The Association of Anticoagulation Intensity with Outcomes in Hospitalized COVID-19 Patients.

Venous thromboembolism (VTE) risk is increased in patients infected with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). A key question was whether increased intensity of anticoagulation would help prevent VTE and improve patient outcomes, including transfer to the intensive care unit (ICU) and mortality. At the start of the coronavirus disease-19 (COVID-19) pandemic, our institution, Boston Medical Center, instituted a VTE risk stratification protocol based on patients' initial D-dimer levels, medical history, and presence of thrombosis to determine whether they should receive standard-dose prophylaxis, high-dose prophylaxis, or therapeutic anticoagulation. We performed a retrospective observational cohort study examining the association of degree of anticoagulation with outcomes in 915 hospitalized COVID-19 patients hospitalized initially on the general inpatient wards between March 1,, 2020, and June 1, 2020. Patients directly hospitalized in the ICU were excluded. Most, 813 patients (89%), in our cohort were on standard-dose prophylaxis; 32 patients (3.5%) received high-dose prophylaxis; 70 patients (7.7%), were treated with therapeutic anticoagulation. VTE occurred in 45 patients (4.9%), and the overall in-hospital mortality rate was 5.4% (49 deaths). On multivariable analysis of clinical outcomes in relation to type of anticoagulation, in the high-dose prophylaxis group, there was a trend towards increased in-hospital mortality (odds ratio 2.4 (0.8-7.5, 95% CI)) and increased ICU transfer (odds ratio 2.2 (0.9-5.7, 95% CI)). Our results suggest that patients receiving high-dose prophylaxis had more severe disease that was not mitigated by intermediate-dose anticoagulation.

Navigating the expanded access investigational new drug protocol for tecovirimat: lessons learned from a public-private hospital partnership during the 2022 NYC mpox outbreak.

During the 2022 mpox outbreak, tecovirimat was accessed through an expanded access investigational new drug (EA-IND) protocol. We leveraged a unique public/private hospital partnership in New York City to create a novel infrastructure to navigate the EA-IND's regulatory requirements and rapidly provide tecovirimat to patients.

Bictegravir-Induced Drug Reaction With Eosinophilia and Systemic Symptoms in a Patient With Acute Human Immunodeficiency Virus.

Although drug reaction with eosinophilia and systemic symptoms (DRESS) is associated with antiretrovirals, there are no published reports of bictegravir-induced DRESS. Bictegravir is recommended as first-line treatment for patients with human immunodeficiency virus (HIV). Recognition of DRESS, its skin manifestations, and potential complications is vital for appropriate care and management of acute HIV.

Performance of three screening tools to predict COVID-19 positivity in emergency department patients.

BACKGROUND: COVID-19 symptoms vary widely. This retrospective study assessed which of three clinical screening tools-a nursing triage screen (NTS), an ED review of systems (ROS) performed by physicians and physician assistants and a standardised ED attending (ie, consultant) physician COVID-19 probability assessment (PA)-best identified patients with COVID-19 on a subsequent reverse transcription PCR (RT-PCR) confirmation. METHODS: All patients admitted to Boston Medical Center from the ED between 27 April 2020 and 17 May 2020 were included. Sensitivity, specificity and positive predictive value (PPV) and negative predictive value (NPV) were calculated for each method. Logistic regression assessed each tool's performance. RESULTS: The attending physician PA had higher sensitivity (0.62, 95% CI 0.53 to 0.71) than the NTS (0.46, 95% CI 0.37 to 0.56) and higher specificity (0.76, 95% CI 0.72 to 0.80) than the NTS (0.71, 95% CI 0.66 to 0.75) and ED ROS (0.62, 95% CI 0.58 to 0.67). Categorisation as moderate or high probability on the ED physician PA was associated with the highest odds of having COVID-19 in regression analyses (adjusted OR=4.61, 95% CI 3.01 to 7.06). All methods had a low PPV (ranging from 0.26 for the ED ROS to 0.40 for the attending physician PA) and a similar NPV (0.84 for both the NTS and the ED ROS, and 0.89 for the attending physician PA). CONCLUSION: The ED attending PA had higher sensitivity and specificity than the other two methods, but none was accurate enough to replace a COVID-19 RT-PCR test in a clinical setting where transmission control is crucial. Therefore, we recommend universal COVID-19 testing prior to all admissions.

