BREAKING! Stanford Study Confirms Favipiravir Use In Mild Or Asymptomatic COVID-19 Patients Has No Efficacy. Doctors Should Be Sued For Prescribing It!
Since the beginning of the pandemic, certain countries like China and Japan were advocating the use of Favipravir (Avigan) to treat COVID-19 despite lack of evidence to show its efficacy. Surprisingly, although China was advocating its use to other countries by giving and selling stocks of the drug, it was never really endorsed in its own national guidelines for COVID-19 treatment neither was it used extensively. The same could be said of Japan. However, one of the countries where the ignorant local physicians were prescribing its extensive use to treat COVID-19 based on recommendations by the local Ministry of Health despite not questioning its efficacy was Thailand. Thailand’s Ministry of Health is run by a non-medically trained politician whose intellectual background comes from the construction industry!
As far as April 2020, Thailand Medical News had reported the US FDA studies that showed Favipiravir had no effects against the SARS-CoV-2 coronavirus. https://www.thailandmedical.news/news/breaking-covid-19-drugs-us-fda-drug-trial-concludes-that-most-drugs-being-used-including-favipiravir,-lopinavir,-ritonavir,-chloroquine-has-no-effects
Many other studies then also showed that Favipiravir had no efficacy against the COVID-19 disease. https://www.thailandmedical.news/news/favipiravir-studies-involving-animal-models-shows-favipiravir-has-very-weak-effect-on-sars-cov-2-and-not-viable-as-an-effective-therapeutic
Despite all these and many more studies showing that favipiravir was not effective to treat COVID-19, Thailand still ordered millions of stocks of the drug at high costs to treat its unknowing citizens and even spend millions more to produce its own local generic versions.
Unknown to many, favipiravir is both a mutagenic and also teratogenic drug that’s why its use was highly restricted in Japan. To make matters worse, during the COVID-19 pandemic, its use was found to cause liver damage and also liver issues and many experts suspect that in the long term, a variety of liver conditions could arise after having used the drug even for a short period of time. https://www.thailandmedical.news/news/covid-19-drugs-latest-japanese-study-shows-association-between-high-serum-favipiravir-concentrations-and-drug-induced-liver-injury
There are more emerging studies that Thailand Medical News
will be covering soon in detail showing the adverse effects of having used Favipiravir even for a
Meanwhile, a new study by researchers from Stanford University School Of medicine has validated that Favipiravir has no efficacy as a treatment for COVID-19 when prescribed to both asymptomatic or mild patients.
The study team conducted a phase 2 double-blind randomized controlled outpatient trial of favipiravir in asymptomatic or mildly symptomatic adults with a positive SARS-CoV2 RT-PCR within 72 hours of enrollment.
Participants were randomized 1:1 to receive placebo or favipiravir (1800 mg BID Day 1, 800mg BID Days 2-10). The primary outcome was SARS-CoV-2 shedding cessation in a modified intention-to-treat (mITT) cohort of participants with positive enrollment RT-PCRs. Using SARS-CoV-2 deep sequencing.
From July 8, 2020 - March 23, 2021, the study team randomized 149 participants with 116 included in the mITT cohort. The participants’ mean age was 43 years (SD 12.5) and 57 (49%) were women.
The study findings showed no difference in time to shedding cessation by treatment arm overall (HR 0.76 favoring placebo, 95% confidence interval [CI] 0.48 – 1.20) or in sub-group analyses (age, sex, high-risk comorbidities, seropositivity or symptom duration at enrollment).
The study team no difference in time to symptom resolution (initial: HR 0.84, 95% CI 0.54 – 1.29; sustained: HR 0.87, 95% CI 0.52 – 1.45).
The study findings
did not support favipiravir use at commonly used doses in outpatients with uncomplicated COVID-19.
The study team is calling for further research to assess the safety of the drug.
The study findings were published on a preprint server and are currently being peer reviewed for publication into a leading medical journal. https://www.medrxiv.org/content/10.1101/2021.11.22.21266690v1
Favipiravir is a ribonucleic acid (RNA) dependent RNA polymerase (RdRp) anti-viral drug that is also known to be mutatgenic and teratogenic.
Initial in vitro
studies of favipiravir showed chain termination or accumulation of deleterious mutations in the severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2) genome, thus indicating that it might be a potent drug against SARS-CoV-2. However, it should be noted that mutagenic drugs can also help to give rise to more mutations and variants and also damage human host DNA, giving rise to a multitude of issues and health problems in the future.
Though some early usage suggested that favipiravir can improve clinical or virologic outcomes in coronavirus disease 2019 (COVID-19) patients, data on this is was extremely limited and no research was ever conducted on a large scale.
