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To the Editor:

We read with interest the article by Kamal et al.1 on the impact of treatment duration for the treatment of acute hepatitis C. The paper suggests that shorter treatment durations of 8-12 weeks may be sufficient for HCV genotypes 2-4, while acute hepatitis C genotype 1 infection requires 24 weeks of treatment with pegylated interferon alpha. The authors were able to recruit a remarkable 173 patients with acute hepatitis C within less than 2 years of screening. (The study was conducted until May 2005, thus the last patient in the 24-week treatment group must have entered the trial in February 2004.) Furthermore, the same group of investigators performed another trial within an almost identical time frame, including a study of 175 patients with acute hepatitis C which was published in February 2006.2 At least 4 additional trials on acute hepatitis C with always slightly differing study designs have been presented during the last 2 years by Kamal and colleagues either as full paper3 or in abstract from recent EASL, DDW, and AASLD meetings.4–6 Overall, data on more than 600 acute hepatitis C patients have been described. Thus, we would like to ask on what criteria patients were assigned to which trial if 6 protocols were running in parallel. Furthermore, we have the impression that the characteristics of patients declining participation in the trials presented in the journals HEPATOLOGY and Gastroenterology are partially overlapping although not being completely identical.

Finally, there are several errors in data analysis and data presentation questioning the conclusions drawn. For example, sustained virological responses (SVR) presented in Table 2 do not match sustained response rates given in Fig. 2a. According to Fig. 2, a SVR was reached in 21 patients treated for 8 weeks while Table 2 is listing 23 SVR patients for this group of patients. Also for groups B and C, the numbers on the primary endpoint of the study do not match between Table 2 and Fig. 2. Moreover, P values given in Table 2 are not correct, e.g., the difference between the 8 weeks of therapy group and the 24 weeks of therapy group in SVR is not P < .001 but P = .02 and none of the other P values in the table is <.05. Numbers and bars do not match in Fig. 2b for genotype 1 patients with low viral load and almost all P values given in Fig. 2 need recalculation.

References

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  • 1
    Kamal SM, Moustafa KN, Chen J, Fehr J, Moneim AA, Khalifa KE, et al. Duration of peginterferon therapy in acute hepatitis C: a randomized trial. HEPATOLOGY 2006; 43: 923931.
  • 2
    Kamal SM, Fouly AE, Kamel RR, Hockenjos B, Al Tawil A, Khalifa KE, et al. Peginterferon alfa-2b therapy in acute hepatitis C: impact of onset of therapy on sustained virologic response. Gastroenterology 2006; 130: 632638.
  • 3
    Kamal SM, Ismail A, Graham CS, He Q, Rasenack JW, Peters T, et al. Pegylated interferon alpha therapy in acute hepatitis C: relation to hepatitis C virus-specific T cell response kinetics. HEPATOLOGY 2004; 39: 17211731.
  • 4
    Kamal SM, Madwar MA, He Q, Al Fouly A, Ismail A, El Sayed K, et al. Peginterferon alfa compared with conventional interferon alfa and ribavirin combination therapy in asymptomatic acute hepatitis C: A randomized trial of treatment onset, duration and cost-effectiveness [Abstract]. HEPATOLOGY 2004; 40(Suppl): 178A.
  • 5
    Kamal S, Ismail A, Al Tawil A, Hakam S, He Q, Rasenack J, et al. Peginterferon alfa 2-B therapy for 8 weeks in acute hepatitis C genotypes 1 and 4: a pilot study [Abstract]. Gastroenterology 2005; 128: A683.
  • 6
    Kamal S, He Q, Al Tawil A, Khalifa K, Hakam S, Saleh W, et al. Peginterferon alpha-2b therapy in acute hepatitis C: impact of onset and duration of therapy on sustained virologic response [Abstract]. J Hepatol 2005; 42: 8.

Heiner Wedemeyer M.D.*, Markus Cornberg M.D.*, Johannes Wiegand M.D.*, Michael Manns M.D.*, * Medizinische Hochschule Hannover, Department of Gastroenterology, Hepatology and Endocrinology, Hannover, Germany