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Pegylated interferon alpha‐2b plus ribavirin in patients with genotype 4 chronic hepatitis C: The role of rapid and early virologic response
Author(s) -
Kamal Sanaa M.,
El Kamary Samer S.,
Shardell Michelle D.,
Hashem Mohamed,
Ahmed Imad N.,
Muhammadi Mohamed,
Sayed Khalifa,
Moustafa Ashraf,
Hakem Sarah Abdel,
Ibrahiem Amany,
Moniem Mohamed,
Mansour Hoda,
Abdelaziz Mohamed
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.21917
Subject(s) - medicine , ribavirin , discontinuation , gastroenterology , pegylated interferon , hepatitis c virus , adverse effect , incidence (geometry) , viral load , hepatitis c , immunology , virus , physics , optics
In patients chronically infected with hepatitis C virus (HCV) genotype 4, the optimum duration of therapy and the predictors of sustained virologic response (SVR) have not been adequately determined. In this study, 358 patients with chronic hepatitis C genotype 4 were randomly assigned to pegylated interferon (PEG‐IFN) alpha‐2b (1.5 μg/kg/week) plus oral ribavirin (10.6 mg/kg/day) for a fixed duration of 48 weeks (control group, n = 50) or for a variable duration (n = 318). In the variable‐duration group, patients with undetectable HCV RNA at week 4 were treated for 24 weeks (group A, n = 69), patients with undetectable HCV RNA at week 12 were treated for 36 weeks (group B, n = 79), and the rest of the patients were treated for 48 weeks (group C, n = 160). The primary endpoint was SVR (undetectable HCV RNA 24 weeks after treatment cessation). Groups A‐C and the control group had SVR rates of 86%, 76%, 56%, and 58%, respectively. After the study was controlled for predictors, a low baseline histologic grade and stage were associated with SVR ( P < 0.029) in all groups. In addition, among patients in group C, older age ( P = 0.04), a higher baseline body mass index ( P = 0.013), and low baseline HCV RNA ( P < 0.001) were also associated with SVR attainment. The incidence of adverse events and the rate of discontinuation were higher in patients in the variable‐duration and fixed‐duration groups treated for 48 weeks. Conclusion: In patients with chronic hepatitis C genotype 4 and undetectable HCV RNA at weeks 4 and 12, treatment with PEG‐IFN alpha‐2b and ribavirin for 24 weeks and 36 weeks, respectively, is sufficient. (H EPATOLOGY 2007.)