„Tecovirimat“ – Versionsunterschied
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→top: Reference: NEJM "Oral Tecovirimat for the Treatment of Smallpox" |
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Tecovirimat can be taken orally and has recently been granted permission to conduct Phase II trials by the [[Food and Drug Administration (United States)|U.S. Food and Drug Administration]] (FDA). In Phase I trials tecovirimat was generally well tolerated with no serious adverse events.<ref>{{cite journal | pmc = 2346641| year = 2008| author1 = Jordan| first1 = R| title = Single-Dose Safety and Pharmacokinetics of ST-246, a Novel Orthopoxvirus Egress Inhibitor| journal = Antimicrobial Agents and Chemotherapy| volume = 52| issue = 5| pages = 1721–1727| last2 = Tien| first2 = D| last3 = Bolken| first3 = T. C.| last4 = Jones| first4 = K. F.| last5 = Tyavanagimatt| first5 = S. R.| last6 = Strasser| first6 = J| last7 = Frimm| first7 = A| last8 = Corrado| first8 = M. L.| last9 = Strome| first9 = P. G.| last10 = Hruby| first10 = D. E.| doi = 10.1128/AAC.01303-07| pmid = 18316519}}</ref> Due to its importance for biodefense, the FDA has designated tecovirimat for 'fast-track' status, creating a path for expedited FDA review and eventual regulatory approval. On July 13, 2018, FDA announced approval of Tecovirimat.<ref>[https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm613496.htm U.S. Food and Drug Administration]</ref> |
Tecovirimat can be taken orally and has recently been granted permission to conduct Phase II trials by the [[Food and Drug Administration (United States)|U.S. Food and Drug Administration]] (FDA). In Phase I trials tecovirimat was generally well tolerated with no serious adverse events.<ref>{{cite journal | pmc = 2346641| year = 2008| author1 = Jordan| first1 = R| title = Single-Dose Safety and Pharmacokinetics of ST-246, a Novel Orthopoxvirus Egress Inhibitor| journal = Antimicrobial Agents and Chemotherapy| volume = 52| issue = 5| pages = 1721–1727| last2 = Tien| first2 = D| last3 = Bolken| first3 = T. C.| last4 = Jones| first4 = K. F.| last5 = Tyavanagimatt| first5 = S. R.| last6 = Strasser| first6 = J| last7 = Frimm| first7 = A| last8 = Corrado| first8 = M. L.| last9 = Strome| first9 = P. G.| last10 = Hruby| first10 = D. E.| doi = 10.1128/AAC.01303-07| pmid = 18316519}}</ref> Due to its importance for biodefense, the FDA has designated tecovirimat for 'fast-track' status, creating a path for expedited FDA review and eventual regulatory approval. On July 13, 2018, FDA announced approval of Tecovirimat.<ref>[https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm613496.htm U.S. Food and Drug Administration]</ref> |
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Tecovirimat inhibits the function of a major [[Viral envelope|envelope protein]] required for the production of extracellar virus. Thus the virus is prevented from leaving an infected cell and the spread of the virus within the body is prevented.<ref>{{cite journal | pmc = 1235851| year = 2005| author1 = Yang| first1 = G| title = An Orally Bioavailable Antipoxvirus Compound (ST-246) Inhibits Extracellular Virus Formation and Protects Mice from Lethal Orthopoxvirus Challenge| journal = Journal of Virology| volume = 79| issue = 20| pages = 13139–13149| last2 = Pevear| first2 = D. C.| last3 = Davies| first3 = M. H.| last4 = Collett| first4 = M. S.| last5 = Bailey| first5 = T| last6 = Rippen| first6 = S| last7 = Barone| first7 = L| last8 = Burns| first8 = C| last9 = Rhodes| first9 = G| last10 = Tohan| first10 = S| last11 = Huggins| first11 = J. W.| last12 = Baker| first12 = R. O.| last13 = Buller| first13 = R. L.| last14 = Touchette| first14 = E| last15 = Waller| first15 = K| last16 = Schriewer| first16 = J| last17 = Neyts| first17 = J| last18 = Declercq| first18 = E| last19 = Jones| first19 = K| last20 = Hruby| first20 = D| last21 = Jordan| first21 = R| doi = 10.1128/JVI.79.20.13139-13149.2005| pmid = 16189015}}</ref> |
Tecovirimat inhibits the function of a major [[Viral envelope|envelope protein]] required for the production of extracellar virus. Thus the virus is prevented from leaving an infected cell and the spread of the virus within the body is prevented.<ref>{{cite journal | pmc = 1235851| year = 2005| author1 = Yang| first1 = G| title = An Orally Bioavailable Antipoxvirus Compound (ST-246) Inhibits Extracellular Virus Formation and Protects Mice from Lethal Orthopoxvirus Challenge| journal = Journal of Virology| volume = 79| issue = 20| pages = 13139–13149| last2 = Pevear| first2 = D. C.| last3 = Davies| first3 = M. H.| last4 = Collett| first4 = M. S.| last5 = Bailey| first5 = T| last6 = Rippen| first6 = S| last7 = Barone| first7 = L| last8 = Burns| first8 = C| last9 = Rhodes| first9 = G| last10 = Tohan| first10 = S| last11 = Huggins| first11 = J. W.| last12 = Baker| first12 = R. O.| last13 = Buller| first13 = R. L.| last14 = Touchette| first14 = E| last15 = Waller| first15 = K| last16 = Schriewer| first16 = J| last17 = Neyts| first17 = J| last18 = Declercq| first18 = E| last19 = Jones| first19 = K| last20 = Hruby| first20 = D| last21 = Jordan| first21 = R| doi = 10.1128/JVI.79.20.13139-13149.2005| pmid = 16189015}}</ref> |
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Version vom 1. August 2018, 15:16 Uhr
Tecovirimat (ST-246 or Tpoxx)[1] is an antiviral with activity against orthopoxviruses (such as smallpox) which is currently undergoing clinical trials. Originally researched by the National Institute of Allergy and Infectious Diseases, the drug was previously owned by Viropharma and discovered in collaboration with scientists at USAMRIID. It is currently owned and manufactured by Siga Technologies, a pharmaceutical company in the biodefense arena that won a government contract to develop the drug.
