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Abstract Aneurysm rupture is a life-threatening event, yet its underlying mechanisms remain largely unclear. This study investigated the fracture properties of the thoracic aneurysmatic aorta (TAA) using the symmetry-constraint Compact Tension (symconCT) test and compared results to native and enzymatic-treated porcine aortas’ tests. With age, the aortic stiffness increased, and tissues ruptured at lower fracture energy $$D$$ . Patients with bicuspid aortic valves were more sensitive to age, had stronger aortas and required more $$D$$ than tricuspid valves individuals (peak load: axial loading 4.42 $$\pm$$ 1.56 N vs 2.51 $$\pm$$ 1.60 N; circumferential loading 5.76 $$\pm$$ 2.43 N vs 4.82 $$\pm$$ 1.49 N. Fracture energy: axial loading 1.92 $$\pm$$ 0.60 kJ m-2 vs 0.74 $$\pm$$ 0.50 kJ m-2; circumferential loading 2.12 $$\pm$$ 2.39 kJ m-2 vs 1.47 $$\pm$$ 0.91 kJ m-2). Collagen content partly explained the variability in $$D$$ , especially in bicuspid cases. Besides the primary crack, TAAs and enzymatic-treated porcine aortas displayed diffuse and shear-dominated dissection and tearing. As human tissue tests resembled enzymatic-treated porcine aortas, microstructural degeneration, including elastin loss and collagen degeneration, seems to be the main cause of TAA wall weakening. Additionally, a tortuous crack developing during the symconCT test reflected intact fracture toughening mechanisms and might characterize a healthier aorta.

Knowing the target oxygen saturation (SpO2) range that results in the best outcomes for acutely hypoxemic adults is important for clinical care, training, and research in low-income and lower-middle income countries (collectively LMICs). The evidence we have for SpO2 targets emanates from high-income countries (HICs), and therefore may miss important contextual factors for LMIC settings. Furthermore, the evidence from HICs is mixed, amplifying the importance of specific circumstances. For this literature review and analysis, we considered SpO2 targets used in previous trials, international and national society guidelines, and direct trial evidence comparing outcomes using different SpO2 ranges (all from HICs). We also considered contextual factors, including emerging data on pulse oximetry performance in different skin pigmentation ranges, the risk of depleting oxygen resources in LMIC settings, the lack of access to arterial blood gases that necessitates consideration of the subpopulation of hypoxemic patients who are also hypercapnic, and the impact of altitude on median SpO2 values. This process of integrating prior study protocols, society guidelines, available evidence, and contextual factors is potentially useful for the development of other clinical guidelines for LMIC settings. We suggest that a goal SpO2 range of 90-94% is reasonable, using high-performing pulse oximeters. Answering context-specific research questions, such as an optimal SpO2 target range in LMIC contexts, is critical for advancing equity in clinical outcomes globally.

Abstract Growth of abdominal aortic aneurysms (AAAs) is often described as erratic and discontinuous. This study aimed at describing growth patterns of AAAs with respect to maximal aneurysm diameter (Dmax) and aneurysm volume, and to characterize changes in the intraluminal thrombus (ILT) and biomechanical indices as AAAs grow. 384 computed tomography angiographies (CTAs) from 100 patients (mean age 70.0, standard deviation, SD = 8.5 years, 22 women), who had undergone at least three CTAs, were included. The mean follow-up was 5.2 (SD = 2.5) years. Growth of Dmax was 2.64 mm/year (SD = 1.18), volume 13.73 cm3/year (SD = 10.24) and PWS 7.3 kPa/year (SD = 4.95). For Dmax and volume, individual patients exhibited linear growth in 87% and 77% of cases. In the tertile of patients with the slowest Dmax-growth (

