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.

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.

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.

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.