History
Originally researched by the National Institute of Allergy and Infectious Diseases, the drug was owned by Viropharma and discovered in collaboration with scientists at the United States Army Medical Research Institute of Infectious Diseases. It is owned and manufactured by Siga Technologies. Siga and Viropharma were issued a patent for tecovirimat in 2012. Clinical trials
As of 2009, the results of clinical trials support its use against smallpox and other related orthopoxviruses. It shows potential for a variety of uses including preventive healthcare, as a post-exposure therapeutic, as a therapeutic, and an adjunct to vaccination.Tecovirimat can be taken by mouth and as of 2008, was permitted for phase II trials by the U.S. Food and Drug Administration (FDA). In phase I trials, tecovirimat was generally well tolerated with no serious adverse events. Due to its importance for biodefense, the FDA designated tecovirimat for fast-track status, creating a path for expedited FDA review and eventual regulatory approval. On 13 July 2018, the FDA announced approval of tecovirimat for the treatment of smallpox.On 25 August 2022, the AIDS Clinical Trials Group (ACTG) began a randomized, placebo-controlled, double-blinded trial on the safety and efficacy of tecovirimat for monkeypox, known as STOMP (Study of Tecovirimat for Human Monkeypox Virus), aiming to enroll at least 500 participants with acute monkeypox infection.
The treatment was considered successful if the participant maintained low-levels (less than 50 copies/mL) of HIV RNA in their blood for at least 48 weeks. In these studies, 91% of subjects with HIV-1 who took the dolutegravir/lamivudine combination no longer had detectable levels of HIV (i.e. they had fewer than 50 copies per ml) after 48 weeks compared with 93% of those who were taking the triple combination. In neither study was there a case of resistance to treatment after 48 weeks. References
External links
"Dolutegravir". Drug Information Portal. U.S. National Library of Medicine. "Lamivudine". Drug Information Portal. U.S. National Library of Medicine.