Efficacy of 8-week daclatasvir-sofosbuvir regimen in chronic hepatitis C: a systematic review and meta-analysis.

IF 4 3区 医学 Q2 VIROLOGY Virology Journal Pub Date : 2024-11-04 DOI:10.1186/s12985-024-02544-2
Ahmed N Farrag, Ahmed M Kamel
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Abstract

Background: The high rates of the sustained virologic response 12 weeks after treatment (SVR12) in real world settings provoked the adoption of shortened courses of the costly direct-acting antivirals (DAAs) regimens. This study provides, to our knowledge, the first systematic review and meta-analysis for the efficacy of the shortened 8-week course of sofosbuvir (SOF) plus daclatasvir (DCV), the most accessible DAAs in the low-middle income countries (LMICs).

Methods: We performed a proportion meta-analysis to determine a reliable rate of SVR12 by pooling all studies that evaluated the results of the 8-week regimen of DCV + SOF. In addition, we applied sensitivity analyses using two imputation paradigms: a conservative approach, and a pragmatic approach to avoid overestimating the efficacy of the 8-week regimen in studies that followed a response-guided treatment (RGT) approach.

Results: Six studies with a total of 159 patients were included. The pooled SVR12 rate ranged from 91 to 97% in the included scenarios. The pragmatic scenario showed that the pooled SVR12 was 97% (95% confidence interval (CI) 91%; 100%) with lower variability as assessed by the prediction interval. The conservative approach revealed an SVR12 of 93% (95% CI 84%; 95%).

Conclusion: The 8-week course of 60 mg DCV with SOF provided a comparable SVR12 to the standard 12-week regimen in treatment-naïve, non-HIV co-infected patients with a minimum estimated efficacy of 90%.

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为期 8 周的达卡他韦-索非布韦方案对慢性丙型肝炎的疗效:系统综述和荟萃分析。
背景:在现实环境中,治疗 12 周后的持续病毒学应答(SVR12)率很高,这促使人们采用缩短疗程的昂贵直接作用抗病毒药物(DAAs)治疗方案。据我们所知,本研究首次对索非布韦(SOF)加达拉他韦(DCV)缩短8周疗程的疗效进行了系统综述和荟萃分析:我们进行了一项比例荟萃分析,通过汇集所有评估 DCV + SOF 8 周治疗方案结果的研究来确定可靠的 SVR12 率。此外,我们还采用了两种归因范式进行了敏感性分析:一种是保守方法,另一种是实用方法,以避免在采用应答指导治疗(RGT)方法的研究中高估8周方案的疗效:结果:共纳入了六项研究,共计 159 名患者。在纳入的方案中,汇总的 SVR12 率介于 91% 与 97% 之间。务实方案显示,汇总 SVR12 为 97%(95% 置信区间 (CI) 91%;100%),预测区间评估的变异性较低。保守方案显示 SVR12 为 93% (95% CI 84%; 95%):60毫克DCV联合SOF的8周疗程与标准的12周疗程相比,对未经治疗的非艾滋病毒合并感染者的SVR12疗效相当,估计最低疗效为90%。
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来源期刊
Virology Journal
Virology Journal 医学-病毒学
CiteScore
7.40
自引率
2.10%
发文量
186
审稿时长
1 months
期刊介绍: Virology Journal is an open access, peer reviewed journal that considers articles on all aspects of virology, including research on the viruses of animals, plants and microbes. The journal welcomes basic research as well as pre-clinical and clinical studies of novel diagnostic tools, vaccines and anti-viral therapies. The Editorial policy of Virology Journal is to publish all research which is assessed by peer reviewers to be a coherent and sound addition to the scientific literature, and puts less emphasis on interest levels or perceived impact.
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