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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

PubMedAnalytical chemistry2026-11-11

Deciphering the In Vivo Fate of PEGylated rhGH via a Molecular Ruler-Based MS Strategy.

Liu Kexin K, Zou Yuqing Y, Gu Qian Q, Song Shiwen S et al.

A growing number of long-acting protein therapeutics rely on high-molecular-weight (HMW) polyethylene glycol (PEG) conjugation to extend circulation time, yet the in vivo fate of PEG-derived species remains a critical blind spot for drug safety and regulatory evaluation. A key analytical challenge is that intact conjugates and PEG-derived species cannot be resolved by intact-protein or total-PEG measurements alone. Here we report a molecular ruler-based mass spectrometry strategy that integrates MSALL acquisition, PEG standard calibration anchors spanning broad molecular-weight ranges, and a self-built high-resolution mass spectral (HRMS) library to convert broad, overlapping PEG signal envelopes into temporally traceable, molecular-weight-referenced analytical targets. Applied to 40 kDa PEG-modified recombinant human growth hormone (PEG-rhGH) in rats, the workflow quantitatively traced the intact conjugate (plasma half-life t1/2 = 26.83 h) and concurrently resolved tissue-associated PEG 40 kDa and a PEG-related metabolite series. Intact PEG-rhGH remained below the validated tissue LLOQ, whereas PEG-derived components accumulated preferentially in the liver (peak at 48 h), with total urinary and fecal recovery of the quantitatively monitored intact PEG-rhGH and PEG 40 kDa below 10% by 144 hindicating profoundly delayed elimination. HRMS interrogation revealed low-molecular-weight PEG oligomers (PEG7-PEG21) together with carboxylic-acid- and aldehyde-terminated species in liver, consistent with in vivo chain shortening and end-group transformation. By linking intact-conjugate exposure, tissue accumulation, metabolite profiling, and excretion within a single transferable framework, this strategy provides a measurement-science tool for the systematic evaluation of HMW PEGylated protein therapeutics and other pharmaceutical polymer systems.

PMID 43010503
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PubMedThe Turkish journal of gastroenterology : the official journal of Turkish Society of Gastroenterology2026-11-11

Castor Oil Plus Polyethylene Glycol Electrolyte for Colonoscopic Bowel Preparation: A Prospective 3-Arm Randomized Controlled Trial.

Li Yanxia Y, Wang Wenjuan W, Jiang Xiaoda X, Huang Xu X et al.

The aim of this study was to compare 2 reduced-volume polyethylene glycol (PEG) electrolyte solution regimens combined with castor oil (CaO) with conventional 3-L PEG for bowel preparation before colonoscopy. This single-center, prospective, randomized, endoscopist-blinded trial enrolled 720 adults undergoing elective colonoscopy. Participants were assigned to receive 3-L PEG (group A), 2-L PEG plus 40 mL of CaO (group B), or 1-L PEG plus 40 mL of CaO (group C). The primary outcome was right-colon cleansing assessed using the Boston Bowel Preparation Scale (BBPS). Secondary outcomes included BBPS scores for other colonic segments and the total colon, Colon Endoscopic Bubble Scale (CEBuS) scores, adenoma detection rate (ADR), and preparation-related adverse events. Complete colonoscopy was achieved in 691 participants. Mean right-colon BBPS scores were 2.03 Å} 0.57, 2.45 Å} 0.53, and 2.31 Å} 0.27 in groups A, B, and C, respectively (overall P = .013). The score was higher in group B than in group A (P = .048), whereas the difference between groups B and C was not statistically significant (P = .096). Group B also had a lower CEBuS score than group A (1.02 Å} 0.42 vs. 1.73 Å} 0.16; P = .048). ADRs were 22.1%, 34.5%, and 29.9% in groups A, B, and C, respectively (overall P = .012), with a higher rate in group B than in group A (P = .038). Most pairwise differences in adverse events were not significant. No serious preparation-related adverse events occurred. The 2-L PEG plus CaO regimen improved right-colon cleansing and bubble clearance and was associated with a higher ADR compared with conventional 3-L PEG.

PMID 43012342
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PubMedAnimal welfare (South Mimms, England)2026-11-11

Erratum: PsittaWel: A welfare assessment tool for companion parrots - ERRATUM.

Piseddu Andrea A, van Zeeland Yvonne Y, Hemsworth Lauren L, Rault Jean-Loup JL

[This corrects the article DOI: 10.1017/awf.2026.10089.].

PMID 43011697
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PubMedBMC pediatrics2026-11-11

Comparison of long-acting versus short-acting growth hormone therapy in children with idiopathic short stature: a retrospective cohort study with advanced causal inference methods.

