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Treatment Week (treatment + week)
Selected AbstractsDeterminants of relapse after a short (12 weeks) course of antiviral therapy and re-treatment efficacy of a prolonged course in patients with chronic hepatitis C virus genotype 2 or 3 infection,HEPATOLOGY, Issue 2 2009Alessandra Mangia In hepatitis C virus (HCV) genotypes 2 and 3 patients, the high rate of relapse after 12 to 16 weeks of antiviral therapy is the main concern for shortening treatment duration. This study was undertaken to delineate predictors of relapse after short treatment in patients with undetectable HCV RNA at treatment week 4 (RVR), and to report in RVR patients with relapse the sustained virological response (SVR) after a second 24-week course of therapy. RVR patients received pegylated interferon (Peg-IFN) alfa-2b (1.5 ,g/kg) and ribavirin (1000-1200 mg/day) for 12 weeks; those who relapsed were re-treated with the same drug doses but for the extended standard duration of 24 weeks. Logistic regression analysis was applied to delineate predictors of relapse by using age, sex, route of transmission, body mass index (BMI), serum alanine aminotransferase (ALT), HCV genotypes, serum HCV RNA levels, and platelet counts as covariates. Of 718 patients with genotypes 2 and 3 who were started on therapy, 496 (69.1%) had undetectable HCV RNA at week 4. Of them, 409 patients (82.5%, CI 79.1-85.8) attained SVR, and 67 (14.1%, CI 10.4-16.5) relapsed. At regression analysis, only platelet count less than 140,000 mm3 [odds ratio, 2.51; confidence interval (CI), 1.49-4.20] and BMI 30 or higher (odds ratio, 1.7; CI, 1.03-2.70) were independently associated with relapse. Forty-three of 67 patients with relapse agreed to be re-treated, and an SVR was achieved in 30 (70.0%) of them. Conclusion: We recommend 12 weeks course of therapy for patients with undetectable HCV RNA at treatment week 4, providing they present with no advanced fibrosis and low BMI. (HEPATOLOGY 2008.) [source] Ribavirin dosage in patients with HCV genotypes 2 and 3 who completed short therapy with peg-interferon ,-2b and ribavirinALIMENTARY PHARMACOLOGY & THERAPEUTICS, Issue 12 2010A. MANGIA Aliment Pharmacol Ther,31, 1346,1353 Summary Background, The optimal dose of ribavirin to be used in combination with Peg-IFN in patients with HCV genotypes 2 and 3 undergoing short treatment has not been established. Aim, To explore the relationship between starting ribavirin doses, expressed as mg/kg body weight and both rapid viral response at treatment week 4 (RVR) and sustained virological response (SVR) in patients treated for 12,14 weeks with peg-interferon ,-2b and ribavirin. Methods, A post hoc analysis of data collected from two multicenter clinical trials was performed. Multiple regression analyses were employed to identify independent baseline and on-treatment predictors of RVR and SVR. For each dose of ribavirin, the empirical estimated probability of response was computed and the continuous exposure index was dichotomized by using a recursive partitioning and amalgamation method. Results, A nonlinear relationship was ascertained between ribavirin dose and RVR, but not SVR. A dose of 15.2 mg/kg was selected as the best splitting value for discriminating RVR vs. non-RVR. Regression analysis identified low baseline viraemia, genotype 2 and high ribavirin dose as independent prognostic factors for RVR. The likelihood of an SVR was not correlated with baseline ribavirin dose, but was independently predicted by adherence to the full dose throughout treatment and normal platelet counts. Conclusions, Starting high ribavirin doses appears capable of increasing the rate of RVR in patients with HCV genotypes 2 and 3 undergoing short treatment. Maintenance of the full planned dose throughout treatment is essential for achieving optimal SVR rates. [source] Sustained virological responses following standard anti-viral therapy in decompensated HCV-infected cirrhotic patientsALIMENTARY PHARMACOLOGY & THERAPEUTICS, Issue 2 2009A. IACOBELLIS Summary Background, Little data is available about predictors of sustained virological response (SVR) during anti-viral therapy of patients with decompensated