Gschwantler Michael, Bamberger Thomas, Graziadei Ivo, Maieron Andreas, Katalinic Nives, Stauber Rudolf
Department of Medicine IV, Wilhelminen Hospital, Montleartstraße 37, 1160, Vienna, Austria.
Sigmund Freud University, Vienna, Austria.
Wien Klin Wochenschr. 2019 Jan;131(1-2):8-16. doi: 10.1007/s00508-018-1404-2. Epub 2018 Nov 14.
The direct-acting antiviral regimen of ombitasvir/paritaprevir/ritonavir (OBV/PTV/r) ± dasabuvir (DSV) ± ribavirin (RBV) is approved to treat patients with chronic hepatitis C (CHC) infection genotypes 1 or 4, including compensated cirrhosis. The aim of the prospective, multicenter, observational REAL study was to provide evidence of the effectiveness of this regimen in an Austrian real-world setting and to determine the impact on patient-reported outcomes (PROs).
Effectiveness was defined as sustained virologic response 12 weeks after the end of treatment (SVR12). EuroQol 5 Dimension 5 Level (EQ-5D-5L) and Work Productivity and Activity Impairment HepC v2.0 (WPAI) questionnaires were used to assess PROs.
A total of 173 patients were enrolled. The SVR12 was 95.9% (140/146) in the core population with sufficient follow-up (i. e. patients without SVR12 data not due to efficacy/safety reasons, such as lost to follow-up, were excluded) and 84.8% (140/165) in the core population (CP). Data at all timepoints for the EQ-5D-5L index score and visual analog scale and the total activity impairment score of the WPAI were available for 88, 95 and 72 patients, respectively. All PROs remained generally unaltered during treatment with OBV/PTV/r ± DSV ± RBV but showed a statistically significant (p < 0.01) improvement 12 weeks after the end of treatment versus baseline.
These are the first data on PROs in a real-world setting with OBV/PTV/r ± DSV ± RBV treatment; this study demonstrated that treatment did not negatively impact quality of life. Results from the Austrian REAL study support the effectiveness of OBV/PTV/r ± DSV ± RBV in patients with CHC genotype 1 and 4 in everyday clinical practice.
奥比他韦/帕利哌韦/利托那韦（OBV/PTV/r）联合或不联合达沙布韦（DSV）及利巴韦林（RBV）的直接抗病毒方案已被批准用于治疗1或4型慢性丙型肝炎（CHC）感染患者，包括代偿期肝硬化患者。前瞻性、多中心、观察性的REAL研究旨在提供该方案在奥地利真实临床环境中的有效性证据，并确定其对患者报告结局（PRO）的影响。
有效性定义为治疗结束后12周的持续病毒学应答（SVR12）。使用欧洲五维健康量表第5版（EQ-5D-5L）和工作效率与活动能力受损量表丙型肝炎v2.0（WPAI）问卷来评估PRO。
共纳入173例患者。在有充分随访的核心人群中（即排除因疗效/安全性原因如失访而无SVR12数据的患者），SVR12为95.9%（140/146），在核心人群（CP）中为84.8%（140/165）。分别有88例、95例和72例患者可获得EQ-5D-5L指数评分和视觉模拟量表以及WPAI总活动能力受损评分在所有时间点的数据。在使用OBV/PTV/r联合或不联合DSV及RBV治疗期间，所有PRO总体保持不变，但在治疗结束后12周相对于基线有统计学显著改善（p<0.01）。
这些是关于OBV/PTV/r联合或不联合DSV及RBV治疗的真实临床环境中PRO的首批数据；本研究表明该治疗对生活质量无负面影响。奥地利REAL研究的结果支持OBV/PTV/r联合或不联合DSV及RBV在日常临床实践中对1和4型CHC患者的有效性。
