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Background Hepatitis B virus (HBV)/hepatitis C virus (HCV) confection has been rarely studied in nonasian series. Aim To compare the characteristics of HBV/HCV coinfected patients to those of HBV- or HCV-monoinfected patients in the ANRS CO22 HEPATHER cohort study. Patients and Methods Of the 20 936 included patients, 95 had HBV/ HCV coinfection (hepatitis B surface antigen, anti- HCV antibody and HCV RNA positive) and were matched with 375 HBV- and 380 HCV-monoinfected patients on age, gender and time since HBV or HCV diagnosis. Results F3-F4 fibrosis was more frequent in coinfected patients (58%) than in HBV- (32%, P < .0001), but similar in HCV-monoinfected patients (52%, P = .3142). Decompensated cirrhosis was more frequent in coinfected patients (11%) than in HBV- (2%, P = .0002) or HCV- (4%, P = .0275) monoinfected patients. Past excessive alcohol use was more frequent in coinfected patients (26%) than in HBV (12%, P = .0011), but similar in HCV monoinfected patients (32%, P = .2868). Coinfected patients had a higher proportion with arterial hypertension (42%) than HBV- (26%) or HCV-monoinfected patients (25%) ( P < .003). Multivariable analysis confirmed the association between F3-F4 fibrosis and HCV infection in HBV-infected patients ( OR = 3.84, 95% CI 1.99-7.43) and the association between decompensated cirrhosis and coinfection in HBV infected ( OR = 5.58, 95% CI 1.42-22.0) or HCV infected patients ( OR = 3.02, 95% CI 1.22-7.44). Conclusions HCV coinfection harmfully affects liver fibrosis in HBV patients, while decompensated cirrhosis is increased in coinfected patients compared with HBV- or HCV-monoinfected patients. HCV treatment is as safe and effective in coinfected as monoinfected patients and should be considered following the same rules as HCV monoinfected patients. [ABSTRACT FROM AUTHOR]

A large number of new anticancer agents are currently under development in order to obtain marketing authorisation. By the end of 2005, centralised European submission will become mandatory for any new drug in the field of oncology. New regulations will apply to the registration of anticancer products. Some of these compounds exert their effects through mechanisms of action that do not involve direct cytotoxicity. A new version of the Guideline for Evaluation of Anticancer Medicinal Products in Man will take this fact into account and will integrate as far as possible the experience linked to the most recent procedures. This paper briefly summarizes the main regulatory changes and their corresponding scientific adaptations. [ABSTRACT FROM AUTHOR]