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Impact of weight‐based ribavirin with peginterferon alfa‐2b in african americans with hepatitis C virus genotype 1
Author(s) -
Jacobson Ira M.,
Brown Robert S.,
McCone Jonathan,
Black Martin,
Albert Clive,
Dragutsky Michael S.,
Siddiqui Firdous A.,
Hargrave Thomas,
Kwo Paul Y.,
Lambiase Louis,
Galler Greg W.,
Araya Victor,
Freilich Bradley,
Harvey Joann,
Griffel Louis H.,
Brass Clifford A.
Publication year - 2007
Publication title -
hepatology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 5.488
H-Index - 361
eISSN - 1527-3350
pISSN - 0270-9139
DOI - 10.1002/hep.21670
Subject(s) - ribavirin , medicine , dosing , discontinuation , gastroenterology , pegylated interferon , adverse effect , hepatitis c virus , hepatitis c , weight loss , immunology , virus , obesity
Abstract WIN‐R ( W eight‐based dosing of peg IN terferon alfa‐2b and R ibavirin) was a multicenter, randomized, open‐label, investigator‐initiated trial involving 236 community and academic sites in the United States, comparing response to pegylated interferon (PEG‐IFN) alfa‐2b plus a flat or weight‐based dose of ribavirin (RBV) in treatment‐naive patients with chronic hepatitis C and compensated liver disease. Patients were randomized to receive PEG‐IFN alfa‐2b at 1.5 μg/kg/week plus flat‐dose (800 mg/day) or weight‐based‐dose RBV (800 mg/day for weight <65 kg, 1000 mg/day for 65‐85 kg, 1200 mg/day for >85‐105 kg, or 1400 mg/day for >105‐<125 kg). Sustained virologic response (SVR; undetectable [<125 IU/mL] hepatitis C virus [HCV] RNA at end of follow‐up) in patients ≥65 kg was the primary end point. Low SVR rates have been reported among African American individuals, in whom there is a preponderance of HCV genotype 1. This subanalysis of WIN‐R was conducted to evaluate the efficacy of weight‐based dosing among African American individuals with genotype 1 infection enrolled in the trial. Of 362 African American patients in the primary efficacy analysis, 188 received RBV flat dosing and 174 received weight‐based dosing. SVR rates were higher (21% versus 10%; P = 0.0006) and relapse rates were lower (22% versus 30%) in the weight‐based‐dose group than in the flat‐dose group. Safety and rates of drug discontinuation were similar between the 2 groups. Conclusion: Weight‐based dosing of RBV is more effective than flat dosing in combination with PEG‐IFN alfa‐2b in African American individuals with HCV genotype 1. Even with weight‐based dosing, response rates in African American individuals are lower than reported in other ethnic groups. (H EPATOLOGY 2007.)