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Generalized use of Nirmatrelvir plus ritonavir (Paxlovid): Raising concerns
Uso generalizado de Nirmatrelvir más ritonavir (Paxlovid): Algunos planteamientos
David Sánchez Fabraa,
Corresponding author
davidsanchezfabra@gmail.com

Corresponding author.
, Tina Herrero Jordánb
a F.E.A (Facultativo Especialistas de Área) de Medicina Interna, Servicio de Medicina Interna del Hospital Reina Sofía de Tudela, Tudela, Navarra, Spain
b F.E.A (Facultativo Especialista de Área) de Neumología, Servicio de Medicina Interna del Hospital Reina Sofía de Tudela, Tudela, Navarra, Spain
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    "textoCompleto" => "<span class="elsevierStyleSections"><p id="par0005" class="elsevierStylePara elsevierViewall">Nirmatrelvir plus Ritonavir &#40;Paxlovid&#41; will be used in Spain soon&#46;<a class="elsevierStyleCrossRef" href="#bib0055"><span class="elsevierStyleSup">1</span></a> Although the potential effect of the drug against COVID-19 infection has biochemical explanation and has been demonstrated in several in vitro studies&#44;<a class="elsevierStyleCrossRef" href="#bib0060"><span class="elsevierStyleSup">2</span></a> final acceptance arrived from the Randomized Clinical Trial &#40;RCT&#41; supported by Pfizer and published by Hammond et al&#46;&#44;<a class="elsevierStyleCrossRef" href="#bib0065"><span class="elsevierStyleSup">3</span></a> which was carried out in patients who were neither vaccinated nor had previously had COVID-19 infection&#44; with a mild COVID-19 infection of less than 5 days&#46; Despite the spectacular results of this RCT&#44; several concerns should be considered&#46;</p><p id="par0010" class="elsevierStylePara elsevierViewall">First&#44; patients with at least one risk factor for severe COVID-19 disease were selected&#46; These risk factors were&#44; among others&#44; being over 60 years of age&#44; having a Body Mass Index &#40;BMI&#41; greater than 25 or having one of several relatively prevalent diseases such as high blood pressure&#44; smoking&#44; heart disease or lung disease&#46; It is necessary to highlight that the proportion of people with at least one risk factor in our environment is very high&#46; More than 40&#37; of the Spanish population would have a BMI<span class="elsevierStyleHsp" style=""></span>&#62;<span class="elsevierStyleHsp" style=""></span>25<a class="elsevierStyleCrossRef" href="#bib0070"><span class="elsevierStyleSup">4</span></a> or almost 20&#37; of the population is over 65 years old&#44;<a class="elsevierStyleCrossRef" href="#bib0075"><span class="elsevierStyleSup">5</span></a> which could mean an excessive number of potentially treatable patients&#46;</p><p id="par0015" class="elsevierStylePara elsevierViewall">Another important point to keep in mind is that the composite variable &#8220;admission or death&#8221; was chosen as outcome&#46; Thanks to this&#44; the Number Needed to Treat &#40;NNT&#41; to avoid an outcome was 18 patients &#40;event rate in the treatment group of 0&#46;78&#37; vs&#46; 6&#46;40&#37; in the placebo group&#59; absolute risk reduction of 5&#46;62&#37;&#41;&#46; However&#44; when analysing events&#44; we found that death was 18&#46;2&#37; of events &#40;12&#47;66 cases&#41;&#46; Looking only at deaths&#44; risk reduction was 1&#46;15&#37; &#40;0&#37; vs 1&#46;15&#37;&#41; with an NNT of 87 patients&#46; Mortality could be more useful to take decisions since many admissions may be short and perfectly assumable nowadays&#46; Thus&#44; it is essential to deepen into the characteristics of patients with adverse outcomes&#44; both in terms of their comorbidities as well as the implications of such admission &#40;stay&#44; clinical severity&#44; maximum need for oxygen flow or admission to the ICU&#41;&#44; the latter being missed from the study&#46;</p><p id="par0020" class="elsevierStylePara elsevierViewall">It should also be noted at this point that it seems that COVID-19 disease is beginning to behave like any other viral infection with the potential effect of producing community-acquired pneumonia &#40;CAP&#41;&#46; An unintended fact that emerges from the article is that mortality in unvaccinated patients with risk factors in the placebo group was only 1&#46;15&#37;&#46; We must not lose sight of the fact that CAP has an incidence and hospitalization rate of 4&#46;63 and 1&#46;64 cases per 1000 people&#47;year in Spain&#44;<a class="elsevierStyleCrossRefs" href="#bib0080"><span class="elsevierStyleSup">6&#44;7</span></a> with a mortality of 4&#8211;18&#37; in hospitalized patients&#44; increasing dramatically in those with one or several comorbidities&#44;<a class="elsevierStyleCrossRef" href="#bib0090"><span class="elsevierStyleSup">8</span></a> and that most of them are caused by viruses&#46;<a class="elsevierStyleCrossRef" href="#bib0095"><span class="elsevierStyleSup">9</span></a></p><p id="par0025" class="elsevierStylePara elsevierViewall">Regarding the results&#44; it seems clear that Paxlovid has a beneficial effect in preventing worsening of COVID-19 disease in selected mild patients with less than 5 days of symptoms&#44; which is a promising milestone in the development of antiviral agents&#46; Despite this&#44; prudence is needed when regulating and using this medicine&#46; When extrapolating the data to our daily clinical practice&#44; and despite the fact that Pfizer is already carrying out another similar RCT in vaccinated patients &#40;EPIC-Standard Risk &#91;SR&#93;&#59; <a href="ctgov:NCT05011513">NCT05011513</a>&#41;&#44; it is important to be aware that at the moment there is only one published RCT and that it has been carried out in unvaccinated population that had not had COVID-19 disease&#46; In Spain&#44; at the end of March 2022&#44; more than 80&#37; of the population has been vaccinated and one in four people has already overcome the disease&#46;<a class="elsevierStyleCrossRef" href="#bib0100"><span class="elsevierStyleSup">10</span></a> Thus&#44; clinicians should perform optimal risk stratification before prescribing such drug so that Paxlovid does not become inappropriately used&#46;</p><p id="par0030" class="elsevierStylePara elsevierViewall">It may seem obvious&#44; but we must not forget that the process of approving new drugs requires prudence&#44; and although at the worst of the pandemic it was necessary to practice a medicine that was not strictly based on the evidence&#44; fact that we all remember well&#44; our situation today is no longer critical&#46; That is why it is more necessary than ever to recover the scepticism and critical sense usually associated with scientific methodology&#44; as well as the individual common sense of the art and science of medical practice&#46;</p></span>"
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ISSN: 2529993X
Original language: English
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es en pt

¿Es usted profesional sanitario apto para prescribir o dispensar medicamentos?

Are you a health professional able to prescribe or dispense drugs?

Você é um profissional de saúde habilitado a prescrever ou dispensar medicamentos