Abstract
Background
WHO defines Post–Acute Sequelae of SARS–CoV–2 (PASC) as a condition that occurs several weeks after the infection, which persists for at least 8 weeks and cannot be explained by ...alternative diagnoses. Symptoms of PASC are: palpitations, dyspnoea, chest pain. These symptoms require an initial cardiological investigation, but also a cardiological follow–up that could be carried out with telemedicine. Principal aim: To assess the feasibility of cardiological televisit and its socio–economic impact in patients with PASC. Secondary aims: 1) To describe the clinical, laboratory and instrumental characteristics of patients with PASC and to define the possible role of cardiovascular risk factors in the development of the disease; 2) To correlate the symptoms reported by the patients with any clinical objectivity or instrumental alterations; 3) To assess the patient‘s perception of the use of specialist televisit and its possible economic and social impact.
Methods
Prospective observational study. All patients with previous COVID–19 with suspected PASC will be screened. After the first cardiological face–to–face visit, patients with suspected PASC who require follow–up will be consecutively enrolled and assigned in a 1:1 ratio to the televised study group (GT) and the standard of care (GC) control group. Patients in the GT group will perform the control cardiology examination in televisit, while patients in the GC group will perform the cardiological control according to the current standard of care. The specialist televisit (booking mode, use of freeware platform) will be provided as indicated by the latest regional directives. Exclusion criteria: Failure to sign informed consent; inadequate computer literacy (of the patient or his/her caregiver). Evaluation: Patients in the GT and GC group will take a questionnaire with specific questions on how the specialist check–up will be delivered. Expected results: The use of televisit for the follow–up of patients with PASC, as defined in this protocol, play a key role for the digital transition in our operational context and, above all, for the optimisation of healthcare resources.
To assess the effectiveness of bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) among people poorly represented in clinical trials and potentially at higher risk of suboptimal response ...to ART.
Observational cohort study on persons with HIV (PWH) enrolled in ICONA who started BIC/FTC/TAF as initial therapy or as switching regimen while virologically suppressed. Primary endpoint was time to treatment failure (TF): new AIDS/death or virological failure (VF) or discontinuation for toxicity/failure. Secondary endpoints were time to treatment discontinuation for toxicity (TDT) and to VF. Groups of interest were those aged >50 years, female sex, and advanced HIV disease at first ART start. Probability of the events overall and according to groups and adjusted HR for every endpoint were calculated by Kaplan-Meier curves and Cox regression models.
Nine hundred and thirty-three ART-naive and 1655 ART-experienced PWH initiated BIC/FTC/TAF. Over a median follow-up of 69.8 weeks, 89 (9.6%) PWH at their first regimen experienced TF. PWH aged >50 years had 1.83-fold (95% CI: 1.19-2.83) higher risk of TF; PWH with advanced HIV disease had 2.21-fold (95% CI: 1.53-3.82) higher risk; there were no differences in TF according to sex.Over a median follow-up of 146.3 weeks, 109 (6.6%) out of 1655 switching PWH experienced TF; no differences were found in the risk of TF, TDT and VF according to groups of interest.
Overall, BIC/FTC/TAF is well tolerated and virologically effective in the real-world scenario for ART-naive and -experienced PWH. Older ART-naive PWH and those with advanced HIV disease may respond less well as the burden of diseases might compromise treatment efficacy.
Objectives
We aimed to study hepatitis D virus (HDV) prevalence and risk of progression to severe liver‐related events (SLRE) in HBsAg positive people living with HIV (PLWH) in Italy; role of HDV‐RNA ...copy levels, HCV coinfection and nadir CD4 counts were also investigated.
Methods
People living with HIV (PLWH) from Italian Foundation cohort Naïve antiretrovirals (ICONA) with available HBsAg and HDV Ab were enrolled. HBsAg, HDV Ab, HDV‐RNA and HDV genotypes were tested. Primary end‐point: time from first HDV screening to Severe Liver Related Events (SLRE: decompensated cirrhosis, liver transplantation, HCC). Fine‐grey regression models were used to evaluate the association of HDV Ab, HDV‐RNA, HDV/HCV coinfection, CD4 nadir and outcome. Secondary end‐points: time to SLRE or death; HDV Ab and HDV‐RNA prevalence.
