AIM:To evaluate the efficacy of L-carnitine on alleviating anemia,thrombocytopenia and leukopenia,and minimizing dose reductions in patients with chronic hepatitis C virus(HCV)in treatment with Interferonα(IFN-α...AIM:To evaluate the efficacy of L-carnitine on alleviating anemia,thrombocytopenia and leukopenia,and minimizing dose reductions in patients with chronic hepatitis C virus(HCV)in treatment with Interferonα(IFN-α)plus ribavirin.METHODS:Sixty-nine patients with chronic hepatitis C were enrolled in the study and divided into two groups.group A(n=35)received Peg-IFN-α2b plus ribavirin plus L-carnitine,and group B(n=34)received Peg-IFN-αand ribavirin for 12 mo.All patients underwent laboratory investigations including:red cell count,he-moglobin,white cell count,platelets,bilirubin,alanineaminotransferase(ALT),aspartate aminotransferase(AST),and viremia.RESULTS:After 12 mo in group A compared to group B we observed significant differences in AST 108.8 vs 76.8(IU/L;P0.001),ALT 137.vs 112.3(IU/L;P 0.001),viremia 4.04 vs 2.36(106 copies/mL;P 0.001),Hb 1 vs 3.5(g/dL;P0.05),red blood cells 0.3 vs 1.1(1012/L;P0.001),white blood cells 1.5 vs 3(10/L;P0.001)and platelets 86 vs 85(×10/L;P0.001).The end treatment responders were 18 vs 12(60%vs 44%)and the non responders were 12 vs 15(40%vs 50%)[odds ratio(OR)1.65,5%CI =0.65-5.37,P0.05.In group A compared to group B there was a significant improvement of sustained vi-rological response in 15 vs 7 patients(50%vs25%),while the relapsers were 3 vs 5(10%vs 18%)(OR 3.57,5%CI=0.65-1.3,P0.001).CONCLUSION:L-carnitine supplementations modulate erythropoiesis,leucopoiesis and thrombocytopoiesis,and may be useful in patients treated for HCV.L-carni-tine treatment offers the possibility of achieving a sus-tained virological response while preventing overtreat-ment.展开更多
AIM: To investigate the safety/efficacy of Boceprevirbased triple therapy in hepatitis C virus(HCV)-G1 menopausal women who were historic relapsers, partial-responders and null-responders. METHODS: In this single-assi...AIM: To investigate the safety/efficacy of Boceprevirbased triple therapy in hepatitis C virus(HCV)-G1 menopausal women who were historic relapsers, partial-responders and null-responders. METHODS: In this single-assignment, unblinded study, we treated fifty-six menopausal women with HCV-G1, 46% F3-F4, and previous PEG-α/RBV failure(7% null, 41% non-responder, and 52% relapser) with 4 wk lead-in with PEG-IFNα2b/RBV followed by PEGIFNα2b/RBV+Boceprevir for 32 wk, with an additional 12 wk of PEG-IFN-α-2b/RBV if patients were HCV-RNApositive by week 8. In previous null-responders, 44 wk of triple therapy was used. The primary objective of retreatment was to verify whether a sustained virological response(SVR)(HCV RNA undetectable at 24 wk of follow-up) rate of at least 20% could be obtained. The secondary objective was the evaluation of the percent of patients with negative HCV RNA at week 4(RVR), 8(RVR BOC), 12(EVR), or at the end-of-treatment(ETR) that reached SVR. To assess the relationship between SVR and clinical and biochemical parameters, multiple logistic regression analysis was used.RESULTS: After lead-in, only two patients had RVR; HCV-RNA was unchanged in all but 62% who had ≤1 log10 decrease. After Boceprevir, HCV RNA became undetectable at week 8 in 32/56(57.1%) and at week 12 in 41/56(73.2%). Of these, 53.8% and 52.0%, respectively, achieved SVR. Overall, SVR was obtained in 25/56(44.6%). SVR was achieved in 55% previous relapsers vs. 41% non-responders(P = 0.250), in 44% F0-F2 vs 54% F3-F4(P = 0.488), and in 11/19(57.9%) of patients with cirrhosis. At univariate analysis for baseline predictors of SVR, only previous response to antiviral therapy(OR = 2.662, 95%CI: 0.957-6.881, P = 0.043), was related with SVR. When considering "on treatment" factors, 1 log10 HCV RNA decline at week 4(3.733, 95%CI: 1.676-12.658, P = 0.034) and achievement of RVR BOC(7.347, 95%CI: 2.156-25.035, P = 0.001) were significantly related with the SVR, although RVR BOC only(6.794, 95%CI: 1.596-21.644, P = 0.010) maintained significance at multivariate logistic regression analysis. Anemia and neutropenia were managed with Erythropoietin and Filgrastim supplementation, respectively. Only six patients discontinued therapy. CONCLUSION: Boceprevir obtained high SVR response independent of previous response, RVR or baseline fibrosis or cirrhosis. RVR BOC was the only independent predictor of SVR.展开更多
