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Introduction…

Introduction…

Abstract

Background

In March 2020, the WHO declared the novel coronavirus outbreak a global pandemic. While great success in coronavirus disease 2019 (COVID-19) control has been achieved in China, imported cases have become a major challenge. This study aimed to describe the epidemiological and clinical characteristics of imported COVID-19 cases and to assess the effectiveness of screening strategies in Beijing, China.

Methods

This retrospective study included all imported cases transferred to Beijing Ditan Hospital from 29 February to 20 March 2020 who were screened by both chest computed tomography (CT) and reverse-transcriptase-polymerase chain reaction (RT-PCR) at the initial presentation. Demographic, clinical and laboratory data, in addition to chest CT imaging, were collected and analysed.

Results

In total, 2545 cases were included, among which 71 (2.8%) were finally diagnosed with laboratory-confirmed COVID-19. The majority 63 (88.7%) were from Europe. The most common initial symptoms were cough and fever, which accounted for 49.3% and 42.3%, respectively. Only four cases (5.6%) had lymphocytopenia, and thirteen cases (18.3%) demonstrated elevated levels of C-reactive protein (CRP). All cases had normal serum levels of procalcitonin (PCT). At initial presentation, among the 71 confirmed cases, 59 (83.1%) had a positive RT-PCR assay, and 35 (49.3%) had a positive chest CT. Twelve (16.9%) had a negative RT-PCR assay but a positive chest CT.

Conclusions

A combination of RT-PCR and chest CT is an effective strategy for the screening of imported COVID-19 cases. Our findings provide important information and clinical evidence about the infection control of imported COVID-19 cases.

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Abstract

Background and aim

For over 40 years of the HIV/AIDS global epidemic, no effective cure nor vaccine is yet available, making the current control strategies focused on curbing new infections through risk reduction. The study aimed to determine the prevalence of HIV risk factors and their associated socio-demographics among women of reproductive age in Sierra Leone.

Methods

We used weighted data from the Sierra Leone Demographic and Health Survey (SLDHS) of 2019 for 12,005 women aged 15–49 years. Multistage sampling was used to select study participants. Exposure to HIV risk factors was considered if a woman reported at least one of the following; having multiple sexual partners, transactional sex, non-condom use for the unmarried, and having other sexually transmitted infections (STIs). We, then, conducted multivariable logistic regression to explore the associated socio-demographics. All the analyses were done using SPSS (version 25).

Results

Of the 12,005 women, 38.1% (4577/12005) (95% confidence interval (CI) 37.3–39.0) had at least one of the four risk factors. Women of 15 to 19 years (adjusted odds ratio (AOR) = 1.34, 95% CI 1.00–1.80) and 20 to 34 years (AOR = 1.25, 95% CI 1.05–1.49) had more odds of having HIV risk factors compared to those of 35 to 49 years. Urban residents (AOR = 1.49, 95% CI 1.17–1.89) and those from the Northwestern region (AOR = 1.81, 95% CI 1.26–2.60) were also more likely to encounter HIV risk factors compared to their respective counterparts. Moreover, unmarried women (AOR = 111.17, 95% CI 87.55–141.18) and those working (AOR = 1.38, 95% CI 1.14–1.67) also had higher odds of having HIV risk factors, compared to their respective counterparts. Sex of household head and parity were also significant associates.

Conclusions

More than a third of women in Sierra Leone had encountered at least one HIV risk factor, and this was associated with age, place of residence, region, marital status, working status, household head and parity. There is a need for strengthening HIV/AIDS education programs, laws and policies targeting the young, working, unmarried and urban-resident women.

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Abstract

Background

Although an increase in hepatitis C virus (HCV) prevalence from Northern to Southern Italy has been reported, the burden of asymptomatic individuals in different Italian regions is currently unknown.

Methods

A probabilistic approach, including a Markov chain for liver disease progression, was applied to estimate current HCV viraemic burden. The model defined prevalence by geographic area using an estimated annual historical HCV incidence by age, treatment rate, and migration rate from the Italian National database. Viraemic infection by age group was estimated for each region by main HCV transmission routes of individuals for stage F0–F3 (i.e. patients without liver cirrhosis and thus potentially asymptomatic) and F4 (patients with liver cirrhosis, thus potentially symptomatic).

Results

By January 2020, it was estimated that there were 409,184 Italian individuals with HCV (prevalence of 0.68%; 95% CI: 0.54–0.82%), of which 300,171 (0.50%; 95% CI: 0.4–0.6%) were stage F0–F3. Considering all individuals with HCV in stage F0–F3, the geographical distributions (expressed as the proportion of HCV infected individuals by macroarea within the overall estimated number of F0–F3 individuals and prevalence values, expressed as the percentage of individuals with HCV versus the overall number of individuals for each macroarea) were as follows: North 42.1% (0.45%; 95% CI: 0.36–0.55%), Central 24.1% (0.61%; 95% CI: 0.48–0.74%), South 23.2% (0.50%; 95% CI: 0.4–0.61%), and the Isles 10.6% (0.49%; 95% CI: 0.39–0.59%). The population of people who inject drugs accounted for 50.4% of all individuals infected (F0–F3). Undiagnosed individuals (F0–F3) were ~ 15 years younger (⁓ 50 years) compared with patients with stage F4 (⁓ 65 years), with similar age distributions across macroareas. In contrast to what has been reported on HCV epidemiology in Italy, an increasing trend in the proportion of potentially undiagnosed individuals with HCV (absolute number within the F0–F3) from South (23.2%) to North (42.1%) emerged, independent of similar regional prevalence values.

Conclusion

This targeted approach, which addresses the specific profile of undiagnosed individuals, is helpful in planning effective elimination strategies by region in Italy and could be a useful methodology for other countries in implementing their elimination plans.

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One billion people worldwide are affected by fungal pathogens, of which 1.6 million succumb to fungal infections per year. This review discusses the emergence and evolution of fungal pathogenesis in humans in the form of opportunistic commensal and environmental fungi. We explore the attributes that contribute to their success as pathogens and the scenarios which may have caused the evolutionary selection of virulence factors. This includes antivirulence and avirulence genes, notions that are new for fungal pathogens of humans but which are based on well established concepts in bacterial pathogens and phytopathogenic fungi.

Fluid therapy is an important supportive measure for patients with severe malaria. Patients with severe malaria usually have normal cardiac index, vascular resistance, and blood pressure and a small degree of hypovolaemia due to dehydration. Cell hypoxia, reduced kidney function, and acidosis result from microcirculatory compromise and malarial anaemia, which reduce tissue oxygenation, not hypovolaemia. Hence, aggressive fluid loading does not correct acid–base status, enhance kidney function, or improve patient outcomes, and it risks complications such as pulmonary oedema.

