Ignite Creation Date:
2025-12-24 @ 10:09 PM
Ignite Modification Date:
2026-03-04 @ 10:38 PM
Study NCT ID:
NCT02745535
Status:
COMPLETED
Last Update Posted:
2022-03-10
First Post:
2016-04-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety, Tolerability and Efficacy of Sofosbuvir, Velpatasvir, and Voxilaprevir in Subjects With Previous DAA Experience
Sponsor:
University of Maryland, Baltimore
Organization:
Study Overview
Official Title:
Safety, Tolerability and Efficacy of Sofosbuvir, Velpatasvir, and Voxilaprevir in Subjects With Previous DAA Experience
Status:
COMPLETED
Status Verified Date:
2022-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RESOLVE
Brief Summary:
This study will evaluate the safety, tolerability, and efficacy of sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) in adults with chronic hepatitis C infection who have failed to eradicate hepatitis C despite previous combination directly acting antiviral therapy.
Detailed Description:
The treatment of chronic Hepatitis C with combination directly acting antiviral agents (DAAs) represents a dramatic improvement over previous therapies in safety, tolerability and efficacy, but these therapies are not universally effective. Some patients fail to achieve sustained virologic response (SVR) following therapy with combination DAAs, yet the ideal retreatment strategy for these patients has not yet been determined. As DAA medications become more widely available outside clinical trial settings, it is important to evaluate retreatment strategies in patients who fail combination DAA therapy, regardless of whether they had virologic failure, post-treatment relapse, or discontinued treatment prematurely.
The RESOLVE study will evaluate the safety, tolerability, and efficacy of treatment with a fixed dose combination of sofosbuvir (an approved NS5B inhibitor), velpatasvir (formerly GS-5816, a second generation NS5A inhibitor) and voxilaprevir (formerly GS-9857, an approved NS3/4A protease inhibitor) in HCV infected patients with early and advanced liver disease, including those with HIV or hepatitis B, who have failed previous combination DAA therapy. Patients with early stage and compensated cirrhosis will receive 12 weeks of therapy, and be followed for adverse events and SVR following completion of therapy.
RESOLVE will aid our understanding of the determinants of response to re-treatment with combination DAA therapy
* With and without cirrhosis
* In patients with HCV GT1 subtypes a and b
* In patients who previously failed DAA therapy
* With and without HIV or hepatitis B
RESOLVE will also examine factors associated with treatment response, including
* the viral and pharmacokinetics of patients receiving the combination of SOF/VEL/VOX, in patients with and without cirrhosis
* differential interferon sensitive gene responses
* host genetic and proteomic factors
* evolution of HCV quasispecies and resistance associated variants at baseline and in response to therapy
* changes in host HCV-specific immunity in patients with and without advanced liver disease
The RESOLVE study will evaluate the safety, tolerability, and efficacy of treatment with a fixed dose combination of sofosbuvir (an approved NS5B inhibitor), velpatasvir (formerly GS-5816, a second generation NS5A inhibitor) and voxilaprevir (formerly GS-9857, an approved NS3/4A protease inhibitor) in HCV infected patients with early and advanced liver disease, including those with HIV or hepatitis B, who have failed previous combination DAA therapy. Patients with early stage and compensated cirrhosis will receive 12 weeks of therapy, and be followed for adverse events and SVR following completion of therapy.
RESOLVE will aid our understanding of the determinants of response to re-treatment with combination DAA therapy
* With and without cirrhosis
* In patients with HCV GT1 subtypes a and b
* In patients who previously failed DAA therapy
* With and without HIV or hepatitis B
RESOLVE will also examine factors associated with treatment response, including
* the viral and pharmacokinetics of patients receiving the combination of SOF/VEL/VOX, in patients with and without cirrhosis
* differential interferon sensitive gene responses
* host genetic and proteomic factors
* evolution of HCV quasispecies and resistance associated variants at baseline and in response to therapy
* changes in host HCV-specific immunity in patients with and without advanced liver disease
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: