High viral load predicts virologic failure in chronic genotype 2 hepatitis C virus-infected patients receiving glecaprevir/pibrentasvir therapy

Chen, Wei Ming; Wei, Kuo‐Liang; Tung, Shui‐Yi; Shen, Chien-Heng; Chang, Te‐Sheng; Yen, Chih-Wei; Hsieh, Yung‐Yu; Chiu, Wen Nan; Hu, Jin Hung; Lu, Sheng–Nan; Hung, Chao‐Hung

doi:10.1016/j.jfma.2020.08.010

Cited by 8 publications

(6 citation statements)

References 31 publications

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“…In addition to drug adherence, another factor associated with a higher risk of treatment failure in the present study is HCV RNA level ≥ 6,000,000 IU/ml with an adjusted OR of 20.58 (95% CI 1.98–214.10, p = 0.01) compared to HCV RNA level < 6,000,000 IU/ml. Our result is in concordance with another real-world study which demonstrated that high viral load (≥ 10 7 IU/ml) was a significant predictor associated with virologic failure in non-cirrhotic genotype 2 patients receiving 8-week GLE/PIB therapy [ 30 ]. These results suggest that more caution is needed with a short-course GLE/PIB regimen when treating HCV patients with a high viral load.…”

Section: Discussionsupporting

confidence: 92%

Effectiveness and safety of 8-week glecaprevir/pibrentasvir in HCV treatment-naïve patients with compensated cirrhosis: real-world experience from Taiwan nationwide HCV registry

et al. 2023

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Background Large-scale real-world data of the 8-week glecaprevir/pibrentasvir (GLE/PIB) therapy for treatment-naïve patients of chronic hepatitis C virus (HCV) infection with compensated cirrhosis is scarce. Methods The TASL HCV Registry (TACR) is an ongoing nationwide registry program that aims to set up a database and biobank of patients with chronic HCV infection in Taiwan. In this study, data were analyzed as of 31 October 2021 for treatment-naïve HCV patients with compensated cirrhosis receiving 8-week GLE/PIB therapy. Effectiveness reported as sustained virologic response at off-therapy week 12 (SVR12) and safety profiles were assessed. Patient characteristics potentially related to SVR12 were also evaluated. Results Of the 301 patients enrolled, 275 had available SVR12 data. The SVR12 rate was 98.2% (270/275) in the modified intention-to-treat (mITT) population and 89.7% (270/301) in the ITT population. For those mITT patients with genotype 3, FibroScan > 20 kPa, platelet < 150,000/µl, and FibroScan > 20 kPa and platelet < 150,000/µl, the SVR12 rates were 100% (6/6), 100% (12/12), 98.0% (144/147), 100% (7/7), respectively. Overall, 24.9% (75/301) patients experienced adverse events (AEs). The most frequent AEs (> 5%) included fatigue (9.0%) and pruritus (7.0%). Seven (2.3%) patients experienced serious AEs and two (0.7%) resulted in permanent drug discontinuation. None of them were considered as GLE/PIB-related. Conclusions In this large-scale real-world Taiwanese cohort, 8-week GLE/PIB therapy was efficacious and well tolerated for treatment-naïve compensated cirrhosis patients. SVR12 rates were similarly high as in the clinical trials, including those with characteristics of advanced liver disease. Supplementary Information The online version contains supplementary material available at 10.1007/s12072-023-10506-z.

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Section: Discussionsupporting

confidence: 92%

Effectiveness and safety of 8-week glecaprevir/pibrentasvir in HCV treatment-naïve patients with compensated cirrhosis: real-world experience from Taiwan nationwide HCV registry

et al. 2023

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“…In contrast to the overall HCV genotype distribution in Taiwan, wherein genotype 1 is predominant [ 1 ], the preponderance of genotype 2 (62.26%) in this study reflected the evolution of DAAs, because the DAA regimens for treating genotype 1 infection were licensed and reimbursed earlier than those for other genotypes [ 17 , 19 ]. Although high viral load was previously associated with a high virological failure rate for genotype 2 patients receiving GLE/PIB [ 32 ], this phenomenon was not replicated in our genotype 2–dominant cohort, in which PP analysis suggested that all of the patients achieved SVR. The higher number of patients with HCC history and lower levels of hemoglobin, platelet count, and serum albumin in the 12-week group relative to the 8-week group suggest a higher severity of liver disease in this group.…”

Section: Discussioncontrasting

confidence: 70%

Comparison of 8- versus 12-weeks of glecaprevir/pibrentasvir for Taiwanese patients with hepatitis C and compensated cirrhosis in a real-world setting