Zoonotic toxocariasis is increasingly prominent as knowledge of its insidious impact on human health accumulates. Toxocara canis dominates research attention, with Toxocara cati relegated to the periphery. We argue that there are few grounds to support this bias, and that differences in life history and epidemiology between T. canis and T. cati could have implications for disease impacts and control. Research on T. cati should be cognisant of its unique characteristics and not extrapolate uncritically from knowledge about T.

Abstract

Background

In March 2020, the WHO declared the novel coronavirus outbreak a global pandemic. While great success in coronavirus disease 2019 (COVID-19) control has been achieved in China, imported cases have become a major challenge. This study aimed to describe the epidemiological and clinical characteristics of imported COVID-19 cases and to assess the effectiveness of screening strategies in Beijing, China.

Methods

This retrospective study included all imported cases transferred to Beijing Ditan Hospital from 29 February to 20 March 2020 who were screened by both chest computed tomography (CT) and reverse-transcriptase-polymerase chain reaction (RT-PCR) at the initial presentation. Demographic, clinical and laboratory data, in addition to chest CT imaging, were collected and analysed.

Results

In total, 2545 cases were included, among which 71 (2.8%) were finally diagnosed with laboratory-confirmed COVID-19. The majority 63 (88.7%) were from Europe. The most common initial symptoms were cough and fever, which accounted for 49.3% and 42.3%, respectively. Only four cases (5.6%) had lymphocytopenia, and thirteen cases (18.3%) demonstrated elevated levels of C-reactive protein (CRP). All cases had normal serum levels of procalcitonin (PCT). At initial presentation, among the 71 confirmed cases, 59 (83.1%) had a positive RT-PCR assay, and 35 (49.3%) had a positive chest CT. Twelve (16.9%) had a negative RT-PCR assay but a positive chest CT.

Conclusions

A combination of RT-PCR and chest CT is an effective strategy for the screening of imported COVID-19 cases. Our findings provide important information and clinical evidence about the infection control of imported COVID-19 cases.

…

Abstract

Background and aim

For over 40 years of the HIV/AIDS global epidemic, no effective cure nor vaccine is yet available, making the current control strategies focused on curbing new infections through risk reduction. The study aimed to determine the prevalence of HIV risk factors and their associated socio-demographics among women of reproductive age in Sierra Leone.

Methods

We used weighted data from the Sierra Leone Demographic and Health Survey (SLDHS) of 2019 for 12,005 women aged 15–49 years. Multistage sampling was used to select study participants. Exposure to HIV risk factors was considered if a woman reported at least one of the following; having multiple sexual partners, transactional sex, non-condom use for the unmarried, and having other sexually transmitted infections (STIs). We, then, conducted multivariable logistic regression to explore the associated socio-demographics. All the analyses were done using SPSS (version 25).

Results

Of the 12,005 women, 38.1% (4577/12005) (95% confidence interval (CI) 37.3–39.0) had at least one of the four risk factors. Women of 15 to 19 years (adjusted odds ratio (AOR) = 1.34, 95% CI 1.00–1.80) and 20 to 34 years (AOR = 1.25, 95% CI 1.05–1.49) had more odds of having HIV risk factors compared to those of 35 to 49 years. Urban residents (AOR = 1.49, 95% CI 1.17–1.89) and those from the Northwestern region (AOR = 1.81, 95% CI 1.26–2.60) were also more likely to encounter HIV risk factors compared to their respective counterparts. Moreover, unmarried women (AOR = 111.17, 95% CI 87.55–141.18) and those working (AOR = 1.38, 95% CI 1.14–1.67) also had higher odds of having HIV risk factors, compared to their respective counterparts. Sex of household head and parity were also significant associates.

Conclusions

More than a third of women in Sierra Leone had encountered at least one HIV risk factor, and this was associated with age, place of residence, region, marital status, working status, household head and parity. There is a need for strengthening HIV/AIDS education programs, laws and policies targeting the young, working, unmarried and urban-resident women.

…

Abstract

Background

Although an increase in hepatitis C virus (HCV) prevalence from Northern to Southern Italy has been reported, the burden of asymptomatic individuals in different Italian regions is currently unknown.

Methods

A probabilistic approach, including a Markov chain for liver disease progression, was applied to estimate current HCV viraemic burden. The model defined prevalence by geographic area using an estimated annual historical HCV incidence by age, treatment rate, and migration rate from the Italian National database. Viraemic infection by age group was estimated for each region by main HCV transmission routes of individuals for stage F0–F3 (i.e. patients without liver cirrhosis and thus potentially asymptomatic) and F4 (patients with liver cirrhosis, thus potentially symptomatic).

Results

By January 2020, it was estimated that there were 409,184 Italian individuals with HCV (prevalence of 0.68%; 95% CI: 0.54–0.82%), of which 300,171 (0.50%; 95% CI: 0.4–0.6%) were stage F0–F3. Considering all individuals with HCV in stage F0–F3, the geographical distributions (expressed as the proportion of HCV infected individuals by macroarea within the overall estimated number of F0–F3 individuals and prevalence values, expressed as the percentage of individuals with HCV versus the overall number of individuals for each macroarea) were as follows: North 42.1% (0.45%; 95% CI: 0.36–0.55%), Central 24.1% (0.61%; 95% CI: 0.48–0.74%), South 23.2% (0.50%; 95% CI: 0.4–0.61%), and the Isles 10.6% (0.49%; 95% CI: 0.39–0.59%). The population of people who inject drugs accounted for 50.4% of all individuals infected (F0–F3). Undiagnosed individuals (F0–F3) were ~ 15 years younger (⁓ 50 years) compared with patients with stage F4 (⁓ 65 years), with similar age distributions across macroareas. In contrast to what has been reported on HCV epidemiology in Italy, an increasing trend in the proportion of potentially undiagnosed individuals with HCV (absolute number within the F0–F3) from South (23.2%) to North (42.1%) emerged, independent of similar regional prevalence values.

Conclusion

This targeted approach, which addresses the specific profile of undiagnosed individuals, is helpful in planning effective elimination strategies by region in Italy and could be a useful methodology for other countries in implementing their elimination plans.

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Abstract

Background

Many studies examined the spread of SARS-CoV-2 within populations using seroprevalence. Healthcare workers are a high-risk population due to patient contact, and studies are needed to examine seroprevalence of SARS-CoV-2 antibodies among healthcare workers. Our study investigates the seroprevalence of anti-SARS-CoV-2 antibodies among staff at primary healthcare institutions in Prishtina, and factors associated with seroprevalence.

