Trial reportBritish journal of clinical pharmacology2009
Pharmacokinetics and response of obese patients with chronic hepatitis C treated with different doses of PEG-IFN alpha-2a (40KD) (PEGASYS).
Trial report in British journal of clinical pharmacology, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers, 1 of them a synthesis that pooled it.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
6 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Meta-analysis: mortality and serious adverse events of peginterferon plus ribavirin therapy for chronic hepatitis C.Journal of gastroenterology · 2013Pooled it
- A Bayesian Approach for Population Pharmacokinetic Modeling of Pegylated Interferon α-2a in Hepatitis C Patients.Clinical pharmacokinetics · 2017Article
- Use of an integrated modelling and simulation approach to develop a simplified peginterferon alfa-2a dosing regimen for children with hepatitis C.British journal of clinical pharmacology · 2016Article
- Pegylated interferon pharmacokinetics and self-reported depressive symptoms during antiviral treatment for chronic hepatitis C.Pharmacopsychiatry · 2014Article
- The treatment response of chronically hepatitis C virus-infected patients depends on interferon concentration but not on interferon gene expression in peripheral blood mononuclear cells.Antimicrobial agents and chemotherapy · 2012Article
- A meta-analysis that compares the use of either peginterferon-α2a or peginterferon-α2b plus ribavirin for HCV infection.Hepatic medicine : evidence and research · 2010Article
Corrections and comments
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Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
aimsTo evaluate whether higher doses of peginterferon alpha-2a (40KD) [PEG-IFN alpha-2a (40KD)] can compensate for lower exposure observed among obese patients with chronic hepatitis C (CHC) treated with the standard dose of PEG-IFN alpha-2a (40KD).
methodsNoncirrhotic, obese (body mass index > or =30 kg m(-2)) patients with CHC participated in a single-centre, open-label study. Patients were randomized to 180 or 270 microg week(-1) PEG-IFN alpha-2a (40KD) + ribavirin (1000/1200 mg day(-1)) for 48 weeks. Blood samples were collected predose and up to 168 h after the first dose and at week 12 for pharmacokinetic analysis. Trough serum concentrations (C(trough)) were determined up to week 24.
resultsIn the 180 microg week(-1) group mean +/- SD steady-state (week 12) estimates of AUC(0-168) (ng h(-1) ml(-1)), C(max) (ng ml(-1)) and CL/F (l h(-1)) were 2154 +/- 919, 13.8 +/- 6.7 and 0.102 +/- 0.051, respectively. In the 270 microg week(-1) group, estimates were 3374 +/- 1844, 23.4 +/- 10.7 and 0.090 +/- 0.042, respectively. The mean (range) C(trough) (ng ml(-1)) was 11.2 (4.4-18.5) in the 180 microg week(-1) group and 16.1 (0.4-44.2) in the 270 microg week(-1) group. Overall, 14 of 20 (70%) and 16 of 20 (80%) patients in the 180 microg week(-1) and 270 microg week(-1) groups were infected with hepatitis C virus genotype 1 or 4. In the 180 microg week(-1) and 270 microg week(-1) groups 14 of 20 (70%) and 15 of 19 (79%) patients, respectively, achieved a sustained viral response. Safety was similar between groups.
conclusionsMean PEG-IFN alpha-2a (40KD) exposure was dose proportional from 180 to 270 microg week(-1). Increasing PEG-IFN alpha-2a (40KD) from 180 to 270 microg week(-1) achieves higher serum drug exposure in obese patients.
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