Results
A total of 152/809 (18.8%) HBsAg positive PLWH showed HDV Ab reactivity; 63/93 (67.7%) were HDV‐RNA positive. Being male, persons who inject drugs (PWID), HCV Ab positive, with FIB‐4 > 3.25 were independent factors of HDV Ab positivity. In a median follow‐up of 5 years, 37 PLWH (4.1% at 5‐year) developed SLRE and 97 (12.0%) reached the SLRE or death end‐point. HDV‐RNA positive (independently from HDV‐RNA copy level) PLWH had a 4.6‐fold (95%CI 2.0–10.5) higher risk of SLRE than HDV negatives. PLWH positive for both HCV Ab and HDV Ab showed the highest independent risk of SLRE (ASHR: 11.9, 95%CI: 4.6–30.9 vs. HCV neg/HDV neg). Nadir CD4 < 200/mL was associated with SLRE (ASHR: 3.9, 95% 1.0–14.5).
Conclusions
One‐fifth of the HBsAg positive PLWH harbour HDV infection, and are at high risk of progression to advanced liver disease. HCV contributes to worse outcomes. This population needs urgently effective treatments.
Transmitted drug-resistance (TDR) remains a critical aspect for the management of HIV-1-infected individuals. Thus, studying the dynamics of TDR is crucial to optimize HIV care.
In total, 4323 HIV-1 ...protease/reverse-transcriptase sequences from drug-naive individuals diagnosed in north and central Italy between 2000 and 2014 were analysed. TDR was evaluated over time. Maximum-likelihood and Bayesian phylogenetic trees with bootstrap and Bayesian-probability supports defined transmission clusters.
Most individuals were males (80.2%) and Italian (72.1%), with a median (IQR) age of 37 (30-45) years. MSM accounted for 42.2% of cases, followed by heterosexuals (36.4%). Non-B subtype infections accounted for 30.8% of the overall population and increased over time (<2005-14: 19.5%-38.5%, P < 0.0001), particularly among Italians (<2005-14: 6.5%-28.8%, P < 0.0001). TDR prevalence was 8.8% and increased over time in non-B subtypes (<2005-14: 2%-7.1%, P = 0.018). Overall, 467 transmission clusters (involving 1207 individuals; 27.9%) were identified. The prevalence of individuals grouping in transmission clusters increased over time in both B (<2005-14: 12.9%-33.5%, P = 0.001) and non-B subtypes (<2005-14: 18.4%-41.9%, P = 0.006). TDR transmission clusters were 13.3% within the overall cluster observed and dramatically increased in recent years (<2005-14: 14.3%-35.5%, P = 0.005). This recent increase was mainly due to non-B subtype-infected individuals, who were also more frequently involved in large transmission clusters than those infected with a B subtype median number of individuals in transmission clusters: 7 (IQR 6-19) versus 4 (3-4), P = 0.047.
The epidemiology of HIV transmission changed greatly over time; the increasing number of transmission clusters (sometimes with drug resistance) shows that detection and proper treatment of the multi-transmitters is a major target for controlling HIV spread.
Introduction
There is paucity of data related to potential gender differences in the use of interventions to prevent and treat cardiovascular disease (CVD) among HIV‐positive individuals. We ...investigated whether such differences exist in the observational D:A:D cohort study.
Methods
Participants were followed from study enrolment until the earliest of death, six months after last visit or February 1, 2015. Initiation of CVD interventions lipid‐lowering drugs (LLDs), angiotensin‐converting enzyme inhibitors (ACEIs), anti‐hypertensives, invasive cardiovascular procedures (ICPs) were investigated and Poisson regression models calculated whether rates were lower among women than men, adjusting for potential confounders.
Results
Women (n = 12,955) were generally at lower CVD risk than men (n = 36,094). Overall, initiation rates of CVD interventions were lower in women than men; LLDs: incidence rate 1.28 1.21, 1.35 vs. 2.40 2.34, 2.46; ACEIs: 0.88 0.82, 0.93 vs. 1.43 1.39, 1.48; anti‐hypertensives: 1.40 1.33, 1.47 vs. 1.72 1.68, 1.77 and ICPs: 0.08 0.06, 0.10 vs. 0.30 0.28, 0.32, and this was also true for most CVD interventions when exclusively considering periods of follow‐up for which individuals were at high CVD risk. In fully adjusted models, women were less likely to receive CVD interventions than men (LLDs: relative rate 0.83 0.78, 0.88; ACEIs: 0.93 0.86, 1.01; ICPs: 0.54 0.43, 0.68), except for the receipt of anti‐hypertensives (1.17 1.10, 1.25).
Conclusion
The use of most CVD interventions was lower among women than men. Interventions are needed to ensure that all HIV‐positive persons, particularly women, are appropriately monitored for CVD and, if required, receive appropriate CVD interventions.
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