12/23/21: CDC Releases Emergency Guidance for Healthcare Facilities to Prepare for Potential Omicron Surge
And this, from NBC News:
H Kuriry et al. Clin Gastroenterol Hepatol 2021; 19: 2398-2406. Spontaneous Clearance After Relapse Following Direct-Acting Antiviral Treatment for Chronic HCV Infection
This retrospective case-control study identified 93 patients out of 1032 with chronic HCV infection who had a relapse of detectable infection following treatment. Key findings:
My take: In those with a low level virological relapse after DAA therapy for HCV, it is a good idea to repeat testing before consideration of further treatment.
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C Rajan et al. JPGN Reports: November 2021 – Volume 2 – Issue 4 – p e124. Open Access: Hepatocellular Carcinoma in the Absence of Cirrhosis in a Child With Inactive Chronic Hepatitis B Infection
In this case study, the authors “describe an unusual case of a child with chronic hepatitis B infection who developed HCC in the absence of active hepatitis or cirrhosis.” Based on their case report, they advocate for “regular HCC surveillance for all children with chronic hepatitis B, regardless of presence or absence of hepatitis or cirrhosis.”
However, the authors suggestions to expand surveillance to all children with hepatitis B is NOT aligned with current expert opinion (by most experts). This potential recommendation deserves (deserved) more commentary in their discussion. The AASLD recommends offering surveillance when the risk of HCC is at least 1.5% per year and the incidence is greater than 0.2% per year, which includes patients with cirrhosis and some non-cirrhotic hepatitis B carriers [7]. In a study from Taiwan (blog post: HBV Vaccination Prevents Cancer), the authors showed the beneficial effects of vaccination: HCC incidence per 105 person-years was 0.92 in the unvaccinated cohort and 0.23 in the vaccinated birth cohorts. This study also showed how rare HCC cases are in children; thus, showing benefit of vaccination was impressive.
The AASLD guidelines on HCC (Link to PDF: Diagnosis, Staging, and Management of
Hepatocellular Carcinoma: 2018 Practice Guidance by the American Association for
the Study of Liver Diseases) notes the following high risk categories:
My take: This case report is helpful in emphasizing the risk of HCC in patients with HBV, even in those without significant risk factors. However, at this time most experts do not recommend surveillance in those with a low risk of developing HCC.
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EC Oldfield, PJ Parekh. Clin Gastroenterol Hepatol 2021; 19: xxv. Open Access: Thoracic Aortic Erosion into the Esophagus With Aortoesophageal Fistula
The authors recognized a “visible thoracic aorta eroding into the esophagus through a large transmural defect (Figure A) and a nonbleeding aortoesophageal fistula (Figure B) directly superior to the erosion in the middle third of the esophagus. This 76 year old patient had a known thoracic aortic aneurysm.
My take: This is an amazing case report because the patient survived. It is very easy to imagine the circumstance of massive exsanguination. In all patients with known cardiac repair and disease, it is important to consider the possibility of an major vessel fistula into the esophagus in those presenting with significant hematemesis and to consider how this could be managed.
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MI Pinto-Sanchez et al. Clin Gastroenterol Hepatol 2021; 19: 2343-2352. Open Access: Gluten-Free Diet Reduces Symptoms, Particularly Diarrhea, in Patients With Irritable Bowel Syndrome and Antigliadin IgG
In this prospective study of 50 patients with IBS (ROME III, all subtypes), with and without serologic reactivity to gluten (antigliadin IgG and IgA), and 25 healthy subjects (controls) were studied before and after 4 weeks of a GFD. Celiac disease (CD) was ruled out in patients and controls by negative tissue transglutaminase (tTG) IgA antibody and deamidated gliadin IgA or IgG antibodies and by the absence of mucosal atrophy in a duodenal biopsy specimen (Marsh 0 or 1). At least 4 and 2 biopsy specimens were obtained from the second and the first part of the duodenum, respectively.
Key findings:
The associated editorial (A Rej et al. Open Access: Personalizing Dietary Therapies For Irritable Bowel Syndrome: What Is Gluten’s Role?) provides some useful points:
My take: This prospective study indicates that a GFD is associated with clinical improvement in a significant number of individuals with IBS (with and without antigliadin antibodies) who did not report any gluten sensitivity or were not on a gluten-restricted diet before study entry. Based on a number of other studies, however, it seems that a low FODMAPs diet is likely to have a higher efficacy for patients with IBS.
