PMID- 15336466
OWN - NLM
STAT- MEDLINE
DCOM- 20041108
LR  - 20190922
IS  - 0149-2918 (Print)
IS  - 0149-2918 (Linking)
VI  - 26
IP  - 7
DP  - 2004 Jul
TI  - Peginterferon alfa-2a: a review of approved and investigational uses.
PG  - 991-1025
AB  - BACKGROUND: In October 2002, the US Food and Drug Administration approved 
      peginterferon alfa-2a for the management of chronic hepatitis C virus (HCV) 
      infection. The addition of polyethylene glycol (PEG) moiety to the interferon 
      (IFN) molecule results in a product with altered pharmacokinetic properties. 
      OBJECTIVE: The aim of this article is to review the pharmacology, medications 
      interactions, adverse events (AEs), and approved or investigational uses of 
      PEG-IFN alfa-2a for viral hepatitis and oncologic conditions. METHODS: Relevant 
      articles were identified through searches of MEDLINE (1980-July 2003) and EMBASE 
      (1980-July 2003). Search terms included, but were not limited to, peginterferon 
      alfa-2a, pharmacokinetics, pharmacology, pharmacodynamics, and therapeutic use, 
      as well as terms for specific disease states and AEs. Further publications were 
      identified from citations of resulting papers. RESULTS: Pegylation of IFN alfa-2a 
      results in major changes in the pharmacokinetics of the product. Absorption is 
      prolonged and serum concentrations are sustained over the dosing regimen. PEG-IFN 
      alfa-2a has been shown to be more effective with or without ribavirin (RBV), in 
      the management of treatment-naive patients with chronic HCV infection, than 
      unmodified IFN alfa-2a with or without RBV. Results in other disease states are 
      still preliminary. AEs are similar, in incidence and severity, to those occurring 
      with unmodified IFN. They include earlier hematologic symptoms and fewer 
      influenza-like symptoms. Drug-drug interactions are the same as those occurring 
      with the unmodified IFN product. CONCLUSIONS: The pharmacokinetic profile of IFN 
      alfa-2a is improved by pegylation, which enables less frequent administration and 
      results in improved efficacy with a similar side-effect profile. Combination of 
      PEG-IFN alfa-2a with RBV is associated with a greater chance of achieving a 
      sustained virologic response in treatment-naive patients with chronic HCV, 
      compared with unmodified IFN alfa-2a/RBV combinations. Documentation of efficacy 
      in other conditions awaits results of controlled clinical trials.
FAU - Matthews, S James
AU  - Matthews SJ
AD  - Department of Pharmacy Practice, School of Pharmacy, Bouve College of Health 
      Sciences, Northeastern University, Boston, MA 02115, USA. s.matthews@neu.edu
FAU - McCoy, Christopher
AU  - McCoy C
LA  - eng
PT  - Journal Article
PT  - Review
PL  - United States
TA  - Clin Ther
JT  - Clinical therapeutics
JID - 7706726
RN  - 0 (Antiviral Agents)
RN  - 0 (Interferon alpha-2)
RN  - 0 (Interferon-alpha)
RN  - 0 (Recombinant Proteins)
RN  - 3WJQ0SDW1A (Polyethylene Glycols)
RN  - Q46947FE7K (peginterferon alfa-2a)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Animals
MH  - *Antiviral Agents/adverse effects/pharmacokinetics/therapeutic use
MH  - Area Under Curve
MH  - Child
MH  - Child, Preschool
MH  - Cost-Benefit Analysis
MH  - Drug Interactions
MH  - Female
MH  - Half-Life
MH  - Hepatitis C, Chronic/*drug therapy
MH  - Humans
MH  - Interferon alpha-2
MH  - *Interferon-alpha/adverse effects/pharmacokinetics/therapeutic use
MH  - Male
MH  - Metabolic Clearance Rate
MH  - Middle Aged
MH  - *Polyethylene Glycols/adverse effects/pharmacokinetics/therapeutic use
MH  - Quality of Life
MH  - Randomized Controlled Trials as Topic
MH  - Recombinant Proteins
MH  - Tissue Distribution
MH  - Treatment Outcome
RF  - 149
EDAT- 2004/09/01 05:00
MHDA- 2004/11/09 09:00
CRDT- 2004/09/01 05:00
PHST- 2004/09/01 05:00 [pubmed]
PHST- 2004/11/09 09:00 [medline]
PHST- 2004/09/01 05:00 [entrez]
AID - S0149291804901737 [pii]
AID - 10.1016/s0149-2918(04)90173-7 [doi]
PST - ppublish
SO  - Clin Ther. 2004 Jul;26(7):991-1025. doi: 10.1016/s0149-2918(04)90173-7.