Coastal Health District

Introduction: Trauma-related deaths are rising in low- and middle-income countries (LMICs) like Nepal, where pre-hospital care systems are limited. Community health responders (CHRs) could reduce the time to post-injury care in rural settings. This pilot study evaluates the feasibility and impact of a CHR-based trauma program in rural Nepal. Methods: A quasi-experimental study first adapted a trauma curriculum for CHRs in Achham, Nepal, using global guidelines from the World Health Organization and the American College of Surgeons, using a modified Delphi process. The final program included three components: a two-day skills training, a pictorial guidebook for reference, and a one day refresher after three months. Two municipalities in Achham were assigned to intervention or control, with only the intervention group’ CHRs receiving the training. Outcomes measured included CHRs’ knowledge and confidence assessed over six months, and patient-based pre-hospital care process indicators. Care process indicators were assessed at the hospital emergency department. Changes in knowledge over time were analyzed using repeated measures ANOVA. Bivariate analysis was performed to assess differences in pre-hospital trauma care indicators by study group. Results: The intervention group showed a significant increase in knowledge and confidence immediately post-course and sustained over six months. There was no significant difference in mean patient age (26.5 years versus 22.1) and trauma mechanism (p = 0.14) across the two groups. The most common mechanism was falls (n=165, 77.5%). Intervention municipalities had higher rates of pre-hospital care provision, including fracture immobilization (51.4% versus 17.1%, p < .001) and cervical collar use, compared to controls. Conclusion: This study adapted and implemented a contextual trauma training program for CHRs in rural Nepal. Results show early feasibility and appropriateness in this context. The program leverages existing community networks and offers a potential approach in LMICs to bridge the existing critical gaps in rural pre-hospital trauma care that require further investigation.

Abstract Background Black communities are disproportionately affected by HIV and may have a greater lifetime risk of comorbidities compared with non-Black people with HIV (PWH). Despite this, they have historically been underrepresented in clinical studies. Here, we report efficacy and safety through 5 years of first-line therapy with bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) in Black PWH. Methods Studies 1489 (NCT02607930; B/F/TAF vs dolutegravir/abacavir/lamivudine [DTG/ABC/3TC]) and 1490 (NCT02607956; B/F/TAF vs DTG+F/TAF) were randomized, double-blind, multicenter, Phase 3 studies in adult PWH. This pooled analysis reports the outcomes of Black and non-Black participants who received B/F/TAF in the 144-week (W) randomization phase and the 96W open-label extension. Baseline demographics and clinical characteristics; proportion of participants with HIV-1 RNA < 50 copies/mL (missing=excluded); adherence; treatment-emergent adverse events (TEAEs); and changes in CD4 count and metabolic and renal parameters are presented. Results Overall, 211 (33.4%) Black and 421 (66.6%) non-Black PWH (91.0% and 54.2% from the US, respectively) received B/F/TAF up to W240. Baseline demographics and clinical characteristics are shown in the Table; 19.9% Black and 18.1% non-Black PWH had HIV-1 RNA > 100,000 copies/mL, 17.5% and 10.0% had CD4 < 200 cells/µL, and 19.4%/8.1% and 13.5%/5.0% had a history of hypertension/diabetes mellitus, respectively. At W240, high proportions of both Black (97.2%) and non-Black PWH (99.3%) had HIV-1 RNA < 50 copies/mL, despite Black PWH being more likely than non-Black PWH to have low (< 85%) adherence (11.2% vs 5.0%; P=0.0074 [Fisher’s exact test]). A smaller proportion of Black vs non-Black PWH experienced study drug–related TEAEs (20.4% vs 31.8%; P=0.0026 [Fisher’s exact test]). Changes in CD4 count, metabolic and renal parameters, and TE hypertension and diabetes were similar between groups (Table). Conclusion At Year 5, B/F/TAF maintained high rates of virologic suppression in Black PWH, despite a greater proportion of Black vs non-Black PWH having low adherence. B/F/TAF was well tolerated, with a smaller proportion of Black vs non-Black PWH with study drug–related TEAEs. These findings further support the long-term use of B/F/TAF in Black PWH. Disclosures Anson K. Wurapa, MD, Gilead: Honoraria|Gilead Sciences, Inc.: Medical writing support provided by Aspire Scientific (Bollington, UK) Jose Ramon Arribas, MD, Alexa: Advisor/Consultant|Gilead Sciences, Inc.: Advisor/Consultant|Gilead Sciences, Inc.: Expert Testimony|Gilead Sciences, Inc.: Grant/Research Support|Gilead Sciences, Inc.: Medical writing support provided by Aspire Scientific (Bollington, UK)|Janssen: Advisor/Consultant|Janssen: Expert Testimony|Lilly: Advisor/Consultant|MSD: Advisor/Consultant|MSD: Expert Testimony|Serono: Advisor/Consultant|Teva: Advisor/Consultant|ViiV: Advisor/Consultant|ViiV: Expert Testimony|ViiV: Grant/Research Support Yazdan Yazdanpanah, MD, PhD, Gilead Sciences, Inc.: Medical writing support provided by Aspire Scientific (Bollington, UK) Chloe Orkin, MBChB, FRCP, MD, AstraZeneca: Grant/Research Support|Gilead Sciences, Inc.: Grant/Research Support|Gilead Sciences, Inc.: Honoraria|Gilead Sciences, Inc.: Medical writing support provided by Aspire Scientific (Bollington, UK)|GSK: Honoraria|MSD: Honoraria|ViiV Healthcare: Grant/Research Support|ViiV Healthcare: Honoraria Hui Liu, PhD, Gilead Sciences, Inc.: Employee; Medical writing support provided by Aspire Scientific (Bollington, UK)|Gilead Sciences, Inc.: Stocks/Bonds (Private Company) Rachel Rogers, Gilead Sciences, Inc.: Employee; Medical writing support provided by Aspire Scientific (Bollington, UK)|Gilead Sciences, Inc.: Stocks/Bonds (Private Company) David Malebranche, MD, MPH, Gilead Sciences, Inc.: Employee; Medical writing support provided by Aspire Scientific (Bollington, UK)|Gilead Sciences, Inc.: Stocks/Bonds (Private Company) Jason Hindman, PharmD, MBA, Gilead Sciences, Inc.: Employee; Medical writing support provided by Aspire Scientific (Bollington, UK)|Gilead Sciences, Inc.: Stocks/Bonds (Private Company) Debbie P. Hagins, MD, FAPCR, AAHIVS, Gilead Sciences, Inc.: Medical writing support provided by Aspire Scientific (Bollington, UK)