Chen

et al. 2022

PLoS ONE

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Real-world data on the effectiveness of glecaprevir/pibrentasvir (GLE/PIB) for patients with HCV infection and compensated cirrhosis is limited, especially for the 8-week regimen and in an Asian population. This retrospective study enrolled 159 consecutive patients with HCV and compensated cirrhosis who were treated with GLE/PIB at a single center in Taiwan. Sustained virological response (SVR) and adverse events (AEs) were evaluated. Among the 159 patients, 91 and 68 were treated with GLE/PIB for 8 and 12 weeks, respectively. In the per protocol analysis, both the 8- and 12-week groups achieved 100% SVR (87/87 vs. 64/64); and in the evaluable population analysis, 95.6% (87/91) of the 8-week group and 94.1% (64/68) of the 12-week group achieved SVR. The most commonly reported AEs, which included pruritus (15.4% vs. 26.5%), abdominal discomfort (9.9% vs. 5.9%), and skin rash (5.5% vs. 5.9%), were mild for the 8- and 12-week groups. Two patients in the 8-week group exhibited total bilirubin elevation over three times the upper normal limit. One of these two patients discontinued GLE/PIB treatment after 2 weeks but still achieved SVR. Both 8- and 12-week GLE/PIB treatments are safe and effective for patients of Taiwanese ethnicity with HCV and compensated cirrhosis.

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“…Previous studies have shown that the SVR12 rate significantly decreased in the high baseline viral load group compared to that in the low viral load group. However, the optimal cutoff values for high vs. low viral loads vary across studies [ 21 , 22 ]. While pan-genotypic DAAs can be safely administered in traditionally difficult-to-treat HCV populations, managing patients with active HCC, decompensated liver cirrhosis, RASs, or prior DAA failure requires special attention [ 3 ].…”

Section: Discussionmentioning

confidence: 99%

Artificial intelligence predicts direct-acting antivirals failure among hepatitis C virus patients: A nationwide hepatitis C virus registry program

Lu,

Huang,

Hung

et al. 2023

Clin Mol Hepatol

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Background/Aims: Despite the high efficacy of direct-acting antivirals (DAAs), approximately 1–3% of hepatitis C virus (HCV) patients fail to achieve a sustained virological response. We conducted a nationwide study to investigate risk factors associated with DAA treatment failure. Machine-learning algorithms have been applied to discriminate subjects who may fail to respond to DAA therapy.Methods: We analyzed the Taiwan HCV Registry Program database to explore predictors of DAA failure in HCV patients. Fifty-five host and virological features were assessed using multivariate logistic regression, decision tree, random forest, eXtreme Gradient Boosting (XGBoost), and artificial neural network. The primary outcome was undetectable HCV RNA at 12 weeks after the end of treatment. Results: The training (n=23,955) and validation (n=10,346) datasets had similar baseline demographics, with an overall DAA failure rate of 1.6% (n=538). Multivariate logistic regression analysis revealed that liver cirrhosis, hepatocellular carcinoma, poor DAA adherence, and higher hemoglobin A1c were significantly associated with virological failure. XGBoost outperformed the other algorithms and logistic regression models, with an area under the receiver operating characteristic curve of 1.000 in the training dataset and 0.803 in the validation dataset. The top five predictors of treatment failure were HCV RNA, body mass index, α-fetoprotein, platelets, and FIB-4 index. The accuracy, sensitivity, specificity, positive predictive value, and negative predictive value of the XGBoost model (cutoff value=0.5) were 99.5%, 69.7%, 99.9%, 97.4%, and 99.5%, respectively, for the entire dataset.Conclusions: Machine learning algorithms effectively provide risk stratification for DAA failure and additional information on the factors associated with DAA failure.

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High viral load predicts virologic failure in chronic genotype 2 hepatitis C virus-infected patients receiving glecaprevir/pibrentasvir therapy

Cited by 8 publications

References 31 publications

Effectiveness and safety of 8-week glecaprevir/pibrentasvir in HCV treatment-naïve patients with compensated cirrhosis: real-world experience from Taiwan nationwide HCV registry

Effectiveness and safety of 8-week glecaprevir/pibrentasvir in HCV treatment-naïve patients with compensated cirrhosis: real-world experience from Taiwan nationwide HCV registry

Comparison of 8- versus 12-weeks of glecaprevir/pibrentasvir for Taiwanese patients with hepatitis C and compensated cirrhosis in a real-world setting

Artificial intelligence predicts direct-acting antivirals failure among hepatitis C virus patients: A nationwide hepatitis C virus registry program

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