Unexpected effects of COVID-19 outbreak: adaption of Anti-Retroviral Therapy (ART) delivery policies improved adherence in a population of People Living With HIV (PLWH).

Background: Adherence to Anti-Retroviral Therapy (ART) is crucial for People Living With HIV (PLWH). In Italy, ART is delivered by Hospital Pharmacies, on a renewable prescription from the hospital physician. The measurement of package-refill (the rate of ART packages actually collected out of those to be collected in order to comply with therapy) is an effective tool to evaluate the adherence.During COVID-19 outbreak, at "D. Cotugno" hospital in Naples, Italy, the ART delivery policies have been adapted, in order to reduce the number of patients' access. We analysed the impact of these changes on the pill-refill of ART in January-August 2020, compared with 2018-2019. Methods: "D. Cotugno" hospital is a mono-specialistic Infectious Diseases hospital, caring for about 2500 PLWH. Since February 2020, the hospital was almost entirely dedicated to COVID-19 patients. All out-patient activities were interrupted, except for those dedicated to HIV/AIDS patients.In this preliminary study we included all patients assigned to one of the three Medical Divisions dedicated to HIV, who were already under treatment since at least 2017. Rate of package-refill was obtained by the Hospital Pharmacy registry, demographic and clinical data were derived from clinical database.During COVID-19, many measures were adopted in order to increase safety of PLWH attending to hospital. Among these, medical prescription validity increased from 4 to 6 months, and number of packages to be collected increased from 2 to 4, adopting a multi-month dispensing strategy.Package-refill is adequate if at least 95% of ART have been actually collected; partial and inadequate if 75%-94% or less than 75% of ART, respectively, have been collected. Package-refill was measured during the first year of COVID-19 (March 2020 - February 2021), compared to the same period in the two years before. Results: A total of 594 PLWH were included. PLWH with optimal pill-refill significantly increased in 2020-21 compared to 2018-2020 (62% vs 55%, p 0.013). Discussion: Due to COVID-19, we would have expected a reduction in ART deliveries. Surprisingly, the opposite occurred. The increase of pill-refill rates may be due to different reasons, but we hypothesized that the adaption of delivery policies, with a higher number of packages allowed to be collected, strongly contributed to this result. This study suggests that multi-month dispensing policies may contribute to the improvement of adherence among PLWH.

Obesity as a Risk Factor of Severe Outcome of COVID-19: A Pair-Matched 1:2 Case-Control Study.

BACKGROUND AND AIM: The nature of the association between obesity and poor prognosis of COVID-19 without the evaluation of other co-pathologies associated has not yet been clearly evaluated. The aim of the present pair-matched case-control study was to investigate the outcome of patients with SARS-CoV-2 infection in obese and non-obese patients matched considering gender, age, number of comorbidities, and Charlson Comorbidity Index. METHODS: All the adults hospitalized for SARS-CoV-2 infection and with BMI ≥ 30 kg/m2 were included (Cases). For each Case, two patients with BMI < 30 kg/m2 pair matched for gender, age (±5 years), number of comorbidities (excluding obesity), and Charlson Comorbidity Index (±1) were enrolled (Controls). RESULTS: Of the 1282 patients with SARS-CoV-2 infection followed during the study period, 141 patients with obesity and 282 patients without were enrolled in the case and control groups, respectively. Considering matching variables, there was no statistical difference between the two groups. Patients in the Control group developed more frequently a mild-moderate disease (67% vs. 46.1%, respectively), whereas obese patients were more prone to need intensive care treatment (41.8% vs. 26.6%, respectively; p = 0.001). Moreover, the prevalence of death during hospitalization was higher in the Case group than in the Control group (12.1% vs. 6.4%, p = 0.046). DISCUSSION: We confirmed an association between obesity and severe outcome of patients with COVID-19, also considering other factors associated with a severe outcome of COVID-19. Thus, in the case of SARS-CoV-2 infection, the subjects with BMI ≥ 30 kg/m2 should be evaluated for early antiviral treatment to avoid the development of a severe course.

