PIB. Next Generation Direct-Acting Antivirals. Collectively: G/P. Pibrentasvir (formerly ABT-530) pangenotypic NS5A inhibitor
|
|
- Arabella Griffith
- 6 years ago
- Views:
Transcription
1 Surveyor-II, Part 3: Efficacy and Safety of Glecaprevir/Pibrentasvir (Abt-493/Abt-53) in Patients with Hepatitis C Virus Genotype 3 Infection with Prior Treatment Experience and/or Cirrhosis David L. Wyles, Fred Poordad, Stanley Wang, Laurent Alric, Franco Felizarta, Paul Y. Kwo, Benedict Maliakkal, Kosh Agar- wal, Tarek I. Hassanein, Frank Weilert, Samuel S. Lee, Ran Liu, Chih-Wei Lin, Teresa Ng, Federico Mensa Abstract 3 Next Generation Direct-Acting Antivirals Glecaprevir (formerly ABT-493) PIB pangenotypic NS3/4A protease inhibitor Pibrentasvir (formerly ABT-53) pangenotypic NS5A inhibitor Collectively: In vitro:, Clinical PK & metabolism: High barrier to resistance Potent against common NS3 polymorphisms (eg, positions 8, 55, and 68) and NS5A polymorphisms (eg, positions 8, 3, 3 and 93) Additive/synergistic antiviral activity Once-daily oral dosing Minimal metabolism and primary biliary excretion Negligible renal excretion (<%) is coformulated and dosed once daily as three mg/4 mg pills for a total dose of 3 mg/ mg Glecaprevir was identified by AbbVie and Enanta. Ng TI, et al. Abstract 636. CROI, 4.. Ng TI, et al. Abstract 639. CROI, 4.. Wyles D, et al. 67th AASLD; Boston, MA; November -5, 6; Abst. 3.
2 SURVEYOR-II Part 3: Study Design and Patient Population : Randomized Treatment Period TE without cirrhosis TE without cirrhosis N = 4 TN with cirrhosis N = 47 TE with cirrhosis Post-Treatment Period SVR SVR SVR SVR Weeks Included GT3 Patients without cirrhosis or with compensated cirrhosis Excluded prior treatment with HCV DAA other than SOF Excluded HBV or HIV coinfection Wyles D, et al. 67th AASLD; Boston, MA; November -5, 6; Abst. 3. Baseline Demographics and Clinical Characteristics Characteristic : Randomized Treatment Experienced Treatment Experienced Cirrhosis Cirrhosis Weeks 6 Weeks Treatment Naïve Cirrhosis Weeks N = 4 Treatment Experienced Cirrhosis 6 Weeks N = 47 Male, n (%) 4 (64) 4 (64) 4 (6) 36 (77) White race, n (%) 7 (77) (9) 37 (93) 4 (89) Age, median years (range) 56 (35 68) 59 (9 66) 56 (36 7) 59 (47 7) BMI, median kg/m (range) 6 (9 4) 8 ( 48) 9 ( 5) 7 ( 4) IL8B non-cc genotype, n (%) 5 (68) 9 (86) (5) 34 (7) HCV RNA, median log IU/mL (range) 6.6 (5. 7.5) 6. ( ) 6. (4. 7.) 6.5 (4.6 7.) HCV RNA 6,, IU/mL, n (%) 9 (4) 7 (3) 4 () () Prior treatment history, n (%) Naïve 4 () IFN/pegIFN ± RBV 4 (64) 3 (59) (47) SOF RBV ± pegifn 8 (36) 9 (4) 5 (53) Baseline Fibrosis Stage*, n (%) F-F (5) 5 (68) F 4 (8) (9) F3 7 (3) 5 (3) F4 4 () 47 () BMI, body mass index;, coformulated glecaprevir and pibrentasvir; HCV, hepatitis C virus; IFN, interferon; IL8B, interleukin 8; NS, non-structural protein; pegifn, pegylated interferon; SOF, sofosbuvir *Data missing for patient in Arm A (column ) and patient in Arm B (column 3) Wyles D, et al. 67th AASLD; Boston, MA; November -5, 6; Abst. 3.
3 Baseline Polymorphisms Baseline Polymorphism, n (%) Treatment Experienced Cirrhosis Weeks Treatment Experienced Cirrhosis 6 Weeks N = Treatment Naïve Cirrhosis Weeks N = 39 Treatment Experienced Cirrhosis 6 Weeks N = 47 6 (73) 8 (86) 9 (74) 4 (85) NS3 only (3) () NS5A only 6 (7) 3 (4) 9 (3) 6 (3) Both NS3 and NS5A *Baseline polymorphisms detected at 5% next-generation sequencing threshold only within samples that had sequences available for both targets at key amino acid positions: NS3: 55, 56, 68 NS5A: 4, 8, 3, 3, 58, 9, 93 Wyles D, et al. 67th AASLD; Boston, MA; November -5, 6; Abst. 3. SURVEYOR-II, Part 3: SVR Weeks Cirrhosis T-Experience Breakthrough LTFU SVR, % Patients 9 - : Randomized GT GT4 GT5 GT % of patients had HCV RNA <LLOQ by treatment week 4 Wyles D, et al. 67th AASLD; Boston, MA; November -5, 6; Abst. 3.
