Introduction: In a perspective of economic constraints the prioritizing of patients to IFN-free regimens is mainly based on the determination of liver stiffness by transient elastography (TE). Being a continuous variable the interpretation of TE results requires the identification of cut-off values, to date set to maximize diagnostic accuracy even if such values should be better based on more helpful outcome prediction endpoints. Aim: To define the TE cut-off values in different clinical scenarios, including new IFN-free regimens, and to balance the clinical benefits versus harms in treated and untreated patients. Methods: We assessed the accuracy of TE in staging 728 consecutive HCV patients and the distribution of TE values in 1,001 blood donors. Ten experts quantified the expected harm/benefit ratio for 6 scenarios resulting from 2 stages of liver disease (F≥2 or F≥3) and 3 treatment regimens: PEGIFN+ribavirin, PEGIFN+RBV+first-generation protease inhibitor, and IFNfree regimens. The optimal TE cut-off values were identified using the Metz equation. Results: The estimated mean expected harm/benefit ratio for IFN-free regimens was 1/8.3 in patients with F≥2 and 1/10 in those with F≥3. The resulting optimal cut-off values were respectively 4.5 kPa with sensitivity at 99% and specificity at 12%, and 6.8 kPa with sensitivity at 94% and specificity at 41%. These cut-off values are lower than those maximizing accuracy and allow to reduce the number of false negative results. Conclusions: The optimal TE cut-off values to prioritize patients for IFN-free regimens, are sensibly lower than those used to maximize diagnostic accuracy.
Deciding on interferon-free treatment for chronic hepatitis C : Updating liver stiffness cut-off values to maximize benefit / A. Colli, M. Fraquelli, D. Prati, A. Riva, A. Berzuini, D. Conte, A. Aghemo, M. Colombo, G. Casazza. - In: PLOS ONE. - ISSN 1932-6203. - 11:10(2016 Oct). [10.1371/journal.pone.0164452]
Deciding on interferon-free treatment for chronic hepatitis C : Updating liver stiffness cut-off values to maximize benefit
D. Conte;A. Aghemo;M. ColomboPenultimo
;G. CasazzaUltimo
2016
Abstract
Introduction: In a perspective of economic constraints the prioritizing of patients to IFN-free regimens is mainly based on the determination of liver stiffness by transient elastography (TE). Being a continuous variable the interpretation of TE results requires the identification of cut-off values, to date set to maximize diagnostic accuracy even if such values should be better based on more helpful outcome prediction endpoints. Aim: To define the TE cut-off values in different clinical scenarios, including new IFN-free regimens, and to balance the clinical benefits versus harms in treated and untreated patients. Methods: We assessed the accuracy of TE in staging 728 consecutive HCV patients and the distribution of TE values in 1,001 blood donors. Ten experts quantified the expected harm/benefit ratio for 6 scenarios resulting from 2 stages of liver disease (F≥2 or F≥3) and 3 treatment regimens: PEGIFN+ribavirin, PEGIFN+RBV+first-generation protease inhibitor, and IFNfree regimens. The optimal TE cut-off values were identified using the Metz equation. Results: The estimated mean expected harm/benefit ratio for IFN-free regimens was 1/8.3 in patients with F≥2 and 1/10 in those with F≥3. The resulting optimal cut-off values were respectively 4.5 kPa with sensitivity at 99% and specificity at 12%, and 6.8 kPa with sensitivity at 94% and specificity at 41%. These cut-off values are lower than those maximizing accuracy and allow to reduce the number of false negative results. Conclusions: The optimal TE cut-off values to prioritize patients for IFN-free regimens, are sensibly lower than those used to maximize diagnostic accuracy.File | Dimensione | Formato | |
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2016 PlosOne Deciding on Interferon Free Treatment for Chronic Hepatitis C Updating Liver Stiffness Cut Off Values to Maximize Benefit.pdf
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