Methods

We carried out a cross-sectional survey including SARS-CoV-2 serological testing and questionnaires with primary healthcare workers from primary healthcare facilities in the Prishtina, the capital city of Kosovo. We calculated prevalence of anti-SARS-CoV-2 antibodies, and of self-reported positive PCR test among primary healthcare workers, as well as crude and adjusted ORs for explanatory factors.

Results

Eighty-three of the healthcare workers (17.47%) tested positive for SARS-CoV-2 antibodies IgG or IgM, while 231 (48.63%) either had antibodies or a previous positive PCR test. Odds of seropositivity were affected by male gender (OR 2.08, 95% CI 1.20, 3.61), and infected family members (OR 3.61, 95% CI 2.25, 5.79) of healthcare workers. Higher education, being part of larger families and having infected family members gave higher odds of positive PCR test and seropositivity. Other healthcare workers had lower odds of positive PCR test and seropositivity than physicians.

Conclusion

Over 17% of healthcare workers were seropositive for SARS-CoV-2 antibodies and close to half of them were either seropositive or PCR self-reported positive test. Several factors are associated with decreased and increased odds for such outcomes. These findings should be explored further and addressed to Kosovo policy makers, and assist them to intensify vaccination efforts, and maintain control measures until we achieve herd immunity.

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Nature Medicine, Published online: 17 January 2022; doi:10.1038/s41591-021-01647-5COVID-19 and its neurological consequences particularly burden marginalized communities, and so can only be effectively treated by advancing health equity.

Nature Medicine, Published online: 17 January 2022; doi:10.1038/s41591-021-01596-zPervasive inequality in the Americas has fueled the COVID-19 pandemic and must be tackled.

Introduction

SARS-CoV-2, a highly contagious severe acute respiratory syndrome, has spread to most countries in the world and resulted in a change to practice patterns for the assessment and diagnosis of people with voice disorders. Many services are transitioning to telehealth models to maintain physical distancing measures and conserve personal protective equipment used by healthcare workers during laryngoscopy examinations. The speech–language pathology primary contact (SLPPC) assessment for patients referred to ear, nose and throat (ENT) services in Australia has been shown to reduce waiting times for assessment while streamlining access to ENT assessment and allied health practitioner treatment pathways.

Methods and analysis

A prospective observational cohort study will see patients in a newly developed telehealth model which uses the principles from a usual care SLPPC assessment protocol. Participants will be offered an initial telehealth assessment (speech–language pathology primary contact telehealth (SLPPC-T)) prior to being prioritised for a face-to-face laryngoscopy assessment to complete the diagnostic process. The telehealth assessment will collect sociodemographic information, personal and family medical history, key symptoms, onset and variability of symptoms, red-flag signs or symptoms for laryngeal malignancy, and clinical voice assessment data for auditory–perceptual and acoustic analysis. The study outcomes include (1) association of signs, symptoms and specific voice measures collected during SLPPC-T with voice disorder classification provided after laryngoscopy; (2) degree of concordance between voice disorder classification after SLPPC-T and after laryngoscopy; (3) health service and patient-related costs and health outcomes of the SLPPC-T; (4) patient and stakeholder views and beliefs about the SLPPC-T process.

Ethics and dissemination

Ethical approval has been granted prior to commencement of the study enrolment by the Gold Coast Hospital and Health Service Human Research Ethics Committee (reference number HREC/2020/QGC/62832). Results will be shared through the publication of articles in peer-reviewed medical journals and presentation at national and international scientific meetings.

Trial registration number

ACTRN12621000427875.

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Introduction

Despite the success of antiretroviral therapy (ART) in transforming HIV disease into a chronic infection, people living with HIV (PLWH) remain at risk for various non-AIDS inflammatory comorbidities. Risk of non-AIDS comorbidities is associated with gut dysbiosis, epithelial gut damage and subsequent microbial translocation, and increased activation of both circulating CD4+ and CD8+ T-cells. Therefore, in addition to ART, novel gut microbiota-modulating therapies could aid in reducing inflammation and immune activation, gut damage, and microbial translocation. Among various gut-modulation strategies under investigation, the Amazonian fruit Camu Camu (CC) presents itself as a prebiotic candidate based on its anti-inflammatory and antioxidant properties in animal models and tobacco smokers.

Method and analysis

A total of 22 PLWH on ART for more than 2 years, with a viral load <50 copies/mL, a CD4 +count >200 and a CD4+/CD8 +ratio <1 (suggesting increased inflammation and risk for non-AIDS comorbidities), will be recruited in a single arm, non-randomised, interventional pilot trial. We will assess tolerance and effect of supplementation with CC in ART-treated PLWH on reducing gut damage, microbial translocation, inflammation and HIV latent reservoir by various assays.

Ethics and dissemination

The Canadian Institutes of Health Research (CIHR)/Canadian HIV Trials Network (CTN) pilot trial protocol CTNPT032 was approved by the Natural and Non-prescription Health Products Directorate of Health Canada and the research ethics board of the McGill university Health Centre committee (number 2020-5903). Results will be made available as free access through publications in peer-reviewed journals and through the CIHR/CTN website.

Trial registration number

NCT04058392.

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Objective

To identify the key individual-level (demographics, attitudes, mobility) and contextual (COVID-19 case numbers, tiers of mobility restrictions, urban districts) determinants of adopting the NHS COVID-19 contact tracing app and continued use overtime.

Design and setting

A three-wave panel survey conducted in England in July 2020 (background survey), November 2020 (first measure of app adoption) and March 2021 (continued use of app and new adopters) linked with official data.

Participants

N=2500 adults living in England, representative of England’s population in terms of regional distribution, age and gender (2011 census).

Primary outcome

Repeated measures of self-reported app usage.

Analytical approach

Multilevel logistic regression linking a range of individual level (from survey) and contextual (from linked data) determinants to app usage.

Results

We observe initial app uptake at 41%, 95% CI (0.39% to 0.43%), and a 12% drop-out rate by March 2021, 95% CI (0.10% to 0.14%). We also found that 7% of nonusers as of wave 2 became new adopters by wave 3, 95% CI (0.05% to 0.08%). Initial uptake (or failure to use) of the app associated with social norms, privacy concerns and misinformation about third-party data access, with those living in postal districts with restrictions on mobility less likely to use the app. Perceived lack of transparent evidence of effectiveness was associated with drop-out of use. In addition, those who trusted the government were more likely to adopt in wave 3 as new adopters.

Conclusions

Successful uptake of the contact tracing app should be evaluated within the wider context of the UK Government’s response to the crisis. Trust in government is key to adoption of the app in wave 3 while continued use is linked to perceptions of transparent evidence. Providing clear information to address privacy concerns could increase uptake, however, the disparities in continued use among ethnic minority participants needs further investigation.

