Safety, Tolerability and Efficacy of Sofosbuvir, Velpatasvir, and Voxilaprevir in Subjects With Previous DAA Experience (RESOLVE)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02745535|
Recruitment Status : Completed
First Posted : April 20, 2016
Results First Posted : March 27, 2019
Last Update Posted : March 27, 2019
|Condition or disease||Intervention/treatment||Phase|
|Chronic Hepatitis C||Drug: Sofosbuvir/Velpatasvir/Voxilaprevir||Phase 2|
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
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||77 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Safety, Tolerability and Efficacy of Sofosbuvir, Velpatasvir, and Voxilaprevir in Subjects With Previous DAA Experience|
|Actual Study Start Date :||May 2016|
|Actual Primary Completion Date :||October 24, 2018|
|Actual Study Completion Date :||October 24, 2018|
Fixed dose combination of SOF/VEL/VOX (Sofosbuvir 400mg/Velpatasvir 100mg/ Voxilaprevir 100mg) dosed once daily for 12 weeks.
- Number of Participants With Grade 3 and 4 Adverse Events [ Time Frame: up to 16 weeks ]Number of participants with grade 3 and 4 adverse events during treatment with and/or within 30 of completion of SOF/VEL/VOX in HCV infected
- Number of Participants Who Achieve Sustained Virologic Response (SVR) 12 Weeks After Completion of Therapy (SVR12) [ Time Frame: Post-treatment week 12 ]Intention to treat (ITT) analysis. Sustained Virologic Response as measure by an undetectable HCV RNA level 12 weeks after completion of therapy.
- Number of Participants Who Achieve End of Treatment Virologic Response (ETR) at Completion of Therapy. [ Time Frame: Week 12 ]Per protocol analysis. End of Treatment Virologic Response as measure by an undetectable HCV RNA level completion of therapy.
- Number of Participants Who Achieve Sustained Virologic Response (SVR) 4 Weeks After Completion of Therapy. [ Time Frame: Post-treatment week 4 ]Per protocol analysis. Sustained Virologic Response as measure by an undetectable HCV RNA level 4 weeks after completion of therapy.
- Number of Participants Who Achieve Sustained Virologic Response (SVR) 24 Weeks After Completion of Therapy. [ Time Frame: Post-treatment week 24 ]Per protocol analysis. Sustained Virologic Response as measure by an undetectable HCV RNA level 24 weeks after completion of therapy.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02745535
|United States, Maryland|
|Institute of Human Virology|
|Baltimore, Maryland, United States, 21201|
|Principal Investigator:||Eleanor Wilson, MD||University of Maryland Institute of Virology|