4 Virologic Failure: Patient Details Characteristic SURVEYOR-II Treatment Virologic Failure Compensated Cirrhosis Prior Treatment Experience Fibrosis Stage Baseline HCV RNA, IU/mL Treatment Compliance Patient A weeks No F-F 8,4, Patient B weeks No F 9,4, Patient C 6 weeks No F-F 8,9, Patient D 6 weeks F4,84, Patient E 6 weeks BT F4 7,4, NA* Sequence Analysis Baseline NS3 Failure Patient A Patient B Patient C Patient D Patient E A66S Y56H, Q68R A56G, A66S Baseline Y93H A3K A3K Failure Y93H A3K, Y93H A3K, Y93H L3F, Y93H A3K, Y93H NS5A BT, breakthrough NA, not available; *Patient E had drug exposures 85% lower than average at week 4 Substitutions detected by next-generation sequencing at 5% detection threshold NS3: 36, 43, 54, 55, 56, 8, 55, 56, 66, and 68 NS5A: 4, 8, 9, 3, 3, 3, 58, 9, and 93 Wyles D, et al. 67th AASLD; Boston, MA; November -5, 6; Abst. 3. SURVEYOR-II, Part 4: Glecaprevir/Pibrentasvir Demonstrates High SVR Rates in Patients with HCV Genotype, 4, 5, or 6 Infection without Cirrhosis Following an 8-Week Treatment Duration T.I. Hassanein, D.L. Wyles, S. Wang, R. Liu, T. Ng, C. Lin, F.J. Mensa, P.Y. Kwo, M.L. Shiffman, Z. Younes, S. Greenbloom, C.A. Stedman, J. Sasadeusz, H.I. Aguilar, J. Heo, Abstract LB-5
5 SURVEYOR-II, Part 4: Study Design SVR Assessment GT, 4, 5, 6 N =3 3 mg/ mg * Day Wk 8 Wk Wk 4 Open-label Treatment *Three mg/4 mg pills taken once daily. Hassanein T, et al. 67th AASLD; Boston, MA; November -5, 6; Abst. LB-5. SURVEYOR-II, Part 4: Results - SVR, ITT Population % Patients with SVR Breakthrough Discontinuation Missing SVR Data : : : 3: 4 45 * Overall GT GT4 GT5 GT6 9 Dotted line (yellow) represents the non-inferiority threshold (89%) *Patient discontinued on Day 5 due to loss to follow-up. Patient discontinued on Day 36 due to non-compliance. Hassanein T, et al. 67th AASLD; Boston, MA; November -5, 6; Abst. LB-5.
6 SURVEYOR-II, Part 4: Characteristics of Patients with Virologic Failure Time of Failure Patient A* Patient B post-treatment Day 9, post-treatment Day 55 Age/Race/Gender 56-year-old white female 55-year-old white male Genotype/Subtype GTa GTa C/C C/T IL8B Genotype Fibrosis Stage F F F3 5 IU/mL 7 IU/mL Experienced Experienced Treatment Compliant Compliantƚ NS3 NS5A Baseline Viral Load Prior Treatment Exposure Treatment Treatment-emergent substitutions at time of failure *Patient had a medical history of gastric bypass. Exposure of GLE on Day and Week 4 was >75% lower than the men in patients in the same treatment arm; exposure of PIB was comparable to the other patients in the cohort. ƚ Measured as the percentage of tables taken relative to the total tablets expected to be taken during the treatment period; compliance achieved if percentage was 8%. Hassanein T, et al. 67th AASLD; Boston, MA; November -5, 6; Abst. LB-5. EXPEDITION-IV: Safety and Efficacy of GLE/PIB in Adults with Renal Impairment and Chronic Hepatitis C Virus Genotype 6 Infection D. Pugatch, Y. Lei, M.P. Kosloski, F.J. Mensa, E. Lawitz, E.J. Gane, G.V. Papatheodoridis, N. Bräu, James J. Peters, A.S. Brown, S. Pol, V. Leroy, M. Persico, C. Moreno, M. Colombo, E.M. Yoshida, D.R. Nelson, G.V. Papatheodoridis, N. Bräu Abstract LB-
7 EXPEDITION-IV: Safety and Efficacy of GLE/PIB in Adults with Renal Impairment and Chronic Hepatitis C Virus Genotype 6 Infection EXPEDITION-4: Objective and Study Design GT 6 Stage 4/5 CKD /- cirrhosis TN or TE Treatment Period N = 4 Post-Treatment Period SVR Weeks Objective Determine the efficacy and safety of pangenotypic for weeks in patients with HCV GT-6 and stage 4 or 5 chronic kidney disease (CKD) Endpoints Efficacy: SVR defined as HCV RNA below the lower limit of quantification (LLOQ; 5 IU/mL) Safety: Adverse events (AEs) and laboratory abnormalities is coformulated and dosed once daily as three mg/4 mg pills for a total dose of 3 mg/ mg Gane E, et al. 67th AASLD; Boston, MA; November -5, 6; Abst. LB-. EXPEDITION-IV: Baseline Characteristics Characteristic N = 4 Male, n (%) 79 (76) Black race, n (%) 6 (5) Age, median years (range) 57 (8 83) BMI, median kg/m (range) 6 (8 45) IL8B non-cc genotype, n (%) 8 (77) HCV RNA, median log IU/mL (range) 5.9 ( ) Concomitant PPI use, n (%) 43 (4) Patients were enrolled across 9 countries: Australia, Belgium, Canada, France, Greece, Italy, New Zealand, the United Kingdom, and United States BMI, body mass index; CrCl, creatinine clearance; egfr, estimated glomerular filtration rate;, coformulated glecaprevir/pibrentasvir; HCV, hepatitis C virus; IL8B, interleukin 88; PPI, proton pump inhibitor Gane E, et al. 67th AASLD; Boston, MA; November -5, 6; Abst. LB-.
