Aug 4, 2022

FDA Should Expand Access of Tecovirimat for Monkeypox Now

Unfortunately, access to tecovirimat is severely restricted due to bureaucracy.

By Dr. Leo Nissola, Dr. Graham Walker and Dr. MIchael Bosco
By Dr. Leo Nissola, Dr. Graham Walker and Dr. MIchael Bosco

In 2020, the federal government’s response to COVID-19 was lethargic, and we've all felt the consequences of its inaction. 2022’s monkeypox epidemic however, is different: we have a safe and effective medication available to treat and potentially slow the growth of monkeypox cases. So why are we not utilizing it?

The current treatment for monkeypox consists of 2-4 weeks of isolation at home while enduring excruciatingly painful lesions and waiting for them to heal, heralding the end of the contagious period. These patients suffer in silence at home, frequently receiving no income during this time, and face significant stigma. It may be possible, however, to shorten the duration of these lesions—and therefore, the duration of infectiousness—down to a week using an already-available medication that we have at our disposal.

Enter tecovirimat, better known by its brand name TPOXX—a medication approved for the treatment of smallpox. In 2018, the New England Journal of Medicine published a study demonstrating TPOXX's efficacy against monkeypox infections in animal models as well as its safety in human subjects (monkeypox is in the same genetic family of viruses as smallpox).

Unfortunately, TPOXX access is highly restricted by dozens of pages of CDC and FDA paperwork per patient and a limited CDC supply. Questions to local health departments regarding how to obtain TPOXX are going unanswered and clinicians are being left in the dark. There is currently no way for a patient in New York or San Francisco, two of the cities hardest hit by the monkeypox pandemic, to fill a TPOXX prescription at their local pharmacy. Instead, because tecovirimat is considered "experimental" due to a lack of human monkeypox trials, it can only be obtained through special request to the CDC, despite the fact that research has demonstrated an excellent safety profile for human use against a virus from the same family, smallpox.

The recovery stories and photographs of the few monkeypox patients who have received tecovirimat are remarkable: in many cases, lesions begin to heal and disappear within days of starting the medication. Case series published August 1 from Massachusetts General Hospital suggests the same: lesions resolving and no progression to severe monkeypox disease while taking tecovirimat. Even with the inherent limitations of this small case series, tecovirimat has an excellent safety profile, appears to have few drug interactions, and no rebound (unlike the COVID antiviral Paxlovid, which is widely available by prescription even without proper clinical studies on triple-vaccinated patients).

While monkeypox cases rapidly expand, primarily affecting adult males in the LGBTQ community, we continue to lack vaccines in more than 95% of US counties, even if we target only high-risk groups. While we are expanding vaccine access, TPOXX sits safe, effective, studied, and vastly underused due to regulatory burden. Not only does it appear to shorten healing time, but that same healing time leads to less contagious time as well.

With the U.S. sitting on a supply of over 1.7 million doses of TPOXX as part of the Strategic National Stockpile under Project BioShield, we should not be struggling to obtain a medication with clear benefit, especially in the midst of a rapidly growing outbreak. The CDC reported that less than 250 patients have been treated. Restriction criteria should be eased and the ability to prescribe TPOXX should be streamlined and expanded. Non-infectious disease specialists, such as those working in primary care, dermatology, and emergency medicine, should be able to prescribe TPOXX as soon as a  monkeypox diagnosis is confirmed. As of now, hours of paperwork—per patient—is falling on the shoulders of infectious disease specialists, who are in short supply and are already exhausted from their dedication to the ongoing COVID-19 pandemic.

The treatment of monkeypox can also be the prevention of monkeypox, and we should use every tool available to slow its spread in the United States. It would be a terrible error to keep tecovirimat locked up in federal bureaucracy when we can prevent the spread of this disease by taking immediate action.

Key Takeaways:

FDA Should Expand Access to Tecovirimat For Patients Infected With the Monkeypox Virus.
Treatment For Monkeypox Can Be A Preventative Measure To Slow The Spread of The Virus.
Immediate Action Could Prevent Patients From Suffering Needlessly.

Dr. Walker is an emergency physician and the developer of MDCalc, one of the most broadly used medical reference tools used for clinical decision and content used by millions of medical professionals globally, including more than 65% of US physicians, every month. He is a contributor writer to State of the Virus News sharing his opinions, insights and public service announcements. Follow him on Twitter.

Dr. Bosco is a board-certified infectious disease pharmacist based in New York. He holds additional board certification from the American Academy of HIV Medicine. His practice interests include antimicrobial stewardship and antimicrobial resistance. He is a contributing writer to State of the Virus News. Follow him on Twitter.

Dr. Nissola is an award-winning doctor, immunotherapy clinical scientist, researcher, and member of the American Academy of Immunologists. He is an adviser to leaders and stakeholders in life sciences, health technology and the public safety sector. Follow him on Twitter @LeoNissolaMD and @DoctorLeo on Instagram. 

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