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    An Open-Label, Randomized, Active-Controlled Trial of 8 Versus 12 Weeks of Elbasvir/Grazoprevir for Treatment-Naive Patients With Chronic Hepatitis C Genotype 1b Infection and Mild Fibrosis (EGALITE Study): Impact of Baseline Viral Loads and NS5A Resistance-Associated Substitutions
    (2019-08-15)
    Huang, Chung-Feng
    ;
    Hung, Chao-Hung
    ;
    Cheng, Pin-Nan
    ;
    Bair, Ming-Jong
    ;
    Huang, Yi-Hsiang
    Background. A 12-week grazoprevir/elbasvir regimen is highly effective against hepatitis C virus genotype 1 (HCV-1) infection. The efficacy of an 8-week regimen for treatment-naive HCV-1-infected patients with mild fibrosis has not been determined. Methods. Treatment-naive HCV-1b-infected patients with mild fibrosis were randomly assigned to receive 8 (n = 41) or 12 (n = 41) weeks of grazoprevir/elbasvir therapy. The primary end point was a sustained virologic response, defined as an HCV RNA level of < 12 IU/mL, at posttreatment week 12 (SVR12). Results. SVR12 was achieved by 87.8% of patients (36 of 41) in the 8-week arm and 100% (41 of 41) in the 8-week arm of the full-analysis population and by 90.0% (36 of 40) and 100% (41 of 41), respectively, in the per-protocol population (all P = .055). In the 8-week arm, a significantly lower SVR12 rate was observed among patients with a high HCV-1b load, defined as >= 1 500 000 IU/mL (79% vs 100%; P =.042), and among those with a baseline Y93H resistance-associated substitution (RAS) frequency of >15% in HCV nonstructural protein 5A (NS5A; 40.0% vs 97.1%; P = .004). Between-group analysis demonstrated that, among patient with a high HCV-1b load and a baseline Y93H RAS frequency of >15%, those in the 8-week arm had a substantially lower SVR12 rate than those in the 12-week arm (40.0% vs 100.0%). All 4 HCV-1b relapses had a Y93H RAS frequency of >99% at posttreatment week 12. Conclusions. Twelve weeks of grazoprevir/elbasvir therapy is highly effective for treatment-naive patients with mild fibrosis. A truncated, 8-week grazoprevir/elbasvir regimen might be applied for those with low viral loads or without a significant NS5A RAS frequency.
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    Improvement of hyperuricemia in chronic hepatitis C patients receiving directly acting antiviral agents
    (1970-01-01)
    Jang, Tyng-Yuan
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    Huang, Ching-, I
    ;
    Yeh, Ming-Lun
    ;
    Liang, Po-Cheng
    ;
    Tsai, Pei-Chien
    Background and Aim Hepatitis C virus eradication via the use of antivirals ameliorates metabolic profiles. The changes in serum uric acid (SUA) levels in chronic hepatitis C patients who receive antivirals are not well understood. We aimed to address this issue by comparing the SUA changes before and after the achievement of a sustained virological response (which is defined as hepatitis C virus RNA seronegativity at 12 weeks after the end of treatment). Methods Two hundred and thirteen sustained virological response patients who were treated by directly acting antivirals were consecutively enrolled. Pretreatment and post-treatment SUA levels were compared. Hyperuricemia was defined as a uric acid level > 7.0 mg/dL in men and > 6.0 mg/dL in women. Results The SUA levels significantly decreased after treatment, as compared to the pretreatment levels (5.6 +/- 1.5 vs 6.0 +/- 1.7 mg/dL, respectively; P < 0.001). The proportion of hyperuricemia incidences significantly decreased after treatment (25.8% vs 35.7%, respectively; P = 0.001). The improvement was only observed in patients with a fibrosis-4 index (FIB-4) < 6.5 (25.7% vs 37.1%, P = 0.001) but not in those patients with a FIB-4 >= 6.5 (26.3% vs 28.9%, P = 1.00). A multivariate analysis revealed that the factor that was associated with significantly decreased SUA levels was FIB-4 < 6.5 (odds ratio [OR]/95% confidence interval [CI]: 3.22/1.04-9.95, P = 0.04) and estimated glomerular filtration rate < 60 mL/min/1.73 m(2) (OR/CI: 4.34/1.94-9.73, P < 0.001). There existed a trend of a higher proportion of patients with significant SUA improvement along with the decrement of FIB-4 (29.7%, 25%, and 10.5% in patients with FIB-4 < 3.25, 3.25-6.5, and > 6.5, respectively; trend P = 0.03). Conclusions SUA levels were significantly decreased in chronic hepatitis C patients after viral eradication. The improvement was particularly enhanced in patients with mild liver disease.
