Pegylated interferon alpha-2b plus ribavirin in patients with genotype 4 chronic hepatitis C: The role of rapid and early virologic response

✍ Scribed by Sanaa M. Kamal; Samer S. El Kamary; Michelle D. Shardell; Mohamed Hashem; Imad N. Ahmed; Mohamed Muhammadi; Khalifa Sayed; Ashraf Moustafa; Sarah Abdel Hakem; Amany Ibrahiem; Mohamed Moniem; Hoda Mansour; Mohamed Abdelaziz

• Publisher: John Wiley and Sons
• Year: 2007
• Tongue: English
• Weight: 251 KB
• Volume: 46
• Category: Article
• ISSN: 0270-9139
• DOI: 10.1002/hep.21917

✦ Synopsis

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 mug/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.