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New HCV Drugs at EASL 2017
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Jules Levin, NATAP
below are links to 4 new HCV drug regimens from EASL: Abbvie's new next generation protease inhibitor & NS5A inhibitor known as G/P or GLECAPREVIR/PIBRENTASVIR, and Gilead's new triple of Sofosbuvir+Velpatasvir+Voxilaprevir which contains their new protease inhibitor. Merck reported 3 studies below for their new triple regimen of MK-3682 (Uprifosbuvir)+Grazoprevir+Rusasvir. And Janssen reported data in patients for their new triple AL-335+Odalasvir+Simeprevir. Much further back in development, in preclinical development are 3-4 new HCV drugs by Cocrystal
Clinical Pharmacokinetics and Antiviral Activity of CC-31244, a Pan-genotypic, Potent Nonnucleoside NS5B Polymerase Inhibitor (NNI) for the Treatment of Hepatitis C - (02/21/17)
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A Few Extra Noteworthy Presentations:
EASL: Elbasvir/Grazoprevir Plus Sofosbuvir ± Ribavirin in Treatment-Naive And Treatment-Experienced People With Hepatitis C Virus Genotype 3 Infection and Compensated Cirrhosis: SVR24 Results of the C-ISLE Study - (04/21/17)
EASL: Ledipasvir/Sofosbuvir ± Ribavirin for 12 or 24 Weeks Is Safe and Effective in Children 6-11 years old with Chronic Hepatitis C Infection - (04/24/17)
EASL: Ledipasvir/Sofosbuvir for 12 Weeks Is Safe and Effective in Patients with Chronic Hepatitis C and Hepatitis B Coinfection: A Phase 3 Study in Taiwan - (04/24/17)
EASL: Gilead Announces Scientific Presentations Demonstrating Efficacy of Harvoni® (Ledipasvir/Sofosbuvir) in Special Patient Populations With HCV Infection - (04/24/17)
EASL: THERAPY WITH DIRECT ANTIVIRAL AGENTS IN PATIENTS WITH HCV-RELATED LYMPHOPROLIFERATIVE DISORDERS AND MIXED CRYOGLOBULINEMIA - (04/26/17)
EASL: Prognostic value of viral eradication for major adverse cardiovascular events in hepatitis C cirrhotic patients. ANRS CO12 CirVir Cohort - (04/26/17)
EASL: The PREVAIL Study: Intensive Models of HCV Care for People Who Inject Drugs - (04/26/17)
EASL: Four weeks of Ledipasvir/Sofosbuvir + Ribavirin with or without interferon give very high and sustained cure rates in difficult to reach but easy to treat injecting drug users with chronic hepatitis C. Final results of the 4WIDUC study. - (04/26/17)
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Abbvie's Glecaprevir/Pibrentasvir - FDA approval expected by August 2017
EASL: High SVR Rates With Eight and Twelve Weeks of Pangenotypic Glecaprevir/Pibrentasvir: Integrated Efficacy Analysis of Genotype 1-6 Patients Without Cirrhosis - (04/25/17)
EASL: Pooled Resistance Analysis in HCV Genotype 1-6 Infected Patients Treated With Glecaprevir/Pibrentasvir in Phase 2 and 3 Clinical Trials - (04/24/17)
EASL: EXPEDITION-I: Efficacy and Safety of Glecaprevir/Pibrentasvir for Treatment of Chronic Hepatitis C Virus Genotype 1, 2, 4, 5 or 6 Infection in Adults with Compensated Cirrhosis - (04/21/17)
EASL: MAGELLAN-1, PART 2: GLECAPREVIR/PIBRENTASVIR FOR 12 OR 16 WEEKS IN PATIENTS WITH CHRONIC HCV GENOTYPE 1 OR 4 AND PRIOR DIRECT-ACTING ANTIVIRAL TREATMENT FAILURE - (04/24/17)
EASL: Safety and Efficacy of Glecaprevir/Pibrentasvir in Adults With Chronic Hepati is C Virus Infection Genotype 1-6 as a Function of Chronic Kidney Disease Stage - (04/25/17)
EASL: MAGELLAN-2: SAFETY AND EFFICACY OF GLECAPREVIR/PIBRENTASVIR IN LIVER OR RENAL TRANSPLANT ADULTS WITH CHRONIC HEPATITIS C GENOTYPE 1-6 INFECTION - (04/24/17)
