Hepatitis web study Hepatitis web study Boceprevir in Treatment Experienced RESPOND-2 Phase 3 Treatment Experienced Bacon BR, et al. N Engl J Med. 2011;364:1207-17.

Slides:



Advertisements
Similar presentations
Hepatitis web study Hepatitis web study Boceprevir for Patients with Prior Failure to PEG + RIB PROVIDE Phase 3 Treatment Experienced Vierling JM, et al.
Advertisements

Hepatitis web study Hepatitis web study Sofosbuvir in Genotype 2 or 3 FUSION Trial Phase 3 *Note: Published in NEJM in tandem with POSITRON Trial (GT 2,3.
Hepatitis web study Hepatitis web study Simeprevir in Genotype 1 (Viral Relapsers) PROMISE Trial Phase 3 Treatment Experienced Forns X, et al. Gastroenterology.
Hepatitis web study Hepatitis web study Sofosbuvir in HCV Genotype 2, 3 (PEG not an Option) POSITRON Phase 3 *Note: Published in tandem with FUSION Trial.
Hepatitis web study Hepatitis web study Sofosbuvir + Peginterferon + Ribavirin in Genotype 2 or 3 LONESTAR-2 Phase 2 Treatment Experienced Lawitz E, et.
Hepatitis web study Hepatitis web study Hepatitis web study Hepatitis web study Ombitasvir-Paritaprevir-Ritonavir and Dasabuvir +/- RBV in GT1 PEARL-III.
Hepatitis web study Hepatitis web study 3D (Paritaprevir-Ritonavir-Ombitasvir + Dasabuvir) +/- RBV in GT1 PEARL-III and PEARL-IV Phase 3 Treatment Naïve.
Hepatitis web study Hepatitis web study Peginterferon alfa-2b + Ribavirin in GT 1-6 (Flat versus Weight-Based Ribavirin Dosing) WINR Study Phase 3 Treatment.
Hepatitis web study Hepatitis web study Hepatitis web study Hepatitis web study Ombitasvir-Paritaprevir-Ritonavir and Dasabuvir + RBV in Liver Transplant.
Hepatitis web study Hepatitis web study Hepatitis web study Hepatitis web study Ombitasvir-Paritaprevir-Ritonavir and Dasabuvir + RBV in GT1 SAPPHIRE-II.
Hepatitis web study Hepatitis web study Hepatitis web study Ombitasvir-Paritaprevir-Ritonavir and Dasabuvir + RBV in GT1 TURQUOISE-II Phase 3 Treatment.
Hepatitis web study Hepatitis web study Telaprevir in Treatment Experienced GT-1 REALIZE (Study 216) Phase 3 Treatment Experienced Zeuzem S, et al. N Engl.
Hepatitis web study Hepatitis web study Ledipasvir-Sofosbuvir +/- Ribavirin in HCV Genotype 1 ION-1 Phase 3 Treatment Naïve Source: Afdhal N, et al. N.
Hepatitis web study Hepatitis web study Peginterferon alfa-2b + Weight-based Ribavirin in HCV GT 2,3 Phase 4 Treatment Naïve, Chronic HCV Zeuzem S, et.
Hepatitis web study Hepatitis web study Telaprevir in Treatment Naïve GT-1 ADVANCE (Study 108) Phase 3 Treatment Naïve Jacobson IM, et. al. N Engl J Med.
Hepatitis web study Hepatitis web study Ledipasvir-Sofosbuvir +/- Ribavirin in HCV Genotype 1 ION-2 Phase 3 Treatment Experienced Source: Afdhal N, et.
Hepatitis web study Hepatitis web study Ledipasvir-Sofosbuvir for 8 or 12 weeks in HCV GT1 ION-3 Phase 3 Treatment Naïve Kowdley K, et al. N Engl J Med.
Hepatitis web study Hepatitis web study Sofosbuvir in Genotypes 2 or 3 VALENCE Trial Phase 3 Treatment Naïve and Treatment Experienced Zeuzem S, et al.
Hepatitis web study Hepatitis web study Sofosbuvir + Peginterferon + Ribavirin in Genotypes 1,4,5,6 ATOMIC Phase 2 Treatment Naïve Kowdley K, et al. Lancet.
