In the face of the global epidemic situation, WHO recently released relevant information on covid-19 treatment drugs, which highly recommends Pfizer's anti-COVID-19 oral drug Paxlovid. As soon as this news comes out, it is estimated that many people will begin to advocate this anti-new crown drug again, and what is the RECOMMENDATION of the WHO, and the anti-new crown drug is suitable for which groups of people to use, but often will not get enough attention from everyone.
Recently, there have been many controversies on the Internet about anti-new crown drugs, and the most concerned are two drugs, one is Lianhua Qingpest, and the other is Pfizer's Paxlovid. The collision of the two extreme views is also quite fierce, one is to completely deny the potential benefits and efficacy of traditional Chinese medicine, and because the clinical data of Lianhua Qingpeng is not convincing enough, it has become the main attack point of these "black" people; and the other extreme view is that Americans are not credible, American drugs are never available, and this kind of situation that brings "patriotism" into drug disputes is also relatively common.
Whether it is the capital manipulation behind it, or some personal overly extreme views, whether it is Lianhua Qingpest, or Pfizer's special drugs, drugs are drugs, we should not take the evaluation of drugs with the color of personal subjectivism. How effective the drug is, how efficient it is, how safe it is, needs to be gradually confirmed after years of clinical practice, rather than according to the personal likes and dislikes or interests, open your mouth to deny, more hateful is cloaked in the so-called "scientific" cloak, in order to benefit the "black" and "black" group.
That's a bit of a stretch. Today's popular science article, mainly combined with the WHO's new crown treatment recommendation for Paxlovid, as well as Paxlovid's specific clinical trial results and data, to introduce this drug for everyone, after reading the following points, we will find that in fact, this so-called "miracle drug", its application scope is still relatively limited.
Pfizer oral anti-COVID-19 drugs strongly recommended by WHO are not needed by everyone
Paxlovid, which is highly recommended by WHO, is actually a combination of the new drug nimatrevir and the anti-AIDS drug ritonavir, which was approved by the US FDA in December 2021 and was only authorized in March 2022 in the mainland, which is an anti-COVID-19 oral drug that has been clinically validated in phase III of randomized controls.
But to be clear, WHO recommends this drug, not all people infected with the new crown virus should take this drug, WHO's original words are:
WHO made a strong recommendation for nirmatrelvir and ritonavir, sold under the name Paxlovid, for mild and moderate COVID-19 patients at highest risk of hospital admission, calling it the best therapeutic choice for high-risk patients to date.
What that translates is that WHO highly recommends Paxlovid for people with mild and moderate COVID-19 infections at the highest risk of hospitalization and is by far the best treatment option for high-risk patients.
I have to say that the WHO recommendation is still relatively rigorous. This drug is aimed at mild or severe COVID-19 infections with a high risk of hospitalization, and the purpose of taking the drug is also to reduce the risk of hospitalization. Who are the high-risk covid-19 patients at risk of hospitalization? In fact, from Paxlovid's clinical trial data, we can understand that the participants in the phase III clinical selection of this drug are also new crown infections with at least one risk of hospitalization, and the factors that increase the risk of hospitalization of the new crown virus mainly include:
- Elderly people
- Unvaccinated groups
- Immunosuppressed populations
- People with cardiovascular disease
- People with diabetes
- Cancer population
In addition, the risk of hospitalization after the new crown infection will be further increased for smokers, obese people, and doctors should pay more attention when assessing the risk of hospitalization. That is to say: after this part of the population is infected with the new crown, it is recommended to use Paxlovid after assessment and there is a higher risk of hospitalization.
In addition, WHO specifically recommends that Paxlovid should not be used in low-risk patients, as the benefits are negligible.
Therefore, if we look closely at the first half of this report, we will know that the so-called WHO highly recommended is actually premised and limited. Low-risk patients infected with COVID-19 do not need to take Paxlovid.
WHO makes such a recommendation, mainly based on the phase III clinical data of this drug, in the phase III clinical trial, the main group of this drug is the relevant infected people who are at risk of hospitalization, so patients outside of this, taking this drug, there is no clear clinical benefit.
Paxlovid's phase III clinical data also have certain deficiencies
Compared with the controversial and criticized Lianhua Qingpeng, Pfizer is an anti-COVID-19 oral drug that has truly completed phase III clinical trials, but is its phase III clinical data really perfect enough?
Combined with the results of the Phase 2/3 clinical trial of Paxlovid recently published in the New England Journal of Medicine, this data is relatively good, but it is not without flaws. Regarding the question that the mortality rate of the control group is much higher than that of real-world data, it has been pointed out that the subjects of Pfizer are all participants who have not been vaccinated and have at least one high-risk factor, so there is no death in the drug group, and nearly 2.0% mortality rate in the placebo group (7 deaths in 385 patients who take placebo), it is entirely possible, and we will not discuss whether this data is false today, mainly on other issues.
