PROPORTION of PLWH NOT VACCINATED for COVID-19 in ITALY and PREDICTORS

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.

Influenza and pneumococcal vaccines in cancer patients on active therapy: A prospective study

Background: Due to immunosuppression, influenza virus and S. pneumoniae infections in cancer patients (pts) are responsible of a 4 times higher morbidity and mortality rates. Inadequate data are available about efficacy, safety, timing and immunogenicity of influenza (I) and pneumococcal (P) vaccine (vax) in pts undergoing active oncologic treatment. Nevertheless, the main Oncology societies recommend I and P vax in cancer pts and their family members (FMs). Materials and Methods: This is a single institution prospective study conducted at L. Sacco Hospital (Milan) between Sept 20 and Apr 21. The aim was to evaluate efficacy and safety of vax. Pts with diagnosis of tumor, age>18ys, in active antineoplastic treatment and FMs age>18ys were included. Each pt received I+P vax on the same day of therapy. Pts were compared with a control group of FMs, with age- and gender-adjusted logistic regression. Monthly monitoring was scheduled to register any Adverse Events (AEs) after injection (local and systemic AEs), episode of Influenza Like Illness (ILI), pneumococcal infection, access to Emergency department (ED) or Hospital admission (HA) and delay of treatment (DT). Results: 194 pts (63y median age, 67.5% female) and 140 FMs (59y median age, 49% female) were enrolled. CANCER: 92% solid and 8% hematological malignancy, 69% metastatic stage. TREATMENTS: 54% =1 previous line of therapy;38% chemotherapy, 31% target, 17% chemo+target, 14% hormone therapy. VAX: 47% pts and 72% FMs received I-vax for first time. I+P-vax were administered in 100% pts and 49% FMs. LOCAL AEs: I-vax: 34% pts and 19.6% FMs (p=0.01), P-vax: 35.7% pts and 20.7% FMs (p=0.11). The most common was pain in site of injection. SISTEMIC AEs: 19.6% pts and 8.5% FMs (p=0.11);the most frequent was fatigue. EFFICACY: ILI were recorded in 8.8% pts (3 had a HA and 1 a DT) and 3.6% FMs (p=0.04). No PI was recorded. Type of therapy, previous treatment and the use of steroid don't significantly impact on vax safety and efficacy. Conclusions: Despite the atypical season, I+P vax are safe and effective in cancer pts. The limited number of ILI events observed could be referred to vax but also to COVID-19 risk prevention and mitigation measures. No differences in efficacy and safety were observed between the 2 groups, except for local I-vax AEs. Moreover, the vax administration in the Oncology department, a wide vaccination coverage was achieved (>70% of cancer pts), reducing the pressure on territorial healthcare system.

Safety and efficacy of influenza and pneumococcal vaccines in cancer patients on active therapy: A prospective study

