This study aims to examine the diagnostic accuracy of dried blood spot (DBS) samples contrast to serum samples for detection of hepatitis B virus (HBV) and hepatitis C virus (HCV) sero-markers in large scale epidemiological study in the resource limited settings and then to determine the prevalence of each sero-marker from DBS samples collected during 2017 Cambodia nationwide study.
This study included 921 paired DBS and serum samples. HBsAg, HBsAg-HQ, anti-HBs, anti-HBc and anti-HCV were detected in all DBS/serum pairs but HBeAg and anti-HBe in 109 DBS/serum pairs using chemiluminescent enzyme immunoassay (CLEIA). Thereafter, the individual DBS's diagnostic accuracy was calculated. Additionally, the prevalence of each sero-marker was calculated in 4541 DBS samples from nationwide study in Cambodia.
The sensitivity of DBS for detection of HBsAg, HBsAg-HQ, HBeAg and antiHBe were high (≥90%) with 100% specificity. Anti-HBc and anti-HBs showed low sensitivity (70.73% and 69.25% respectively) than other sero-markers, but their diagnostic accuracies were 94.58% and 89.32%. Therefore, the overall prevalence of HBsAg, HBsAg-HQ, anti-HBc, anti-HBs and anti-HCV using DBS samples in Cambodia were 2.38%, 2.53%, 14.27%, 31.84% and 0.15%, respectively. HBeAg and anti-HBe positivity among HBsAg positives were 31.48% and 53.7%.
Our study indicates that DBS has high diagnostic accuracy for HBsAg, HBsAg-HQ, HBeAg and anti-HBe. Having the benefit of simple procedure, easy and compact transportation and storage, it is considered as an alternative to serum samples in examining the serological profiles of HBV infection through a large-scale epidemiological study in the resource limited settings.
Anti-tumour necrosis factor therapy is an established treatment for moderate-to-severely active ulcerative colitis (UC). Recent network meta-analyses of controlled trial data have indicated a superiority of intravenous drugs (infliximab) over subcutaneous (adalimumab). We conducted a retrospective multi-centre cohort study to determine the comparative effectiveness of these two drugs.
Patients with UC administered infliximab or adalimumab as their first biologic, identified from the therapy databases of five UK hospitals, were included, if they had completed induction and were on maintenance treatment. Patients receiving infliximab as ‘rescue’ therapy for acute severe UC were excluded. The primary end-points for comparison were the number of patients remaining on initial therapy (infliximab or adalimumab) at 52 weeks and the number of patients in clinical remission at 52 weeks (Simple Clinical Colitis Activity [SCCAI] score ≤ 3).
Seventy-eight infliximab and 63 adalimumab patients were analysed. At 52 weeks, 83% of infliximab patients and 59% of adalimumab patients remained on therapy (P = 0.001). At 52 weeks, 62% of the infliximab group were in clinical remission compared to 32% of the adalimumab group (P = 0.0004). Primary non-response was reported in 24% of adalimumab patients and 5% of infliximab patients (P = 0.001). There were no significant differences in colectomy rates or hospital admission for acute flares at 52 weeks.
Our real-world results affirm the findings of network meta-analyses of clinical trials, suggesting that infliximab is superior to adalimumab in the maintenance of remission in UC up to 52 weeks.
Direct-acting antivirals (DAAs) against HCV have an immune modulatory effect, this could possibly lead to a decreased tumour control. We, therefore, aimed to assess the risk of extrahepatic cancer (EHC) during and the first years after DAA treatment.
This is a nationwide cohort study with prospectively collected data for 19 685 persons with HCV, 4013 DAA treated, 3071 interferon (IFN) treated and 12 601 untreated, from 2008 to 2016. Follow-up time was maximum 3 years. The risk for EHC was compared between the groups using Cox regression analyses, with adjustment for age and Charlson Comorbidity Index (CCI). The HCV-infected groups were also compared with matched cohorts without HCV from the general population. In total 341 EHCs were identified, 84, 43 and 214 EHC in the DAA, IFN and untreated group respectively. The EHC risk in DAA treated compared with IFN treated was doubled, but when adjusted for age and CCI the HR was 1.07 (95% CI 0.74-1.56). Compared with the general population, the HR of EHC for the DAA group was 1.45 (CI 1.13-1.86), with the difference remaining statistically significant after adjusting for CCI.
We found no increased risk for EHC associated with DAA therapy after adjustment for age and CCI. An increased risk of EHC in DAA treated compared with the general population was though seen, and attention should be paid to this association in the ageing population with a history of HCV infection.
Symptoms of chronic hepatitis B (CHB) are not well characterised.
To evaluate CHB symptoms and associations with disease activity and clinical outcomes.
Longitudinal data from 1576 participants in the Hepatitis B Research Network Cohort Study who completed symptom assessments were analysed. A composite symptom score was calculated using a Symptom Checklist (0 = none to 40 = extreme). Multivariable mixed models assessed variables associated with symptom change over time. Latent class symptom trajectories were evaluated. The cumulative probability of long-term clinical outcomes (new onset cirrhosis, hepatic decompensation, hepatocellular carcinoma, liver transplantation, death) was examined by baseline symptom groups.
Participants median age was 42 (range: 18-80), 51% were male, 75% Asian, (68% of whom were born outside North America) with a median follow-up of 4.2 years. On average, symptoms did not significantly change over time. The multivariable model identified several variables associated with higher symptoms during follow-up: being female, non-Asian, born in the United States/Canada, lower education, higher AST, lower platelets and more comorbidities. Two patient subgroups were identified based on longitudinal symptom trajectories: a low symptom group (92%, n = 1451) with symptom scores averaging 2.4 over time and a moderate symptom group (8%, n = 125) with symptom scores averaging 11.5. During follow-up, 7.3% in the moderate symptom group, but only 3.2% of the low symptom group, developed adverse outcomes (P = 0.02).
In this large cohort of CHB patients, symptoms were generally mild and stable over time. However, in some patients with moderate symptoms at baseline, deleterious clinical outcomes were more frequent at follow-up.
ClinicalTrials.gov Identifier: NCT01263587.
Tofacitinib is an oral, small molecule Janus kinase inhibitor for the treatment of ulcerative colitis (UC). In patients with UC, associations between endoscopic findings and UC symptoms are not well described.
Post hoc analysis of data from two randomised, placebo-controlled, 8-week, phase 3 studies of tofacitinib for the treatment of patients with UC.
Associations of stool frequency and rectal bleeding subscores with endoscopic improvement (Mayo endoscopic subscore ≤1) were assessed and relationships studied using regression analyses.
Analysis of two-by-two contingency tables showed that dichotomised stool frequency and rectal bleeding were each or both not good predictors of endoscopic improvement. Using stool frequency and/or rectal bleeding as predictors of endoscopic subscore, regression modelling analyses demonstrated a weak relationship between variables. However, a robust relationship was observed with endoscopic subscore as a predictor of stool frequency and rectal bleeding. In OCTAVE Induction 1, normal/inactive disease (endoscopic subscore 0) corresponded to a least-squares mean value of 0.05 for rectal bleeding (no blood), and severe disease (endoscopic subscore 3) corresponded to a value of 1.5 (interpreted as streaks of blood with stool <50% of the time [score of 1] or obvious blood with stool most of the time [score of 2]). OCTAVE Induction 2 results were similar.
Results suggest that the likelihood of endoscopic improvement or normalisation is higher in patients with normal stool frequency and without rectal bleeding, but that these symptoms alone are not predictive of endoscopic improvement or normalisation, and endoscopy is needed for disease assessment.
ClinicalTrials.gov: NCT01465763; NCT01458951.
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