8 EXPEDITION-IV: Baseline Demographics and Clinical Characteristics Characteristic N = 4 Male, n (%) 79 (76) Black race, n (%) 6 (5) Age, median years (range) 57 (8 83) BMI, median kg/m (range) 6 (8 45) IL8B non-cc genotype, n (%) 8 (77) HCV RNA, median log IU/mL (range) 5.9 ( ) Concomitant PPI use (%) 43 (4) Characteristic, (n%) N = 4 HCV genotype a / b / other 3 () / 9 (8) / () 7 (6) 3 () 4 / 5 / 6 (9) / () / () Prior treatment history Naïve 6 (58) IFN/pegIFN ± RBV 4 (4) SOF RBV ± pegifn () Compensated cirrhosis (9) No 84 (8) CKD stage Stage 4 3 () Stage 5 9 (88) Hemodialysis 85 (8) Patients were enrolled across 9 countries: Australia, Belgium, Canada, France, Greece, Italy, New Zealand, the United Kingdom, and United States Gane E, et al. 67th AASLD; Boston, MA; November -5, 6; Abst. LB-. EXPEDITION-IV: Results SVR by Intent-To-Treat (ITT) Analysis % Patients with SVR Breakthrough Discontinuation LTFU 98 GT ITT mitt = --% SVR 4 AEs leading to study drug discontinuation One death weeks post-treatment due to cerebral hemorrhage non study drug related Gane E, et al. 67th AASLD; Boston, MA; November -5, 6; Abst. LB-.
9 EXPEDITION-IV: Post-Baseline Laboratory Abnormalities N = 4 Event, n (%) Hemoglobin Grade 3 (< g/dl) 5 (5) AST Grade (>3 x ULN) ALT Grade (>3 x ULN) Total bilirubin Grade 3 (>3 x ULN) () Grade 3 or higher laboratory abnormalities were rare Gane E, et al. 67th AASLD; Boston, MA; November -5, 6; Abst. LB-.
Felizarta, Bo Fu, Teresa Ng, Chih-Wei Lin, Federico Mensa Abstract 253. Pibrentasvir (formerly ABT-530) pangenotypic NS3/4A protease inhibitor
ENDURANCE-1: A Phase 3 Evaluation of the Efficacy and Safety of 8- versus 12-week Treatment with Glecaprevir/ Pibrentasvir (formerly ABT-493/ABT-53) in HCV Genotype 1 Infected Patients with or without
More informationSURVEYOR-II Part 2 Study Design
HIGH SVR RATES WITH + CO-ADMINISTERED FOR 8 WEEKS IN NON-CIRRHOTIC PATIENTS WITH HCV GENOTYPE 3 INFECTION A.J. Muir, S. Strasser, S. Wang, S. Shafran, M. Bonacini, P. Kwo, D. Wyles, E. Gane, S.S. Lovell,
More informationGlecaprevir-Pibrentasvir in Non-Cirrhotic Genotype 2 ENDURANCE-2
Phase 3 Treatment Naïve or Experienced Glecaprevir-Pibrentasvir in Non-Cirrhotic Genotype 2 ENDURANCE-2 *ENDURANCE-2: Study Features ENDURANCE-2 Trial Design: Randomized, double-blind, placebo-controlled
More informationNEXT GENERATION DIRECT-ACTING ANTIVIRALS
EFFICACY AND SAFETY OF GLECAPREVIR/PIBRENTASVIR IN PATIENTS CO-INFECTED WITH HEPATITIS C VIRUS AND HUMAN IMMUNODEFICIENCY VIRUS-1: THE EXPEDITION-2 STUDY J. Rockstroh, K. Lacombe, R. Viani, C. Orkin, D.
More informationSupplementary Material
Supplementary Material High Efficacy Rates of ABT-493 and ABT-530 Treatment in Patients with HCV Genotype 1 or 3 Infection and Compensated Cirrhosis Edward Gane, Fred Poordad, Stanley Wang, Armen Asatryan,
More informationGlecaprevir-Pibrentasvir in Cirrhotic Genotype 1, 2, 4, 5, and 6 EXPEDITION-1
Phase 3 Treatment-Naïve and Treatment-Experienced Glecaprevir-Pibrentasvir in Cirrhotic Genotype 1, 2, 4, 5, and 6 EXPEDITION-1 EXPEDITION-1: Study Features EXPEDITION-1 Trial Design: Open-label, single-arm,
More informationGlecaprevir-Pibrentasvir in HCV GT 1 or 4 & Prior DAA Treatment MAGELLAN-1 (Part 2)
Phase 3 Treatment-Experienced in HCV GT 1 or 4 & Prior DAA Treatment MAGELLAN-1 (Part 2) in HCV GT 1 or 4 & Prior DAA Treatment MAGELLAN-1 (Part 2): Study Features MAGELLAN-1 (Part 2) Trial Design: Randomized,
More informationDirect-acting Antiviral (DAA) Regimens in Late-stage Development: Which Patients Should Wait? Fred Poordad, MD
Direct-acting Antiviral (DAA) Regimens in Late-stage Development: Which Patients Should Wait? Fred Poordad, MD The HCV Lifecycle: Multiple Targets Polymerase Inhibitors Protease Inhibitors NS5A Inhibitors
More informationOnline Supporting Information
Wyles et al Supporting Information 1 Online Supporting Information Glecaprevir/Pibrentasvir for HCV Genotype 3 Patients with Cirrhosis and Prior Treatment Experience David Wyles, Fred Poordad, Stanley
More informationHCV therapy : Clinical case
