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Posted By: Richard S. Pope, PA-C, MPAS
April 24, 2020
What We Know
We know that hydroxychloroquine (HCQ) is FDA approved for rheumatoid arthritis (RA), systemic lupus erythematosus (SLE), and discoid lupus; chloroquine is approved for prevention and treatment of malaria. We also know that a number of hospitals are treating adult patients who are COVID-19 positive with short courses of HCQ. The drug has been released from the strategic national stockpile under an emergency use authorization (EUA) issued on March 29th by the Office of the Assistant Secretary for Preparedness and Response under the department of Health and Human Services (HHS). This action is taken only when a clinical trial is not available or feasible, according to the department.
As a result of this EUA, patients with SLE, discoid lupus, and RA began having difficulty getting their prescriptions filled. If this wasn't bad enough, there have been validated reports by pharmacies and a confirmation from Patrice A. Harris, President of the AMA, that doctors have been hoarding HCQ for themselves and their families—I confirmed this with two pharmacists this week in my small town of just over 20,000 residents.
Rheumatic patients began to report these concerns to the American College of Rheumatology, the Lupus Foundation of America, and other national organizations in March and April. Their prescriptions had been changed from 90-day supplies to as little as one to two weeks. Hospital-based physician leaders were asking rheumatologists and dermatologists to decrease dosing or change to alternative medications to assure access to the supply.
Vice President Mike Pence received a letter in April from the presidents of the American College of Rheumatology, the Lupus Foundation of America, the Arthritis Foundation, and the American Academy of Dermatologists asking him and the SARS CoV-2 Task Force, specifically, to work together to assure timely access to HCQ and chloroquine for their patients.
What we also know is that many clinical trials are underway, both in the US and worldwide, investigating the efficacy of HCQ and chloroquine in COVID-19 infection. HCQ and chloroquine are being tested in varying doses and with varying durations compared to lopinavir/ritonavir, while other trials are testing these agents against "standard of care," which is supportive measures only.
What We Don't Know
We still don't know whether HCQ and chloroquine are effective—in which populations and in which stages of COVID-19 infection. The virus is moving faster than the research, and we are trying to keep up. With all these scenarios in play, it behooves us PAs and NPs to watch the literature, recommendations, and reports carefully. Let's hope there are enough eggs for both the chicken and the rooster.
Reported in The Hill on April 21: The largest number of COVID-19 positive patients in a retrospective analysis (looking at adults in the VA medical system; reviewed up until April 11, not yet peer reviewed) showed an increased rate of death in those treated with HCQ, with or without azithromycin. Patients given HCQ without azithromycin had a death rate of about 28% compared to 11% getting standard of care alone. The researchers did note that those who were more severely ill were more likely to get HCQ and azithromycin.
- Cortegiani A, et al. A systematic review on the efficacy and safety of chloroquine for the treatment of COVID-19. J Crit Care. 2020; [epub ahead of print].
- Lupus Foundation of America, et al. Joint statement. www.rheumatology.org/Portals/0/Files/Joint-Statement-HCQ-LFA-ACR-AADA-AF.pdf. ACcessed April 24, 2020.
- Weixel N. Largest analysis of hydroxychloroquine use finds no benefit for coronavirus, increased deaths. thehill.com/policy/healthcare/493931-largest-analysis-of-hydroxychloroquine-use-finds-no-benefit-increased. Accessed April 24, 2020.
- Yale New Haven Health System. YNHHS initial treatment algorithm for hospitalized adults with non–severe* COVID-19. medicine.yale.edu/intmed/COVID-19%20TREATMENT%20ADULT%20Algorithm%2004142020_382832_5_v3.pdf. Accessed April 24, 2020.