EASL: ENDURANCE-3: SAFETY AND EFFICACY OF GLECAPREVIR/PIBRENTASVIR COMPARED TO SOFOSBUVIR PLUS DACLATASVIR IN TREATMENT-NAïVE HCV GENOTYPE 3-INFECTED PATIENTS WITHOUT CIRRHOSIS - (04/21/17)
EASL: Eight Weeks of Treatment with AbbVie's Investigational, Pan-Genotypic Regimen of Glecaprevir/Pibrentasvir (G/P) Achieved High SVR(12) Rates in Challenging to Treat Genotype 3 Chronic Hepatitis C - (05/02/17)
EASL: Safety of Glecaprevir/Pibrentasvir in Adults With Chronic Genotype 1-6 Hepatitis C Virus Infection: An Integrated Analysis - (04/24/17)
EASL: Efficacy and Safety of Glecaprevir/Pibrentasvir in Patients Co-infected With Hepatitis C Virus and Human Immunodeficiency Virus-1: The EXPEDITION-2 Study - (04/20/17)
CROI: GLECAPREVIR AND PIBRENTASVIR INTERACTIONS WITH COMBINATION ANTIRETROVIRAL REGIMENS - (02/20/17)
Efficacy and Safety of Glecaprevir/Pibrentasvir in Japanese Patients With Chronic Genotype 2 Hepatitis C Virus Infection With and Without Cirrhosis - (05/01/17)
CERTAIN-1: Efficacy and Safety of Glecaprevir/Pibrentasvir in Japanese Patients With Chronic Genotype 1 Hepatitis C Virus Infection With and Without Cirrhosis - (05/01/17)
EASL: Pharmacokinetics and Safety of Glecaprevir/Pibrentasvir in Adults With Chronic Genotype 1-6 Hepatitis C Virus Infection and Compensated Cirrhosis: An Integrated Analysis - (04/21/17)
Glecaprevir and pibrentasvir for 12 weeks for hepatitis C virus genotype 1 infection and prior direct-acting antiviral treatment - (04/13/17)
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Gilead's Sofosbuvir + Velpatasvir + Voxilaprevir - FDA approval expected by August
EASL: SOF/VEL/VOX Results in High SVR12 Rates When Administered for 12 Weeks in DAA-Experienced Patients or for 8 Weeks in DAA-Naïve Patients: an Integrated Analysis of the POLARIS-1, POLARIS-2, POLARIS-3, and POLARIS-4 Studies - (04/25/17)
EASL: Treatment With SOF/VEL or SOF/VEL/VOX Is Well Tolerated and Results in High SVR12 in Genotype 1-6 HCV-Infected Patients With Minimal Fibrosis: a Retrospective Analysis of the ASTRAL and POLARIS Clinical Studies - (04/21/17)
EASL: SOF/VEL/VOX for 8 or 12 Weeks Is Well Tolerated and Results in High SVR12 Rates in Patients Receiving Opioid Substitution Therapy - (04/24/17)
EASL: Efficacy and safety of sofosbuvir/velpatasvir in people with chronic hepatitis C virus infection and recent injecting drug use: The SIMPLIFY study - (04/24/17)
EASL: No Impact of RASs on the High Efficacy of SOF/VEL/VOX for 12 Weeks in DAA-Experienced Patients: an Integrated Resistance Analysis of the POLARIS-1 and POLARIS-4 Studies - (04/26/17)
AASLD: A Randomized, Phase 3 Trial of Sofosbuvir/Velpatasvir/Voxilaprevir for 8 Weeks and Sofosbuvir/Velpatasvir for 12 Weeks for Patients with Genotype 3 HCV Infection and Cirrhosis: The POLARIS-3 Study - (11/15/16)
AASLD: A Randomized Phase 3 Trial of Sofosbuvir/Velpatasvir/Voxilaprevir for 8 Weeks Compared to Sofosbuvir/Velpatasvir for 12 Weeks in DAA-Naïve Genotype 1-6 HCV Infected Patients: The POLARIS-2 Study - (11/15/16)
EASL2017: No Impact of RASs on the High Efficacy of SOF/VEL/VOX for 8 Weeks in DAA-Naïve Patients: an Integrated Resistance Analysis of the POLARIS-2 and POLARIS-3 Studies - (04/20/17)
AASLD: Sofosbuvir/Velpatasvir/Voxilaprevir for 12 Weeks as a Salvage Regimen in NS5A Inhibitor-Experienced Patients With Genotype 1-6 Infection: The Phase 3 POLARIS-1 Study - (11/15/16)
AASLD: Sofosbuvir/Velpatasvir Fixed-Dose Combination for 12 Weeks Compared to Sofosbuvir with Ribavirin for 24 Weeks in Genotype 3 HCV-Infected Patients: The Randomized Controlled Phase 3 ASTRAL-3 Study - (11/30/15)