It was surprising how health authorities and doctors could have even supported its use despite the lack of any proper data on its efficacy. In Thailand, lots of stupid stem graduates and even local foreign educated idiots were simply demanding for the drug and ignorant local doctors were prescribing it. It should also be noted that in Thailand, there are really no specialists or so called properly qualified virologists who really have a superior macro and micro perspective of the COVID-19 disease and its pathogen. Most simply regurgitate whatever they have learnt from other foreign studies provided if their level of English gave them the ability to properly comprehend and decipher what they were reading in the first place!
The new Stanford study involved phase II randomized placebo-controlled, double-blinded trial between July 8, 2020, and March 23. 2021.
Participants who tested positive for SARS-CoV-2 infection by reverse-transcription polymerase chain reaction (RT-PCR) test and exhibited mild or no symptoms were enrolled in the study, as they were at an early stage of infection and were most likely to be benefited. The participants enrolled in the current study were randomized into either a control group with a placebo or were treated with favipiravir.
In all a total of 149 patients were enrolled and randomized in the intention-to-treat (ITT) cohort study. Of these, 116 patients whose RT-PCR test was positive within 72 hours of enrollment were included in the modified intention-to-treat (mITT) cohort, and 135 patients who reported at least one symptom other than a mild cough, mild fatigue, or reduced taste or smell during enrollment were included in the symptomatic modified intention-to-treat (smITT) cohorts.
Also, a total of 112 patients were included in all 3 analytic cohorts.
The patients were examined for 28 days and their clinical assessment included RT-PCR tests from oropharyngeal (OP) swabs and anti-SARS-CoV-2 serology tests from blood samples collected by study staff during each visit.
It was noted that during primary analyses, a Cox proportional hazards model was used to compare the time to shedding cessation of SARS-CoV-2 between both arms.
The study findings were in favor of the placebo group; however, no statistically significant difference was observed in shedding cessation between the placebo and treatment groups.
Detailed secondary analyses were also carried out using a Cox proportional hazards model to compare symptom resolution in both groups. To this end, no statistically significant difference was observed between the two treatment groups.
Surprisingly however, the control group showed earlier symptom resolution by one day as compared to the treatment group. Fatigue, cough/dyspnea, myalgia, and headache were the most common symptoms observed and fewer and milder symptoms were reported over time.
It was also noted that twelve participants (7 control and 5 treatment) from the ITT cohort reported at least one visit to the emergency room and four participants from the control group were hospitalized.
The detailed pre-specified and post hoc analyses in gender, high-risk comorbid, age group, seropositivity, or duration of symptoms at enrollment subgroups showed no difference in time to shedding cessation. In the sensitivity analysis using the ITT cohort, the median time to shedding declined to nine days in both the control and treatment groups.
In order to determine the role of favipiravir in the mutagenesis of SARS-CoV-2, the researchers sequenced SARS-CoV-2 from nasal swab samples of participants on residual days 1, 5, and 10. No evidence of mutagenesis was observed in the treatment group after at least 5 days of favipiravir administration. However further detailed studies need to be conducted to see if favipiravir usage is linked to with the rise of mutations and new SARS-CoV-2 variants.
The study findings were in contrast to in vitro studies that showed a three-fold increase in the total number of mutations and a 12-fold increase in C to T or G to A transitions in SARS-CoV-2-infected Vero cells treated with favipiravir compared to the controls.
Importantly, participants in the treatment group reported more Adverse Effects (AEs) as compared to the control group, although this difference was not statistically significant. The most common AE reported in the treatment group was dizziness. Furthermore, many participants receiving favipiravir developed hyperuricemia on day 10, while only three participants were symptomatic.
The study did have a few limitations. Using the RT-PCR test to detect antiviral activity is not a fool-proof method, as individuals can have viral RNA for extended periods of time after illness and may therefore not reflect actively replicating virus.
Furthermore, the primary endpoint of the current study was based on the nasal swabs, which are less accurate as compared to nasopharyngeal swabs; however, similar results were obtained from oropharyngeal swabs collected by study staff. Additionally, this study was performed before the arrival of the now dominant Delta variant in the United States.
The study findings do not favor the use of favipiravir at currently recommended doses in mild or asymptomatic COVID-19 patients. Further studies on dose optimization are required to determine the efficacy and safety of favipiravir at high doses or in combination with other therapeutic agents in COVID-19 patients.
Consumer groups and patient right groups around the world are now calling that legal suits should be filed against doctors, hospital and health authorities for using that drug to treat COVID-19 that did not have proper supporting data in the first place.
Studies are now being conducted to assess what damage the drug could have caused at the prescribed doses and also the possible long-term damages.
Thailand Medical News will continue to provide updates on the issue and also be providing more coverages on COVID-19 Drug Scams.
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Read Also: https://www.thailandmedical.news/news/does-the-teratogenic-drug-avigan-favipiravir-really-work-on-covid-19-or-is-it-just-a-placebo-that-china-wants-to-use-as-a-bargaining-chip