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Recently, the Food and Drug Administration (BPOM) announced a permit to use remdesivir in patient management Covid-19 with the condition of a health emergency or emergency use authorization (EUA). The distribution of the license given to PT Kalbe Farma Tbk has attracted public attention.
Remdesivir, which has been used since the beginning of the pandemic in the United States, is known as an expensive drug. In addition, it has not been proven to be able to treat Covid-19 patients, like other types of drugs that are also used by the government, namely oseltamivir, favipiravir, and lopinavir.
Professor of Pharmacology and Clinical Pharmacy, Faculty of Pharmacy, Gadjah Mada University (UGM) Prof. Zullies Ikawati said that so far there has not been any corona drug. However, he stated that some antiviral drugs have shown promise in treating Covid-19 patients.
“From the testing process, it seems that remdesivir is the most promising result,” Zullies said in a special interview with Katadata.co.id, Wednesday (7/10).
Zullies explained many things about various therapies for the treatment of Covid-19, including the regeneron used by United States President Donald Trump when he was positive for Covid-19. He also explained the ability of herbs to empon-empon to increase the immunity of corona patients.
The following are excerpts of the interview with Ameidyo Daud, Yuliawati, and Dini Apriliyana from Katadata.co.id:
Many parties produce and distribute covid-19 antivirals, one of which is remdesivir. Will this be an effective antivirus to reduce critical covid symptoms?
Indeed, until now there is no truly effective drug in the Covid-19 pandemic. Chloroquine and hydroxychloroquine were used for the first time. Other countries have tried other drugs such as lopinavir / ritonavir and remdesivir.
Because nothing has been clinically proven, the WHO organized solidarity trial. There were four treatment groups tested, namely remdesivir, lopinavir / ritonavir, hydroxychloroquine-chloroquine, then plasma. convalescent.
How is the result ?
From the testing process, it seems that remdesivir is really the most promising the result. While the clinical trials of lopinavir / ritonavir and hydroxychloroquine were stopped by WHO because the results were not very promising.
Why is remdesivir most promising?
Because he was developed as an antivirus. Meanwhile, hydroxychloroquine is originally an anti-malarial drug and immunosuppressant (immune system suppressant). As lopinavir / ritonavir used to be a cure for HIV, then it was tried for Covid-19 and the results were not very encouraging.
Remdesivir is a slightly different story. Remdesivir has never been marketed, but has been developed since the 2010s by Gilead Science from the United States. They are working with the American CDC and the US Army to develop the antiviral drug RNA. Viruses have genetic material in the form of DNA (deoxyribonucleic acid) or RNA (ribonucleic acid)
Now Covid-19 is an example of an RNA virus. This drug has been used during the Ebola and MERS outbreaks in 2013-2014 and has undergone clinical trials. The results were quite good because the mechanism could inhibit virus replication, but at that time it could not be marketed. Gilead brought up this drug again during the Covid-19 pandemic.
How is it effective on Covid-19?
The results of clinical trials in various countries are available, although not all of them have been completed. As reported in The New England Journal of Medicine (NEJM), of the 1,064 subjects who were divided into two groups, one received remdesivir and the other was an empty drug (placebo). The result, the remdesivir group recovered about 4 days faster. Other test results were almost the same, accelerating healing. From there, that’s why it is allowed to circulate but use emergency use authorization or distribution authorization in emergency situations. This means that as long as there is no truly definitive drug, this drug can be used.
Who has used it?
India is fast, they buy a license from Gilead Science and several industries there are already producing. Including Covifor from Hetero and Desrem from Mylan Pharmaceutical. Several pharmaceutical industries then produced under license from Gilead Science.
In Indonesia, whoever distributes it ?
There were several, the first time PT Kalbe Farma imported Covifor from Hetero then followed by Desrem from Indo Farma. Both private and state-owned enterprises have started importing and must be registered in Indonesia. BPOM also gave distribution permits to be circulated with status emergency use authorization.
Is remdesivir safe for pregnant and lactating women ?
The results of the clinical trial of Remdesivir stated that it could be used at the age of over 12 years with a body weight over 40 kg. For pregnant and lactating women there is no safety information so it is recommended to avoid it.
