Hamran Shahd, Al-Rajhi Amani A, Jasim Kawthar, Al-Theyab Majed A, Elahtam Mohamed, Al-Hail Mooza K, Al-Fahaidi Wadha, Khamis Yaman A, Dweidri Yara, Elzouki Abdel-Naser, Chivese Tawanda
College of Medicine, QU Health, Qatar University, Doha P.O. Box 2713, Qatar.
Internal Medicine, Hamad Medical Corporation, Doha P.O. Box 3050, Qatar.
Diseases. 2025 Apr 29;13(5):138. doi: 10.3390/diseases13050138.
BACKGROUND: There is still debate whether ribavirin should be added to direct-acting antivirals (DAAs) for the management of treatment-experienced individuals with non-genotype-1 hepatitis C. This study compared the efficacy and safety of adding ribavirin to sofosbuvir-based combinations compared to sofosbuvir-based regimens alone in treating non-genotype 1 hepatitis C virus (HCV) in individuals who have been previously treated. METHODS: We searched Cochrane CENTRAL, PubMed, SCOPUS, CINAHL and preprint databases from inception to September 2023 for randomized controlled trials (RCTs) that compared sofosbuvir-based regimens with ribavirin to sofosbuvir-based regimens alone in previously treated individuals with non-genotype 1 HCV infection. Data extraction and quality of study assessments were performed by two independent authors, and synthesis was performed using bias-adjusted models, heterogeneity using I2, and publication bias using funnel plots. RESULTS: Eight RCTs compared sofosbuvir-based combinations with and without ribavirin were included. Overall, the addition of ribavirin to sofosbuvir, compared to sofosbuvir alone, did not show a benefit in achieving sustained virological response (SVR) (OR 0.91, 95% CI 0.26-3.17, I2 = 70.0%) with moderate certainty in Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) evidence. In subgroup analysis, there was no benefit of adding ribavirin to sofosbuvir in individuals with non-genotype 1 HCV. The additional ribavirin was associated with increased adverse events (OR 2.03, 95% CI 1.58-2.6, I2 = 8.0%) and treatment discontinuation (OR 1.81, 95% CI 0.78-4.28, I2 = 0.0%). CONCLUSIONS: The moderate certainty evidence suggests that adding ribavirin to sofosbuvir-based regimens may not confer benefit in achieving SVR in previously treated individuals with non-genotype 1 HCV but increases the odds of adverse events and treatment discontinuation. More evidence is needed on the effect of additional ribavirin in achieving SVR in individuals with decompensated cirrhosis. REGISTRATION: The protocol is registered on the International Prospective Register of Systematic Reviews (PROSPERO) (CRD42022368868).
背景：对于在治疗过的非1型丙型肝炎患者管理中是否应将利巴韦林添加到直接作用抗病毒药物（DAA）中，仍存在争议。本研究比较了在先前接受过治疗的个体中，与仅使用基于索磷布韦的方案相比，在基于索磷布韦的联合方案中添加利巴韦林治疗非1型丙型肝炎病毒（HCV）的疗效和安全性。 方法：我们检索了Cochrane CENTRAL、PubMed、SCOPUS、CINAHL和预印本数据库，从数据库创建至2023年9月，以查找随机对照试验（RCT），这些试验比较了在先前接受过治疗的非1型HCV感染个体中，基于索磷布韦并联合利巴韦林的方案与仅基于索磷布韦的方案。数据提取和研究质量评估由两名独立作者进行，并使用偏倚调整模型进行综合分析，使用I²评估异质性，使用漏斗图评估发表偏倚。 结果：纳入了8项比较基于索磷布韦并联合或不联合利巴韦林的RCT。总体而言，在推荐分级、评估、制定和评价（GRADE）证据中，中等确定性证据表明，与单独使用索磷布韦相比，在索磷布韦中添加利巴韦林在实现持续病毒学应答（SVR）方面未显示出益处（OR 0.91，95% CI 0.26 - 3.17，I² = 70.0%）。在亚组分析中，在非1型HCV个体中，在索磷布韦中添加利巴韦林没有益处。额外使用利巴韦林与不良事件增加（OR 2.03，95% CI 1.58 - 2.6，I² = 8.0%）和治疗中断（OR 1.81，95% CI 0.78 - 4.28，I² = 0.0%）相关。 结论：中等确定性证据表明，在先前接受过治疗的非1型HCV个体中，在基于索磷布韦的方案中添加利巴韦林在实现SVR方面可能没有益处，但会增加不良事件和治疗中断的几率。关于额外使用利巴韦林在失代偿期肝硬化个体中实现SVR的效果，还需要更多证据。 注册情况：该方案已在国际系统评价前瞻性注册库（PROSPERO）（CRD42022368868）上注册。
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