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HCV 99.7% SVR-Cure Rates in GT1a
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from Jules: essentially in treatment-naive GT1 we have 99.7% SVR-cure rates with 1 relapse or viral failure in each of the Mavyret or Epclusa studies of hundreds of patients with either 8 or 12 weeks therapy. Mavyret approved for 8 weeks in GT1 treatment-naives. Vosevi (SOF/Velapasvir/Voxilaprevir) is the approved regimen for previously DAA treated failures. As stated in FDA PI - Mavyret is also indicated for the treatment of adult patients with HCV genotype 1 infection, who previously have been treated with a regimen containing an HCV NS5A inhibitor or an NS3/4A protease inhibitor, but not both - study results below. Visevi FDA PI says - is indicated for the treatment of adult patients with chronic HCV infection without cirrhosis or with compensated cirrhosis (Child-Pugh A) who have (1, 2.2, 14): • genotype 1, 2, 3, 4, 5, or 6 infection and have previously been treated with an HCV regimen containing an NS5A inhibitor. • genotype 1a or 3 infection and have previously been treated with an HCV regimen containing sofosbuvir without an NS5A inhibitor. SOF+G/P has been studied, reported results below & effective. Treating former or current IV drug users is no longer contraindicated, as stated by AASLD/IDSA guidelines and it is commonly said now by leading HCV treaters that IVDUs can & should be treated, of course support is needed for these patients regarding adherence & reinfection, reported studies below show good SVR-cure rates for these patients: Simplify, Prevail, C-Edge Co-Star studies.HCV/HIV coinfected respond equally well to HCV therapy. Studies for reatment for HCV patients with kidney disease show excellent results, studies reported below.
AASLD: ENDURANCE-1: A Phase 3 Evaluation of the Efficacy and Safety of 8- versus 12-week Treatment with Glecaprevir/Pibrentasvir (formerly ABT-493/ABT-530) in HCV Genotype 1 Infected Patients with or without HIV-1 Co-infection and without Cirrhosis - (11/15/16)
AASLD: ENDURANCE-2: Safety and Efficacy of Glecaprevir/Pibrentasvir in Hepatitis C Virus Genotype 2-infected Patients without Cirrhosis: a Randomized, Double-Blind, Placebo-Controlled Study - (11/14/16)
AASLD: EXPEDITION-4: EFFICACY AND SAFETY OF GLECAPREVIR/PIBRENTASVIR (ABT-493/ABT-530) IN PATIENTS WITH RENAL IMPAIRMENT AND CHRONIC HEPATITIS C VIRUS GENOTYPE 1 - 6 INFECTION - (11/15/16)
AASLD: SURVEYOR-II, PART 3: EFFICACY AND SAFETY OF GLECAPREVIR/PIBRENTASVIR (ABT-493/ABT-530) IN PATIENTS WITH HEPATITIS C VIRUS GENOTYPE 3 INFECTION WITH PRIOR TREATMENT EXPERIENCE AND/OR CIRRHOSIS - (11/14/16)
AASLD: SURVEYOR-II, Part 4: Glecaprevir/Pibrentasvir Demonstrates High SVR Rates in Patients With HCV Genotype 2, 4, 5, or 6 Infection Without Cirrhosis Following an 8-Week Treatment Duration - (11/16/16)
AASLD: ENDURANCE-4: Efficacy and Safety of Glecaprevir/Pibrentasvir (Formerly ABT-493/ABT-530) Treatment in Patients with Chronic HCV Genotype 4, 5, or 6 Infection - (11/14/16)
Efficacy and Safety of Glecaprevir/Pibrentasvir in Renally-Impaired Patients With Chronic HCV Genotype 1-6 Infection - (04/12/18)
AASLD: A Phase 3 Double-Blind Placebo-Controlled Evaluation of Sofosbuvir/Velpatasvir Fixed-Dose Combination for 12 Weeks in Genotype 1, 2, 4, 5, 6 HCV-Infected Patients: Results of the ASTRAL-1 Study - (11/17/15) published: http://www.natap.org/2015/AASLD/AASLD_52.htm
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)
