ClinicoEconomics and Outcomes Research最新文献

{"title":"Prediction of Future Medical Costs by Modifiable Measures of Health.","authors":"Farnoosh Haji-Sheikhi,&nbsp;Maren S Fragala,&nbsp;Lance A Bare,&nbsp;Charles M Rowland,&nbsp;Steven E Goldberg","doi":"10.2147/CEOR.S406525","DOIUrl":"https://doi.org/10.2147/CEOR.S406525","url":null,"abstract":"<p><strong>Introduction: </strong>Strategies to mitigate rising health-care costs are a priority for patients, employers, and health insurers. Yet gaps currently exist in whether health risk assessment can forecast medical claims costs. This study examined the ability of a health quotient (HQ) based on modifiable risk factors, age, sex, and chronic conditions to predict future medical claims spending.</p><p><strong>Methods: </strong>The study included 18,695 employees and adult dependents who participated in health assessments and were enrolled in an employer-sponsored health plan. Linear mixed effect models stratified by chronic conditions and adjusted for age and sex were utilized to evaluate the relationship between the health quotient (score of 0-100) and future medical claims spending.</p><p><strong>Results: </strong>Lower baseline health quotient was associated with higher medical claims cost over 2 years of follow up. For participants with chronic condition(s), costs were $3628 higher for those with a low health quotient (<73; N = 2673) compared to those with high health quotient (>85; N = 1045), after adjustment for age and sex (P value = 0.004). Each one-unit increase in health quotient was associated with a decrease of $154 (95% CI: 87.4, 220.3) in average yearly medical claims costs during follow up.</p><p><strong>Discussion: </strong>This study used a large employee population with 2 years of follow-up data, which provides insights that are applicable to other large employers. Results of this analysis contribute to our ability to predict health-care costs using modifiable aspects of health, objective laboratory testing and chronic condition status.</p>","PeriodicalId":47313,"journal":{"name":"ClinicoEconomics and Outcomes Research","volume":null,"pages":null},"PeriodicalIF":2.1,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/41/12/ceor-15-525.PMC10319160.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10180401","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"CELESTIA: Cost-Effectiveness Analysis of Empagliflozin Versus Sitagliptin in Patients with Type 2 Diabetes in Greece.","authors":"Gianni Ghetti,&nbsp;Lorenzo Pradelli,&nbsp;Giannis Papageorgiou,&nbsp;George Karpouzos,&nbsp;Yelda Arikan","doi":"10.2147/CEOR.S400522","DOIUrl":"https://doi.org/10.2147/CEOR.S400522","url":null,"abstract":"<p><strong>Purpose: </strong>Globally, the prevalence of diabetes is on the rise, with the number of affected individuals predicted to cross 700 million by 2045. In Greece, in 2015, almost 700,000 people received prescribed medication for type 2 diabetes. The CELESTIA study aims to assess the cost-effectiveness of empagliflozin compared to branded sitagliptin in type 2 diabetes patients both with and without established cardiovascular disease in Greece from a third payer perspective.</p><p><strong>Methods: </strong>The IQVIA Core Diabetes Model was used and analyses were conducted from the Greek healthcare payer perspective. Patients received either empagliflozin or sitagliptin until HbA1c threshold of 8.5% (69 mmol/mol) was exceeded. Subsequently, patients were assumed to intensify to insulin therapy. Baseline cohort characteristics and treatment effects were derived from clinical trial data. Literature data were used for input (utilities, treatment costs and costs of diabetes-related complications costs). A lifetime time horizon (50 years) was applied, and costs and benefits were discounted at an annual rate of 3.5%.</p><p><strong>Results: </strong>Over a lifetime horizon, for empagliflozin, the estimated ICER was of €6,587 and €966 per quality-adjusted life years gained versus sitagliptin, in patients without established cardiovascular disease and in patients with established cardiovascular disease, respectively. Probabilistic sensitivity analysis confirmed the robustness of the analysis.