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Objective

To elucidate the symptoms of laboratory-confirmed COVID-19 cases as compared with laboratory-confirmed negative individuals and to the untested general population among all participants who reported symptoms within a large prospective cohort study.

Setting and design

This work was conducted within the framework of the Arizona CoVHORT, a longitudinal prospective cohort study conducted among Arizona residents.

Participants

Eligible participants were any individual living in Arizona and were recruited from across Arizona via COVID-19 case investigations, participation in testing studies and a postcard mailing effort.

Primary and secondary outcome measures

The primary outcome measure was a comparison of the type and frequency of symptoms between COVID-19-positive cases, tested but negative individuals and the general untested population who reported experiencing symptoms consistent with COVID-19.

Results

Of the 1335 laboratory-confirmed COVID-19 cases, 180 (13.5%) reported having no symptoms. Of those that did report symptoms, the most commonly reported were fatigue (82.2%), headache (74.6%), aches, pains or sore muscles (66.3%), loss of taste or smell (62.8) and cough (61.9%). In adjusted logistic regression models, COVID-19-positive participants were more likely than negative participants to experience loss of taste and smell (OR 12.1; 95% CI 9.6 to 15.2), bone or nerve pain (OR 3.0; 95% CI 2.2 to 4.1), headache (OR 2.6; 95% CI 2.2 to 3.2), nausea (OR 2.4; 95% CI 1.9 to 3.1) or diarrhoea (OR 2.1; 95% CI 1.7 to 2.6). Fatigue (82.9) and headache (74.9) had the highest sensitivities among symptoms, while loss of taste or smell (87.2) and bone or nerve pain (92.9) had the high specificities among significant symptoms associated with COVID-19.

Conclusion

When comparing confirmed COVID-19 cases with either confirmed negative or untested participants, the pattern of symptoms that discriminates SARS-CoV-2 infection from those arising from other potential circulating pathogens may differ from general reports of symptoms among cases alone.

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Purpose

The Asking Questions about Alcohol in Pregnancy (AQUA) study, established in 2011, is a prebirth cohort of 1570 mother and child pairs designed to assess the effects of low to moderate prenatal alcohol exposure and sporadic binge drinking on long-term child development. Women attending general antenatal clinics in public hospitals in Melbourne, Australia, were recruited in their first trimester, followed up three times during pregnancy and at 12 and 24 months postpartum. The current follow-up of the 6–8-year-old children aims to strengthen our understanding of the relationship between these levels of prenatal alcohol exposure and neuropsychological functioning, facial dysmorphology, brain structure and function.

Participants

Between June 2018 and April 2021, 802 of the 1342 eligible AQUA study families completed a parent-report questionnaire (60%). Restrictions associated with COVID-19 pandemic disrupted recruitment, but early school-age neuropsychological assessments were undertaken with 696 children (52%), and 482 (36%) craniofacial images were collected. A preplanned, exposure-representative subset of 146 children completed a brain MRI. An existing biobank was extended through collection of 427 (32%) child buccal swabs.

Findings to date

Over half (59%) of mothers consumed some alcohol during pregnancy, with one in five reporting at least one binge-drinking episode prior to pregnancy recognition. Children’s craniofacial shape was examined at 12 months of age, and low to moderate prenatal alcohol exposure was associated with subtle midface changes. At 2 years of age, formal developmental assessments showed no evidence that cognitive, language or motor outcome was associated with any of exposure level.

Future plans

We will investigate the relationship between prenatal alcohol exposure and specific aspects of neurodevelopment at 6–8 years, including craniofacial shape, brain structure and function. The contribution of genetics and epigenetics to individual variation in outcomes will be examined in conjunction with national and international collaborations.

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Objectives

Healthcare workers (HCWs) are among the risk groups for COVID-19. Determining transmission routes and risk levels during healthcare is of great importance in preventing nosocomial outbreaks. This study aimed to investigate the frequency of nosocomial transmission and factors affecting the transmission in HCW.

Methods

HCWs admitted to the infectious diseases outpatient clinic due to contact with a COVID-19 patient and diagnosed with SARS-COV-2 by reverse-transcriptase PCR (RT-PCR) between 20 March 2020 and 30 June 2020 were included in the study.

Results

A total of 822 HCWs with 295 low, 284 intermediate and 243 high-risk exposures were included in the study. 27.1% of the HCWs were male, and the median age was 31.9 years (20–62). 89.5% of these patients were directly in charge of patient care. Of the index cases contacted, 72.6% were HCW, and 27.4% were non-HCW patients. Most of the risky exposure (51.7%) occurred in nurses. The occurrence frequency of high-risk exposure was lower in those assigned to direct patient care when compared with the occurrence frequency of moderate-risk or low-risk exposures (76.5%, 94.7, 95.3, respectively p<0.001). In most high-risk exposures (220/253), the index cases were HCWs (p<0.001). Symptoms were detected in 311 of the HCWs (37.8%) during the follow-up. The median time to perform SARS-CoV-2 RT-PCR was 5.3 days (IQR) after the last risky exposure. In multivariate analysis, SARS-CoV-2 RT-PCR positivity was 5.65 times higher in HCWs not directly involved in patient care than HCWs who are not involved in patient care (95% CI 2.437 to 13.111; p<0.001).

Conclusions

This study provides particularly useful information on post-exposure COVID-19 follow-up and management of working schedules and procedures of HCWs.

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Objectives

The COVID-19 pandemic has produced radical changes in international health services. In Ireland, the National Ambulance Service established a novel home and community testing service that was central to the national COVID-19 screening programme. This service was overseen by a multidisciplinary response room. This research examined the response room service, particularly areas that performed well and areas requiring improvement, using a quality improvement (QI) framework.

Design

This was a qualitative study comprising semi-structured, individual interviews. Maximum variation sampling was used. The data were analysed using an established thematic analysis procedure. The analysis was guided by the framework, which comprised six QI drivers.

Setting

Response room employees, including clinicians, dispatchers and administrators, were interviewed via telephone.

Results

Leadership for quality: participants valued person-oriented leadership, including regular, open communication and consultation with staff. Person/family engagement: participants endeavoured to provide patient-centred care. Formal patient feedback mechanisms and shared decision-making could be beneficial in the future. Staff engagement: working in a response room could affect well-being, though it also provided networking and learning opportunities. Staff require support and teambuilding. Use of improvement methods: improvements were made in a relatively informal, ad hoc manner. The use of robust methods based on improvement science was not reported. Measurement for quality: data were collected to improve efficiency and accuracy. More rigorous measurement would be beneficial, especially formally collecting stakeholder feedback. Governance for quality: close alignment with collaborators and clear communication with staff are essential. Information and communications technology for quality: this seventh driver was added because the importance of information technology specially designed for pandemics was frequently highlighted.

