Gilead Halts Remdesivir Access for COVID-19 Amid Other U.S. Drug Shortages
Gilead Halts Remdesivir Access for COVID-19 Amid Other U.S. Drug Shortages
March 23, 2020 - Leigh Ann Anderson, PharmD
In a jarring headline on Sunday, Gilead Sciences Inc. announced a temporary measure to halt remdesivir access for an individual compassionate use basis for patients with COVID-19. Remdesivir is an experimental antiviral drug being used on an emergency basis and in research studies for patients with COVID-19. This new respiratory disease, which can lead to pneumonia and death, is caused by the novel coronavirus known as SARS-CoV-2. 1,2,3
Gilead states their current system was overwhelmed due to an unprecedented increase in requests for the investigational drug in the last week. The new system will speed up access for patients and allow comprehensive data collection.2,3
Pregnant women and children under 18 years of age with severe COVID-19 disease are exceptions and can still receive the drug under individual compassionate use.2
The company has said they are continuing to process previously approved requests for their coronavirus drug remdesivir and are creating a new, expanded access program to better handle the “overwhelming demand”. For patients, the timeframe to receive the drug will be similar to the former program.
What is Expanded Access?
“Expanded access” is just another name for “compassionate use” programs put in place by the FDA. According to the Agency, “expanded access” is a “potential pathway for a patient with an immediately life-threatening condition or serious disease or condition to gain access to an investigational medical product (drug, biologic, or medical device) for treatment outside of clinical trials when no comparable or satisfactory alternative therapy options are available.” 4,5
There is currently no approved treatment or vaccine for COVID-19, which has resulted in over 292,000 cases worldwide with close to 13,000 deaths according to the latest World Health Organization (WHO) data.6 Most patients are only able to receive the standard of care, which primarily includes breathing assistance. In the US, the CDC reports over 33,000 cases with close to 400 deaths in all 50 states, the District of Columbia, Puerto Rico, Guam, and US Virgin Islands, as of March 23rd.7
Enrolling in a clinical trial is the primary way for patients to receive remdesivir. Several large clinical trials of remdesivir are ongoing in the US and China, but some patients with severe disease or other factors may not qualify to be enrolled. These “expanded access” protocols will allow patients without other approved options and who are unable to enroll in a study to be considered for remdesivir treatment. The programs are under rapid development worldwide.2
Other drug shortages due to COVID-19
The unprecedented demand for remdesivir is occurring in tandem with a recent concern over availability of other experimental coronavirus treatments such as the antimalarial drugs chloroquine and hydroxychloroquine. Over the weekend, several US State Boards of Pharmacy took action to limit the amount of these drugs that could be prescribed at one time.8,9
Hydroxychloroquine is a drug with early, although unproven, hope for COVID-19 treatment. The drug is currently FDA-approved for use in patients with systemic lupus erythematosus (often just called “lupus”) and rheumatoid arthritis. However, pharmacists in the US are reporting a rash of prescriptions, some from doctors, attempting to access the malaria drugs for personal or family use. Pharmacists and other healthcare providers are now concerned these drugs will be unavailable for patients who need them to treat the FDA approved conditions.8,9
The Ohio State Board of Pharmacy, in an emergency meeting on Sunday, “barred pharmacists from dispensing chloroquine or hydroxychloroquine for COVID-19 unless a person has tested positive for the virus or is otherwise approved by the pharmacy board’s executive director.” Prescriptions are limited to a 14-day supply, require documentation of a positive test for the virus, and also require a newly written prescription for any refills.8,9
Other state board restrictions have been placed on the antibiotic azithromycin (Zithromax, Z-Pak), which has been used in combination with the anti-malarial drugs. Limits are also in place for mefloquine, another malaria treatment and preventive drug.8 Chloroquine phosphate tablets and hydroxychloroquine phosphate tablets have been listed as in current short supply in the U.S. as of March 19th and 20th respectively. Azithromycin injection was added to the list back on March 8th.
Although President Trump widely promoted the combination of hydroxychloroquine and azithromycin as a “game changer” for COVID-19 last week, Dr. Anthony Fauci, director of the U.S. National Institute of Allergy and Infectious Diseases (NIAID) and a leading public health expert stated that the drug combination needs further study to determine if it is safe and effective.8
- Information for Clinicians on Therapeutic Options for COVID-19 Patients. The US Centers for Disease Control and Prevention (CDC). Accessed March 23, 2020 at https://www.cdc.gov/coronavirus/2019-ncov/hcp/therapeutic-options.html
- Emergency Access to Remdesivir Outside of Clinical Trials. Gilead Sciences. Accessed March 23, 2020 at https://www.gilead.com/purpose/advancing-global-health/covid-19/emergency-access-to-remdesivir-outside-of-clinical-trials
- Herper M. (2020 March 22). Gilead pauses access to experimental Covid-19 drug due to ‘overwhelming demand’. StatNews. Online. Accessed March 23, 2020 at https://www.statnews.com/2020/03/22/gilead-suspends-access-to-experimental-covid-19-drug-remdesivir/
- Expanded Access | Keywords, Definitions, and Resources. US Food and Drug Administration (FDA). Accessed March 23, 2020 at https://www.fda.gov/news-events/expanded-access/expanded-access-keywords-definitions-and-resources
- Expanded Access. US Food and Drug Administration (FDA). Accessed March 23, 2020 at https://www.fda.gov/news-events/public-health-focus/expanded-access
- Coronavirus disease 2019 (COVID-19) Situation Report – 62. World Health Organization (WHO). Accessed March 23, 2020 at https://www.who.int/docs/default-source/coronaviruse/situation-reports/20200322-sitrep-62-covid-19.pdf?sfvrsn=f7764c46_2
- Coronavirus Disease 2019 (COVID-19). Cases in US. US Centers for Disease Control and Prevention (CDC). Accessed March 23, 2020 at https://www.cdc.gov/coronavirus/2019-ncov/cases-updates/cases-in-us.html
- Erman M. (2020 March 22). States work to limit prescriptions of potential coronavirus drugs. Reuters. Online. Accessed March 23, 2020 at https://www.reuters.com/article/us-health-coronavirus-usa-pharmacies/states-work-to-limit-prescriptions-of-potential-coronavirus-drugs-idUSKBN2190XC
- Sullivan L. (2020 March 21). Ohio pharmacy board restricts prescriptions for experimental coronavirus treatment drugs. The Columbus Dispatch. Accessed March 23, 2020 at https://www.dispatch.com/news/20200321/ohio-pharmacy-board-restricts-prescriptions-for-experimental-coronavirus-treatment-drugs
Posted March 2020
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