</p><p><strong>Conclusion: </strong>The analysis demonstrated that for type 2 diabetes patients, empagliflozin is a cost-effective treatment option versus branded sitagliptin in Greece.</p>","PeriodicalId":47313,"journal":{"name":"ClinicoEconomics and Outcomes Research","volume":null,"pages":null},"PeriodicalIF":2.1,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/43/85/ceor-15-97.PMC9942503.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10831343","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Elicitation of Health State Utility Values in Retinitis Pigmentosa by Time Trade-off in the United Kingdom.","authors":"Paul O'Brien,&nbsp;Ashley Enstone,&nbsp;Daisy Bridge,&nbsp;Robin Wyn,&nbsp;Judit Banhazi","doi":"10.2147/CEOR.S385094","DOIUrl":"https://doi.org/10.2147/CEOR.S385094","url":null,"abstract":"<p><strong>Introduction: </strong>Retinitis pigmentosa (RP) is an inherited retinal pathology associated with \"night blindness\" and progressive loss of peripheral vision, in some cases leading to complete blindness. Health state utility values are required for activities such as modelling disease burden or the cost-effectiveness of new interventions. The current study aimed to generate utility values for health states of varying levels of functional vision in RP, with members of the general public in the UK.</p><p><strong>Methods: </strong>Five health states were defined according to standard clinical measures of visual ability. Health state descriptions were developed following interviews with patients with RP in the UK (n=5). Further interviews were conducted for confirmation with healthcare professionals with specific experience of managing patients with RP in the UK (n=2). Interviews with members of the general public in the UK were conducted to value health states. A time trade-off (TTO) process based on the established Measurement and Valuation of Health (MVH) protocol was used. Due to the ongoing COVID-19 pandemic, all interviews were web-enabled and conducted 1:1 by a trained moderator.</p><p><strong>Results: </strong>In total, n=110 TTO interviews were conducted with members of the UK general public. Mean TTO utility values followed the logical and expected order, with increasing visual impairment leading to decreased utility. Mean values varied between 0.78 ± 0.20 (\"moderate impairment\"), and 0.33 ± 0.26 (\"hand motion\" to \"no light perception\"). Supplementary visual analogue scale (VAS) scores also followed the logical and expected order: mean VAS values varied between 47.95 ± 15.38 (\"moderate impairment\") and 17.22 ± 12.49 in (\"hand motion\" to \"no light perception\").</p><p><strong>Discussion: </strong>These data suggest that individuals living with RP have substantially impaired quality of life. Utility values for RP have been elicited here using a method and sample that is suitable for economic modelling and health technology assessment purposes.</p>","PeriodicalId":47313,"journal":{"name":"ClinicoEconomics and Outcomes Research","volume":null,"pages":null},"PeriodicalIF":2.1,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/8b/1d/ceor-15-29.PMC9850830.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10538947","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Effectiveness of Disinfecting Caps for Intravenous Access Points in Reducing Central Line-Associated Bloodstream Infections, Clinical Utilization, and Cost of Care During COVID-19.","authors":"Yuefeng Hou,&nbsp;Leah P Griffin,&nbsp;Kari Ertmer,&nbsp;Stéphanie F Bernatchez,&nbsp;Tarja J Kärpänen,&nbsp;Maria Palka-Santini","doi":"10.2147/CEOR.S404823","DOIUrl":"https://doi.org/10.2147/CEOR.S404823","url":null,"abstract":"<p><strong>Purpose: </strong>Intravenous (IV) access point protectors, serving as passive disinfection devices and a cover between line accesses, are available to help reduce the risk of central line-associated bloodstream infections (CLABSIs). This low-maintenance disinfection solution is particularly valuable in situations with excessive workloads. This study examined the effect of a disinfecting cap for an IV access point on CLABSI rates, hospital length of stay, and cost of care in an inpatient setting during the coronavirus disease 2019 (COVID-19) pandemic.