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- |||| voxilaprevir (GS-9857) / Gilead, Sovaldi (sofosbuvir) / Gilead
Clinical: This was an informative case: Sofosbuvir, Velpatasvir, and Voxilaprevir for Treatment of Recurrent Hepatitis C Virus Infection After Liver Transplantation https://t.co/TZGlAsol8T (Twitter) - Nov 14, 2019
- | voxilaprevir (GS-9857) / Gilead, Sovaldi (sofosbuvir) / Gilead
Clinical, Journal: Patient-Reported Outcomes Following Treatment of Chronic Hepatitis C Virus Infection With Sofosbuvir and Velpatasvir, With or Without Voxilaprevir. (Pubmed Central) - Oct 26, 2019
In an analysis of data from 2 phase 3 clinical trials of patients with chronic HCV infection of any genotype, we found the combination of sofosbuvir, velpatasvir, with or without voxilaprevir, to increase PRO scores compared with placebo. These findings indicate the comprehensive benefit of these regimens during treatment and after SVR.
- | velpatasvir (GS-5816) / Gilead, voxilaprevir (GS-9857) / Gilead
Clinical, Journal: Hepatitis C in Patients with Minimal or No Hepatic Fibrosis: The Impact of Treatment and Sustained Virologic Response on Patient-Reported Outcomes. (Pubmed Central) - Oct 18, 2019
In multivariate analysis, receiving interferon-containing (β=-5.3 to -28.5, p<0.01) or interferon-free ribavirin-containing (β=-2.8 to -10.6, p<0.01) regimens were predictive of PRO impairments during and after treatment. HCV subjects with none or minimal fibrosis treated with interferon- and ribavirin-free regimens experience on-treatment and post-SVR PRO improvements.
- | voxilaprevir (GS-9857) / Gilead, Sovaldi (sofosbuvir) / Gilead
Journal: Computational analysis of naturally occurring resistance-associated substitutions in genes NS3, NS5A, and NS5B among 86 subtypes of hepatitis C virus worldwide. (Pubmed Central) - Oct 3, 2019
For example, D168E, highly resistanct to all protease inhibitors except voxilaprevir, was nearly absent in all subtypes except in 43.48% of GT5a sequences...A150V in GT3a, associated with sofosbuvir treatment failure, was most prevalent in Asia (44.09%), followed by Europe (31.19%), Oceania (24.29%), and North America (19.05%)...Considering the specific RASs prevalence will help the clinicians to make optimal treatment choices. The RASs pairs would benefit anti-HCV drug development.
- velpatasvir (GS-5816) / Gilead, voxilaprevir (GS-9857) / Gilead
CLINICAL AND VIROLOGICAL CHARACTERISTICS AND RETREATMENT OF HCV-INFECTED PATIENTS WITH FAILURE TO MULTIPLE SUBSEQUENT DAA THERAPIES (Hynes Convention Center, Hall B) - Sep 29, 2019 - Abstract #AASLD2019AASLD_2722;
We observed multiple DAA treatment failures in real-world to all approved DAA regimens and GT3, cirrhosis and NS5A RASs were highly prevalent. Virologic response to VOX/VEL/SOF was still above 90% even in patients with failure to multiple previous DAA-therapies.
- voxilaprevir (GS-9857) / Gilead
EARLY PLASMA AND INTRAHEPATIC HEPATITIS C VIRUS KINETICS DURING DAA TREATMENT WITH SOFOSBUVIR, VELPATASVIR, AND VOXILAPREVIR (Hynes Convention Center, Hall B) - Sep 29, 2019 - Abstract #AASLD2019AASLD_2457;
Combination DAA therapy with sofosbuvir and velpatasvir potently reduced plasma and liver HCV; intensification with voxilaprevir enhanced the reduction in both compartments. By extrapolating, we predict that SVV treatment might decrease the time to HCV clearance in this cohort by 10 days: a predicted time to clearance of <56 days would have occurred in 4/5 taking SVV compared to 2/5 taking SV.