Conclusions

The study provides insights on what worked well and what required improvement in a pandemic response room. It can inform health services, particularly emergency services, in their preparation for additional COVID-19 waves, as well as future crises.

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Objective

To use the digital story completion method to prompt participants to describe thoughts, fears and mental health experiences in response to a story stem about COVID-19, to capture a specific sociohistoric moment.

Design

We used digital story completion, a qualitative research method, to gather narratives from Australians coping with physical distancing and social restriction measures. Our reflexive thematic analysis of the data was underpinned by a constructionist approach to reflect the importance of social context in understanding health experiences.

Setting

Australia.

Participants

52 people living in Australia (aged 18 years and over).

Results

Four meta-themes were prevalent across 52 stories submitted: (1) expressions of mental distress linked to COVID-19; (2) various coping strategies offered by characters in stories; (3) narratives outlining social support offered to alleviate distress; and (4) specialised COVID-19 vocabulary.

Conclusion

We cautiously propose that points of convergence across stories indicate a level of shared experience among participants relating to COVID-19 in Australia. We suggest this is due to intensive media coverage of the pandemic, persistent public health messaging, engagement with social media and instant messaging technologies, and extended lockdowns that impacted the mental health of vast numbers of Australians.

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Objectives

Existing UK prognostic models for patients admitted to the hospital with COVID-19 are limited by reliance on comorbidities, which are under-recorded in secondary care, and lack of imaging data among the candidate predictors. Our aims were to develop and externally validate novel prognostic models for adverse outcomes (death and intensive therapy unit (ITU) admission) in UK secondary care and externally validate the existing 4C score.

Design

Candidate predictors included demographic variables, symptoms, physiological measures, imaging and laboratory tests. Final models used logistic regression with stepwise selection.

Setting

Model development was performed in data from University Hospitals Birmingham (UHB). External validation was performed in the CovidCollab dataset.

Participants

Patients with COVID-19 admitted to UHB January–August 2020 were included.

Main outcome measures

Death and ITU admission within 28 days of admission.

Results

1040 patients with COVID-19 were included in the derivation cohort; 288 (28%) died and 183 (18%) were admitted to ITU within 28 days of admission. Area under the receiver operating characteristic curve (AUROC) for mortality was 0.791 (95% CI 0.761 to 0.822) in UHB and 0.767 (95% CI 0.754 to 0.780) in CovidCollab; AUROC for ITU admission was 0.906 (95% CI 0.883 to 0.929) in UHB and 0.811 (95% CI 0.795 to 0.828) in CovidCollab. Models showed good calibration. Addition of comorbidities to candidate predictors did not improve model performance. AUROC for the International Severe Acute Respiratory and Emerging Infection Consortium 4C score in the UHB dataset was 0.753 (95% CI 0.720 to 0.785).

Conclusions

The novel prognostic models showed good discrimination and calibration in derivation and external validation datasets, and performed at least as well as the existing 4C score using only routinely collected patient information. The models can be integrated into electronic medical records systems to calculate each individual patient’s probability of death or ITU admission at the time of hospital admission. Implementation of the models and clinical utility should be evaluated.

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AbstractBackgroundPeople in prison are at increased risk of SARS-CoV-2 infection due to overcrowding and challenges in implementing infection prevention and control measures. We examined the seroprevalence of SARS-CoV-2 and associated carceral risk factors among incarcerated adult men in Quebec, Canada.MethodsWe conducted a cross-sectional seroprevalence study in 2021 in three provincial prisons, representing 45% of Quebec’s incarcerated male provincial population. The primary outcome was SARS-CoV-2 antibody seropositivity (Roche Elecsys® serology test). Participants completed self-administered questionnaires on sociodemographic, clinical, and carceral characteristics. The association of carceral variables with SARS-CoV-2 seropositivity was examined using Poisson regression models with robust standard errors. Crude and adjusted prevalence ratios (aPR) with 95% confidence intervals (95%CI) were calculated.ResultsBetween January 19 and September 15, 2021, 246 of 1,100 (22%) recruited individuals tested positive across three prisons (range 15–27%). Seropositivity increased with time spent in prison since March 2020 (aPR 2.17, 95%CI 1.53–3.07 for “all” vs. “little time”), employment during incarceration (aPR 1.64, 95%CI 1.28–2.11 vs. not), shared meal consumption during incarceration (“with cellmates”: aPR 1.46, 95%CI 1.08–1.97 vs. “alone”; “with sector”: aPR 1.34, 95%CI 1.03–1.74 vs. “alone”), and incarceration post-prison outbreak (aPR 2.32, 95% CI 1.69–3.18 vs. “pre-outbreak”).ConclusionsThe seroprevalence of SARS-CoV-2 among incarcerated individuals was high and varied between prisons. Several carceral factors were associated with seropositivity, underscoring the importance of decarceration and occupational safety measures, individual meal consumption, and enhanced infection prevention and control measures including vaccination during incarceration.

AbstractOur case report describes the rapid detection of the SARS-CoV-2 omicron variant using a combination of targeted spike SNP PCR and viral genome sequencing. This case occurred in a fully vaccinated and boosted returning traveler with mild symptoms who was identified through community surveillance rather than presentation for clinical care.

AbstractWhile SARS-CoV-2 vaccines prevent severe disease effectively, post-vaccination ‘breakthrough’ COVID-19 infections and transmission among vaccinated individuals remain ongoing concerns. We present an in-depth characterization of transmission and immunity among vaccinated individuals in a household, revealing complex dynamics and unappreciated comorbidities, including autoimmunity to type1 interferon in the presumptive index case.

AbstractBackgroundSeveral studies have investigated whether pregnancy is a risk factor for developing severe COVID-19; however, the results remain controversial. In addition, the information regarding risk factors for developing severe COVID-19 in pregnant women is limited.MethodsA retrospective cohort study analyzing the data from the nationwide COVID-19 registry in Japan was conducted. Propensity score matched analysis was performed to compare COVID-19 severity between pregnant and nonpregnant women. Multivariate analysis was also conducted to evaluate risk factors for developing moderate-to-severe COVID-19 in pregnant women.ResultsDuring the study period, 254 pregnant and 3752 nonpregnant women of reproductive age were identified. After propensity score matching, 187 pregnant women and 935 nonpregnant women were selected. A composite outcome of moderate-to-severe COVID-19 was more frequently observed in pregnant women than that of nonpregnant women (n=18, 9.6% vs. n=46, 4.9%; P=0.0155). In multivariate analysis, the presence of underlying diseases and being in the second-to-third trimester of pregnancy were recognized as risk factors for moderate-to-severe COVID-19 in pregnant women (odds ratio [95% confidence interval]: 5.295 [1.21-23.069] and 3.871 [1.201-12.477], respectively).ConclusionsPregnancy could be a risk factor for moderate-to-severe COVID-19 for women in Japan. In addition to the presence of comorbidities, advanced pregnancy stages may contribute to greater risks for developing moderate-to-severe COVID-19 in pregnant women.