</p><p><strong>Methods: </strong>The study utilized data from the Premier Healthcare Database, focusing on 200,411 hospitalizations involving central venous catheters between January 2020 and September 2020. Among these cases, 7423 patients received a disinfecting cap, while 192,988 patients did not use any disinfecting caps and followed the standard practice of hub scrubbing. The two cohorts, Disinfecting Cap and No-Disinfecting Cap groups, were compared in terms of CLABSI rates, hospital length of stay (LOS), and hospitalization costs. The analysis accounted for baseline group differences and random clustering effects by employing a 34-variable propensity score and mixed-effect multiple regression, respectively.</p><p><strong>Results: </strong>The findings demonstrated a significant 73% decrease in CLABSI rates (p= 0.0013) in the Disinfecting Cap group, with an adjusted CLABSI rate of 0.3% compared to 1.1% in the No-Disinfecting Cap group. Additionally, the Disinfecting Cap group exhibited a 0.5-day reduction in hospital stay (9.2 days versus 9.7 days; p = 0.0169) and cost savings of $6703 ($35,604 versus $42,307; p = 0.0063) per hospital stay compared to the No-Disinfecting Cap group.</p><p><strong>Conclusion: </strong>This study provides real-world evidence that implementing a disinfecting cap to protect IV access points effectively reduces the risk of CLABSIs in hospitalized patients compared to standard care, ultimately optimizing the utilization of healthcare resources, particularly in situations where the healthcare system is under significant strain or overloaded.</p>","PeriodicalId":47313,"journal":{"name":"ClinicoEconomics and Outcomes Research","volume":null,"pages":null},"PeriodicalIF":2.1,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/7f/73/ceor-15-477.PMC10290837.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9721379","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Erratum: Real-World Cost of Nasal Polyps Surgery and Risk of Major Complications in the United States: A Descriptive Retrospective Database Analysis [Corrigendum].","authors":"","doi":"10.2147/CEOR.S410629","DOIUrl":"https://doi.org/10.2147/CEOR.S410629","url":null,"abstract":"<p><p>[This corrects the article DOI: 10.2147/CEOR.S380411.].</p>","PeriodicalId":47313,"journal":{"name":"ClinicoEconomics and Outcomes Research","volume":null,"pages":null},"PeriodicalIF":2.1,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/a1/33/ceor-15-209.PMC10066894.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9241354","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Cost-Effectiveness Analysis of Nefecon versus Best Supportive Care for People with Immunoglobulin A Nephropathy (IgAN) in the United States.","authors":"Lauren Ramjee,&nbsp;Nesrin Vurgun,&nbsp;Christopher Ngai,&nbsp;Mit Patel,&nbsp;Gabriel Tremblay","doi":"10.2147/CEOR.S389456","DOIUrl":"https://doi.org/10.2147/CEOR.S389456","url":null,"abstract":"<p><strong>Purpose: </strong>To estimate the cost-effectiveness of Nefecon in addition to the best supportive care (BSC) vs BSC in a hypothetical cohort of commercially insured adult patients with primary immunoglobulin A nephropathy (IgAN) from a United States (US) societal perspective.</p><p><strong>Methods: </strong>A lifetime horizon, semi-Markov model was developed that consisted of nine health states: chronic kidney disease (CKD) stage 1, 2, 3a, 3b, 4, end-stage renal disease (ESRD) with dialysis, ESRD without dialysis, post-kidney transplant, and death. Health state occupancy was estimated from individual patient-level data from the Phase 3 randomized controlled trial NefIgArd Part A (NCT03643965). Additional scenarios evaluated the impact of varying the time horizon, discounting, costs included, rounds of treatment, and the method used to calculate transition probabilities.