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.

Slides:

Advertisements

Similar presentations

Hepatitis web study Hepatitis web study Sofosbuvir and Ribavirin +/- Peginterferon in GT 1-3 ELECTRON Trial (Arms 1-8) Phase 2a Treatment Naïve and Treatment.

Advertisements

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 Hepatitis web study Hepatitis web study Ombitasvir-Paritaprevir-Ritonavir and Dasabuvir +/- RBV in GT1b PEARL-II.

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 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 Sofosbuvir + Ribavirin in HCV-HIV Coinfection: HCV GT 1,2,3,4 PHOTON-2 Trial Phase 3 Molina JM, et al. IAC. 2014;

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 Ledipasvir + Sofosbuvir +/- Ribavirin in GT 1-3 ELECTRON 2 Phase 2 Treatment Naïve and Treatment Experienced Source:

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 Simeprevir + Sofosbuvir +/- Ribavirin in Genotype 1 COSMOS Trial Phase 2a, Treatment Naïve and Treatment Experienced.

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 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 Sofosbuvir-Ledipasvir +/- Ribavirin in GT-1 LONESTAR Trial Phase 2a Treatment Naïve and Treatment Experienced Source:

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 in HCV-HIV Coinfection & HCV GT 1,2,3 PHOTON-1 Trial Phase 3 Sulkowski MS, et al. JAMA. 2014;312:

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 Ledipasvir-Sofosbuvir in Treatment-Experienced GT1 with Cirrhosis SIRIUS Phase 2 Treatment Experienced Bourliere.

Hepatitis web study Hepatitis web study Sofosbuvir + Ribavirin in HCV Recurrence Following Liver Transplantation Phase 2 Charlton M, et al. Gastroenterology.

Hepatitis web study Hepatitis web study Ledipasvir-Sofosbuvir + RBV in Sofosbuvir-Experienced HCV GT1 Retreatment of Sofosbuvir Failures Phase 2 Treatment.

Hepatitis web study Hepatitis web study 3D (Paritaprevir-Ritonavir-Ombitasvir + Dasabuvir) +/- RBV in GT1b PEARL-II Phase 3 Treatment Experienced Andreone.

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 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 Simeprevir + Sofosbuvir +/- Ribavirin in Genotype 1 COSMOS Trial Phase 2a, Treatment Naïve and Treatment Experienced.

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 Ledipasvir-Sofosbuvir in GT1 or GT4 and HIV Coinfection ION-4 Phase 3 Treatment Naïve and Treatment Experienced.

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 Daclatasvir-Asunaprevir-Beclabuvir in Genotype 1 Cirrhotics UNITY-2 Study Phase 3 Treatment-Naïve and Treatment-Experienced.

Hepatitis web study Hepatitis web study Daclatasvir + Sofosbuvir in Genotype 3 ALLY-3 Study Phase 3 Treatment-Naïve and Treatment-Experienced Nelson DR,

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 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 + 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 Sofosbuvir + Ribavirin to Prevent Post-Transplant HCV Recurrence Phase 2 Curry MP, et al. Gastroenterology. 2014;September.

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

Phase 3 Treatment-Naïve and Treatment-Experienced

Ombitasvir + Paritaprevir + Ritonavir +/- Ribavirin in HCV GT4 PEARL-I

Phase 3 Treatment-Naïve and Treatment-Experienced

Phase 2 Treatment Naïve and Treatment Experienced

Ledipasvir-Sofosbuvir +/- Ribavirin for 8 or 12 weeks in HCV GT1 ION-3

Phase 2 Treatment Experienced (with Sofosbuvir and Ribavirin)

Presentation transcript:

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 NEUTRINO Trial (Genotypes 1,4,5,6) Treatment Naïve Lawitz E, et al. N Engl J Med. 2013;368:

Hepatitis web study Source: Lawitz E, et al. N Engl J Med. 2013;368: Sofosbuvir + Ribavirin for Treatment-Naïve HCV GT 2 or 3 FISSION Trial: Features

Hepatitis web study Source: Lawitz E, et al. N Engl J Med. 2013;368: N=243 N=256 SVR12 Sofosbuvir + Ribavirin for Treatment-Naïve HCV GT 2 or 3 FISSION Trial: Design Peginterferon + RBV (fixed-dose) Sofosbuvir + RBV (weight-based) Drug Dosing Sofosbuvir: 400 mg once daily Peginterferon alfa-2a: 180 µg once weekly Weight-based Ribavirin (in 2 divided doses): 1000 mg/day if < 75 kg or 1200 mg/day if ≥ 75 kg Fixed-dose Ribavirin (in 2 divided doses): 800 mg/day Week

Hepatitis web study Sofosbuvir + Ribavirin for Treatment-Naïve HCV GT 2 or 3 FISSION Trial: Results FISSION: HCV RNA <25 IU/ml by Study Timepoint (GT 2, 3 Combined) Source: Lawitz E, et al. N Engl J Med. 2013;368: RBV = Ribavirin; PEG = Peginterferon 249/250158/236249/253217/243170/253162/243

Hepatitis web study Sofosbuvir + Ribavirin for Treatment-Naïve HCV GT 2 or 3 FISSION Trial: Results FISSION: SVR12 by Genotype Source: Lawitz E, et al. N Engl J Med. 2013;368: RBV = Ribavirin; PEG = Peginterferon 68/7052/67102/183110/176170/253162/243

Hepatitis web study Sofosbuvir + Ribavirin for Treatment-Naïve HCV GT 2 or 3 FISSION Trial: Results FISSION: SVR12 by Presence of Cirrhosis Source: Lawitz E, et al. N Engl J Med. 2013;368: RBV = Ribavirin; PEG = Peginterferon 147/20423/4919/50143/193

Hepatitis web study Sofosbuvir + Ribavirin for Treatment-Naïve HCV GT 2 or 3 FISSION Trial: Adverse Effects Source: Lawitz E, et al. N Engl J Med. 2013;368: EventSofosbuvir + RBV (n=256) PEG + RBV (n=243) Discontinuation due to adverse event3 (1%)26 (11%) Fatigue92 (36%)134 (55%) Headache64 (25%)108 (44%) Nausea46 (18%)70 (29%) Pruritus19 (7%)42 (17%) Hemoglobin < 10 g/dl23 (9%)35 (14%) Neutropenia030 (12%) Influenza-like illness7 (3%)43 (18%) Depression14 (5.5%)34 (14%) Insomnia31 (12%)70 (29%)

Hepatitis web study Source: Lawitz E, et al. N Engl J Med. 2013;368: Sofosbuvir + Ribavirin for Treatment-Naïve HCV GT 2 or 3 FISSION Trial: Conclusions Conclusions: “In the randomized trial of previously untreated patients with genotype 2 or 3 infection, the efficacy of the all-oral regimen of sofosbuvir plus ribavirin was similar to that of peginterferon–ribavirin, but response rates among patients with genotype 3 infection were lower than the rates among those with genotype 2 infection.” *Note: This conclusion pertains to both the FISSION and NEUTRINO trials, which were published in tandem

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.