ABSTRACT
Background: Vaccines can be less immunogenic in people living with HIV (PLWH). So far, the immune response after SARS-CoV-2 vaccination of PLWH is not well-established. Methods: A prospective cohort study in 22 HIV treatment centres in the Netherlands examined the immunogenicity of SARS-CoV-2 vaccines in PLWH. Included were adult PLWH without prior COVID-19 infection, invited by the national vaccination programme to receive the BNT162b2, mRNA-1273, ChAdOx1-S or Ad26.COV2.S vaccine. Data from HIV-negative healthy controls were acquired from 2 concurrent prospective vaccination trials. The primary endpoint was the anti-SARS-CoV-2 IgG response (Liaison Trimeric Spike IgG in BAU/ml) measured 4-6 weeks after vaccination with one of the 2 mRNA vaccines in PLWH versus controls. Secondary endpoints included antibody response according to sex, CD4+ T-cell count, and vaccine reactogenicity. Results: Between February 14th and September 7th 2021, 1269 PLWH were enrolled and complete results were available for 1148 PLWH as well as for 440 healthy controls. 879 of the PLWH were vaccinated with BNT162b2 while 100, 150 and 19 had received mRNA-1273, ChAdOx1-S and 19 Ad26.COV2.S respectively. Their median age was 53 years [IQR 44-60], 85.5% was male, the median CD4+ T-cell count was 710/μ L [IQR 520-913]. 99% was on cART with HIV-RNA <50 copies/ml in 97.7%. The control group consisted of 440 healthy people;247 vaccinated with mRNA-1273, 94 with BNT162b2, 26 with ChAdOx1-S and 73 with Ad26.COV2.S. Their median age was 43 [IQR 33-53] and 28.6% was male. PLWH had a significantly lower anti-SARS-CoV-2 RBD IgG response compared to controls (mean value of 2171 BAU/mL (95% CI 1888-2453) versus 3586 BAU/ml (95% CI 3250-3922, p<0.001)). In the multivariable analysis, being HIV positive, age >65 years, being male and having received a non-mRNA vaccination were all independently associated with a lower antibody concentration (p<0.01 for all). In the PLWH vaccinated with BNT162b2 or mRNA-1273, mean antibody levels were significantly lower in those with a CD4+ T-cell counts <250/μ L (1617 BAU/mL, 95% CI 828-2407) compared to CD4 ≥250/μ L (2486 BAU/ml 95% CI 2149-2824, p=0.002). Reactogenicity occurred in 55 and 50% after the first and second vaccination respectively and were generally mild without vaccine-related SAE. Conclusion: After vaccination with BNT162b2 or mRNA-1273, Anti-Spike IgG levels were lower in PLWH compared to healthy controls. In PLWH, a CD4+ T cell count <250/μ L was associated with lower antibody concentration.
ABSTRACT
Background. The long-term effects of COVID-19 are still unknown. This study aims to assess the impact of COVID-19 among survivors after one year. Methods. All confirmed COVID-19 cases who presented at OLVG hospital in Amsterdam during the first wave of the COVID-19 pandemic were invited to participate in our prospective observational cohort study. The participants were divided into three subgroups: patients not admitted, admitted to the general ward and admitted to the ICU. Questionnaires were sent at 3, 6 and 12 months after presentation. We used the Research and Development - 36-item health survey, the Hospital Anxiety and Depression Scale and the PTSS Checklist for DSM-5. We compared the RAND-36 scores at the timepoints with a Dutch healthy control population in 2020 and between the three subgroups using the Kruskal-Wallis test and the Mann-Whitney U test. Results. Of the 466 confirmed cases, 75 patients died of COVID-19, 64 patients were lost to follow up and 12 patients were excluded because they were unable to complete the questionnaires due to mental illness or cognitive impairment, they moved back to their home country or refused to participate. Of the remaining 315 patients, 182 (57.8%) completed the questionnaires at 3 months. Subsequently, 163 patients provided informed consent for follow up. At 6 and 12 months, 98 (60.1%) and 131 (80.4%) completed the survey. The average score of all domains at 3 months was 58, compared to 79 at twelve months and 81 in the control group. There was a statistically significant increase from 3 and 12 and 6 and 12 months (figure 1). At twelve months participants recovered to levels of the healthy control group (N=459), except for the ICU group, who still experienced bodily pain and decreased physical function. The improvement was most noticeable in the domains of social functioning, role limitations - physical and role limitations - emotional. The percentage of patients with abnormal total HADS scores (cutoff at 16) and PCL5- scores (cutoff at 33) at 3 months decreased from 27.8 to 22.1% and 18.9 to 7.6% at 12 months, respectively (figure 2 and 3). Blue line is after 3 months, orange line is after 6 months, green line is after 12 months, yellow line is healthy control. The p-value in the right-upper corner shows statistical significant difference between all total scores, the asterisks indicate significance between groups. PF = physical functioning;SF = social functioning;RP = role limitations-physical;RE = role limitations-emotional;MH = mental health;VT = vitality;BP = pain;GH = general health;HC = health change. Figure 2 The blue column is after 3 months, the orange after 6 months and the green after 12 months. The numbers above the columns are percentages per group. Figure 3 The blue column is after 3 months, the orange after 6 months and the green after 12 months. The numbers above the columns are percentages per group. Conclusion. Although, COVID-19 may cause a decreased health-related quality of life and impaired mental health, this study shows important recovery up to normal levels after one year.
ABSTRACT
BACKGROUND: The global push for the use of hydroxychloroquine (HCQ) and chloroquine (CQ) against COVID-19 has resulted in an ongoing discussion about the effectivity and toxicity of these drugs. Recent studies report no effect of (H)CQ on 28-day mortality. We investigated the effect of HCQ and CQ in hospitalized patients on the non-ICU COVID-ward. METHODS: A nationwide, observational cohort study was performed in The Netherlands. Hospitals were given the opportunity to decide independently on the use of three different COVID-19 treatment strategies: HCQ, CQ, or no treatment. We compared the outcomes between these groups. The primary outcomes were 1) death on the COVID-19 ward, and 2) transfer to the intensive care unit (ICU). RESULTS: The analysis included 1064 patients from 14 hospitals: 566 patients received treatment with either HCQ (n = 189) or CQ (n = 377), and 498 patients received no treatment. In a multivariate propensity-matched weighted competing regression analysis, there was no significant effect of (H)CQ on mortality on the COVID ward. However, HCQ was associated with a significantly decreased risk of transfer to the ICU (hazard ratio (HR) = 0.47, 95% CI = 0.27-0.82, p = 0.008) when compared with controls. This effect was not found in the CQ group (HR = 0.80, 95% CI = 0.55-1.15, p = 0.207), and remained significant after competing risk analysis. CONCLUSION: The results of this observational study demonstrate a lack of effect of (H)CQ on non-ICU mortality. However, we show that the use of HCQ - but not CQ - is associated with a 53% reduction in risk of transfer of COVID-19 patients from the regular ward to the ICU. Recent prospective studies have reported on 28-day, all-cause mortality only; therefore, additional prospective data on the early effects of HCQ in preventing transfer to the ICU are still needed.