tratamiento antiretroviral(tar) · ausencia de beneficio de inicio precoz del tar conclusions:...
TRANSCRIPT
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Tratamiento antiretroviral (TAR)
Maitines 2012. JL Mostaza
De dónde venimos y hacia dónde vamos
Funded by…
…en apoyo de los “desayunos de Maitines”
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Aspectos del tratamiento
antiretroviral
• Infección aguda.
• Infección crónica.
• Embarazo.
• Profilaxis pre y post-exposición.
• Vacunas.
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MMWR. Jun 1981
N Engl J Med. Dec 1981
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Barre-Sinoussi F. Science. 1983.
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La prehistoria del TAR: AZT
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Una decepción…
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Concorde Coordinating Committee. Lancet 1994.
Concorde Trial
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El inicio de la historia del TAR...
Highly active antiretroviral therapy (HAART)
TARGA TARV
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Los motores del cambio…
• Marcadores subrogados:
– Linfocitos CD4.
– Carga viral de VIH.
• Estudio de resistencias
genotípicas al TAR
• Inhibidores proteasa.
Tratamientos combinados
HAART
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Hª natural del VIH
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N Engl J Med. Aug. 1995
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Hammer SM. N Engl J Med 1997.
CV
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Palella FJ Jr et al. N Engl J Med. 1998.
Descenso en la mortalidad por SIDA
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Limitaciones de los primeros
“TARGA”
1. Incapacidad de “curar” la infección.
2. Aparición de cepas resitentes al TAR.
3. Toxicidad del TAR.
4. Ausencia de beneficio de inicio precoz del TAR.
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1. Incapacidad de “curar” la infección y
aparición de cepas resitentes al TAR
Swiss HIV Cohort Study. Lancet 1999.
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2. Toxicidad del TAR
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Problemas en el paciente VIH+ con TAR
• Resistencias al TAR
– Adherencia al tratamiento.
• Comorbilidad
– Coinfección VIH /Virus hepatitis.
• Cambios en metabolismo de los lípidos.
• Lipodistrofia.
• Aumento de resistencia a la insulina.
Aumento del riesgo cardiovascular
� Osteoporosis
� Acidosis láctica
� IRC.
Toxicidad TAR a largo plazo
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A.C. Lepria. ICONA study. AIDS 2001.
3. Ausencia de beneficio de inicio precoz del TAR
Conclusions: There was no clear immunological or virological advantage in
starting HAART at a CD4 cell count > 350 rather than at 200-350 x 106 cells/l.
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Riesgo/Beneficio
A favor En contra
Prevenir progresión enfermedad
Disminuir transmisión
Aparición de efectos adversos
Aparición de resistencias
Disminución calidad de vida
Gasto económico
Beneficio Riesgo
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Lancet 2000
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¿Qué cambios se han producido
en los últimos años?
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• Desarrollo de nuevos antiretrovirales.
• La infección asintomática por VIH no es inocua.
• Riesgo de transmisión es menor en pacientes tratados.
• Diagnóstico tardío de la infección por VIH.
“Test and treat”
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1. Desarrollo de nuevosantiretrovirales
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FI: T20
R5I: Maraviroc
NUCS
NNUCS
II: Raltegravir
PIs
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’87 ’91 ’92 ’94 ’95 ’96 ’97 ’98 ’99 ’00’88 ’89 ’90 ’01 ’02 ’03’93 ’05’04 ’06
ddC
3TC
INNTI
INTI
IPs
Inhibidores
Entrada
ddI
IDV
SQR LPV/r
TDFNVP
DRV
TPV
T-20
ZDV d4TABC
DLV
EFV FTC
RTV
NFV ATV
FPV
’07
MVC
APV
Entre 1987 y 1995, se comercializaron 4 antirretrovirales.
Desde 1995, se han introducido 26 nuevos productos.
Entre 1987 y 1995, se comercializaron 4 antirretrovirales.
Desde 1995, se han introducido 26 nuevos productos.
ETV
Inhibidores
Integrasa
RGV
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1997
HOY
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VS. Gill. Clin Infect Dis. 2010
Improved Virological Outcomes in British Columbia
Annual incidence rate of drug resistance
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Changing Patterns of the Causes of Death in a
Swiss Cohort (SHCS)
Ruppik M, et al. 18th CROI; Boston, 2011. Abst. 789.
Causes of Death in Participants in the Swiss HIV Cohort Study in 3 different Time Periods, and in the Swiss Population in 2007
Years of Death of HIV+ Persons Versus Swiss Population
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¿Por qué los pacientes VIH+ no alcanzan supervivencia normal?
Retraso diagnóstico: presentación tardía.
Coinfecciones: hepatitis virales
Hiperestimulación inmune
Envejecimiento precoz = � Comorbilidad•Riesgo cardiovascular.
•Tumores.
•Enfermedad renal.
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2. La infección asintomáticapor VIH no es inocua.
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Estrategia: tratamiento intermitente guiado por CD4.
Grupos:
•TAR contínuo.
•TAR intermitente según CD4.
• Inicio TAR: CD4 < 250
• Suspensión TAR: CD4 > 350
Objetivos:
•1º: Muerte o enf. oportunista.
•2º:
• Enf. CV, hepática, renal.
• Toxicidad.
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SMART Study Group, NEJM 2006.
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ART interruption
HIV replication
–-> endothelial dysfunction.
–-> hypercoagulable state.
–-> IL-6, CRP.
� IL-6 and D-dimer
� MortalityIL-6 (OR 8) and D-dimer (OR 12)
Kuller LH. PLoS 2008.
SMART study (cont.)
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SG. Deeks. Curr HIV/AIDS Rep. 2010.
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T. Ferry,. J Acquir Immune Defic Syndr 2009.
Factors associated with the occurrence of a first non-AIDS event:
-Age > 60 years (HR 2.1)
-CD4 <100 cells/ ml (HR 2.5)
-HIV RNA > 4 log10 copies per milliliter at the time of the event (HR 1.9)
APROCO/COPILOTE (ANRS CO8) Cohort Study.
1281 patients. Median follow-up of 7.3 years,
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Death rates per 1000 person years of follow-up, stratified by latest CD4 cell count
(D:A:D) Study Group. AIDS 2010.
Relación inversa entre mortalidad y CD4
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Estudio NA-ACCORD Supervivencia de TARGA precoz
Kitahata MM. NEJM 2009..
Parámetro asociado con riesgo de muerte Riesgo relativo (IC95%)
1.0 2.50.1
P
Diferir TARGA hasta < 350 céls/mm3
(vs inicio a 350-500 cells/mm3)
1.7 < .001
Diferir TARGA hasta < 500 céls/mm3
(vs inicio a ≥ 500 céls/mm3)
1.6 < .001
N = 17.517 pacientes. 10 años de seguimiento.
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N Engl J Med 2009
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Patient Factors/Comorbidities That
Impact Timing of Antiretroviral Therapy
• Initiation regardless of CD4+ cell count:
– Pregnancy
– HIV-associated nephropathy.
– HBV coinfection.
– CD4+ cell count decline
> 100 cells/mm3 per year.
– HIV-1 RNA > 100,000
copies/mL.
DHHS. Available at: http://aidsinfo.nih.gov/contentfiles/AdultandAdolescentGL.pdf. March 2012.
� Other potential reasons for
starting therapy earlier
– Decreased rates of
transmission in serodiscordant
couples
– Decrease in new HIV diagnoses
within the community
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3. Riesgo de transmisión es menor en pacientes tratados.
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3. Estrategia “Test and treat”
HIV incidence. Yearly cost of the two strategies.
Available and projected funding for HIV.
RM Granich. Lancet 2009.
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Das M. PLoS ONE. 2010
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Montaner JS. Lancet. 2010.
Reduction in New HIV Diagnoses in BC: Testing, HAART, and Community VL
1996
2009
2008
2007
2006
2005
2004
2003
2002
2001
2000
1999
1998
1997
≥ 50,000
10,000-49,999
3500-9999
500-3499
< 500
0
2000
4000
6000
8000
10,000
12,000
Censored at the time of death or move
Pati
en
ts (
n)
HIV-1 RNA, copies/mL
0
200
400
600
New HIV+diagnoses (All)
New
HIV
+ D
iag
no
ses (n
)
800
1000
1200
1400
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ONUSIDA 2011
BotswanaLas nuevas infecciones disminuyeron un 21% (1997 – 2010).
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Prevención de transmisión en parejas serodiscordantesEstudio HPTN 052
MS Cohen. N Engl J Med 2011.
1763 serodiscordant couples 28 linked transmissions
only 1 occurred in the early-therapy group.
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4. El problema del diagnóstico tardío.
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Retraso diagnóstico a la presentación
Test VIH universal
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¿Qué es un TAR?
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� INTIs: � Emtricitabina + tenofovir
�Lamivudina + abacavir
� INNTI: Efavirenz� IP: ATVr, DRVr, LPVr� II: raltegravir.
Fármaco 3
Tratamiento estándar (pautas preferentes)
Fármaco 1+2
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Al elegir un TAR…
Co-morbilidad
• Embarazo
• Cirrosis
• Induficiencia renal
• Riesgo CV
• Enf. Psiquiátrica…
Interacciones
• Metadona
• IFN/RBV
• Tuberculostáticos
• Antiulcerosos/antiácidos
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TAR no convencionalesLibres de análogos nucleósidos
• Monoterapia Ips potenciados con ritonavir.
• IP + Inhib. Integrasa.
• IP + Nucleósidos no análogos
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Profilaxis preexposición
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Preexposure Chemoprophylaxis for HIV Prevention in Men
Who Have Sex with Men.
MS Cohen. N Engl J Med 2010.
Detectable blood levels strongly correlated with the prophylactic effect
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Vacunas anti-VIH
¿Una quimera?
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Vaccination with ALVAC and AIDSVAX to Prevent HIV-1 Infection in Thailand
S. Rerks-Ngarm. N Engl J Med 2009
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Infección por VIH
¿Se puede curar?
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Clinical Course and HIV-1 Viremia.G. Hutter. N Engl J Med 2009.
Long-Term Control of HIV by CCR5 Delta32/ Delta32 Stem-Cell
Transplantation.
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Conclusión
¡Test and treat!
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Test de resistencias