- Zepatier (grazoprevir/elbasvir) / Merck (MSD), voxilaprevir (GS-9857) / Gilead
EFFECTIVENESS OF SOFOSBUVIR/VELPATASVIR AND ELBASVIR/GRAZOPREVIR FOR THE TREATMENT OF HCV GENOTYPE 1 INFECTION IN A REAL-WORLD COHORT WITH NUMEROUS PEOPLE WHO USE DRUGS (PWUD) (Hynes Convention Center, Hall B) - Sep 29, 2019 - Abstract #AASLD2019AASLD_2431;
This was accompanied by a LTFU rate of 10% overall, increasing the reliability of the results within the entire target population. Despite the perceived challenges of HCV treatment among PWUD, very high success rates can be achieved with two currently available single tablet regimens, and LTFU can be minimized within the system of care in place at our centre.
- velpatasvir (GS-5816) / Gilead, voxilaprevir (GS-9857) / Gilead, Daklinza (daclatasvir) / BMS
HAS REAL LIFE EFFICACY OF SOFOSBUVIR-BASED REGIMENS CHANGED OVER TIME? FINDINGS FROM THE ANRS CO22 HEPATHER COHORT (Hynes Convention Center, Hall B) - Sep 29, 2019 - Abstract #AASLD2019AASLD_2194;
P=N/A
In May 2018, 8278 patients with a least a 12 weeks post-treatmentfollow-uphad been treated with sofosbuvirin combination for 12 weeks with Ribavirin (RBV)(n =342, median date of prescription April 2014), Simeprevir (n=1033, October 2014, 14.5% with RBV and 8.8/4.7% for 24 weeks for cirrhotic/non cirrhotic patients), Daclatasvir (n=2755, January 2015, 30.4% with RBV and 64.5/27.4% for 24 weeks for cirrhotic/non cirrhotic patients), Ledipasvir (n=3526, November 2015, 50.3% with RBV and 16.0/2.8% for 24 weeks for cirrhotic/non cirrhotic patients), Velpatasvir (n=583, September 2017) and Velpatasvir+Voxilaprevir (n =39 for DAA failures, April 2018). In this large prospective cohort of French patients treated for HCV by a sofosbuvir- including regimen, SVR12 rates was greater than 95% in most of patients and did not significantly changed over time with the prioritization of the DAA combinations.
- | voxilaprevir (GS-9857) / Gilead
Journal, Monotherapy: Characterization of HCV resistance from a 3-day monotherapy study of voxilaprevir, a novel pangenotypic NS3/4A protease inhibitor. (Pubmed Central) - Sep 28, 2019
P1
In this large prospective cohort of French patients treated for HCV by a sofosbuvir- including regimen, SVR12 rates was greater than 95% in most of patients and did not significantly changed over time with the prioritization of the DAA combinations. The lack of selection of NS3 RASs in the majority of patients demonstrates a high resistance barrier for VOX.
- | Vosevi (sofosbuvir/velpatasvir/voxilaprevir) / Gilead, voxilaprevir (GS-9857) / Gilead
Enrollment open, Trial initiation date: Simplifying HCV Treatment in Rwanda for Elsewhere in the Developing World: Pangenotypic and Retreatment Study (SHARED3) (clinicaltrials.gov) - Sep 11, 2019
P4, N=100, Recruiting, Sponsor: Partners in Health
The lack of selection of NS3 RASs in the majority of patients demonstrates a high resistance barrier for VOX. Not yet recruiting --> Recruiting | Initiation date: May 2019 --> Aug 2019
- voxilaprevir (GS-9857) / Gilead, Sovaldi (sofosbuvir) / Gilead
A Rare Case of Alloimmune Hepatitis Induced After Direct-Acting Antiviral Treatment in a Liver Transplant Patient (Exhibit Halls 3 and 4 (Street Level)) - Aug 8, 2019 - Abstract #ACG2019ACG_2964;
Treatment was started with sofosbuvir, velpatasvir, and voxilaprevir...The patient was started on IV methylprednisolone and N-acetyl cysteine...In summary, we report a rare case of alloimmune hepatitis in a liver transplant patient with recurrent HCV responding to DAAs and steroid. Thorough follow up of patients undergoing DAA therapy after liver transplantation for alloimmune hepatitis is warranted.
