Background and Aim Real‐world data on sofosbuvir/velpatasvir with and without ribavirin (SOF/VEL ± RBV), particularly among patients with genotype 3 (GT3) decompensated cirrhosis, prior treatment, coinfection, and hepatocellular carcinoma (HCC), are scarce. We aimed to assess the efficacy and safety of SOF/VEL ± RBV in a real‐world setting that included both community and incarcerated GT3 hepatitis C virus (HCV) patients. Methods We included all GT3 HCV patients treated with SOF/VEL ± RBV in our institution. The primary outcome measure was the overall sustained virological response 12 weeks after treatment (SVR12), reported in both intention‐to‐treat (ITT) and per‐protocol analyses. The secondary outcome measures were SVR12 stratified by the presence of decompensated cirrhosis, prior treatment, HCC, and HIV/hepatitis C virus coinfection and the occurrence rate of serious adverse events requiring treatment cessation or hospitalization. Results A total of 779 HCV patients were treated with 12 weeks of SOF/VEL ± RBV, of which 85% were treated during incarceration. Among the 530 GT3 HCV patients, 31% had liver cirrhosis, and 6% were treatment‐experienced. The overall SVR12 for GT3 was 98.7% (95% confidence interval: 97.3%, 99.5%) and 99.2% (95% confidence interval: 98.1%, 99.8%) in ITT and per‐protocol analyses, respectively. High SVR12 was also seen in ITT analysis among GT3 HCV patients with decompensated cirrhosis (88%), prior treatment (100%), HCC (100%), and HIV/hepatitis B virus coinfection (100%). Apart from one patient who developed myositis, no other serious adverse events were observed. Conclusion The SOF/VEL ± RBV is a safe and efficacious treatment option for GT3 HCV patients in a real‐world setting. SOF/VEL with RBV may be considered for decompensated GT3 HCV patients.
Biliary tract cancer (BTC) is a rare, but aggressive, disease that comprises of gallbladder carcinoma, intrahepatic cholangiocarcinoma and extrahepatic cholangiocarcinoma, with heterogeneous molecular profiles. Advanced disease has limited therapeutic options beyond first-line platinum-based chemotherapy. Immunotherapy has emerged as a viable option for many cancers with a similar unmet need. Therefore, we reviewed current understanding of the tumor immune microenvironment and recent advances in cellular immunotherapy and therapeutic cancer vaccines against BTC. We illustrated the efficacy of dendritic cell vaccination in one patient with advanced, chemorefractory, melanoma-associated antigen (MAGE)-positive gallbladder carcinoma, who was given multiple injections of an allogenic MAGE antigen-positive melanoma cell lysate (MCL)-based autologous dendritic cell vaccine combined with sequential anti-angiogenic therapy. This resulted in good radiological and tumor marker response and an overall survival of 3 years from diagnosis. We postulate the potential synergism of adding anti-angiogenic therapy, such as bevacizumab, to immunotherapy in BTC, as a rational scientific principle to positively modulate the tumor microenvironment to augment antitumor immunity.
Background: Recent work suggests that APOE ɛ4/4 females with Alzheimer’s disease (AD) are more susceptible to developing neuropsychiatric symptoms (NPS). Objective: To examine the interaction of sex and APOE ɛ4 status on NPS burden using two independent cohorts: 1) patients at risk for AD with mild cognitive impairment and/or major depressive disorder (n = 252) and 2) patients with probable AD (n = 7,261). Methods: Regression models examined the interactive effects of sex and APOE ɛ4 on the number of NPS experienced and NPS Severity. APOE ɛ3/4 and APOE ɛ4/4 were pooled in the at-risk cohort due to the sample size. Results: In the at-risk cohort, there was a significant sex*APOE ɛ4 interaction (p = 0.007) such that the association of APOE ɛ4 with NPS was greater in females than in males (incident rate ratio (IRR) = 2.0). APOE ɛ4/4 females had the most NPS (mean = 1.9) and the highest severity scores (mean = 3.5) of any subgroup. In the clinical cohort, APOE ɛ4/4 females had significantly more NPS (IRR = 1.1, p = 0.001, mean = 3.1) and higher severity scores (b = 0.31, p = 0.015, mean = 3.7) than APOE ɛ3/3 females (meanNPS = 2.9, meanSeverity = 3.3). No association was found in males. Conclusion: Our study suggests that sex modifies the association of APOE ɛ4 on NPS burden. APOE ɛ4/4 females may be particularly susceptible to increased NPS burden among individuals with AD and among individuals at risk for AD. Further investigation into the mechanisms behind these associations are needed.
Adenomyomas are benign lesions that are most frequently found in the gallbladder but can also be rarely found in the biliary tract. Although benign, they present close similarity to malignant lesions and thus deserve important clinical consideration. We present a case of a 74‐year‐old Chinese man who presented acutely with fever and painless obstructive jaundice. CT imaging showed a large calculus within a dilated common bile duct (CBD) and, despite undergoing an endoscopic retrograde cholangiopancreatography (ERCP) with stone clearance, there was a persistent filling defect that was adherent to the wall of the proximal common bile duct. His CA 19–9 was also significantly raised. Intraductal ultrasonography (IDUS) showed a polypoid mass with papillary‐like projections, and ERCP forcep biopsies were unable to exclude a lesion with neoplastic potential. The patient subsequently underwent cholecystectomy with open CBD excision and Roux‐en‐Y hepaticojejunostomy, and histology showed features consistent with a biliary adenomyoma.
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