Mpox: The alarm went off. Have we gone back to sleep?

Résumé

Right at the outset of an outbreak that was later declared a Public Health Emergency of International Concern (PHEIC), we hoped there would be a wakeup call for the international community to pay attention to mpox [1].It did, but not quite enough.Despite some 91,000 cases of clade IIb mpox virus registered worldwide to-date [2], little progress has been made into gathering essential evidence as to what works or does not in preventing and treating mpox, with stark inequalities in access to therapy and vaccination between high-income and lowand middle-income countries, including the African countries with recurring outbreaks of clade I and clade IIa mpox virus [3].While the PHEIC has been successfully curbed, we see again the challenges of mounting an effective and timely clinical research response within the timeframe of relatively short-lived, geographically dispersed outbreaks.The search for safe and effective treatments is a clear example of this.Ahead of the 2022 clade IIb outbreak there were 2 main candidate therapeutics: tecovirimat and brincidofovir [4].They have shown activity in vitro and in animal models, but their clinical effectiveness in humans is uncertain.Tecovirimat is currently registered as a treatment for mpox in the European Union (EU) and the United Kindgom (UK), based on "exceptional circumstances."In the United States (US), tecovirimat is approved only for smallpox, under the "animal rule" exception for treatments for which human efficacy studies are not ethical or feasible and can be obtained for mpox through the Centers for Diseases Control and Prevention's Expanded Access Investigational New Drug "compassionate use" protocol [5,6].No similar mechanisms appear to exist at present for brincidofovir.As for clade I endemic countries, tecovirimat can be accessed under expanded access programme [7] in the Central African Republic (CAR) [8] where the treatment is not registered.Additionally, cidofovir is also being used off-label.The current research landscape for mpox therapeutics-made up of both interventional and observational studies as well as Expanded Use Protocols (EAP)-is summarised in Table 1.While the situation is evolving, it is clear that, bar a major rebound of cases, this has been a missed opportunity for gathering evidence on the management of clade IIb cases (Fig 1).While recruitment to one study, MOSAIC, started in July 2022, no more than 2 months after the outbreak commenced, most active trials began recruiting after the peak of the epidemic had passed and cases were already in a rapid decline (Fig 1), and as of October 2023, the rest are not recruiting.The EAP taking place in the US has to-date included almost 7,000

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