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Last update 08 May 2025

PIVKA-II

Last update 08 May 2025

Basic Info

Synonyms-

Introduction-

Drugs associated with PIVKA-II

CN118271449

Patent Mining

Target

PIVKA-II

Mechanism-

Active Org.

Fapon Biotech, Inc.

Originator Org.

Fapon Biotech, Inc.

Active Indication

Carcinoma [+1]

Inactive Indication-

Drug Highest PhaseDiscovery

First Approval Ctry. / Loc.-

First Approval Date20 Jan 1800

CN115850495

Patent Mining

Target

PIVKA-II

Mechanism-

Active Org.

Nanjingjinsirui Science & Technology Biology Corp.

Originator Org.

Nanjingjinsirui Science & Technology Biology Corp.

Active Indication

Liver Diseases

Inactive Indication-

Drug Highest PhaseDiscovery

First Approval Ctry. / Loc.-

First Approval Date20 Jan 1800

100 Clinical Results associated with PIVKA-II

100 Translational Medicine associated with PIVKA-II

0 Patents (Medical) associated with PIVKA-II

806

Literatures (Medical) associated with PIVKA-II

31 Dec 2025·Journal of Investigative Surgery

Establishment and Validation of Diagnostic Model of Microvascular Invasion in Solitary Hepatocellular Carcinoma

Article

Author: Wang, Xiu-Qin ; Hou, Dong-Xing ; Fan, Ying-Qi ; Pan, Cui-Cui ; Zheng, Ni ; Si, Yuan-Quan

BACKGROUNDThe microvascular invasion (MVI) score evaluates the presence of MVI in patients with hepatocellular carcinoma (HCC) by integrating multiple factors associated with MVI. We aimed to establish a MVI scoring system for HCC based on the clinical characteristics and serum biomarkers of patients with HCC.METHODSA total of 1027 patients with HCC hospitalized at Shandong Provincial Hospital from January 2016 to August 2021 were included and randomly divided into the development group and validation group at a ratio of 3:1. Univariable and multivariable logistic regression analyses were conducted to identify independent risk factors for MVI in HCC patients. Based on these independent risk factors, the preoperative MVI scoring system (diagnostic model) for HCC was established and verified. The receiver operating characteristic (ROC) curves, calibration curves and decision curve analyses (DCA) were employed to evaluate the discrimination and clinical application of the diagnostic model.RESULTSIndependent risk factors for MVI of HCC involved Hepatitis B virus infection (HBV), large tumor diameter, higher logarithm of Alpha-fetoprotein (Log AFP), higher logarithm of AFP-L3% (Log AFP-L3%), higher logarithm of protein induced by vitamin K absence or antagonist-II (Log PIVKA-II) and higher logarithm of Carbohydrate antigen 125 (Log CA125). The diagnostic model incorporating these six independent risk factors was finally established. The areas under the ROC curve (AUC) assessed by the nomogram in the development cohort and validation cohort were 0.806 (95% CI, 0.773-0.839) and 0.818 (95% CI, 0.763-0.874) respectively. The calibration curve revealed that the results predicted by our diagnostic model for MVI in HCC were highly consistent with the postoperative pathological outcomes. The DCA further indicated promising clinical application of the diagnostic model.CONCLUSIONAn effective preoperative diagnostic model for MVI of HCC based on readily available tumor markers and clinical characteristics has been established, which is both clinically significant and easy to implement for diagnosing MVI.

01 Jul 2025·Journal of Clinical and Experimental Hepatology

Predictors of Non-response to Atezolizumab Plus Bevacizumab in Patients With Unresectable Hepatocellular Carcinoma: A Multicentre Real World Study (HCC-AB Study)

Article

Author: Duseja, Ajay ; Kumar, Karan ; Shah, Samir ; Rathi, Sahaj ; Nagaraja Rao, P ; Kumar, Guresh ; Taneja, Sunil ; Singh, Satender P ; Sarin, Shiv K ; Choudhury, Ashok ; Saraswat, Vivek ; Arora, Vinod ; Chaubal, Alisha ; Kulkarni, Anand ; Kumar, Ashish

