Purpose of studyIrregular FUP/ADH were associated with virologic failure [1] leading to an increase in mortality [2]. SEAD was a multidimensional intervention project, designed from the patient's perspective, to specifically attend patients with poor FUP/ ADH in an HIV/AIDS outpatient clinic.MethodsFrom Jan 2006 to May 2010, patients with poor FUP/ADH were offered SEAD inclusion, all were evaluated by a nurse or a psychologist (adherence collaborators) who assessed all the reasons and barriers precluding a correct FUP/ADH. For each identified problem, different interventions were planned, using our own resources or coordinating others. Follow-up was censored in Nov 2011. Univariate and multivariable models were performed to evaluate the influence of SEAD intervention in virological suppression (HIV-ARN <1.7 log copies/mL) at the end of follow-up.Summary of resultsOverall, 242 patients were assessed: mean age 46 years, 78% men, 69% IDU, 51% AIDS, baseline ADH >90% 29.3%; median CD4 cell count 333 [164–536] cells/mL and HIV-RNA <1.57 45%. Patients were admitted in SEAD due to poor ADH 15%, FUP problems 21%, both FUP/ADH 53% and to prevent poor ADH or FUP 11%. Main reasons driving poor FUP/ADH were severe biopsychosocial problems 26%, severe drug and/or alcohol abuse 23%, logistic problems 21.3%, other psychiatric disorders 14%, oversights 10%, unknown 3% and antiretroviral intolerance 2%. Cocaine/heroin and alcohol abuse was reported by 33% and 16%. Only 57% of patients received >50% of planned interventions. After a median follow-up of 3.9 (3.27–4.43) years 218 patients received 8 (3–12) interventions/year, 95% evaluation interview and 30% psychological counselling (3 sessions/year [2–5]). Virological suppression was achieved by 67% of patients. In logistic regression analysis an intervention higher than 50% of planned HR 0.220 [IC 95% (0.112–0.44)] and receiving psychological counselling HR 0.44 [IC 95% (0.20–0.97)] were independent predictors of virological suppression whereas alcohol 3.11 (95% CI 1.24–7.80) and severe biopsychosocial problems HR 2.39 (95% CI 1.134–5.040) were associated with worse virological response, after adjusting for age, alcohol or cocaine abuse, degree of adherence, baseline virological suppression, median follow–up, intravenous acquisition of HIV, and family support.ConclusionsGeneral and psychological SEAD intervention resulted in higher virological suppression in patients with severe follow-up and adherence barriers.
Purpose of the study: To evaluate the economic impact of a swiching strategy to DRV/r mx in clinical practice using Spanish prices. Methods: Multicenter retrospective study of four tertiary hospitals in Spain. The analysis includes 147 patients switching to DRV/r mx mainly due to toxicity or simplification from March 2009 to June 2011. The Spanish costs (ex-factory price+VAT) per patient with HIV RNA<50 copies/ml were calculated, accounting for additional/ switch antiretroviral taken after initial treatment failure and management of adverse events. Cost of adverse events were based on a Spanish publication [1] (updated by the inflation rate until april 2012) The horizon of the analysis was of 48 weeks. Summary of results: Baseline characteristics were: women (30.6%), median age (49 yr), IDU (45%), AIDS stage (32%), HCV coinfected (48%, 40% with advanced fibrosis), length of HIV-RNA<1.7 before DRV/rtv mtx 67.6. Most frequent reasons for switching to DRVr mx were toxicity (62.6%) and simplification (23.8%). If a hospital with 600 patients in ART treatment, switched from 10% to 20% of its patients to DRV/r mx, there is a potential to save up to 448,000€/year. Conclusions: Switching to DRV/r mx is a cost-effective strategy that allows more patients to be treated for a fixed budget. Higher cost saving is expected when toxicity is the reason for switching. 48 Weeks Cost-Efficacy analysis: Simplification strategy to DRV/r monotherapy Hospital Budget Impact Analysis: assuming that 10%–20% of 600 patients in ARV treatment simplifies to DRV/r monotherap
Aim and objectives To investigate the dose accuracy and dose precision attained after manipulation of a commercially available prednisolone tablet, and to compare the results with those previously found for aspirin, a drug substance where solubility may similarly be challenging. Material and methods Prednisolone tablets: Prednisolon Alternova 5 mg, Alternova A/S. Instrument: UHPLC-system from Shimadzu Corp (Nexera, with prominence DAD detector). Analytical column: ACE Excel 2 mm C18-AR, 2.1 × 100 mm (Advanced Chromatography Technologies Ltd). The analytical method was validated for linearity, precision and specificity. Dosing accuracy study: six tablets were dissolved in 10 mL water. After 4 min of intermittent stirring, samples of 1 mL, a 10th of the tablet, were withdrawn. Dosing accuracy was recorded and compared with previous findings for aspirin. Results After manipulation of Prednisolon Alternova 5 mg tablets, 92.2% (85.3-95.1%) of the intended dose was retrieved. Conclusion and relevance After manipulation by dispersion and dose extraction, the prednisolone tablets were found to give doses within the limits of tablet fractions according to the European Pharmacopeia (85-115%). In contrast, conventional tablets containing aspirin (Aspirin 'Bayer' 500 mg), a slightly soluble drug substance, has previously been shown to have never exceeded 55% of the intended dose when a 10th of the tablet was extracted. 2 This shows that knowledge about solubility is not always sufficient for estimating the suitability for manipulation of tablets.
BackgroundThe emergence of new direct acting antiviral drugs (DAAs) for hepatitis C virus (HCV) has been a major advance in the treatment of disease. It is interesting to see the results of the first patients treated in our setting. Purpose To evaluate the effectiveness of treatment with the new DAAs in monoinfected patients with HCV and coinfected with HCV and HIV.Material and methodsRetrospective observational study at a university hospital in Spain. All cirrhotic patients who started treatment with DAAs against HCV from September 2014 until February 2015 were included. An investigator registered if the patient was coinfected with HIV and if the patient was liver transplanted. A blood test was done 12 weeks after the beginning of treatment. Sustained virologic response was defined as aviraemia 12 weeks after completion of antiviral treatment (SVR12). SVR12 was the measure of effectiveness. Outcomes for effectiveness were expressed using the percentage of patients with SVR12 divided by the total number of treated patients times 100. Monoinfected and coinfected patient effectiveness was compared by calculating relative risk (RR) ratios with 95% CI.Results42 patients were treated for 12 weeks. At week 12, 83.3% of patients (n = 35) were negative for the virus but 7 had positive HCV blood tests. Of the 35 patients with negative blood tests, all were still negative 12 weeks after treatment had finished. Therefore, SVR12 was 83.3% (35 out of 42). Of these 42 patients 57.1% (n = 24) had received prior liver transplantation and 66.6% (n = 28) were coinfected with HIV. Of the 7 patients with treatment failure, 57.1% (n = 4) were liver transplanted and 71% (n = 5) were coinfected with HIV. No statistically significant differences in effectiveness were observed between monoinfected and coinfected patients (RR=1.25 (95% CI 0.28 to 5.65)).ConclusionTreatment with new DDAs was effective in cirrhotic patients, with SVR12 rates of approximately 83%. No differences in effectiveness were observed between coinfected and monoinfected patients.No conflict of interest.
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