Novel direct-acting antivirals (DAAs) are now the standard of care for the management of hepatitis C virus (HCV) infection. Branded DAAs are associated with high sustained virological response at 12 weeks post-completion of therapy (SVR12), but are costly. We aimed to assess the efficacy of generic oral DAAs in a real-life clinical scenario. Consecutive patients with known HCV infection who were treated with generic-oral DAA regimens (May 2015 to January 2017) were included. Demographic details, prior therapy and SVR12 were documented. Four hundred and ninety patients (mean age: 38.9 ± 12.7 years) were treated with generic DAAs in the study time period. Their clinical presentations included chronic hepatitis (CHC) in 339 (69.2%) of cases, compensated cirrhosis in 120 (24.48%) cases and decompensated cirrhosis in 31 (6.32%) cases. Genotype 3 was most common (n = 372, 75.9%) followed by genotype 1 (n = 97, 19.8%). Treatment naïve and treatment-experienced (defined as having previous treatment with peginterferon and ribavirin) were 432 (88.2%) and 58 (11.8%), respectively. Generic DAA treatment regimens included sofosbuvir in combination with ribavirin (n = 175), daclatasvir alone (n = 149), ribavirin and peginterferon (n = 80), ledipasvir alone (n = 43), daclatasvir and ribavirin (n = 37), and ledipasvir and ribavirin (n = 6). Overall SVR12 was 95.9% (470/490) for all treatment regimens. SVR12 for treatment naïve and experienced patients was 97.0% (419/432) and 87.9% (51/58), respectively, P = .005. High SVR12 was observed with various regimens, irrespective of genotype and underlying liver disease status. There were no differences in SVR12 with 12 or 24 weeks therapy. No major adverse event occurred requiring treatment stoppage. Generic oral DAAs are associated with high SVR rates in patients with HCV infection in a real-life clinical scenario.
Goals:
The aim of this study was to assess the use of thromboelastography (TEG)-directed blood product transfusion in cirrhotic patients with acute variceal bleeding compared with conventional transfusion for correction of coagulopathy.
Background:
Coagulopathy is common in patients with cirrhosis. Recommendations for correction of conventional parameters of coagulation—platelets and the international normalized ratio before endoscopy in patients with acute variceal bleeding—need more validation.
Study:
In this randomized controlled trial, cirrhotic patients with severe coagulopathy and acute variceal bleeding were randomized to either TEG-guided blood product transfusion or conventional transfusion from March 2017 to December 2017. The primary outcome was the difference in the amount of fresh frozen plasma and platelet units transfused between the groups. Secondary outcomes were rebleeding at 5 days and 42 days, and 6-week mortality.
Results:
Of the 60 recruited patients, 30 each were randomized to the TEG and conventional transfusion groups. There were no differences in baseline characteristic and endoscopic findings between the 2 groups. Four subjects in the TEG group received blood product transfusions versus all in the conventional transfusion group (13.3% vs. 100%; P<0.001). The control of bleeding on initial endoscopy was similar in the 2 groups. Rebleeding in the TEG and conventional transfusion groups at 5 days was similar [1 (3.3%) vs. 4 (13.3%), P=0.167], whereas it was significantly less in the TEG group at 42 days [3 (10%) vs. 11 (36.7%), P=0.012]. Mortality at 6 weeks was seen in 4 (13.3%) in the TEG group and in 8 (26.7%) patients in the conventional transfusion group (P=0.176).
Conclusions:
TEG-guided strategy was associated with reduced blood product transfusion to correct coagulopathy without compromising hemostasis in cirrhotic patients (Clinical trial ID: CTRI/2017/02/007864).
Background/Aims: Direct-Acting Antivirals (DAAs) are now the standard of care for management of Chronic Hepatitis C (CHC) infection. The aim of this study was to evaluate change in Liver Stiffness Measurement (LSM) and Controlled Attenuation Parameter (CAP) by transient elastography (FibroScan1) after completion of DAA therapy. Methods: LSM and CAP were measured serially (baseline pre-treatment, at 12 weeks post therapy, and one year after completion of therapy) in a prospective cohort of 372 CHC patients treated with DAAs. Patients with at least two FibroScan measurements were included. Results: The mean age was [ 2 3 5 _ T D $ D I F F ] 38.1 AE 12.6 years; 58.3% males. Cirrhosis as defined by biopsy or fibroscan measurement (!12.5) [ 2 3 6 _ T D $ D I F F ] kPa was found in 25.5%. On paired analysis (n [ 2 3 7 _ T D $ D I F F ] = 317), LSM (IQR) decreased from a baseline value 7.1 (5.3-13.8) [ 2 3 8 _ T D $ D I F F ] kPa to 6.2 (4.8-11.2) kPa 12 weeks post therapy with a median decline 0.7 (À0.
Background and Aim
Anticoagulants play an important role in the management of Budd–Chiari syndrome. There is a paucity of data on the efficacy and safety of direct‐acting oral anticoagulants—dabigatran, among patients with Budd–Chiari syndrome.
Methods
In a retrospective analysis of prospectively maintained data, the stent patency rates, major bleeding episode, and a composite endpoint of major bleed and/or mortality rates were compared between Budd–Chiari syndrome patients treated with dabigatran (n = 36) or vitamin K antagonists (n = 62) following endovascular intervention.
Results
The baseline characteristics, including sites of block and types of interventions, were similar between the two groups. The mean duration of follow‐up in the dabigatran and vitamin K antagonist groups was 10.5 ± 6.7 and 14.1 ± 6.9 months (P = 0.006), respectively. The endovascular stent patency rates were comparable between the dabigatran and vitamin K antagonist groups at 6 months (91% vs 96.5%) and 12 months (91% vs 93%), P = 0.296 (log‐rank test), respectively. Major bleeding events were comparable between the dabigatran and vitamin K antagonist groups at 6 months (3.5% vs 2%) and 12 months (3.5% vs 6.5%), P = 0.895 (log‐rank test), respectively. The composite endpoint of mortality and major bleed was comparable between dabigatran and vitamin K antagonists at 6 months (4% vs 5%) and 12 months (4% vs 8%), P = 0.875 (log‐rank test), respectively.
Conclusions
Dabigatran, as compared with vitamin K antagonists, is associated with similar stent patency rates and complications among patients with Budd–Chiari syndrome post‐endovascular intervention.
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