On Friday, the Ministry of Health and Family Welfare (MoHFW) issued a revised advisory on the use of Hydroxychloroquine (HCQ) as prophylaxis for Covid-19 infection. The the prophylactic use of HCQ is now recommended 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.  

The move came after the Joint Monitoring Group under the chairmanship of the Director General of Health Services (DGHS), and including representatives from the All India Institute of Medical Sciences (AIIMS), Indian Council of Medical Research (ICMR), National Center for Disease Control (NCDC), National Disaster Management Authority (NDMA), World Health Organisation (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.

According to the revised advisory, “At National Institute of Virology (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.” Additionally, “A retrospective case-control analysis at ICMR has found that there is a significant dose-response relationship between the number of prophylactic doses taken and frequency of occurrence of SARSCoV-2 infection in symptomatic healthcare workers who were tested for SARS-CoV-2 infection.”

The advisory also sites other studies conducted at hospitals in New Delhi. It says, “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.”

As per another study mentioned in the advisory, “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.”

However, this is advisory also warns that “It is reiterated that the intake of above medicine should not instil a sense of false security.”

This is critical in wake of several questions being raised about the efficacy of HCQ. According to a recent study published in The Lancet, a highly respected peer-reviewed medical journal, “Hydroxychloroquine or chloroquine, often in combination with a second-generation macrolide, are being widely used for treatment of COVID-19, despite no conclusive evidence of their benefit. Although generally safe when used for approved indications such as autoimmune disease or malaria, the safety and benefit of these treatment regimens are poorly evaluated in COVID-19.”

The methodology of the study by Mandeep R Mehra, Sapan S Desai, Frank Ruschitzka and Amit N Patel is explained as follows:

“We did a multinational registry analysis of the use of hydroxychloroquine or chloroquine with or without a macrolide for treatment of COVID-19. The registry comprised data from 671 hospitals in six continents. We included patients hospitalised between Dec 20, 2019, and April 14, 2020, with a positive laboratory finding for SARS-CoV-2. Patients who received one of the treatments of interest within 48 h of diagnosis were included in one of four treatment groups (chloroquine alone, chloroquine with a macrolide, hydroxychloroquine alone, or hydroxychloroquine with a macrolide), and patients who received none of these treatments formed the control group. Patients for whom one of the treatments of interest was initiated more than 48 h after diagnosis or while they were on mechanical ventilation, as well as patients who received remdesivir, were excluded. The main outcomes of interest were in-hospital mortality and the occurrence of de-novo ventricular arrhythmias (non-sustained or sustained ventricular tachycardia or ventricular fibrillation).”

Here are their key findings:

96 032 patients (mean age 53·8 years, 46·3% women) with COVID-19 were hospitalised during the study period and met the inclusion criteria. Of these, 14 888 patients were in the treatment groups (1868 received chloroquine, 3783 received chloroquine with a macrolide, 3016 received hydroxychloroquine, and 6221 received hydroxychloroquine with a macrolide) and 81 144 patients were in the control group. 10 698 (11·1%) patients died in hospital.

After controlling for multiple confounding factors (age, sex, race or ethnicity, body-mass index, underlying cardiovascular disease and its risk factors, diabetes, underlying lung disease, smoking, immunosuppressed condition, and baseline disease severity), when compared with mortality in the control group (9·3%), hydroxychloroquine (18·0%; hazard ratio 1·335, 95% CI 1·223–1·457), hydroxychloroquine with a macrolide (23·8%; 1·447, 1·368–1·531), chloroquine (16·4%; 1·365, 1·218–1·531), and chloroquine with a macrolide (22·2%; 1·368, 1·273–1·469) were each independently associated with an increased risk of in-hospital mortality.

Compared with the control group (0·3%), hydroxychloroquine (6·1%; 2·369, 1·935–2·900), hydroxychloroquine with a macrolide (8·1%; 5·106, 4·106–5·983), chloroquine (4·3%; 3·561, 2·760–4·596), and chloroquine with a macrolide (6·5%; 4·011, 3·344–4·812) were independently associated with an increased risk of de-novo ventricular arrhythmia during hospitalisation.

The study therefor concluded, “We were unable to confirm a benefit of hydroxychloroquine or chloroquine, when used alone or with a macrolide, on in-hospital outcomes for COVID-19. Each of these drug regimens was associated with decreased in-hospital survival and an increased frequency of ventricular arrhythmias when used for treatment of COVID-19.”

The entire study may be read here:

The Health Ministry’s latest revised advisory may be viewed here

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The post India revises stand on HCQ, concerns about efficacy remain appeared first on SabrangIndia.

Congress MP Shashi Tharoor, who has served as  under Secretary General of the United Nations, has continued to keep the spotlight on India’s export of hydroxychloroquine (HCQ), and other drugs, to the United States of America, in face of a possible ‘retaliation’ if the earlier ban continued.

Today, on April 8, Tharoor bounced the ball back in the court of  US President Trump and asked him to give something back in return for HCQ, “Mr President @realDonaldTrump, since India has selflessly agreed to give you the supply you seek of hydroxychloroquine, will you grant India first priority in sharing with us any #COVID19 vaccine that might be developed in US labs?”

