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


Ontology type: schema:ScholarlyArticle     


Article Info

DATE

2017-05-04

AUTHORS

Sumit Kunwar, Ashok Raj Devkota, Dipesh K. C. Ghimire, Prabhat Adhikari

ABSTRACT

BackgroundNovel 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.MethodsWe 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.ResultsA 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.ConclusionTwelve 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. More... »

PAGES

348-360

Identifiers

URI

http://scigraph.springernature.com/pub.10.1007/s40267-017-0401-2

DOI

http://dx.doi.org/10.1007/s40267-017-0401-2

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1085138881


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