News Analysis India

Tag: Plasma therapy

  • Top medical experts welcome move to remove plasma therapy from COVID-19 treatment protocol

    By ANI
    NEW DELHI: Several top medical experts have welcomed the Indian Council of Medical Research (ICMR)’s updated advisory released on Monday dropping the use of convalescent plasma from recommended treatment protocols for COVID-19.

    Sir Ganga Ram Hospital chairman Dr DS Rana said plasma therapy has failed to change the “course of mortality” and asserted that some scientists are also of the view that it is helping in promoting mutations and variants.

    “I think it is wise that plasma therapy has been taken off the list because over a period of one year it has failed to change the course of mortality. Every step taken should absolutely be based on the evidence. Some scientists are also of the view that this is helping in promoting mutations and variants,” he added.

    With an exponential rise in COVID-19 cases across the country, there has been an unprecedented spur in the demand for plasma which many experts believe to have done more harm than good.

    Dr Sheeba Marwah, Assistant Professor and COVID-19 Nodal Officer, Department of Obstetrics and Gynaecology Vardhman Mahavir Medical College and Safdarjung Hospital said: “The current research being done globally using convalescent plasma of patients recovered from COVID-19 for treatment of new COVID-19 patients have not yielded any efficacious results when it comes to modifying the disease course or thwarting its progression to severe disease and averting mortality. Even the ICMR’s PLACID Trial concluded convalescent plasma therapy to be non-beneficial.”

    Marwah stated that on the contrary, “possibilities of more virulent strains having surfaced due to its irrational use are very much there, so it’s a good decision to remove it from the national protocol.”

    Earlier, as per the ICMR advisory on April 22, Convalescent plasma (Off label) was considered only when the following criteria were met: Early moderate disease (preferably within 7 days of symptom onset, no use after 7 days) and Availability of high titre donor plasma (Signal to the cut-off ratio (S/O) >3.5 or equivalent depending on the test kit being used).

    As per the previous advisory, Remdesivir, Tocilizumab (off label) and Convalescent plasma (Off label) were used for the treatment of COVID-19 patients. However, the latest advisory mentions that only Remdesivir, Tocilizumab (off label) can be used.

    The recent view on discontinuing the use of plasma therapy comes a day after a meeting of ICMR-National Task Force for COVID-19 was held during which its ‘ineffectiveness’ in a number of cases was discussed.

    As India’s daily spike of coronavirus cases witnesses, a dip with only 2,63,533 fresh infections recorded in the last 24 hours, the number of deaths due to COVID-19 continues to remain alarmingly high with 4,329 more fatalities, the highest toll in a single day since the pandemic began.

    According to the Union Health Ministry, the country also saw a massive jump in the number of recoveries with 4,22,436 fresh discharges.

    The cumulative caseload stands at 2,52,28,996, including 2,15,96,512 recoveries, 33,53,765 active cases and 2,78,719 deaths.

  • ‘Irrational and non-scientific’: Centre drops plasma therapy as suggested treatment for COVID-19 patients in India

    By Express News Service
    NEW DELHI: Convalescent plasma therapy has been dropped from the national treatment protocol for coronavirus as a suggested experimental treatment option for patients, days after the evidence from the recovery trial in the US showed that it offers no benefit.

    The decision to remove it from the guidelines comes in the backdrop of some clinicians and scientists writing to Principal Scientific Advisor K VijayRaghavan cautioning against the “irrational and non-scientific use” of convalescent plasma for COVID-19 in the country.

    In the letter, which was also marked to ICMR chief Balram Bhargava and AIIMS Director Randeep Guleria, public health professionals alleged that the current guidelines on plasma therapy are not based on existing evidence and pointed out some very early evidence that indicates a possible association between emergence of variants with “lower susceptibility to neutralising antibodies in immunosuppressed” people given plasma therapy.

    This raises the possibility of more virulent strains developing due to irrational use of plasma therapy which can fuel the pandemic, according to the letter signed by vaccinologist Gagandeep Kang, surgeon Pramesh C S and others.

    “We are writing to you as concerned clinicians, public health professionals and scientists from India about the irrational and non- scientific use of convalescent plasma for COVID-19 in the country.”

    “This has stemmed from guidelines issued by government agencies, and we request your urgent intervention to address the issue which can prevent harassment of COVID-19 patients, their families, their clinicians and COVID-19 survivors,” said the letter.

