Supervisor Elham AbolFateh
Editor in Chief Mohamed Wadie

When Will COVID-19 Drugs Remdesivir, Favipiravir Be Available in Egypt?


Fri 26 Jun 2020 | 11:02 PM
shawar ibrahim

Eva Pharma announced on Thursday that it has started production of Remdesivir and Favipiravir, two drugs used to treat COVID-19 patients.

According to Reuters, the drug Remdesivir is used in the treatment of moderate to severe cases of patients suffering from the new coronavirus and those whose condition requires intensive care while Favipiravir is used in the treatment of mild to moderate cases.

Earlier this month, Eva Pharma announced  it had reached a “historic” deal with Gilead Sciences Inc to become the licensed manufacturer of the US company’s antiviral treatment Remdesivir for coronavirus in 127 countries.

General Manager of the corporation Amgad Talat, announced that the company would initially manufacture 500 thousand doses per month to be sold locally for less than 2000 Egyptian pounds each, adding that it had already started delivering the medicine to quarantine hospitals.

Talat added that Eva Pharma also started producing one million Favipiravir tablets per month and it will be available at pharmacies within two to three weeks, noting that the final price has not been decided yet.

Japan's Fujifilm Holdings Corp, which manufactures Favipiravir, said this month that its researches for the drug as a possible treatment for COVID-19 may need to continue until July.

Whats is Favipiravir ?

Favipiravir is an oral antiviral approved for the treatment of influenza in Japan. It selectively inhibits RNA polymerase, which is necessary for viral replication.

How Does it Work?

The mechanism of its actions is thought to be related to the selective inhibition of viral RNA-dependent RNA polymerase. Other research suggests that favipiravir induces lethal RNA transversion mutations, producing a nonviable viral phenotype.

Favipiravir is a prodrug that is metabolized to its active form, favipiravir-ribofuranosyl-5′-triphosphate (favipiravir-RTP), available in both oral and intravenous formulations.

Human hypoxanthine guanine phosphoribosyltransferase (HGPRT) is believed to play a key role in this activation process. Favipiravir does not inhibit RNA or DNA synthesis in mammalian cells and is not toxic to them

Effectiveness Against Covid-19:

In February 2020, favipiravir was being studied in China for experimental treatment of the emergent COVID-19. Trials are also being planned in Japan.

A study on 80 people in comparison to lopinavir/ritonavir found that it reduced viral clearance time, and that 91% of people had improved CT scans with few side effects. The limitation of this study was that it was not randomized double-blinded and placebo-controlled.

The drug has been approved for use in clinical trials of coronavirus disease 2019 in China. In March 2020, Italy approved the drug for experimental use against COVID-19 and has begun conducting trials in three regions most affected by the disease.

The Italian Pharmaceutical Agency, however, has reminded the public that the existing evidence in support of this drug is scant and preliminary. There are plans to study it in three hospitals in Massachusetts, USA as of April 20, 2020.As of early May 2020, a trial is starting in London, UK.

The drug was approved for the treatment of COVID-19 in the hospital settings in Russia on May 29, 2020, after an ongoing open-label randomized clinical trial had recruited 60 subjects on favipiravir.

According to the government clinical trial registry, this study COVID-FPR-01 is expected to recruit 390 subjects overall and finish by December 31, 2020.

On May 30, 2020, the Russian Health Ministry approved a generic version of favipiravir named Avifavir. RDIF backed the development of Avifavir and found it highly effective in the first phase of clinical trials.

 

Whats is Remdesivir ?

The broad-spectrum antiviral agent remdesivir (GS-5734; Gilead Sciences, Inc) is a nucleotide analog prodrug. On May 1, 2020, The US FDA issued EUA of remdesivir to allow emergency use of the agent for severe COVID-19 (confirmed or suspected) in hospitalized adults and children.

Remdesivir was studied in clinical trials for Ebola virus infections but showed limited benefit. Remdesivir has been shown to inhibit replication of other human coronaviruses associated with high morbidity in tissue cultures, including severe acute respiratory syndrome coronavirus (SARS-CoV) in 2003 and Middle East respiratory syndrome coronavirus (MERS-CoV) in 2012.

Effectiveness against Coronavirus:

As of April 2020, remdesivir was viewed as the most promising treatment for COVID-19,and was included among four treatments under evaluation in the international Solidarity trial and European Discovery trial.

The FDA stated on 1 May 2020, that it is “reasonable to believe” that known and potential benefits of remdesivir outweigh its known and potential risks, in some specific populations hospitalized with severe COVID‑19. As of May 2020, there was no good evidence that remdesivir reduced mortality in people with COVID-19.

In January 2020, Gilead began laboratory testing of remdesivir against SARS-CoV-2, stating that remdesivir had been shown to be active against severe acute respiratory syndrome (SARS) and Middle East respiratory syndrome (MERS) in animal models. On 21 January 2020, the Wuhan Institute of Virology applied for a Chinese “use patent”, for treating COVID‑19.

In a trial in China over February-March 2020, remdesivir was not effective in reducing the time for improvement from COVID‑19 or deaths, and caused various adverse effects, requiring the investigators to terminate the trial.

On 18 March 2020, the World Health Organization (WHO) announced the launch of a trial that would include one group treated with remdesivir. Other clinical trials are underway or planned.

Preliminary data from an international multi-center, placebo controlled double-blind randomized controlled trial carried out by the U.S. National Institutes of Health, suggests that remdesivir is effective in reducing the recovery time from 15 to 11 days in people hospitalized with COVID‑19.

On 29 April 2020, based on results of the ACTT trial, the National Institute of Allergy and Infectious Diseases (NIAID) announced that remdesivir was better than a placebo in reducing time to recovery for people hospitalized with advanced COVID‑19 and lung involvement.

The study appeared on The New England Journal of Medicine website almost a month later on 22 May 2020, and despite generally positive results, the study concluded that “given high mortality despite the use of remdesivir, it is clear that treatment with an antiviral drug alone is not likely to be sufficient.”

A previous Chinese study published in The Lancet did not show significant benefits or drawbacks of using remdesivir, concluding that further research is required to understand the effectiveness of the drug.

This article was criticised as underpowered due to a lack of significant results as well as the fact that the study was ended prematurely. Based on the results of its study, the NIH stopped the ACTT trial and provided remdesivir to participants assigned to received placebo.

In April 2020, the European Medicines Agency (EMA) started a ‘rolling review’ of data on the use of remdesivir in COVID‑19. It completed the review in May 2020.

In May 2020, a number of companies in India and Pakistan have been given the right to make the medication.

In June 2020, the Committee for Medicinal Products for Human Use (CHMP) of the EMA started evaluating remdesivir for a conditional marketing authorization after receiving an application from Gilead Sciences.