads, National Diabetes Obesity and Cholesterol Foundation (NDOC). Misra emphasized that in the current situation, a “quick and fast trial” with a lesser number of patients would be enough.
Other authors of the study include Dr Awadesh Kumar Singh, Senior Consultant Endocrinologist, G. D Hospital & Diabetes Institute, Kolkata, Dr Akriti Singh, College of Medicine & JNM Hospital, Kalyani, Nadia, West Bengal, Dr Altamash Shaikh, Saifee Hospital, Mumbai, and Dr Ritu Singh, G. D Hospital & Diabetes Institute, Kolkata.
Despite the note of caution from experts, drugs stores across the country—just like in the US— reported that they are running out of stocks for hydroxychloroquine, leaving patients with rheumatoid arthritis, for instance, in a difficult situation.
“I received around 10 calls since morning enquiring about the role of hydroxychloroquine sulphate (HSQS) in prophylaxis of COVID-19. And they are also asking for chemist stores from where they can get these drugs because they are not able to get from the nearby chemists as they are being told that the drug is sold out,” Dr Harjit Singh Bhatti, National President, Progressive Medicos & Scientists Forum(PMSF) told THE WEEK.
“I told them that there is no scientific basis behind this, and they should not take this without prescription. All stores are going out of stock for HCQS and patients of rheumatoid arthritis, SLE and DLE [forms of lupus] who seriously require these medicines are not getting them,” said Bhatti.
The WHO has already launched a global mega trial of four most promising treatments for coronavirus, including the combination of hydroxychloroquine and choloroquine.
"High quality research is a need of the hour," Dr Soumya Swaminathan, chief scientist, WHO, tweeted on March 21, in reference to media reports about the potential of several drugs to treat COVID-19.