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ESTADO ACTUAL DEL TRATAMIENTO DE LA HEPATITIS CRÓNICA C

ESTADO ACTUAL DEL TRATAMIENTO DE LA HEPATITIS CRÓNICA C. DR C ENRIQUE ARÚS SOLER. MAGNITUD. Importante problema de salud a nivel mundial. 185 millones personas infectadas. 3 % de la población mundial. Depende de la región geográfica y desarrollo del país.  1% – 10%. MAGNITUD.

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ESTADO ACTUAL DEL TRATAMIENTO DE LA HEPATITIS CRÓNICA C

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  1. ESTADO ACTUAL DEL TRATAMIENTO DE LA HEPATITIS CRÓNICA C DR C ENRIQUE ARÚS SOLER

  2. MAGNITUD Importante problema de salud a nivel mundial • 185 millones • personas • infectadas 3 % de la población mundial Depende de la región geográfica y desarrollo del país  1% – 10%

  3. MAGNITUD 1. Primera causa de enfermedad hepática 2. Primera causa de descompensación hepática 3. Primera causa de carcinoma hepatocelular 4. Primera causa de transplante hepático 5.VHC cinco veces mas frecuente que el VIH Dr. E. Arús Soler

  4. EVOLUCIÓN DE LA EFICACIA DEL TRATAMIENTO DE LA HEPATITIS CRÓNICA C 92 -100% TRATAMIENTOS POR VÍA ORAL, LIBRES DE IFN 67 % INTERFERON PEGILADO MAS RIBAVIRINA MAS TELAPREVIR 66 % INTERFERON PEGILADO MAS RIBAVIRINA MAS BOCEPREVIR INTERFERON PEGILADO MAS RIBAVIRINA 56 % INTERFERON PEGILADO 39 % INTERFERON MAS RIBAVIRINA 48 SEM 41 % 16 % INTERFERON ALFA 48 SEM 6 % INTERFERON ALFA 24 SEM

  5. NUEVAS DROGAS EN EL TRATAMIENTO AGENTES ANTIVIRALES DE ACCIÓN DIRECTA AADS Fármacos que inhiben directamente la replicación viral en diferentes momentos del ciclo vital del virus Inhibidores de la entrada del virus a la célula Inhibidores de Proteasa NS3 / NS4A Inhibidores de polimerasa NS5 Dr. E. Arús Soler

  6. Dr. E. Arús Soler

  7. TERAPEÚTICA BÁSICA APROBADAEN EL 2011 INHIBIDORES DE PROTEASA INTERFERÓN PEGILADO RIBAVIRINA BOCEPREVIR TELAPREVIR Dr. E. Arús Soler

  8. NUEVAS ESTRATEGIAS DE TRATAMIENTO Terapia triple y cuádruple: ☻IFN Pegylado ☻ Ribavirina ☻ AADs Terapia toda por vía oral: ☻ No incluye IFN ☻ Incluye varios AADs ☻ con Ribavirina ☻ sin Ribavirina Dr. E. Arús Soler

  9. Nucleotide Polymerase Inhibitor Sofosbuvirplus Ribavirin for Hepatitis C 95 pacientes Genotipos 2 y 3 Genotipo 1 Gare EJ. et al N Engl J Med 2013: 368: 34-44

  10. Nucleotide Polymerase Inhibitor Sofosbuvirplus Ribavirin for Hepatitis C 95 pacientes Genotipos 2 y 3 Genotipo 1 Gare EJ. N Engl J Med 2013: 368: 34-44

  11. Treatment of HCV with ABT-450/r–Ombitasvir and Dasabuvir with Ribavirin ABT- 450/r Inhibidor de proteasa mas Ritonavir Ombitasvir Inhibidor NS5A (Fosfoproteina) Dasabuvir Inhibidor de polimerasa ENSAYO MULTICÉNTRICO CONTROLADO ALEATORIZADO DOBLE CIEGO CON PLACEBO PACIENTES GENOTIPO 1 SIN CIRROSIS N = 631 Jordan J. Feld, et al N Engl J Med 2014

  12. Treatment of HCV with ABT-450/r– Ombitasvir and Dasabuvir with Ribavirin RESPUESTA VIROLÓGICA SOSTENIDA (12 SEMANAS) 96, 2 % 1a 1b 95,3 %98% Jordan J. Feld, et al N Engl J Med 2014