OBJECTIVES:. To describe clinical, management, and outcome features of critically ill patients admitted to ICUs and high-dependency units (HDUs) in Kenya. DESIGN:. Prospective registry-based observational study. SETTING:. Three HDUs and eight ICUs in Kenya. PATIENTS:. Consecutive adult patients admitted between January 2021 and June 2022. INTERVENTIONS:. None. MEASUREMENTS AND MAIN RESULTS:. Data were entered in a cloud-based platform using a common data model. Study endpoints included case-mix variables, management features, and patient-centered outcomes. Patients with COVID-19 were reported separately. Of the 3892 of 4546 patients without COVID-19, 2445 patients (62.8%) were from HDUs, and 1447 patients (37.2%) were from ICUs. Patients had a median age of 53 years (interquartile range [IQR] 38–68), with HDU patients being older but with a lower severity (Acute Physiology and Chronic Health Evaluation II 6 [3–9] in HDUs vs. 12 [7–17] in ICUs; p < 0.001). One in four patients was postoperative with 604 (63.4%) receiving emergency surgery. Readmission rate was 4.8%. Hypertension and diabetes were prevalent comorbidities, with a 4.0% HIV/AIDS rate. Invasive mechanical ventilation was applied in 3.4% in HDUs versus 47.6% in ICUs (p < 0.001), with a duration of 7 days (IQR 3–21). There was a similar use of renal replacement therapy (4.0% vs. 4.7%; p < 0.001). Vasopressor use was infrequent while half of patients received antibiotics. Average length of stay was 2 days (IQR 1–5). Crude HDU mortality rate was 6.5% in HDUs versus 30.5% in the ICUs (p < 0.001). Of the 654 COVID-19 admissions, most were admitted in ICUs (72.3%) with a 33.2% mortality. CONCLUSIONS:. We provide the first multicenter observational cohort study from an African ICU National Registry. Distinct management features and outcomes characterize HDU from ICU patients.

Keypoints Industrial chicory waste streams can be upgraded. Chicory by-product was treated with enzymes to produce an antimicrobial ingredient. Process is profitable and product suitable for cosmetic/personal care applications.

Background Improved access to healthcare in low- and middle-income countries (LMICs) has not equated to improved health outcomes. Absence or unsustained quality of care is partly to blame. Improving outcomes in intensive care units (ICUs) requires delivery of complex interventions by multiple specialties working in concert, and the simultaneous prevention of avoidable harms associated with the illness and the treatment interventions. Therefore, successful design and implementation of improvement interventions requires understanding of the behavioural, organisational, and external factors that determine care delivery and the likelihood of achieving sustained improvement. We aim to identify care processes that contribute to suboptimal clinical outcomes in ICUs located in LMICs and to establish barriers and enablers for improving the care processes. Methods Using rapid evaluation methods, we will use four data collection methods: 1) registry embedded indicators to assess quality of care processes and their associated outcomes; 2) process mapping to provide a preliminary framework to understand gaps between current and desired care practices; 3) structured observations of processes of interest identified from the process mapping and; 4) focus group discussions with stakeholders to identify barriers and enablers influencing the gap between current and desired care practices. We will also collect self-assessments of readiness for quality improvement. Data collection and analysis will be led by local stakeholders, performed in parallel and through an iterative process across eight countries: Kenya, India, Malaysia, Nepal, Pakistan, South Africa, Uganda and Vietnam. Conclusions The results of our study will provide essential information on where and how care processes can be improved to facilitate better quality of care to critically ill patients in LMICs; thus, reduce preventable mortality and morbidity in ICUs. Furthermore, understanding the rapid evaluation methods that will be used for this study will allow other researchers and healthcare professionals to carry out similar research in ICUs and other health services.

A number of sophisticated estimators of longitudinal effects have been proposed for estimating the intervention-specific mean outcome. However, there is a relative paucity of research comparing these methods directly to one another. In this study, we compare various approaches to estimating a causal effect in a longitudinal treatment setting using both simulated data and data measured from a human immunodeficiency virus cohort. Six distinct estimators are considered: (i) an iterated conditional expectation representation, (ii) an inverse propensity weighted method, (iii) an augmented inverse propensity weighted method, (iv) a double robust iterated conditional expectation estimator, (v) a modified version of the double robust iterated conditional expectation estimator, and (vi) a targeted minimum loss-based estimator. The details of each estimator and its implementation are presented along with nuisance parameter estimation details, which include potentially pooling the observed data across all subjects regardless of treatment history and using data adaptive machine learning algorithms. Simulations are constructed over six time points, with each time point steadily increasing in positivity violations. Estimation is carried out for both the simulations and applied example using each of the six estimators under both stratified and pooled approaches of nuisance parameter estimation. Simulation results show that double robust estimators remained without meaningful bias as long as at least one of the two nuisance parameters were estimated with a correctly specified model. Under full misspecification, the bias of the double robust estimators remained better than that of the inverse propensity estimator under misspecification, but worse than the iterated conditional expectation estimator. Weighted estimators tended to show better performance than the covariate estimators. As positivity violations increased, the mean squared error and bias of all estimators considered became worse, with covariate-based double robust estimators especially susceptible. Applied analyses showed similar estimates at most time points, with the important exception of the inverse propensity estimator which deviated markedly as positivity violations increased. Given its efficiency, ability to respect the parameter space, and observed performance, we recommend the pooled and weighted targeted minimum loss-based estimator.

