Conference Reports for NATAP

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63rd Annual Meeting of the American Association for the Study of Liver Diseases Boston, MA Nov 9-12 2012     Pharmacokinetics and Safety of Co-administered ABT-450 plus Ritonavir (ABT 450/r), ABT-267 and ABT-333 as a Single Dose in Subjects with Normal Hepatic Function and in Subjects with Mild, Moderate and Severe Hepatic Impairment (DAAs PK; Sofosbivur+Daclatasvir in Liver transplant; and "Pharmacologic Considerations when using DAAs in Cirrhosis" - at 2013 1st Intl Wkp on the Optimal Use of DAAs in Liver Transplantation April 23, by Jennifer Kiser PharmD - (12/23/13)   Effect of Hepatic Impairment on the Pharmacokinetics of Asunaprevir (BMS-650032, ASV) - (12/04/13)   IDX719, HCV NS5A Inhibitor, Demonstrates Pan-Genotypic Activity after Three Days of Monotherapy in Genotype 1, 2, 3 or 4 HCV-Infected Subjects - (01/31/13)   GS-7977 & HIV ARTs PK - No Clinically Significant Pharmacokinetic Interactions Between Sofosbuvir (GS-7977) and HIV Antiretrovirals Atripla, Rilpivirine, Darunavir/Ritonavir, or Raltegravir in Healthy Volunteers - (01/31/13)   First ever successful use of Daclatasvir and GS-7977 (Sofosbuvir) , an IFN-free regimen, in a Liver Transplant recipient with severe recurrent Hepatitis C - (01/12/13)   No Clinically Significant Pharmacokinetic Drug-Drug Interactions Between Sofosbuvir (GS-7977) and the Immunosuppressants Cyclosporine A or Tacrolimus in Healthy Volunteers - (01/07/13)   The Pharmacokinetic Interaction Between the Investigational NS3/4A HCV Protease Inhibitor TMC435 and Methadone - (01/08/13)   No clinically significant interaction between the investigational HCV protease inhibitor simeprevir (TMC435) and the immunosuppressive agents cyclosporine and tacrolimus - (01/07/13)   No pharmacokinetic interaction between the investigational HCV protease inhibitor simeprevir (TMC435) and an oral contraceptive containing ethinylestradiol and norethindrone - (01/07/13)   Preliminary Results of Twice Daily Dosing (Q12 hr) Of Telaprevir (TVR) for Treatment Naïve and Previously Treated Patients with Genotype 1 HCV: Comparable RVR, eRVR and SVR12 to Standard Daily Dosing at Q8 hr - (11/13/12)   Chronic hepatitis B patients with advanced fibrosis/compensated cirrhosis can benefit from peginterferon alfa-2a (40KD): improved or comparable response rates versus mild fibrosis in the phase III studies - (11/26/12)   No Impact of Cirrhosis on Mericitabine (MCB) Pharmacokinetics and Early Antiviral Activity in Hepatitis C-Infected Patients Receiving MCB plus Peginterferon Alfa-2A (40KD)/Ribavirin (P/R) - (11/26/12)   Lack of Mericitabine Resistance Mutation NS5B S282T and Detection and Characterization of a Novel Mericitabine Double Resistance Mutation NS5B L159F+L320F in Patients Treated with Mericitabine Plus Peginterferon Alfa-2a (40KD)/Ribavirin Provides Further Evidence for the High Resistance Barrier to Mericitabine - (11/26/12)   Ritonavir-boosted Danoprevir plus PegIFN Alfa-2a/Ribavirin (P/R) Demonstrates up to 100% SVR24 with 12 or 24 Weeks of Total Treatment in Treatment-Naive Patients with HCV Genotype 4 Infection in the DAUPHINE Study - (11/26/12)   Everolimus-Facilitated Reduction of Tacrolimus Provides Comparable Efficacy and Superior Renal Function versus Standard Tacrolimus in De Novo Liver Transplant Recipients: 24-month Results of a Randomized