Hepatitis web study Hepatitis web study Daclatasvir + Sofosbuvir +/- Ribavirin in Genotypes 1-3 A Trial Phase 2a Treatment Naïve and Treatment.
Hepatitis web study Hepatitis web study Peginterferon alfa-2b + RBV versus Interferon alfa-2b RIBAVIC STUDY Phase 3 Treatment Naïve, Chronic HCV and HIV.
Hepatitis web study Hepatitis web study Simeprevir + PEG + RBV in Treatment-Naïve Genotype 1 QUEST-2 Trial Phase 3 Treatment Naïve Manns M, et al. Lancet.
Hepatitis web study Hepatitis web study Simeprevir + PEG + RBV in Treatment-Naïve Genotype 1 QUEST-1 Trial Phase 3 Treatment Naïve Jacobson IM, et al.
Hepatitis web study Hepatitis web study Peginterferon alfa-2a versus Interferon alfa-2a Phase 3 Treatment Naïve, Chronic HCV Zeuzem S, et al. N Engl J.
Hepatitis web study Hepatitis web study PEG alfa-2a + RBV versus PEG alfa-2a versus INF + RBV APRICOT STUDY Phase 3 Treatment Naïve, Chronic HCV and HIV.
Hepatitis web study Hepatitis web study Peginterferon alfa-2b + RBV vs. Peginterferon alfa-2a + RBV IDEAL STUDY Phase 3, Treatment Naïve Treatment Naïve,
Hepatitis web study Hepatitis web study Duration and Dose Finding Peginterferon alfa-2a + Ribavirin Phase 3 Treatment Naïve, Chronic HCV Randomized study.
Hepatitis web study Hepatitis web study Telaprevir in Treatment Naïve GT-1 ILLUMINATE (Study 111) Phase 3 Treatment Naïve Sherman KE, et. al. N Engl J.
Hepatitis web study Hepatitis web study Peginterferon alfa-2a + RBV versus Interferon alfa-2a + RBV ACTG 5071 Phase 2 Treatment Naïve, Chronic HCV and.
Hepatitis web study Hepatitis web study Peginterferon alfa-2b + Ribavirin versus Interferon alfa-2b + Ribavirin Phase 3 Treatment Naïve, Chronic HCV Manns.
Hepatitis web study Hepatitis web study Peginterferon alfa-2b + Ribavirin for 12 or 24 Weeks in GT 2,3 Phase 3 Treatment Naïve, Chronic HCV Mangia A, et.
Hepatitis web study Hepatitis web study Peginterferon alfa -2a+/- Ribavirin versus Interferon alfa-2b + Ribavirin Phase 3 Treatment Naïve, Chronic HCV.
Hepatitis web study Hepatitis web study Sofosbuvir + Ribavirin to Prevent Post-Transplant HCV Recurrence Phase 2 Curry MP, et al. Gastroenterology. 2015;148:100-7.
Hepatitis web study Hepatitis web study 3D (Paritaprevir-Ritonavir-Ombitasvir + Dasabuvir) + RBV in GT1 SAPPHIRE-II Phase 3 Treatment Experienced Zeuzem.
Compensated Cirrhosis
Hepatitis web study Hepatitis web study 3D (Paritaprevir-Ritonavir-Ombitasvir + Dasabuvir) + RBV in GT1 SAPPHIRE-I Phase 3 Treatment Naïve Feld JJ, et.
Hepatitis web study Hepatitis web study WINR Study Flat versus Weight-Based Ribavirin Dosing Phase 3 Treatment Naïve, Chronic HCV Jacobson IM, et. al.
Hepatitis web study Hepatitis web study Sofosbuvir + Ribavirin in HCV GT 4 Egyptian Ancestry Trial Phase 2 Ruane PJ, et al. J Hepatol. 2015;62:
ALAN FRANCISCUS EXECUTIVE DIRECTOR, HEPATITIS C SUPPORT PROJECT EDITOR-IN-CHIEF, HCV ADVOCATE WEBSITE JOIN ME ON TWITTER & FACEBOOK – HCVADVOCATE BLOG:
Hepatitis web study Hepatitis web study Interferon alfa-2b +/- Ribavirin for 24 or 48 weeks Phase 3 Treatment Naïve, Chronic HCV McHutchison JG, et al.