Mpox in the Emergency Department: A Case Series.

Introduction: We sought to describe the demographic characteristics, clinical features, and outcomes of a cohort of patients who presented to our emergency departments with mpox (formerly known as monkeypox) infection between May 1-August 1, 2022. Case Series: We identified 145 patients tested for mpox, of whom 79 were positive. All positive cases were among cisgender men, and the majority (92%) were among men who have sex with men. A large number of patients (39%) were human immunodeficiency virus (HIV) positive. There was wide variation in emergency department (ED) length of stay (range 2-16 hours, median 4 hours) and test turnaround time (range 1-11 days, median 4 days). Most patients (95%) were discharged, although a substantial proportion (22%) had a return visit within 30 days, and 28% ultimately received tecrovirimat. Conclusion: Patients who presented to our ED with mpox had similar demographic characteristics and clinical features as those described in other clinical settings during the 2022 outbreak. While there were operational challenges to the evaluation and management of these patients, demonstrated by variable lengths of stay and frequent return visits, most were able to be discharged.

Exploring Coronavirus Disease 2019 Vaccine Hesitancy on Twitter Using Sentiment Analysis and Natural Language Processing Algorithms.

BACKGROUND: Vaccination can help control the coronavirus disease 2019 (COVID-19) pandemic but is undermined by vaccine hesitancy. Social media disseminates information and misinformation regarding vaccination. Tracking and analyzing social media vaccine sentiment could better prepare health professionals for vaccination conversations and campaigns. METHODS: A real-time big data analytics framework was developed using natural language processing sentiment analysis, a form of artificial intelligence. The framework ingests, processes, and analyzes tweets for sentiment and content themes, such as natural health or personal freedom, in real time. A later dataset evaluated the relationship between Twitter sentiment scores and vaccination rates in the United States. RESULTS: The real-time analytics framework showed a widening gap in sentiment with more negative sentiment after vaccine rollout. After rollout, using a static dataset, an increase in positive sentiment was followed by an increase in vaccination. Lag cross-correlation analysis across US regions showed evidence that once all adults were eligible for vaccination, the sentiment score consistently correlated with vaccination rate with a lag of around 1 week. The Granger causality test further demonstrated that tweet sentiment scores may help predict vaccination rates. CONCLUSIONS: Social media has influenced the COVID-19 response through valuable information and misinformation and distrust. This tool was used to collect and analyze tweets at scale in real time to study sentiment and key terms of interest. Separate tweet analysis showed that vaccination rates tracked regionally with Twitter vaccine sentiment and might forecast changes in vaccine uptake and/or guide targeted social media and vaccination strategies. Further work is needed to analyze the interplay between specific populations, vaccine sentiment, and vaccination rates.

COVID-19 guidelines for pregnant women and new mothers: A systematic evidence review.

BACKGROUND: Nearly a year after COVID-19 was initially detected, guidance for pregnant and new mothers remains varied. OBJECTIVE: The goal of this systematic review is to summarize recommendations for three areas of maternal and fetal care-breastfeeding, post-partum social distancing, and decontamination. SEARCH STRATEGY: We searched PubMed, Embase and Web of Science spanning from inception to November 9, 2020. SELECTION CRITERIA: Articles were included if they focused on COVID-positive mothers, commented on at least one of the three areas of interest, and were published in English. DATA COLLECTION AND ANALYSIS: Our combined database search yielded 385 articles. After removing duplicates and articles that did not cover the correct populations or subject matter, a total of 74 articles remained in our analysis. MAIN RESULTS: Most articles recommended direct breastfeeding with enhanced precaution measures. Recommendations regarding post-partum social distancing varied, although articles published more recently often recommended keeping the mother and newborn in the same room when possible. Decontamination recommendations emphasized mask wearing, good hand hygiene, and proper cleaning of surfaces. CONCLUSION: In general, there was a focus on shared decision making when approaching topics such as breastfeeding and post-partum social distancing. Guidelines for decontamination were fairly uniform.

