Q) I read that there was a drug which became approved for the treatment of COVID-19. What can you tell me about it?
A) The anti-viral drug remdesivir has been generating a ton of media for several reasons. On the good news front, it has become the first drug approved by several regions of the world, including the United States and the European Union just this week, for the treatment of COVID-19. This is indeed massive news as many of our previously hyped treatments such as President Trump’s hydroxychloroquine/ Plaquenil or the HIV treatment mainstays lopinavir and ritonavir have proven to be unhelpful so far.
Interestingly enough, remdesivir itself was once seen as a “failed drug” when it was originally tested against another lethal infection, the Ebola virus. As well, with respect to treating COVID-19, this drug took its time to find its place after generating some initial hype.
The background here was that it was one of the drugs touted by Mr. Trump as being “promising” but its initial trial conducted within China in April of this year did not appear to go well. It generated numerous headlines as being just one more failure although the WHO said these released conclusions were premature, one of the many challenges science faces when dealing with the media’s thirst to be first with a storey.
As it turns out, remdesivir does appear to be very helpful for a select group of patients who are already very sick from the effects of this virus. It is indicated for use in adults and adolescents from the age of 12 and up who are also suffering from pneumonia (a serious complication that some people get from COVID-19) and are currently requiring oxygen therapy. As such, this is not a run of the mill treatment for the average person who gets infected with this virus. Just about anyone who meets the criteria for treatment with this drug has already been hospitalized and is quite probably in the intensive care unit.
Remdesivir’s approval is based upon a study conducted on 1,063 patients who received either the drug or a placebo (the term we use for a treatment that looks like the real drug but instead contains harmless substances such as a starch or sugar) for a treatment course of up to 10 days. The researchers were looking to measure whether the drug sped up a patient’s recovery which was defined as either a discharge from the hospital or that they were kept in the hospital but only for the purposes of preventing the patient from spreading the virus further.
When the data was collected and analyzed, it was found that patients who received remdesivir had an average recovery of 11 days (versus 15 days in those who received the placebo treatment) along with a reduction in estimated mortality within 14 days (at 7.1% with remdesivir and 11.9% with the placebo). As far as safety goes, serious adverse events occurred somewhat surprisingly less frequently in the treatment group than they did with the placebo faction at 21.1% of patients versus 27.0%. All in all, these results are very strong (when we say strong you have to keep in mind that this is the same industry that has turned a certain vaccine into a billion dollar entity for preventing one disease in one person for every 32 patients vaccinated) and this has lead to massive shortages of this drug which we will discuss in due course.
First, a background on this medication. Remdesivir is part of a family of drugs known as the nucleoside analogues (there are more than 30 members in this class) that have been around for decades and have been used to treat a variety of conditions such as other viruses, parasites, bacterial and fungal infections as well as certain cancers. It works because it closely resembles naturally occurring molecules within our body known as nucleosides, hence the chosen name for this class of drugs.
Nucleosides are the “building blocks” of our DNA and RNA which carry our genetic information and are essential in virtually everything our body does. Viruses take up our natural nucleosides as they replicate within our body. When they take up a nucleoside analogue by accident such as remdesivir, it prevents the virus from replicating further leading to the death of the virus. This is because while the drug looks the same to the virus, there are slight differences in the drug’s structure which in essence messes up the chemistry within the virus preventing it from reproducing further.
The drugs as a whole are generally considered safe considering they are reserved for treating serious and often life threatening conditions but can cause side effects such as respiratory failure, organ impairment, changes in the levels of our blood cells that help with clotting and certain liver issues. With potentially serious adverse effects such as these, there is little chance this drug will ever be used in those who are just mildly ill from this coronavirus. The drug is given by an IV infusion usually just once a day.
Remdesivir is also making headlines for its lack of availability to most of the countries in the world. The U.S. government struck up a deal with the drug’s manufacturer (U.S. based manufacturer Gilead) allocating virtually all of its world-wide supply to that particular country. This once again raises important socio-economic questions that we will no doubt face again if and when an effective vaccine is manufactured.
Was it wrong for the U.S. to effectively monopolize the supply of this drug when it has perhaps the direst need in the world considering the rapid escalation in the number of cases across the border? Was it wrong for Gilead to strike a deal with one country when it is a “for profit” organization that originated within that same country? The current American government has never been less popular with the rest of the citizens of the world for many reasons so it has taken on an avalanche of criticism over this deal that may, or may not, be justified.
They are certainly not the first country to stockpile badly needed supplies (see China and its initial lockdown of various PPE’s or India’s initial ban on exporting hydroxychloroquine) and can state quite honestly that they are only trying to care for their citizen’s health, which should be a priority for every government (although the Trump administration’s record in this whole area is at best troubling up to now).
Regardless, hopefully one of the many outcomes that will come from this pandemic sometime down the road is an honest conversation about how to collectively, as a world, deal with supply shortages of any resource so that the most benefit can be gleaned from the resources that we do have. For more information about this or any other health related questions, contact your pharmacist.