Hepatitis web study H EPATITIS W EB S TUDY H EPATITIS C O NLINE Boceprevir (Victrelis) Prepared by: David Spach, MD & H. Nina Kim, MD Last Updated: March.
Hepatitis web study Hepatitis web study Peginterferon alfa-2a +/- Ribavirin for Chronic HCV Phase 3 Treatment Naïve, Chronic HCV Fried MW, et. al. N Engl.
Hepatitis web study Hepatitis web study Telaprevir BID versus q8 in Treatment Naïve GT-1 OPTIMIZE (Study C211) Phase 3 Treatment Naïve Buti M, et al. Gastroenterology.
Hepatitis web study Hepatitis web study Sofosbuvir ELECTRON (Overview): 6 parts, 22 arms Phase 2 Treatment Naïve and Treatment Experienced Source: Gilead.
Response Guided Therapy Fabien Zoulim Hepatology Department & INSERM Unit 1052, Lyon University Lyon, France.
Hepatitis web study Hepatitis web study Simeprevir with Peginterferon and Ribavirin in GT-4 RESTORE Phase 3 Treatment Naïve and Treatment Experienced Moreno.
Hepatitis web study H EPATITIS W EB S TUDY H EPATITIS C O NLINE Ribavirin (Copegus, Rebetol, Ribasphere) Prepared by: David Spach, MD and H. Nina Kim,
Hepatitis web study Hepatitis web study Peginterferon alfa-2b + Ribavirin in Blacks & Non-Hispanic Whites Phase 3 Treatment Naïve, Chronic HCV Muir AJ,
Hepatitis web study Hepatitis web study Sofosbuvir + Ribavirin in HCV Genotype 1 NIAID/NIH Trial Phase 2, Treatment Naïve Treatment Naïve (unfavorable.
Hepatitis C Nonresponders
Hepatitis web study Hepatitis web study Sofosbuvir + RBV in Treatment-Naïve Genotypes 2,3 FISSION Trial* Phase 3 *Note: Published in NEJM in tandem with.
Hepatitis web study Hepatitis web study Daclatasvir + Sofosbuvir +/- Ribavirin in Genotype 1-3 AI Trial Phase 2a Treatment-Naïve and Treatment-Experienced.
Hepatitis web study Hepatitis web study Boceprevir with PEG + RBV in Genotype 1 SPRINT-1 Phase 2 Treatment Naïve Kwo PY, et al. Lancet. 2010;376:
Hepatitis web study Hepatitis web study Daclatasvir + Asunaprevir + Peg/RBV in Genotype 1 and 4 HALLMARK-QUAD Study Phase 3 Treatment-Experienced Jensen.
Hepatitis web study Hepatitis web study Simeprevir versus Telaprevir with PR in GT1 ATTAIN Trial Phase 3 Treatment Experienced Reddy KR, et al. Lancet.
Phase 3 Treatment Experienced
Daclatasvir + Sofosbuvir +/- Ribavirin in Genotype 1-3 Trial
Elbasvir + Grazoprevir + Ribavirin in PI-experienced HCV GT1 C-SALVAGE
Boceprevir in Treatment Naive SPRINT-2
Phase 2 Treatment Naïve Elbasvir + Grazoprevir +/- Ribavirin in Treatment-Naïve HCV GT 2, 4, 5, or 6 C-SCAPE Brown A, et al. EASL 2015; Abstract P0771.
Ombitasvir + Paritaprevir + Ritonavir +/- Ribavirin in HCV GT4 PEARL-I
Daclatasvir + Peg/RBV in Treatment-Naïve Genotype 4 COMMAND-4 Study
Ledipasvir-Sofosbuvir +/- Ribavirin in HCV Genotype 1 ION-2
Phase 2 Treatment Naïve and Treatment Experienced
Ledipasvir-Sofosbuvir +/- Ribavirin for 8 or 12 weeks in HCV GT1 ION-3
Phase 2b Treatment Naïve and Treatment Experienced
Phase 2 Treatment Experienced (with Sofosbuvir and Ribavirin)
Telaprevir in Treatment Experienced GT-1 PROVE3
Telaprevir + Peginterferon + Ribavirin for GT1 PROVE1 Study
The Results of Phase III Clinical Trials With Telaprevir and Boceprevir Presented at the Liver Meeting 2010: A New Standard of Care for Hepatitis C Virus.
Presentation transcript:

Hepatitis web study Hepatitis web study Boceprevir in Treatment Experienced RESPOND-2 Phase 3 Treatment Experienced Bacon BR, et al. N Engl J Med. 2011;364:

Hepatitis web study Source: Bacon BR, et al. N Engl J Med. 2011;364: Boceprevir for Retreatment of HCV Genotype 1 Infection RESPOND-2 Trial: Study Design Drug Dosing Boceprevir = 800 mg three times daily Peginterferon alfa-2b = 1.5 µg/kg once weekly Ribavirin = mg/day (based on weight)

Hepatitis web study Placebo Boceprevir Source: Bacon BR, et al. N Engl J Med. 2011;364: Boceprevir for Retreatment of HCV Genotype 1 Infection RESPOND-2 Trial: Treatment Regimens Peginterferon + Ribavirin B44 PR48 36 Peginterferon + Ribavirin PR48 Boceprevir Peginterferon + Ribavirin 0 Undetectable HCV RNA at week 8 &12 Detectable HCV RNA at week 8, but Undetectable at week 12 Stop Therapy Week Lead In ✔ 8 HCV RNA ✔ Peginterferon + Ribavirin B32 PR36-48

Hepatitis web study Boceprevir for Retreatment of HCV Genotype 1 Infection RESPOND-2 Trial: Results RESPOND-2: SVR 24 by Prior Response and Regimen Source: Bacon BR, et al. N Engl J Med. 2011;364: SVR = Sustained Virologic Response; B = Boceprevir; PR = Peginterferon + Ribavirin *Prior Nonresponse = decrease in HCV RNA of at least 2 logs by week 12, but detectable HCV RNA level during therapy period 30/5823/57 2/29 77/10372/10515/51107/16195/16217/80

Hepatitis web study Boceprevir for Retreatment of HCV Genotype 1 Infection RESPOND-2 Trial: Results Based on Initial Week 4 Response RESPOND-2: SVR 24, by Initial Response and Regimen Source: Bacon BR, et al. N Engl J Med. 2011;364: SVR = Sustained Virologic Response; B = Boceprevir; PR = Peginterferon + Ribavirin *Poor Initial Response to PR = decrease in HCV RNA level 1 log 10 IU/ml after 4 week lead in 90/11480/11017/6715/4415/46 0/12

Hepatitis web study Source: Bacon BR, et al. N Engl J Med. 2011;364: Boceprevir for Retreatment of HCV Genotype 1 Infection RESPOND-2 Trial: Conclusions Conclusions: “The addition of boceprevir to peginterferon–ribavirin resulted in significantly higher rates of sustained virologic response in previously treated patients with chronic HCV genotype 1 infection, as compared with peginterferon–ribavirin alone.”