Reply:
Authors: Sanaa Kamal, Khalifa Khalifa, Khairy Moustafa, Margaret Koziel, Leila El Gohary, Amr Ramy, Nezan Afdhal
Journal: Hepatology (2006)

We acknowledge the letter of Dr. Wedemeyer and colleagues and will happily respond to both their questions and also their not so subtle insinuations. It is well known that Egypt has the highest prevalence (15%) and incidence of HCV in the world. The Egyptian program for the screening, identification and treatment of acute HCV has enabled large scale studies of acute HCV with documented seroconversion in predominantly healthcare workers. Directly observed therapy and the almost universal inclusion of healthcare workers and their families has led to clinical trials with large numbers of highly motivated patients. These studies have in fact enrolled approximately 250 patients over a period of 3 years. Additional patients were screened or followed, but these patients were not treated because they either refused therapy or did not meet inclusion criteria. There were 3 clinical trials undertaken between 2002 and 2005, of which two have been published in addition to a 3rd small trial comparing Interferon and ribavirin to PEG-Interferon monotherapy. Interim analysis and some data from the above mentioned articles, as well as a study comparing PEG-IFN and conventional IFN in a small cohort, were presented in part during AASLD, EASL and DDW meetings in 2004 and 2005. Randomization was centralized for these trials and all trials ran in tandem with patients randomly being offered entry into a trial — a common practice at many large academic centers, where at any one time 10 to 15 therapeutic HCV trials may be ongoing. The comment that the control groups in the HEPATOLOGY1 and Gastroenterology papers2 are the same is incorrect as they differ with respect to nearly all demographic criteria and are different patients. However, the most disturbing aspect of this letter and the prior letter from the same group to Gastroenterology,3 is the insinuation that this research could not be done as described in Egypt. We have voluntarily provided the independent DSMB reports for this trial to the Editorial Board at Gastroenterology outlining the recruitment strategies, patient enrollment and validating the data and study design and we have offered to provide the independent DSMB report to the Editors of HEPATOLOGY. Competition between groups is healthy but we consider this a series of unprecedented attacks by an established leading European Investigator on an Egyptian/US consortium doing very important, validated and meaningful studies. We congratulate the HepNet group on doing acute HCV studies in a country with a prevalence of HCV of 0.5%, needle free hospitals, needle exchange programs and with the lowest incidence of acute HCV worldwide.4 In spite of several inconsistencies in the HepNet study, we rely on the principle of truth in scientific communication. Acute HCV research is moving east where there is a real clinical problem with the disease and the ability to perform larger, equally well-run clinical trials with all HCV genotypes included. Finally, an erratum with correction missed in the proofs had already been submitted to HEPATOLOGY prior to receipt of the letter from Wedemeyer and we are sorry for the confusion on the part of the readers. Sanaa Kamal*, Khalifa Khalifa , Khairy Moustafa , Margaret Koziel , Leila El Gohary , Amr Ramy , Nezan Afdhal§, * Harvard Institutes of Medicine, Department of Infectious Diseases, Boston, MA, Ain Shams University, Liver Disease Center, Cairo, Egypt, Beth Israel Deaconess Medical Center, Boston, MA, § Director, Liver Center Division of Gastroenterology, Beth Israel Deaconess Medical Center, Boston, MA