- ||| voxilaprevir (GS-9857) / Gilead, Sovaldi (sofosbuvir) / Gilead
New #AusPAR for #Vosevi [#Sofosbuvir / #Velpatasvir / #Voxilaprevir] for #HCV treatment: https://t.co/Qwqy4YLqjj (Twitter) - May 8, 2019
- | Vosevi (sofosbuvir/velpatasvir/voxilaprevir) / Gilead, voxilaprevir (GS-9857) / Gilead
New P4 trial: Simplifying HCV Treatment in Rwanda for Elsewhere in the Developing World: Pangenotypic and Retreatment Study (SHARED3) (clinicaltrials.gov) - Mar 25, 2019
P4, N=100, Not yet recruiting, Sponsor: Partners in Health
- | P3 data, Journal: Sofosbuvir-Based Direct-Acting Antiviral Therapies for HCV in People Receiving Opioid Substitution Therapy: An Analysis of Phase 3 Studies. (Pubmed Central) - Feb 18, 2018
Among patients receiving OST, SVR12 was high among those receiving methadone (95%) and buprenorphine (96%). Sofosbuvir-based therapies are effective and safe in patients receiving OST.
- | velpatasvir (GS-5816) / Gilead, voxilaprevir (GS-9857) / Gilead
Journal: Efficacy of 8 Weeks of Sofosbuvir, Velpatasvir, and Voxilaprevir In Patients With Chronic HCV Infection: 2 Phase 3 Randomized Trials. (Pubmed Central) - Sep 8, 2017
P3
Mild gastrointestinal adverse events were associated with treatment regimens that included voxilaprevir. ClinicalTrials.gov numbers: POLARIS-2, NCT02607800; and POLARIS-3, NCT02639338.
- | velpatasvir (GS-5816) / Gilead, voxilaprevir (GS-9857) / Gilead
Journal: Sofosbuvir, Velpatasvir, and Voxilaprevir for Previously Treated HCV Infection. (Pubmed Central) - Jun 21, 2017
P3
Sofosbuvir-velpatasvir-voxilaprevir taken for 12 weeks provided high rates of sustained virologic response among patients across HCV genotypes in whom treatment with a DAA regimen had previously failed. (Funded by Gilead Sciences; POLARIS-1 and POLARIS-4 ClinicalTrials.gov numbers, NCT02607735 and NCT02639247 .).
- | velpatasvir (GS-5816) / Gilead, voxilaprevir (GS-9857) / Gilead
Journal: Efficacy of Sofosbuvir, Velpatasvir, and GS-9857 in Patients with Genotype 1 Hepatitis C Virus Infection in an Open-label, Phase 2 Trial. (Pubmed Central) - Jun 2, 2017
P2
The combination was safe and effective in patients with or without compensated cirrhosis. Clinicaltrials.gov no: NCT02378935.
- |||| voxilaprevir (GS-9857) / Gilead
Trial completion: LEPTON: Efficacy and Safety of Oral Regimens for the Treatment of Chronic HCV Infection (clinicaltrials.gov) - May 14, 2016
P2, N=269, Completed, Sponsor: Gilead Sciences
Clinicaltrials.gov no: NCT02378935. Active, not recruiting --> Completed
- |||| Vosevi (sofosbuvir/velpatasvir/voxilaprevir) / Gilead, voxilaprevir (GS-9857) / Gilead
Trial completion: Safety and Efficacy of Voxilaprevir Plus Sofosbuvir/Velpatasvir Fixed Dose Combination in Adults With Chronic Genotype 1 HCV Infection (clinicaltrials.gov) - Apr 19, 2016
P2, N=205, Completed, Sponsor: Gilead Sciences
Active, not recruiting --> Completed Active, not recruiting --> Completed
- | voxilaprevir (GS-9857) / Gilead
Trial completion: Pharmacokinetics of Voxilaprevir in Adults With Normal Hepatic Function and Moderate or Severe Hepatic Impairment (clinicaltrials.gov) - Mar 18, 2016
P1, N=33, Completed, Sponsor: Gilead Sciences
Active, not recruiting --> Completed Recruiting --> Completed
- |||| Vosevi (sofosbuvir/velpatasvir/voxilaprevir) / Gilead, voxilaprevir (GS-9857) / Gilead
