Valganciclovir versus valacyclovir prophylaxis for prevention of cytomegalovirus: an economic perspective.

INTRODUCTION: Valganciclovir (vGCV) and valacyclovir (vACV) are used in cytomegalovirus (CMV) prophylaxis in renal transplant recipients. The aim of this study was to compare the economic impact of both regimens during 1-year follow-up. METHODS: A total of 117 renal transplant recipients at risk for CMV were randomized to 3-month prophylaxis either with vGCV (900 mg/day, n = 60) or vACV (8 g/day, n = 57) and their data used in a pharmacoeconomic analysis. The pharmacoeconomic evaluation involved all direct CMV-related expenses in the first year after transplantation. Sensitivity analysis was employed to examine the effects of various prices of antiviral drugs and diagnostic procedures on overall CMV-related costs. Simulation of the more expensive US healthcare perspective was performed, and a scenario involving costs of acute rejection (AR) was examined. RESULTS: Overall CMV-related costs were significantly lower in the vACV arm; median United States dollars (USD) 3473 (3108-3745) vs. USD 5810 (4409-6757; P < 0.001) per patient, respectively. Our data showed that the critical determinant of the major disparity between the prophylactic regimens was the prophylaxis price. Median cost of prophylaxis in the vACV group was USD 1729 (1527-2173) compared to USD 3968 (2683-4857) in the vGCV group (P < 0.001). In sensitivity analysis of the overall CMV-related costs, the least and the most expensive pharmacotherapy and diagnostic scenarios were used; nevertheless, the vACV arm remained markedly less expensive. Simulation considering the higher physician/nurse and hospitalization fees of the US healthcare system and the scenario including expenditure associated with AR episodes also favored vACV. CONCLUSION: VACV prophylaxis for CMV is associated with a significant 44% lower cost than vGCV at the first year after renal transplantation.

"High risk" HPV types are frequently detected in potentially malignant and malignant oral lesions, but not in normal oral mucosa.

Studies on the involvement of the human papillomavirus (HPV) in initiation and progression of oral neoplasia have generated conflicting results. The observed discrepancy is attributable mainly to the varying sensitivity of the applied methodologies and to epidemiologic factors of the examined patient groups. To evaluate the role of HPV in oral carcinogenesis, we analyzed 53 potentially neoplastic and neoplastic oral lesions consisting of 29 cases of hyperplasia, 5 cases of dysplasia, and 19 cases of squamous cell carcinomas, as well as 16 oral specimens derived from healthy individuals. A highly sensitive nested polymerase chain reaction (PCR) assay was used, along with type-specific PCR, restriction fragment length polymorphism analysis, dot blotting, and nonisotopic in situ hybridization. Nested PCR revealed the presence of HPV DNA in 48 of the 53 (91%) pathologic samples analyzed, whereas none (0%) of the normal specimens was found to be infected. Positivity for HPV was independent of histology and the smoking habits of the analyzed group of patients. At least one "high risk" type, such as HPV 16, 18, and 33, was detected by type-specific PCR in 47 (98%) infected specimens, whereas only 1 (2%) squamous cell carcinoma was solely infected by a "low risk" type (HPV 6). HPV 16 was the prevailing viral type, being present in 71% of infected cases. Single HPV 16 and HPV 18 infections were confirmed by restriction fragment length polymorphism. HPV 58 was detected by dot blotting in three hyperplastic lesions. HPV positivity and genotyping were further confirmed, and the physical status of this virus was evaluated by nonisotopic in situ hybridization. Diffuse and punctate signals, indicative of the episomal and integrative pattern of HPV infection, were observed for low- and high-risk types, respectively. Our findings are suggestive of an early involvement of high-risk HPV types in oral carcinogenesis.

A clinical study to assess the effect of heparin in dialyzer rinsing solutions.

The solution usually recommended for rinsing the blood side, which is an indispensable step in preparing a dialyzer for hemodialysis (HD), contains saline and heparin. The heparin used for rinsing is said to reduce the thrombogenic properties of the dialysis membrane and, hence, also the need for systemic heparinization during the whole procedure. The aim of our study was to establish whether this postulate also applies to polysulphone steam-sterilized dialyzers. To do so, 16 patients on long-term dialysis were randomized into two groups of eight. One group was subsequently treated with polysulphone low-flux dialyzers (F6HPS), the other with polysulphone high-flux dialyzers (F6OS). Both groups were examined, in a crossover manner during HD using a dialyzer previously rinsed with 1000 ml of saline plus 2,000 IU of heparin, and during HD using a dialyzer previously rinsed with 500 ml of saline without heparin. Except for the rinsing, HD conditions were completely identical. Blood obtained before HD, and at 15, 60 and 240 min of HD at the dialyzer inlet, was used to determine the activated partial thromboplastin time (to test heparinization control), the thrombin-antithrombin III complex (ELISA, to evaluate coagulation system activation), platelet factor 4 (ELISA, a substance with antiheparin activity), and platelet count. None of the above parameters showed, at any of the collecting intervals, a statistically significant difference between HD with and without heparin with a reduced volume of rinsing solution, or between HD using low- and high-flux dialyzers. It is concluded that heparin used to rinse polysulphone dialyzers before HD has no effect on blood coagulation or on the need for heparin during the procedure.

[The effect of acetate-free biofiltration on anemia and use of erythropoietin]. / Vliv bezacetátové biofiltrace na anémii a spotrebu erytropoetinu.

BACKGROUND: Chronic renal failure is associated with anaemia and a large percentage of patients is indicated for erythropoietin (rHuEPO) treatment. The degree of anaemia depends also on the quality of substitution of renal function. The objective of the present study was to assess whether transfer of patients from haemodialysis (HD) to acetate-free biofiltration (AFB) will influence the anaemia and rHuEPO consumption. METHODS AND RESULTS: Anaemia and rHuEPO consumption were investigated in 10 patients in a stabilized condition with regular dialyzation treatment. The patients suffered from corrected anaemia on a maintenance dose of rHuEPO. During AFB (follow-up period one year) the rHuEPO consumption declined as compared with the condition during HD, while the target haemoglobin level (95-110 g/l) was maintained. The easier control of anaemia during AFB was not due to a change of iron saturation, the aluminium level or a change of the residual blood volume in the dialyzer. During AFB metabolic acidosis was controlled more effectively, the elimination of urea and beta-2-microglobulin increased. CONCLUSIONS: During AFB, as compared with HD, the rHuEPO consumption declines sufficiently to correct anaemia. The authors conclude that one of the reasons may be the more effective control of metabolic acidosis and elimination of uraemic toxins with a low or medium molecular weight. The authors discuss also other factors which affect anaemia during treatment of renal failure by extracorporcal clearing methods.