Urgent efforts explore possible treatments and vaccines for COVID-19



Renee Rayburg, RPh, Vice President of Specialty Clinical Consulting
March 27, 2020

We’re receiving ongoing inquiries from our clients regarding potential treatment options for COVID-19 and vaccine development for the coronavirus. Here’s our take on where things currently stand.

Amidst the anxiety-producing headlines, those of us who work in pharmacy are seeing a few areas of hope. With the high standard for Federal Drug Administration (FDA) approval, and the rapidly-evolving nature of the COVID-19 outbreak, it’s too early to tell which of the drugs, vaccines and treatments currently being researched hold the most promise. But many in the medical and pharmacy community are encouraged by the volume of research already underway – and are eagerly monitoring the early results.

Chloroquine and hydroxychloroquine are showing promise in the treatment of COVID-19
Data from the global treatment of the disease shows that two drugs that have been on the market for a long time are emerging as possible treatments for COVID-19: chloroquine, used for the treatment of malaria, and hydroxychloroquine, used in the treatment of rheumatoid arthritis and lupus.

Chloroquine is showing significant promise in initial research, with data demonstrating the efficacy of chloroquine in COVID-19 related pneumonia at different levels of severity. As a result, 20 clinical studies were launched in hospitals in China. Results of one study with over 100 patients showed the superiority of chloroquine compared to the control group treatment, without severe side effects, in the following:

  • Reduced exacerbation of pneumonia
  • Shorter duration of symptoms
  • Delay of viral clearance

China now includes chloroquine in the recommendations regarding the prevention and treatment of pneumonia related to COVID-19.

Hydroxychloroquine (Plaquenil) is showing promise in a small study of 24 patients in France. Results show that of those who received the drug, only 25 percent tested positive after six days, compared to 90 percent of patients who did not receive the drug. These results are boosted when azithromycin (Zithromax / generic Z-pak) is paired with hydroxychloroquine. With this combination therapy, less than five percent of patients tested positive after six days. The French government is planning additional studies.

Earlier this week, the state of New York initiated two clinical trials: one to study chloroquine and the other to study hydroxychloroquine combined with azithromycin (Zithromax) in the treatment of COVID-19.

In response, companies are ramping up supplies of chloroquine products. On March 19, Bayer announced they are donating three million tablets of their chloroquine product, Resochin, and seeking an emergency use authorization for the drug in the U.S. where it is not approved. Mylan has restarted production of hydroxychloroquine-sulfate tablets and Teva says it will donate more than six million doses this month.

Although some shortages are being reported, our discussions with PBMs indicate that there is ample supply. We are working with our clients to identify plan members currently using these drugs so they can take action to protect medication access for their patients.

A note of caution: these drugs are not the same as chloroquine phosphate, an aquarium cleaning product linked to the death of an Arizona man who attempted to self-medicate. Patients should not experiment or attempt to self-medicate with chloroquine products. 

More than 14 companies in the U.S. are exploring additional drugs and/or vaccines for development and use
HHS has set up a website to solicit proposals for the development of medical products to diagnose, prevent or treat COVID-19. The FDA has stated that all options are being considered, and there is an ever-changing list of drug therapies under review. (This Forbes page provides a good overview of what’s in the works.)

The World Health Organization (WHO) announced March 18 that they are launching a multinational trial to jumpstart the search for drugs to treat COVID-19. Four drugs or drug combinations will be tested:

  • Remdesivir, an investigational antiviral drug (see recent developments noted below)
  • Lopinavir + ritonavir, a combination of two HIV drugs
  • Ritonavir + interferon beta, a combination of the HIV drug, ritonavir, and the multiple sclerosis drug, interferon, which changes the way the immune system works
  • Chloroquine (and possibly hydroxychloroquine)

Except for remdesivir, the other drugs listed are already FDA approved and available in the U.S., meaning they have already been proven to be safe. The new testing is to determine if they are an effective treatment for this specific virus.

The government is taking steps to expedite the process of developing vaccines and facilitate the necessary clinical trials to grant FDA approval for these drug therapies, including granting approval for compassionate use to enable patients to access the investigational drug, remdesivir. However Gilead, the manufacturer, has since stopped accepting new compassionate use requests due to “overwhelming demand.” They’re hoping to repurpose the drug as a potential treatment for COVID-19 and are continuing to accept compassionate use requests only for pregnant women, children under 18 and those with “severe manifestations of the disease.” Their focus is on transitioning from individual compassionate use requests to expanded access programs, which should accelerate access for severely ill patients and enable more effective data collection from all patients.

Antibodies from plasma are being used for treatment
An immunologist from John Hopkins University is exploring an older treatment of using antibodies found in the blood plasma of patients who have recovered from COVID-19 to help boost the immunity of those currently infected. Plasma donated from one patient can be used to treat two patients.

In addition, a San Francisco-based company, Vir Biotechnology, is in the early stages of development with BioGen to manufacture antibodies specifically for the treatment of COVID-19. They are studying antibodies from people who recovered from SARS to see if these might be effective against this new virus.

Vaccine trials are already underway in the U.S.
The National Institute of Health launched their phase-one trial at Kaiser Permanente Washington Research Institute in Seattle, where the first doses of a potential COVID-19 vaccine were administered to volunteers. The study includes 45 healthy adults ranging in age from 18-55 and will involve two doses separated by 28 days. The vaccine was developed by scientists within the infectious-disease arm of the NIH and Moderna Inc., a biotech company out of Cambridge, Massachusetts. The vaccine has shown promise in animals.

In addition, Inovio is teaming up with Ology Bioservices in the development of a vaccine candidate for COVID-19. They have received a grant of $11.9 million from the U.S. Department of Defense to manufacture the vaccine. They expect to start clinical trials next month, with first results expected sometime this fall. An estimated one million doses for additional trial and emergency use are expected by the end of the year.

 


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Renee Rayburg helps lead Artemetrx services in Clinical Consulting with more than 23 years in pharmacy and medical benefit management to support our health plan sponsors, providers, and patients.  Her thought leadership and passion for specialty pharmacy continues to influence the market, including important changes to specialty vendor clinical management products for the betterment of clients.