Trial - (11/26/12)   Coadministration of Ritonavir with the HCV Protease Inhibitor Danoprevir Substantially Reduces Reactive Metabolite Formation Both In Vitro and In Vivo - (11/26/12)   The outcome of 24 vs. 48 weeks of peginterferon alfa-2a (40KD) plus ribavirin on sustained virologic response rates in patients infected with genotype 2 or 3 hepatitis C virus who do not achieve a rapid viral response: the N-CORE study - (11/26/12)   Sustained Virological Response (SVR) Rate of 67% in HCV Genotype 1-Infected Prior Null Responders Treated with Danoprevir/Ritonavir (DNVr) in Combination with Peginterferon Alfa-2a (40KD) plus Ribavirin (PegIFN Alfa-2a/RBV) - (11/26/12)   Safety and efficacy of telaprevir or boceprevir in combination with peginterferon alfa/ribavirin, in 497 cirrhotic non responders. Week 16 analysis of the French early access program (ANRS CO20-CUPIC) in real-life setting) - (11/20/12)   Daclatasvir, an NS5A Replication Complex Inhibitor, Combined With Peginterferon Alfa-2a and Ribavirin in Treatment-Naive HCV-Genotype 1 or 4 Patients: Phase 2b COMMAND-1 SVR12 Results - (11/20/12)   Twelve- or 16-Week Treatment With Daclatasvir Combined With Peginterferon Alfa and Ribavirin for Hepatitis C Virus Genotype 2 or 3 Infection: COMMAND GT 2/3 Study - (11/20/12)   Treatment of Hepatitis C Genotype 1 Patients with Severe Fibrosis or Compensated Cirrhosis: The International Telaprevir Early Access Program - (11/19/12)   New treatment strategy: switching from long-term entecavir to peginterferon alfa-2a (40 kD) induces HBeAg seroconversion/HBsAg loss in patients with HBeAg-positive chronic hepatitis B (The OSST study) - (11/19/12)   Six Years of Treatment With Tenofovir Disoproxil Fumarate for Chronic Hepatitis B Virus Infection Is Safe and Well Tolerated and Associated With Sustained Virological, Biochemical, and Serological Responses With No Detectable Resistance - (11/19/12)   Antiviral Efficacy of Entecavir in Black/African American and Hispanic Patients with Chronic Hepatitis B who are Nucleos(t)ide Naïve - (11/19/12)   SWITCHING TO TENOFOVIR IS SAFE IN MOST CHRONIC HEPATITIS B PATIENTS WITH A REDUCED GLOMERULAR FILTRATION RATE DUE TO PREVIOUS EXPOSURE TO ADEFOVIR DIPIVOXIL - (11/19/12)   Entecavir treatment for NUC naïve, field practice patients with chronic hepatitis B: excellent viral suppression and safety profile over 5 years of treatment - (11/19/12)   Tenofovir monotherapy suppressed viral replication in most field practice, treatment-naïve patients with CHB followed for 3 years in a multicenter European study - (11/19/12)   Nucleos(t)ide analogues can be safely discontinued in CHB patients achieving HBsAg clearance - (11/19/12)   Week 24 and End of Treatment Response for Direct Acting Antiviral (DAA)-Based Therapy in Veterans With Chronic Hepatitis C - (11/19/12)   Peginterferon Lambda-1a (Lambda) Compared With Peginterferon Alfa-2a (Alfa) in Treatment-Naive Patients With HCV Genotypes 1 or 4: SVR24 Results From EMERGE Phase 2b - (11/15/12)   First Report of Peginterferon Lambda/Ribavirin in Combination With Either Daclatasvir or Asunaprevir in HCV Genotype 1 Japanese Patients: Early Sustained Virologic Response (SVR4) Results From the D-LITE Japanese Substudy - (11/15/12)   Timing and Magnitude of Ribavirin Dose Reduction do not impact SVR with Boceprevir + Peginterferon / Ribavirin in the Anemia Management Study in HCV G1 Patients - (11/15/12)   PPI-668, A Potent New Pan-Genotypic HCV NS5A Inhibitor: Phase 1 Efficacy and Safety - (11/15/12)   Alisporivir (ALV) plus Peg-interferon/Ribavirin (P/R) Achieves High On-Treatment Undetectable HCV RNA Levels Among the Most Difficult to Treat HCV G1 Patients. Results of a Planned Treatment Week 24 Interim Analysis of a Randomized, Double Blind, Placebo Controlled Trial (FUNDAMENTAL study) - (11/15/12)   Alisporivir plus Ribavirin achieves high rates of sustained HCV clearance (SVR24) as interferon (IFN)-free or IFN-add-on regimen in treatment-naive patients with HCV GT2 or GT3: Final results from VITAL-1 study - (11/15/12)   Once Daily Sofosbuvir (GS-7977) Regimens in HCV Genotype 1-3: The ELECTRON Trial - (11/14/12)   GILEAD ANNOUNCES 100 PERCENT SUSTAINED VIROLOGIC RESPONSE RATE (SVR4) FOR AN INTERFERON-FREE REGIMEN OF SOFOSBUVIR (GS-7977), GS-5885 AND RIBAVIRIN IN TREATMENT-NAïVE GENOTYPE 1 HEPATITIS C INFECTED PATIENTS - (11/14/12)   Abbott Presents Promising Phase 2b Interferon-free Hepatitis C Results at 2012 Liver Meeting® - (11/14/12)   Data from Viral Kinetic Study Showed Rapid Reduction of HCV RNA with ALS-2200 (VX-135), Vertex's Oral Nucleotide Analogue in Development for the Treatment of Hepatitis C - (11/14/12)   Vertex Presents New Phase 3 Data that Showed People with Hepatitis C Treated with Twice-Daily Telaprevir Achieved Viral Cure (SVR12) Rates Similar to Those Treated Three Times Daily - (11/14/12)   Boehringer Ingelheim's interferon-free all-oral hepatitis C treatment+ shows up to 85% viral cure in Phase II study including patients with advanced liver disease - (11/14/12)   Investigational Hepatitis C Dual DAA Regimen of Daclatasvir and Asunaprevir Achieved SVR12 in 78% of Difficult-to-Treat Genotype 1b Prior Null Responders In Expanded Phase II Study - (11/14/12)   Investigational Triple DAA Regimen of Daclatasvir, Asunaprevir and BMS-791325 Achieved SVR12 of 94% in Treatment-Naïve Patients with Genotype 1 Chronic Hepatitis C Infection in Phase II Trial - (11/14/12)   Bristol-Myers Squibb's Investigational Hepatitis C Compounds Lambda and Daclatasvir Plus Ribavirin Achieved SVR12 in 93% of Genotype 1b Treatment-Naive Patients In Phase IIb Study - (11/14/12)   Gilead Announces 100 Percent Sustained Virologic Response Rate (SVR4) for an Interferon-Free Regimen of Sofosbuvir (GS-7977), GS-5885 and Ribavirin in Treatment-Naïve Genotype 1 Hepatitis C Infected Patients - (11/14/12)   Once Daily Sofosbuvir (GS-7977) plus PEG/RBV In Treatment-Naïve Patients With HCV Genotype 1, 4, and 6 Infection: The ATOMIC Study - (11/14/12)   INTERFERON (IFN)-FREE COMBINATION TREATMENT WITH THE HCV NS3/4A PROTEASE INHIBITOR FALDAPREVIR (BI 201335) AND THE NON-NUCLEOSIDE NS5B INHIBITOR BI 207127 ± RIBAVIRIN: FINAL RESULTS OF SOUND-C2 AND PREDICTORS OF RESPONSE - (11/14/12)   EFFICACY AND SAFETY OF THE INTERFERON-FREE COMBINATION OF FALDAPREVIR (BI 201335) + BI 207127 ± RIBAVIRIN IN TREATMENT-NAIVE PATIENTS WITH HCV GT-1 AND COMPENSATED LIVER CIRRHOSIS: RESULTS FROM THE SOUND-C2 STUDY - (11/14/12)   Efficacy and tolerability of simeprevir (TMC435) 150 mg once daily with peginterferon and ribavirin for treatment of HCV genotype 1 infection in patients with Metavir score F3 and F4 (PILLAR and ASPIRE trials) - (11/13/12)   OPTIMIZE Trial: Noninferiority of Twice-daily Telaprevir Versus Administration Every 8 Hours inTreatment-naïve, Genotype 