Hou Yanfang Y

To compare the efficacy and safety of polyethylene glycol-modified recombinant human growth hormone (PEG-rhGH) versus daily rhGH in children with idiopathic short stature (ISS) during 12-24 months of follow-up and to propose individualised treatment strategies incorporating mid-parental height standard deviation score (MPH-SDS) correction for genetic potential. This single-centre retrospective cohort study enrolled patients aged 4-14 years with ISS consecutively between January 2018 and December 2024. Treatment assignment reflected real-world physician-guardian shared decision-making after counselling regarding observation, daily rhGH and PEG-rhGH, and prescribed starting doses averaged 0.17 ± 0.03 mg/kg/week for PEG-rhGH and 0.23 ± 0.04 mg/kg/week for daily rhGH. Propensity score matching (1:1, calliper = 0.2) and inverse probability treatment weighting controlled for confounding. Linear mixed-effects models estimated treatment × time interactions, and marginal structural models adjusted for time-dependent confounding. Multiple sensitivity analyses, including E-value calculation, negative control outcomes and sex-stratified subgroup analyses, were conducted. Among 596 patients (187 PEG-rhGH, 213 daily rhGH and 196 controls), 12-month height SDS changes were 0.82 ± 0.31, 0.65 ± 0.28 and 0.18 ± 0.21, respectively. Adjusted mean differences versus controls were 0.64 SDS (95% confidence interval [CI]: 0.58-0.70) for PEG-rhGH and 0.47 SDS (95% CI: 0.41-0.53) for daily rhGH (both p < 0.001). Direct comparison showed PEG-rhGH superior by 0.17 SDS, increasing to 0.31 SDS after MPH-SDS adjustment (95% CI: 0.24-0.38, p < 0.001), exceeding the preset minimal clinically important difference of 0.3 SDS. At 24 months, height SDS improvements were 1.38 ± 0.42, 1.09 ± 0.38 and 0.31 ± 0.27, respectively. Sex-stratified analyses confirmed consistent effects in boys and girls (interaction p = 0.72). Children with lower MPH-SDS showed greater benefit from PEG-rhGH. Safety profiles were comparable. Growth hormone treatment significantly improved height SDS in children with ISS, and PEG-rhGH demonstrated marginal superiority over daily rhGH that reached clinical significance after MPH-SDS correction. Children with lower genetic height potential preferentially benefit from long-acting formulations.

PMID 43009862
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PubMedFASEB journal : official publication of the Federation of American Societies for Experimental Biology2026-11-11

Aryl Hydrocarbon Receptor Is Dispensable for the Early Transcriptional Response of Mouse Macrophages to Type I Interferon.

Tabtim-On Darawan D, Segura Elodie E

Type I interferon (IFN-I) signaling is essential in the homeostasis and activation of immune cells, and macrophages play a central role in the IFN-I system. Dysregulation leads to tissue damage and autoimmunity, and IFN-I signaling needs to be tightly fine-tuned. One reported mechanism involves interactions with the transcription factor aryl hydrocarbon receptor (AhR). However, it remains to be determined whether AhR is required for the early transcriptional response of macrophages to IFN-I. Here we used macrophages from genetically deficient mice to investigate the involvement of AhR in the induction of early IFN-I-driven responses. We show that constitutive AhR deficiency does not impair the canonical transcriptional response to IFN-I in bone marrow-derived macrophages nor the expression of IFN-stimulated molecules by peritoneal macrophages upon in vivo exposure. These findings contrast with observations made in other cell types, in particular astrocytes and lung cancer cells, and support the notion of a context-dependent crosstalk between AhR and IFN-I-dependent signaling.

PMID 43012672
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PubMedAnalytical chemistry2026-11-11

Ultrasensitive Quantification of Poloxamer 188 in Adeno-Associated Virus Products by All-Ion Fragmentation MS/MS.

Zhang Sisi S, Wang Jing J, Xiao Hui H, Li Ning N

Poloxamer 188 (P188; Pluronic F68) is a nonionic surfactant frequently used in biotherapeutics, particularly in adeno-associated virus (AAV) formulations, in which it is present at trace concentrations (0.001%-0.005%). However, its accurate quantification is difficult, because of its low abundance, frequently limited sample volumes, and the ionization variability of its PEO-PPO-PEO triblock. Here, we developed an all-ion fragmentation (AIF) workflow with 44 Da and 58 Da neutral-loss-triggered data dependent (dd)-MS2 that fragments all precursors and performs quantification via the polyethylene glycol (PEG) diagnostic ion (m/z 133.1), thereby decreasing spectral complexity and adduct variability. In contrast to the most sensitive reported method, LC-MRM, using a 20 μL injection volume, which achieved a dynamic range of 250-10,000 ng/mL (0.000025%-0.001%), our method achieved a 0.00002% LLOQ with 1 μL injections, thus providing an ∼20-fold sensitivity gain that enables replicate analysis and a dynamic range 2 orders of magnitude wider (0.00002%-0.1%). Our assay is vendor-, formulation-, and LC-buffer-agnostic, and achieves ±10% accuracy and ∼10% CVs across AAV-relevant levels. Significant P188 losses attributable to container adsorption were observed; incorporation of 50% acetonitrile restored recovery and is recommended for sample preparation.

PMID 43010524
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