Younossi Zobair M, Stepanova Maria, Racila Andrei, Afendy Arian, Lawitz Eric J, Schwabe Christian, Ruane Peter J, Lalezari Jay, Reddy K Rajender, Jacobson Ira M, Muir Andrew J, Gaggar Anuj, Myers Robert P, Younossi Issah, Nader Fatema
Center for Liver Diseases, Department of Medicine, Inova Fairfax Hospital, Falls Church, Virginia; Betty and Guy Beatty Center for Integrated Research, Inova Health System, Falls Church, Virginia.
Center for Outcomes Research in Liver Disease, Washington, District of Columbia.
Clin Gastroenterol Hepatol. 2020 Feb;18(2):468-476.e11. doi: 10.1016/j.cgh.2019.07.047. Epub 2019 Jul 31.
BACKGROUND & AIMS: Patients with hepatitis C virus (HCV) infections who achieve a sustained virologic response (SVR) to treatment have improved patient-reported outcomes (PROs). We compared post-treatment PRO scores between patients with chronic HCV infection who did and did not achieve an SVR to treatment.
Patients who completed treatment in clinical trials were enrolled in 2 registries, depending on the treatment outcome (NCT01457755, NCT01457768), from 2016 to 2017 in 17 countries in North America, Europe, and the Asia-Pacific region. PRO scores (scale, 0-100) were collected at pretreatment (baseline); the last day of treatment; the post-treatment week 12 follow-up visit (in patients with SVR only); the registry baseline; and on registry weeks 12, 24, 36, 48, and 96 (the non-SVR registry) or every 24 weeks until week 96 (SVR registry), using the Short Form-36 (SF-36) instrument.
Our analysis included 4234 patients with an SVR and 242 without an SVR from whom pretreatment PRO data were available (mean age, 54 ± 10 y; 63% male; 65% enrolled in the United States; 17% with cirrhosis; 12% with human immunodeficiency virus co-infection). Upon registry enrollment, patients with an SVR had significant increases in all PRO scores compared with pretreatment baseline levels (all P < .05). Patients without an SVR had mean reductions of 9.2 points or less in PRO scores while followed up on the registry (P < .05 for 4-8 of 8 PRO domains measured by the SF-36). In contrast, patients with an SVR had sustained increases in PRO scores (mean increase, ≤7.0 points) while on the registry. In multivariate analysis, achieving an SVR was associated independently with superior scores in all SF-36 domains at all registry time points (β, +4.8 to +15.9 points, all P ≤ .01).
In a follow-up analysis of participants in clinical trials, we found that those with an SVR to treatment for HCV infection had significant increases in well-being, based on PRO scores. Patients without an SVR had decreasing PRO scores over the follow-up period.
对丙型肝炎病毒（HCV）感染治疗获得持续病毒学应答（SVR）的患者，其患者报告结局（PRO）有所改善。我们比较了慢性HCV感染患者中治疗获得和未获得SVR者的治疗后PRO评分。
2016年至2017年期间，在北美、欧洲和亚太地区的17个国家，根据治疗结局（NCT01457755、NCT01457768）将在临床试验中完成治疗的患者纳入2个注册登记处。使用简明健康调查量表（SF-36）在治疗前（基线）、治疗最后一天、治疗后第12周随访（仅针对获得SVR的患者）、注册登记处基线以及注册登记处第12、24、36、48和96周（未获得SVR的注册登记处）或直至第96周每24周（获得SVR的注册登记处）收集PRO评分（范围0-100）。
我们的分析纳入了4234例获得SVR的患者和242例未获得SVR的患者，这些患者有治疗前PRO数据（平均年龄54±10岁；63%为男性；美国入组患者占65%；17%有肝硬化；12%合并人类免疫缺陷病毒感染）。在注册登记时，与治疗前基线水平相比，获得SVR的患者所有PRO评分均显著升高（均P<.05）。未获得SVR的患者在注册登记随访期间PRO评分平均降低9.2分或更低（SF-36测量的8个PRO领域中有4-8个P<.05）。相比之下，获得SVR的患者在注册登记期间PRO评分持续升高（平均升高≤7.0分）。在多变量分析中，在所有注册登记时间点，获得SVR均与所有SF-36领域的更高评分独立相关（β值为+4.8至+15.9分，均P≤.01）。
在对临床试验参与者的随访分析中，我们发现，基于PRO评分，HCV感染治疗获得SVR的患者幸福感显著提高。未获得SVR的患者在随访期间PRO评分下降。
