Top 5 Takeaways

1. Widespread Use and Tolerability: Tecovirimat (Tpoxx), initially FDA-approved for smallpox, was used under an Expanded Access Investigational New Drug protocol to treat 549 monkeypox patients in the U.S., with a high oral outpatient administration rate (99.8%) and few reported adverse events.
2. Demographics and Outcomes: The majority of patients were men (97.7%), with a median age of 36.5 years. Half of the patients were living with HIV, and the median time from tecovirimat initiation to subjective improvement was 3 days, irrespective of HIV status.
3. Safety Profile: Adverse events were rare (3.5%), with all but one being nonserious. This supports tecovirimat’s continued use during the monkeypox outbreak.
4. Efficacy and Administration: Efficacy in humans is still under evaluation, with initial findings showing a median time to subjective improvement of 3 days. Tecovirimat is administered mostly orally, reflecting the outpatient treatment of most cases.
5. Considerations for Future Use: The report stresses the need for ongoing evaluation and clinical trials to better understand tecovirimat’s efficacy, ideal treatment duration, and impact on various patient populations, including those with HIV.

Note:

This MMWR Article was created prior to the conventional renaming of Monkeypox to its more standard and appropriate name, Mpox. To avoid confusion, Monkeypox is retained when writing this article, but all future works should use Mpox.

Original Article Author and Citation

Corresponding Author

Farrell Tobolowsky, oqk3@cdc.gov.

Suggested Citation

O’Laughlin K, Tobolowsky FA, Elmor R, et al. Clinical Use of Tecovirimat (Tpoxx) for Treatment of Monkeypox Under an Investigational New Drug Protocol — United States, May–August 2022. MMWR Morb Mortal Wkly Rep 2022;71:1190–1195. DOI: http://dx.doi.org/10.15585/mmwr.mm7137e1.

Summary

This report details the use of tecovirimat (Tpoxx) for treating monkeypox in the United States between May and August 2022, under an FDA-regulated Expanded Access Investigational New Drug protocol. The data, which includes demographic and clinical information from 549 patients, highlights the drug’s safety and potential efficacy.

Methods

The study analyzed demographic and clinical data from tecovirimat treatment forms. Patients’ demographic characteristics, clinical signs and symptoms, and treatment outcomes, including adverse events, were recorded and analyzed.

Discussion

The discussion centers on the favorable safety profile of tecovirimat and its widespread outpatient use. It also addresses the limitations of the study, including the lack of a control group, which precludes definitive conclusions about tecovirimat’s effectiveness against monkeypox.

Conclusion

Tecovirimat shows promise as a treatment for monkeypox, with a favorable safety profile and early indications of efficacy. However, further clinical trials are necessary to confirm its effectiveness and determine the best practices for its use.

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