BackgroundPeople with HIV (PWH) who are initiated on guidelines-recommended first-line INSTI-based antiretroviral therapy routinely achieve rapid virologic suppression; however, those with a high baseline (BL) HIV-1 RNA and/or low CD4 count may be more challenging to manage in the short- and long-term. To further characterize long-term outcomes over 5 years in select subgroups, we analyzed results from two studies examining B/F/TAF as initial treatment stratified by BL HIV-1 RNA and/or CD4 count.MethodsAdults with HIV were randomized to receive blinded initial treatment with B/F/TAF versus dolutegravir [DTG]/abacavir/lamivudine (Study 1489) or DTG+F/TAF (1490) for 144 weeks (W) of blinded treatment followed by an optional switch to open-label B/F/TAF for 96W. We present virologic response (HIV-1 RNA < 50 c/mL, missing=excluded and missing=failure) and study drug-related adverse events (DRAE) from a pooled analysis of participants originally randomized to B/F/TAF who had BL HIV-1 RNA 100,00-400,000 copies(c)/mL, HIV-1 RNA >400,000 c/mL and/or CD4 count < 200 cells/µL through W240.Results634 adults (median age 32 years, 89% men, 33% Black/African descent, 24% Hispanic/LatinX) originally randomized to B/F/TAF were included for analysis. At BL, 80 participants had a BL CD4 count < 200 cells/µL and 119 participants had HIV-1 RNA >100,000 c/mL, of whom, 20 had HIV-1 RNA >400,000 c/mL. At W240, virologic suppression was high for the low CD4 count and/or high HIV-1 RNA subgroups (Table). No participant in the final resistance analysis developed virologic resistance to any component of B/F/TAF. Across the subgroups, the most common DRAEs were nausea, headache and diarrhea and there were no serious DRAEs. There was only one discontinuation due to a DRAE in the low CD4 count subgroup, and none in the high HIV-1 RNA subgroup.ConclusionInitial treatment with B/F/TAF was safe and efficacious over 5 years of follow-up in people with a high BL HIV-1 RNA and/or low CD4 count. These outcomes provide additional evidence that B/F/TAF is an effective and durable regimen for a broad range of PWH, including those with advanced disease.DisclosuresMoti Ramgopal, MD, FACP, FIDSA, Gilead Sciences: Advisor/Consultant|Gilead Sciences: Speakers Bureau|Janssen: Advisor/Consultant|Janssen: Speakers Bureau|Merck: Advisor/Consultant|Merck: Speakers Bureau|ViiV: Advisor/Consultant|ViiV: Speakers Bureau Axel Baumgarten, MD, AbbVie: Honoraria|Gilead Sciences: Honoraria|Janssen: Honoraria|MSD: Honoraria|ViiV: Honoraria Anton Pozniak, MD, FRCP, Gilead: Grant/Research Support|Gilead: Honoraria|Janssen: Grant/Research Support|Janssen: Honoraria|Merck: Honoraria|theratec: Honoraria|ViiV: Grant/Research Support|ViiV: Honoraria Chloe Orkin, MBChB, FRCP, MD, Gilead Sciences: Honoraria|GSK: Honoraria|Janssen: Honoraria|MSD: Honoraria Juan Manuel Tiraboschi, PhD, Gilead Sciences: Advisor/Consultant|Gilead Sciences: Grant/Research Support|Janssen: Advisor/Consultant|Janssen: Grant/Research Support|MSD: Advisor/Consultant|MSD: Grant/Research Support|ViiV Healthcare: Advisor/Consultant|ViiV Healthcare: Grant/Research Support Debbie P. Hagins, MD, FAPCR, AAHIVS, Gilead Sciences: Advisor/Consultant|Gilead Sciences: Grant/Research Support|Gilead Sciences: Speakers Bureau|Janssen: Grant/Research Support|Merck: Advisor/Consultant|Merck: Grant/Research Support|ViiV: Advisor/Consultant|ViiV: Grant/Research Support Hailin Huang, PhD, Gilead Sciences, Inc.: Employer|Gilead Sciences, Inc.: Stocks/Bonds Kristin Andreatta, MSc, Gilead Sciences, Inc: Employee of Gilead Sciences|Gilead Sciences, Inc: Stocks/Bonds Nathan Unger, PharmD, AAHIVP, Gilead Sciences: Employee|Gilead Sciences: Stocks/Bonds Jason Hindman, PharmD, MBA, Gilead Sciences: Employee|Gilead Sciences: Stocks/Bonds Hal Martin, MD, Gilead Sciences: employee|Gilead Sciences: Stocks/Bonds Jared Baeten, MD, PhD, Gilead Sciences: Employee|Gilead Sciences: Stocks/Bonds Olayemi Osiyemi, MD, Gilead: Advisor/Consultant|gsk: Advisor/Consultant|viiv: Advisor/Consultant.

