In 2009, various independent research teams provided evidence tha

In 2009, various independent research teams provided evidence that the interleukin 28B (IL28B) rs12979860 and rs8099917 polymorphisms were associated with spontaneous clearance of HCV [8] and with sustained virological response to treatment with pegIFN�� and ribavirin [9]�C[11] in HCV mono-infected patients. Further studies have consistently confirmed these associations [12], [13]. Similar findings have also been reported in HCV-HIV co-infected patients [14]�C[17]. Recently, we carried out a randomised trial to compare the efficacy and safety of the two available forms of pegIFN�� plus ribavirin in HCV-HIV co-infected patients [18]. No significant differences in either efficacy or safety were found between the two treatment arms. The present report is a pharmacogenetic substudy of that study.

Here we assess the possible relationship between the efficacy and safety of pegIFN�� plus ribavirin and polymorphisms in the genes that encode for several proteins involved in the metabolism of interferon �� and ribavirin and in the defence against viral infections. Methods Study design and patients This was a pharmacogenetic substudy of the PegIFN�� 2a vs. PegIFN�� 2b, both plus ribavirin, study (Clinical Trial Registry Number: ISRCTN81765620. Registration Number in AEMPS: 03-0198), which was a prospective, multicentred, randomised, open-label trial. Details of the study design and characteristics have been reported elsewhere [18]. From the 182 patients included in that trial, 123 had stored DNA available and constitute the basis of the current pharmacogenetic study.

Of these patients, 10 had discontinued the study (2 voluntary and 8 protocol violation) and 14 had not completed the scheduled 48-week treatment regimen because of discontinuation due to severe adverse effects. Hence, 99 patients completed the study protocol (or stopped it according to standart early virological stopping rules) and had DNA available. The pharmacogenetic substudy of efficacy was performed in these 99 individuals. For the pharmacogenetic substudy of safety we assessed these 99 patients plus the 14 who had discontinued treatment because of toxicity (n=113). Patients were evaluated before beginning treatment, 2 weeks after initiation and every 4 weeks thereafter until cessation of therapy. One last evaluation of the sustained viral response (SVR) was made 24 weeks after cessation of therapy.

A complete cell count and routine biochemical Anacetrapib tests including lactate were conducted at every medical visit, together with a medical interview in order to monitor possible secondary effects associated with treatment. Ethics Participants provided written informed consent before taking part in the study. The institutional ethics committees of the participating centres specifically approved this study.

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