    “The current research evidence unanimously indicates that there is no benefit offered by convalescent plasma for treatment of COVID-19. However, it continues to be prescribed rampantly in hospitals across India,” the letter said.

    The guidelines have been issued by the ICMR and AIIMS, Delhi joint monitoring group under the union ministry of health and family welfare.

    The off label use of convalescent plasma, despite evidence earlier that it offered no benefit to Covid patients in reducing mortality or disease outcome, has been part of India’s coronavirus treatment guideline as an investigational therapy.

    It has often led kin of serious Covid patients to scramble for plasma, sometimes even by paying exorbitantly, despite under the existing norms it cannot be sold and purchased, in the hope of saving the sick in the absence of any definitive treatment for the disease.

    Results from the randomised evaluation of Covid-19 therapy (recovery) trial, whose results were published in The Lancet on Friday said that the use of plasma therapy on hospitalised Covid patients does not improve survival rate or any other pre-specified clinical outcomes.

    Earlier, a trial by the ICMR too, in September last year, had shown that the therapy does not benefit either in reducing mortality or arresting progression of the disease.

    The trial, called PLACID, was carried out in 39 hospitals across 14 states and Union Territories. 

    The government however, had not dropped this investigation therapy from the Covid19 treatment protocol, despite suggestions by researchers and scientists that its rampant use may be leading to unwanted mutation in SARS-CoV2, a fact publicly acknowledged by the ICMR chief several months ago.

    “We have to maintain judicious use of therapies which are going to benefit, if their benefit is not established, we should not use those therapies otherwise they would put tremendous immune pressure on the virus, and the virus will tend to mutate more,” ICMR director general Balram Bhargava had said in December.

    “Therapies that are well established should be used, and those that are not well-established, their judicious use has to happen.”

    Many experts have been saying that rampant use of plasma therapy without prior testing for neutralizing antibodies will do more harm than good but a lot of treating doctors in several parts of the country routinely ask attendants to arrange it for hospitalised Covid patients.

    (With PTI Inputs)

  • INTERVIEW | Pandemic will end up as an endemic, says immunologist Dr Dipyaman Ganguly

    Express News Service
    Senior immunologist Dr. Dipyaman Ganguly, principal scientist, CSIR-Indian Institute of Chemical Biology in Kolkata, has seen some encouraging signs. Few cases of reinfection and effectiveness of therapy using immunosuppressants are some of those. He prescribes a combination of personal commitments and policy-level commitments in addition to mass vaccination in order to reduce the pandemic to a manageable proportion. Excerpts…

    Q: So far, what have we understood about our immune response to the SARS CoV 2, and what remains to be understood?

    A: We could gather quite a bit of information from the earlier stints of the pandemic in 2020. But I must say the disease caused by the coronavirus is too enigmatic to be confident that we know everything about it by now. The most important lacunae are how the new variants will affect the course of the pandemic. It was clear from the very beginning that the virus is going to be a menace for humanity for a long time in the future. It is mostly clear that the pandemic will end up as an endemic disease.

    Q: We know that the immunity conferred by the natural infections, contributed by antibody-producing B cells and the T cells, is working well for one and half years. Even in this fast-evolving second wave of infection in India reports of reinfections are rare, which is a dependable testimony for this assuring conclusion.

    A: The evidence gathered from all over the world in support of a hyperactivated immune response in the patients succumbing to severe disease is also being supported in the second wave as well. Thus the medical therapy using immunosuppressants like corticosteroids is saving a lot of lives.

    The vaccines have been rolled out and most of the health care workers and a considerable fraction of the senior citizens in the country have received a complete regimen of the vaccines and anecdotal evidence suggests they are also not being documented to succumb to symptomatic disease in the second wave. These are all dependable positive information. Regarding the duration of immune protection conferred by the vaccines, we do not have enough data as the vaccines have been there for just six months or so. If vaccine-induced immunity also follows the pattern similar to natural infections, a lot of lives will be saved.

    Q: What does the current wave of Covid-19 infections, which is worse than the first national wave, indicate, and has it surprised you in any way?

    A: There are several non-mutually exclusive reasons for the much steeper and higher amplitude of the second wave. I believe a major reason has been an insidious complacency resulting from the gradual reduction in the number of cases, and more importantly too much stress upon the information that younger citizens are protected from disease severity. These had made the younger citizens too casual as the statutory lockdowns were over.