AbstractBackgroundAcute respiratory infections (ARI) are the most common infectious diseases globally. Community surveillance may provide a more comprehensive picture of disease burden than medically-attended illness alone.MethodsIn this longitudinal study conducted from 2012-2017 in the Washington Heights/Inwood area of New York City, we enrolled 405 households with 1,915 individuals. Households were sent research text messages twice weekly inquiring about ARI symptoms. Research staff confirmed symptoms by follow-up call. If ≥2 criteria for ARI were met (fever/feverish, cough, congestion, pharyngitis, myalgias), staff obtained a mid-turbinate nasal swab in participants’ homes. Swabs were tested using the FilmArray RT-PCR respiratory panel.ResultsAmong participants, 43.9% were children, and 12.8% had a chronic respiratory condition. During the five years, 114,724 text messages were sent; the average response rate was 78.8% +/- 6.8%. Swabs were collected for 91.4% (2756/3016) of confirmed ARI; 58.7% had a pathogen detected. Rhino/enteroviruses (51.9%), human coronaviruses (13.9%) and influenza (13.2%) were most commonly detected. The overall incidence was 0.62 ARI/person-year, highest (1.73) in <2 year-olds and lowest (0.46) in 18-49 year-olds. Approximately one-fourth of those with ARI sought healthcare; percents differed by pathogen, demographic factors, and presence of a chronic respiratory condition.ConclusionsText messaging is a novel method for community-based surveillance that could be used both seasonally as well as during outbreaks, epidemics and pandemics. The importance of community surveillance to accurately estimate disease burden is underscored by the findings of low rates of care-seeking that varied by demographic factors and pathogens.

AbstractBackgroundThe effect of pneumococcal vaccination of mothers with HIV on infant responses to childhood vaccination has not been studied. We compared the immunogenicity of PCV-10 in HIV-exposed uninfected infants born to mothers who received PCV-10, PPV-23 or placebo during pregnancy.MethodsAntibody levels against seven serotypes were measured at birth, before the 1 st and 2 nd doses of PCV-10 and after the completion of the 2-dose regimen in 347 infants, including 112 born to mothers who received PPV-23, 112 PCV-10, and 119 placebo during pregnancy. Seroprotection was defined by antibody levels ≥0.35µg/ml.ResultsAt birth and 8 weeks of life, antibody levels were similar in infants born to PCV-10- or PPV-23-recipient mothers and higher than infants of placebo-recipient mothers. After the last dose of PCV-10, infants in the maternal PCV-10 group had significantly lower antibody levels against five serotypes compared to infants in the maternal PPV-23 group; against three serotypes compared to infants in the maternal placebo group; and did not have higher antibody levels against any serotype. The seroprotection rate against seven serotypes was 50% in infants in the maternal PCV-10 compared to 71% in each of the maternal PPV-23 and placebo groups (p<0.0001).ConclusionsAdministration of PCV-10 during pregnancy was associated with decreased antibody responses to PCV-10 and seroprotection rates in infants. Considering that PCV-10 and PPV-23 had similar immunogenicity in pregnant women with HIV and that administration of PPV-23 did not affect the immunogenicity of PCV-10 in infants, PPV-23 in pregnancy may be preferred over PCV-10.

Abstract

Background

In the Greater Mekong Subregion of Southeast Asia, Plasmodium vivax malaria is endemic and causes significant morbidity. In this study, the efficacy of chloroquine for treating uncomplicated P. vivax malaria at the eastern and western borders of Myanmar was investigated.

Methods

A total of 197 participants with microscopically confirmed P. vivax infection were enrolled from three townships of the southeastern (Thanbyuzayat and Kawthoung) and western (Kyauktaw) borders of Myanmar. Patients were treated with chloroquine according to the national malaria treatment guidelines and followed for 28 days.

Results

Among the 197 enrollments, 172 completed the 28-day follow-up. Twelve recurrent P. vivax infections, all occurring in the third and fourth week, were detected, resulting in an overall cumulative rate of recurrence of 4.7% [95% confidence interval (CI) 1.5–7.8]. The incidence rate of recurrence varied among the three sites. In Thanbyuzayat township, no patients had recurrent parasitemia between days 7 and 28. In contrast, Kyauktaw township had a day 28 cumulative incidence rate of recurrence of 7.2% (95% CI 0.6–13.9%) compared to 6.9% (95% CI 0.6–13.2) in Kawthoung township.

Conclusion

While this study confirmed the relatively high clinical efficacy of chloroquine for treating P. vivax in Myanmar with modest rates of recurrent infections within 28 days of the treatment, it also revealed considerable geographical heterogeneity of chloroquine efficacy, which warrants continuous surveillance efforts.

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Abstract

Background

Many studies examined the spread of SARS-CoV-2 within populations using seroprevalence. Healthcare workers are a high-risk population due to patient contact, and studies are needed to examine seroprevalence of SARS-CoV-2 antibodies among healthcare workers. Our study investigates the seroprevalence of anti-SARS-CoV-2 antibodies among staff at primary healthcare institutions in Prishtina, and factors associated with seroprevalence.

Methods

We carried out a cross-sectional survey including SARS-CoV-2 serological testing and questionnaires with primary healthcare workers from primary healthcare facilities in the Prishtina, the capital city of Kosovo. We calculated prevalence of anti-SARS-CoV-2 antibodies, and of self-reported positive PCR test among primary healthcare workers, as well as crude and adjusted ORs for explanatory factors.

Results

Eighty-three of the healthcare workers (17.47%) tested positive for SARS-CoV-2 antibodies IgG or IgM, while 231 (48.63%) either had antibodies or a previous positive PCR test. Odds of seropositivity were affected by male gender (OR 2.08, 95% CI 1.20, 3.61), and infected family members (OR 3.61, 95% CI 2.25, 5.79) of healthcare workers. Higher education, being part of larger families and having infected family members gave higher odds of positive PCR test and seropositivity. Other healthcare workers had lower odds of positive PCR test and seropositivity than physicians.