Introduction SARS-CoV-2 has been identified as the cause of the disease officially named COVID-19, primarily a respiratory illness. COVID-19 was characterised as a pandemic on 11 March 2020. It has been estimated that approximately 20% of people with COVID-19 require oxygen therapy. Oxygen has been listed on the WHO Model List of Essential Medicines List and Essential Medicines List for Children for almost two decades. The COVID-19 pandemic has highlighted, more than ever, the acute need for scale-up of oxygen therapy. Detailed data on the use of oxygen therapy in low-and-middle income countries at the patient and facility level are needed to target interventions better globally.Methods and analysis We aim to describe the requirements and use of oxygen at the facility and patient level of approximately 4500 patients with COVID-19 in 30 countries. Our objectives are specifically to characterise type and duration of different modalities of oxygen therapy delivered to patients; describe demographics and outcomes of hospitalised patients with COVID-19; and describe facility-level oxygen production and support. Primary analyses will be descriptive in nature. Respiratory support transitions will be described in Sankey plots, and Kaplan-Meier models will be used to estimate probability of each transition. A multistate model will be used to study the course of hospital stay of the study population, evaluating transitions of escalating respiratory support transitions to the absorbing states.Ethics and dissemination WHO Ad Hoc COVID-19 Research Ethics Review Committee (ERC) has approved this global protocol. When this protocol is adopted at specific country sites, national ERCs may make require adjustments in accordance with their respective national research ethics guidelines. Dissemination of this protocol and global findings will be open access through peer-reviewed scientific journals, study website, press and online media.Trial registration number NCT04918875.

Key Clinical Message This case highlights the need for thorough clinical examination to rule out Takayasu arteritis (TA) as a cause of stroke in a young asymptomatic East‐African male. Available clinical management guidelines should guide management of TA patients. Abstract We present a case of a young, previously asymptomatic East‐African Black male presenting with large territory ischemic infarct at first diagnosis of TA. To our knowledge, this is the first published report of a male patient in East Africa with a stroke as the first presentation of TA.

Knowing the target oxygen saturation (SpO2) range that results in the best outcomes for acutely hypoxemic adults is important for clinical care, training, and research in low-income and lower-middle income countries (collectively LMICs). The evidence we have for SpO2 targets emanates from high-income countries (HICs), and therefore may miss important contextual factors for LMIC settings. Furthermore, the evidence from HICs is mixed, amplifying the importance of specific circumstances. For this literature review and analysis, we considered SpO2 targets used in previous trials, international and national society guidelines, and direct trial evidence comparing outcomes using different SpO2 ranges (all from HICs). We also considered contextual factors, including emerging data on pulse oximetry performance in different skin pigmentation ranges, the risk of depleting oxygen resources in LMIC settings, the lack of access to arterial blood gases that necessitates consideration of the subpopulation of hypoxemic patients who are also hypercapnic, and the impact of altitude on median SpO2 values. This process of integrating prior study protocols, society guidelines, available evidence, and contextual factors is potentially useful for the development of other clinical guidelines for LMIC settings. We suggest that a goal SpO2 range of 90-94% is reasonable, using high-performing pulse oximeters. Answering context-specific research questions, such as an optimal SpO2 target range in LMIC contexts, is critical for advancing equity in clinical outcomes globally.

Background: Sustained arrhythmias are frequently encountered in cardiac care units (CCU), but their types and outcomes in Africa are unknown. Studies from high-income countries suggest arrhythmias are associated with worse outcomes. Objectives: To determine the types and proportion of cardiac arrhythmias among patients admitted to the CCU at Moi Teaching and Referral Hospital (MTRH), and to compare 30-day outcomes between patients with and without arrhythmias at the time of CCU admission. Methods: We conducted a prospective study of a cohort of all patients admitted to MTRH-CCU between March and December 2021. They were stratified on the presence or absence of arrhythmia at the time of CCU admission, irrespective of whether it was the primary indication for CCU care or not. Clinical characteristics were collected using a structured questionnaire. Participants were followed up for 30 days. The primary outcome of interest was 30-day all-cause mortality. Secondary outcomes were 30-day all-cause readmission and length of hospital stay. The 30-day outcomes were compared between the patients with and without arrhythmia, with a p value < 0.05 being considered statistically significant. Results: We enrolled 160 participants. The median age was 46 years (IQR 31, 68), and 95 (59.4%) were female. Seventy (43.8%) had a diagnosis of arrhythmia at admission, of whom 62 (88.6%) had supraventricular tachyarrhythmias, five (7.1%) had ventricular tachyarrhythmias, and three (4.3%) had bradyarrhythmia. Atrial fibrillation was the most common supraventricular tachyarrhythmia (82.3%). There was no statistically significant difference in the primary outcome of 30-day mortality between those who had arrhythmia at admission versus those without: 32.9% versus 30.0%, respectively (p = 0.64). Conclusion: Supraventricular tachyarrhythmias were common in critically hospitalized cardiac patients in Western Kenya, with atrial fibrillation being the most common. Thirty-day all-cause mortality did not differ significantly between the group admitted with a diagnosis of arrhythmia and those without.

