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      • Efficacy/Safety of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir with Ribavirin in Asian Patients with Genotype 1b HCV-Infected, Compensated Cirrhosis: ONYX-II SVR 24 Results

        ( Lai Wei ),( Gui-qiang Wang ),( Yan Luo ),( Chi-jen Chu ),( Seung Woon Paik ),( Jinlin Hou ),( Jun Cheng ),( Qing Xie ),( Zhongping Duan ),( Jia-horng Kao ),( Linda Fredrick ),( Bo Fu ),( Niloufar Mo 대한간학회 2017 춘·추계 학술대회 (KASL) Vol.2017 No.1

        Aims: ONYX-II is a phase 3, open-label study of 3-DAA regimen of OBV/PTV/r and DSV with RBV in treatment-naive and experienced patients with genotype 1b HCV infection and compensated cirrhosis in China, South Korea and Taiwan. SVR12 rate was 100% and the favourable safety profile was shown. The present analysis reports efficacy( SVR24) and safety results. Methods: Patients with chronic GT1b HCV infection and compensated cirrhosis received OBV/PTV/r + DSV + RBV for 12 weeks and will be followed for 48 weeks post-treatment. Efficacy was assessed by SVR12 and SVR24. Safety was assessed as the percentage of patients wi th treatment-emergent adverse events (TEAEs) and laboratory evaluation. Results: Total of 104 patients with chronic GT1b HCV infection (62% female, 100% Asian, 58% treatment-experienced) were enrolled from China (n=63), South Korea (n=21) and Taiwan (n=20). All patients received at least one dose of study drugs. The SVR24 rate was 100% (concordant with SVR12), with no patient relapsing between post-treatment week 12 and 24. Most TEAEs were mild in severity. The most common TEAEs (≥10%) were increased blood bilirubin levels (25%), pruritus (15%), anaemia (14%), asthenia (12%), bilirubin conjugated increased (12%), blood bilirubin unconjugated increased (12%), dizziness (11%) and fatigue (11%). Four patients had serious AEs and all were assessed as not being related to the 3-DAA regimen (one was assessed as being possibly related to RBV). One patient discontinued treatment due to TEAEs (elevations in alanine aminotransferase [ALT], aspartate aminotransferase [AST] and blood bilirubin) after 3 weeks of dosing but achieved SVR12 and SVR24. Laboratory abnormalities ≥ grade 3 were infrequent (ALT: 3%; AST 2%; total bilirubin: 7%). No grade 3 haemoglobin decrease was reported. Conclusions: SVR24 and SVR12 rates were concordant (100%) in HCV GT1b-infected Asian patients with compensated cirrhosis. The regimen was generally well tolerated with mostly mild TEAEs reported.

      • Changes in Markers of Liver Function in HCV 1b Patients with Compensated Cirrhosis Treated with Ombitasvir/Paritaprevir/ Ritonavir plus Dasabuvir with Ribavirin

        ( Jeong Heo ),( Yan Luo ),( Wan-long Chuang ),( Jidong Jia ),( Kwang-hyub Han ),( Ming-lung Yu ),( Hong Tang ),( Young-suk Lim ),( Cheng-yuan Peng ),( Min Xu ),( Maorong Wang ),( Bo Fu ),( Niloufar Mo 대한간학회 2017 춘·추계 학술대회 (KASL) Vol.2017 No.1

        Aims: Patients chronically infected with HCV are at risk of developing extrahepatic manifestations of HCV as well as progressing to compensated or decompensated cirrhosis and HCC. Although current treatments have high rates of SVR, relatively little is known about possible regression of liver fibrosis after achieving an SVR. The ONYX-II trial examined the efficacy and safety of ombitasvir/paritaprevir/ritonavir plus dasabuvir + ribavirin (RBV) in Asian patients with HCV genotype 1b infection and compensated cirrhosis. Here we report changes in key markers of liver fibrosis and function. Methods: Patients with chronic HCV GT1b infection and compensated cirrhosis were enrolled in China, South Korea and Taiwan and received 12 weeks of OBV/PTV/r (25 mg/150 mg/100 mg once daily) and DSV (250 mg twice daily) with weight-based RBV. The primary objective of ONYX-II was to assess efficacy (SVR12) and safety of the regimen. Changes in markers of liver fibrosis and function between baseline (BL) and post-treatment week (PTW) 12 are presented. Results: Overall, 104 patients were enrolled and treated in ONYX-II. All patients (104/104, 100%) achieved SVR12. BL and PTW12 data for FibroTest score, alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin, albumin, platelet count and alpha fetoprotein (AFP) are shown in Table 1. All selected parameters showed numerical improvements between BL and PTW12. Mean ALT and AST levels returned to within normal range and FibroTest scores demonstrated a numerical improvement, suggesting improvement in liver status. The complete set of data between BL and PTW12 will be presented for these parameters and other liver composite parameters at the conference. Conclusions: Measurement of key liver function markers during the ONYX-II trial showed a numerical improvement within 12 weeks of completion of treatment in HCV GT1b-infected patients with compensated cirrhosis. Further follow-up of these patients will determine the long-term durability of these changes.

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