A fixed-dose combination of ledipasvir and sofosbuvir ± ribavirin for treatment of hepatitis C infection: a systematic review and meta-analysis

被引：0
作者：
Kunwar S. [1 ]
Devkota A.R. [2 ]
Ghimire D.K.C. [3 ]
Adhikari P. [4 ]
机构：
[1] Department of Rheumatology, Washington Hospital Center, 110 Irving Street, NW, Room 2A-66, Washington, 20010-2975, DC
[2] Division of Hospital Medicine, Rhode Island Hospital, Alpert Medical School of Brown University, Providence, RI
[3] Department of Medicine, Interfaith Medical Center, Brooklyn, NY
[4] Division of Infectious Diseases, David Geffen School of Medicine at UCLA, Los Angeles, CA
来源：
Drugs & Therapy Perspectives | 2017年 / 33卷 / 7期
关键词：
Sustained Virologic Response; Sofosbuvir; Baseline Viral Load; Previous Treatment Failure; Improve Sustained Virologic Response Rate;
D O I：
10.1007/s40267-017-0401-2
中图分类号：
学科分类号：
摘要：
Background: Novel antivirals have shown promising results in the treatment of hepatitis C. Our objective was to perform a meta-analysis of the efficacy and safety of a fixed-dose combination (FDC) of ledipasvir + sofosbuvir and compare outcomes with the addition of ribavirin (RBV) to treatment with the FDC. Methods: We searched PubMed, EMBASE, and Cochrane CENTRAL from inception through to 9 February 2017. We used a random effects model to calculate untransformed proportions (PRs) and pooled odds ratios (ORs) with 95% confidence intervals (CIs) to compare outcome measures [sustained virologic response at 12 weeks after treatment completion (SVR12); any, serious, and individual adverse events] between groups receiving the FDC ± RBV. We performed the systematic review according to PRISMA guidelines. Results: A total of 21 studies with 3826 patients were included in the meta-analysis. Ledipasvir/sofosbuvir was effective in achieving SVR12 after 8 weeks of therapy in genotype (GT) 1 treatment-naïve patients without cirrhosis (PR 0.941; 95% CI 0.910–0.971; p < 0.001; I2 = 0%). Similarly, it was effective after 12 weeks of therapy in GT1a and 1b patients irrespective of baseline viral load, presence of cirrhosis and CC interleukin-28B (IL28B) GT status. The SVR12 results after 12 weeks of therapy in GT1 patients were similar in groups ± RBV [PR 0.968 (95% CI 0.952–0.985), p < 0.001, I2 = 46%, and PR 0.973 (95% CI 0.958–0.988), p < 0.001, I2 = 64%, respectively]. Meta-analysis of comparative studies showed no benefit of adding RBV to ledipasvir/sofosbuvir in achieving SVR12 after 12 weeks of treatment in GT1 patients [OR 1.44 (95% CI 0.34–6.07); p = 0.62; I2 = 57%], irrespective of cirrhosis. Conclusion: Twelve weeks of ledipasvir/sofosbuvir is effective in the treatment of GT1a and 1b patients, including those with cirrhosis and difficult to treat non-CC IL28B GTs, and addition of RBV does not confer any benefit in these patients. Eight weeks of ledipasvir/sofosbuvir therapy alone may be sufficient in treatment-naïve GT1 patients without cirrhosis. © 2017, Springer International Publishing Switzerland.
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页码：348 / 360
页数：12
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