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PE

PEG IFN alpha-2a (CAP/CTM HCV 2.0)

✓ Approved

Roche · Companion diagnostic · Companion diagnostic

What is PEG IFN alpha-2a?

PEG IFN alpha-2a is a companion diagnostic developed by Roche. It is approved for therapeutic indications via others.

Drug Profile

Brand NamesCAP/CTM HCV 2.0
CompanyRoche
Drug ClassCompanion diagnostic
RouteOthers
StatusApproved
Sources: ClinicalTrials.gov, Roche

Related Research Articles

PubMedCureus2026-08-30

Treatment of Persistent Gastrocutaneous Fistula After Percutaneous Endoscopic Gastrostomy Using Endoscopic Suturing With Argon Plasma Coagulation: A Report of Two Cases.

Washington Miles J MJ, Washington Morris J MJ, Biswas Saptarshi S

Persistent gastrocutaneous fistula (PGCF) is an uncommon but often challenging complication following removal of a percutaneous endoscopic gastrostomy (PEG) tube. Prolonged PEG tube requirement leads to epithelialization of the PEG tube tract, resulting in a PGCF when the tube is removed. Several management options have been described for this complication, many of which demonstrate variable success rates. However, no definitive treatment for PGCF has been established. We report two adult male patients, aged 63 and 30 years, who developed PGCF after PEG tube removal following prolonged PEG placement. The first patient had persistent low-volume drainage for approximately one year after removal of the PEG tube, despite an attempt at external purse-string suture closure with simultaneous endoscopic clip placement. The second patient developed persistent high-volume drainage with peristomal skin breakdown despite local wound care and ostomy appliance placement for 3 months after removal of the PEG tube. Both patients underwent argon plasma coagulation of the fistula tract followed by endoscopic suture closure using the Boston Scientific OverStitch device (Boston Scientific Corporation, Marlborough, USA). In both cases, fistula drainage resolved within one week, with no documented recurrence during available follow-up. These cases are reported to highlight the technical feasibility of combined argon plasma coagulation and endoscopic suturing for selected chronic post-PEG PGCFs and to add to the limited published experience with this approach.

PMID 42668957
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PubMedKidney medicine2026-08-30

Metabolomic Signatures of Inflammation in Chronic Kidney Disease.

Chen Teresa K TK, Surapaneni Aditya L AL, Estrella Michelle M MM, Appel Lawrence J LJ et al.

Inflammation is associated with adverse kidney, cardiovascular, and mortality outcomes. Investigation of the metabolic milieu as it relates to inflammation may provide important insights into these disease processes. Prospective cohort. African American Study of Kidney Disease and Hypertension (AASK), Atherosclerosis Risk in Communities (ARIC) study, and Boston Kidney Biopsy Cohort (BKBC) participants with available metabolomics and inflammatory protein data. Baseline blood levels of 718 metabolites. Baseline and longitudinal changes in blood levels of tumor necrosis factor receptors 1 and 2 (TNFR1, TNFR2), tumor necrosis factor-alpha (TNF-α), interferon-gamma (IFN-γ), interleukins 6, 8, and 10 (IL-6, IL-8, IL-10), uromodulin (UMOD), and epidermal growth factor (EGF). Multivariable linear regression and linear mixed-effects models. Among 491 AASK participants (mean age 54 years; 37% women; mean glomerular filtration rate, 45 mL/min/1.73 m2), 367 cross-sectional associations between metabolites and inflammatory proteins were significant after correction for multiple comparisons. The direction of association was mostly positive for TNFR1 (97%), TNFR2 (97%), IL-8 (77%), and IL-10 (100%); negative for UMOD (80%) and EGF (97%); and variable for TNF-⍺, IFN-γ, and IL-6. Pathways were distinct for several inflammatory proteins (eg, tryptophan metabolism for TNFR2). Forty-five associations between metabolites and longitudinal change in inflammatory proteins were identified. Notable metabolites included tigylcarnitine and N 2,N 5-diacetylornithine, which were associated with 2-year increases in TNFR1 and/or TNFR2, and 1,5-anhydroglucitol, where lower levels were associated with decreases in UMOD. In ARIC (n = 3,773) and BKBC (n = 413), replication of cross-sectional associations was excellent for TNFR1 (ARIC 83%; BKBC 85%) and TNFR2 (ARIC 64%; BKBC 79%) but poor for IL-8 (ARIC 3%; BKBC 3%). Metabolite data limited to baseline visit; potential for residual confounding. Using an untargeted approach, multiple metabolites were cross-sectionally and longitudinally associated with inflammatory proteins in persons with chronic kidney disease.

