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Objective: Abacavir sulfate is a synthetic carbocyclic nucleoside analogue indicated for the treatment of HIV-1 infection in combination with other antiretroviral agents. The objective of the current study was to determine the bioequivalence between a generic formulation of abacavir and the innovator product. Material and methods: A total of 80 subjects were randomly assigned to receive a single 300 mg oral dose ofabacavir sulfate as the generic (Ranbaxy-Abacavir, Ranbaxy Laboratories Ltd., equivalent to 300 mg ofabacavir) and innovator (Ziagen, GlaxoSmithKline) tablet formulations in 2-way crossover studies performed under fasting (n = 40) and fed (n = 40) conditions. Multiple blood samples were collected over 14 hours and plasma concentrations of abacavir were assayed using an LC/MS/MS method with a limit of quantitation of 25.0 ng/ml. Pharmacokinetic (PK) parameters were calculated using noncompartmental methods. Results: Under fasting conditions, geometric mean area under the curve from time 0 to the last measurable concentration (AUC 0-t ), area under the curve extrapolated to infinity (AUC 0-x ) and maximum plasma concentrations (C max ) of abacavir for the generic (5,565 ng × h/ml, 5,668 ng × h/ml and 2,526 ng/ml, respectively) and innovator (5,675 ng × h/ml, 5,770 ng × h/ml and 2,528 ng/ml, respectively) products were very similar. Under fed conditions, mean values of AUC 0-t , AUC 0-∝ and C max for the generic (4,487 ng × h/ml, 4,571 ng × h/ml and 1,841 ng/ml, respectively) and innovator (4,574 ng × h/ml, 4,654 ng × h/ml and 1,781 ng/ml, respectively) formulations were also very similar. Ratios of LSM and 90% confidence intervals ofPK parameters between the 2 formulations were within 80.0 - 125.0% under fasting and fed conditions, suggesting that the 2 tablet formulations resulted in similar rate and extent of bioavailability. Adverse events for the generic and innovator products were similar in nature and frequency in the fasting and fed studies. Conclusions: Based on the above results, the generic tablet formulation of abacavir developed by Ranbaxy should be equally effective as the innovator product.

AIM Zidovudine is a synthetic nucleoside analogue of thymidine with activity against the human immunodeficiency virus type 1 (HIV-1). In patients with HIV infections or the acquired immunodeficiency syndrome (AIDS), zidovudine is a first-line therapy that was shown to reduce morbidity, mortality, and hospitalization. A generic formulation of zidovudine offers the possibility of considerable savings to HIV/AIDS patients in developed and Third World countries. The objective of the current study was to characterize the pharmacokinetic and safety profiles of zidovudine administered as a generic tablet formulation relative to the innovator product. VOLUNTEERS AND METHODS A total of 68 healthy adult volunteers received a 300 mg oral dose of zidovudine as the generic formulation (AVIRO-Z 300 mg tablet, Ranbaxy Laboratories Limited) and as the innovator product (Retrovir tablet, GlaxoSmithKline) in a randomized, 2-way crossover study. Multiple blood samples were collected over 12 hours and plasma concentrations of zidovudine were assayed using an LC/MS/MS method with an analytical range of 5.00 to 2,000 ng/ml. Pharmacokinetic parameters were calculated using non-compartmental methods. RESULTS Mean plasma concentrations of zidovudine declined in a mono-exponential manner, with mean concentration values falling below the limit of quantitation 12 hours after administration of both formulations. Mean area under the curve from time 0 to the last measurable concentration (AUC(0-t)), mean area under the curve from time 0 to infinity (AUC(0-infinity)) and peak plasma concentrations (C(max)) of zidovudine for the generic tablet formulation (2,220.6 ng x h/ml, 2,236.0 ng x h/ml and 1,087.9 ng/ml, respectively) were very similar to those observed for the innovator product (2,139.7 ng x h/ml, 2,158.6 ng x h/ml and 1,066.5 ng/ml, respectively). Ratios of least-squares means and 90% confidence intervals of AUC(0-t) AUC(0-infinity) and C(max) between the 2 formulations were within 80-125%, suggesting that the two tablet formulations displayed similar rate and extent of bioavailability. The oral clearance (CL/F) of zidovudine for the generic and innovator formulations were 2.11 1/h/kg and 2.16 1/h/kg, respectively. For the two formulations, adverse events were similar in nature and frequency. CONCLUSION Since the two formulations displayed similar in vivo delivery rate of zidovudine in the bloodstream, the generic tablet formulation of zidovudine developed by Ranbaxy should be equally effective as the innovator product and is expected to produce considerable cost-savings in AIDS patients worldwide.

Background: To assess inter-reader agreement for US BI-RADS descriptors using S-Detect: a computer-guided decision-making software assisting in US morphologic analysis. Methods: 73 solid focal breast lesions (FBLs) (mean size: 15.9mm) in 73 consecutive women (mean age: 51years) detected at US were randomly and independently assessed according to the BI-RADS US lexicon, without and with S-Detect, by five independent reviewers. US-guided core-biopsy and 24-month follow-up were considered as standard of reference. Kappa statistics were calculated to assess inter-operator agreement, between the baseline and after S-Detect evaluation. Agreement was graded as poor (≤ 0.20), moderate (0.21–0.40), fair (0.41–0.60), good (0.61–0.80), or very good (0.81–1.00). Results: 33/73 (45.2%) FBLs were malignant and 40/73 (54.8%) FBLs were benign. A statistically significant improvement of inter-reader agreement from fair to good with the use of S-Detect was observed for shape (from 0.421 to 0.612) and orientation (from 0.417 to 0.7) (p < 0.0001) and from moderate to fair for margin (from 0.204 to 0.482) and posterior features (from 0.286 to 0.522) (p < 0.0001). At baseline analysis isoechoic (0.0485) and heterogeneous (0.1978) echo pattern, microlobulated (0.1161) angular (0.1204) and spiculated (0.1692) margins and combined pattern (0.1549) for posterior features showed the worst agreement rate (poor). After S-Detect evaluation, all variables but isoechoic pattern showed an agreement class upgrade with a statistically significant improvement of inter-reader agreement (p < 0.0001). Conclusions: S-Detect significantly improved inter-reader agreement in the assessment of FBLs according to the BI-RADS US lexicon but evaluation of margin and echo pattern needs to be further improved, particularly isoechoic pattern.

