G. B. Migliori - Cenaprece Salud · G. B. Migliori WHO Collaborating Centre for TB and Lung...
Transcript of G. B. Migliori - Cenaprece Salud · G. B. Migliori WHO Collaborating Centre for TB and Lung...
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ERS/OMS CONSILLIUM: APOYANDO A LOSCLÍNICOS EN CASOS DIFÍCILES
G. B. MiglioriWHO Collaborating Centre for TB and Lung Disease,Fondazione S. Maugeri, Care and Research Institute
Tradate, Italy; ERS Secretary General
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IntroducciónOBJETIVOS: para discutir la situación MDR-TB
hoy para demostrar que los nuevosmedicamentos por sí solos no son suficientes
• Epidemiología• Resultados del tratamiento de la MDR-TB• Los nuevos fármacos• La prevención de que se produzca la MDR• Cuestiones abiertas: el estigma, la toxicidad,
costos, control de infecciones• El TB Consilium de la ERS/OMS
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La epidemiologíaes muyaburrido...
… pero muyimportante
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13 mejores áreas con mayor % de MDR-TBentre los casos nuevos, 2001-2010
16.5
19.2
19.3
19.4
20.0
22.3
23.8
27.3
28.3
15.4
14.8
16.0
16.1
0 5 10 15 20 25 30
Tashkent, Uzbekistan (2005)
Estonia (2008)
Donetsk Oblast, Ukraine (2006)
Mary El Republic, Russian Federation (2008)
Dushanbe city and Rudaki district, Tajikistan (2009)
Belgorod Oblast, Russian Federation (2008)
Kaliningrad Oblast, Russian Federation (2008)
Republic of Moldova (2006)
Ivanovo Oblast, Russian Federation (2008)
Baku city, Azerbaijan (2007)
Arkhangelsk Oblast, Russian Federation (2008)
Pskov Oblast, Russian Federation (2008)
Murmansk Oblast, Russian Federation (2008)
35.3Minsk, Bielorrussia (2010) Preliminary results ERJ 2012
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5
Age/sex
Countryof birth
prevTX >
30days
Drug receivedduring previous
TX periods
Drug resistance atXDR diagnosis
HospitAdmis(days)
SSconv
(days)
C conv(days)
Outcome
TXdur(mo
43/F IT 3 SRHEZ;FQ,Eth,AK,PAS,C,K,Cyc,Rb,Clof,Dap,Cl,Th
SRHEZ;FQ,Eth,AK,PAS,C,K,Cyc,Rb,Clof
422 No No Died 94
49/F IT 3 SRHEZ;FQ,Eth,AK,PAS,C,K,Cyc,Rb,Clof, Dap,Cl,Th
SRHEZ;FQ,Eth,AK,PAS,C,K,Cyc,Rb,Clof,Dap,Cl,Th
625 No No Died 60
Casos de tuberculosis por primera vez en Italia resistentes a todos losfármacos probados
Eurosurveillance 2007
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Udwadia ZF, Amale RA, Ajbani KK, Rodrigues C. Totally drug-resistanttuberculosis in India. Clin Infect Dis. 2012 Feb 15;54(4):579–81.
