PMID- 24790244
OWN - NLM
STAT- PubMed-not-MEDLINE
DCOM- 20140505
LR  - 20211021
IS  - 0011-393X (Print)
IS  - 0011-393X (Linking)
VI  - 66
IP  - 5
DP  - 2005 Sep
TI  - Clinical experience with nonstandard doses ofinterferon alfa-2b and ribavirin in 
      the treatment of chronic hepatitis C infection: A retrospective analysis.
PG  - 433-50
LID - 10.1016/j.curtheres.2005.10.005 [doi]
AB  - BACKGROUND: Hepatitis C virus (HCV) infection is the most common blood-borne 
      virus in the United States. Several mono- and combination therapies have been 
      approved by the US Food and Drug Administration for the treatment of HCV, but 
      their routes of administration, dosing approaches, eras of introduction, and 
      actual use in clinical practice and resulting effectiveness have not yet been 
      reported. OBJECTIVES: The aim of this article was to characterize clinical use 
      and virologic response (VR) of the HCV treatments interferon alfa-2b plus 
      ribavirin (IFN + RBV) and peginterferon alfa-2b plus ribavirin (peg-IFN + RBV). 
      METHODS: This retrospective chart review of office-based practices in theUnited 
      States was conducted at 200 physicians' offices across the United States. We 
      collected data concerning dosing patterns, VR (HCV RNA load, </=1000 IU/mL or 
      "negative" on polymerase chain reaction qualitative analysis), and adverse events 
      (AEs) from the medical records of a geographically diverse sample of patients 
      receiving treatment for chronic HCV infection in the United States from July 2001 
      to June 2002. For efficacy assessment, factors that were statistically different 
      at baseline were adjusted using logistic regression. Providers also reviewed the 
      medical records for symptoms or signs consistent with HCV treatment-related AEs. 
      RESULTS: Data from the records of 675 patients (423 men, 252 women; mean [SD] age 
      of 45.5 [8.2] years; mean [SD] body weight, 80.8 [19.4] kg) were analyzed. At 
      baseline, the IFN + RBV treatment group (330 patients) had significantly higher 
      percentages of black patients (22.1% vs 15.7%; P = 0.032) and patients with 
      hepatic disease based on clinician-reported cirrhosis and liver dysfunction 
      (18.8% vs 9.9%; P < 0.001), and a significantly lower percentage of white 
      patients (60.3% vs 69.6%; P = 0.012) compared with the peg-IFN + RBV treatment 
      group (345 patients). The difference in log-transformed baseline HCV RNA loads 
      between the 2 treatment groups in this study was <1 log unit. A significantly 
      higher percentage of IFN + RBV-treated patients compared with peg-IFN + 
      RBV-treated patients were prescribed HCV therapy on diagnosis (37.3% vs 29.9%; P 
      = 0.041), and the mean (SD) duration of treatment was significantly different 
      between the 2 treatment groups (52.5 [37.0] vs 27.5 [15.0] weeks; P < 0.001). 
      Peg-IFN + RBV was associated with a higher rate of VR compared with IFN + RBV on 
      univariate analysis (28.5% vs 17.5%; P = 0.018). Recommended doses of peg-IFN and 
      higher-than-recommended doses of RBV were associated with an increased likelihood 
      of VR. Higher-than-recommended doses of peg-IFN without a concomitant increase in 
      RBV was not associated with an increased likelihood of VR. The incidences of the 
      3 most commonly reported AEs in the IFN + RSV group were significantly higher 
      compared with those in the peg-IFN + RSV group: fatigue, 217 (65.8%) versus 185 
      (53.6%) patients (P = 0.001); depression, 147 (44.5%) versus 120 (34.8%) (P = 
      0.009); and anxiety, 87 (26.4%) versus 64 (18.6%) (P = 0.014). Nausea, however, 
      was reported in a significantly higher number of patients in the peg-IFN group 
      compared with the IFN + RBV group (74 [21.4%] vs 51 [15.5%]; P = 0.045). The 
      frequencies of dose modification and treatment discontinuation due to AEs were 
      similar between the 2 treatments and were similar to or less than those reported 
      in other studies. CONCLUSIONS: In this retrospective data analysis of US 
      office-based practicesconcerning HCV treatment, clinicians were observed to 
      prescribe IFN + RBV at doses that differ from recommendations in the product 
      information (PI), as well as prescribe the RBV component of peg-IFN + RBV at 
      doses that differed from PI recommendations. Although patients treated with 
      peg-IFN + RBV appeared to achieve higher VR compared with those treated with IFN 
      + RBV in our analysis of data from clinical practice, peg-IFN + RBV was 
      associated with lower VR rates compared with those reported in clinical studies.
FAU - Hare, C Bradley
AU  - Hare CB
AD  - University of California, San Francisco, Positive Health Program, San Francisco 
      GeneralHospital, San Francisco, California, USA.
FAU - Loveland, Jacqueline J
AU  - Loveland JJ
AD  - ProSanos Corporation, La Jolla, California, USA.
FAU - Chu, Alice
AU  - Chu A
AD  - ProSanos Corporation, La Jolla, California, USA.
FAU - Morris, Jonathan A
AU  - Morris JA
AD  - ProSanos Corporation, La Jolla, California, USA.
FAU - Gotz, Vincent
AU  - Gotz V
AD  - ProSanos Corporation, La Jolla, California, USA.
FAU - Klaskala, Winslow
AU  - Klaskala W
AD  - Department of Medical Science, Roche Laboratories, Inc, Nutley, New Jersey, USA.
LA  - eng
PT  - Journal Article
PL  - United States
TA  - Curr Ther Res Clin Exp
JT  - Current therapeutic research, clinical and experimental
JID - 0372621
PMC - PMC4003805
OTO - NOTNLM
OT  - dosing
OT  - hepatitis C
OT  - interferon alfa-2b and ribavirin
OT  - outcomes
OT  - pegylated interferon
OT  - ribavirin
EDAT- 2005/09/01 00:00
MHDA- 2005/09/01 00:01
PMCR- 2005/09/01
CRDT- 2014/05/03 06:00
PHST- 2005/08/03 00:00 [accepted]
PHST- 2014/05/03 06:00 [entrez]
PHST- 2005/09/01 00:00 [pubmed]
PHST- 2005/09/01 00:01 [medline]
PHST- 2005/09/01 00:00 [pmc-release]
AID - S0011-393X(05)00097-4 [pii]
AID - 10.1016/j.curtheres.2005.10.005 [doi]
PST - ppublish
SO  - Curr Ther Res Clin Exp. 2005 Sep;66(5):433-50. doi: 
      10.1016/j.curtheres.2005.10.005.