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1.
Topics in Antiviral Medicine ; 30(1 SUPPL):348, 2022.
Article in English | EMBASE | ID: covidwho-1880938

ABSTRACT

Background: The vaccination campaign against COVID-19 has a substantial beneficial public health impact, but vaccine hesitancy or issues to the access to vaccine could undermine the efforts made. We aim to determine the proportion of people living with HIV (PLWH) not vaccinated for COVID-19 in a cohort of PLWH in Italy and identify predictors of missing vaccination. Methods: Cross sectional study conducted in the Icona network. All PLWH of the centers participating the study with at least 1 follow-up in 2020-2021 were included. Their vaccination status for COVID-19 has been evaluated till 08Oct2021, before entering in the 3rd booster dose campaign for fragile populations in Italy. Data on vaccination status have been collected by medical records and/or administrative databases. Descriptive statistics, crude and adjusted logistic regression models for identifying predictors of not being vaccinated (0 doses received) were used. Results: Vaccination status has been assessed for 3,242 subjects from 17 centers of the cohort. 319/3,242 resulted still not vaccinated (9.8%) and 2,923 received at least one dose (90.2%). The full cycle has been completed by 2,732 subjects (85.5%). 89.1% of PLWH received a mRNA vaccine, 6.6% a viral vector and 4.3% unknown. Characteristics of patients according to being vaccinated or not are shown in Table 1A. In the adjusted logistic regressions, PLWH who did not receive the vaccine were more frequently younger (per 10 years younger AOR=1.22, 95%CI 1.07-1.38), and current/ex injecting drug users (IDU) (AOR=1.61, 95%CI 1.01-2.57), while having a current HIV-RNA < 50 copies mL (AOR=0.62, 95%CI 0.44-0.89), no previous diagnosis of COVID-19 (AOR=0.52, 95%CI 0.30-0.92) and being MSM (AOR=0.63, 95%CI 0.46-0.86) had lower risk to miss vaccination. Conclusion: The acceptance and uptake of vaccine among PLWH has been high, with a proportion of patients who completed the full vaccination cycle higher than targeted general population in Italy (85.5% vs 78.3% at W40-2021). Access to vaccination has been favourable for PLWH but some challenges remain for IDU/ex-IDU PLWH. The vaccination hesitancy lasts in younger population. MSMs seem to have a stronger attitude to protection, whereas patients with unsuppressed HIV-RNA could have a lower compliance reflected also in a lower COVID-19 vaccine uptake. Some selection bias on the population in analysis cannot be ruled out. These findings could help to develop interventions for increasing vaccination uptake for PLWH in future.

2.
Topics in Antiviral Medicine ; 30(1 SUPPL):109, 2022.
Article in English | EMBASE | ID: covidwho-1880214

ABSTRACT

Background: The pivotal BNT162b2 trials included only ∼60 vaccine recipients, all with well controlled HIV, and there is a need to gather more information on vaccine safety and immunogenicity in diverse populations. This prospective study evaluated solicited and unsolicited adverse events (AEs) and anti-S and anti-NC serological profiles in a diverse cohort of people with HIV undergoing BNT162b2 vaccination (2 doses 3 weeks apart). Methods: Participants completed structured questionnaires modelled on the BNT162b2 trials (FDA submission, Nov 2020) to report solicited and unsolicited AEs in the 7 days after each vaccine dose, indicating severity and duration. Serum samples collected prior to dose-1 (T0) and 3-6 weeks after dose-2 (T1) underwent qualitative anti-NC and quantitative anti-S testing by Elecsys®. Factors associated with T1 anti-S titres were explored in linear regression models including all available parameters. Results: Overall, 259 adults received dose-1 (26% female, 77% white, 44% MSM, 44% history of advanced disease, 31% ≥1 comorbidity, 10% HIV RNA >50 cps/ml [median 122 cps], 7% prior COVID-19 diagnosis, 15% anti-NC positive;median age 48 years, ART duration 7 years, nadir/current CD4 count 225/708 cells/mm3, CD4:CD8 ratio 0.8);257 received dose-2. Local AEs were more common after dose-1 than dose-2 (70% vs. 62%, p=0.015), whereas systemic AEs increased with dose-2 (50% vs 60%;p=0.006) (Fig 1a-c);22% experienced moderate-severe systemic AEs after dose-2. Unsolicited AEs (mainly nausea and light-headedness) were reported by 7% after dose-1 and 9% after dose-2. Among 206 participants with T1 samples, 205 (99%) had measurable anti-S (>0.8 U/ml). Anti-S levels were significantly lower at CD4 counts <200 cells/mm3 (Fig 1d). In adjusted regression analyses, factors associated with anti-S titres comprised anti-NC positivity (fold-change 7.39;95% CI 3.92-13.91;p<0.01), HIV viraemia (FC 0.24;0.11-0.50;p<0.01), reporting moderate-severe systemic AEs after dose-2 (FC 1.77;1.03-3.04;p=0.04) and either the CD4 count (FC 1.01;1.00-1.01;p=0.04) or CD4:CD8 ratio (FC 1.05;1.00-1.10;p=0.05). Conclusion: In this cohort with HIV, AE patterns after vaccination were similar to those seen in the pivotal BNT162b2 trials and most AEs were mild and short-lived. Whilst prior exposure to SARS-CoV-2 predicted higher anti-S responses, CD4 counts <200 cells/mm3 and low-level viraemia predicted reduced anti-S responses, thus identifying a subset potentially vulnerable to reduced vaccine efficacy.