HCV therapy : Clinical case PHC 2018 Paris January 14th, 2018 Tarik Asselah (MD, PhD) Professor of Medicine Hepatology, Chief INSERM UMR 1149, Hôpital Beaujon, Clichy, France. Disclosures Professor Asselah
More informationGlecaprevir and Pibrentasvir in HCV GT 1-6 without Cirrhosis SURVEYOR-I and SURVEYOR-II
Phase 3 Treatment-Naïve and Treatment-Experienced Glecaprevir and Pibrentasvir in HCV GT 1-6 without Cirrhosis SURVEYOR-I and SURVEYOR-II Glecaprevir and Pibrentasvir in HCV GT 1-6 without Cirrhosis SURVEYOR-I
More informationAbstract LB-12. POLARIS-2: Pangenotypic Single Tablet Regimen with Inhibitors of HCV NS5B (Nucleotide) + NS5A + NS3
A Randomized Phase 3 Trial of Sofosbuvir/Velpatasvir/Voxilaprevir for 8 Weeks Compared to Sofosbuvir/Velpatasvir for 1 Weeks in DAA-Naïve Genotype 1 6 HCV Infected Patients: The POLARIS- Study Ira M. Jacobson,
More informationDebate: Do We Need More HCV Drugs Con Standpoint
Debate: Do We Need More HCV Drugs Con Standpoint 18 th Antivirals PK Workshop, Friday 16 th June 2017, Chicago Jürgen Rockstroh Department of Medicine I University Hospital Bonn, Bonn, Germany Conflict
More information5/12/2016. Learning Objectives. Management of Hepatitis C Virus Genotype 2 or 3 Infected Treatment-Naive or Experienced Patients
5/12/216 Management of Hepatitis C Virus Genotype 2 or 3 Infected Treatment-Naive or Experienced Patients Alexander Monto, MD Professor of Clinical Medicine University of California San Francisco San Francisco,
More informationICVH 2016 Oral Presentation: 28
Ledipasvir/Sofosbuvir Is Safe and Effective for the Treatment of Patients with Genotype 1 Chronic HCV Infection in Both HCV Mono- and HIV/HCV Coinfected Patients A Luetkemeyer 1, C Cooper 2, P Kwo 3, K
More information2.0 Synopsis. ABT-450/r, ABT-267 M Clinical Study Report R&D/17/0539. (For National Authority Use Only)
2.0 Synopsis AbbVie Inc. Name of Study Drug: ABT-450, ritonavir, ABT-267, ribavirin, pegylated interferon Name of Active Ingredient: ABT-450, Ritonavir, ABT-267, Ribavirin, Pegylated interferon Individual
More informationHCV Update from AASLD 2016
HCV Update from AASLD 2016 Ahmed Elsharkawy Consultant Hepatologist QE Birmingham Secretary and Chair-Elect of BVHG BHIVA/BVHG Feedback Meeting November 2016 Speaker Name Ahmed Elsharkawy Statement Speaking
More informationNew Antivirals for Hep C in Context of HIV: Vosevi and Mavyret
New Antivirals for Hep C in Context of HIV: Vosevi and Mavyret John Scott, MD, MSc, FIDSA November 16, 2017 This presentation is intended for educational use only and does not in any way constitute medical
More informationFuture strategies with new DAAs
Future strategies with new DAAs Ola Weiland professor New direct antiviral drugs Case no 1 male with genotype 2b Male with gt 2b chronic HCV Male with gt 2b relapse afer peg-ifn + RBV during 24 weeks
More informationCase 4: A 61-year-old man with HCV genotype 3 with cirrhosis. Ira M. Jacobson, M.D. Weill Cornell Medical College New York, New York USA
Case 4: A 61-year-old man with HCV genotype 3 with cirrhosis Ira M. Jacobson, M.D. Weill Cornell Medical College New York, New York USA 1 Genotype 3 case 61-year-old man with HCV genotype 3 Cirrhosis on
More informationVII CURSO AVANCES EN INFECCIÓN VIH Y HEPATITIS VIRALES
VII CURSO AVANCES EN INFECCIÓN VIH Y HEPATITIS VIRALES REGIMENES TERAPÊUTICOS DE LA HEPATITIS C, INTERFERÓN FREE A Coruña 2 Febrero 2013 Rui Sarmento e Castro Centro Hospitalar do Porto HJU ECS Universidade
More informationClinical Management: Treatment of HCV Mono-infection
Clinical Management: Treatment of HCV Mono-infection Curtis Cooper, MD, FRCPC Associate Professor-University of Ottawa The Ottawa Hospital- Infections Diseases Viral Hepatitis Program- Director Industry
More informationSofosbuvir-Velpatasvir-Voxilaprevir in DAA-Experienced GT 1-6 POLARIS-4
Phase 3 Treatment Experienced Sofosbuvir-Velpatasvir-Voxilaprevir in DAA-Experienced GT 1-6 POLARIS-4 Bourlière M, et al. N Engl J Med. 217;376:2134-46. POLARIS-4: Study Features POLARIS-4 Trial Design:
More informationHCV-G3: Sofosbuvir with ledipasvir or daclatasvir?