El caso de Mumbaiy el "brote TDR-TB”
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Resistance to fluoroquinolones and second-line injectable drugs: impact on MDR-TB outcomes. Eur Respir J. 2012 Oct 25; doi:10.1183/09031936.00134712
El éxito del tratamiento, entre diferentes grupos de pacientes con TBMDR
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Treatment outcomeXDR-alone XDR+2sli XDR+sliG4 XDR+sliG4EZ
n = 301 n = 68 n = 48 n =42
Cured 1.0 (reference) 0.4 (0.2, 0.8) 0.6 (0.2, 1.6) 0.5 (0.2, 1.7)
Failed 1.0 (reference) 2.1 (1.0, 4.5) 1.8 (0.7, 4.7) 1.9 (0.7, 5.3)
Died 1.0 (reference) 1.6 (0.6, 4.4) 1.7 (0.6, 4.9) 1.8 (0.6, 5.3)
Failed or Died 1.0 (reference) 2.6 (1.2, 4.4) 2.6 (1.1, 6.7) 2.8 (1.0, 7.9)
Defaulted 1.0 (reference) 1.0 (0.3, 2.6) 0.5 (0.2, 1.8) 0.5 (0.1, 2.0)
Treatment outcomeXDR alone XDR+2sli XDR+sliG4† XDR+sliG4EZ
n = 301 n = 68 n = 48 n =42
Cured 43 (27, 58) 30 (17, 43) 34 (-, -) 19 (0, 48)*
Failed 20 (15, 25) 29 (8, 50) 33 (-, -) 26 (14, 38)
Died 13 (6, 20) 18 (7, 29) 30 (18, 41)* 35 (21, 50)*
Failed or died 35 (26, 45) 54 (40, 69)* 48 (-, -) 49 (37, 61)
Defaulted 15 (5, 24) 15 (3, 27) 18 (-, -) 19 (6, 32)
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1st-lineoral
•INH
•RIF
•PZA
•EMB
•(Rfb)
Injectables
•SM
•KM
•AMK
•CM
Fluoroquinolones
•Cipro
•Oflox
•Levo
•Moxi
•(Gati)
Oral bacteriostatic 2nd line
Unclear efficacy•ETA/PTA
•PASA
•CYS
Not routinely recommended,efficacy unknown, e.g.,amoxacillin/clavulanic acid,clarithromycin, clofazamine,linezolid, inmipenem/cilastatin,high dose isoniazid
XDR= HR + 1 FQ + 1 Injectable (AMK, CM or KM)
XDR= extensively drug-resistant TB
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FirstsanatoriumGermany,1857
First DispensaryScotland, 1897
Koch, Mtb,1882
MMR,1950-1980
Fox: Ambulatorytreatment, 1968
Styblo model,1978DOTS, 1991
BCG vaccination,1921
Pneumotorax,Italy, 1907
1900
1890
1880
1910
1920
19301940
1950
1960
1970
1980
1990
2000
2010
2020
Post-2015 global TB strategy2014 – WHO Framework forTB elimination, 2014
2030
Streptomycin1943 PAS
1948
Thiacetazone1951
Pyrazinamide/Clofazimine1954
Isoniazid1952
Cycloserine1955
Kanamycin/Rifapentine/Rifampicin
1957
Ethionamide1960
TBelimination
2040
2050
Ethambutol1961
Capreomycin1963
Ofloxacin1982
Gatifloxacin1992 Moxifloxacin
1996 Pretomanid2000
Bedaquiline2005
Delamanid2006
1946: first randomized clinical controlledtrial:streptomycin monotherapy caused resistance
1952: first regimen: streptomycin,P-aminosalicylic acid and isoniazid for 24 months
1960s:aminosalicylic acid was replaced by ethambutolstreptomycin, isoniazid and ethambutol for 18 months
1970s: streoptomycin, isoniazid, rifampicinand ethambutol for 9-12 months 1980s: isoniazid, rifampicin,pyrazinamide,
ethambutol for 6-8 months (oral) 2020s: new universal andshorter regimen (2-4 months)for TB disease and infection?
Sutezolid/Linezolid1990s
Meropenem1976
Benzothiazinones/SQ1092000s
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Después de 40 años, 2 nuevosmedicamentos aprobados por laFood and Drug Administration(FDA) y / o la Agencia Europea deMedicamentos (EMA)
En 1966, el último fármaco anti-TB se introdujo en elmercado
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Bedaquiline
Delamanid
Pretomanid
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Delamanid
• Los resultados favorables en 143/192 pacientes(74.5%) que recibieron delamanid ≥6 meses, vs.126/229 pacientes (55,0%) que recibierondelamanid ≤2 meses.
• Reducción de la mortalidad a 1,0% VS 8,3% (nodelamanid), p <0,001.
Skripconoka V, ERJ 2013
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Delamanid añadido a un régimen deMDR-TB mejora la conversión SS-C enel mes 2 (45.4 vs. 29.6%)
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Bedaquiline (Bq) y Pretomanid (PA-824)
• Nuevo trial de fase IIb a comparar laactividad bactericida después de 8-semanas: moxifloxacin + pretomanid(100 mg o 200 mg), + Z vs régimenestándar OMS
• actividad bactericida superiordespués de 2 meses de tratamiento.
