Vanesa Lopez
06/08/2020 - 16:31
- Clarín.com
- Society
A drug for a type of cancer, called acalabrutinib , showed signs that it could help hospitalized patients with severe cases of coronavirus.
The study - which was done in a small group of patients - was led by researchers from the United States National Cancer Institute (NCI) and the results were published Friday in the journal Science Immunology.
It is a new example of "off-label", that is, a drug that has a certain use and is now being tested to treat the coronavirus. It is the same with hydroxychloroquine (approved for malaria, rheumatoid arthritis, and some cases of lupus), and ritonavir and lopinavir (an association used for HIV).
Acalabrutinib was approved in the United States, by the Food and Drug Administration (FDA), as a treatment for a type of cancer called mantle lymphoma, which is of very low incidence worldwide. It is also in the approval process in Spain.
Consulted by Clarín about the use of this medicine in our country, Rubén Sajem, director of the Center of Argentine Pharmaceutical Professionals (Ceprofar), explains that " it is not in the Vademecum of the national drug bank, nor in that of the Pami".
"It could be used in Argentina for patients who have this pathology (mantle lymphoma) as a compassionate use: it is called that because it does not have a definitive approval record in Argentina, but it does have a record in other countries. In those cases, when there is no other medication, you can decide to apply it, "continues Sajem.
In that case, the pharmacist explains that the doses are given every 12 hours and that the price in the Vademecum ANMAT is 823 thousand pesos . "It is a very expensive medicine , because it is biological, of the new generation," he says.
It is a targeted drug that interferes with a protein called Bruton's Tyrosine Kinase (BTK), which plays an important role in the immune system.
"Although BTK inhibitors are approved to treat certain cancers, they are not approved as a treatment for Covid-19. This strategy should be tested in a randomized, controlled clinical trial to understand the best and safest treatment options for patients with severe Covid-19, ”says the NCI in a statement.
The trial included 19 patients with a confirmed diagnosis of Covid-19 who were in a very unstable situation. All were hospitalized, with low blood oxygen levels, and evidence of inflammation.
Within one to three days after starting acalabrutinib, most patients had a substantial drop in the molecular markers of inflammation and an improvement in oxygenation levels.
Specifically, the drug was administered to 11 patients with supplemental oxygen and to 8 patients with mechanical ventilation in a 10-14 day course of treatment. Ultimately, 8 of the 11 patients with supplemental oxygen breathed room air, and 4 of the 8 ventilated patients were extubated.
Furthermore, blood samples from patients in the study showed that levels of interleukin-6 (IL-6), a cytokine associated with hyperinflammation in severe Covid-19, decreased after treatment with acalabrutinib .
However, the researchers acknowledge that the scope of the study has its limitations . "These findings should not be considered clinical advice, but are shared to aid the public health response to Covid-19," clarified the NCI.
According to Sajem, it is a "very limited" study that was done without comparison, only in 19 patients. "It only serves as an observational indicator, it is not even a clinical study. It would have to be seen, from now on, like so many other drugs that are being studied, what possibilities does it have," concludes the pharmacist.
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