基金Supported by Ministero dell’Università e Ricerca Scientifica e Tecnologica
文摘AIM:To evaluate the efficacy of L-carnitine on alleviating anemia,thrombocytopenia and leukopenia,and minimizing dose reductions in patients with chronic hepatitis C virus(HCV)in treatment with Interferonα(IFN-α)plus ribavirin.METHODS:Sixty-nine patients with chronic hepatitis C were enrolled in the study and divided into two groups.group A(n=35)received Peg-IFN-α2b plus ribavirin plus L-carnitine,and group B(n=34)received Peg-IFN-αand ribavirin for 12 mo.All patients underwent laboratory investigations including:red cell count,he-moglobin,white cell count,platelets,bilirubin,alanineaminotransferase(ALT),aspartate aminotransferase(AST),and viremia.RESULTS:After 12 mo in group A compared to group B we observed significant differences in AST 108.8 vs 76.8(IU/L;P0.001),ALT 137.vs 112.3(IU/L;P 0.001),viremia 4.04 vs 2.36(106 copies/mL;P 0.001),Hb 1 vs 3.5(g/dL;P0.05),red blood cells 0.3 vs 1.1(1012/L;P0.001),white blood cells 1.5 vs 3(10/L;P0.001)and platelets 86 vs 85(×10/L;P0.001).The end treatment responders were 18 vs 12(60%vs 44%)and the non responders were 12 vs 15(40%vs 50%)[odds ratio(OR)1.65,5%CI =0.65-5.37,P0.05.In group A compared to group B there was a significant improvement of sustained vi-rological response in 15 vs 7 patients(50%vs25%),while the relapsers were 3 vs 5(10%vs 18%)(OR 3.57,5%CI=0.65-1.3,P0.001).CONCLUSION:L-carnitine supplementations modulate erythropoiesis,leucopoiesis and thrombocytopoiesis,and may be useful in patients treated for HCV.L-carni-tine treatment offers the possibility of achieving a sus-tained virological response while preventing overtreat-ment.
文摘AIM: To investigate the safety/efficacy of Boceprevirbased triple therapy in hepatitis C virus(HCV)-G1 menopausal women who were historic relapsers, partial-responders and null-responders. METHODS: In this single-assignment, unblinded study, we treated fifty-six menopausal women with HCV-G1, 46% F3-F4, and previous PEG-α/RBV failure(7% null, 41% non-responder, and 52% relapser) with 4 wk lead-in with PEG-IFNα2b/RBV followed by PEGIFNα2b/RBV+Boceprevir for 32 wk, with an additional 12 wk of PEG-IFN-α-2b/RBV if patients were HCV-RNApositive by week 8. In previous null-responders, 44 wk of triple therapy was used. The primary objective of retreatment was to verify whether a sustained virological response(SVR)(HCV RNA undetectable at 24 wk of follow-up) rate of at least 20% could be obtained. The secondary objective was the evaluation of the percent of patients with negative HCV RNA at week 4(RVR), 8(RVR BOC), 12(EVR), or at the end-of-treatment(ETR) that reached SVR. To assess the relationship between SVR and clinical and biochemical parameters, multiple logistic regression analysis was used.RESULTS: After lead-in, only two patients had RVR; HCV-RNA was unchanged in all but 62% who had ≤1 log10 decrease. After Boceprevir, HCV RNA became undetectable at week 8 in 32/56(57.1%) and at week 12 in 41/56(73.2%). Of these, 53.8% and 52.0%, respectively, achieved SVR. Overall, SVR was obtained in 25/56(44.6%). SVR was achieved in 55% previous relapsers vs. 41% non-responders(P = 0.250), in 44% F0-F2 vs 54% F3-F4(P = 0.488), and in 11/19(57.9%) of patients with cirrhosis. At univariate analysis for baseline predictors of SVR, only previous response to antiviral therapy(OR = 2.662, 95%CI: 0.957-6.881, P = 0.043), was related with SVR. When considering "on treatment" factors, 1 log10 HCV RNA decline at week 4(3.733, 95%CI: 1.676-12.658, P = 0.034) and achievement of RVR BOC(7.347, 95%CI: 2.156-25.035, P = 0.001) were significantly related with the SVR, although RVR BOC only(6.794, 95%CI: 1.596-21.644, P = 0.010) maintained significance at multivariate logistic regression analysis. Anemia and neutropenia were managed with Erythropoietin and Filgrastim supplementation, respectively. Only six patients discontinued therapy. CONCLUSION: Boceprevir obtained high SVR response independent of previous response, RVR or baseline fibrosis or cirrhosis. RVR BOC was the only independent predictor of SVR.