    Secondly, a major fraction of the infections in this second wave is due to the newly emerging variant strains. A number of them have documented higher transmission rates, e.g. the B.1.1.7 strain or UK strain. As a result of these different factors, we are actually seeing a high-amplitude second wave with a large number of younger citizens also being afflicted with symptomatic diseases.

    ALSO READ | Covaxin found to be effective against most Covid variants; expert says result “not surprising”

    Q: Do you think mutation might be having a big role to play in the ongoing wave of infections?

    a: As I already mentioned, the variant strains harbouring the concerning mutations are constituting a large fraction of the new infections, and some of them do have higher transmission rates, e.g. the N501Y mutation (now nicknamed Nelly) in the UK strain spike gene.

    As you must have noted from myriad media reports, a large number of these variants do have abilities to somewhat escape the immune protection conferred by the natural infection with the earlier strains or vaccines, e.g. the Eek (E484K) mutation in the South African B.1.351 and the Indian double mutant (B.1.617) strains. But personally, I am keenly following reports of reinfections in the second wave among individuals with a previous history of natural infection with the earlier strain or people who are fully vaccinated. Till now such reports are rare. That is sort of indicating that the immune escape of these mutant viruses registered in the laboratories may not be getting too dangerous in real-life scenarios. It may be that even the suboptimally efficient immune protection, against these so-called escape variants, is being able to prevent severe symptomatic diseases from occurring. We will have to be actively vigilant for such occurrences, by ramping up viral sequencing efforts all over the country as well as meticulously documenting the reinfections. If this trend remains as such it will be a great relief.

    I would also like to point out here that this also means that therapeutic approaches like convalescent plasma therapy should be explored in this wave too. The only antiviral therapy which is sought after leading to a temporary crisis regarding its supply is the repurposed drug Remdesivir. Interestingly, the importance that CPT was given in the first wave of the pandemic is absent in the second wave. The major reason for that has been contradicting results from different randomised control trials done in different parts of the world that explored its efficacy. Most meta-analyses failed to show a ‘universal’ efficacy of CPT in Covid-19. Of note here, the therapeutic benefit of Remdesivir was also not proven in clinical trials worldwide.

    In this regard, one should keep in mind that some of the well-documented trials, both from India and abroad, did show that CPT may confer a very significant survival benefit in the younger Covid-19 patients who were succumbing to severe disease. A smaller study done in Kolkata reported significant benefits in patients below 66 years of age. A much larger trial in the USA reported a similar efficacy in patients below 65 years of age. Given the larger number of younger citizens succumbing to severe symptoms in the second wave, these data should be paid heed to. After all precision medicine is the way forward in the medical sciences and thus depriving patients of a therapy that may be beneficial to them, even if not to all patients, is not prudent. At this phase of the epidemic, the potential convalescent donors are not in dearth. Just a well-coordinated awareness campaign, smooth running plasma banks, and a prudent protocol for selecting recipients who will benefit from it can save a lot of lives.

    Q: Some metropolitan cities like Delhi, Mumbai, and Pune which had seen quite a few peaks before are also seeing even a worse situation. Do you think serosurveys — showing quite high seropositivity rates in these cities- painted a misleading picture and lulled people and governments into some sort of complacence?

    A: I do not think that the seropositivity rates were misleading. The serosurveys never reported a level of seroprevalence that could even theoretically prevent pandemic progression. A large number of citizens were left susceptible and they are now getting infected. As I mentioned the second wave of the epidemic in India is yet to record a significant number of reinfections. One may consider the possibility that the seroprevalence data were wrongly read by the lay citizens, which perhaps led to their complacent behaviour of doing away with the physical distancing measures.

    Q: What level of Covid vaccinations should be achieved before we can see the pandemic ebbing?

    A: My understanding about the pandemic tells me that vaccination alone cannot end the pandemic. The so-called ‘Swiss cheese’ model of pandemic protection, which was originally proposed in 1990 by James Reason, a cognitive psychologist, to explain how to prevent accidents from occurring, is being frequently invoked by experts in the context of the present pandemic. This tells you that a single measure cannot be full-proof in preventing the pandemic from progressing. A combination of personal commitments to pandemic-related restrictions (like mask use and physical distancing) as well as policy level commitments to contact-tracing, ramped up testing and viral sequencing, easy accessibility to necessary healthcare, in addition to the mass vaccination measures, can reduce the pandemic to a manageable proportion and save a lot of lives.