Final analysis of the international observational S-Collate study of peginterferon alfa-2a in patients with chronic hepatitis B

Background and aims Sustained off-treatment immune control is achievable in a proportion of patients with chronic hepatitis B treated with peginterferon alfa-2a. We evaluated on-treatment predictors of hepatitis B surface antigen (HBsAg) clearance 3 years after peginterferon alfa-2a treatment and determined the incidence of hepatocellular carcinoma. Methods A prospective, international, multicenter, observational study in patients with chronic hepatitis B who have been prescribed peginterferon alfa-2a (40KD) in a real-world setting. The primary endpoint was HBsAg clearance after 3 years' follow-up. Results The modified intention-to-treat population comprised 844 hepatitis B e antigen (HBeAg)positive patients (540 [64%] completed 3 years' follow-up), and 872 HBeAg-negative patients (614 [70%] completed 3 years' follow-up). At 3 years' follow-up, HBsAg clearance rates in HBeAg-positive and HBeAg-negative populations, respectively, were 2% (16/844) and 5% (41/872) in the modified intention-to-treat population and 5% [16/328] and 10% [41/ 394] in those with available data. In HBeAg-positive patients with data, Week 12 HBsAg levels <1500, 1500-20,000, and >20,000 IU/mL were associated with HBsAg clearance rates at 3 years' follow-up of 11%, 1%, and 5%, respectively (Week 24 predictability was similar). In HBeAg-negative patients with available data, a 6510% decline vs a <10% decline in HBsAg at Week 12 was associated with HBsAg clearance rates of 16% vs 4%. Hepatocellular carcinoma incidence was lower than REACH-B (Risk Estimation for Hepatocellular Carcinoma in Chronic Hepatitis B) model predictions. Conclusions Sustained off-treatment immune control is achieved with peginterferon alfa-2a in a real-world setting. HBsAg clearance 3 years after completion of peginterferon alfa-2a can be predicted on the basis of on-treatment HBsAg kinetics

Parameter Dependence and Prediction of Fatigue Properties of Elastomer Products

Abstract Fatigue tests on ethylene propylene (EPDM) and styrene-butadiene (SBR) rubber reveal physical behavior that is not seen in conventional linear elastic solids. Uniaxial cyclical tests, using cylindrical dumbbell specimens, with the same minimum stress of zero (Smin=0) and varying stress amplitude (sa), predictably gave decreased fatigue life with increased stress amplitude and hence maximum stress (Smax). However, tensile uniaxial cyclic tests where Smin was increased in successive tests while alternating stress (sa) remained constant, produced longer fatigue lives for higher values of Smax. EPDM and SBR compounds were chosen for the tests because they do not strain crystallize during deformation. Consequently, this phenomenon has no influence. The results show that Smax can not be used as criterion to predict fatigue life of elastomers. Preliminary evaluation of recorded data of stress vs. strain gave evidence that energies control the fatigue life rather than stress and strain. Experimental results on filled and unfilled rubber materials are evaluated and discussed as well as the consequences on predictions of component properties.</jats:p