Conclusion

Over 17% of healthcare workers were seropositive for SARS-CoV-2 antibodies and close to half of them were either seropositive or PCR self-reported positive test. Several factors are associated with decreased and increased odds for such outcomes. These findings should be explored further and addressed to Kosovo policy makers, and assist them to intensify vaccination efforts, and maintain control measures until we achieve herd immunity.

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Abstract

Background

Previous reports have described hypogonadism associated with virus infection such as hantavirus, human immunodeficiency virus (HIV) or severe acute respiratory syndrome coronavirus 2 (SARS-COV-2). However, to our best knowledge there has been no case report of secondary hypogonadism following hand, foot, and mouth disease (HFMD).

Case presentation

A previously healthy 28-year-old man with no history of major physical and psychological trauma, presented with bilateral gynecomastia and erectile dysfunction 2 weeks after HFMD. Laboratory testament showed the level of gonadotropin hormones declined. Imaging examination demonstrated no major abnormal change in pituitary or reproductive system. The diagnosis of hypogonadism was established. Then the patient was ordered to maintain mental health outward of hospital without drug intervention. One month after presentation, his gonadotropin hormone level and sexual desire had recovered, while bilateral gynecomastia and erectile dysfunction symptoms disappeared.

Conclusions

Physicians should notice the possibility for hypogonadism in adult patients with a recent history of HFMD.

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Abstract

Background

Early start of highly active antiretroviral therapy (HAART) in perinatally HIV-1 infected children is the optimal strategy to prevent immunological and clinical deterioration. To date, according to EMA, only 35% of antiretroviral drugs are licenced in children < 2 years of age and 60% in those aged 2–12 years, due to the lack of adequate paediatric clinical studies on pharmacokinetics, pharmacodynamics and drug safety in children.

Methods

An observational retrospective study investigating the rate and the outcomes of off-label prescription of HAART was conducted on 225 perinatally HIV-1 infected children enrolled in the Italian Register for HIV Infection in Children and followed-up from 2001 to 2018.

Results

22.2% (50/225) of included children were receiving an off-label HAART regimen at last check. Only 26% (13/50) of off-label children had an undetectable viral load (VL) before the commencing of the regimen and the 52.0% (26/50) had a CD4 + T lymphocyte percentage > 25%. At last check, during the off label regimen, the 80% (40/50) of patients had an undetectable VL, and 90% (45/50) of them displayed CD4 + T lymphocyte percentage > 25%. The most widely used off-label drugs were: dolutegravir/abacavir/lamivudine (16%; 8/50), emtricitbine/tenofovir disoproxil (22%; 11/50), lopinavir/ritonavir (20%; 10/50) and elvitegravir/cobicistat/emtricitabine/ tenofovir alafenamide (10%; 10/50). At logistic regression analysis, detectable VL before starting the current HAART regimen was a risk factor for receiving an off-label therapy (OR: 2.41; 95% CI 1.13–5.19; p = 0.024). Moreover, children < 2 years of age were at increased risk for receiving off-label HAART with respect to older children (OR: 3.24; 95% CI 1063–7.3; p = 0.001). Even if our safety data regarding off-label regimens where poor, no adverse event was reported.

Conclusion

The prescription of an off-label HAART regimen in perinatally HIV-1 infected children was common, in particular in children with detectable VL despite previous HAART and in younger children, especially those receiving their first regimen. Our data suggest similar proportions of virological and immunological successes at last check among children receiving off-label or on-label HAART. Larger studies are needed to better clarify efficacy and safety of off-label HAART regimens in children, in order to allow the enlargement of on-label prescription in children.

…

Abstract

Background

In the Greater Mekong Subregion of Southeast Asia, Plasmodium vivax malaria is endemic and causes significant morbidity. In this study, the efficacy of chloroquine for treating uncomplicated P. vivax malaria at the eastern and western borders of Myanmar was investigated.

Methods

A total of 197 participants with microscopically confirmed P. vivax infection were enrolled from three townships of the southeastern (Thanbyuzayat and Kawthoung) and western (Kyauktaw) borders of Myanmar. Patients were treated with chloroquine according to the national malaria treatment guidelines and followed for 28 days.

Results

Among the 197 enrollments, 172 completed the 28-day follow-up. Twelve recurrent P. vivax infections, all occurring in the third and fourth week, were detected, resulting in an overall cumulative rate of recurrence of 4.7% [95% confidence interval (CI) 1.5–7.8]. The incidence rate of recurrence varied among the three sites. In Thanbyuzayat township, no patients had recurrent parasitemia between days 7 and 28. In contrast, Kyauktaw township had a day 28 cumulative incidence rate of recurrence of 7.2% (95% CI 0.6–13.9%) compared to 6.9% (95% CI 0.6–13.2) in Kawthoung township.

Conclusion

While this study confirmed the relatively high clinical efficacy of chloroquine for treating P. vivax in Myanmar with modest rates of recurrent infections within 28 days of the treatment, it also revealed considerable geographical heterogeneity of chloroquine efficacy, which warrants continuous surveillance efforts.

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Abstract

Background

The evolution of malaria infection has necessitated the development of highly sensitive diagnostic assays, as well as the use of dried blood spots (DBS) as a potential source of deoxyribonucleic acid (DNA) yield for polymerase chain reaction (PCR) assays. This study identified the different Plasmodium species in malaria-positive patients, and the anti-malarial drug resistance profile for Plasmodium falciparum using DBS samples collected from patients attending Kisoro Hospital in Kisoro district, Southwestern Uganda.

Methods

The blood samples were prospectively collected from patients diagnosed with malaria to make DBS, which were then used to extract DNA for real-time PCR and high-resolution melting (HRM) analysis. Plasmodium species were identified by comparing the control and test samples using HRM-PCR derivative curves. Plasmodium falciparum chloroquine (CQ) resistance transporter (pfcrt) and kelch13 to screen the samples for anti-malarial resistance markers. The HRM-PCR derivative curve was used to present a summary distribution of the different Plasmodium species as well as the anti-malarial drug profile.

Results

Of the 152 participants sampled, 98 (64.5%) were females. The average age of the participants was 34.9 years (range: 2 months–81 years). There were 134 samples that showed PCR amplification, confirming the species as Plasmodium. Plasmodium falciparum (N = 122), Plasmodium malariae (N = 6), Plasmodium ovale (N = 4), and Plasmodium vivax (N = 2) were the various Plasmodium species and their proportions. The results showed that 87 (71.3%) of the samples were sensitive strains/wild type (CVMNK), 4 (3.3%) were resistant haplotypes (SVMNT), and 31 (25.4%) were resistant haplotypes (CVIET). Kelch13 C580Y mutation was not detected.

