TY - JOUR
T1 - Systematic review with meta-analysis
T2 - effectiveness and tolerability of interferon-free direct-acting antiviral regimens for chronic hepatitis C genotype 1 in routine clinical practice in Asia
AU - Ji, F.
AU - Wei, B.
AU - Yeo, Y. H.
AU - Ogawa, E.
AU - Zou, B.
AU - Stave, C. D.
AU - Li, Z.
AU - Dang, S.
AU - Furusyo, N.
AU - Cheung, R. C.
AU - Nguyen, M. H.
N1 - Funding Information:
We would like to thank Dr. Yasuhito Tanaka, MD, PhD from Nagoya City University Graduate School of Medical Sciences, Dr. Shahin Merat, MD from Tehran University of Medical Sciences, Dr. Ajay Duseja, MD from the Post Graduate Institute of Medical Education and Research, India, Dr. Tatsuya Minami, MD, PhD, from the University of Tokyo Graduate School of Medicine for their kind support in providing additional detailed data of their studies and Dr. Guido Schwarzer, PhD for his kind assistance with the R-programming for our meta-regression analysis. Declaration of personal interests: Fanpu Ji, Bin Wei, Yee Hui Yeo, Eiichi Ogawa, Biyao Zou, Christopher Stave, Zongfang Li, Shuangsuo Dang: none to disclose. Ramsey C. Cheung: Grant/research support, Gilead Sciences. Norihiro Furusyo: Grant/research support: MSD, Gilead Sciences, Bristol-Myers Squibb and Janssen Pharmaceuticals. Speaker's bureau: Gilead Sciences, MSD, Bristol Myers, and Janssen Pharmaceuticals. Advisory board: Gilead Sciences, Abbvie, Bristol Myers Squibb. Mindie Nguyen: Grant/research support: B. K. Kee Foundation, Asian Health Foundation, Bristol-Myers Squibb, Gilead Sciences, Janssen Pharmaceuticals, National Cancer Institute and Pfizer Pharmaceutical. Advisory board member or consultant: Dynavax Laboratories, Gilead Sciences, Intercept Pharmaceuticals, Alnylam Pharmaceutical, Bristol-Myers Squibb, Novartis Pharmaceutical, and Janssen Pharmaceutical.
Publisher Copyright:
© 2018 John Wiley & Sons Ltd
PY - 2018/3
Y1 - 2018/3
N2 - Background: Direct-acting antiviral (DAA) regimens have shown high efficacy and tolerability for patients with HCV genotype 1/1b (GT1/1b) in clinical trials. However, robust real-world evidence of interferon (IFN)-free DAA treatment for HCV GT1-infected patients in Asia is still lacking. Aim: To systematically review and meta-analyse the effectiveness and tolerability of IFN-free DAA therapy for HCV GT1 infection in Asia. Methods: We included studies that enrolled adult patients with HCV GT1 infection in routine clinical practice in Asia, using IFN-free DAA regimens, and reported sustained virological response (SVR) after 12/24 weeks end-of-treatment by 31 May 2017. The pooled SVR rates were computed with a random-effects model. Subgroup analysis and meta-regression as previously registered in PROSPERO were performed to determine how pre-planned variables might have affected the pooled estimates. Results: We included 41 studies from eight countries and regions, comprising of 8574 individuals. The pooled SVR rates for GT1 were 89.9% (95% CI 88.6-91.1, I 2 = 55.1%) with daclatasvir/asunaprevir (DCV/ASV) and 98.1% (95% CI 97.0-99.0, I 2 = 41.0%) with ledipasvir/sofosbuvir ± ribavirin (LDV/SOF ± RBV). Baseline cirrhosis but not prior treatment history and age, attenuated the effectiveness of both regimens. Baseline resistance associated substitutions (RASs) severely attenuated SVR of DCV/ASV (65.4% vs 94.3%, P < 0.001) and only minimally with LDV/SOF ± RBV (94.5% vs 99.2%, P = 0.003). Patients with renal dysfunction treated with DCV/ASV showed a higher SVR rate (93.9% vs 89.8%, P = 0.046). Patients with hepatocellular carcinoma (HCC) LDV/SOF ± RBV achieved a lower SVR than those without HCC (94.1% vs 98.7%, P = 0.001). Conclusion: All oral DAA treatment of HCV GT1 resulted in high cure rates in Asian patients in routine clinical practice setting including elderly patients and those with end-stage renal disease.
AB - Background: Direct-acting antiviral (DAA) regimens have shown high efficacy and tolerability for patients with HCV genotype 1/1b (GT1/1b) in clinical trials. However, robust real-world evidence of interferon (IFN)-free DAA treatment for HCV GT1-infected patients in Asia is still lacking. Aim: To systematically review and meta-analyse the effectiveness and tolerability of IFN-free DAA therapy for HCV GT1 infection in Asia. Methods: We included studies that enrolled adult patients with HCV GT1 infection in routine clinical practice in Asia, using IFN-free DAA regimens, and reported sustained virological response (SVR) after 12/24 weeks end-of-treatment by 31 May 2017. The pooled SVR rates were computed with a random-effects model. Subgroup analysis and meta-regression as previously registered in PROSPERO were performed to determine how pre-planned variables might have affected the pooled estimates. Results: We included 41 studies from eight countries and regions, comprising of 8574 individuals. The pooled SVR rates for GT1 were 89.9% (95% CI 88.6-91.1, I 2 = 55.1%) with daclatasvir/asunaprevir (DCV/ASV) and 98.1% (95% CI 97.0-99.0, I 2 = 41.0%) with ledipasvir/sofosbuvir ± ribavirin (LDV/SOF ± RBV). Baseline cirrhosis but not prior treatment history and age, attenuated the effectiveness of both regimens. Baseline resistance associated substitutions (RASs) severely attenuated SVR of DCV/ASV (65.4% vs 94.3%, P < 0.001) and only minimally with LDV/SOF ± RBV (94.5% vs 99.2%, P = 0.003). Patients with renal dysfunction treated with DCV/ASV showed a higher SVR rate (93.9% vs 89.8%, P = 0.046). Patients with hepatocellular carcinoma (HCC) LDV/SOF ± RBV achieved a lower SVR than those without HCC (94.1% vs 98.7%, P = 0.001). Conclusion: All oral DAA treatment of HCV GT1 resulted in high cure rates in Asian patients in routine clinical practice setting including elderly patients and those with end-stage renal disease.
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U2 - 10.1111/apt.14507
DO - 10.1111/apt.14507
M3 - Review article
C2 - 29327780
AN - SCOPUS:85040602429
SN - 0269-2813
VL - 47
SP - 550
EP - 562
JO - Alimentary Pharmacology and Therapeutics
JF - Alimentary Pharmacology and Therapeutics
IS - 5
ER -