Does COVID-19 Vaccination with BNT162b2 Influence HIV-Related Immunological and Virological Markers? Data from 235 Persons Living with HIV at Cotugno Hospital, Naples, Italy: Immune Response After Second and Third Doses, and Influence on Immunovirological Markers.

Few data are available on the impact of COVID-19 vaccination on CD4 counts and HIV-RNA in persons living with HIV (PLWH). We present the data of 235 PLWH who were vaccinated with BNT162b2 in March 2021-February 2022 at the "Cotugno" hospital in Naples. PLWH treated at the "Cotugno" hospital, who were vaccinated at the hospital vaccination center, without prior COVID-19 and for whom immunological/virological data were available in the last 12 months and in the 6 months after vaccination were included. Antispike Ab were available for 187 and 64 PLWH after the second and third doses: PLWH with antispikes >33 binding antibodies units (BAU)/mL increased from 91% to 98%. Antinucleocapsid Ab performed in 147 and 56 patients identified 19 (13%) asymptomatic/paucisymptomatic COVID-19 infections after the second dose and an additional 15 (27%) after the third dose. Immunological/virological data were collected before vaccination (T0), after the second dose (T1), and after the third dose (T2). The absolute number of CD4 increased after the third dose (median 663, 657, and 707 at T0, T1, and T2; p < 0.000 T0 vs. T2). The proportion of patients with HIV-RNA <50 copies/mL increases significantly after the second dose (73%; 85.7%; 87.7%; p < 0.000 T0 vs. T2). The presence of COVID-19 asymptomatic/paucisymptomatic infections (demonstrated by the presence of antinucleocapsid Ab) significantly increases SARS-CoV-2 antispike Ab after second dose, but not after third dose. Asymptomatic/paucisymptomatic COVID-19 infections do not have influence on CD4 cell number and HIV-RNA level. Similarly, the presence of not-controlled HIV-RNA (HIV-RNA >50 copies/mL) does not influence antispike Ab response. According to our data, the response to SARS-CoV2 vaccination is effective in people living with HIV. Vaccination against COVID-19 appears to positively affect immunological and virological levels in people living with HIV.

Adherence to antiretroviral therapy thought package-refill among HIV+ persons at "D. Cotugno" hospital, Naples, Italy.

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.

Evolving epidemiology of HIV/AIDS in Campania region, 2011-2018: Is HIV/AIDS population in Campania different?

Objectives: Data on HIV/AIDS cases in Italy are collected using a standardised form. Regional epidemiology may vary. We described the epidemiological and clinical characteristics of newly diagnosed persons with HIV in the 'Cotugno' hospital in Naples during 2011-2018 and compared them with national data to identify similarities and differences. Methods: Data source for the Campania region is the data collection forms sent to the national surveillance system. The data source for the national data is from the periodic annual bulletins on HIV/AIDS published by the National Institute of Health. Results: In all, 1149 persons with HIV were diagnosed in 'Cotugno' (69.7% of those diagnosed in Campania). Persons with HIV in Campania showed many similarities with the Italian population: men were in the majority in both groups (about 75%), foreign origin was about 30%, heterosexuals were the most represented risk group, followed by men who have sex with men and injecting drug use in both samples. Some notable differences are also present. Among the risk factors for HIV acquisition, injecting drug use is significantly more common in Campania. Among the reasons for testing, significant differences are evident for almost all reasons, with screening activities (testing for concurrent diseases, for diagnosis of sexually transmitted diseases, screening in hospital during maternity care and screening in drug-addition services or prisons) being more common at the national level. The Campania population has a more severe disease pattern, with a significantly higher proportion of patients diagnosed with less than 200 CD4 cells/µL and AIDS. For each variable, we compared trends in the Campania region and in Italy using Spearman's correlation coefficient. Almost all trends show a weak correlation. Conclusion: In conclusion, the prevalence of injecting drug use is still consistent, and requires specific campaigns. The reasons for testing are different: screening activities work less in Campania than in Italy. This untimely approach contributes to a more severe clinical picture in Campania.