The study reports on the safety and efficacy of tecovirimat in the treatment of monkeypox

The study reports on the safety and efficacy of tecovirimat in the treatment of monkeypox

A UC Davis Health study found that the antiviral tecovirimat appears to be safe and effective for treating monkeypox symptoms and skin lesions. The study is one of the first to evaluate and report the results of treatment of monkeypox patients with this antiviral.

Tecovirimat (TPOXX) is an antiviral drug approved by the FDA for the treatment of chickenpox. It limits the spread of the virus in the body by inhibiting the work of the protein involved in the release of the enveloped virus. Recently, the Centers for Disease Control and Prevention (CDC) allowed physicians to prescribe tecovirimat on a compassionate use basis to treat adults and children with orthopoxvirus infections, including monkeypox.

In a research letter published in PITUC Davis infectious disease experts presented findings on 25 monkeypox patients treated with tecovirimat.

“We have very limited clinical data on the use of tecovirimat for monkeypox infection. Much remains to be learned about the natural progression of the disease and how tecovirimat and other antivirals may affect it,” said lead author Angel Desai. She is an adult infectious disease specialist at UC Davis Health.

Treatment of monkeypox with tecovirimat

A recent global outbreak of monkeypox has resulted in more than 45,500 cases as of August 22, 2022. While symptoms usually resolve on their own in 2-4 weeks, a recent study showed that 13% of patients require hospitalization.

The new study included patients referred to UC Davis Medical Center, primarily through the Sacramento County Department of Public Health, between June 3 and August 13, 2022.

Patients with skin lesions on multiple parts of the body or in sensitive areas such as the face or genital area were offered treatment with oral tecovirimate. Treatment was based on weight, given every 8 or 12 hours, and given within 30 minutes of a high-fat meal.

The researchers collected clinical data at the first face-to-face treatment assessment and at a face-to-face or telephone interview on days 7 and 21 after starting therapy.

A total of 25 patients with confirmed monkeypox infection completed treatment with tecovirimat. They were all men. Their ages ranged between 27 and 76 years (median age was 40). Nine patients had HIV.

Only one patient had smallpox vaccine (taken more than 25 years ago) and four others received a dose of JYNNEOS vaccine after the onset of symptoms.

Symptoms in patients with monkeypox, MPX

The study found that 92% of patients had lesions in the genital or anal region. While all patients had painful lesions, about half had fewer than 10 lesions throughout the body.

On average, patients had symptoms or lesions 12 days before starting antiviral therapy. The most common symptom was fever (76% of patients), followed by fatigue (32%), sore throat (20%) and chills (20%). Other symptoms included back pain (12%), muscle pain (8%), nausea (4%) and diarrhea (4%).

All patients completed tecovirimat therapy and tolerated their treatment well. They were treated for two weeks, except for one patient who was treated for 21 days.

On day 7 of therapy, 40% of the patients were healed of the lesions. By day 21, 92% were healed and pain free.

The most commonly reported adverse events on day 7 of therapy included: fatigue (28%), headache (20%), nausea (16%), pruritus (8%), and diarrhea (8%).

“We have to be very careful in how we interpret the data. It’s hard to distinguish side effects due to therapy from those caused by infection,” said infectious disease expert and co-author George Thompson. Thompson is a professor at UC Davis School of Medicine in the Department of Internal Medicine, Division of Infectious Diseases, and Department of Medical Microbiology and Immunology.

The study was small and did not include a control group. Thus, evaluation of antiviral efficacy in terms of symptom duration and severity was limited. The time from onset of symptoms to initiation of antiviral therapy also varied among patients.

The researchers called for large-scale studies to examine the dosage of antiviral efficacy and side effects. The study was co-authored by Sonja Neumeister, Anna Arutyunova, Katelyn Trigg, and Stuart H. Cohen.

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