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    Association of serial serum major histocompatibility complex class I chain-related A measurements with hepatocellular carcinoma in chronic hepatitis C patients after viral eradication
    (2019-01-01)
    Huang, Chung-Feng
    ;
    Wang, Shu-Chi
    ;
    Yeh, Ming-Lun
    ;
    Huang, Ching-I
    ;
    Tsai, Pei-Chien
    Background and Aim Major histocompatibility complex class I chain-related A (MICA) genetic variants and their serum levels (sMICA) were associated with the development of hepatitis C virus-related hepatocellular carcinoma (HCC) in untreated cohorts. The dynamic changes in serial sMICA levels and their association with HCC in the post-curative status are elusive. Methods Single nucleotide polymorphism rs2596542 of MICA and serial sMICA levels were analyzed in chronic hepatitis C patients with a sustained virologic response after antivirals. Forty-two patients who developed HCC and 84 age-matched, gender-matched, and cirrhosis propensity score-matched non-HCC controls were compared. Serial sMICA levels were measured within 6 months before treatment initiation (pre-sMICA), 6 months after the end of treatment (post-sMICA), and on the last visit before the development (or not) of HCC (last-sMICA). Results Cox regression analysis revealed that last-sMICA was the only predictive factor of HCC development (hazard ratio/95% confidence interval: 2.27 (per 1 log pg/mL increase)/1.672-3.082, P < 0.001). Patients without HCC development showed a significantly reduced trend of sMICA levels during follow-up (trend P = 0.001), which was observed only in GG genotype (trend P < 0.001) but not A allele carriers (P = 0.88). In contrast, patients with HCC showed an increased trend of sMICA levels (trend P = 0.024). However, only the GG genotype "high expressors" (trend P = 0.06) but not A allele carriers (P = 0.18) showed a correlation of substantially increased trend of sMICA levels and HCC development. Conclusions Serial sMICA levels were associated with HCC development in SVR patients. The clinical utility of this finding is restricted to MICA rs2596542 GG genotype carriers.
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    Growth factors-loaded calcium phosphate/polymer hybrid coating with sequential release behavior prepared via electrochemical deposition method
    (2016-10-15)
    Sar, Jenny I-Chun
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    Lin, Yen-Zhu
    ;
    Lin, Chung-Kwei
    ;
    Liu, Tse-Ying
    ;
    Chen, San-Yuan
    In this study, the dicalcium phosphate dehydrate (DCPD)/carboxymethyl hexanoyl chitosan (CHC) hybrid coating layer with sequential release of BMP-2 and TGF-beta 1 was deposited onto Ti6Al4V substrate by electrochemical co-precipitation method. Different concentrations of amphiphatic chitosan derivative (carboxymethyl hexanoyl chitosan, CHC), BMP-2 and TGF-beta 1-loaded PLA microspheres (PLA/TGF-beta 1 MSs) were co-precipitated with the precursor of DCPD. The resulting DCPD/CHC hybrid coating incorporated with BMP-2 and PLA/TGF-beta 1 MSs was designed for improving the osteoconductive and osteoinductive functionalities of Ti6Al4V. FTIR spectroscopy and X-ray diffraction were used to characterize these hybrid coatings. The drug release profile, MC3T3-E1 cell proliferation and alkaline phosphatase activity were used to investigate the functionality of these hybrid coatings. It was found that the incorporation of CHC could be used as a mean to manipulate the release behavior of growth factor from the DCPD/CHC hybrid coating. In addition, the BMP-2- and PLA/TGF-beta 1 MSs-incorporated DCPD/CHC hybrid coating exhibited a sequential release of BMP-2 and TGF-beta 1 during the first and second two weeks, respectively. Importantly, the DCPD/CHC hybrid coating immersed in simulated body fluid gradually transformed to hydroxyapatite phase. Hence, the BMP-2 and PLA/TGF-beta 1 MSs-incorporated DCPD/CHC hybrid coating exhibited the best cell viability and the highest ALP activity after 14 days. The biocompatible hybrid coating with sequential release functionality proposed in the present study can enhance the osseointegration process and possess promising potential for clinical applications in bone implants and tissue engineering. (C) 2016 Elsevier B.V. All rights reserved.
  • Thumbnail Image
    Item type:Item,
    Growth factors-loaded calcium phosphate/polymer hybrid coating with sequential release behavior prepared via electrochemical deposition method
    (2016-10-15)
    Sar, Jenny I-Chun
    ;
    Lin, Yen-Zhu
    ;
    Lin, Chung-Kwei
    ;
    Liu, Tse-Ying
    ;
    Chen, San-Yuan
    In this study, the dicalcium phosphate dehydrate (DCPD)/carboxymethyl hexanoyl chitosan (CHC) hybrid coating layer with sequential release of BMP-2 and TGF-beta 1 was deposited onto Ti6Al4V substrate by electrochemical co-precipitation method. Different concentrations of amphiphatic chitosan derivative (carboxymethyl hexanoyl chitosan, CHC), BMP-2 and TGF-beta 1-loaded PLA microspheres (PLA/TGF-beta 1 MSs) were co-precipitated with the precursor of DCPD. The resulting DCPD/CHC hybrid coating incorporated with BMP-2 and PLA/TGF-beta 1 MSs was designed for improving the osteoconductive and osteoinductive functionalities of Ti6Al4V. FTIR spectroscopy and X-ray diffraction were used to characterize these hybrid coatings. The drug release profile, MC3T3-E1 cell proliferation and alkaline phosphatase activity were used to investigate the functionality of these hybrid coatings. It was found that the incorporation of CHC could be used as a mean to manipulate the release behavior of growth factor from the DCPD/CHC hybrid coating. In addition, the BMP-2- and PLA/TGF-beta 1 MSs-incorporated DCPD/CHC hybrid coating exhibited a sequential release of BMP-2 and TGF-beta 1 during the first and second two weeks, respectively. Importantly, the DCPD/CHC hybrid coating immersed in simulated body fluid gradually transformed to hydroxyapatite phase. Hence, the BMP-2 and PLA/TGF-beta 1 MSs-incorporated DCPD/CHC hybrid coating exhibited the best cell viability and the highest ALP activity after 14 days. The biocompatible hybrid coating with sequential release functionality proposed in the present study can enhance the osseointegration process and possess promising potential for clinical applications in bone implants and tissue engineering. (C) 2016 Elsevier B.V. All rights reserved.