TY - JOUR
T1 - Interferon alfacon-1 and ribavirin versus interferon α-2b and ribavirin in the treatment of chronic hepatitis C
AU - Sjogren, Maria H.
AU - Sjogren, Robert
AU - Holtzmuller, Kent
AU - Winston, Bradley
AU - Butterfield, Betty
AU - Drake, Stanley
AU - Watts, Amber
AU - Howard, Robin
AU - Smith, Milton
N1 - Funding Information:
This work was partially funded by Amgen Inc. and Intermune Inc.
PY - 2005/4
Y1 - 2005/4
N2 - Despite advances in the therapy of chronic hepatitis C, a large number of patients do not respond to current therapies. The study objective was to assess whether a combination of interferon (IFN) alfacon-1 and ribavirin improves the response rate compared with a combination of INF α-2b and ribavirin in chronic hepatitis C subjects. The study was designed as an open-label, prospective, randomized, controlled study; 128 subjects with chronic hepatitis C were randomized to INF alfacon-1, 15 μg three times per week, plus ribavirin, 1 g/day, or IFN-α2b, 3 million units three times per week, plus ribavirin, 1 g/day for 48 weeks. The end point of the study was a sustained viral response, defined as undetectable HCV RNA at 24 weeks post 48 weeks of treatment. Overall, 57% of subjects in the INF alfacon-1/ribavirin group achieved a sustained antiviral response, compared with 40% of subjects in the IFN-α2b/ribavirin group (P = 0.052). In the subset of subjects with a high viral load, HCV RNA was successfully eradicated in more individuals who received INF alfacon-1/ribavirin than subjects who received IFN-α2b/ ribavirin (57 versus 31%; P = 0.025). Among individuals with genotype 1 and a high viral load, the sustained antiviral response was significantly higher with INF alfacon-1/ribavirin than with IFN-α2b/ribavirin (46 versus 14%; P = 0.019). Adverse events were similar in both treatment groups. In conclusion, this study demonstrated that the combination of INF alfacon-1 and ribavirin provides a significantly better treatment response compared with the combination of IFN-α 2b and ribavirin in chronic HCV subjects infected with genotype 1 and a high viral RNA load.
AB - Despite advances in the therapy of chronic hepatitis C, a large number of patients do not respond to current therapies. The study objective was to assess whether a combination of interferon (IFN) alfacon-1 and ribavirin improves the response rate compared with a combination of INF α-2b and ribavirin in chronic hepatitis C subjects. The study was designed as an open-label, prospective, randomized, controlled study; 128 subjects with chronic hepatitis C were randomized to INF alfacon-1, 15 μg three times per week, plus ribavirin, 1 g/day, or IFN-α2b, 3 million units three times per week, plus ribavirin, 1 g/day for 48 weeks. The end point of the study was a sustained viral response, defined as undetectable HCV RNA at 24 weeks post 48 weeks of treatment. Overall, 57% of subjects in the INF alfacon-1/ribavirin group achieved a sustained antiviral response, compared with 40% of subjects in the IFN-α2b/ribavirin group (P = 0.052). In the subset of subjects with a high viral load, HCV RNA was successfully eradicated in more individuals who received INF alfacon-1/ribavirin than subjects who received IFN-α2b/ ribavirin (57 versus 31%; P = 0.025). Among individuals with genotype 1 and a high viral load, the sustained antiviral response was significantly higher with INF alfacon-1/ribavirin than with IFN-α2b/ribavirin (46 versus 14%; P = 0.019). Adverse events were similar in both treatment groups. In conclusion, this study demonstrated that the combination of INF alfacon-1 and ribavirin provides a significantly better treatment response compared with the combination of IFN-α 2b and ribavirin in chronic HCV subjects infected with genotype 1 and a high viral RNA load.
KW - Antiviral theraphy
KW - Consensus interferon
KW - Genotype 1
KW - HCV RNA
KW - Hepatitis C
KW - Interferon α-2b
KW - Ribavarin
UR - http://www.scopus.com/inward/record.url?scp=17644415729&partnerID=8YFLogxK
U2 - 10.1007/s10620-005-2564-2
DO - 10.1007/s10620-005-2564-2
M3 - Article
C2 - 15844709
AN - SCOPUS:17644415729
SN - 0163-2116
VL - 50
SP - 727
EP - 732
JO - Digestive Diseases and Sciences
JF - Digestive Diseases and Sciences
IS - 4
ER -