PMID 42668601
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PubMedPakistan journal of medical sciences2026-08-30

Diagnostic value of platelet-lymphocyte ratio for pediatric sepsis: A systematic review and meta-analysis.

Chen Li L, Yang Qiuping Q

Early diagnosis of pediatric sepsis remains challenging due to limitations of conventional biomarkers. The platelet-to-lymphocyte ratio (PLR), derived from routine blood tests, has emerged as a potential diagnostic marker. This study aimed to evaluate the diagnostic accuracy of PLR for pediatric sepsis. A systematic search of PubMed, Embase, Web of Science, and Scopus was conducted from inception to March 15, 2026. Studies assessing the diagnostic performance of PLR in pediatric sepsis and reporting sufficient data to construct 2×2 contingency tables were included. Pooled sensitivity and specificity were calculated using a random-effects model. Summary receiver operating characteristic (SROC) analysis and Deeks' funnel plot were performed. Fifteen studies with 1,980 patients were included. The pooled sensitivity and specificity of PLR for diagnosing pediatric sepsis were 0.81 (95% CI: 0.73-0.87) and 0.72 (95% CI: 0.60-0.82), respectively. The SROC curve demonstrated an area under the curve of 0.79, indicating moderate diagnostic accuracy. Significant heterogeneity was observed. Subgroup analysis showed better performance in larger studies (≥150 patients) and studies using higher PLR cut-offs (>50). Deeks' funnel plot showed no evidence of publication bias (p = 0.536). Evidence from studies with high-risk of bias indicates that PLR may have moderate diagnostic accuracy for pediatric sepsis and may serve as a simple, cost-effective adjunctive biomarker. Since, most studies were on neonatal population, evidence may not be generalized to older pediatric populations. Further large-scale prospective studies are needed to establish standardized cut-off values and validate its clinical utility.Registration No: PROSPERO (No. CRD420261338676).

PMID 42668943
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PubMedBDJ open2026-08-30

Ultrasensitive multiplex salivary cytokine profiling reveals distinct immune signatures in dental caries.

Dubois Margaux M, Ortis Morgane M, Tonoyan Lilit L, Dubois Emma E et al.

Dental caries is a prevalent chronic disease characterized by complex inflammatory responses in the oral environment. This case-control pilot study evaluated the analytical performance of an ultra-sensitive electrochemiluminescence multiplex assay (MSD S-PLEX®) for salivary cytokine profiling and explored whether combined cytokine signatures can discriminate dental caries lesions (CL) from healthy (H) and non-carious gingival inflammation (GI). Unstimulated whole saliva from 65 individuals (H, CL, GI) was analyzed using the S-PLEX assay to quantify nine salivary cytokines (IL-1β, TNF-α, IL-6, IL-4, IL-10, IL-12p70, IFN-γ, IL-17, and IL-2). Group comparisons were performed using Mann-Whitney tests, and diagnostic performance was assessed by logistic regression and the area under the receiver operating characteristic curve. The assay showed high sensitivity and reproducibility. Cytokine profiling revealed selective elevation of certain cytokines in saliva from CL. Among the models tested, TNF-α + IL-17 provided the best discrimination between CL and H (AUC = 0.901, p < 0.001) and between CL and H + GI (AUC = 0.795, p = 0.0003). Inclusion of additional cytokines did not improve performance. However, discrimination between CL and GI was limited with TNF-α + IL-17, while IL-1β + IL-17 provided a modest but significant discrimination (AUC = 0.737, p = 0.004). This proof-of-concept study demonstrated the feasibility of ultrasensitive multiplex salivary cytokine profiling using the S-PLEX platform and revealed distinct cytokine signatures associated with clinically detected carious lesions. While preliminary, these findings support further investigation of salivary host-response biomarkers in caries research. Future longitudinal studies integrating comprehensive clinical, microbial, and immunological data together with detailed clinical characterization, including radiographic assessment and lesion severity evaluation, will be necessary to validate these associations and clarify their potential biological and clinical significance in caries research and their potential role in personalized caries management.

PMID 42668302
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PubMedTherapeutic advances in musculoskeletal disease2026-08-30

Diagnostic performance of salivary gland ultrasonography using the OMERACT scoring system in Sjögren disease: A cross-sectional diagnostic accuracy study.

Hossain Md Ismail MI, Choudhury Minhaj Rahim MR, Majumder Muhammad Shoaib Momen MSM, Shazzad Md Nahiduzzamane MN et al.

