Real-world anti-viral treatment decisions among chronic hepatitis C patients in Taiwan: The INITIATE study

Liu, Chen–Hua; Yu, Ming; Peng, Cheng Yuan; Hsieh, Tsai Yuan; Huang, Yi Hsiang; Su, Wei; Cheng, Pin Nan; Lin, Chun-Han; Lo, Ching Chu; Chen, Chi Yi; Chen, Jyh Jou; Ma, Qiang; Brooks-Rooney, C.; Kao, Jia‐Horng

doi:10.1016/j.jfma.2018.10.020

Cited by 9 publications

(6 citation statements)

References 36 publications

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“…The presence of cirrhosis played an important risk factor for developing HCC among HCV patients [18]. HCV genotype 1b-related cirrhosis carry a significantly higher risk of developing HCC than other genotypes [21,22]. In Taiwan, the Type 1b virus is the predominant genotype of HCV [22], and it was also a major cause of HCC in patients receiving DAA therapy in our study.…”

Section: Discussionmentioning

confidence: 59%

Impact of direct-acting antiviral therapy for hepatitis C–related hepatocellular carcinoma

Lin

Chang

et al. 2020

PLoS ONE

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With the introduction of direct-acting antiviral (DAA) agents, hepatitis C virus (HCV) treatment has dramatically improved. However, there are insufficient data on the benefits of DAA therapy in hepatocellular carcinoma (HCC). The purpose of this study was to investigate the outcome of patients who received DAA therapy after HCC treatment. We retrospectively reviewed patients with HCV-related HCC in a single medical center, and the outcome of patients with or without DAA therapy was analyzed. In total, 107 HCC patients were enrolled, of whom 60 had received DAA therapy after treatment for HCC. There were no significant intergroup differences in age, sex, laboratory results, or tumor burden. A more advanced stage was noted in the no DAA group (P = 0.003). In the treatment modality, sorafenib was commonly prescribed in the no DAA group (P = 0.007). The DAA group had a longer overall survival (OS) time than the no DAA group (P<0.001). When stratified by Barcelona Clinic Liver Cancer staging, the DAA group had better OS in the HCC stages 0-A and B-C (P = 0.034 and P = 0.006). There were 35 patients who received DAA therapy after curative HCC therapy. At a median follow-up of 20 months, 37.1% patients had HCC recurrence after DAA therapy. There was no statistical difference in recurrence-free survival between patients receiving and those not receiving DAA (P = 0.278). DAA therapy improved the survival outcome of HCC patients and did not increase recurrent HCC after curative therapy.

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Section: Discussionmentioning

confidence: 59%

Impact of direct-acting antiviral therapy for hepatitis C–related hepatocellular carcinoma

Lin

Chang

et al. 2020

PLoS ONE

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“…Based on the excellent efficacy, applying PrOD would be a preferred choice for treating East Asian HCV GT1b non-cirrhotic patients receiving hemodialysis. 31,32 Because other NS3/NS5A DAA regimens, such as EBR/GZR or GLE/PIB, also have excellent efficacy and safety for HCV GT1b patients receiving hemodialysis, patients may receive such treatment if PrOD treatment is contraindicated or in countries where PrOD is not available. 15,16 In our study, a significant proportion of patients had baseline viral load of ≥ 2 000 000 IU/mL (24%), IL-28B non-CC genotypes (20%), baseline HCV RASs at NS3, NS5A, and NS5B regions (13%-33%), and failed to IFN-based therapies (26%) who might compromise the SVR 12 rate.…”

Section: Discussionmentioning

confidence: 99%

Paritaprevir/ritonavir, ombitasvir plus dasabuvir for East Asian non‐cirrhotic hepatitis C virus genotype 1b patients receiving hemodialysis