Background: Influenza virus and S. pneumoniae infections in cancer patients (pts) are responsible of a higher morbidity and mortality rates. Limited data are available about safety, efficacy, immunogenicity and timing of influenza (I) and pneumococcal (P) vaccine (vax) in pts receiving active treatment. However, I and P vax in cancer pts and their family members (FMs) are reccomended. Methods: This is a single institution prospective study conducted at L. Sacco Hospital (Milan, Italy) between Sept 20 and Apr 21. The aim was to assess efficacy and safety of vax. Cancer pts, age>18yo, in active antineoplastic treatment and FMs age>18yo were included. Each pt received I+P vax on the same day of therapy. Any local and systemic Adverse Event (AE), episode of Influenza Like Illness (ILI), pneumococcal infection (PI), access to Emergency Department (ED) or Hospital admission (HA) and delay of therapy (DoT) were recorded. The frequency of AEs, ILI episodes and PI among pts and age- and gender- matching FMs were compared. Results: 194 pts (63y median age, 67.5% female) and 140 FMs (59y median age, 49% female) were enrolled. CANCER: 92% solid and 8% hematological malignancy, 69% metastatic stage. TREATMENTS: 54% ≥1 previous line of therapy;38% chemotherapy, 31% target, 17% chemo+target, 14% hormone therapy. VAX: I-vax received for first time in 47% pts and 72% FMs. 100% pts and 49% FMs received I+P-vax. LOCAL AEs: I-vax: 34% pts and 19.6% FMs (p=0.01). P-vax: 35.7% pts and 20.7% FMs (p=0.11). The most common was pain in site of injection. SISTEMIC AEs: 19.6% pts and 8.5% FMs (p=0.11);the most frequent was fatigue. EFFICACY: ILI were recorded in 8.8% pts (3 had a HA and 1 a DoT) and 3.6% FMs (p=0.04). No PI was recorded. In a logistic regression analysis type of therapy, previous treatment and the use of steroid don’t significantly impact on vax safety and efficacy. Conclusions: Few ILI events were observed due to vax and probably to all measures adopted to prevent SARS-CoV-2 virus spread. Except for local I-vax AEs, no differences were observed in efficacy and safety between the 2 groups. During the observation time, >70% of cancer pts in active treatment received I and P vax, so the vaccination coverage was achieved, reducing the pressure on territorial healthcare system. Clinical trial identification: Trial protocol n. 2020/ST/433 release by Local Ethic Committee. Legal entity responsible for the study: The authors. Funding: Has not received any funding. Disclosure: N.M. La Verde: Financial Interests, Personal, Advisory Board: Novartis;Financial Interests, Personal, Advisory Board: Pfizer;Financial Interests, Personal, Advisory Board: Roche;Financial Interests, Personal, Advisory Board: MSD;Financial Interests, Personal, Speaker’s Bureau: Gentili;Financial Interests, Institutional, Funding: EISA. D. Dalu: Financial Interests, Personal, Invited Speaker: Gentili;Financial Interests, Personal, Other: MSD. A. Riva: Financial Interests, Personal, Other: MSD,;Financial Interests, Personal, Other: ViiV;Financial Interests, Personal, Other: Gilead;Financial Interests, Personal, Other: Janseen;Financial Interests, Personal, Other: Cilag. S. Antinori: Financial Interests, Personal, Other: Pfizer;Financial Interests, Personal, Other: Merck. M. Galli: Financial Interests, Personal, Other: ViiV;Financial Interests, Personal, Other: BMS;Financial Interests, Personal, Other: MSD;Financial Interests, Personal, Other: AbbVie;Financial Interests, Personal, Other: Gilead;Financial Interests, Personal, Other: Janssen;Financial Interests, Personal, Other: Roche. All other authors have declared no conflicts of interest.

Compassionate remdesivir treatment of severe COVID-19 pneumonia in intensive care unit (ICU) and non-ICU patients: clinical outcome and differences in post-treatment hospitalisation status. (Special Issue: Pharmacoepidemiology and pathogenetics of 2019-nCoV.)

SARS-CoV-2 is causing an increasing number of deaths worldwide because no effective treatment is currently available. Remdesivir has shown in vitro activity against coronaviruses and is a possible antiviral treatment for SARS-CoV-2 infection. This prospective (compassionate), open-label study of remdesivir, which was conducted at Luigi Sacco Hospital, Milan, Italy, between February 23 and March 20, 2020, involved patients with SARS-CoV-2 pneumonia aged 18 years undergoing mechanical ventilation or with an oxygen saturation level of 94% in air or a National Early Warning Score 2 of 4. The primary outcome was the change in clinical status based on a 7-category ordinal scale (1 = not hospitalised, resuming normal daily activities;7 = deceased). The 35 patients enrolled from February 23 to March 20, 2020, included 18 in intensive care unit (ICU), and 17 in our infectious diseases ward (IDW). The 10-day course of remdesivir was completed by 22 patients (63%) and discontinued by 13, of whom eight (22.8%) discontinued because of adverse events. The median follow-up was 39 days (IQR 25-44). At day 28, 14 (82.3%) patients from IDW were discharged, two were still hospitalized and one died (5.9%), whereas in ICU 6 (33.3%) were discharged, 8 (44.4%) patients died, three (16.7%) were still mechanically ventilated and one (5.6%) was improved but still hospitalized. Hypertransaminasemia and acute kidney injury were the most frequent severe adverse events observed (42.8% and 22.8% of the cases, respectively). Our data suggest that remdesivir can benefit patients with SARS-CoV-2 pneumonia hospitalised outside ICU where clinical outcome was better and adverse events are less frequently observed. Ongoing randomised controlled trials will clarify its real efficacy and safety, who to treat, and when.

The importance of anamnesis in differential diagnosis: a case of SARS-CoV-2 and dengue virus co-infection

Dengue fever should be included in the differential diagnosis of febrile illness even if another infection such as COVID-19 has been found in returning travellers from tropical and sub-tropical area where dengue virus circulates epidemically. We describe a 40-year-old man diagnosed with laboratory-confirmed COVID-19 and dengue fever during the COVID-19 outbreak in Milan, Italy.