Safety and Efficacy of Sofosbuvir/Velpatasvir with and without Ribavirin in Genotype 3 HCV-Infected Patients with Cirrhosis - (04/13/18)
AASLD: Sofosbuvir/Velpatasvir Fixed-Dose Combination for the Treatment of HCV in Patients With Decompensated Liver Disease: the Phase 3 ASTRAL-4 Study / ASTRAL 1, 2 and 3 - (11/30/15)
Sofosbuvir/Velpatasvir for 12 Weeks in Patients
Coinfected With HCV and HIV-1: The ASTRAL-5 Study
Sofosbuvir and Velpatasvir for the Treatment of HCV in Patients Coinfected with HIV-1: an Open-Label, Phase 3 Study - (04/12/17)
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)
8 weeks sofosbuvir/velpatasvir in genotype 3 patients with significant fibrosis: Highly effective amongst an OST cohort - (04/13/18)
Resistance Analysis in 1284 Patients With Genotype 1-6 HCV Infection Treated With Sofosbuvir/Velpatasvir in the Phase 3 ASTRAL-1, ASTRAL-2, ASTRAL-3, and ASTRAL-4 Studies
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
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)
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)
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)
RETREATMENT OF HEPATITIS C VIRUS INFECTION IN PATIENTS WHO FAILED GLECAPREVIR/PIBRENTASVIR - (04/12/18)
Phase 3b, Multi-Center, Randomized, Open-Label, Pragmatic Study of Glecaprevir/Pibrentasvir (G/P) +/- Ribavirin for GT1 Subjects with Chronic Hepatitis C Previously Treated with an NS5A Inhibitor + Sofosbuvir Therapy - (04/16/18)
AASLD: Prevalence and Impact of Baseline NS5A Resistance-Associated Variants (RAVs) on the Efficacy of Elbasvir/Grazoprevir (EBR/GZR) Against GT1a Infection - 16 Weeks vs 12 weeks - (11/23/15)
AASLD: The Combination of Elbasvir and Grazoprevir ± RBV Is Highly Effective for the Treatment of GT1a-Infected Patients
APASL/2018: REAL-WORLD EFFECTIVENESS OF 12 WEEK ELBASVIR/GRAZOPREVIR (EBR-GZR) IN PATIENTS WITH GENOTYPE 1 (GT1) CHRONIC HEPATITIS C (HCV) AND CHRONIC KIDNEY DISEASE (CKD): RETROSPECTIVE DATA ANALYSES FROM THE TRIO NETWORK
EASL/2018: UTILIZATION OF ELBASVIR / GRAZOPREVIR (EBR/GZR) AND ADOPTION OF RESISTANCE ASSOCIATED SUBSTITUTIONS (RAS) TESTING IN REAL-WORLD TREATMENT OF HCV GENOTYPE 1 (GT1) INFECTION: RESULTS FROM THE GERMAN HEPATITIS C REGISTRY (DHC-R)
EASL/2018: Effectiveness of Elbasvir/Grazoprevir in Patients with Cirrhotic Genotype
1 or 4 Chronic Hepatitis C: Updated Retrospective Data Analyses from the TRIO Network
C-SURFER: GRAZOPREVIR PLUS ELBASVIR IN TREATMENT-NAIVE AND TREATMENT-EXPERIENCED PATIENTS WITH HEPATITIS C VIRUS GENOTYPE 1 INFECTION AND CHRONIC KIDNEY DISEASE - (04/23/15)
THE PHASE 3 C-EDGE TREATMENT-NAIVE (TN) STUDY OF A 12-WEEK ORAL REGIMEN OF GRAZOPREVIR (GZR, MK-5172)/ELBASVIR (EBR, MK-8742) IN PATIENTS WITH CHRONIC HCV GENOTYPE (GT) 1, 4, OR 6 INFECTION - (04/24/15)
C-EDGE COINFECTION: PHASE 3 STUDY OF GRAZOPREVIR/ELBASVIR IN PATIENTS WITH HCV/HIV - (04/23/15)
EFFICACY AND SAFETY OF GRAZOPREVIR/ELBASVIR +/- RBV FOR 12 OR 16 WEEKS IN PATIENTS WITH HCV G1, G4 OR G6 INFECTION WHO PREVIOUSLY FAILED PEGINTERFERON/RBV: C-EDGE TREATMENT-EXPERIENCED - (04/23/15)
EASL: The PREVAIL Study: Intensive Models of HCV Care for People Who Inject Drugs - (04/26/17)
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)
C-EDGE CO-STAR: Interim Results From the 3-year Follow-up Trial on Risk Factors and Rate of Reinfection in Patients on Opiate Agonist Therapy Previously Treated With Elbasvir/Grazoprevir for 12 Weeks
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