HCV-G3: Sofosbuvir with ledipasvir or daclatasvir? Ioannis Goulis, MD Aristotelian University of Thessaloniki XXIII International Hepatitis B & C Meeting of Athens Hadziyannis HCV genotype 3 therapy Chronic
More informationIntroduction. The ELECTRON Trial
63rd AASLD November 9-13, 12 Boston, Massachusetts Faculty Douglas T. Dieterich, MD Professor of Medicine and Director of CME Department of Medicine Director of Outpatient Hepatology Division of Liver
More informationViva La Revolución: Options to Combat Hepatitis C
Viva La Revolución: Options to Combat Hepatitis C David L. Wyles, MD Professor of Medicine University of Colorado Chief, Division of Infectious Disease Denver Health Learning Objectives After attending
More informationTREATMENT OF GENOTYPE 2
Treatment of Genotype 2, 3,and 4 David E. Bernstein, MD, FACG Advisory Committee/Board Member: AbbVie Pharmaceuticals, Gilead, Merck, Janssen Consultant: AbbVie Pharmaceuticals, Bristol-Myers Squibb, Gilead,
More informationHCV Resistance Clinical Aspects. Sanjay Bhagani Royal Free Hospital/UCL London
HCV Resistance Clinical Aspects Sanjay Bhagani Royal Free Hospital/UCL London DAAs in 2018, and beyond % patients % patients Changing characteristics of patients treated with DAA over time Prospective,
More information2017 Bruce Lucas Hepatology and Liver Transplant Symposium October 13th 2017 Management of Hepatitis C in Pre- and Post-Transplant Patients
2017 Bruce Lucas Hepatology and Liver Transplant Symposium October 13th 2017 Management of Hepatitis C in Pre- and Post-Transplant Patients Jens Rosenau, MD Associate Professor of Medicine Acting Director
More informationSaeed Hamid, MD Alex Thompson, MD, PhD
Saeed Hamid, MD Alex Thompson, MD, PhD 1 We will review some top line data from EASL Majority of the time discussing how the data affects daily practice 2 Grazoprevir (GZR; MK-5172) + Elbasvir (EBR; MK-
More informationLatest Treatment Updates for GT 2 and GT 3 Patients
Latest Treatment Updates for GT 2 and GT 3 Patients Eric Lawitz, MD, AGAF, CPI Vice President, Scientific and Research Development The Texas Liver Institute Clinical Professor of Medicine University of
More informationHow to optimize treatment in G3 patients? Jérôme GOURNAY, MD Hépatologie Centre Hospitalier Universitaire de Nantes France
How to optimize treatment in G3 patients? Jérôme GOURNAY, MD Hépatologie Centre Hospitalier Universitaire de Nantes France Paris Hepatitis Conference, January 12, 2016 Disclosures I have received funding
More informationONE REGIMEN, ALL GENOTYPES, 8 WEEKS
For UK healthcare professionals only INTRODUCING MAVIRET ONE REGIMEN, ALL GENOTYPES, 8 WEEKS FOR TREATMENT-NAÏVE, NON-CIRRHOTIC PATIENTS 1 Maviret is indicated for the treatment of chronic hepatitis C
More informationEvolution of Therapy in HCV
Hepatitis C: Update on New Therapies and AASLD 13 David Bernstein, MD, FACP, AGAF, FACP Professor of Medicine Hofstra North Shore-LIJ School of Medicine Evolution of Therapy in HCV 199 1999 1 13 (%) SVR
More informationDisclosures. Advanced HCV management. Overview. Renal failure 1/10/2018. Research Grant support to UCSF from AbbVie Gilead Merck Proteus NIH
Disclosures Advanced HCV management Annie Luetkemeyer, MD Division of HIV, ID and Global Medicine ZSFG, UCSF Research Grant support to UCSF from AbbVie Gilead Merck Proteus NIH Overview Renal failure Acute
More informationPhase 3. Treatment Experienced. Ledipasvir-Sofosbuvir +/- Ribavirin in HCV Genotype 1 ION-2. Afdhal N, et al. N Engl J Med. 2014;370:
Phase 3 Treatment Experienced Ledipasvir-Sofosbuvir +/- Ribavirin in HCV Genotype 1 ION-2 Afdhal N, et al. N Engl J Med. 2014;370:1483-93. Ledipasvir-Sofosbuvir +/- Ribavirin in Treatment-Experienced HCV
More informationUpdates on the AASLD/IDSA HCV Guidance
Updates on the AASLD/IDSA HCV Guidance Susanna Naggie, MD, MHS Associate Professor of Medicine Duke University School of Medicine Durham, North Carolina Learning Objectives After attending this presentation,
More informationExpert Perspectives: Best of HCV from EASL 2015
Best of HCV from EASL 2015 Expert Perspectives: Best of HCV from EASL 2015 Saeed Hamid, MD Alex Thompson, MD, PhD This activity is supported by educational grants from AbbVie, Bristol-Myers Squibb, and
More informationManagement of HCV in Prior Treatment Failure
Management of HCV in Prior Treatment Failure Arthur Y. Kim, MD Associate Professor of Medicine Harvard Medical School Boston, Massachusetts Learning Objectives After attending this presentation, learners
More informationHepatitis C in Special Populations
Hepatitis C in Special Populations David E. Bernstein, MD, FACG Vice Chairman of Medicine for Clinical Trials Chief, Division of Hepatology and Sandra Atlas Bass Center for Liver Diseases Northwell Health
More informationEASL 2013 Interferon Free, All Oral Regimens for Hepatitis C. Maria Buti Hospital Universitario Valle Hebron Barcelona Spain
EASL 2013 Interferon Free, All Oral Regimens for Hepatitis C Maria Buti Hospital Universitario Valle Hebron Barcelona Spain The first Results with Oral therapy: a Protease Inhibitor and NS5A inhibitor
More informationCases: Management of Hepatitis C in Prior Treatment Failure
Cases: Management of Hepatitis C in Prior Treatment Failure David L. Wyles, MD Professor of Medicine University of Colorado Chief, Division of Infectious Disease Denver Health Learning Objectives After
More informationSTATE OF THE ART Update: Treatment Options 2016 Mark Sulkowski, MD
Housekeeping Please turn off or silence cell phones. Restrooms are located on this floor. Make a left out of the ballroom foyer and the men s room is on your left. The ladies room is across from the elevators