• bien toleradoLancet 2015, in press
18
• IIb trial, BQ + background regimen VS placebo,•reducida mediana de tiempo hasta la conversiónC, (125 a 83 días) y aumento de la conversión C alas 24 semanas (79% vs. 58%) y en 120 semanas(62% vs. 44%). Las tasas de curación en 120semanas fueron 58% frente a 32% de incidenciade eventos adversos similares (10 muertes BQ gr)
• EBA 2 semanas: PA-824+moxi+Z mejorque: bq, bq+Z, bq+PA-824 Comparable aOMS Grupo 1
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A primera experiencia de uso compasivo debedaquilina
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Recomendaciones de la OMS sobre Bq y delamanid
• 100 mg BD añadidoa OBR en adultos
• Farmacovigilancia• El consentimiento
informado• No se agregó a BQ
20
•400 mg al día (200)añadido a OBR enadultos• Farmacovigilancia• El consentimientoinformado• Monitoreo QT
•Preparación para el país yplanificación•Plan Nacional de nuevasherramientas•M & E (DRS y farmacovigilancia)•El sector privado participa•Suministro de Medicamentos•Investigación operativa
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Meropenem
21
Variables Total 37 Cases 61 Controls p-value
SS conv at 90 d, n (%)37/48(77.1)
28/32 (87.5) 9/16 (56.3) 0.02
C conv at 30 d, n (%)24/66(36.4)
12/37 (32.4) 12/29 (41.4) 0.45
C conv at 60 d, n (%)37/62(59.7)
24/37 (64.9) 13/25 (52.0) 0.31
C conv at 90 d, n (%)46/61(75.4)
31/37 (83.8) 15/24 (62.5) 0.06
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Adverse events0 0.2 0.4 0.6 0.8 1
Alffenaar JWC et al. [46] 0.00 (0.00 - 0.37)Anger HA/Condos R et al. [34] 1.00 (0.78 - 1.00)De Lorenzo S et al. [35] 0.67 (0.09 - 0.99)FortunJ et al. [22] 1.00 (0.29 - 1.00)Koh WJ et al. [45] 0.82 (0.48 - 0.98)Migliori GB et al. [8] 1.00 (0.03 - 1.00)Park IN et al. [44] 0.71 (0.29 - 0.96)Schecter GF et al. [30] 0.22 (0.07 - 0.44)Singla R et al. [31] 0.71 (0.42 - 0.92)Udwadia ZF et al. [32] 1.00 (0.29 - 1.00)Villar M et al. [33] 0.22 (0.03 - 0.60)Von der Lippe B et al. [43] 0.80 (0.44 - 0.97)
Proportion of adverse events (95% CI)
Pooled Proportion = 0.59 (0.49 to 0.68)Chi-square = 61.94; df = 11 (p = 0.0000)Inconsistency (I2) = 82.2 %
Linezolid interruption due to adverse events0 0.2 0.4 0.6 0.8 1
Alffenaar JWC et al. [46] 0.00 (0.00 - 0.37)Anger HA/Condos R et al. [34] 0.87 (0.60 - 0.98)FortunJ et al. [22] 1.00 (0.29 - 1.00)Koh WJ et al. [45] 0.82 (0.48 - 0.98)Migliori GB et al. [8] 1.00 (0.03 - 1.00)Park IN et al. [44] 0.40 (0.05 - 0.85)Schecter GF et al. [30] 1.00 (0.03 - 1.00)Singla R et al. [31] 1.00 (0.69 - 1.00)Udwadia ZF et al. [32] 0.54 (0.25 - 0.81)Villar M et al. [33] 1.00 (0.03 - 1.00)Von der Lippe B et al. [43] 0.70 (0.35 - 0.93)
Proportion of linezolid interruption due to adverse events (95% CI)
Pooled Proportion = 0.69 (0.58 to 0.79)Chi-square = 37.19; df = 10 (p = 0.0001)Inconsistency (I2) = 73.1 %
Los eventos adversos en regímenes que contienen Linezolid, Sotgiu et al, ERJ 2012
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TDM: ¿es el futuro deTratamiento de la MDR-
TB?