AASLD: Sofosbuvir and Velpatasvir for HCV Genotype 2 and 3 Infection - (11/30/15) published
EASL: High Efficacy is Accompanied with Substantial Gains in Patient Reported Outcomes in Cirrhotic Patients with Chronic Hepatitis C Treated with Sofosbuvir, Velpatasvir with or without Voxilaprevir: The Data from POLARIS-1, -2, -3 and -4 - (05/02/17)
EASL: The Safety and Tolerability of SOF/VEL/VOX for 8 or 12 Weeks in >1000 Patients Treated in the POLARIS-1, POLARIS-2, POLARIS-3, and POLARIS-4 Studies: an Integrated Analysis - (04/26/17)
EASL: Safety and Efficacy of Sofosbuvir and Velpatasvir with or without Ribavirin for the Treatment of HCV Genotype 1-6: Results of the HCV-TARGET Study - (05/01/17)
EASL: Safety and Efficacy of Sofosbuvir/Velpatasvir for the Treatment of Chronic Hepatitis C in Patients Aged 65 Years or Older: A Retrospective Analysis of Phase 3 Studies - (05/01/17)
GT3 - EASL: Real-world effectiveness and cost per SVR of Sofosbuvir/Velpatasvir in chronic hepatitis C treatment - (05/01/17)
EASL: Does Sofosbuvir (SOF)/Velpatasvir (VEL) with or without Ribavirin (RBV) change the landscape of therapy in chronic hepatitis C genotype 3 (GT 3) infection? - Results from the GErman hepatitis C COhort (GECCO) - (04/28/17)
EASL: Real-world effectiveness and cost per SVR of Sofosbuvir/Velpatasvir in chronic hepatitis C treatment / GT3 - (04/26/17)
EASL: Utilization of DAA therapies ledipasvir/sofosbuvir and sofosbuvir/velpatasvir in patients with genotype 1 HCV: Real-world experience from the TRIO Network. - (04/26/17)
EASL: Sofosbuvir/velpatasvir compared to existing Standards of Care in GT2-6 HCV Real-world experience from the TRIO Network - (04/24/17)
EASL: Safety and Efficacy of Sofosbuvir and Velpatasvir with or without Ribavirin for the Treatment of HCV Genotype 1-6: Results of the HCV-TARGET Study - (05/01/17)
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Merck's MK-3682 (Uprifosbuvir) + Grazoprevir + Rusasvir
EASL: Safety and Efficacy of the Fixed-dose Combination Regimen of Uprifosbuvir (MK-3682) / Grazoprevir / Ruzasvir in Cirrhotic or Non-cirrhotic Patients with Chronic HCV GT1 Infection Who Previously Failed a Direct-acting Antiviral Regimen (C-SURGE) - (04/24/17)
EASL: Efficacy and Safety of the Fixed-Dose Combination Regimen of Grazoprevir/Ruzasvir/Uprifosbuvir (MK-3682) With or Without Ribavirin in Non-cirrhotic or Cirrhotic Participants With Chronic HCV GT1, 2, 3, 4, or 6 Infection (Parts A & B of C-CREST-1 & 2) - (04/20/17)
EASL: High Sustained Virologic Response Rates at 24 Weeks in Participants With Chronic HCV GT1, 2, or 3 Infection Following 16 Weeks of Grazoprevir/Ruzasvir/Uprifosbuvir (MK-3682) Plus Ribavirin After Having Failed 8 Weeks of a Triple Drug Regimen (Part C of C-CREST-1 & 2) - (04/20/17)
EASL: Elbasvir/Grazoprevir effectiveness in patients with Chronic Hepatitis C and Chronic Kidney Disease: Real-world experience from the TRIO Network - (04/25/17)
EASL: Real-world use of elbasvir/grazoprevir and outcomes in patients with Chronic Hepatitis C: Retrospective data analyses from the TRIO Network. - (04/26/17)
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Janssen's AL-335 + Odalasvir + Simeprevir
EASL: Short Duration Treatment with AL-335 and Odalasvir, with or without Simeprevir, in Treatment Naïve Patients with Hepatitis C Infection with or without Cirrhosis - (04/24/17)
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