Real-world efficacy and safety of 12-week sofosbuvir/velpatasvir treatment for patients with decompensated liver cirrhosis caused by hepatitis C virus infection
Authors: Takaoka, Yoshinari; Miura, Kouichi; Morimoto, Naoki; Ikegami, Tadashi; Kakizaki, Satoru; Sato, Ken; Ueno, Takashi; Naganuma, Atsushi; Kosone, Takashi; Arai, Hirotaka; Hatanaka, Takeshi; Tahara, Toshiyuki; Tano, Shigeo; Ohtake, Takaaki; Murohisa, Toshimitsu; Namikawa, Masashi; Asano, Takeharu; Kamoshida, Toshiro; Horiuchi, Katsuhiko; Nihei, Takeshi; Soeda, Atsuko; Kurata, Hidekazu; Fujieda, Takeshi; Ohtake, Toshiya; Fukaya, Yukimura; Iijima, Makoto; Watanabe, Shunji; Isoda, Norio; Yamamoto, Hironori
Aim This study aimed to evaluate the real-world efficacy and safety of 12-week sofosbuvir/velpatasvir (SOF/VEL) treatment for patients with decompensated liver cirrhosis caused by hepatitis C virus (HCV) infection. Methods A total 72 of patients with Child-Pugh (CP) class B or C were enrolled. We evaluated the sustained virologic response at 12 weeks after the end of treatment (SVR12), adverse events (AEs), and changes in the liver function. Results All participants had genotype 1 or 2 HCV infection. At baseline, the numbers of patients with CP class B and C were 59 and 13, respectively. The overall SVR12 rate was 95.8% (69/72); 94.9% (56/59) in CP class B and 100% (13/13) in CP class C. The serum albumin level, prothrombin time and ascites were significantly improved (P < 0.01); however, the serum bilirubin level and encephalopathy did not improve. Among patients who achieved SVR12, 75.0% showed an improvement in their CP score, while 5.9% showed a worsening. The presence of large portosystemic shunt (diameter >= 6 mm) and hyperbilirubinemia (>= 2.0 mg/dL) were independent factors that interfered with the improvement in the CP score (P < 0.05). The most common AEs were encephalopathy (15.3%) and skin symptoms (7.9%). Two patients discontinued SOF/VEL due to AEs. Conclusions Treatment with SOF/VEL for 12 weeks was relatively safe and effective for patients with decompensated cirrhosis. An SVR provided an improvement of the liver function in the majority of patients. However, large portosystemic shunt and hyperbilirubinemia were independent factors that interfered with the improvement in the CP score.
Remnant cholesterol as a risk factor for cardiovascular, cancer or other causes mortality: A competing risks analysis
NUTRITION METABOLISM AND CARDIOVASCULAR DISEASES
Authors: Bonfiglio, Caterina; Leone, Carla M.; Silveira, Liciana V. A.; Guerra, Rocco; Misciagna, Giovanni; Caruso, Maria G.; Bruno, Irene; Buongiorno, Claudia; Campanella, Angelo; Guerra, Vito M. B.; Notarnicola, Maria; Deflorio, Valentina; Franco, Isabella; Bianco, Antonella; Mirizzi, Antonella; Aballay, Laura R.; Cisternino, Anna M.; Sorino, Paolo; Pesole, Pasqua L.; Osella, Alberto R.
Background and aims: Cardiovascular diseases (CVDis) are leading causes of morbidity and mortality. Even after the introduction of pharmacological therapy to lower Cholesterol, there is still a residual risk that may be ascribed to remnant cholesterol (RC). We aimed, by analyzing two prospective cohort studies, to estimate the effect of RC on risk and hazard of cardiovascular deaths ( CVDs), while accounting for competing risks such as cancer ( CDs) and other-causes deaths (OCDs). Methods and results: Cohorts were enrolled in 1992 and 2005. Personal data history was recorded. A fasting venous blood sample was obtained, and RC was calculated at baseline. Cause of Death was coded by using ICD-10th version. Follow-up ended on December 31, 2017. Flexible parametric competing-risks models were applied, with age at death as time-axis. In total, 5729 subjects were enrolled. There were 861 (15.1%) deaths: 234 CVDs (27.2%), 245 CDs (28.5%), 271 OCDs (31.5%) and 111 unknown causes of death (12.8%). RC exposure was a strong risk factor only for CVDs (Risk 2.54, 95% Confidence Interval 1.21; 5.34; Trend 1.26 (1.00; 1.58) for >= 1.29 mmol/L). Conclusions: RC is a strong independent risk factor for cardiovascular mortality. Competing risk analysis is demonstrably a useful tool to disentangle associations among different competing events with a common risk factor. (C) 2020 The Italian Diabetes Society, the Italian Society for the Study of Atherosclerosis, the Italian Society of Human Nutrition and the Department of Clinical Medicine and Surgery, Federico II University. Published by Elsevier B.V. All rights reserved.