R&D companies also hope to prove that taking medicine can alleviate the symptoms of patients with mild and moderate symptoms of COVID-19.
Text/Ling Xin Picture/Visual China
On June 28, 2022, Anthony Fauci, the 81-year-old chief medical adviser to US President Biden, publicly admitted that the new coronavirus test result was "positive" again. This happened after he turned negative after taking Pfizer's new coronavirus drug Paxlovid, so the efficacy of Paxlovid was questioned. Previously, other patients "recovered" after taking the drug.
Fauci was infected with the new crown earlier in June. He completed the full course of vaccination and received two booster shots. After "recovering", he developed symptoms that were "more severe than the first time" and started taking the second course of Paxlovid. The second course of treatment is now almost over and the symptoms have not disappeared.
On June 14, Pfizer announced that a clinical trial that mainly included people infected with Omicron had failed because it failed to achieve sustained improvement in all symptoms within four days.
Two major pieces of news have challenged Paxlovid’s position as the “overlord” of COVID-19 oral drugs, which is not good news for domestic companies committed to the research and development of COVID-19 drugs.
However, for the entire China’s epidemic prevention mechanism, vaccines and oral drugs are the basis for liberalizing the epidemic prevention policy, and China still needs specific drugs for the new crown.
Is "Fuyang" an isolated case, or is it a drug defect?
Fauci revealed the news that he "recovered positive" after taking Paxlovid when he participated in the US Foreign Policy Global Health Forum on June 28. "After the first five-day course of treatment, my antigen test was negative for three consecutive days. On the fourth day, I tested myself again and the result became positive."
Director of Shenzhen Third People's Hospital Lu Hongzhou analyzed that the main reason may be that Fauci is older and his immune function is not that strong. "Antiviral drugs need to stimulate the body's immunity to work. It is normal for him to have this situation." ".
Research by Chinese AIDS expert He Dayi shows that resumption of yang may not be significantly related to age. On May 23, He Dayi and his collaborators jointly published a report disclosing 10 cases of "recovery" after taking Paxlovid. The age of the patients ranged from 31 to 71 years old, including He Dayi himself.
71-year-old He Dayi also experienced "recovery" in April. Like the first infection, he developed chills, chills, and respiratory infection symptoms. This "recovery", his clinical symptoms and positive test results lasted for three days.
In the study published by He Dayi and others, most of the 10 subjects rebounded 2 to 8 days after the end of the drug treatment. All 10 recovered without treatment and again. Two of them had close contact with family members before and after they became positive again, and the close contacts were infected.
He Dayi and others believe that these cases show that relapse after Paxlovid treatment is not uncommon, and genetic testing results show that it is not a mutation of the virus strain or the patient being infected again.
The U.S. Centers for Disease Control and Prevention (CDC) stated that it is currently unclear whether the patient's recurrence of symptoms is related to Paxlovid, or whether it is just a natural development of the new coronavirus.
Virology expert Chang Rongshan analyzed that "returned to positive" after taking medicine to turn negative, indicating that the replication of the virus in the human body has not been completely terminated. "It should be that after the first infection, the virus was suppressed by the drug, or it was undetectable. ".
According to Pfizer’s public data, the rate of nucleic acid conversion to negative and then “positive” after taking the medicine is about 1%-2%. However, this was also the case in the placebo group.
However, researchers such as He Dayi monitored 1,000 infected people who had not taken Paxlovid, and no one "recovered positive".
Many interviewed virologists and epidemiologists emphasized to "Financial Health" that they do not want to overexaggerate Fauci's "recovery positive" case. "Even if there is a 1% return to positive, it is equivalent to scoring 99 points on the test. We cannot deny a certain medicine." Zhang Hongtao, associate professor at the University of Pennsylvania School of Medicine in the United States, said.
Can extending the medication time improve symptoms better?
Paxlovid cannot well improve the symptoms of mild patients in standard risk groups, which has been confirmed by data.
On June 14, Pfizer admitted that a clinical trial that mainly included people infected with Omicron had failed, and the subjects failed to achieve "four consecutive days of sustained relief of all symptoms."