Sjögren disease (SjD) is an autoimmune disorder characterized by salivary and lacrimal gland dysfunction. Salivary gland ultrasonography (SGUS) is a non-invasive, accessible imaging modality for assessing glandular structural changes, although its diagnostic performance compared with conventional diagnostic tests requires further evaluation. To evaluate the diagnostic accuracy of OMERACT-scored salivary gland ultrasonography in patients with suspected primary or secondary SjD. This is a cross-sectional diagnostic accuracy study of salivary ultrasonography. This study was conducted in the Department of Rheumatology, Bangladesh Medical University, from February 2023 to February 2024. Patients presenting with sicca symptoms were classified according to the 2016 ACR/EULAR classification criteria, which served as the reference standard. All participants underwent clinical evaluation, Schirmer's test, unstimulated whole salivary flow rate (UWSFR), anti-SSA/anti-SSB antibody testing, and SGUS of the parotid and submandibular glands. SGUS images were scored using the OMERACT semiquantitative grayscale scoring system (0-3 per gland) by a blinded examiner. Diagnostic performance was assessed using sensitivity, specificity, and receiver operating characteristic (ROC) curve analysis. Among 100 participants, 50 fulfilled the 2016 ACR/EULAR classification criteria for SjD. Patients with SjD had significantly higher mean SGUS scores and lower mean UWSFR compared with those without SjD (p < 0.001). An OMERACT SGUS grade ≥2 in at least one gland demonstrated 84% sensitivity and 92% specificity. A total SGUS score ≥4 showed 88% sensitivity and 86% specificity, whereas a score ≥6 provided 100% specificity with reduced sensitivity (64%). SGUS showed excellent diagnostic performance with an area under the ROC curve (AUC) of 0.94 (95% CI: 0.90-0.99). Compared with SGUS, Schirmer's test demonstrated lower diagnostic accuracy (sensitivity 65.3%, specificity 52%), while UWSFR showed high sensitivity (92%) but limited specificity (48%). SGUS score showed a weak positive correlation with disease duration (r = 0.33, p < 0.05). OMERACT-scored salivary gland ultrasonography demonstrated excellent diagnostic accuracy and superior specificity compared with conventional functional tests. SGUS may serve as a valuable non-invasive adjunctive tool in the diagnostic evaluation of patients with suspected SjD.

PMID 42668827
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PubMedMaterials today. Bio2026-08-30

Intranasal L-DOPA/TPP-engineered extracellular vesicles deliver icariin to ameliorate mitochondrial dysfunction with associated sphingolipid remodeling in Alzheimer's disease models.

Wu Beibei B, Wu Junyong J, Zhu Lemei L, Li An A et al.

Alzheimer's disease (AD) is associated with mitochondrial dysfunction, oxidative stress, and disrupted lipid homeostasis, but the therapeutic translation of mitochondrial-protective agents remains limited by inefficient brain delivery, insufficient neuronal selectivity, and poor subcellular precision. Here, we developed an intranasal extracellular vesicle formulation (L-DOPA/TPP-EV-ICA) by loading icariin (ICA) into mesenchymal stem cell-derived extracellular vesicles and post-inserting DSPE-PEG-Levodopa and TPP-PEG-PE to enhance nasal environment, neuronal association, and mitochondria-associated intracellular enrichment. The engineered vesicles retained EV-like morphology, showed measurable ICA encapsulation, and maintained colloidal stability under the tested storage and simulated nasal conditions. In a human nasal epithelial Transwell model, L-DOPA/TPP-EV-ICA showed greater neuronal uptake than unmodified EVs without detectable disruption of epithelial barrier integrity and exhibited preferential colocalization with mitochondria-associated structures after cellular internalization. In Aβ-injured neuronal cells, L-DOPA/TPP-EV-ICA treatment reduced mitochondrial oxidative stress and mPTP opening, improved membrane potential, and enhanced ATP production and redox-related parameters. Following intranasal administration, the engineered formulation generated stronger and more persistent brain-associated fluorescence and showed preferential association with NeuN-positive cells. In APP/PS1 mice, treatment improved cognitive performance, and attenuated histopathological and mitochondrial abnormalities. Integrated proteomic, metabolomic analyses, and protein-level analyses further identified treatment-associated alterations in sphingolipid-related pathways. These findings support L-DOPA/TPP-EV-ICA as a promising preclinical intranasal EV platform for improving mitochondrial function and modulating sphingolipid-associated alterations in AD-related models.

PMID 42668476
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