Abstract It remains difficult to predict when which patients with abdominal aortic aneurysm (AAA) will require surgery. The aim was to study the accuracy of geometric and biomechanical analysis of small AAAs to predict reaching the threshold for surgery, diameter growth rate and rupture or symptomatic aneurysm. 189 patients with AAAs of diameters 40–50 mm were included, 161 had undergone two CTAs. Geometric and biomechanical variables were used in prediction modelling. Classifications were evaluated with area under receiver operating characteristic curve (AUC) and regressions with correlation between observed and predicted growth rates. Compared with the baseline clinical diameter, geometric-biomechanical analysis improved prediction of reaching surgical threshold within four years (AUC 0.80 vs 0.85, p = 0.031) and prediction of diameter growth rate (r = 0.17 vs r = 0.38, p = 0.0031), mainly due to the addition of semiautomatic diameter measurements. There was a trend towards increased precision of volume growth rate prediction (r = 0.37 vs r = 0.45, p = 0.081). Lumen diameter and biomechanical indices were the only variables that could predict future rupture or symptomatic AAA (AUCs 0.65–0.67). Enhanced precision of diameter measurements improves the prediction of reaching the surgical threshold and diameter growth rate, while lumen diameter and biomechanical analysis predicts rupture or symptomatic AAA.

Fatimah Osman Juma, Leonard Mzee Ngunga, Wangari Waweru-Siika, Dilraj Singh Sokhi Department of Medicine, Faculty of Health Sciences, Aga Khan University Medical College of East Africa, Nairobi, KenyaCorrespondence: Dilraj Singh SokhiAga Khan University Medical College of East Africa, Nairobi Campus, Room 405, 4th Floor East Tower Block, Third Avenue Parklands, P.O. Box 30270, Nairobi, 00100, GPO, KenyaTel +254 710 559 541Email Dilraj.Sokhi@aku.eduAbstract: Isolated left ventricular non-compaction (ILVNC) is a rare congenital cardiomyopathy and is associated with arrhythmias, heart failure and thromboembolism including ischaemic stroke. Pregnancy is a relative contraindication to thrombolysis for acute ischaemic stroke, although case reports suggest the treatment can be given in selected cases. We report a case of recurrent cryptogenic strokes in a 36-year-old female who was thrombolysed with good outcome at 37 weeks’ gestation and was eventually found to have ILVNC as the cause. She had a predilection to recurrent posterior circulatory strokes due to foetal posterior communicating arteries. To our knowledge this is the first case report of safe thrombolysis for acute ischaemic stroke in pregnancy caused by ILVNC.Keywords: left ventricular non-compaction, ischaemic stroke, stroke in pregnancy, foetal posterior communicating artery

Abstract Background Patient engagement is effective in promoting adherence to HIV care. In an effort to promote patient-centered care, we implemented an enhanced patient care (EPC) intervention that addresses a combination of system-level barriers including provider training, continuity of clinician-patient relationship, enhanced treatment dialogue and better clinic scheduling. We describe the initial implementation of the EPC intervention in a rural HIV clinic in Kenya, and the factors that facilitated its implementation. Methods The intervention occurred in one of the rural Academic Model Providing Healthcare (AMPATHplus) health facilities in Busia County in the western region of Kenya. Both qualitative and quantitative data were collected through training and meeting proceedings/minutes, a patient tracking tool, treatment dialogue and a peer confirmation tool. Qualitative data were coded and emerging themes on the implementation and adaptation of the intervention were developed. Descriptive analysis including percentages and means were performed on the quantitative data. Results Our analysis identified four key factors that facilitated the implementation of this intervention. (1) The smooth integration of the intervention as part of care that was facilitated by provider training, biweekly meetings between the research and clinical team and having an intervention that promotes the health facility agenda. (2) Commitment of stakeholders including providers and patients to the intervention. (3) The adaptability of the intervention to the existing context while still maintaining fidelity to the intervention. (4) Embedding the intervention in a facility with adequate infrastructure to support its implementation. Conclusions This analysis demonstrates the value of using mixed methods approaches to study the implementation of an intervention. Our findings emphasize how critical local support, local infrastructure, and effective communication are to adapting a new intervention in a clinical care program.

