Author:
Lurie Y, et al J Viral Hepat 2002 Sep;9(5):346-353
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Date Posted: Wed, September 25 2002, 6:39:37 PDT
A multicentre, randomized study to evaluate the safety and efficacy of histamine dihydrochloride and interferon-alpha-2b for the treatment of chronic hepatitis C.
Lurie Y, Nevens F, Aprosina ZG, Fedorova TA, Kalinin AV, Klimova EA, Ilan Y, Maevskaya MV, Warnes TW, Yuschuk ND, Hellstrand K, Gehlsen KR.
Department of Gastroenterology and Hepatology, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel; UZ Gasthuisberg, Hepatologie, Leuven, Belgium; Clinic of Occupational Diseases, Moscow Medical Academy, Botkinskaya Hospital, State Institute of Post-Graduate Education, Ministry of Defense of Russian Federation, 1st Infectious Diseases Hospital, Department of Infectious Hepatitis #19, Moscow, Russia; Department of Medicine A, Liver and Gastroenterology Units, Hadassah-Hebrew University Medical Center, Jerusalem, Israel; Department of Propedeutics, Moscow Medical Academy, Moscow, Russia; Manchester Royal Infirmary, Manchester, UK; Department of Infectious Diseases, 2nd Infectious Disease Hospital, Moscow, Russia; Department of Virology, University of Goteborg, Goteborg, Sweden; Maxim Pharmaceuticals, San Diego, California, USA.
Interferon- (IFN-)alpha is currently the standard of care treatment for patients with chronic hepatitis C virus (HCV) infection. A significant part of the benefit of IFN-alpha in chronic hepatitis C is believed to be related to the activation of lymphocytes such as T cells and natural killer (NK) cells, which participate in the elimination of infected cells. Histamine dihydrochloride (HDC) has been shown to potentiate the IFN-alpha-induced activation of T cells and NK cells by a mechanism that involves the protection of these lymphocytes against oxygen radical-induced functional inhibition and apoptosis. This study was designed to examine the efficacy and safety of HDC in combination with IFN-alpha-2b in treatment-naive patients with chronic HCV infection. All patients received IFN-alpha-2b, 3 MIU, three times weekly via subcutaneous injection, and were randomized to one of four HDC regimens (1 mg of either: once a day, three times a week; once a day, five times a week; twice a day, three times a week or; twice a day, five times a week). The doses of HDC in combination with IFN-alpha-2b resulted in sustained viral response rates ranging from 31% to 38%. Sustained biochemical response rates ranged from 28% to 41% across the four treatment groups. Patients infected with HCV genotype 1, and those with high baseline viral levels, which are characteristics associated with poor prognosis, had sustained virologic response rates ranging from 18% to 42% and 15% to 39%, respectively. Combination treatment was generally well tolerated. We propose that the potential benefit of HDC + IFN therapy for chronic HCV infection should be the focus of further investigation.
PMID: 12225329
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