  13. ABT-450/r–Ombitasvir and Dasabuvir with Ribavirin for Hepatitis C with Cirrhosis ENSAYO CLÍNICO FASE 3 MULTICENTRO ALEATORIZADO ABIERTO PACIENTES GENOTIPO 1CON CIRROSIS (CHILD-PUGH A) N = 380 RESPUESTA VIROLÓGICA SOSTENIDA (12 SEMANAS) 91,8 % 12 sem. de tto. 95,9 % 24 sem. de tto. Fred Poordad, et al N Engl J Med 2014

  14. Retreatment of HCV with ABT-450/r– Ombitasvir and Dasabuvir with Ribavirin ENSAYO MULTICÉNTRICO CONTROLADO ALEATORIZADO DOBLE CIEGO CON PLACEBO PACIENTES GENOTIPO 1 (RECAIDA, RESPONDEDORES PARCIALES Y RESPONDEDORES NULOS) N = 394 RESPUESTA VIROLÓGICA SOSTENIDA (12 SEMANAS) 96,3 % 95,3% RECAÍDA 100% RESP.PARCIAL 95,2% RESP. NULA Stefan Zeuzem,et al N Engl J Med 2014

  15. Ledipasvir and Sofosbuvir for Untreated HCV Genotype 1 Infection LEDIPASVIR SOFOSBUVIR INHIBIDOR NS5A (FOSFOPROTEINA) INHIBIDOR DE POLIMERASA NS5B ENSAYO CLÍNICO FASE 3 MULTICENTRO ALEATORIZADO ABIERTO PACIENTES GENOTIPO 1 NO TRATADOS (HEPATITIS CRÓNICA Y CIRROSIS) N = 865 Nezam Afdhal,et al N Engl J Med 2014

  16. Ledipasvir and Sofosbuvir for Untreated HCV Genotype 1 Infection RESPUESTA VIROLÓGICA SOSTENIDA (12 SEMANAS) LEDISPAVIR MAS SOFOSBUVIR 12 SEM. 99% LEDISPAVIR MAS SOFOSBUVIR MAS RIBAVIRINA 12 SEM. 97% LEDISPAVIR MAS SOFOSBUVIR 24 SEM. 98% LEDISPAVIR MAS SOFOSBUVIR MAS RIBAVIRINA 24 SEM. 99% Nezam Afdhal,et al N Engl J Med 2014

  17. Ledipasvir and Sofosbuvir for Previously Treated HCV Genotype 1 Infection ENSAYO CLÍNICO MULTICENTRO ALEATORIZADO ABIERTO PACIENTES GENOTIPO 1 PREVIAMENTE TRATADOS (HEPATITIS CRÓNICA Y CIRROSIS) N = 440 RESPUESTA VIROLÓGICA SOSTENIDA (12 SEMANAS) LEDISPAVIR MAS SOFOSBUVIR 12 SEM. 94% LEDISPAVIR MAS SOFOSBUVIR MAS RIBAVIRINA 12 SEM. 96% LEDISPAVIR MAS SOFOSBUVIR 24 SEM. 99% LEDISPAVIR MAS SOFOSBUVIR MAS RIBAVIRINA 24 SEM. 99% Nezam Afdhal,et al N Engl J Med 2014

  18. Ledipasvir and Sofosbuvir for 8 or 12 Weeks for Chronic HCV without Cirrhosis ENSAYO CLÍNICO FASE 3 MULTICENTRO ALEATORIZADO ABIERTO PACIENTES GENOTIPO 1. NO TRATADOS. SIN CIRROSIS N = 831 RESPUESTA VIROLÓGICA SOSTENIDA (12 SEMANAS) LEDISPAVIR MAS SOFOSBUVIR 8 SEM LEDISPAVIR MAS SOFOSBUVIR MAS RIBAVIRINA 8 SEM. LEDISPAVIR MAS SOFOSBUVIR 12 SEM 94% 93% 95% Kris V. Kowdley, et al N Engl J Med 2014

  19. Daclatasvir plus Sofosbuvir for Previously Treated or Untreated Chronic HCV Infection ENSAYO CLINICO MULTICENTRO, ALEATORIZADO, ABIERTO PACIENTES CON HEPATITIS CRÓNICA NO TRATADOS Y PREVIAMENTE TRATADOS N = 211 DACLATASVIR INHIBIDOR DE POLIMERASA NS5A SOFOSBUVIR INHIBIDOR DE POLIMERASA NS5B Sulkowski MS, et al N Engl J Med 2014;370:211-21.