Institutional policies and readiness in management of critical illness among patients with viral hemorrhagic fever.

OBJECTIVE: In response to the 2013-2016 Ebola virus disease outbreak, the US government designated certain healthcare institutions as Ebola treatment centers (ETCs) to better prepare for future emerging infectious disease outbreaks. This study investigated ETC experiences and critical care policies for patients with viral hemorrhagic fever (VHF). DESIGN: A 58-item questionnaire elicited information on policies for 9 critical care interventions, factors that limited care provision, and innovations developed to deliver care. SETTING AND PARTICIPANTS: The questionnaire was sent to 82 ETCs. METHODS: We analyzed ordinal and categorical data pertaining to the ETC characteristics and descriptive data about their policies and perceived challenges. Statistical analyses assessed whether ETCs with experience caring for VHF patients were more likely to have critical care policies than those that did not. RESULTS: Of the 27 ETCs who responded, 17 (63%) were included. Among them, 8 (47%) reported experience caring for persons under investigation or confirmed cases of VHF. Most felt ready to provide intubation, chest compressions, and renal replacement therapy to these patients. The factors most cited for limiting care were staff safety and clinical futility. Innovations developed to better provide care included increased simulation training and alternative technologies for procedures and communication. CONCLUSIONS: There were broad similarities in critical care policies and limitations among institutions. There were several interventions, namely ECMO and cricothyrotomy, which few institutions felt ready to provide. Future studies could identify obstacles to providing these interventions and explore policy changes after increased experience with novel infectious diseases, such as COVID-19.

Impact of Universal Antiretroviral Treatment Eligibility on Rapid Treatment Initiation Among Young Adolescents with Human Immunodeficiency Virus in Sub-Saharan Africa.

BACKGROUND: Young adolescents with perinatally acquired human immunodeficiency virus (HIV) are at risk for poor care outcomes. We examined whether universal antiretroviral treatment (ART) eligibility policies (Treat All) improved rapid ART initiation after care enrollment among 10-14-year-olds in 7 sub-Saharan African countries. METHODS: Regression discontinuity analysis and data for 6912 patients aged 10-14-years were used to estimate changes in rapid ART initiation (within 30 days of care enrollment) after adoption of Treat All policies in 2 groups of countries: Uganda and Zambia (policy adopted in 2013) and Burundi, Democratic Republic of the Congo, Kenya, Malawi, and Rwanda (policy adopted in 2016). RESULTS: There were immediate increases in rapid ART initiation among young adolescents after national adoption of Treat All. Increases were greater in countries adopting the policy in 2016 than in those adopting it in 2013: 23.4 percentage points (pp) (95% confidence interval, 13.9-32.8) versus 11.2pp (2.5-19.9). However, the rate of increase in rapid ART initiation among 10-14-year-olds rose appreciably in countries with earlier treatment expansions, from 1.5pp per year before Treat All to 7.7pp per year afterward. CONCLUSIONS: Universal ART eligibility has increased rapid treatment initiation among young adolescents enrolling in HIV care. Further research should assess their retention in care and viral suppression under Treat All.

Psychosocial Factors Associated with Food Insufficiency Among People Living with HIV/AIDS (PLWH) Initiating ART in Ethiopia.

Food insufficiency is associated with suboptimal HIV treatment outcomes. Less is known about psychosocial correlates of food insufficiency among PLWH. This sample includes 1176 adults initiating antiretroviral therapy at HIV clinics in Ethiopia. Logistic regression modeled the association of psychological distress, social support, and HIV-related stigma with food insufficiency. Among respondents, 21.4% reported frequent food insufficiency. Psychological distress [adjusted odds ratio (aOR) 2.61 (95% CI 1.79, 3.82)], low social support [aOR 2.20 (95% CI 1.57, 3.09)] and enacted stigma [aOR 1.69 (95% CI 1.26, 2.25)] were independently associated with food insufficiency. Food insufficiency interventions should address its accompanying psychosocial context.

