58 Randomized, Open-Label, 12-Week Comparison of Controlled-Release Interferon Alpha2b +Ribavrin vs. Pegylated-Interferon Alpha2b +Ribavrin in Treatment-Naive Genotype1 Hepatitis C: 4 Week Results From 480study (Panel A)

Krastev, Zahary; Kotzev, Iskren; Tchernev, К.; Rigney, A.; Nikolovska, D; Vladimirov, B.; Căruntu, Florin Alexandru; Diaconescu, Iulian; Voiculescu, M; Long, W.A.

doi:10.1016/s0168-8278(10)60060-8

Journal of Hepatology

2010

DOI: 10.1016/s0168-8278(10)60060-8

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58 Randomized, Open-Label, 12-Week Comparison of Controlled-Release Interferon Alpha2b +Ribavrin vs. Pegylated-Interferon Alpha2b +Ribavrin in Treatment-Naive Genotype1 Hepatitis C: 4 Week Results From 480study (Panel A)

Zahary Krastev¹,

Iskren Kotzev²,

К. Tchernev³

et al.

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Controlled-release interferon alpha 2b, a new member of the interferon family for the treatment of chronic hepatitis C

Jansen

Bruijne

2011

Expert Opinion on Investigational Drugs

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CR2b is a slow-release microsphere preparation for the administration of plant-derived recombinant human interferon alpha 2b. Compared with Peg-interferon, treatment with CR2b shows less flu-like reactions and less depression, and is at least as effective as conventional Peg-interferon-based therapy in patients with chronic hepatitis C. CR2b has the added advantage of biweekly instead of once weekly administration. CR2b appears to cause more neutropenia than Peg-interferon alpha 2b. This may be due to higher trough serum levels of CR2b at the end of a dosing interval. The bone marrow effects of CR2b closely resemble those published for the registered Peg-interferon alpha 2a. CR2b appears to have at least comparable efficacy with fewer side effects than current registered Peg-interferons.

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Controlled-release interferon alpha 2b, a new member of the interferon family for the treatment of chronic hepatitis C

Jansen

Bruijne

2011

Expert Opinion on Investigational Drugs

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Recent advances in polymeric microspheres for parenteral drug delivery—part 2

Mao

Guo

Shi

et al. 2012

Expert Opinion on Drug Delivery

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Novel fabrication methods for microspheres have been recently reported but technical challenges and development risks remain high for scale up from bench to industrial commercialization. While the applications of microspheres for delivery of proteins, genes and vaccines have shown promise for clinical use, the approval of newly functionalized polymers as carriers may still face scrutiny on safety and biocompatibility, which can be key factors in securing the regulatory approval of the product.

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58 Randomized, Open-Label, 12-Week Comparison of Controlled-Release Interferon Alpha2b +Ribavrin vs. Pegylated-Interferon Alpha2b +Ribavrin in Treatment-Naive Genotype1 Hepatitis C: 4 Week Results From 480study (Panel A)

Cited by 2 publications

References 0 publications

Controlled-release interferon alpha 2b, a new member of the interferon family for the treatment of chronic hepatitis C

Controlled-release interferon alpha 2b, a new member of the interferon family for the treatment of chronic hepatitis C

Recent advances in polymeric microspheres for parenteral drug delivery—part 2

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