Is it safe for children too ?
We don’t know yet, because there have been no clinical trials conducted on children of a certain age and it is unethical to conduct clinical trials on children. That then after trying to be safe, maybe. But in terms of regulations, it should not be used for children and pregnant / nursing women.
Covid-19 patients in the United States are also taking remdesivir, but the mortality rate remains high?
In Indonesia it is the same. If seen, the highest mortality rate is experienced by those who already have comorbids such as diabetes, hypertension, other respiratory diseases. Likewise with those who are elderly, even though they look healthy, the immune system will not be the same as young people.
Apart from remdesivir, there is favipiravir which is considered effective in Covid-19 patients, what is the mechanism ?
Favipiravir originates from Japan, Fujifilm, which produces it under the patent name Avigan. Formerly this drug was used for influenza as an alternative to oseltamivir. It’s been clinically tested, has been used for SARS. Pak Jokowi bought this drug based on information from China because it was used and the results were quite good.
The mechanism is similar to remdesivir, inhibits viral replication by targeting enzymes called RNA dependent and RNA polymerase needed for viral synthesis and replication.
Which is more effective, remdesivir or favipiravir ?
I guess almost apple to apple same as remdesivir. It’s just that the use of remdesivir is wider because it has solidarity trial in several countries. If favipiravir is still in clinical trials and the results are not definitive, but enough promising until get emergency use authorization in Indonesia. Only the form is different, if Favipiravir is a tablet while remdesivir is an injection.
Some doctors demand that the sale of untested drugs be carried out by the government, not by the private sector. From a pharmaceutical point of view, what should it be like? ?
I honestly don’t know exactly why. But to say it unproven, everyone unproven or it has not been proven to be a Covid-19 drug, but the government has provided it. Such as hydroxychloroquine and oseltamivir from the government. Especially for this remdesivir, I don’t really know why the private sector has initiated it, even though BUMN has also started it.
There is an assumption that Covid-19 treatment is relatively expensive and cannot be reached by the public. What needs to be done so that drug availability and prices are affordable ?
Drug development is costly and takes a long time. But if it has been around for a long time and the patent has expired, it can usually be made generic and it will be cheaper. I heard favipiravir is already generic and can be cheaper. In contrast to remdesivir which is still new. So when buying imports, that’s it under license from Gilead. So the price is still expensive.
So how do patients get cheap treatment ?
If you want it to be cheap, you have oseltamivir
But how effective is it ?
You see, the conditions of Covid-19 patients themselves are very varied. In fact, many do not need to use drugs and recover. Enough to increase the immune system, take vitamins. Then by eliminating the symptoms, so if you cough, have a fever, and use a fever, it will also heal.
So there is no need for antivirus ?
I don’t think these antivirals are mandatory because many people are positive without symptoms and don’t need antivirals. Indeed, in certain conditions an antivirus is needed. In the medical professional organization guidelines, the choice is a combination of the antibiotic levofloxacin or azithromycin with favipirafir. Or with lopinavir / ritonavir, hydroxychloroquine or chloroquine plus vitamin C.
If people have an issue with expensive drugs, don’t use those drugs. Moreover, remdesivir is only used in patients with severe symptoms. There are already instructions that it is used in severe cases and should be used by doctors because it is an injection. If that is the case, of course it will be borne by the government because most of them are treated at referral hospitals.
Before the antiviral drugs that have been mentioned, there was a malaria drug chloroquine that was given to Covid-19 patients. Does it work?
As long as it is used properly, it means that it is not harmful. Instead of not taking medicine, just give it. But if you look at the results of clinical trials, they weren’t so promising until WHO stopped testing. But it does no harm and causes death.
In Indonesia, what is the case like? Are there cases of dangerous side effects?
Based on BPOM observations, the use of hydroxychloroquine or chloroquine is not harmful so far, but as far as it is used correctly. Hydroxychloroquine and chloroquine are side effects to the heart, because there is an acceleration and disturbance of the heart beat rhythm. So it will not be given to patients who have heart problems. If the patient uses it, it will be closely monitored and any worsening will be stopped. Until now it has done no harm and there are no better options.
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