Cost-effectiveness of rapid hepatitis C virus (HCV) testing and simultaneous rapid HCV and HIV testing in substance abuse treatment programs.

AIMS: To evaluate the cost-effectiveness of rapid hepatitis C virus (HCV) and simultaneous HCV/HIV antibody testing in substance abuse treatment programs. DESIGN: We used a decision analytic model to compare the cost-effectiveness of no HCV testing referral or offer, off-site HCV testing referral, on-site rapid HCV testing offer and on-site rapid HCV and HIV testing offer. Base case inputs included 11% undetected chronic HCV, 0.4% undetected HIV, 35% HCV co-infection among HIV-infected, 53% linked to HCV care after testing antibody-positive and 67% linked to HIV care. Disease outcomes were estimated from established computer simulation models of HCV [Hepatitis C Cost-Effectiveness (HEP-CE)] and HIV [Cost-Effectiveness of Preventing AIDS Complications (CEPAC)]. SETTING AND PARTICIPANTS: Data on test acceptance and costs were from a national randomized trial of HIV testing strategies conducted at 12 substance abuse treatment programs in the United States. MEASUREMENTS: Lifetime costs (2011 US$) and quality-adjusted life years (QALYs) discounted at 3% annually; incremental cost-effectiveness ratios (ICERs). FINDINGS: On-site rapid HCV testing had an ICER of $18,300/QALY compared with no testing, and was more efficient than (dominated) off-site HCV testing referral. On-site rapid HCV and HIV testing had an ICER of $64,500/QALY compared with on-site rapid HCV testing alone. In one- and two-way sensitivity analyses, the ICER of on-site rapid HCV and HIV testing remained <$100,000/QALY, except when undetected HIV prevalence was <0.1% or when we assumed frequent HIV testing elsewhere. The ICER remained <$100,000/QALY in 91% of probabilistic sensitivity analyses. CONCLUSIONS: On-site rapid hepatitis C virus and HIV testing in substance abuse treatment programs is cost-effective at a <$100,000/quality-adjusted life year threshold.

Development, calibration and performance of an HIV transmission model incorporating natural history and behavioral patterns: application in South Africa.

Understanding HIV transmission dynamics is critical to estimating the potential population-wide impact of HIV prevention and treatment interventions. We developed an individual-based simulation model of the heterosexual HIV epidemic in South Africa and linked it to the previously published Cost-Effectiveness of Preventing AIDS Complications (CEPAC) International Model, which simulates the natural history and treatment of HIV. In this new model, the CEPAC Dynamic Model (CDM), the probability of HIV transmission per sexual encounter between short-term, long-term and commercial sex worker partners depends upon the HIV RNA and disease stage of the infected partner, condom use, and the circumcision status of the uninfected male partner. We included behavioral, demographic and biological values in the CDM and calibrated to HIV prevalence in South Africa pre-antiretroviral therapy. Using a multi-step fitting procedure based on Bayesian melding methodology, we performed 264,225 simulations of the HIV epidemic in South Africa and identified 3,750 parameter sets that created an epidemic and had behavioral characteristics representative of a South African population pre-ART. Of these parameter sets, 564 contributed 90% of the likelihood weight to the fit, and closely reproduced the UNAIDS HIV prevalence curve in South Africa from 1990-2002. The calibration was sensitive to changes in the rate of formation of short-duration partnerships and to the partnership acquisition rate among high-risk individuals, both of which impacted concurrency. Runs that closely fit to historical HIV prevalence reflect diverse ranges for individual parameter values and predict a wide range of possible steady-state prevalence in the absence of interventions, illustrating the value of the calibration procedure and utility of the model for evaluating interventions. This model, which includes detailed behavioral patterns and HIV natural history, closely fits HIV prevalence estimates.

