Preliminary study shows that tecovirimat was well tolerated in patients with monkeypox

Preliminary study shows that tecovirimat was well tolerated in patients with monkeypox

In a recently published study in JAMA Researchers investigated the use of tecovirimat against monkeypox infections.

Lernen: Compassionate Use of Tecovirimat zur Behandlung von Affenpocken-Infektionen. Bildnachweis: joshimerbin/Shutterstock

background

A zoonotic orthopoxvirus that belongs to the same genus as Variola is monkeypox, which also causes smallpox. As of August 18, 2022, over 39,000 cases have been reported as a result of a recent global outbreak. In previous outbreaks, symptoms of monkeypox typically lasted between two and four weeks.

In a recent study, 13% of patients required hospitalization, indicating the need for efficient therapy. The antiviral Tecovirimat prevents enveloped virus release, viral pathogenicity and viral spread by inhibiting the activity of the p37 protein and has demonstrated a positive clinical safety profile.

About studying

In the present study, investigators evaluated adverse events and clinical remission of systemic symptoms and lesions in an uncontrolled cohort study of monkeypox-infected patients receiving tecovirimat as compassionate use therapy.

After confirmation of orthopoxvirus infection through skin lesions by polymerase chain reaction test, patients were eligible for treatment with tecovirimat. The treatment was made available to outpatients with lesions that had spread to sensitive areas such as the face or vaginal area. To improve absorption, oral tecovirimat therapy in adult patients was based on weight, administered every eight or 12 hours, and taken within 30 minutes of a moderate-to-high fat meal.

The 14-day duration of therapy can be extended depending on the patient's clinical condition. Clinical information was collected through face-to-face or telephone interviews during the initial in-person assessment for treatment and on days 7 and 21 after initiation of therapy.

Results

As of August 13, 2022, a total of 25 people infected with monkeypox had completed their therapy with Tecovirimat. The average age of the patients, all of whom were men, was 40.7 years. One patient reported receiving the smallpox vaccine over 25 years ago, four patients received a dose of the JYNNEOS vaccine after the onset of symptoms, and nine reported HIV.

Systemic signs, lesions, or both were observed for an average of 12 days at the time of treatment. 76% of patients had fever, 32% headache, 28% fatigue, 20% chills, 12% back pain, 8% myalgia, 4% nausea, and 4% diarrhea. In addition, 92% of subjects had genital and/or perianal problems and 15% had fewer than ten lesions on their entire body.

While the other patients were treated for only 14 days, one patient was treated for 21 days. On day 7 of therapy, complete remission of lesions was observed in 40% of patients, while on day 21, complete resolution of lesions and symptoms was documented in 92% of patients. No patient discontinued therapy during tecovirimat treatment, which was typically well tolerated. On the seventh day of therapy, the following side effects were most commonly reported: fatigue in 28% of patients, headache in 20%, nausea in 16%, itching in 8% and diarrhea in 8% of patients.

Overall, the study results showed that all people with monkeypox infection tolerated oral tecovirimat with few side effects. Patients' timelines for symptom development and presentation varied. Therefore, it is important to exercise caution when completing the use of antivirals compared to the natural course of the infection.

Reference:

• Desai, A. et al. (2022) „Compassionate Use of Tecovirimat for the Treatment of Monkeypox Infection“, JAMA. doi: 10.1001/jama.2022.15336. https://jamanetwork.com/journals/jama/fullarticle/2795743?guestAccessKey=300cc546-00c4-47df-99d6-0a606da1e210

.