In conducting studies on an exposure of interest, a systematic roadmap should be applied for translating causal questions into statistical analyses and interpreting the results. In this paper we describe an application of one such roadmap applied to estimating the joint effect of both time to availability of a nurse-based triage system (low risk express care (LREC)) and individual enrollment in the program among HIV patients in East Africa. Our study population is comprised of 16,513 subjects found eligible for this task-shifting program within 15 clinics in Kenya between 2006 and 2009, with each clinic starting the LREC program between 2007 and 2008. After discretizing follow-up into 90-day time intervals, we targeted the population mean counterfactual outcome (i. e. counterfactual probability of either dying or being lost to follow up) at up to 450 days after initial LREC eligibility under three fixed treatment interventions. These were (i) under no program availability during the entire follow-up, (ii) under immediate program availability at initial eligibility, but non-enrollment during the entire follow-up, and (iii) under immediate program availability and enrollment at initial eligibility. We further estimated the controlled direct effect of immediate program availability compared to no program availability, under a hypothetical intervention to prevent individual enrollment in the program. Targeted minimum loss-based estimation was used to estimate the mean outcome, while Super Learning was implemented to estimate the required nuisance parameters. Analyses were conducted with the ltmle R package; analysis code is available at an online repository as an R package. Results showed that at 450 days, the probability of in-care survival for subjects with immediate availability and enrollment was 0.93 (95% CI: 0.91, 0.95) and 0.87 (95% CI: 0.86, 0.87) for subjects with immediate availability never enrolling. For subjects without LREC availability, it was 0.91 (95% CI: 0.90, 0.92). Immediate program availability without individual enrollment, compared to no program availability, was estimated to slightly albeit significantly decrease survival by 4% (95% CI 0.03,0.06, p

Abstract Background Substantial efforts have been made to ensure people living with HIV (PLHIV) are linked to and retained in care but many challenges deter care utilization. We report perceived benefits of seeking HIV care and barriers to HIV care that were identified through a formative assessment conducted to advise the development of an alternative care model to deliver antiretroviral treatment therapy (ART) in Trans Nzoia County, Kenya. Methods Data were collected in 2015 through key informant interviews (KIIs), in-depth interviews (IDIs), and focus group discussions (FGDs). The study involved 55 participants of whom 53% were female. Ten KIIs provided community contextual information and viewpoints on the HIV epidemic in Trans Nzoia County while 20 PLHIV (10 male and 10 female) participated in IDIs. Twenty-five individuals living with HIV participated in four FGDs - two groups for men and two for women. Key informants were purposively selected, while every third patient above 18 years at the Kitale HIV Clinic was invited to share their HIV care experience through IDIs or FGDs. Trained research assistants moderated all sessions and audio recordings were transcribed and analyzed thematically. Results Findings showed that PLHIV in Trans Nzoia County used both conventional and complementary alternative care for HIV; however, public health facilities were preferred. Popular perceived benefits of adopting care were relief from symptoms and the chance to live longer. Benefits of care uptake included weight gain, renewed energy, and positive behavior change. Individual-level barriers to HIV care included lack of money and food, use of alternative care, negative side effects of ART, denial, and disclosure difficulties. At the community level, stigma, limited social support for conventional HIV treatment, and poor means of transport were reported. The health system barriers were limited supplies and staff, long distance to conventional HIV care, and unprofessional providers. Conclusions Diverse individual, community and health system barriers continue to affect HIV care-seeking efforts in Kenya. Appreciation of context and lived experiences allows for development of realistic care models.