High-resolution ultrasonography (US) is a valuable tool in breast imaging. Nevertheless, US is an operator-dependent technique: to overcome this issue, the American College of Radiology (ACR) has developed the breast imaging-reporting and data system (BI-RADS) US lexicon. Despite this effort, the variability in the assessment of focal breast lesions (FBLs) with the use of BI-RADS US lexicon is still an issue. Within this framework, evidence shows that computer-aided image analysis may be effective in improving the radiologist’s assessment of FBLs. In particular, S-Detect is a newly developed image-analytic computer program that provides assistance in morphologic analysis of FBLs seen on US according to the BI-RADS US lexicon. This pictorial essay describes state-of-the-art of sonographic characterization of FBLs by using S-Detect.

Splenosis is a benign acquired condition characterized by the presence of heterotopic viable splenic tissue in other organs or within cavities such as peritoneum, retroperitoneum, or thorax after splenic trauma or surgery. Abdominal splenosis is often an incidental finding and computed tomography and magnetic resonance usually allow a confident diagnosis. The typical enhancement that parallels the spleen is a useful hallmark of splenosis. Splenic implants lack contrast uptake in the hepatobiliary phase and show high signal at high b-values on diffusion-weighted images. In some cases splenosis may mimic malignant and benign conditions in the peritoneum as well as in hollow and parenchymal abdominal organs and further investigations – including scintigraphy with Tc99m-labelled heat-denatured red blood cells or biopsy – are sometimes required in challenging cases. This pictorial essay reviews the imaging presentation and potential differential diagnosis of splenosis according to the site of implantation. A prompt and accurate radiological diagnosis of splenosis can avoid unnecessary biopsy or surgery.

Purpose: To evaluate whether a structured radiology report improves the completeness of preoperative CT staging of pancreatic ductal adenocarcinoma (PDA) compared to conventional free-text reports. Methods: We retrospectively included 27 patients (mean age, 64 ± 11.1years) referred for pancreatic preoperative CT scan for staging of PDA between 2015 and 2018 and in whom a diagnosis of pancreatic adenocarcinoma was ultimately confirmed. Four readers independently reported CT scans with both conventional free-text and structured reports. Differences in reported morphologic and vascular features with the two reports were assessed through McNemar Test. Intra-reader and inter-reader were calculated. Results: A total of 216 reports were completed by four different readers including 108 free-text and 108 structured reports. Overall, 139 of 540 morphologic characteristics of PDA and 869 of 1188 vascular key features were only described in structured reports. Encasement of left gastric artery, gastroduodenal artery and splenic artery was described in up to 14.8% using free-text reports and in up to 29.6% using structured report, resulting in low-intra-reader agreement (k = 0.033–0.216). Inter-reader agreement improved with structured report compared to free-text one for left gastric artery (ICC = 0.844 vs. ICC = 0.493, respectively), gastroduodenal artery (ICC = 0.730 vs. ICC = 0.449, respectively), portal vein (ICC = 0.847 vs. ICC = 0.638, respectively), portal confluence (ICC = 0.848 vs. ICC = 0.422, respectively) superior mesenteric vein (ICC = 0.765 vs. ICC = 0.695, respectively), and splenic vein (ICC = 0.921 vs. ICC = 0.841, respectively). Conclusion: Structured reports for PDA staging significantly reduces the number of missing morphological and vascular features of PDA and improves the inter-reader agreement compared to free-text reports.

Epiploic appendagitis is the acute inflammation and infarction of epiploic appendages, commonly secondary to torsion. It is a great mimicker as its clinical manifestation may be similar to appendicitis, diverticulitis, or colitis. Focal abdominal pain, tenderness, and mild pyrexia are clinical features of the condition [1]. Epiploic appendages are pedunculated adipose structures which extend from the serosal surface of the colon, along the free taenia and taenia omentalis. They are abundant in the caecum and sigmoid colon and absent in the rectum

Background Adalimumab is effective in the treatment of Crohn's disease. We have already reported data on the efficacy of adalimumab in 110 steroid-dependent patients. At the end of the study 90 patients (64.5%) maintained clinical remission. Aims To assess efficacy and safety of adalimumab after 6 years in patients of the original cohort who responded to treatment. Methods The present study is an extension of the published paper on 90/110 patients. We report results on clinical remission and safety of 6 year maintenance therapy with adalimumab. Results Of the original cohort 90 patients completed the study, 17 were lost to follow-up and 3 died. At the end of follow-up (74.16 ± 10.3 months) 37/90 patients (41%) maintained clinical remission. Of these, 32 (86%) continued adalimumab and 5 (13%) discontinued treatment due to clinical remission and mucosal healing. Of the remaining 53/90 patients, 47 (52%) discontinued adalimumab due to clinical failure and 6 (7%) to adverse events. We obtained endoscopy data in 31/32 patients in clinical remission continuing adalimumab: 11 (36%) did not improve, 6 (19%) worsened, 14 (45%) improved. At univariable analysis no variables were related to treatment outcome. Conclusions This “real life” prospective study shows that adalimumab is a long-term effective and safe maintenance treatment in steroid-dependent Crohn's disease patients.