</p><p><strong>Results: </strong>In the deterministic base case analysis over a lifetime horizon, Nefecon plus BSC (hereafter Nefecon) had an incremental cost of $3,810 vs BSC. Nefecon resulted in a mean survival gain of 0.247 quality-adjusted life years (QALYs), 0.195 life years (LYs), and 0.244 equal value life years (evLYs) vs BSC alone - this resulted in incremental cost-effectiveness ratios (ICERs) of $15,428 per QALY, $19,502 per LY, and $15,611 per evLY gained. Probabilistic sensitivity analyses estimated that with willingness to pay thresholds of $100,000, $150,000, and $250,000 per QALY gained, Nefecon would be cost-effective over BSC in 66.70%, 75.02%, and 86.82% of cases, respectively. In the scenario analysis, Nefecon remained cost-effective with 4 rounds of treatment.</p><p><strong>Conclusion: </strong>Nefecon was associated with LY and QALY gains vs BSC, with an incremental cost of $3,810. Based on these values, with a willingness to pay threshold of $100,000 per QALY gained, Nefecon was found to be a cost-effective treatment for US adults with primary IgAN.</p>","PeriodicalId":47313,"journal":{"name":"ClinicoEconomics and Outcomes Research","volume":null,"pages":null},"PeriodicalIF":2.1,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/d3/76/ceor-15-213.PMC10067365.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9256548","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The High Cost of Death After Acute Myocardial Infarctions: Results from a National US Hospital Database.","authors":"Peter J Mallow,&nbsp;Frederick Browne,&nbsp;Kamal Shemisa","doi":"10.2147/CEOR.S397220","DOIUrl":"https://doi.org/10.2147/CEOR.S397220","url":null,"abstract":"<p><strong>Introduction: </strong>This study described the differences in costs and length of stay (LOS) among patients with AMI who died versus survived using a large, nationally representative cohort of AMI patients.</p><p><strong>Methods: </strong>The 2019 HCUP NIS was used to analyze costs, and LOS among all patients with a principal diagnosis of AMI. A propensity-score matched analysis and multivariable regression were used to adjust for patient and hospital characteristics.</p><p><strong>Results: </strong>There were 4559 visits in each of the cohorts (total 9118). The adjusted mean hospital cost was $18,970 (95% CI $16,453 - $21,871) for those that survived and $23,173 (95% CI $20,167 - $26,626; p <0.001) for those that died. The LOS was 3.95 (95% CI 3.41-4.57) in survivors and 4.24 (95% CI 3.67-4.89; p <0.001) in those who died.</p><p><strong>Conclusion: </strong>Survivors of AMI incurred lower costs and length of stay than those who died. Higher costs were attributed to greater LOS and higher-level care. The results suggest that economic evaluations of cardiovascular interventions that do not include the cost of dying may underestimate the benefits of the intervention.</p>","PeriodicalId":47313,"journal":{"name":"ClinicoEconomics and Outcomes Research","volume":null,"pages":null},"PeriodicalIF":2.1,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/72/02/ceor-15-63.PMC9899015.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10673812","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Eleven-Year Trends in Lipid-Modifying Medicines Utilisation and Expenditure in a Low-Income Country: A Study from the Republic of Srpska, Bosnia and Herzegovina.","authors":"Dragan Kalinić,&nbsp;Ranko Škrbić,&nbsp;Duško Vulić,&nbsp;Svjetlana Stoisavljević-Šatara,&nbsp;Nataša Stojaković,&nbsp;Miloš P Stojiljković,&nbsp;Vanda Marković-Peković,&nbsp;Ana Golić Jelić,&nbsp;Nataša Pilipović-Broćeta,&nbsp;Nevena Divac","doi":"10.2147/CEOR.S410711","DOIUrl":"https://doi.org/10.2147/CEOR.S410711","url":null,"abstract":"<p><strong>Background: </strong>In last two decades, there have been substantial changes in the pattern of lipid-modifying medicines utilisation following the new treatment guidelines based on clinical trials. The main purpose of this study was to analyse the overall utilisation and expenditure of lipid-modifying medicines in the Republic of Srpska, Bosnia and Herzegovina during an 11-year follow-up period and to express its share in relation to the total cardiovascular medicines (C group) utilisation.