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( Sam Keeping ),( Keith Chan ),( Eric Druyts ),( Shelby Corman ),( Chizoba Nwankwo ),( Park Hye-min ) 대한간학회 2017 춘·추계 학술대회 (KASL) Vol.2017 No.1
Aims: Genotype 1b accounts for the majority of chronic hepatitis c virus (HCV) infections in high income countries in Asia. The combination of daclastasvir plus asunaprevir for 24 weeks (DCV24 + ASV24) is currently licensed for the treatment of genotype 1b patients in Japan, Korea and Taiwan, and can be considered one of the current standard of care in this population. The fixed-dose combination of elbasvir/grazoprevir taken for 12 weeks (EBR/GZR12) has also demonstrated high rates of sustained viral response (SVR) in genotype 1b patients. We performed a systematic review and indirect treatment comparison of EBR/GZR12 and DCV24 + ASV24 in HCV patients with genotype 1b. Methods: Randomized or single-arm clinical trials of at least one of the treatments of interest were identified by searching Medline (including Medline in Process), Embase, and Cochrane Central Register of Controlled Trials. For each intervention, an overall SVR across all trials was calculated using a fixed-effects model with inverse- variance weighting and no transformation of the underlying data. A naive comparison was then made using standard statistical methods (2x2 contingency tables, Normal test for difference), without accounting for differences across trial populations. Analyses were conducted for the overall population as well as subgroups stratified by prior-treatment experienced and cirrhosis status. Results: A total of 27 relevant citations were identified with information from 15 clinical trials (9 for EBR/GZR, 6 for DCV + ASV). The pooled SVRs in all patients were 98.28% (95% CI 97.07%, 99.48%) for EBR/GZR12, and 86.68% (95% CI 84.73%, 88.62%) for DCV24 + ASV24. In the naive comparison, a statistically significant difference was observed between the two treatments with a relative risk (RR) of 1.12 (95% CI 1.09, 1.16). The subgroup analysis showed that EBR/GZR12 had higher SVRs than DCV24 + ASV24 in all subgroups that were assessed. These differences in SVRs were also statistically significant in all patient groups except in treatment-naive patients with compensated cirrhosis (RR 1.10 [95% CI 0.99, 1.23]), where the lower bound of the confidence interval approached 1 (see Table 1). Due to a lack of head-to-head trials within the evidence base or trials with a common control group, it was not possible to carry out a network meta-analysis. Conclusions: These results suggest that EBR/GZR12 is likely to offer clinical benefits over DCV24 + ASV24 in terms of higher SVRs in patients with genotype 1b chronic hepatitis C infection.