The total clinical data for Paxlovid was that a total of 2246 patients were enrolled, of whom 1120 took Paxlovid and 1126 took placebo, with a safe follow-up time of 34 days and no follow-up long-term follow-up.
The results showed that in the final analysis of patients treated within 3 days of the onset of symptoms of COVID-19 infection, 5 were hospitalized out of 697 patients taking Paxlovid, while of the 682 people taking placebo, 44 patients were admitted to the hospital, and the risk of hospitalization and death of COVID-19 infection decreased by 88.9%, of which 9 all-cause deaths occurred in the placebo group and no deaths in the Paxlvoid group.
In the population who took the drug within 5 days of the onset of symptoms, the drug group compared with the placebo group reduced the risk of hospitalization and all-cause death by 87.8%.
This data can be said to look very good, but there is still a problem of a small number of clinical cases, and more real-world clinical data is needed to further prove the real efficiency of Paxlovid's application in a wide range of high-risk groups of new crown infection. In addition, the optimal time to take this drug is within 3 or 5 days after the onset of symptoms, and further verification is still needed for whether people who have taken the drug at other times still benefit.
Another noteworthy thing is that the approval of this drug in China has not completed the corresponding clinical trials in China, because it is an emergency authorization approval, which is not in violation of the law first, and is in line with the relevant provisions of the national drug regulatory authority on emergency authorization.
In view of the fact that remdesivir has been clinically shown to be effective in the United States, but in the domestic phase III clinical proof of ineffectiveness, and the current vaccination coverage rate in China is high, and Paxlovid has a lack of specific data on the benefits of drug use in the population after vaccination, therefore, there is still a lack of data on the application of this drug in domestic new crown infection.
With the continuous occurrence of domestic epidemics, Paxlovid has also entered the country, we may wish to carry out a corresponding double-blind, randomized controlled clinical study in China like remdesivir in china to prove the effectiveness and safety of this drug on Chinese.
The safety of Paxlovid is noteworthy
Regarding Pfizer's new anti-covid-19 oral drug, how safe it is in clinical application, it also needs to be further verified in real-world clinical use. In the phase III clinical trial, the results showed that Paxlovid compared with placebo, the main adverse reaction risks are loss of smell, diarrhea, vomiting, etc., but most of them are tolerated, but in addition, there are no other adverse reaction risks, which are also worthy of our attention.
In addition, in Paxlovid, ritonavir is a drug to enhance the anti-coronavirus efficacy of nimatrevir, which is itself an anti-HIV drug, but also a potent inhibitor of the liver drug enzyme CYP3A4, so there are many things to pay attention to in terms of drug interactions. Many patients with a high risk of hospitalization for infection with the new crown are often patients with a variety of chronic diseases, new crown infection should be resisted, but chronic diseases can not be treated, ergotamine drugs for the treatment of migraines, itraconazole for the treatment of fungal infections, cesarprid for the treatment of gastroesophageal reflux, atorvastatin for the control of high blood lipids, simvastatin and other drugs, for the treatment of pulmonary hypertension and male dysfunction of sildenafil, tadalafil and other drugs, there is a risk of drug interaction with ritonavir, therefore, In the treatment of new crown infection, taking Paxlovid should also pay attention to the safety risks of medication with other drugs taken, and how to weigh the pros and cons is also worthy of special attention.
To summarize briefly, for Paxlovid, we should recognize the following 5 points:
- Paxlvoid is not intended for everyone and is only recommended for COVID-19-infected people at high risk of hospitalization.
- The time of taking of Paxlovid should be verified is within 3 days or 5 days after the onset of symptoms, and the rest of the time window for administration is not verified.
- Paxlovid's clinical trials target populations, which are unvaccinated people, and whether vaccinated people benefit needs to be further verified.
- Paxlovid has not conducted double-blind, randomized controlled clinical studies in China, and its effect on reducing the rate of severe covid-19 infection in Chinese people also needs to be further verified.
- In terms of clinical application, Paxlovid needs to pay attention to drug safety issues and drug interaction risks, which will also limit its wide application.
Understanding these 5 points, is it not for Pfizer's anti-new crown oral drug, everyone also feels that it is not so "god"? In fact, although its phase III clinical data shows that it is a drug with a good effect on preventing new crown hospitalization, in fact, its application scope is actually not so extensive, and many places also need further data accumulation and verification, we hope that it is a good drug, but we should also pay attention to the potential drug risks and the applicable population of the drug, in order to achieve real scientific and rational use.
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