Trial completion: Safety and Efficacy of Voxilaprevir Plus Sofosbuvir/Velpatasvir Fixed Dose Combination in Adults With Chronic Non-Genotype 1 HCV Infection (clinicaltrials.gov) - Jan 11, 2016
P2, N=128, Completed, Sponsor: Gilead Sciences
Recruiting --> Completed Active, not recruiting --> Completed
- ||| Vosevi (sofosbuvir/velpatasvir/voxilaprevir) / Gilead, voxilaprevir (GS-9857) / Gilead
Enrollment change, Trial primary completion date: Safety and Efficacy of Voxilaprevir Plus Sofosbuvir/Velpatasvir Fixed Dose Combination in Adults With Chronic Non-Genotype 1 HCV Infection (clinicaltrials.gov) - Oct 23, 2015
P2, N=128, Active, not recruiting, Sponsor: Gilead Sciences
Active, not recruiting --> Completed N=210 --> 128 | Trial primary completion date: Feb 2016 --> Sep 2015
- | voxilaprevir (GS-9857) / Gilead
Trial completion: Pharmacokinetics of Voxilaprevir in Adults With Normal Renal Function and Severe Renal Impairment (clinicaltrials.gov) - Oct 14, 2015
P1, N=20, Completed, Sponsor: Gilead Sciences
N=210 --> 128 | Trial primary completion date: Feb 2016 --> Sep 2015 Active, not recruiting --> Completed
- ||| voxilaprevir (GS-9857) / Gilead
Trial completion: Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of Voxilaprevir in Adults With Chronic Hepatitis C Virus Infection (clinicaltrials.gov) - Oct 14, 2015
P1, N=100, Completed, Sponsor: Gilead Sciences
Active, not recruiting --> Completed Active, not recruiting --> Completed
- ||| Vosevi (sofosbuvir/velpatasvir/voxilaprevir) / Gilead, voxilaprevir (GS-9857) / Gilead
Enrollment closed: Safety and Efficacy of Voxilaprevir Plus Sofosbuvir/Velpatasvir Fixed Dose Combination in Adults With Chronic Genotype 1 HCV Infection (clinicaltrials.gov) - Sep 24, 2015
P2, N=205, Active, not recruiting, Sponsor: Gilead Sciences
Active, not recruiting --> Completed Recruiting --> Active, not recruiting
- voxilaprevir (GS-9857) / Gilead
Enrollment closed: Pharmacokinetics of Voxilaprevir in Adults With Normal Renal Function and Severe Renal Impairment (clinicaltrials.gov) - Sep 24, 2015
P1, N=20, Active, not recruiting, Sponsor: Gilead Sciences
Recruiting --> Active, not recruiting Recruiting --> Active, not recruiting
- ||| voxilaprevir (GS-9857) / Gilead
Enrollment closed: LEPTON: Efficacy and Safety of Oral Regimens for the Treatment of Chronic HCV Infection (clinicaltrials.gov) - Sep 15, 2015
P2, N=295, Active, not recruiting, Sponsor: Gilead Sciences
Recruiting --> Active, not recruiting Recruiting --> Active, not recruiting
- |||| Vosevi (sofosbuvir/velpatasvir/voxilaprevir) / Gilead, voxilaprevir (GS-9857) / Gilead
Enrollment open: Safety and Efficacy of Voxilaprevir Plus Sofosbuvir/Velpatasvir Fixed Dose Combination in Adults With Chronic Genotype 1 HCV Infection (clinicaltrials.gov) - Aug 5, 2015
P2, N=218, Recruiting, Sponsor: Gilead Sciences
Recruiting --> Active, not recruiting Active, not recruiting --> Recruiting
- voxilaprevir (GS-9857) / Gilead
Trial primary completion date: LEPTON: Efficacy and Safety of Oral Regimens for the Treatment of Chronic HCV Infection (clinicaltrials.gov) - Jul 16, 2015
P2, N=295, Recruiting, Sponsor: Gilead Sciences
Active, not recruiting --> Recruiting Trial primary completion date: Oct 2015 --> Apr 2016
- ||| Vosevi (sofosbuvir/velpatasvir/voxilaprevir) / Gilead, voxilaprevir (GS-9857) / Gilead
Enrollment closed: Safety and Efficacy of Voxilaprevir Plus Sofosbuvir/Velpatasvir Fixed Dose Combination in Adults With Chronic Genotype 1 HCV Infection (clinicaltrials.gov) - May 19, 2015
