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Pharmacokinetics comparison of two pegylated interferon alfa formulations in healthy volunteers

Overview of attention for article published in BMC Pharmacology and Toxicology, January 2018
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Title
Pharmacokinetics comparison of two pegylated interferon alfa formulations in healthy volunteers
Published in
BMC Pharmacology and Toxicology, January 2018
DOI 10.1186/s40360-017-0192-z
Pubmed ID
Authors

Marisa Boff Costa, Paulo Dornelles Picon, Guilherme Becker Sander, Hugo Nodarse Cuni, Carmen Valenzuela Silva, Rolando Páez Meireles, Ana Carolina Magalhães Andrade Góes, Nadia Maria Batoreu, Maria de Lourdes de Sousa Maia, Elizabeth Maciel Albuquerque, Denise Cristina de Souza Matos, Pedro Lopez Saura

Abstract

Several countries have used pegylation technology to improve the pharmacokinetic properties of essential drugs. Recently, a novel interferon alfa-2b protein conjugated to four-branched 12 kDa polyethylene glycol molecules was developed jointly between Cuba and Brazil. The aim of this study was to compare the pharmacokinetic properties of BIP48 (pegylated interferon alfa-2b from Bio-Manguinhos/Fiocruz, Brazil) to those of PEGASYS® (commercially available pegylated interferon alfa-2a from Roche Pharmaceutical). This phase I, single-centre, randomized, double-blind crossover trial enrolled 31 healthy male volunteers aged 19 to 35 who were allocated to two stages, either side of a 5-week wash-out period, with each arm lasting 14 consecutive days after subcutaneous administration of 180 μg of one formulation or the other (study or comparator). The main outcome variable was serum pegylated interferon concentrations in 15 samples collected during the course of the study and tested using an enzyme immunoassay. There were no differences between formulations in terms of magnitude or absorption parameters. Analysis of time parameters revealed that BIP48 remained in the body significantly longer than PEGASYS® (Tmax: 73 vs. 54 h [p = 0.0010]; MRT: 133 vs. 115 h [p = 0.0324]; ke: 0.011 vs. 0.013 h(-1) [p = 0.0153]; t1/2: 192 vs. 108 h [p = 0.0218]). BIP48 showed the expected pharmacokinetic profile for a pegylated product with a branched molecular structure. Compared to PEGASYS®, the magnitude absorption was similar, but time parameters were consistent with slower elimination. Further studies should be conducted to evaluate the clinical implications of these findings. A phase II-III repeated-dose clinical trial is ongoing to study these findings in patients with chronic hepatitis C virus infection. This study is registered on the ClinicalTrials.gov platform (accession number NCT01889849 ). This trial was retrospectively registered in June 2013.

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Mendeley readers

Mendeley readers

The data shown below were compiled from readership statistics for 36 Mendeley readers of this research output. Click here to see the associated Mendeley record.

Geographical breakdown

Country Count As %
Unknown 36 100%

Demographic breakdown

Readers by professional status Count As %
Researcher 8 22%
Student > Bachelor 4 11%
Student > Master 3 8%
Other 2 6%
Student > Ph. D. Student 1 3%
Other 3 8%
Unknown 15 42%
Readers by discipline Count As %
Biochemistry, Genetics and Molecular Biology 5 14%
Medicine and Dentistry 5 14%
Pharmacology, Toxicology and Pharmaceutical Science 3 8%
Nursing and Health Professions 1 3%
Computer Science 1 3%
Other 3 8%
Unknown 18 50%
Attention Score in Context

Attention Score in Context

This research output has an Altmetric Attention Score of 1. This is our high-level measure of the quality and quantity of online attention that it has received. This Attention Score, as well as the ranking and number of research outputs shown below, was calculated when the research output was last mentioned on 27 March 2019.
All research outputs
#20,458,307
of 23,015,156 outputs
Outputs from BMC Pharmacology and Toxicology
#368
of 442 outputs
Outputs of similar age
#378,532
of 442,576 outputs
Outputs of similar age from BMC Pharmacology and Toxicology
#11
of 11 outputs
Altmetric has tracked 23,015,156 research outputs across all sources so far. This one is in the 1st percentile – i.e., 1% of other outputs scored the same or lower than it.
So far Altmetric has tracked 442 research outputs from this source. They typically receive a little more attention than average, with a mean Attention Score of 5.3. This one is in the 1st percentile – i.e., 1% of its peers scored the same or lower than it.
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We're also able to compare this research output to 11 others from the same source and published within six weeks on either side of this one. This one is in the 1st percentile – i.e., 1% of its contemporaries scored the same or lower than it.