1 HCV-infected Patients - (11/13/12)   Safety and tolerability of simeprevir (TMC435) in combination with peginterferon a-2a and ribavirin for treatment of HCV genotype 1 infection in treatment-naïve and -experienced patients (Phase IIb PILLAR and ASPIRE Trials) - (11/13/12)   Sustained Virologic Response in Chronic HCV Genotype (GT) 1-Infected Null Responders With Combination of Daclatasvir (DCV; NS5A Inhibitor) and Asunaprevir (ASV; NS3 Inhibitor) With or Without Peginterferon Alfa-2a/Ribavirin (PEG/RBV) - (11/13/12)   Up to 100% SVR4 rates with ritonavir-boosted danoprevir (DNVr), mericitabine and ribavirin with or without peginterferon alfa-2a (40KD) in HCV genotype 1-infected partial and null responders: results from the MATTERHORN study - (11/13/12)   Safety and efficacy of ritonavir-boosted danoprevir (DNVr), peginterferon alfa-2a (40KD), and ribavirin with or without mericitabine in HCV genotype 1-infected treatment-experienced patients with advanced hepatic fibrosis: the MATTERHORN study - (11/13/12)   ALS-2200, A Novel Once-daily Nucleotide HCV Polymerase Inhibitor, Demonstrates Potent Antiviral Activity Over 7 Days in Treatmentnaïve Genotype 1 (GT1) Patients - (11/13/12)   Safety and Sustained Viral Response of MK-5172 for 12 Weeks in Combination With Pegylated Interferon Alfa-2b and Ribavirin for 24 Weeks in HCV Genotype 1 Treatment-Naive Noncirrhotic Patients - (11/13/12)   A Combination Containing MK-5172 (HCV NS3 protease inhibitor) and MK-8742 (HCV NS5A inhibitor) Demonstrates High Barrier to Resistance in HCV Replicon - (11/13/12)   A 12-week Interferon-free Treatment Regimen With ABT-450/r, ABT 267, ABT-333, and Ribavirin Achieves SVR12 Rates (Observed Data) of 99% in Treatment-naïve Patients and 93% in Prior Null Responders With HCV Genotype 1 Infection - (11/13/12)   High Efficacy of GS-7977 in Combination with Low or Full dose Ribavirin for 24 weeks in Difficult to Treat HCV Infected Genotype 1 Patients - (11/13/12)   An Interferon-Free, Ribavirin-Free 12-Week Regimen of Daclatasvir (DCV), Asunaprevir (ASV), and BMS-791325 Yielded SVR4 of 94% in Treatment-Naïve Patients with Genotype (GT) 1 Chronic Hepatitis C Virus (HCV) Infection - (11/13/12)   High Rate of Sustained Virologic Response With the All-Oral Combination of Daclatasvir (NS5A Inhibitor) Plus Sofosbuvir (Nucleotide NS5B Inhibitor), With or Without Ribavirin, in Treatment-Naive Patients Chronically Infected With HCV GT 1, 2, or 3 - (11/13/12)   Telaprevir in Combination with Peginterferon Alfa-2a/Ribavirin in HCV/HIV Co-infected Patients: SVR24 Final Study Results - (11/13/12)   The NS5A Inhibitor GS-5885 Is Safe and Well Tolerated in More Than 1000 Patients Treated in Phase 2 Studies - (11/13/12)   Comprehensive Resistance Testing in Patients Who Relapsed After Treatment With Sofosbuvir (GS-7977)-Containing Regimens in Phase 2 Studies - (11/13/12)   In Vitro Analyses of Hepatitis C Virus NS5B S282T Mutants in Multiple HCV Genotypes Show Low Levels of Reduced Susceptibility to Sofosbuvir (GS-7977), No Cross Resistance to Other Classes of Direct-Acting Antivirals, and Hypersensitivity to Ribavirin - (11/13/12)   Six Weeks of an NS5A Inhibitor (GS-5885) and a Protease Inhibitor (GS-9451) Plus Peginterferon+Ribavirin Achieves High SVR4 Rates in Genotype 1 IL28B CC Treatment-Naïve Hepatitis C Virus Patients: Interim Results of a Prospective, Randomized Trial - (11/13/12)