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0
1
2
3
4
5
6
7
1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005
XDR-TB
MDR-TB
El brote en Noruega
paciente somalí
1992 (-) radiografia, no Mantoux
1994 TB pulmonar, resistente H(+5 SLDs): HRZperdido
1995 esputo positivo TB INH, RIF resistante (+ 5 SLDs)
Después de 10 años , otros 23 pacientes (15 XDR) con una cepaidéntica (mismo RFLP y Spoligotyping) diagnosticados
Ulf R Dahle et al. Journal of Clinical Microbiology, 2003
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ESTC(EU Standards
for TB Care)
ERS ha sido muy activaen el desarrollo de unaversión adaptada de lasnormas internacionales aEuropa
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Drogas costosasy tóxicosson necesarios
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El coste (€) para tratar la tuberculosis y el MDR/ XDRes enorme: la prevención es rentable
Cost per case Susceptible MDR-TB XDR-TB
Estonia* 2,615 15,344 15,344
France 5,691
Germany 7,7,51 55,003 188.466
UK 6,234 62,343
Netherlands 8,340 46,990 148,136
Italy 9,294
Finland 8,243
Spain 9,384
AVERAGE 7,848 54,779 168,310
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Áreas visitadas por los pacientes con tuberculosis
asa / reportadopor otras estructuras
Departamento de TB
Aislamiento para TB
Recepción
OPD
VCT
Radiologia
Laboratorio
Farmacia
Otros
Salas generales
Maternidad
Uns
uspe
cted
TB p
atie
nts
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0%
20%
40%
60%
80%
100%
Kazakhstan(2268)
Turkey (263) Uzbekistan(294)
Ecuador (210) Georgia (417) DemocraticRepublic of the
Congo (202)
Philippines(520)
Namibia (221) RussianFederation
(1537)
Brazil (444) Kyrgyzstan(262)
Republic ofMoldova (522)
South Africa(4383)
Romania (816)
Success Died Failed Defaulted Not evaluated
Resultados del tratamiento MDR-TB
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Tratar MDR/ XDR-TB es difícil
www.tbconsilium.org
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Consilium ERS/OMS por MDR/XDR-TB
• desarrollado por la OMS Europa yERS (que financia el proyecto)• plataforma electrónica que apoyaa los médicos a tratar los casos decomplejos TB• el médico incluye datos en 20minutos• dentro de dos días, dos expertosmundiales dañan respuesta• el sistema está libre
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La plataforma web:www.tbconsilium.org
• el sistema habla Español, Inglés,Portugués y Ruso (Francés en preparación)
• web alojado en Suiza (ley Suiza)
Nuevos proyectos:• el sistema de seguimiento de los pacientes que migran de
un país a otro;• servicio para los pacientes (motivación, segunda opinión),• servicio para apoyar el diagnóstico y la terapia de la
infección latente
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Consilium:ERS/OMS 82 casos(2 Marzo, 2015)
• 58 casos + 24 in 2 epidemias (4 TB and 20infecciones)
• 18 Países: India (19/58, 32,7%), Italia (11/58, 18,9%),Reino Unido (8/58 13,7%)
• 26 casos pediátricos• pregunta clínica: régimen de tratamiento (8 uso compasivo)• 18,9% (11) Sensible; 5% (3) Polyr; 6,8% (4) Mono-r; 60,3% (35)
MDR-TB (13 XDR-TB + 4 pre-XDR); 8,6% (5) no clasificado• 62% (36) P; 15,5% (9) EP; 20,6% (12) P+EP; 1,7% (1) no
clasificados
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www.tbconsilium.org
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36
“Nadie quierecerrar…todos tienenmiedo”
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Conclusiones• puntos calientes comprometidas• pacientes prácticamente incurables• nuevos medicamentos después de 40 años: cómo
preservarlos? ¿Qué nuevos regímenes?• para el tratamiento de la MDR/ XDR-TB es largo,
tóxicos y caros• los resultados son pobres• gestión basada en la evidencia adecuada es necesaria• Asistencia online está disponible
(www.tbconsilium.org)• control de infecciones adecuado es necesario
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Conclusiones• puntos calientes comprometidas• pacientes prácticamente incurables• nuevos medicamentos después de 40 años: cómo
preservarlos? ¿Qué nuevos regímenes?• para el tratamiento de la M / XDR-TB es largo, tóxicos y
caros• los resultados son pobres• gestión basada en la evidencia adecuada es necesaria• Asistencia online está disponible (www.tbconsilium.org)• control de infecciones adecuado es necesario• Los nuevos medicamentos serán inútiles sin un fuerte
sistema de salud capaz de apoyar la adherencia de lospacientes
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Gracias a todos!