More informationSYNOPSIS Final Clinical Study Report for Study AI444031
Name of Sponsor/Company: Bristol-Myers Squibb Name of Finished Product: Name of Active Ingredient: () Individual Study Table Referring to the Dossier (For National Authority Use Only) SYNOPSIS for Study
More informationUpdate on Real-World Experience With HARVONI
Update on Real-World Experience With A RESOURCE FOR PAYERS This information is intended for payers only. The HCV-TARGET and TRIO studies were supported by Gilead Sciences, Inc. Real-world experience data
More informationGenotype 1 HCV in 2016: Clinical Decision Making in a Time of Plenty
Genotype 1 HCV in 216: Clinical Decision Making in a Time of Plenty Ira M. Jacobson, MD Chair, Department of Medicine Mount Sinai Beth Israel Senior Faculty and Vice-Chair, Department of Medicine Icahn
More informationEmerging Therapies for HCV: Highlights from AASLD 2012 (Part 1)
Emerging Therapies for HCV: Highlights from AASLD 2012 (Part 1) Goals for Hepatitis C Therapy Compared to PegIFN/RBV, new products should offer: Improved efficacy Efficacy in all patient types including
More informationABT-493/ABT-530 M Clinical Study Report Post-Treatment Week 12 Primary Data R&D/16/0145. Referring to Part of Dossier: Volume: Page:
2.0 Synopsis AbbVie Inc. Name of Study Drug: ABT-493/ABT-530 Name of Active Ingredient: ABT-493: (3aR,7S,10S,12R,21E,24aR)- 7-tert-butyl-N-{(1R,2R)-2- (difluoromethyl)-1-[(1- methylcyclopropane-1- sulfonyl)carbamoyl]cyclopropyl}-20,20-
More informationHCV: The next 18 months. David L. Wyles, M.D. Associate Professor of Medicine UCSD
HCV: The next 18 months David L. Wyles, M.D. Associate Professor of Medicine UCSD FIRST, A LOOK BACK WHAT DID I SAY LAST YEAR? My predictions for genotype 1: Multiple highly efficacious, well-tolerated,
More informationLedipasvir-Sofosbuvir (Harvoni)
HEPATITIS WEB STUDY HEPATITIS C ONLINE Ledipasvir-Sofosbuvir (Harvoni) Robert G. Gish MD Professor, Consultant, Stanford University Medical Center Senior Medical Director, St Josephs Hospital and Medical
More informationABT-493, ABT-530, ABT-493/ABT-530 M Clinical Study Report Primary Analysis R&D/16/0160. Referring to Part of Dossier: Volume: Page:
2.0 Synopsis AbbVie Inc. Name of Study Drug: ABT-493, ABT-530, ABT-493/ABT-530 Name of Active Ingredient: ABT-493: (3aR,7S,10S,12R,21E,24aR)- 7-tert-butyl-N-{(1R,2R)-2- (difluoromethyl)-1-[(1- methylcyclopropane-1-
More informationNew developments in HCV research and their implications for front-line practice
New developments in HCV research and their implications for front-line practice Dr. Curtis Cooper Associate Professor, University of Ottawa Director, Ottawa Hospital Viral Hepatitis Program June 17, 2013
More informationABT-493/ABT-530 M Clinical Study Report Post-Treatment Week 12 Primary Data R&D/16/0144. Referring to Part of Dossier: Volume: Page:
2.0 Synopsis AbbVie Inc. Name of Study Drug: ABT-493/ABT-530 Name of Active Ingredient: ABT-493: (3aR,7S,10S,12R,21E,24aR)- 7-tert-butyl-N-{(1R,2R)-2- (difluoromethyl)-1-[(1- methylcyclopropane-1- sulfonyl)carbamoyl]cyclopropyl}-20,20-
More informationABT-493/ABT-530 M Clinical Study Report Post-Treatment Week 12 Primary Data R&D/16/0162. Referring to Part of Dossier: Volume: Page:
2.0 Synopsis AbbVie Inc. Name of Study Drug: ABT-493/ABT-530 Name of Active Ingredient: ABT-493: (3aR,7S,10S,12R,21E,24aR)- 7-tert-butyl-N-{(1R,2R)-2- (difluoromethyl)-1-[(1- methylcyclopropane-1- sulfonyl)carbamoyl]cyclopropyl}-20,20-
More informationSOLAR-1 (Cohorts A and B)
Phase 2 Treatment Naïve and Treatment Experienced Ledipasvir-Sofosbuvir + RBV in HCV GT 1,4 and Advanced Liver Disease SOLAR-1 (Cohorts A and B) Charlton M, al. Gastroenterology. 2015; 149:649-59. Ledipasvir-Sofosbuvir
More informationTreatment of HCV in 2016
5/1/16 Treatment of HCV in 16 Graham R Foster Professor of Hepatology QMUL Conflicts of Interest Speaker and consultancy fees received from AbbVie, BI, BMS, Gilead, Janssen, Roche, Merck, Novartis, Springbank,
More informationCase 2: A 71-year-old man with cirrhosis
Case 2: A 71-year-old man with cirrhosis 1 JM, 71 year old African American male with known cirrhosis Asymptomatic apart from fatigue No prior history of decompensation Past history: Diabetes for 11 years
More informationTreatment of HCV : 100 % cure?
Treatment of HCV : % cure? PHC 8 PARIS January 5th, 8 Tarik Asselah (MD, PhD) Professor of Medicine Hepatology, Chief ISERM UMR 49, Hôpital Beaujon, Clichy, France. PHC 8 - www.aphc.info Disclosures Employee
More informationVIRAL LIVER DISEASE. OAG Post DDW Course Westin Prince, Toronto, June 13-14, 2015
VIRAL LIVER DISEASE OAG Post DDW Course Westin Prince, Toronto, June 13-14, 2015 Financial Interest Disclosure (over the past 24 months) Dr. Paul Marotta Relationships related to this presentation! Research
More informationUpdate in the Management of Hepatitis C: What Does the Future Hold
Update in the Management of Hepatitis C: What Does the Future Hold Paul Y Kwo, MD, FACG Professor of Medicine Mdi Medical ldirector, Liver Transplantation tti Gastroenterology/Hepatology Division Indiana
More informationDRUG-DRUG INTERACTIONS OF GLECAPREVIR AND PIBRENTASVIR WITH PRAVASTATIN, ROSUVASTATIN, OR DABIGATRAN ETEXILATE
DRUG-DRUG INTERACTIONS OF GLECAPREVIR AND PIBRENTASVIR WITH PRAVASTATIN, ROSUVASTATIN, OR DABIGATRAN ETEXILATE Matthew P. Kosloski, Weihan Zhao, Hong Li, Stanley Subhead Wang, Calibri Joaquin 14pt, Valdes,
More informationNS5A inhibitors: ideal candidates for combination?