The drug works by blocking cellular transmission of the virus, thus preventing the disease.[2] Tecovirimat has been effective in laboratory testing; it has been shown to protect animals from monkeypox and rabbitpox and causes no serious side effects in humans.[1] However, tecovirimat has never been used to treat a human with smallpox due to the disease's successful eradication.
Two million doses of tecovirimat are stockpiled in the US Strategic National Stockpile as a defense against a smallpox outbreak.[3][4]
Clinical study
The results of clinical trials involving tecovirimat supports its use against smallpox and other related orthopoxviruses. It has shown potential for a variety of uses including prophylaxis, as a post-exposure therapeutic, as a therapeutic and an adjunct to vaccination.[5]
Tecovirimat can be taken orally and has recently been granted permission to conduct 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.[6] Due to its importance for biodefense, the FDA has designated tecovirimat for 'fast-track' status, creating a path for expedited FDA review and eventual regulatory approval. On July 13, 2018, FDA announced approval of Tecovirimat.[7]
Mechanism of action
Tecovirimat inhibits the function of a major envelope protein required for the production of extracellar virus. Thus the virus is prevented from leaving an infected cell and the spread of the virus within the body is prevented.[8]
References
- ↑ a b Donald G. McNeil Jr.: Drug to Treat Smallpox Approved by F.D.A., a Move Against Bioterrorism. In: The New York Times. The New York Times, abgerufen am 16. Juli 2018.
- ↑ Douglas W. Grosenbach, Kady Honeychurch, Eric A. Rose, Jarasvech Chinsangaram, Annie Frimm, Biswajit Maiti, Candace Lovejoy, Ingrid Meara, Paul Long, Dennis E. Hruby: Oral Tecovirimat for the Treatment of Smallpox. In: N Engl J Med. 379. Jahrgang, 5. Juli 2018, S. 44–53, doi:10.1056/NEJMoa1705688 (nejm.org [abgerufen am 16. Juli 2018]).
- ↑ Inger K. Damon, Clarissa R. Damaso, Grant McFadden: Are We There Yet? The Smallpox Research Agenda Using Variola Virus. In: PLoS Pathogens. 10. Jahrgang, Nr. 5, 2014, S. e1004108, doi:10.1371/journal.ppat.1004108, PMID 24789223, PMC 4006926 (freier Volltext).
- ↑ https://www.sciencenews.org/article/first-smallpox-treatment-one-step-closer-fda-approval
- ↑ Siga Technologies
- ↑ R Jordan, D Tien, T. C. Bolken, K. F. Jones, S. R. Tyavanagimatt, J Strasser, A Frimm, M. L. Corrado, P. G. Strome, D. E. Hruby: Single-Dose Safety and Pharmacokinetics of ST-246, a Novel Orthopoxvirus Egress Inhibitor. In: Antimicrobial Agents and Chemotherapy. 52. Jahrgang, Nr. 5, 2008, S. 1721–1727, doi:10.1128/AAC.01303-07, PMID 18316519, PMC 2346641 (freier Volltext).
- ↑ U.S. Food and Drug Administration
- ↑ G Yang, D. C. Pevear, M. H. Davies, M. S. Collett, T Bailey, S Rippen, L Barone, C Burns, G Rhodes, S Tohan, J. W. Huggins, R. O. Baker, R. L. Buller, E Touchette, K Waller, J Schriewer, J Neyts, E Declercq, K Jones, D Hruby, R Jordan: An Orally Bioavailable Antipoxvirus Compound (ST-246) Inhibits Extracellular Virus Formation and Protects Mice from Lethal Orthopoxvirus Challenge. In: Journal of Virology. 79. Jahrgang, Nr. 20, 2005, S. 13139–13149, doi:10.1128/JVI.79.20.13139-13149.2005, PMID 16189015, PMC 1235851 (freier Volltext).