P2, N=218, Active, not recruiting, Sponsor: Gilead Sciences
Trial primary completion date: Oct 2015 --> Apr 2016 Recruiting --> Active, not recruiting
- ||| Vosevi (sofosbuvir/velpatasvir/voxilaprevir) / Gilead, voxilaprevir (GS-9857) / Gilead
Enrollment closed: Safety and Efficacy of Voxilaprevir Plus Sofosbuvir/Velpatasvir Fixed Dose Combination in Adults With Chronic Non-Genotype 1 HCV Infection (clinicaltrials.gov) - May 19, 2015
P2, N=210, Active, not recruiting, Sponsor: Gilead Sciences
Recruiting --> Active, not recruiting Recruiting --> Active, not recruiting
- voxilaprevir (GS-9857) / Gilead
Enrollment open: Pharmacokinetics of Voxilaprevir in Adults With Normal Renal Function and Severe Renal Impairment (clinicaltrials.gov) - May 8, 2015
P1, N=20, Recruiting, Sponsor: Gilead Sciences
Recruiting --> Active, not recruiting Not yet recruiting --> Recruiting
- | voxilaprevir (GS-9857) / Gilead
New P1 trial: Pharmacokinetics of Voxilaprevir in Adults With Normal Renal Function and Severe Renal Impairment (clinicaltrials.gov) - Apr 2, 2015
P1, N=20, Not yet recruiting, Sponsor: Gilead Sciences
- | voxilaprevir (GS-9857) / Gilead
New P1 trial: Pharmacokinetics of Voxilaprevir in Adults With Normal Hepatic Function and Moderate or Severe Hepatic Impairment (clinicaltrials.gov) - Mar 25, 2015
P1, N=40, Recruiting, Sponsor: Gilead Sciences
- || voxilaprevir (GS-9857) / Gilead
Enrollment closed: Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of Voxilaprevir in Adults With Chronic Hepatitis C Virus Infection (clinicaltrials.gov) - Mar 12, 2015
P1, N=100, Active, not recruiting, Sponsor: Gilead Sciences
Not yet recruiting --> Recruiting Recruiting --> Active, not recruiting
- ||||| Vosevi (sofosbuvir/velpatasvir/voxilaprevir) / Gilead, voxilaprevir (GS-9857) / Gilead
New P2 trial: Safety and Efficacy of Voxilaprevir Plus Sofosbuvir/Velpatasvir Fixed Dose Combination in Adults With Chronic Genotype 1 HCV Infection (clinicaltrials.gov) - Mar 5, 2015
P2, N=218, Recruiting, Sponsor: Gilead Sciences
- ||||| Vosevi (sofosbuvir/velpatasvir/voxilaprevir) / Gilead, voxilaprevir (GS-9857) / Gilead
New P2 trial: Safety and Efficacy of Voxilaprevir Plus Sofosbuvir/Velpatasvir Fixed Dose Combination in Adults With Chronic Non-Genotype 1 HCV Infection (clinicaltrials.gov) - Mar 5, 2015
P2, N=210, Recruiting, Sponsor: Gilead Sciences
- ||| voxilaprevir (GS-9857) / Gilead
Enrollment change: LEPTON: Efficacy and Safety of Oral Regimens for the Treatment of Chronic HCV Infection (clinicaltrials.gov) - Dec 24, 2014
P2, N=330, Recruiting, Sponsor: Gilead Sciences
Recruiting --> Active, not recruiting N=125 --> 330
- |||| voxilaprevir (GS-9857) / Gilead
Enrollment open: LEPTON: Efficacy and Safety of Oral Regimens for the Treatment of Chronic HCV Infection (clinicaltrials.gov) - Aug 15, 2014
P2, N=125, Recruiting, Sponsor: Gilead Sciences
N=125 --> 330 Not yet recruiting --> Recruiting
- ||||| voxilaprevir (GS-9857) / Gilead
New P2 trial: LEPTON: Efficacy and Safety of Oral Regimens for the Treatment of Chronic HCV Infection (clinicaltrials.gov) - Jul 30, 2014
P2, N=125, Not yet recruiting, Sponsor: Gilead Sciences
- ||| voxilaprevir (GS-9857) / Gilead
New P1 trial: Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of Voxilaprevir in Adults With Chronic Hepatitis C Virus Infection (clinicaltrials.gov) - Jul 12, 2014
P1, N=92, Recruiting, Sponsor: Gilead Sciences