NS5A inhibitors: ideal candidates for combination? Professor Vasily Isakov, MD, PhD, AGAF Dep.Gastroentrology & Hepatology, ION, Russian Academy of Sciences, Moscow Structure and function of NS5A Meigang
More informationAssociate Professor of Medicine University of Chicago
Nancy Reau, MD Associate Professor of Medicine University of Chicago Management of Hepatitis C: New Drugs and New Paradigms HCV is More Lethal than HIV Infection HCV superseded HIV as a cause of death
More informationTreating HCV Genotype 2 & 3
Treating HCV Genotype 2 & 3 3rd Workshop on HCV Therapy Advances, Rome 14.12.2013 Christoph Sarrazin Klinikum der J. W. Goethe-Universität Frankfurt am Main, Germany HCV Genotypes 2 & 3 Laurel and Hardy
More informationHCV in 2017: New Therapies and New Opportunities. Presentation prepared by: Date prepared: OBJECTIVES
Project ECHO HCV Collaborative HCV in 217: New Therapies and New Opportunities Paulina Deming, PharmD Assistant Director Hepatitis C Programs, ECHO Institute Associate Professor College of Pharmacy University
More informationHepatitis C: New Therapies in
Hepatitis C: New Therapies in 216-217 Mark Sulkowski, MD Professor of Medicine Johns Hopkins University School of Medicine Medical Director, Viral Hepatitis Center Divisions of Infectious Diseases and
More informationHCV Treatment Options in 2017/2018: What s Here and What s Coming Soon
HCV Treatment Options in 2017/2018: What s Here and What s Coming Soon Supported by educational grants from AbbVie; Bristol-Myers Squibb; Gilead Sciences; Janssen Therapeutics; Merck & Co., Inc; and ViiV
More informationSVR Updates from the 2013 EASL
Updates from the 2013 EASL By Tracy Swan, Treatment Action Group Streamlining HCV Treatment Treatment for hepatitis C virus (HCV) is becoming simpler, shorter, and more effective. All-oral combinations
More informationAntiviral treatment in HCV cirrhotic patients on waiting list
Antiviral treatment in HCV cirrhotic patients on waiting list Krzysztof Tomasiewicz Department of Hepatology and Infectious Diseases Medical University of Lublin, Poland Disclosures Consultancy/Advisory
More informationC-CREST study, Part A: GZR + EBR or MK MK-3682 for genotypes 1, 2 and 3 - Phase II
Design 18 years Chronic HCV infection Genotype 1, 2 or 3 Treatment-naïve HCV RNA 1 IU/ml No cirrhosis * No HBV or HIV co-infection Randomisation Open-label * Liver biopsy or Fibroscan 12.5 kpa or Fibrotest
More informationTreatement Experienced patients without cirrhosis. Rafael Esteban Hospital Universitario Valle Hebron Barcelona
Treatement Experienced patients without cirrhosis Rafael Esteban Hospital Universitario Valle Hebron Barcelona Agenda With IFN PegIFN+ Ribavirin + Simeprevir PegIFN+ Ribavirin+ Sofosbuvir Without IFN Sofosbuvir
More informationAustralasian Professional Society on Alcohol and other Drugs, Annual Conference 2016 Sydney Australia
Efficacy and safety of ledipasvir/sofosbuvir with and without ribavirin in patients with chronic HCV genotype 1 infection receiving opioid substitution therapy: Analysis of Phase 3 ION trials J Grebely
More informationWhat Should We Do With Difficult to Treat HCV Populations?
What Should We Do With Difficult to Treat HCV Populations? Norah Terrault, MD Professor of Medicine and Surgery Director, Viral Hepatitis Center University of California San Francisco Disclosures Norah
More informationUpdate on Hepatitis C. Francesco Negro Hôpitaux Universitaires de Genève Berne, November 15, 2017
Update on Hepatitis C Francesco Negro Hôpitaux Universitaires de Genève Berne, November 15, 2017 The global prevalence of HCV was 1 0% (95% uncertainty interval 0 8 1 1) in 2015: 71 1 million (62 5 79
More information47 th Annual Meeting AISF
47 th Annual Meeting AISF Rome, 21 February 2014 Present and future treatment strategies for patients with HCV infection: chronic hepatitis and special populations (HCV/HIV coinfection, advanced cirrhosis,
More informationUpdate on Real-World Experience With HARVONI
Update on Real-World Experience With A RESOURCE FOR PAYERS MAY 217 This information is intended for payers only. The HCV-TARGET study was supported by Gilead Sciences, Inc. Real-world experience data were
More informationLearning Objective. After completing this educational activity, participants should be able to:
Learning Objective After completing this educational activity, participants should be able to: Use patient characteristics and preferences to select HCV treatment strategies that maximize the potential
More informationKristen M. Marks, MD Assistant Professor Weill Cornell Medical College New York, New York
Newly Approved Hepatitis C Virus Drugs: Approach to Initial Therapy Kristen M. Marks, MD Assistant Professor Weill Cornell Medical College New York, New York Learning Objectives After attending this presentation,
More informationHepatitis C Agents
Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.01.41 Subject: Hepatitis C Agents Page: 1 of 20 Last Review Date: March 16, 2018 Hepatitis C Agents Description
More informationHepatitis C Agents
Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.01.41 Subject: Hepatitis C Agents Page: 1 of 19 Last Review Date: December 8, 2017 Hepatitis C Agents
More informationHepatitis C Genotypes
