Safety, Tolerability and Efficacy of Sofosbuvir, Velpatasvir, and Voxilaprevir in Subjects With Previous DAA Experience
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 77
- 试验地点
- 1
- 主要终点
- Number of Participants With Grade 3 and 4 Adverse Events
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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:
- •HIV untreated for >8 weeks prior to screening, CD4 >500, no intention of initiating ARV therapy for the duration of the trial.
- •HIV suppressed on a stable, protocol-approved ARV regimen for >4 weeks prior to screening.
排除标准
- •Combination DAA therapy was completed or discontinued less than 8 weeks prior to enrollment.
- •Current or prior history of any clinically significant illness, organ transplantation, and/or concomitant medication that may interfere with the subject treatment, assessment of compliance with the protocol.
- •Chronic liver disease of a non-HCV etiology (e.g., hemochromatosis, Wilson's disease, alfa-1 antitrypsin deficiency, cholangitis)
- •Laboratory results outside acceptable ranges at screening.
- •Female who is pregnant, breast-feeding or planning to become pregnant during study.
研究组 & 干预措施
SOF/VEL/VOX
Fixed dose combination of SOF/VEL/VOX (Sofosbuvir 400mg/Velpatasvir 100mg/ Voxilaprevir 100mg) dosed once daily for 12 weeks.
干预措施: Sofosbuvir/Velpatasvir/Voxilaprevir (Drug)
结局指标
主要结局
Number of Participants With Grade 3 and 4 Adverse Events
时间窗: 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)
时间窗: 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.
次要结局
- Number of Participants Who Achieve End of Treatment Virologic Response (ETR) at Completion of Therapy.(Week 12)
- Number of Participants Who Achieve Sustained Virologic Response (SVR) 4 Weeks After Completion of Therapy.(Post-treatment week 4)
- Number of Participants Who Achieve Sustained Virologic Response (SVR) 24 Weeks After Completion of Therapy.(Post-treatment week 24)
研究者
Eleanor Wilson
Assistant Professor
University of Maryland, Baltimore