  20. Daclatasvir plus Sofosbuvir for Previously Treated or Untreated Chronic HCV Infection RESPUESTA VIROLÓGICA SOSTENIDA (12 SEMANAS) GENOTIPO 1 PACIENTES NO TRATADOS PREVIAMENTE DCL, SOF Y RIB DCL Y SOF PACIENTES TRATADOS PREVIAMENTE IFN-P, RIB, BOC o TEL 94% 98% 98% GENOTIPO 2 GENOTIPO 3 92% 89% Sulkowski MS, et al N Engl J Med 2014;370:211-21

  21. Recommendations for Testing, Managing, and Treating Hepatitis C 2014

  22. Grading System Used to Rate the Level of the Evidence and Strength of the Recommendation Classification Description Class IConditions for which there is evidence and/or general agreement that a given diagnostic evaluation, procedure, or treatment is beneficial, useful, and effective Class IIConditions for which there is conflicting evidence and/or a divergence of opinion aboutthe usefulness and efficacy of a diagnostic evaluation, procedure, or treatment Class IIaWeight of evidence and/or opinion is in favor of usefulness and efficacy Class IIbUsefulness and efficacy are less well established by evidence and/or opinion Class IIIConditions for which there is evidence and/or general agreement that a diagnostic evaluation, procedure, or treatment is not useful and effective or if it in some cases may be harmful Level of Evidence Description Level A Data derived from multiple randomized clinical trials or meta-analyses Level B Data derived from a single randomized trial, or nonrandomized studies Level C Consensus opinion of experts, case studies, or standard

  23. Recommended regimen for treatment-naive patients with HCV genotype 1 who are eligible to receive IFN. Daily sofosbuvir (400 mg) and weight-based RBV (1000 mg [<75 kg] to 1200 mg [≥75 kg]) plus weekly PEGfor 12 weeks Class I, Level A

  24. Recommended regimen for treatment-naive patients with HCV genotype 1 who are not eligible to receive IFN . Daily sofosbuvir(400 mg) plus simeprevir (150 mg), with or without weight-based RBV (1000 mg [<75 kg] to 1200 mg [≥75 kg) for 12 weeks Class I, Level A

  25. Alternative regimens for treatment- naive patients with HCV genotype 1 who are eligible to receive IFN. Daily simeprevir (150 mg) for 12 weeks and weight-based RBV(1000 mg [<75 kg] to 1200 mg [≥75 kg]) plus weekly PEG for 24 weeks Class IIa, Level A

  26. Alternative regimens for treatment-naive patients with HCV genotype 1 who are not eligible to receive IFN Daily sofosbuvir (400 mg) and weight-based RBV(1000 mg [<75 kg] to 1200 mg [≥75 kg]) for 24 weeks Class IIb, Level B

  27. The following regimens are NOT recommended for treatment-naive patients with HCV genotype 1. PEG/RBV with or without telaprevir or boceprevir for 24 to 48 weeks Class IIb, Level A Monotherapy with PEG, RBV, or a DAA Class III, Level A

  28. Recommended regimen for treatment-naive patients with HCV genotype 2, regardless of eligibility for IFN therapy Daily sofosbuvir (400 mg) and weight-based RBV (1000 mg [<75 kg] to 1200 mg [≥75 kg])for 12 weeks Class I, Level A

  29. Recommended regimen for treatment-naive patients with HCV genotype 3 regardless of eligibility for IFN therapy Daily sofosbuvir (400 mg) and weight-based RBV (1000 mg [<75 kg] to 1200 mg [≥75 kg]) for 24 weeks Class I, Level B

  30. The following regimens are NOT recommended for treatment-naive patients with HCV genotype 2 and 3 PEG/RBV for 24 or 48 weekly Class I, Level B Monotherapy with PEG, RBV, or a DAA Class III, Level A Telaprevir-, boceprevir-, or simeprevir-based regimens Class III, Level A

  31. RESPUESTA VIROLÓGICA DURANTE EL TRATAMIENTO RESPUESTA VIROLÓGICA RNA-VHC NEGATIVO A LA SEMANA 4 DE TTO. RÁPIDA( RVR). RESPUESTA VIROLÓGICAREDUCCIÓN DE > 2 LOG RNA-VHC A LA TEMPRANA (RVT)SEMANA 12 DE TTO. (RVT PARCIAL) RNA-VHC NEGATIVO A LA SEMANA 12 DE TTO. (RVT COMPLETA) RESPUESTA AL FINALRNA-VHC NEGATIVO A LA SEMANA 24 O 48 DEL TRATAMIENTO (RFT)DE TTO. RESPUESTA VIROLÓGICARNA-VHC NEGATIVO 24 SEMANAS DESPUÉS SOSTENIDA (RVS)DE TERMINADO EL TTO.

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