9/2/21 OBJECTIVES Project ECHO HCV Collaborative HCV in 21: New Therapies and New Opportunities Paulina Deming, PharmD Assistant Director Hepatitis C Programs, ECHO Institute Associate Professor College
More informationInitial Treatment of HCV G Hugo E. Vargas, MD Professor of Medicine Medical, Director Office of Clinical Research Mayo Clinic Arizona
Initial Treatment of HCV G1 2016 Hugo E. Vargas, MD Professor of Medicine Medical, Director Office of Clinical Research Mayo Clinic Arizona Disclosure Information Disclosure Information Dr. Vargas receives
More informationHepatitis C Update: What s New in 2017
Hepatitis C Update: What s New in 2017 Cody A. Chastain, MD Assistant Professor of Medicine Viral Hepatitis Program Division of Infectious Diseases Vanderbilt University Medical Center Cody.a.Chastain@Vanderbilt.edu
More information10/4/2016. Management of Hepatitis C Virus Genotype 2 or 3 Infection
Management of Hepatitis C Virus Genotype 2 or 3 Infection Kenneth E. Sherman, MD, PHD Gould Professor of Medicine Director, Division of Digestive Diseases University of Cincinnati Cincinnati, Ohio FORMATTED:
More informationEmerging Therapies for HCV: Highlights from AASLD 2012 (Part 2)
Emerging Therapies for HCV: Highlights from AASLD 2012 (Part 2) Goals for Hepatitis C Therapy Compared to PegIFN α/rbv, new treatment regimens for chronic hepatitis C should offer: Improved efficacy Efficacy
More informationHepatitis C: Management of Treatment Naïve Patients with First Line Protease Inhibitors
Hepatitis C: Management of Treatment Naïve Patients with First Line Protease Inhibitors Eric Lawitz, MD, AGAF, CPI The Texas Liver Institute Clinical Professor of Medicine University of Texas Health Science
More informationClinical Сase A previously relapse to PEG IFN + RBV in HCV G3a patient. Konstantin Zhdanov
Clinical Сase A previously relapse to PEG IFN + RBV in HCV G3a patient Konstantin Zhdanov Genotype 3 in Europe Canada Norway Germany Sweden Czech Republic Poland Approximately 1/3 of HCV-infected patients
More informationWhy make this statement?
HCV Council 2014 10 clinical practice statements were evaluated by the Council A review of the available literature was conducted The level of support and level of evidence for the statements were discussed
More informationOmbitasvir-Paritaprevir-Ritonavir + Dasabuvir (Viekira Pak)
HEPATITIS WEB STUDY HEPATITIS C ONLINE Ombitasvir-Paritaprevir-Ritonavir + Dasabuvir (Viekira Pak) Prepared by: Sophie Woolston, MD and David H. Spach, MD Last Updated: December 29, 2014 OMBITASVIR-PARITAPREVIR-RITONAVIR
More informationHepatitis C: Management of Previous Non-responders with First Line Protease Inhibitors
Hepatitis C: Management of Previous Non-responders with First Line Protease Inhibitors Fred Poordad, MD The Texas Liver Institute Clinical Professor of Medicine University of Texas Health Science Center
More informationUpdate on the Treatment of HCV
Update on the Treatment of HCV K. Rajender Reddy, MD Professor of Medicine Director of Hepatology Director, Viral Hepatitis Center University of Pennsylvania Philadelphia, USA 1 K. Rajender Reddy, MD Disclosure
More informationThe ASTRAL Program Abstracts LB-2, LB-12, 205, 209
The ASTRAL Program Abstracts LB-2, LB-12, 5, 9 The ASTRAL Program FDC 1. 2. 3. 4. 5. SOF Nucleotide polymerase inhibitor VEL NS5A inhibitor ASTRAL1 GT1, 2, 4 6 ASTRAL2 GT2 Jacobson IM, et al. N Engl J
More informationDr. Siddharth Srivastava
Dr. Siddharth Srivastava MD, DM (Gastroenterology) Associate Professor GIPMER, New Delhi Rashtriya Gaurav Award 2013 for work on hepatitis B and C Set up Liver clinic at GIPMER and in charge EUS laboratory.
More informationTreatment of Unique Populations Raymond T. Chung, MD
Treatment of Unique Populations Raymond T. Chung, MD Director of Hepatology and Liver Center Vice Chief, Gastroenterology Kevin and Polly Maroni Research Scholar Mass General Hospital Disclosures Research
More informationDo We Need New HCV Drugs? YES
Do We Need New HCV Drugs? YES Nancy Reau, MD Professor of Medicine Chief, Section of Hepatology Associate Director, Solid Organ Transplantation Rush University Medical Center Disclosures Consultation:
More informationWhat is the Optimized Treatment Duration? To Overtreat versus Undertreat. Nancy Reau, MD Associate Professor of Medicine University of Chicago
What is the Optimized Treatment Duration? To Overtreat versus Undertreat Nancy Reau, MD Associate Professor of Medicine University of Chicago Learning Objectives: 1. Discuss patient populations appropriate
More informationHepatitis C Emerging Treatment Paradigms
Hepatitis C Emerging Treatment Paradigms David R Nelson MD Assistant Vice President for Research Professor of Medicine Director, Clinical and Translational Science Institute University of Florida Gainesville,
More informationTreatments of Genotype 2, 3,and 4: Now and in the future
Treatments of Genotype 2, 3,and 4: Now and in the future THERAPY FOR THE TREATMENT OF GENOTYPE 2 1 GT 2 and GT 3 Treatment-Naïve: SOF+RBV vs PEG-IFN+RBV FISSION Study Design HCV GT 2 and GT 3 Treatment-naïve
More informationHepatitis C Treatment 2014
Hepatitis C Treatment 214 Brendan M. McGuire, MD UAB Liver Center Outline Epidemiology/National History Terminology for Treatment Treatment Considerations Current Treatment Options Genotype 1 (GT 1) Genotype
More information