Hepatitis web study Hepatitis web study Peginterferon alfa-2b + RBV vs. Peginterferon alfa-2a + RBV IDEAL STUDY Phase 3, Treatment Naïve Treatment Naïve,

Slides:



Advertisements
Similar presentations
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.
Advertisements

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 Sofosbuvir + Ribavirin + Peginterferon in Genotypes 1-3 PROTON Phase 2 Treatment Naïve Lawitz E, et al. Lancet.
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 Sofosbuvir, Ribavirin, GS-0938 in GT 1-4 QUANTUM Phase 2b Treatment Naïve Lalezari JP, et al. EASL. 2013; Abstract.
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 Hepatitis web study Hepatitis web study Ombitasvir-Paritaprevir-Ritonavir and Dasabuvir + RBV in GT1 SAPPHIRE-I.
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 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 Ombitasvir + Paritaprevir + Ritonavir +/- Ribavirin in HCV GT4 PEARL-I Phase 2b Treatment Naïve and Treatment Experienced.
Hepatitis web study Hepatitis web study 3D + RBV in Liver Transplant Recipients with Recurrent HCV GT1 CORAL-I Phase 2 Treatment Naïve and Treatment Experienced.
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 Simeprevir in HIV Coinfection, GT-1 C212 Trial Phase 3 Treatment Naïve and Treatment Experienced Dieterich D, et.
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:
Hepatitis web study H EPATITIS W EB S TUDY H EPATITIS C O NLINE Peginterferon alfa-2b (PegIntron) Prepared by: David Spach, MD & H. Nina Kim, MD Last Updated:
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 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 Boceprevir in Treatment Experienced RESPOND-2 Phase 3 Treatment Experienced Bacon BR, et al. N Engl J Med. 2011;364:
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.
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 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 Sofosbuvir + Peginterferon + Ribavirin in Genotype 2 or 3 LONESTAR-2 Phase 2 Treatment Experienced Lawitz E, et.
Hepatitis web study Hepatitis web study Simeprevir + Sofosbuvir in GT1 with Cirrhosis OPTIMIST-2 Trial Phase 3 Treatment Naïve and Treatment Experienced.
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.
Hepatitis web study Hepatitis web study Sofosbuvir + Peginterferon+ Ribavirin in HCV-HIV GT 1-4 Phase 2 Rodriguez-Torres M, et al. J Acquir Immune Defic.
Daclatasvir + Sofosbuvir +/- Ribavirin in Genotype 1-3 Trial
Boceprevir in Treatment Naive SPRINT-2
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 3 Treatment Naïve and Treatment Experienced HIV Coinfection
Phase 2 Treatment Experienced (with Sofosbuvir and Ribavirin)
Telaprevir in Treatment Experienced GT-1 PROVE3
Phase 3 Treatment-Naïve and Treatment-Experienced
Telaprevir + Peginterferon + Ribavirin for GT1 PROVE1 Study
Presentation transcript:

Hepatitis web study Hepatitis web study Peginterferon alfa-2b + RBV vs. Peginterferon alfa-2a + RBV IDEAL STUDY Phase 3, Treatment Naïve Treatment Naïve, Chronic HCV McHutchison JG, et. al. N Engl J Med. 2009;361:

Hepatitis web study *Ribavirin dosing: kg: 800 mg/d; >65-85 kg: 1000 mg/d; > kg: 1200 mg/d; > kg: 1400 mg/d ^Ribavirin dosing: 75 kg: 1200 mg/d Peginterferon alfa-2b + Ribavirin vs Peginterferon alfa-2a + Ribavirin IDEAL Study: Design Study - Randomized comparative trial centers in United States Subjects - N = 3070 with chronic hepatitis C - All genotype 1 (other genotypes excluded) - Treatment naïve - Subjects were 18 years of age or older Regimens (Ribavirin Dosed by Weight) - Peginterferon alfa-2b: 1.5 µg/kg 1x/week + Ribavirin mg/day* - Peginterferon alfa-2b: 1.0 µg/kg 1x/week + Ribavirin mg/day* - Peginterferon alfa-2a: 180 µg 1x/week + Ribavirin mg/day^ Primary Endpoint (Sustained Virologic Response [SVR]) - SVR = Undetectable serum HCV RNA 24 weeks after 48-week treatments Source: McHutchison JG, et. al. N Engl J Med. 2009;361:

Hepatitis web study Standard-Dose Peginterferon alfa-2b + Ribavirin Peginterferon alfa-2b: 1.5 µg/kg 1x/week + Ribavirin: mg/d (by weight) Peginterferon alfa-2a + Ribavirin Peginterferon alfa-2a: 180 µg 1x/week + Ribavirin: mg/d (by weight) Low-Dose Peginterferon alfa-2b + Ribavirin Peginterferon alfa-2b: 1.0 µg/kg 1x/week + Ribavirin: mg/d (by weight) Source: McHutchison JG, et. al. N Engl J Med. 2009;361: Peginterferon alfa-2b + Ribavirin vs Peginterferon alfa-2a + Ribavirin IDEAL Study: Design 48720Week SVR24 N = 1016 N = 1019 N = 1035

Hepatitis web study Peginterferon alfa-2b + Ribavirin vs Peginterferon alfa-2a + Ribavirin IDEAL Study: Results IDEAL Study: Virologic Responses by Treatment Regimen Source: McHutchison JG, et. al. N Engl J Med. 2009;361: / / / / / /1035

Hepatitis web study Peginterferon alfa-2b + Ribavirin vs Interferon alfa-2a + Ribavirin IDEAL Study: Results IDEAL Study: Serious Adverse Event Rates Source: McHutchison JG, et. al. N Engl J Med. 2009;361:

Hepatitis web study Source: McHutchison JG, et. al. N Engl J Med. 2009;361: Peginterferon alfa-2b + Ribavirin vs Peginterferon alfa-2a + Ribavirin IDEAL Study: Conclusions Conclusions: “In patients infected with HCV genotype 1, the rates of sustained virologic response and tolerability did not differ significantly between the two available peginterferon-ribavirin regimens or between the two doses of peginterferon alfa-2b.”

Hepatitis web study Hepatitis web study This slide deck is from the University of Washington’s Hepatitis C Online and Hepatitis Web Study projects. Hepatitis C Online Hepatitis Web Study Funded by a grant from the Centers for Disease Control and Prevention. This slide deck is from the University of Washington’s Hepatitis C Online and Hepatitis Web Study projects. Hepatitis C Online Hepatitis Web Study Funded by a grant from the Centers for Disease Control and Prevention.