Liu

Shih

Yang

et al. 2019

J of Gastro and Hepatol

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Background and Aim: Data regarding the efficacy and safety of paritaprevir/ritonavir, ombitasvir plus dasabuvir (PrOD) for East Asian non-cirrhotic hepatitis C virus genotype 1b (HCV GT1b) patients receiving hemodialysis were limited. Methods: Forty-six HCV GT1b non-cirrhotic patients receiving hemodialysis who received PrOD for 12 weeks were prospectively enrolled in seven academic centers in Taiwan. The primary efficacy endpoint was sustained virologic response 12 weeks offtherapy (SVR 12 ). Patients' baseline characteristics, early virokinetics, and HCV resistance-associated substitutions (RASs) potentially related to SVR 12 were analyzed. The safety profiles were also assessed. Results: The SVR 12 rate was 100% (46 of 46 patients). Patients' baseline characteristics, on-treatment viral decline, and baseline HCV resistance-associated substitutions did not affect SVR 12 . All patients tolerated treatment well. One patient with folliculitis temporarily discontinued treatment, and another two patients had serious adverse events (SAEs), which were considered not related to PrOD treatment. The common adverse events were pruritus (19.6%), fatigue (15.2%), and upper respiratory tract infection (6.5%). Twelve (19.6%) and one (2.2%) patients had hemoglobin levels < 10 and 8.5 g/dL, respectively, which were related to renal impairment. Five (10.9%) patients had on-treatment total bilirubin level of 1.5-3.0 mg/dL, but none developed hepatic decompensation. The bilirubin levels peaked at week 1 of treatment and then declined with continuous treatment. Conclusion: Treatment with PrOD for 12 weeks is efficacious and well-tolerated for East Asian non-cirrhotic HCV GT1b patients receiving hemodialysis.

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“…The possible explanation for a better PPV associated with HCV-infection ICD-10-CM codes as compared to HBV-infection ICD-10-CM codes (81% vs 45%) was that the NHI began to reimburse HCV antiviral treatment since 2017 and the correct ICD-10-CM codes in outpatient claims data are one of the requirements for getting approval of antiviral treatment for patients with HCV. 26,27 With regard to nearly half of patients with positive HBVinfection ICD-10-CM codes were false positive, the first possible explanation was that many physicians assigned the HBV-infection related codes to avoid the denial of reimbursement. The physicians did not check the HBV-related test results, and still copied-and-pasted the same diagnosis even after the test results were available.…”

Section: Comparison With Previous Studiesmentioning

confidence: 99%

<p>Validity of ICD-10-CM Codes Used to Identify Patients with Chronic Hepatitis B and C Virus Infection in Administrative Claims Data from the Taiwan National Health Insurance Outpatient Claims Dataset</p>

Sheu¹,

Liang²,

Li³

et al. 2020

CLEP

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Purpose: To validate the use of International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) codes to identify patients with chronic hepatitis B virus (HBV) and hepatitis C virus (HCV) infection in the Taiwan National Health Insurance (NHI) Outpatient Claims Dataset. Methods: We conducted a retrospective study using results of HBV surface antigen (HBsAg), HBV e antigen (HBeAg), and anti-HCV antibody tests in the NHI Lab & Exam Dataset from January 1 to March 31, 2018, as the reference standard to confirm HBV and HCV infection cases. We calculated sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) to assess the performance of HBV infection-specific ICD-10-CM codes (B180, B181, and B191) and HCV infection-specific ICD-10-CM codes (B182 and B192) recorded in the NHI Outpatient Claims Dataset to identify patients with HBV or HCV infection. Results: In total, 196,635 and 120,628 patients had analyzable results for HBsAg/HBeAg tests and anti-HCV tests, respectively. Moreover, 44,574 and 14,443 were confirmed to have HBV and HCV infection, respectively. The sensitivity, specificity, PPV, and NPV were, respectively, 46%, 83%, 45%, and 84% for HBV infection-specific ICD-10-CM codes and 47%, 99%, 81%, and 93% for HCV infection-specific ICD-10-CM codes. The sensitivity demonstrated great variation by region, clinical setting, and physician specialty. Conclusion: The HBV and HCV infection-specific ICD-10-CM codes recorded by physicians in Taiwan NHI outpatient claims data in 2018 had moderate sensitivity and high specificity for both HBV and HCV infection. The PPV was high for HCV ICD-10-CM codes, yet moderate for HBV ICD-10-CM codes.

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Real-world anti-viral treatment decisions among chronic hepatitis C patients in Taiwan: The INITIATE study

Cited by 9 publications

References 36 publications

Impact of direct-acting antiviral therapy for hepatitis C–related hepatocellular carcinoma

Impact of direct-acting antiviral therapy for hepatitis C–related hepatocellular carcinoma

Paritaprevir/ritonavir, ombitasvir plus dasabuvir for East Asian non‐cirrhotic hepatitis C virus genotype 1b patients receiving hemodialysis

<p>Validity of ICD-10-CM Codes Used to Identify Patients with Chronic Hepatitis B and C Virus Infection in Administrative Claims Data from the Taiwan National Health Insurance Outpatient Claims Dataset</p>

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