3.
J Hosp Infect ; 115: 51-58, 2021 Sep.
Article in English | MEDLINE | ID: covidwho-1379144

ABSTRACT

BACKGROUND: Occurrence of hepatitis C virus (HCV) infection is reduced by effective risk management procedures, but patient-to-patient transmission continues to be reported in healthcare settings. AIM: To report the use of phylogenetic analysis in the clinical risk management of an HCV outbreak among 128 thalassaemia outpatients followed at a thalassaemia centre of an Italian hospital. METHODS: Epidemiological investigation and root-cause analysis were performed. All patients with acute hepatitis and known chronic infection were tested for HCV RNA, HCV genotyping, and NS3, NS5A, and NS5B HCV genomic region sequencing. To identify transmission clusters, phylogenetic trees were built for each gene employing Bayesian methods. FINDINGS: All patients with acute hepatitis were infected with HCV genotype 1b. Root-cause analysis, including a lookback procedure, excluded blood donors as the source of HCV transmission. The phylogenetic analysis, conducted on seven patients with acute infection and eight patients with chronic infection, highlighted four transmission clusters including at least one patient with chronic and one patient with acute HCV infection. All patients in the same cluster received a blood transfusion during the same day. Two patients with acute hepatitis spontaneously cleared HCV within four weeks and nine patients received ledipasvir plus sofosbuvir for six weeks, all achieving a sustained virological response. CONCLUSION: Combined use of root-cause analysis and molecular epidemiology was effective in ascertaining the origin of the HCV outbreak. Antiviral therapy avoided the chronic progression of the infection and further spread in care units and in the family environment.


Subject(s)
Hepatitis C , Thalassemia , Antiviral Agents/therapeutic use , Bayes Theorem , Disease Outbreaks , Genotype , Hepacivirus/genetics , Hepatitis C/epidemiology , Humans , Italy/epidemiology , Phylogeny , Risk Management , Thalassemia/complications , Thalassemia/epidemiology , Thalassemia/therapy
4.
Topics in Antiviral Medicine ; 29(1):292, 2021.
Article in English | EMBASE | ID: covidwho-1249891

ABSTRACT

Background: It has been observed that lockdown restrictions during COVID-19 pandemic may have had a negative impact on HIV epidemic goals with disruption in care. We aim to analyse the trends in non-viral suppression for PLWH during and after the lockdown for COVID-19 pandemic in Italy compared to 2019. Methods: We included all participants in the ICONA cohort for whom there was ≥1 viral load (VL) in the window Nov 2019-Jan 2020 and with most recent VL≤50 copies/mL (exposed to lockdown), and over Nov 2018-Jan 2019 (not exposed). New enrolments in the study period were excluded. At population level and separately by year, we calculated proportion with VL≤50 copies/mL at each month over March-September and we performed an intermittent time series (ARIMA) model centred in March. In addition, we defined an individual outcome using the first VL over May-September (>50 vs. ≤50 copies/mL), comparing proportion with VL>50 copies/mL between exposed and not exposed by means of logistic regression models. PLWH with missing VL in the outcome window were excluded from the analysis. We also performed an alternative analysis in which censoring bias was minimised using inverse probability of weighting. Sensitivity analyses were performed after restricting to clinical sites with electronic linkage with laboratory data and to the subset of PLWH under follow-up in both years. Results: A total of 3,684 PLWH were included (2019=2,948;2020=736). PLWH exposed to lockdown were significantly older, less frequently MSM, non-Italian, had a higher CD4+ count and more frequently resident in north of Italy. The mean proportion of VL<50 copies/mL was 97% at March 2020 (ref.), 99% before March 2020, 82% at April 2020 (ARIMA estimates -21% 95% CI:-28%;-14%;P=0.01) and 97% after April 2020. In the 2019, the same proportions were 100%, 98%, 95%, and 97% with evidence for a lower drop in April (-6%, 95% CI:-8%;-3%, p=0.02). The results of the logistic regression model are reported in Table 1. When restricting to sites with electronic VL linkage and to those followed-up in both years the IPW OR of 2020 vs. 2019 were 1.23 (0.69-2.18) and 1.03 (0.48-2.19), respectively. Conclusion: We found little evidence for a difference in the proportion of PLWH with a VL>50 copies/mL, following stable suppression, in the period post lockdown due to COVID-19 as compared to the previous year. Although selection bias was minimized, reasons for a missing VL should be further investigated.

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