BackgroundThe approved immunotherapies for patients with advanced HCC are Atezolizumab and Bevacizumab. However, patients in India present late and healthcare is often available through self-financing. To rationalise the therapy, we conducted a large multicentre study to identify the baseline predictors of non-response to atezolizumab and bevacizumab in advanced unresectable HCC.MethodsA dose of atezolizumab 1200 mg and bevacizumab 15 mg/kg was used every 3 weeks from 6 centres across India. A total of 278 patients were screened, and 160 were included in the study. The study included patients with locally advanced metastatic or inoperable hepatocellular carcinoma who were at least 18 years of age and those who received <3 injections were excluded. Fifty-four percent of the included patients were BCLC-B and 46% were BCLC-C. The primary objective was to study overall survival and progression-free survival. While identifying radiological response, objective response rate and adverse effects were secondary objectives.ResultsThe mean age was 61.9 ± 11.7 years, 88% were male, 55% had NASH, 16.3% had hepatitis C, 18.8% had hepatitis B and the rest were alcohol. The mean Model for End-Stage Liver Disease (MELD) is 12.05 ± 4.46, Albumin-Bilirubin Score (ALBI) is -2.04 ± 0.57. Fifty-five percent received first-line and 45% as second/other line therapy. The median overall survival was 10 (95% confidence interval [CI]: 6.1-15.6) months. Progression-free survival was found to be 8 (95%CI: 5.1-14.7) months overall. Eleven (6.9%) achieved complete response, 28 (17.5%) partial response, 33 (20.6%) had stable disease and 88 (55%) had progressive disease. On multivariate analysis, CRP>1 mg/dl (P-0.007), PIVKA-II>400 mAU/mL (P-0.019), AFP>100 ng/ml (P-0.009), presence of diabetes (P-0.042) were associated with non-response to atezolizumab and bevacizumab injection. Fifty-three percent of patients developed any grade of adverse effect, and 20% developed grade 3/4 adverse events amounting to the stoppage of therapy.ConclusionNon-response to atezolizumab and bevacizumab immunotherapy was predicted by CRP>1 mg/dl, PIVKA-II>400mAU/ml, AFP>100 ng/ml and the presence of diabetes.

01 Jun 2025·Clinical Biochemistry

CA19-9, CEA and PIVKA-Ⅱ as a novel panel of serum markers for diagnosis of pancreatic cancer

Article

Author: Chen, Guodong ; Wang, Meifang ; Cao, Deliang ; Zeng, Xi ; Bu, Hongying ; Luo, Weijia ; He, Yingchun

AIMThis retrospective study was aimed to evaluate the diagnostic value of a combination of carbohydrate antigen 19-9 (CA19-9), carcinoembryonic antigen (CEA) and protein induced by vitamin K absence or antagonist-Ⅱ (PIVKA-II) in pancreatic cancer.METHODSClinical data were collected from 111 pancreatic cancer patients and 158 patients with benign pancreatic diseases (BPD). Serum CA19-9, CEA and PIVKA-II were subjected to receiver operating characteristic curve (ROC) analysis alone and in combination for the diagnosis of pancreatic cancer.RESULTSSerum CA19-9, CEA, and PIVKA-II were higher in pancreatic cancer patients than in BPD patients (P < 0.001). ROC analysis indicated that the cutoff values were 99.390 for CA19-9, 3.065 for CEA, and 42.965 for PIVKA-II, at which the positive rate in pancreatic cancer was 78.38 % for CA19-9, 43.24 % for CEA and 48.65 % for PIVKA-Ⅱ. When serum CA19-9, CEA, and PIVKA-II were used alone, the areas under the curves (AUC), sensitivity and specificity were 0.821, 68.47 % and 89.24 % for CA19-9, 0.763, 61.26 % and 85.44 % for CEA, and 0.681, 45.95 % and 87.34 % for PIVKA-II. When serum CA19-9, CEA, and PIVKA-II were used in combination, the positivity rate was 94.59 % in pancreatic cancer with AUC of 0.903, sensitivity of 81.10 % and specificity of 88.00 %.CONCLUSIONPIVKA-II is a potential serum marker of pancreatic cancer and the combination of CA19-9, CEA, and PIVKA-II is a novel panel of serum markers with promising diagnostic value for pancreatic cancer.

News (Medical) associated with PIVKA-II

05 Dec 2024

·www.drugs.com

PIVKA-II-Based Model IDs Liver Cancer Risk in Hep C-Related Cirrhosis

THURSDAY, Dec. 5, 2024 -- Among patients with hepatitis C virus (HCV)-related cirrhosis with sustained virological response (SVR) to direct-acting antivirals (DAAs), a serum protein induced by vitamin K absence or antagonist-II (PIVKA-II)-based model is accurate for predicting hepatocellular carcinoma (HCC) risk, according to a study published online Nov. 21 in Alimentary Pharmacology & Therapeutics . Gian Paolo Caviglia, Ph.D., from the University of Turin in Italy, and colleagues developed and validated a PIVKA-II-based model for HCC risk stratification in patients with HCV-related cirrhosis with SVR to DAAs. Data were included for 1,220 patients (Turin cohort, 531; Pisa cohort, 335; and Milan cohort, 354). The researchers derived a model including PIVKA-II combined with age, sex, alanine transaminase, aspartate aminotransferase, gamma-glutamyl transferase, platelet count, albumin, and total bilirubin from the training cohort (Turin + Pisa), with a C-index of 0.72. The models showed a C-index of 0.71 in the validation cohort (Milan), with an area under the curve of 0.84 for identifying patients who developed HCC within 12 months of follow-up. The cumulative incidence of HCC was 2.7, 4.0, and 14.3 percent in the low-, medium-, and high-risk groups when the patients were categorized into three risk categories. In the low-risk group, no HCC occurred within three years of follow-up. "Our model allowed the identification of patients at low risk of HCC development that may not need surveillance, reducing costs and harms from surveillance," the authors write. Several authors disclosed ties to the pharmaceutical industry. Abstract/Full Text Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

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