Participants in the trial include unvaccinated adults and vaccinated adults with risk factors for progression to severe disease. The failure of this trial means that there was no significant difference in the symptoms of patients participating in the trial whether they took the drug or not.
Paxlovid was previously approved under emergency approval in the United States for people with mild to moderate symptoms of COVID-19, but only if these people are at high risk of developing severe disease. Its approval in China is based on indications and requires high-risk factors for progression to severe disease.
"Paxlovid cannot achieve the effect of a specific drug, and its effect on ordinary cases is not as obvious as that on severe cases. The main reason is that the drug itself cannot significantly improve the symptoms." Lu Hongzhou told "Financial Health".
For patients with "recovery positive" symptoms, Pfizer recommends taking another course of medication.
"Prolonging the medication time is not a good strategy, and it is easier to develop drug resistance , which is a common phenomenon with antiviral drugs." Chang Rongshan analyzed.
Zhang Hongtao also holds a similar view. The effect of prolonged medication may not be very good. "After being infected with the virus, the human body's immunity has been activated and antibodies have been produced, or some symptoms are caused by immunity."
Lu Hongzhou believes that the proposal to extend the medication time can be considered, but COVID-19 and therapeutic drugs are new things. There are currently no large-scale trials in China and more clinical research is needed.
Regarding the existing controversy, the U.S. Food and Drug Administration (FDA) stated that there is currently no data to show that extending the administration time will significantly benefit.
The current recommendation of US CDC is that patients with COVID-19 "re-positive" follow the CDC's isolation guidance and take additional precautions to prevent spread.
U.S. health officials report that while information is still limited, available data suggests that most people who experience a "relapse" are unlikely to develop severe disease.
What kind of new coronavirus drug do we need
The symptoms caused by the Omicron variant are milder. New drug R&D companies hope to prove that taking drugs can alleviate the symptoms of patients with mild to moderate symptoms, which means a broader drug market in the future.
However, in Chang Rongshan’s view, compared with the recovery of mild patients, how to reduce the severe rate and mortality rate is still the main topic of current drug research and development. “The main problem is that the new coronavirus mutates very quickly, and drugs are always one step behind. . Maybe there will be an update next year."
According to incomplete statistics from "Finance·Big Health", China currently has 14 oral drugs for COVID-19 under emergency research and development. Oral drugs from Kintor Pharmaceuticals, Junshi Biopharmaceuticals, and Real Biotech have all entered Phase III clinical trials.
According to Zhang Hongtao, a new drug may soon be approved in the United States. This drug has the dual properties of antiviral and anti-inflammatory properties, and can inhibit the cytokine storm induced by the new coronavirus. "Many high-risk patients died due to the double attack of the new coronavirus and cytokine storm." This drug has completed clinical trials and is currently applying for emergency approval. It may become the first drug suitable for severe COVID-19.
"The market size of oral COVID-19 drugs in the future is expected to be similar to the market size of influenza drugs. The key is to see which one can be approved first and gain market advantage." said a pharmaceutical industry analyst.
Domestic epidemic control has been loosened. On June 28, the new version of the "Novel Coronavirus Pneumonia Prevention and Control Plan (Ninth Edition)" optimized the isolation policy for entry and close contacts. Subsequently, the "asterisk" on the communication itinerary card of the Ministry of Industry and Information Technology's Propaganda Department was originally used to indicate medium- and high-risk areas.
"Shortening the quarantine time is considered negative news for the new crown oral drug market." A person in charge of investment company analyzed "Finance∙Health", "The adjustment of prevention and control measures represents a reduction in the risk of the epidemic, and will have a positive impact on the new crown pneumonia epidemic in the future." There may be less demand for oral drugs. "
However, vaccines and oral drugs are the basis for liberalizing epidemic prevention policies. "Before the epidemic prevention policy can be relaxed to the greatest extent, it may still be necessary for domestically produced oral COVID-19 drugs to be approved." A pharmaceutical industry analyst believes.
#Fauci returned positive after taking Pfizer’s new coronavirus oral medicine#
