Due to the longer treatment duration of the triple combination, t

Due to the longer treatment duration of the triple combination, there are no sufficient data yet for patients reaching the end of treatment for BOC. In the cohort creatinine results were recorded at baseline, week 12, week 24, and every 12 weeks thereafter until 24 weeks after end of treatment. No documentation of urine analysis was recorded. The eGFR was calculated with the recently presented Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula, which may be best suited to reflect changes of eGFR in patients with normal or mildly impaired renal function.[6] For statistical analysis in a first step, univariate buy Deforolimus regression analysis

was used. All variables reaching P < 0.05 in the univariate analysis were entered in a multiple logistic regression analysis. Software used was IBM SPSS Statistics v. 21.0.0.0. Overall, 895 patients were buy KPT-330 included, 575 on TLV, 211 on BOC, and 109 on dual therapy. Baseline demographics are shown in Table 1. As expected, HCV genotype 1 patients treated with dual

therapy were younger, had more frequently low level HCV-RNA, and had a lower proportion of patients with diabetes mellitus or arterial hypertension, reflecting a selection for variables associated with better treatment outcome or being naïve to HCV therapy. At week 12 a decrease of eGFR to <60 mL/min in patients with >60 mL/min at baseline was observed in 49/895 (5.5%) patients overall. Patients on TLV 38/575 (6.6%) and BOC 10/211 (4.7%) experienced more frequently a decrease in eGFR to <60 mL/min compared to patients on PEG/RBV 1/109 (0.9%) (P < 0.05). Risk factors associated with eGFR <60 mL/min corresponding to renal insufficiency stage 3 were age (P < 0.001), arterial hypertension (P < 0.001), diabetes mellitus (P < 0.05), a higher

serum creatinine at baseline (P < 0.001), 上海皓元 and being on triple therapy with TLV or BOC (P < 0.05). There was no association with baseline hemoglobin, smoking, uric acid, alanine aminotransferase (ALT), aspartate aminotransferase (AST), HCV-RNA, HCV treatment history, sex, APRI score, or comedications including nonsteroidal antiinflammatory drugs. In the multiple regression analysis age (P < 0.001), a higher creatinine at baseline (P < 0.001), being on triple therapy with TLV or BOC (P < 0.01), and arterial hypertension (P < 0.05) remained significantly associated with a decrease in eGFR to <60 mL/min. Patients with a drop of eGFR to <60 mL/min had a lower absolute mean hemoglobin at week 12 with 9.7 g/dL ± 1.4 g/dL compared to 11.0 g/dL ± 1.7 g/dL in patients with an eGFR >60 mL/min (P < 0.001). The absolute decrease in hemoglobin was also different, with 5.3 g/dL ± 1.3 g/dL compared to 3.8 g/dL ± 1.6 g/dL, respectively (P < 0.001). In the second analysis a smaller patient subset which had already reached week 24 of therapy was assessed.

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