Shahd Hamran, Amani A Al-Rajhi, Kawthar Jasim, Majed A Al-Theyab, Mohamed Elahtam, Mooza K Al-Hail, Wadha Al-Fahaidi, Yaman A Khamis, Yara Dweidri, Abdel-Naser Elzouki, Tawanda Chivese
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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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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%).</p><p><strong>Conclusions: </strong>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.</p><p><strong>Registration: </strong>The protocol is registered on the International Prospective Register of Systematic Reviews (PROSPERO) (CRD42022368868).</p>","PeriodicalId":72832,"journal":{"name":"Diseases (Basel, Switzerland)","volume":"13 5","pages":""},"PeriodicalIF":3.0000,"publicationDate":"2025-04-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12110649/pdf/","citationCount":"0","resultStr":"{\"title\":\"Efficacy and Safety of Adding Ribavirin to Sofosbuvir-Based Direct-Acting Antivirals (DAAs) in Re-Treating Non-Genotype 1 Hepatitis C-A Systematic Review and Meta-Analysis.\",\"authors\":\"Shahd Hamran, Amani A Al-Rajhi, Kawthar Jasim, Majed A Al-Theyab, Mohamed Elahtam, Mooza K Al-Hail, Wadha Al-Fahaidi, Yaman A Khamis, Yara Dweidri, Abdel-Naser Elzouki, Tawanda Chivese\",\"doi\":\"10.3390/diseases13050138\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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%).</p><p><strong>Conclusions: </strong>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. 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引用次数: 0
摘要
背景：对于治疗经验丰富的非基因1型丙型肝炎患者，是否应该在直接作用抗病毒药物（DAAs）中加入利巴韦林仍存在争议。本研究比较了在索非布韦联合治疗方案中加入利巴韦林与单用索非布韦方案治疗非基因1型丙型肝炎病毒（HCV）的有效性和安全性。方法：我们检索了Cochrane CENTRAL、PubMed、SCOPUS、CINAHL和预印本数据库，检索了从成立到2023年9月的随机对照试验（rct），这些随机对照试验比较了索非布韦联合利巴韦林方案与索非布韦单独方案在既往治疗过的非基因1型HCV感染患者中的疗效。数据提取和研究质量评估由两位独立作者完成，综合采用偏倚校正模型，异质性采用I2，发表偏倚采用漏斗图。结果：8个随机对照试验比较了索非布韦联合利巴韦林和不联合利巴韦林。总的来说，与单用索非布韦相比，利巴韦林加用索非布韦在实现持续病毒学应答（SVR）方面没有显示出益处（OR 0.91, 95% CI 0.26-3.17, I2 = 70.0%），在推荐、评估、开发和评价分级（GRADE）证据中具有中等确定性。在亚组分析中，在非基因1型HCV患者中，利巴韦林加索非布韦没有益处。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：中等确定性的证据表明，在索非布韦为基础的方案中加入利巴韦林可能不会使先前治疗过的非基因1型HCV患者获得SVR，但会增加不良事件和停药的几率。额外使用利巴韦林对失代偿肝硬化患者实现SVR的影响还需要更多的证据。注册：该方案已在国际前瞻性系统评价登记册（PROSPERO）上注册（CRD42022368868）。
Efficacy and Safety of Adding Ribavirin to Sofosbuvir-Based Direct-Acting Antivirals (DAAs) in Re-Treating Non-Genotype 1 Hepatitis C-A Systematic Review and Meta-Analysis.
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).
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