HCV cirrhosis. Aims, To determine whether rapid and early virological responses (RVR and EVR) could predict SVR and help optimize treatment in these patients. Methods, A total of 94 cirrhotics underwent treatment with peg-interferon alfa-2b (1.5 ,g/kg weekly) and ribavirin (800/1200 mg daily) for 48 or 24 weeks for genotypes 1/4 or genotypes 2/3, respectively. Results, Overall, SVR was achieved in 33 patients (35.1%), 16% with genotype 1/4 and 56.8% with genotype 2/3 (P < 0.01). At treatment week 4, 34 patients had undetectable HCV-RNA, 10 with genotype 1/4 and 24 with genotype 2/3. Of RVR patients, 24 achieved SVR (70.5%), 6 and 18 with genotypes 1 and non-1. At the multivariate analysis, only EVR, genotypes 2 and 3, and adherence to full course and dosage of therapy retained their independent predictive power, with corresponding ORs of 25.5 (95% CI 3.0,217.3), 4.2 (95% CI 1.2,15.3) and 9.1 (95% CI 2.2,38.0), respectively. Conclusion, In decompensated cirrhotic patients, anti-viral therapy with current regimens is feasible and associated with an overall SVR rate of 35.1%. Treatment ought to be pursued among patients who attain an EVR, and maintain a full course and dosage of therapy. [source] Comparison of the efficacy of levocetirizine 5 mg and desloratadine 5 mg in chronic idiopathic urticaria patientsALLERGY, Issue 4 2009P. C. Potter Background:, Nonsedating H1 -antihistamines are recommended for the treatment of urticaria by the recent EAACI/GA2LEN/EDF guidelines. The aim of this study was to compare the efficacy, after 4 weeks of treatment, with levocetirizine 5 mg and desloratadine 5 mg, both once daily in the morning, in symptomatic chronic idiopathic urticaria (CIU) patients. Methods:, This multi-center, randomized, double-blind study involved 886 patients (438 on levocetirizine and 448 on desloratadine). The primary objective was to compare their efficacy on the mean pruritus severity score after 1 week of treatment. Mean pruritus severity score over 4 weeks and pruritus duration score, number and size of wheals, mean CIU composite score (sum of the scores for pruritus severity and numbers of wheals), quality of life, and the patient's and investigator's global satisfaction with treatment, were secondary efficacy measures. Results:, Levocetirizine led to a significantly greater decrease in pruritus severity than desloratadine over the first treatment week; mean pruritus severity scores of 1.02 and 1.18 for levocetirizine and desloratadine, respectively (P < 0.001). The result was similar for the entire 4-week treatment period (P = 0.004). In addition, levocetirizine decreased pruritus duration and the mean CIU composite scores to a significantly greater extent than desloratadine during the first week (P = 0.002 and 0.005, respectively) and over the entire study (P = 0.009 and P < 0.05, respectively). Similarly, levocetirizine increased the patients' global satisfaction after one and 4 weeks (P = 0.012 and 0.021, respectively), compared with desloratadine. Safety and tolerability were similar in both groups. Conclusions:, Levocetirizine 5 mg was significantly more efficacious than desloratadine 5 mg in the treatment of CIU symptoms. [source] Dose selection and population pharmacokinetics of PEG-Intron in patients with chronic myelogenous leukaemiaBRITISH JOURNAL OF CLINICAL PHARMACOLOGY, Issue 3 2007Samir Gupta Aims To assess the dose selection using population pharmacokinetics of Pegylated Intron-,2b (PEG-Intron) in patients with chronic myelogenous leukaemia (CML). Methods PEG-Intron 3,6 µg kg,1 was administered subcutaneously once a week and blood samples were collected up to 48 weeks of treatment. A total of 624 samples collected from 137 patients were included in the analysis. Nonlinear mixed-effects modelling was used to analyse the sparsely sampled concentration data from a clinical efficacy trial. Covariates in the analysis included weight, sex, age, race, serum creatinine and estimated creatinine clearance (CLcr). Results The apparent clearance of PEG-Intron decreased after repeated dosing. The clearance at treatment week 4 was 42.3 l day,1 (patients with CLcr 120 ml min,1) with interpatient variability 30%. At treatment week 48, the clearance