The cost-effectiveness of improved hepatitis C virus therapies in HIV/hepatitis C virus coinfected patients.

OBJECTIVES: To evaluate the effectiveness and cost-effectiveness of strategies to treat hepatitis C virus (HCV) in HIV/HCV coinfected patients in the United States. PARTICIPANTS: Simulated cohort of HIV/HCV genotype 1 coinfected, noncirrhotic, HCV treatment-naive individuals enrolled in US HIV guideline-concordant care. DESIGN/INTERVENTIONS: Monte Carlo simulation comparing five strategies: no treatment; dual therapy with pegylated-interferon (PEG) and ribavirin (RBV); 'PEG/RBV trial' in which all patients initiate dual therapy and switch to triple therapy upon failure; 'IL28B triage' in which patients initiate either dual therapy or triple therapy based on their IL28B allele type; and PEG/RBV and telaprevir (TPV) triple therapy. Sensitivity analyses varied efficacies and costs and included a scenario with interferon (IFN)-free therapy. MAIN MEASURES: Sustained virologic response (SVR), life expectancy, discounted quality-adjusted life expectancy (QALE), lifetime medical costs, and incremental cost-effectiveness ratios (ICERs) in $/quality-adjusted life years (QALY) gained. RESULTS: 'PEG/RBV trial,' 'IL28B triage,' and 'triple therapy' each provided 72% SVR and extended QALE compared with 'dual therapy' by 1.12, 1.14, and 1.15 QALY, respectively. The ICER of 'PEG/RBV trial' compared with 'dual therapy' was $37 500/QALY. 'IL28B triage' and 'triple therapy' provided little benefit compared with 'PEG/RBV trial,' and both had ICERs exceeding $300 000/QALY. In sensitivity analyses, IFN-free treatment attaining 90% SVR had an ICER less than $100 000/QALY compared with 'PEG/RBV trial' when its cost was $109 000 or less (125% of the cost of PEG/RBV/TVR). CONCLUSION: HCV protease inhibitors are most efficiently used in HIV/HCV coinfection after a trial of PEG/RBV, sparing protease inhibitors for those who attain rapid virologic response and SVR. The cost-effectiveness of IFN-free regimens for HIV/HCV coinfection will depend on the cost of these therapies.

Routine HIV screening in Portugal: clinical impact and cost-effectiveness.

OBJECTIVE: To compare the clinical outcomes and cost-effectiveness of routine HIV screening in Portugal to the current practice of targeted and on-demand screening. DESIGN: We used Portuguese national clinical and economic data to conduct a model-based assessment. METHODS: We compared current HIV detection practices to strategies of increasingly frequent routine HIV screening in Portuguese adults aged 18-69. We considered several subpopulations and geographic regions with varying levels of undetected HIV prevalence and incidence. Baseline inputs for the national case included undiagnosed HIV prevalence 0.16%, annual incidence 0.03%, mean population age 43 years, mean CD4 count at care initiation 292 cells/µL, 63% HIV test acceptance, 78% linkage to care, and HIV rapid test cost €6 under the proposed routine screening program. Outcomes included quality-adjusted survival, secondary HIV transmission, cost, and incremental cost-effectiveness. RESULTS: One-time national HIV screening increased HIV-infected survival from 164.09 quality-adjusted life months (QALMs) to 166.83 QALMs compared to current practice and had an incremental cost-effectiveness ratio (ICER) of €28,000 per quality-adjusted life year (QALY). Screening more frequently in higher-risk groups was cost-effective: for example screening annually in men who have sex with men or screening every three years in regions with higher incidence and prevalence produced ICERs of €21,000/QALY and €34,000/QALY, respectively. CONCLUSIONS: One-time HIV screening in the Portuguese national population will increase survival and is cost-effective by international standards. More frequent screening in higher-risk regions and subpopulations is also justified. Given Portugal's challenging economic priorities, we recommend prioritizing screening in higher-risk populations and geographic settings.