Conclusion

The community served by Kisoro hospital has a high Plasmodium species burden, according to this study. Plasmodium falciparum was the dominant species, and it has shown that resistance to chloroquine is decreasing in the region. Based on this, molecular identification of Plasmodium species is critical for better clinical management. Besides, DBS is an appropriate medium for DNA preservation and storage for future epidemiological studies.

…

Abstract

Background

Previous reports have described hypogonadism associated with virus infection such as hantavirus, human immunodeficiency virus (HIV) or severe acute respiratory syndrome coronavirus 2 (SARS-COV-2). However, to our best knowledge there has been no case report of secondary hypogonadism following hand, foot, and mouth disease (HFMD).

Case presentation

A previously healthy 28-year-old man with no history of major physical and psychological trauma, presented with bilateral gynecomastia and erectile dysfunction 2 weeks after HFMD. Laboratory testament showed the level of gonadotropin hormones declined. Imaging examination demonstrated no major abnormal change in pituitary or reproductive system. The diagnosis of hypogonadism was established. Then the patient was ordered to maintain mental health outward of hospital without drug intervention. One month after presentation, his gonadotropin hormone level and sexual desire had recovered, while bilateral gynecomastia and erectile dysfunction symptoms disappeared.

Conclusions

Physicians should notice the possibility for hypogonadism in adult patients with a recent history of HFMD.

…

Abstract

Background

Granulomatous amoebic encephalitis (GAE) is a rare central nervous system infection caused by the Balamuthia mandrillaris or Acanthamoeba species. Diagnosis is challenging because of the non-specific clinical presentation, cerebrospinal fluid analysis, and radiological features. There is no effective treatment for GAE to date.

Case presentation

A 54-year-old male was admitted to hospital after experiencing acute onset of numbness and weakness on his left limb. Due to the initial consideration of intracranial tumor, surgical removal of the right parietal lesion was performed. However, the patient had a headache accompanied by diplopia, difficulty walking and a new lesion was found in the left occipital-parietal lobe two weeks after the first operation. High-throughput next-generation sequencing (NGS) detected the presence of high copy reads of the B. mandrillaris genome sequence in the patient’s blood, cerebral spinal fluid (CSF), and brain tissue. Pathological investigation of the brain tissue showed granulomatous changes and amoebic trophozoite scattered around blood vessels under high magnification. The patient was re-operated due to developing progressive confusion caused by subfalcine herniation of the left cerebral hemisphere. The lesions of the right parietal lobe were obviously decreasing in size after the first surgery, and the lesions of the left occipital lobe and the sunfalcine herniation didn’t ameliorate two months after the second surgery. The patient was transferred to local hospital for continuous treatment with sulfamethoxazole and azithromycin. After five months of the second surgery, the patient showed good recovery with mild headache.

Conclusions

This is the first report of a patient with B. mandrillaris encephalitis initially confirmed by NGS and have experienced two excisions, responding favorably to the combination of surgeries and medications. Early surgical resection of intracranial lesions combined with drug treatment may offer the chance of a cure.

…

Abstract

Background

This study is a baseline survey to assess the knowledge, attitude and practices with regards to the anthrax disease among the communities before demonstrating a One Health approach for elimination of human anthrax in an endemic district of Odisha. A total of 2670 respondents from 112 villages of 14 blocks were interviewed for the study using a structured questionnaire by multi-stage sampling method. Descriptive statistics were reported and logistic regression was performed to estimate the relationship between the variables and knowledge of anthrax.

Result

Out of 2670 participants in the study, 76.25% were male and about half were illiterate. Most of the respondents (54.19%) were involved in agriculture as an occupation. 71% of the respondents had livestock in their houses and farming was the main purpose for keeping the livestock. Only one-fifth of the respondents (20.26%) knew about anthrax and a majority of them have come across the disease during community outbreaks. Almost 25.9% of livestock owners had knowledge about vaccination against anthrax disease although 83.4% of the livestock owners disposed the animal carcass by burial method.

Conclusion

The study findings indicated that the community members had poor knowledge of cause, symptoms, transmission and prevention of anthrax disease which may be improved by a One Health approach.

…

Abstract

Background

Early start of highly active antiretroviral therapy (HAART) in perinatally HIV-1 infected children is the optimal strategy to prevent immunological and clinical deterioration. To date, according to EMA, only 35% of antiretroviral drugs are licenced in children < 2 years of age and 60% in those aged 2–12 years, due to the lack of adequate paediatric clinical studies on pharmacokinetics, pharmacodynamics and drug safety in children.

Methods

An observational retrospective study investigating the rate and the outcomes of off-label prescription of HAART was conducted on 225 perinatally HIV-1 infected children enrolled in the Italian Register for HIV Infection in Children and followed-up from 2001 to 2018.

Results

22.2% (50/225) of included children were receiving an off-label HAART regimen at last check. Only 26% (13/50) of off-label children had an undetectable viral load (VL) before the commencing of the regimen and the 52.0% (26/50) had a CD4 + T lymphocyte percentage > 25%. At last check, during the off label regimen, the 80% (40/50) of patients had an undetectable VL, and 90% (45/50) of them displayed CD4 + T lymphocyte percentage > 25%. The most widely used off-label drugs were: dolutegravir/abacavir/lamivudine (16%; 8/50), emtricitbine/tenofovir disoproxil (22%; 11/50), lopinavir/ritonavir (20%; 10/50) and elvitegravir/cobicistat/emtricitabine/ tenofovir alafenamide (10%; 10/50). At logistic regression analysis, detectable VL before starting the current HAART regimen was a risk factor for receiving an off-label therapy (OR: 2.41; 95% CI 1.13–5.19; p = 0.024). Moreover, children < 2 years of age were at increased risk for receiving off-label HAART with respect to older children (OR: 3.24; 95% CI 1063–7.3; p = 0.001). Even if our safety data regarding off-label regimens where poor, no adverse event was reported.

Conclusion

The prescription of an off-label HAART regimen in perinatally HIV-1 infected children was common, in particular in children with detectable VL despite previous HAART and in younger children, especially those receiving their first regimen. Our data suggest similar proportions of virological and immunological successes at last check among children receiving off-label or on-label HAART. Larger studies are needed to better clarify efficacy and safety of off-label HAART regimens in children, in order to allow the enlargement of on-label prescription in children.

…

Journal of Medical Virology, Accepted Article.

L. A. Pérez-Vera et al.

S. Esmaeili et al.

M. M. Mitchell et al.

Journal of Medical Virology, Accepted Article.

Journal of Medical Virology, Accepted Article.

Journal of Medical Virology, Accepted Article.

Journal of Medical Virology, Accepted Article.

Journal of Medical Virology, Accepted Article.