BackgroundUnique patient identification remains a challenge in many health care settings in low- and middle-income countries (LMICs). Without national-level unique identifiers for whole populations, countries rely on demographic-based approaches that have proven suboptimal. Affordable biometrics-based approaches, implemented with consideration of contextual ethical, legal, and social implications, have the potential to address this challenge and improve patient safety and reporting accuracy. However, limited studies exist to evaluate the actual performance of biometric approaches and perceptions of these systems in LMICs. ObjectiveThe aim of this study is to evaluate the performance and acceptability of fingerprint technology for unique patient matching and identification in the LMIC setting of Kenya. MethodsIn this cross-sectional study conducted at an HIV care and treatment facility in Western Kenya, an open source fingerprint application was integrated within an implementation of the Open Medical Record System, an open source electronic medical record system (EMRS) that is nationally endorsed and deployed for HIV care in Kenya and in more than 40 other countries; hence, it has potential to translate the findings across multiple countries. Participants aged >18 years were conveniently sampled and enrolled into the study. Participants’ left thumbprints were captured and later used to retrieve and match records. The technology’s performance was evaluated using standard measures: sensitivity, false acceptance rate, false rejection rate, and failure to enroll rate. The Wald test was used to compare the accuracy of the technology with the probabilistic patient-matching technique of the EMRS. Time to retrieval and matching of records were compared using the independent samples 2-tailed t test. A survey was administered to evaluate patient acceptance and satisfaction with use of the technology. ResultsIn all, 300 participants were enrolled; their mean age was 36.3 (SD 12.2) years, and 58% (174/300) were women. The relevant values for the technology’s performance were sensitivity 89.3%, false acceptance rate 0%, false rejection rate 11%, and failure to enroll rate 2.3%. The technology’s mean record retrieval speed was 3.2 (SD 1.1) seconds versus 9.5 (SD 1.9) seconds with demographic-based record retrieval in the EMRS (P

Background Globally, critical illness results in millions of deaths every year. Although many of these deaths are potentially preventable, the basic, life-saving care of critically ill patients are often overlooked in health systems. Essential Emergency and Critical Care (EECC) has been devised as the care that should be provided to all critically ill patients in all hospitals in the world. EECC includes the effective care of low cost and low complexity for the identification and treatment of critically ill patients across all medical specialties. This study aimed to specify the content of EECC and additionally, given the surge of critical illness in the ongoing pandemic, the essential diagnosis-specific care for critically ill patients with COVID-19.Methods In a Delphi process, consensus (>90% agreement) was sought from a diverse panel of global clinical experts. The panel iteratively rated proposed treatments and actions based on previous guidelines and the WHO/ICRC’s Basic Emergency Care. The output from the Delphi was adapted iteratively with specialist reviewers into a coherent and feasible package of clinical processes plus a list of hospital readiness requirements.Results The 269 experts in the Delphi panel had clinical experience in different acute medical specialties from 59 countries and from all resource settings. The agreed EECC package contains 40 clinical processes and 67 requirements, plus additions specific for COVID-19.Conclusion The study has specified the content of care that should be provided to all critically ill patients. Implementing EECC could be an effective strategy for policy makers to reduce preventable deaths worldwide.

ObjectivesTenofovir disoproxil fumarate (TDF) has been associated with renal insufficiency. Co-administration with boosted protease inhibitors, which increases its exposure, may further increase the risk of renal insufficiency.MethodsWe compared the incidence of renal events among women taking TDF co-administered with lopinavir/ritonavir (LPV/r) versus those co-administering TDF with nevirapine (NVP). Renal events were defined as a confirmed drop in creatinine clearance associated with a serum creatinine grade 2 or higher, or that leading to treatment modification.ResultsOverall, 741 HIV-infected women were enrolled into the study. Of these, 24 (3.2%) had reportable renal events (18 in LPV/r arm, six in NVP arm). In multivariate analysis, renal events were significantly associated with the LPV/r arm [odds ratio (OR) 3.12, 95% confidence interval (CI) 1.21, 8.05; P = 0.019], baseline HIV-1 RNA (OR 2.65, 95% CI 1.23, 5.69 per 1 log10 copies/ml higher; P = 0.013) and baseline creatinine clearance (OR 0.83, 95% CI 0.70-0.98 per 10 ml/min higher; P = 0.030). In multivariate analysis evaluating renal events requiring treatment modification, only baseline HIV-1 RNA and creatinine clearance were significantly associated (OR 4.41, 95% CI 1.65, 11.78 per 1 log10 copies/ml higher; P = 0.003 and OR 0.80, 95% CI 0.64, 0.99 per 10 ml/min higher; P = 0.040, respectively).ConclusionThe rates of renal events were relatively low in the two treatment arms. However, patients taking TDF co-administered with LPV/r had significantly more renal events compared to those co-administered with NVP. Furthermore, higher baseline HIV RNA and lower creatinine clearance were associated with the development of renal insufficiency requiring treatment modification.