value was reduced to 69% of its week 4 value. CLcr, a composite variable calculated from body weight, sex, age and serum creatinine, had a small but statistically significant influence on the clearance of PEG-Intron. The clearance of PEG-Intron in patients with CML was 40% higher than that of hepatitis C virus-infected patients. Conclusion The dose of PEG-Intron 6.0 µg kg,1 week,1 appeared appropriate in the treatment of patients with CML. [source] Domperidone versus cisapride in the treatment of infant regurgitation and increased acid gastro-oesophageal reflux: a pilot studyACTA PAEDIATRICA, Issue 4 2009Badriul Hegar Abstract Aim: Although domperidone is used frequently to treat infant regurgitation, efficacy data are scarce. Cisapride was previously used in the same indication. Methods: Domperidone and cisapride were compared in an investigator-blinded, prospective comparative trial by evaluating (a) the frequency of regurgitation, (b) acid reflux and (c) cardiac side effects in infants regurgitating >4 times/day since >2 weeks and with reflux-associated symptoms of discomfort, after conservative treatment failure. Results: Within the first treatment week, the frequency of regurgitation decreased in both groups, more rapidly in the cisapride group: the median regurgitation decreased from 6.22 to 3.50 in the cisapride group versus from 4.80 to 3.70 in the domperidone group. The decrease in regurgitation was still significant after 1 month: cisapride from 6.22 to 1.55 versus domperidone from 4.80 to 1.25. However, the natural decrease in the incidence of regurgitation induced by age should also be considered. The median reflux index decreased after 1 month in the cisapride group from 3.60 to 1.75 versus from 2.70 to 2.45 in the domperidone group. One child treated with cisapride developed a significant QT prolongation. Conclusion: The decrease in regurgitation was comparable in both groups, although acid reflux decreased more in the cisapride group. Cisapride induced QT prolongation in one infant. [source] Decision-making models in the analysis of portal films: A clinical pilot studyJOURNAL OF MEDICAL IMAGING AND RADIATION ONCOLOGY, Issue 1 2000Andrew See SUMMARY Portal films continue to play an important role in the verification of radiotherapy treatment. There is still some discussion, however, as to what action should be taken after a port film has shown a radiation field deviation from the prescribed volume. It was the aim of the present pilot study to investigate the performance of three decision-making models (,Amsterdam', ,Quebec' and ,Newcastle') and an expert panel basing their decision on intuition rather than formal rules after portal film acquisition in a clinical setting. Portal films were acquired on every day during the first week of treatment for five head and neck and five prostate cancer patients (diagnostic phase). If required, the field position was modified according to our normal practice following the recommendation of the expert panel. In order to analyse the results of the models, however, additional port films were taken in the following 3 treatment weeks with the patient moved as required by the different models (intervention phase). The portal films were taken over 4 consecutive days, positioning the patient according to each of the different models on one day each. None of the models diagnosed a field misplacement in the head and neck patients, while the ,Amsterdam' and ,Quebec' models predicted a move in one prostate patient. The ,Newcastle' model, which is based on Hotelling's T 2 statistic, proved to be more sensitive and diagnosed a systematic displacement for three prostate patients. The intervention phase confirmed the diagnosis of the model, even if the three portal films taken with the patient position adjusted as required by the model proved to be insufficient to demonstrate an improvement. The ,Newcastle' model does not rely on assumptions about the random movement of patients and requires five portal films before a decision can be reached. This approach lends itself well to incorporation into electronic portal imaging ,packages', where repeated image acquisitions present no logistical difficulty. [source] | ||||||||||