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BACKGROUND: A gold-standard for the measurement of adherence to antiretroviral therapy (ART) is lacking. Aim of this study is to verify the feasibility of a package-refill-based measurement of ART at “D. Cotugno” hospital, Naples, Italy, and the factors associated to adherence. METHODS: In the period January 2018–August 2020, we calculated the package-refill as the ratio between ART-packages actually withdrawn, and the ART packages needed to regularly take ART. Adherence was associated, trough a univariate e multivariate logistic regression, to demographical, behavioural and clinical factors. RESULTS: 1140 HIV+ subjects were included. At univariate logistic regression inadequate package-refill-based adherence is associated with HIV-RNA higher than 50 copies/mmL (OR 3.77-IC95% 2.76–5.13) and with HIVRNA higher than 200 copies/mmL (OR 3.98-IC95% 2.69–5.90). Being not-Italian and Injective-drug-user are associated with low adherence, having HIV/AIDS for more than 8 years is associated with better adherence. CONCLUSIONS: Package-refill is a suitable method for measuring adherence and is associated with the condition of viral failure.

Background: Hypernatremia is a serious event that can occur during intravenous (IV) treatment with fosfomycin, and it can also be caused by a wrong drug preparation. Considering the clinical significance of hypernatremia, we decided to carry out two studies by using two different data sources with the aim to evaluate cases of IV fosfomycin-induced hypernatremia.Methods: A retrospective medical record review was performed from June 2017 to June 2019 using data from two hospitals in Southern Italy. The information collected was related to the patients, the antibiotic treatment regimen, type of adverse drug reaction (ADR), hypernatremia severity classification, and drug withdrawal due to ADRs. Moreover, a pharmacovigilance study was performed from the date of the European marketing authorization of fosfomycin to October 11, 2021, using data reported on the European website of suspected ADRs. Information related to the patient characteristics, treatment, hypernatremia, and type of reporter was retrieved.Results: From the retrospective medical record review, a total of 62 patients (48 men and 14 women) in treatment with fosfomycin were identified, of which 17 experienced ADRs. Specifically, 11 patients experienced hypernatremia. During the period from June 2017 to June 2018, a total of 63.7% of hypernatremia events were related to the wrong reconstitution of the drug. According to these results, a surveillance and training campaign about the correct drug reconstitution was managed. However, from June 2018 to June 2019, we still had four new hypernatremia cases. Drug withdrawal occurred in only one patient with hypernatremia. From the pharmacovigilance study, a total of 25 cases of IV fosfomycin-induced hypernatremia were retrieved. No substantial difference was found for patients’ distribution by sex. Most cases were classified as serious (68%) and reported “Recovered/resolved” as the outcome (44%). In the majority of cases, fosfomycin was the only suspected drug reported (72%).Conclusion: Our results show that training campaigns on the correct drug preparation need to be strengthened to allow a reduction of hypernatremia cases. Moreover, when close monitoring and management is performed by the infectious disease (ID) specialist and hospital pharmacist, there also is a reduction in antibiotic withdrawal due to hypernatremia.

Background real-world data on COVID-19 vaccine safety, immunogenicity and acceptance in adults with congenital heart disease (ACHD) are lacking. Methods ACHD patients who were offered COVID-19 vaccination from January to June 2021 were included. Data on adverse events, on patients’ attitude towards vaccination and antispike IgG titre were retrospectively collected. A group of healthy individuals with similar age and sex undergoing vaccination was included for comparison. Results 208 patients followed in a single ACHD tertiary centre (33.3 [26–45]years,54%male) received COVID-19 vaccine, 65% vaccinated at our institution: 199 (96%)received Pfizer–BioNTech BNT162b2 vaccine, 4 (2%)Moderna-1273 and 5 (2%)AstraZeneca–ChAdOx1. Median follow-up after vaccination was 79 [57–96]days. No major adverse event was reported and there was no difference in the in adverse events incidence between ACHD patients and the control group. One patient was diagnosed with acute pericarditis. There were two unrelated deaths during follow-up. Three (1.5%)vaccinated patients tested positive for COVID-19. Antispike IgG titre, available in 159 (76%)patients, was 1334 [600–3401]BAU/ml, not significantly different from the control group (p = 0.2). One patient with Fontan failure was seronegative. Advanced physiological stage was related to lower antibody response, independently from previous viral exposure (p, Graphical abstract Image 1

The new antivirals for the treatment of hepatitis C virus (HCV) are characterised by short duration with an increased sustained virological response (SVR), a reduced follow-up with a significant impact on HCV natural history and health public burden. However they still lack substantial data on long-term disease evolution in real life.1 More recently Yin et al showed that real-life SVR was similar to clinical study with a reduction in health costs.2 However, despite the noteworthy results on the virus, the long-term outcome, possible related adverse drug reaction (ADR) and their impact on healthcare cost are still controversial, even when achieving SVR3 particularly in regards to hepatocellular carcinoma (HCC). At the beginning of 2015, we started to assess the presence of any kind of ADR of these new DAAs …