</p><p><strong>Methods: </strong>In this retrospective, observational study, medicines utilisation data were analysed between 2010 and 2020 period using the ATC/DDD methodology and expressed as the number of DDD/1000 inhabitants/day (DDD/TID). The medicines expenditure analysis was used to estimate the annual expenditure of medicines in Euro based on DDD.</p><p><strong>Results: </strong>During the analysed period, the use of lipid-modifying medicines increased almost 3-times (12.82 DDD/TID in 2010 vs 34.32 DDD/TID in 2020), with a rise in expenditure from 1.24 million Euro to 2.15 million Euro in the same period. This was mainly driven by an increased use of statins with 163.07%, and among these, rosuvastatin increased more than 1500-fold, and atorvastatin with 106.95% increase. With the appearance of generics, simvastatin showed a constant decline, while the other lipid-modifying medicines in relation to the total utilisation had a neglecting increase.</p><p><strong>Conclusion: </strong>The use of lipid-modifying medicines in the Republic of Srpska has constantly increased and strongly corresponded to the adopted treatment guidelines and the positive medicines list of health insurance fund. The results and trends are comparable with other countries, but still the utilisation of lipid-lowering medicines represents the smallest share of total medicines use for the treatment of cardiovascular diseases, compared to high-income countries.</p>","PeriodicalId":47313,"journal":{"name":"ClinicoEconomics and Outcomes Research","volume":null,"pages":null},"PeriodicalIF":2.1,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/3c/6b/ceor-15-513.PMC10317530.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10179310","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Cost-Effectiveness of Empagliflozin in Combination with Standard Care versus Standard Care Only in the Treatment of Heart Failure Patients in Finland.","authors":"Taru Hallinen,&nbsp;Santtu Kivelä,&nbsp;Erkki Soini,&nbsp;Veli-Pekka Harjola,&nbsp;Mari Pesonen","doi":"10.2147/CEOR.S391455","DOIUrl":"https://doi.org/10.2147/CEOR.S391455","url":null,"abstract":"<p><strong>Purpose: </strong>Sodium-glucose cotransporter-2 (SGLT2) inhibitor empagliflozin has recently been shown to improve the outcomes of heart failure (HF) patients regardless of patient's left ventricular ejection fraction by reducing the combined risk of cardiovascular death or hospitalization for worsening HF. The aim of this study was to assess the cost-effectiveness of adding empagliflozin to the standard care (SC) in comparison to SC only in the treatment of HF in Finland.</p><p><strong>Patients and methods: </strong>The assessment was performed in the cost-utility framework using two Markov cohort state-transition models, one for HF with reduced ejection fraction (HFrEF) and one for HF with preserved ejection fraction (HFpEF). The models have been primarily developed based on the EMPEROR-Reduced and EMPEROR-Preserved trials which informed the modelled patient characteristics, efficacy of treatments in terms of associated risks for heart failure hospitalizations, cardiovascular (CV) and non-CV death, treatment related adverse events (AE), and state- and event-specific health-related quality of life weights (EQ-5D). Direct health care costs were estimated from Finnish published references. Cost-effectiveness was assessed from health care payer perspective based on incremental cost-effectiveness ratio (ICER; cost per quality adjusted life-year [QALY] gained) and probability of cost-effectiveness (at willingness-to-pay [WTP] of 35,000 euros/QALY). The ICER was reported as the weighted (HFrEF, 43.5%; HFpEF, 56.5%) average result of the two models.