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TA Fick et al. J Pediatr 2021; 239: 206-211. Trisomy 18 Trends over the Last 20 Years
Methods: A retrospective analysis using the Kids’ Inpatient Database from 1997 to 2016 (10,151 admissions) was performed for trisomy 18.
Key Findings:
My take: This study documents a change in the approach to treating children with Trisomy 18. Compared to 20 years ago, these children are being offered more medical/surgical treatments rather than only palliative interventions.
R Hegarty et al. J Pediatrics; 236: 124-130. Open Access: Study of Acute Liver Failure in Children Using Next Generation Sequencing Technology
Background: “Despite the progress made over the last 40 years the rate of indeterminate cases [of acute liver failure] remains ~30%”
Methods: The authors identified 41 children (<10 yrs) with DNA sample availability who were admitted to King’s College Hospital, London, with ALF of indeterminate etiology (2000-2018). In addition, trio exome sequencing was performed on 4 children admitted during 2019.
Key Findings:
My take: Genetic testing for underlying metabolic/metabolic disorders is important to further determine the reasons for ALF. Given the potential need for liver transplantation, obtaining these results quickly will be crucial. In addition, interpretation of the results in some cases will be difficult.
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From Gastroenterology and Endoscopy News: New Anti–IL-23 Therapy Shows Benefit in Crohn’s Disease
An excerpt:
Two phase 3 placebo-controlled trials with the immune modulator risankizumab demonstrated control of Crohn’s disease whether or not patients had previously received a biologic agent.
Rates of clinical remission at 12 weeks with the interleukin (IL)-23 inhibitor risankizumab (Skyrizi, AbbVie), were about 48% in patients without prior exposure to biologic therapy and more than 40% in those with prior exposure…
The two trials, ADVANCE and MOTIVATE were presented together at the 2021 Digestive Disease Week (abstract 775a)…
Only 12% of patients in the placebo group achieved endoscopic remission versus 40.3% of those on the 600-mg dose of risankizumab (P<0.001). [Rates of endoscopic remission were higher in the biologic-naive (50.5%)]
My take: In addition to ustekinumab (already approved), a number of other therapeutic agents that target IL-23 are likely to be available soon to help manage Crohn’s disease. This includes risankizumab but others with phase 3 studies include brazikumab, mirikizumab, and guselkumab..
From Gastroenterology & Endoscopy News: Head-to-Head Trial Shows Similar Efficacy and Safety With Ustekinumab and Adalimumab
An excerpt:
The first head-to-head trial comparing ustekinumab and adalimumab has found the two drugs are similarly safe and effective in patients with moderate to severe Crohn’s disease…
Dr. Scherl and her co-investigators in the SEAVUE trial randomly assigned 386 biologic-naive patients with Crohn’s disease to receive one year of treatment with either ustekinumab or adalimumab at standard on-label doses, with no dose escalation throughout the study period and no concomitant immunomodulators...
The findings, which were presented at the 2021 annual meeting of the European Crohn’s and Colitis Organisation (oral presentation OP02), showed that after one year of treatment, 65% of patients who received ustekinumab and 61% of those who received adalimumab achieved clinical remission, defined as a CDAI below 150...[And] similar additional outcomes, including clinical response at one year (72.3% for ustekinumab vs. 66.2% for adalimumab), corticosteroid-free remission at one year (60.7% vs. 57.4%, respectively), endoscopic remission at one year (28.5% vs. 30.7%)
My take: This study indicates that ustekinumab likely has similar safety and efficacy as adalimumab (though the study did not allow dose escalation or immunomodulators); thus, it could be positioned as a first-line treatment. It is administered less frequently as well.
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For those who have not followed the FDA’s controversial decision of approving Aducanumab for the treatment of Alzheimer’s disease, the NEJM has two useful commentaries:
Key points -from 1st article:
Key points -from 2nd article:
My take: This type of huge fiscal burden may provide the rationale for Medicare and Medicaid to reexamine whether/how they cover expensive FDA-approved medications.
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