A warning advising a higher risk of hepatotoxicity in antiretroviral-naive patients starting a nevirapine-containing combination antiretroviral therapy (NcART) has been issued by health authorities. It is unclear whether this higher risk also applies to stable virologically suppressed patients starting NcART. MethodsWe performed a meta-analysis of published randomized studies including virologically suppressed patients who switched to NcART with a follow-up ! 3 months. CD4 cell cell counts were classified as high (HCD4) (400 cells/mL for males and 250 cells/mL for females) or low (LCD4). The main endpoint was hepatotoxicity within the first 3 months. ResultsFour studies with a pooled total of 410 patients were included. The risk of hepatotoxicity within the first 3 months was 2% and 4% in the LCD4 and HCD4 groups, respectively, with a combined odds ratio of 1.46 [95% confidence interval (CI) 0.43-4.98; P 5 0.54]. The risk of hepatotoxicity at any point during the study was similar in both groups, with a combined hazard ratio of 0.8 (95% CI 0.3-2.5; P 5 0.80). ConclusionsIn our study, virologically suppressed patients switching to nevirapine did not have a significantly higher risk of hepatotoxicity or rash when stratified by gender and CD4 cell count, although small differences may have gone undetected because of the sample size limitation.

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Efficacy was measured by the N-terminal pro B-type natriuretic peptide (NT-proBNP), body weight and plasma sodium descent. Security was measured by changes in glomerular filtering (GF). Results 46 FPP were prepared for 31 patients (19 males, 12 females; medium age 69 (30-90) years). 7/31 received two, 1/ 31 three and 3/31 four cycles of FPP. Medium length of treatment was 10 (5-28) days. 30/31 received 120 mg/day furosemide (final concentration 10 mg/mL) per pump and 1/31 80 mg/day furosemide with serum saline (6.6 mg/mL) per pump. Pumps were prescribed for descompensated CHF (31/31), 2 of them after heart transplantation and 1 due to transthyretin amyloidosis.Mean weight loss was 2.6±2.9 kg. NT-proBNP was reduced in 12/31 patients, and unknown in 6/31 patients. Mean NT-proBNP reduction was 280.81 pg/mL. Plasma sodium decreased in 12 patients and the average reduction was 0.85±6 mEq/L.There was worsening GF in 18/31 patients (medium change in GF was -6.50 mL/min). No patient experienced local infection, rash irritation or flow problems with administration. Conclusion and relevance FPP allowed patients to improve some CHF measures outside the hospital. Our study supports the use of FPP, being safe and effective.Pharmacists have a key role by checking the dose, ensuring physical-chemical stability and sterile conditions in preparation, and instructing patients in the use of FPP.

Background Tenofovir alafenamide (TAF) in clinical trials demonstrated less impact than tenofovir disoproxil (TDF) in affecting renal and bone parameters, whereas TDF protects from hypercholesterolaemia and hypertriglyceridaemia. Purpose To analyse in clinical practice of human immunodeficiency virus-infected (HIV-infected), how renal function and fasting lipid parameters are modified when switching TDF to TAF. As a second aim, to evaluate effectiveness and the immunological system. Material and methods Retrospective observational study (July 2016 to August 2018) conducted in HIV-infected patients treated for !6 months with a TDF regimen who switched to a TAF regimen kept >48 weeks. We considered virological success if HIV-1 RNA <35 copies/mL. Demographic variables were registered. Follow-up variables: serum-creatinine, phosphataemia, glomerular filtration rate (GFR calculated by CKD-EPI), total cholesterol (TC), hightdensity-lipoprotein (HDL), low-density-lipoprotein (LDL), triglycerides, CD4 +cell counts and HIV RNA-concentration.Two-sided t-student test was used for comparing pre-post variables except for GFR with two-sided Wilcoxon signed-rank test. We used Pearson correlation coefficient (r) evaluating the relation with TC and HDL-LDL.Variables were extracted from: electronic clinical records (SAP) and the pharmacy-dispensation program (Silicon). The statistical data were analysed with SPSS. Results Forty-eight patients were included, mean age 44 years (range 21-70), 79.2% males. Most received antiretroviral treatment (ART) with emtricitabine/elvitegravir/cobicistat (44/48).There were significant differences from baseline to 48 weeks with serum-creatinine, TC, HDL and CD4+. Serumcreatinine decreased 0.08 mg/dL with TAF (0.98±0.18 mg/dL with TDF, p=0.0001); TC, HDL and CD4 were greater with TAF; difference 19.8 mg/dL (173.4 mg/dL with TDF, p=0.0001), 8.7 mg/dL (47.6 mg/dL with TDF, p=0.0001) and 76 cells/mL (694.2 cells/mL with TDF, p=0.02) respectively. There were no significant differences with phosphataemia, LDL and TG, but all increased with TAF (difference 0.06, 8.03 and 10.77 mg/dL, concentration with TDF 3.31, 106 and 115.4 mg/dL respectively; p>0.05). There were no statistical differences with GFR (p>0.05).Cholesterol correlated with LDL (p=0.0001; r=0.94), but not with HDL (p>0.05; r=0.03).All patients achieved virological success, even three patients with RNA-concentration >35 copies/mL before switching. Conclusion After 48 weeks of patients, in clinical practice, who changed to TAF on their ART, 100% of patients archived virological suppression, with reduction in serum-creatinine and improvement in the immunological system. Nevertheless, hypercholesterolaemia was observed based mainly on LDL elevation.

structure and mechanism of action, may play a unique role in patients who have limited or no alternative treatment options. Aim and objectives The aim of this study was to describe the first cases of prescriptions of cefiderocol used in the 5 months following its availability in Italy, and the hospital pharmacist interventions in assisting clinicians from microbiology select a safe and appropriate antibiotic treatment. Material and methods A standardised prescription form was sent to the infectious disease specialist to collect patients' characteristics, infection type, reasons for cefiderocol use, doses and duration of treatment (concomitant treatments, adverse events and outcome). A susceptibility testing kit (30 mg cefiderocol disc) was provided to the microbiology specialist in order to reserve this new antibiotic for patients with cefiderocol-susceptible isolates. A retrospective study was performed to collect the data of adult patients who received cefiderocol. Results A total of 30 patients with mean age of 56 (23-90) years received cefiderocol (9 females, 21 males). Of these, 19 patients were treated in intensive care units, with the most common regimen of 2 g three times/day tid (n=6), while 3 patients with acute renal failure required a regimen of 750 mg twice daily. The main sites of infection were respiratory tract (n=16), urinary tract (n=3), intra-abdominal (n=4) and bloodstream (n=5). 5 patients had multisite infections.The duration of therapy was in the range 6-16 days. The most common pathogens were Acinetobacter baumannii (n=13), Klebsiella pneumoniae (n= 8), Pseudomonas aeuroginosa (n=10) and Enterobacter spp (n=5). 10 patients had superinfections. The most concomitant therapy was colistin (n=9). No severe adverse events were reported. 7 patients with septic shock died. Conclusion and relevanceOur study describes real-life experience of the use of cefiderocol as a salvage option in critical patients, providing additional data on its benefit, safety and limits in both empirical and targeted treatment of multidrugresistant Gram-negative bacteria (MDR-GNB) infections, and it confirms the need for a multidisciplinary team.