ObjectivesThe single‐tablet regimen rilpivirine, emtricitabine and tenofovir alafenamide (RPV/FTC/TAF) for treatment of HIV‐1‐infected adults was approved based on bioequivalence. We assessed the clinical efficacy, safety and tolerability of switching to RPV/FTC/TAF from either RPV/FTC/tenofovir disoproxil fumarate (TDF) or efavirenz (EFV)/FTC/TDF.MethodsWe conducted two distinct randomized, double‐blind, active‐controlled, noninferiority trials in participants taking RPV/FTC/TDF (Study 1216) and EFV/FTC/TDF (Study 1160). Each study randomized virologically suppressed (HIV‐1 RNA < 50 copies/mL) adults (1:1) to switch to RPV/FTC/TAF or continue their current regimen for 96 weeks. We evaluated efficacy as the proportion with HIV‐1 RNA < 50 copies/mL using the Food and Drug Administration snapshot algorithm and prespecified bone and renal endpoints at week 96.ResultsWe randomized and treated 630 participants in Study 1216 (RPV/FTC/TAF, n = 316; RPV/FTC/TDF, n = 314) and 875 in Study 1160 (RPV/FTC/TAF, n = 438; EFV/FTC/TDF, n = 437). In both studies, the efficacy of switching to RPV/FTC/TAF was noninferior to that of continuing baseline therapy at week 96, with respective percentages of patients with HIV RNA < 50 copies/mL being 89.2% versus 88.5% in Study 1216 [difference 0.7%; 95% confidence interval (CI) −4.3 to +5.8%] and 85.2% versus 85.1% in Study 1160 (difference 0%; 95% CI −4.8 to +4.8%). No participant on RPV/FTC/TAF developed treatment‐emergent resistance versus two on EFV/FTC/TDF and one on RPV/FTC/TDF. Compared with continuing baseline therapy, significant improvements in bone mineral density and renal tubular markers were observed in the RPV/FTC/TAF groups (P < 0.001).ConclusionsSwitching to RPV/FTC/TAF from RPV/FTC/TDF or EFV/FTC/TDF was safe and effective and improved bone mineral density and renal biomarkers up to 96 weeks with no cases of treatment‐emergent resistance.

The purpose of the New Zealand Child and adolescent asthma guidelines: a quick reference guide is to provide simple, practical, evidence-based recommendations for the diagnosis, assessment and management of asthma in children and adolescents in New Zealand, with the aim of improving outcomes and reducing inequities. The intended users are health professionals responsible for delivering asthma care in the community and hospital emergency department settings, and those responsible for the training of such health professionals.