Hydroxychloroquine Not Recommended for COVID-19 by NIH

Apr 23, 2020

This week, the National Institutes of Health issued treatment guidelines for the management of COVID-19. It does not include the use of pharmaceutical agents for pre or post-exposure prophylaxis, including hydroxychloroquine, except for within the confines of a clinical trial. This comes as good news to the rheumatology community. More in this article.

This week, the National Institutes of Health issued treatment guidelines for the management of COVID-19. It does not include the use of pharmaceutical agents for pre or post-exposure prophylaxis, including hydroxychloroquine, except for within the confines of a clinical trial.

This comes as good news to the rheumatology community which was already struggling with securing sufficient supplies of hydroxychloroquine for lupus and rheumatoid arthritis patients who rely on the treatment to control flares. Demand for the drug spiked in early March after President Trump championed it's use to treat patients with COVID-19 despite the lack of supporting scientific evidence. The treatment eventually became standard practice for COVID-19 patients in hospitals across the country while rheumatology patients found it increasingly difficult to fill prescriptions for hydroxychloroquine.

In fact, the NIH consensus panel states there is no current specific treatment for people with a suspected or confirmed, asymptomatic or pre-symptomatic SARS-CoV-2 infection. However, there are hundreds of clinical trials underway, which, in addition to hydroxychloroquine, includes chloroquine, and remdesivir.

Laboratory findings of COVID-19 patients have revealed the presence of leukopenia, and elevations in aminotransferase levels, C-reactive protein, D-dimer, ferritin, and lactate dehydrogenase. Chest X-rays can vary, but in COVID-19 cases, bilateral multi-focal opacities are common. Computed tomography (CT) scans vary, but bilateral peripheral ground-glass opacities with consolidation in late disease stage, is common. The NIH cautioned that imaging may be normal early after infection, but can be abnormal in asymptomatic patients.

"At present, no drug has been proven to be safe and effective for treating COVID-19. There are insufficient data to recommend either for or against the use of any antiviral or immunomodulatory therapy in patients with COVID-19 who have mild, moderate, severe, or critical illness," the NIH wrote in the guidelines.

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Most cases of COVID-19 have been mild, the NIH stated. In an analysis 72,314 cases of COVID-19 in China, 81% were mild, 14% were severe and 5% were critical. The condition disproportionately affects the elderly and people of any age who have uncontrolled hypertension, cardiovascular disease, diabetes, chronic respiratory disease, cancer, renal disease, and obesity.

See next page:  Recommendations for Previously Prescribed Drugs

Treatment Recommendations for the Use of Antivirals for COVID-19

There are insufficient clinical data to recommend either for or against the use of chloroquine, hydroxychloroquine or the investigational antiviral drug remdesivir due to insufficient clinical trials data.

Except for within the context of a clinical trial, the combination of hydroxychloroquine plus azithromycin is not recommended due to potential toxicities.

Lopinavir/ritonavir (or other HIV protease inhibitors) are not recommended due to unfavorable pharmacodynamics and negative clinical trial data.

Host Modifiers/Immune-Based Therapy:

Not recommended due to insufficient evidence:  Convalescent plasma or hyperimmune immunoglobulin; interleukin-6 inhibitors (e.g., sarilumab, siltuximab, tocilizumab); Interleukin-1 inhibitors (e.g., anakinra); and, immunomodulators, such as interferons (due to toxicity and lack of efficacy in SARS and MERS cases); Janus kinase inhibitors (e.g., baricitinib) due to immunosuppressive effect.

Angiotensin-Converting Enzyme (ACE) Inhibitors and Angiotensin Receptor Blockers (ARBs):

These treatments should be continued in people who have been prescribed these treatments for cardiovascular disease or other indications.

Corticosteroids

The recommendations for the use of corticosteroids differ considerably by patient and condition. But for rheumatology patients, oral corticosteroid therapy should not be discontinued. However, “on a case-by-case basis, supplemental or stress-dose steroids may be indicated.”

Nonsteroidal Anti-Inflammatory Drugs (NSAIDs):

Even in the presence of a confirmed COVID-19 diagnosis, NSAIDs typically taken for a co-morbid conditions should be continued as previously directed by a physician.