Mr President @realDonaldTrump, since India has selflessly agreed to give you the supply you seek of hydroxychloroquine, will you grant India first priority in sharing with us any #COVID19 vaccine that might be developed in US labs? @USAndIndia @USAmbIndia @PMOIndia https://t.co/M7Pze4d9CC

— Shashi Tharoor (@ShashiTharoor) April 8, 2020

On April 7, he had  also taken on Trump’s claim on the medication,  “Never in my decades of experience in world affairs have I heard a Head of State or Govt openly threatening another like this. What makes Indian hydroxychloroquine ‘our supply’, Mr President? It only becomes your supply when India decides to sell it to you.” he said.

Senior Congress leader and its working committee member  Randeep Singh Surjewala, had reflected a collective ire against the Centre’s decision to restart exporting hydroxychloroquine after  US Presidents said he may ‘retaliate’ if India did not comply. Surejewala’s short video that he posted on social media sums up the collective reaction Of the Opposition, as well as many citizens who were taken aback at how swiftly the ban was lifted on the slightest pressure from Trump.

Dear Prime Minister,

“India First” & “Indians First” is the “Raj Dharma” before you open the export of life saving drug, hydroxychloroquine!

Follow Smt. Indira Gandhi’s template.#COVID2019
Our statement-: pic.twitter.com/Wn3NVHnsSz

— Randeep Singh Surjewala (@rssurjewala) April 7, 2020

Lifting the ban, Opposition parties have said that was a betrayal of Indians whose needs for medicines should be priorities before any exports are allowed. “No one can browbeat, pressurize or intimidate India. Smt. Indira Gandhi laid the template for future governments. In fight against #COVID, Indian have a first right over life saving drug hydroxychloroquine! Time to follow “Raj Dharma” & “India First” policy!” posted Surjewala. 

Prime Minister Modi’s quick response to the US President’s statement is seen as a sign of weakness by many. Indian political leaders have said that the PM should have, in fact, stood up to the US president’s intimidating words. According to CPI(M) general secretary Sitaram Yechury, the statement by the US President was unacceptable and PM Modi had, “succumbed to the threat by allowing the export. That this happened after an expensive gala was organised for him by Modi, instead of preparing to contain Covid-19, shows how this government has let down India.”

The statement by US President is unacceptable. But Modi govt has succumbed to the threat by allowing the export. That this happened after an expensive gala was organised for him by Modi, instead of preparing to contain Covid-19, shows how this govt has let down India. https://t.co/3g1K4Q0bfi

— Sitaram Yechury (@SitaramYechury) April 7, 2020

According to news reports, Yechury also said that India should prioritise the medical  requirements of Indians first as the nation is fighting against Covid-19 pandemic. He said that India could not afford to risk any “shortages of crucial drugs here. There are no compromises in this struggle to protect Indian lives.”

Senior leaders, who themselves have been at the forefront of fighting the pandemic in their own states have also criticised the fact that the ban was lifted without even consulting state governments. According to a report in the Hindu, Rajasthan Chief Minister Ashok Gehlot has criticized the export of HCQ and said PPEs and other lifesaving equipment has also been exported by the Indian government recently. “A huge number of PPEs and ventilators were exported in the last few days. No details of this have been provided by the Centre yet. This is beyond our understanding,” he said. All the equipment, specially PPEs need to be stockpiled as the Coronavirus pandemic progresses to the next stages across India. According to Gehlot, the Rajasthan government may have to import  PPEs from China to combat the shortfall. “It is a question of life and death. The Centre will have to consider all the aspects. We have to save the lives of people. That should be the first priority,” he said.

Prime Minister Modi and President Trump have always showcased their interactions at massive political events, in India recently and in America before that, as ‘friendship’ between two nations. However is this the time to be friendship, or responsible leadership, is what many are asking. 

Why would Trump even mention ‘relailation if he was a friend of India?’ was a point raised. Congress’s media in-charge Randeep Singh Surjewala had said Trump has no right to threaten India or put pressure on Prime Minister Modi to lift the ban on import. “We hope Modi will take diplomatic measures against such language used by the US President and ensure the safety of Indians,” Surjewala said.

News reports quoted Congress leader and Member of Parliament, Rahul Gandhi saying that  retaliation should not be a factor, “India must help all nations in their hour of need but lifesaving medicines should be made available to Indians in ample quantities first,” he said.

The demand for the drug in the US has been fueled by the president himself mentioning it as a possible cure. However, leading american scientists, including White House coronavirus task force member Anthony Fauci, said the reports that the drug might work were “anecdotal, and said there needs to be further study before its use is encouraged.”

According to Bloomberg Indian manufacturers exported and fulfilled around 47%  of hydroxychloroquine requirements of the U.S, last year. This would have come to a standstill after the ban on the anti-malaria drug that had been “touted by President Donald Trump as a “game changer” for treating the coronavirus” said the report.

India’s export ban, it explained, was aimed at ensuring enough domestic supply for Indians to use. Trump’s personal endorsement of HCQ had set off a massive stockpiling of the anti-malaria medication around the world, said another Bloomberg report. Many countries had banned exports of various items, from food grains, to masks, to certain medication and equipment, to prioritise and meet domestic needs and demands first.

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