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About
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.
Full 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
RESOLVE will also examine factors associated with treatment response, including
Enrollment
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Inclusion criteria
Available for clinical follow-up through Week 44 after enrollment.
Recurrent HCV GT-1
Exposure to combination DAA therapy
Able and willing to complete the informed consent process.
Use of protocol specified methods of contraception
Hepatitis B coinfected participants must have evidence of chronic infection and controlled on treatment
HIV coinfected participants must have HIV status of one of the following:
Exclusion criteria
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Interventional model
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77 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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