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kvlevebis roli TB globaluri gegmis SesrulebaSi. neli solomonia , “ samSabaToba ”, 19.10.10. NEW DIAGNOSTICS WORKING GROUP ANNUAL MEETING
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kvlevebisroliTBglobalurigegmisSesrulebaSi nelisolomonia, “samSabaToba”, 19.10.10
NEW DIAGNOSTICS WORKING GROUP ANNUAL MEETING The Stop TB Partnership New Diagnostics Working Group will hold its annual meeting in Berlin, Germany, in conjunction with the 41st Union World Conference on Lung Health. Thursday, 11th November 2010 13:00-17:00 International Congress Center, Berlin, Hall 7 http://www.stoptb.org/wg/new_diagnostics/# Friday, November 12, 2010, 7:30am-1:00pm The Kempinski Hotel Bristol Berlin, http://www.kempinski-berlin.de/en/hotel/ http://www.newtbdrugs.org/rsvp.php
fundamenturikvlevebi: • adamianisorganizmSiM. tuberculosis moqmedebispaTomorfologiurimeqanizmissrulyofiliSeswavla; • gansxvavebuliimunokompetenciismqoneindividebSispecifiuriimunuripasuxisTaviseburebebisSeswavla; • LTBI-is aqtiurTB-Si gadasvlismeqanizmissworadgansazRvra; • maRalsensitiurimeTodebisSemuSavebaqsovilSimikobaqteriisupiratesilokalizaciismeqanizmisdaimkorelaciisgansazRvrisaTvis, romelicarsebobsmikobaqteriisricxvs/formasadadaavadebisfazas/gamosavalsSoris; • rogoriaqsovilSispecifiuricvlilebebismimdinareobadarogoriapaTfiziologiuricvlilebebisgavlenaTB daavadebisdinamikaze; • maRalsensitiurimeTodologiisSemuSavebamolekulurdonezemikobaqteriis, pacientisdaTBpreparatebisurTierTqmedebissrulyofiladgaSifrisaTvis, mikobaqteriissasicocxlociklSiyvelazefaqizietapisgansazRvramisimaqsimaluradefeqturieliminaciisaTvis; • ramdenadgansxvavebuliamikobaqteriisgenomiindividis, geografiuliarealis, an globalurpopulaciaSi; • TB kvlevebSiyvelasaWirosamecnierodisciplinebiswamyvanimecnierebis/laboratoriebisCarTva;
ZiriTadiaqcentebi: • ukvearsebulidaaxalipreparatebiskombinaciiTDS/DR-TB mkurnalobisxangrZlivobisSemcireba; • M/XDR-TB axalisamkurnalopreparatebisSeqmna; • HIV/AIDS-TB ko-infeqciismaqsimaluriefeqturobiTmarTva; • LTBI-is dabavSvTatuberkulozismkurnaloba.
REMoxTB • DS-TBmkurnalobaSiMfx-is H-iTan E-iTCanacvlebiTmkurnalobisxangrZlivobis 6-dan 4 TvemdeSeamcireba 6H+R+E+Z 4Mfx+R+E+Zan 4Mfx+H+R+Z; • Mfxnaklebadaxdenscitoqrom P-450 fermentisinducirebas, amitommisigamoyenebaSeiZlebaARV mkurnalobispirobebSi; • H-is Mfx-iTCanacvlebaTBmaRalitvirTismqoneqveynebSicSesaZlebelsgaxdisLTBI-s H-iTmkurnalobas. http://www.tballiance.org/downloads/publications/TBA%20Annual%202009.pdf
mkurnalobisxangrZlivobisSemcirebagazrdismkurnalobisadmidamyolobas, SeamcirebswyvetilimkurnalobisSemTxvevebs; • fasismiuxedavadMfx-is gamoyenebaxarjefeqturia; uaryofiTimxareebi: • saqarTveloSimaRaliaqinolonebismimarTjvaredinipirveladirezistentobisarsebobisalbaToba; • Mfx-is gamoyenebas Tan axlavstoqsiurigverdiTimovlenebi; • Mfx-is gamoyenebaarSeiZlebabavSvebSi.
Historic Opportunity to Develop New Therapeutic Options for TB 1950 1970 1980 2010 1960 1974 BMRC Trials add RIF & PZA 1963 Rifampin (RIF) discovered 1970 BMRC Trials add RIF • 1952 • 1st regimen: • Streptomycin • PAS • Isoniazid 2005 Trials substitute Moxifloxacin into regimen 1954 Pyrazainimide (PZA) discovered – but liver toxicity Standard Therapy 2 months: rifampin, isoniazid, pyrazinamide, ethambutol + 4 months: rifampin, isoniazid Standard Regimen by 1960s based on 1952 drugs Rx target: 3-4 months Rx shortened to 6 months Rx shortened to 9 months Rx lasts from 12-24 months
In an animal study*, moxifloxacin regimen shortened treatment duration by 2 months 10 Legend 9 Untreated 8 7 2 months rifampin, isoniazid and pyrazinimide followed by 4 months rifampin and isoniazid 6 5 Log CFU in entire lung 4 2 months rifampin, moxifloxacin and pyrazinimide followed by 4 months rifampin and moxifloxacin 3 2 1 0 0 1 2 3 4 5 6 Duration of treatment (months) *In vivo data does not predict clinical response.
TMC-207 dairqinolonebisjgufispreparati; mikobaqteriisgarsiswarmoqmnisenergetikuliwyaros - specifiuriatf-sinTetazasinhibitori; ZlieribaqteriocidulidamasterizebelimoqmedebaaxasiaTebsrogorc DR-, iseDS-TB Stamze;
PA-824: uaxlesiantibaqteriulipreparatebisjgufi; nitroimidazoli: • aqvsbaqteriocidulidamasterizebelimoqmedeba; • efqturiarogorcsensitiuri, iserezistentuliTB-s samkurnalod; • SeiZlebaARV TerapiasTankombinaciaSigamoyeneba; • 2005 wlidanCarTuliapreklinikurikvlevebis I stadiaSi.
abebisalternativa – PTB-is sainhalacioformiTmkurnaloba • kvlevebimimdinareobsPA-824-is sainhalacioformisdanergvismizniT; • klinikurikvlevebiCatardazRvisgowebze – erTmanetsSedarda 40 mg/kg oraluri, 4.8 mg/kg da 9.7 mg/kg sainhalacio forma da placebo; • orivedozissainhalacio forma plazmaSimaqsimalurkoncentraciasaRwevs 3-4 ssaTSidaorganizmSicirkulirebsinhalaciidan 24 sT-is ganmavlobaSi
Critical Path to TB Regimens (CPTR) will drastically reduce the amount of time needed to register novel regimens for tuberculosis and drug-resistant tuberculosis from decades to years. http://www.tballiance.org/cptr/
Vaccine update • Aeras and Crucell launch vaccine trial in Kenya • In September, Dutch biopharmaceutical company Crucell N.V. and the Aeras Global TB Vaccine Foundation announced the start of a Phase II clinical trial in infants of the jointly developed TB vaccine candidate, AERAS-402/Crucell Ad35. • The main objective of the trial is to test the safety and efficacy of the TB vaccine candidate in infants previously vaccinated with the BacilleCalmette-Guérin (BCG) vaccine. The first part of this clinical trial, which will be conducted in Kenya, will establish the optimal dosing regimen. The selected regimen will then be tested in the second part of the trial, which is planned to begin in 2011 in Kenya, Mozambique, South Africa and Uganda. • AERAS-402/Crucell Ad35 busteriadaadenovirus 35 veqtoriTiwvevsM. tuberculosis 85A, 85B, TB10.4 antigenebiseqspresias, racTavisTavadCD+4 daCD+8markerismqoneTlimfocitebisinducirebasaxdens; http://www.aeras.org/newscenter/news-detail.php?id=1043
Vaccine update • Clinical trial of new investigational vaccine AERAS-422 • At the Second Global Forum on TB Vaccine Development in Tallinn, Estonia in September (see "Recent Events", below), the Aeras Global TB Vaccine Foundation announced that it will initiate a clinical trial of an investigational live recombinant tuberculosis vaccine to be led by researchers at Saint Louis University in St. Louis, Missouri, USA. • AERAS-422 BCG vaqcinisrekombinanti, anumodernizebuliversiaadaSeiqmnapirveladiinficirebis, LTBI-is daLTBI-is reaqtivaciisprevenciismizniT; http://www.aeras.org/newscenter/news-detail.php?id=1044
TB pandemiiswinaaRmdegBCGaraefeqturiaRmoCnda BCG bavSvsmxolodTBdiseminirebuliformebisdaTB meningitis ganviTarebisaganicavs; BCG vericavsorganizmsLTBI-isagan; BCG aiv-inficirebuliCvilebisaTvismaRal risks warmoadgens (yovel 100 000 mosaxlezeaivinficirebulTa 992 SemTxvevaSiBCG-irebamTB diseminirebuliformebisganviTarebagamoiwvia(World Health Organization; Type: Research Article DOI: 10.2471/BLT.08.055657 2009-janmo iZlevarekomendaciasaivtestirebisgareSeCvilebisBCG-irebaarCatardes; - 02.07.09; WHO).
axaliTBvaqcinis aucilebloba • TB globaluri miznis miRweva (>1 TB SemTx./milion mosaxleze) axali vaqcinis, anu daavadebis prevenciis gareSe SeuZlebelia; • aucilebelia TB axali, ekonomiuri, efeqturi vaqcina, romelic saimedod daicavs: • nebismieri asakis organizms; • maT Soris HIV-inficirebulebs; da uzrunvelyofs: • LTBI_is prevencias (preinfeqciuri vaqcinacia); • LTBI-is reaqtivaciis prevencias (postinfeqciuri vaqcinacia); • TB pirveladi da meoradi, maT Soris MDR/XDR formebisprevencias; • TB mkurnalobis xangrZlivobis Semcirebas da TB mkurnalobis efeqturobis zrdas (imunoTerapia).
Block Initial Infection Prevent Latent Infection Prevent Early Disease Prevent Reactivation Disease
operaciulikvlevebi: epidmdgomareobisstatistikuriSefasebidan • TBdiagnostikis; • mkurnalobis; • klinikurimimdinareobis kompleqsurigaanalizebisa TBsrulyofilimarTvisaken
rogorcyovelTvis didimadloba yuradRebisaTvis