</p><p><strong>Results: </strong>Empagliflozin + SC treatment increased the average quality-adjusted life-expectancy, and treatment costs of HF patients by 0.15 QALYs and 1,594 euros, respectively, when compared to SC. An additional QALY with empagliflozin was thus gained at a cost of 10,621 euros. The probability of empagliflozin + SC being cost-effective compared to placebo + SC was 77.6% and 83.5% with WTP of 35,000 and 100,000 euros/QALY, respectively.</p><p><strong>Conclusion: </strong>Empagliflozin is a cost-effective treatment for patients with HF in the Finnish health care setting.</p>","PeriodicalId":47313,"journal":{"name":"ClinicoEconomics and Outcomes Research","volume":null,"pages":null},"PeriodicalIF":2.1,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/98/0a/ceor-15-1.PMC9831000.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10519067","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Weight and BMI Changes Following Initiation of Emtricitabine/Tenofovir Alafenamide Co-Formulated with Darunavir or Co-Administered with Dolutegravir in Overweight or Obese, ART-Naïve People Living with HIV-1.","authors":"Prina Donga,&nbsp;Bruno Emond,&nbsp;Carmine Rossi,&nbsp;Brahim K Bookhart,&nbsp;Johnnie Lee,&nbsp;Gabrielle Caron-Lapointe,&nbsp;Fangzhou Wei,&nbsp;Marie-Hélène Lafeuille","doi":"10.2147/CEOR.S413800","DOIUrl":"https://doi.org/10.2147/CEOR.S413800","url":null,"abstract":"<p><strong>Introduction: </strong>Integrase strand transfer inhibitor-based regimens (eg, containing dolutegravir [DTG]) are associated with weight/body mass index (BMI) increases among people living with HIV-1 (PLWH). Assessing antiretroviral therapy (ART)-related weight/BMI changes is challenging, as PLWH may experience return-to-health weight gain as a result of viral suppression. This retrospective, longitudinal real-world study compared weight/BMI outcomes among overweight/obese (BMI ≥25 kg/m²; thus excluding return-to-health weight/BMI changes), treatment-naïve PLWH who initiated darunavir (DRV)/cobicistat (c)/emtricitabine (FTC)/tenofovir alafenamide (TAF) or DTG + FTC/TAF.</p><p><strong>Methods: </strong>Treatment-naïve PLWH with BMI ≥25 kg/m² who initiated DRV/c/FTC/TAF or DTG + FTC/TAF (index date) had ≥12 months of baseline observation and ≥1 weight/BMI measurement in baseline and post-index periods in the Symphony Health IDV^® database (07/17/2017-12/31/2021) were included. Inverse probability of treatment weighting (IPTW) was used to balance differences in baseline characteristics between cohorts. On-treatment time-to-weight/BMI increases ≥5% were compared between cohorts using weighted adjusted Cox models.</p><p><strong>Results: </strong>Post-IPTW, 76 overweight/obese DRV/c/FTC/TAF-treated (mean age = 51.2 years, 30.7% female, 35.6% Black, mean baseline BMI = 33.2 kg/m²) and 88 overweight/obese DTG + FTC/TAF-treated PLWH (mean age = 51.5 years, 31.4% female, 31.4% Black, mean baseline BMI = 32.7 kg/m²) were included. The median [interquartile range] time from ART initiation to weight/BMI increase ≥5% was shorter for the DTG + FTC/TAF cohort (21.8 [9.9, 32.3] months) than the DRV/c/FTC/TAF cohort (median and interquartile times not reached; Kaplan-Meier rate at 21.8 months = 20.8%). Over the entire follow-up, overweight/obese PLWH initiating DTG + FTC/TAF had a more than twofold greater risk of experiencing weight/BMI increase ≥5% compared to those initiating DRV/c/FTC/TAF (hazard ratio [95% confidence interval]=2.43 [1.02; 7.04]; p = 0.036).</p><p><strong>Conclusion: </strong>Overweight/obese PLWH who initiated DTG + FTC/TAF had significantly greater risk of weight/BMI increase ≥5% compared to similar PLWH who initiated DRV/c/FTC/TAF and had shorter time-to-weight/BMI increase ≥5%, suggesting a need for additional monitoring to assess the risk of weight gain-related cardiometabolic disease.</p>","PeriodicalId":47313,"journal":{"name":"ClinicoEconomics and Outcomes Research","volume":null,"pages":null},"PeriodicalIF":2.1,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/dd/80/ceor-15-579.PMC10377594.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9907232","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}