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Ritonavir‐boosted danoprevir plus peginterferon alfa‐2a and ribavirin in Asian chronic hepatitis C patients with or without cirrhosis
Author(s) -
Kao JiaHorng,
Tung ShuiYi,
Lee Younjae,
Thongsawat Satawat,
Tanwandee Tawesak,
Sheen I.Shyan,
Wu Jinzi J.,
Li Hui,
Brennan Barbara J.,
Zhou Julian,
Le Pogam Sophie,
Najera Isabel,
Thommes James A.,
Hill George
Publication year - 2016
Publication title -
journal of gastroenterology and hepatology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.214
H-Index - 130
eISSN - 1440-1746
pISSN - 0815-9319
DOI - 10.1111/jgh.13374
Subject(s) - medicine , ribavirin , ritonavir , gastroenterology , peginterferon alfa 2a , adverse effect , hepatitis c , cirrhosis , hepatitis c virus , viral load , virology , virus , antiretroviral therapy
Background and Aim Chronic hepatitis C is an important public health problem in Asia. We evaluated the safety, efficacy, and pharmacokinetics of fixed‐dose ritonavir‐boosted danoprevir plus peginterferon alfa‐2a/ribavirin in treatment‐naive Asian patients with chronic hepatitis C virus (HCV) genotype (G)1 infection. Methods Treatment‐naive G1 patients in Taiwan, Thailand, and Korea with serum HCV‐RNA level ≥ 10 5 IU/mL received ritonavir‐boosted danoprevir 125/100 mg twice daily plus peginterferon alfa‐2a/ribavirin for either 12 (noncirrhotic patients: Arm A, n = 34) or 24 weeks (cirrhotic patients: Arm B, n = 27) in this phase II open‐label study. Sustained virologic response was defined as HCV‐RNA < 25 IU/mL 12 weeks after end of treatment (SVR12). Results Similar SVR12 rates were achieved in Arms A (88.2%; 95% confidence interval, 73.4–95.3%) and B (88.9%; 71.9–96.2%). Most patients had G1b infection, among whom SVR12 rates in Arms A and B were 96.7% and 91.7%, respectively. The overall SVR12 rate was 94.0% in noncirrhotic Taiwanese patients (100% in the subset of G1b patients). No patients withdrew for safety reasons. Three (11%) cirrhotic patients (Arm B) experienced serious adverse events, none of which was considered to be related to treatment. No Grade 3/4 alanine aminotransferase elevations were reported. The pharmacokinetic properties of danoprevir were broadly overlapping in noncirrhotic and cirrhotic patients both on Days 1 and 14. Conclusions Ritonavir‐boosted danoprevir plus peginterferon alfa‐2a/ribavirin produced sustained virologic response rates > 90% after 12 weeks' treatment in noncirrhotic and 24 weeks' treatment in cirrhotic Asian patients with G1b infection and was well tolerated. These regimens are well suited to countries where G1b predominates.