FIB-4 and APRI as Predictive Factors for Short- and Long-Term Survival in Patients with Transjugular Intrahepatic Portosystemic Stent Shunts.

(1) Background: Transjugular intrahepatic portosystemic shunt (TIPS) is a standard therapy for portal hypertension. We aimed to explore the association of established baseline scores with TIPS outcomes. (2) Methods: In total, 136 liver cirrhosis patients underwent TIPS insertion, mainly to treat refractory ascites (86%), between January 2016 and December 2019. An external validation cohort of 187 patients was chosen. (3) Results: The majority of the patients were male (62%); the median follow-up was 715 days. The baseline Child­Turcotte−Pugh stage was A in 14%, B in 75% and C in 11%. The patients' liver-transplant-free (LTF) survival rates after 3, 12 and 24 months were 87%, 72% and 61%, respectively. In the univariate analysis, neither bilirubin, nor the international normalized ratio (INR), nor liver enzymes were associated with survival. However, both the APRI (AST-to-platelet ratio index) and the FIB-4 (fibrosis-4 score) were associated with LTF survival. For patients with FIB-4 > 3.25, the hazard ratio for mortality after 2 years was 3.952 (p < 0.0001). Liver-related clinical events were monitored for 24 months. High FIB-4 scores were predictive of liver-related events (HR = 2.404, p = 0.001). Similarly, in our validation cohort, LTF survival was correlated with the APRI and FIB-4 scores. (4) Conclusions: Well-established scores that reflect portal hypertension and biochemical disease activity predict long-term outcomes after TIPS and support clinical decisions over TIPS insertion.

Eligibility and safety of triple therapy for hepatitis C: lessons learned from the first experience in a real world setting.

BACKGROUND: HCV protease inhibitors (PIs) boceprevir and telaprevir in combination with PEG-Interferon alfa and Ribavirin (P/R) is the new standard of care in the treatment of chronic HCV genotype 1 (GT1) infection. However, not every HCV GT1 infected patient is eligible for P/R/PI therapy. Furthermore phase III studies did not necessarily reflect real world as patients with advanced liver disease or comorbidities were underrepresented. The aim of our study was to analyze the eligibility and safety of P/R/PI treatment in a real world setting of a tertiary referral center. METHODS: All consecutive HCV GT1 infected patients who were referred to our hepatitis treatment unit between June and November 2011 were included. Patients were evaluated for P/R/PI according to their individual risk/benefit ratio based on 4 factors: Treatment-associated safety concerns, chance for SVR, treatment urgency and nonmedical patient related reasons. On treatment data were analyzed until week 12. RESULTS: 208 patients were included (F3/F4 64%, mean platelet count 169/nl, 40% treatment-naïve). Treatment was not initiated in 103 patients most frequently due to safety concerns. 19 patients were treated in phase II/III trials or by local centers and a triple therapy concept was initiated at our unit in 86 patients. Hospitalization was required in 16 patients; one patient died due to a gastrointestinal infection possibly related to treatment. A platelet count of <110/nl was associated with hospitalization as well as treatment failure. Overall, 128 patients were either not eligible for therapy or experienced a treatment failure at week 12. CONCLUSIONS: P/R/PI therapies are complex, time-consuming and sometimes dangerous in a real world setting, especially in patients with advanced liver disease. A careful patient selection plays a crucial role to improve safety of PI based therapies. A significant number of patients are not eligible for P/R/PI, emphasizing the need for alternative therapeutic options.