CLINICAL PROFILE AND TREATMENT RESPONSE TO SOFOSBUVIR-VELPATASVIR REGIMEN AND ITS IMPACT ON THE QUALITY OF LIFE IN CHRONIC HEPATITIS C PATIENTS

Ajit Pratap Singh, Pankaj Asati, Kanishk Yadav
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Abstract

Objective: Chronic Hepatitis C infection is one of the major global contributors to liver-related morbidity and mortality. Successful antiviral therapy with the direct-acting antiviral combination sofosbuvir-velpatasvir has shown to improve survival, liver-related outcomes, all-cause mortality, and even reverse fibrosis. We evaluated the treatment response of this regimen in terms of its impact on the Quality of life of patients during and after the therapy. Methods: This is an Observational, prospective, descriptive study of serologic HCV RNA-positive cases. Data on change in clinical, biochemical profile, and quality of life using 2 standardized questionnaires SF-36 and CLDQ was analyzed at baseline, 12 w from baseline, and 24 w after therapy cessation. Results: 62 out of the 87 patients registered during the study completed the desired study duration. 95% achieved sustained virological response (SVR) at 12 w and 100% at 24 w from baseline. Improved clinical profile with symptom resolution and change in the biochemical parameters and quality-of-life scores was statistically significant (P value-<0.001 and 0.005) at 12 w from baseline and 24 w after therapy cessation, respectively. Conclusion: Patients achieving SVR with sofosbuvir-velpatasvir have been shown to improve clinical profile with normalization in biochemical markers of liver disease, which is reflected in all the quality-of-life domains of SF-36 and CLDQ-HCV. However, long-term follow-up with larger sample size is required for improved study validity and to improve long-term liver-related outcomes.
慢性丙型肝炎患者索非布韦-维帕他韦方案的临床概况和治疗反应及其对生活质量的影响
目的:慢性丙型肝炎感染是全球肝脏相关发病率和死亡率的主要原因之一。使用直接作用抗病毒药物sofosbuvir-velpatasvir成功的抗病毒治疗已被证明可以改善生存率、肝脏相关预后、全因死亡率,甚至逆转纤维化。我们根据治疗期间和治疗后对患者生活质量的影响评估了该方案的治疗反应。方法:这是一项对HCV rna阳性血清学病例的观察性、前瞻性、描述性研究。使用2份标准化问卷SF-36和CLDQ分析临床、生化特征和生活质量的变化数据,分别在基线、基线后12 w和停止治疗后24 w进行分析。结果:在研究期间登记的87例患者中有62例完成了预期的研究时间。95%的患者在12周达到持续病毒学应答(SVR), 24周达到100%。临床表现的改善,症状的缓解,生化参数和生活质量评分的改变,分别在治疗结束后12 w和24 w时具有统计学意义(P值<0.001和0.005)。结论:sofosbuvir-velpatasvir达到SVR的患者已被证明可以改善临床状况,肝脏疾病生化指标正常化,这反映在SF-36和CLDQ-HCV的所有生活质量领域。然而,为了提高研究的有效性和改善肝脏相关的长期预后,需要更大样本量的长期随访。
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