Background Acute otitis media (AOM) leads to considerable healthcare resource utilization in children. Streptococcus pneumoniae is an important cause of AOM. Merck is developing V114, an investigational 15-valent PCV that contains PCV13 serotypes as well as 22F and 33F. To demonstrate the potential value of V114, it is important to estimate the remaining clinical burden associated with AOM. This study estimated AOM incidence rates (IRs) before and after the introduction of 7-valent and 13-valent pneumococcal conjugate vaccines (PCV7 and PCV13) in the US. Methods This was a retrospective observational study using IBM MarketScan® Commercial Claims and Encounters (CCAE) (1998-2018) and Multi-State Medicaid databases (2001-2018). AOM claims in children < 18 years old were identified using ICD9 codes 382.x and ICD10 codes H66.x and H67.x. An episode could comprise one or more AOM-related claims. A gap of at least 14 days between two AOM-related claims was required to define the start of a new episode. IRs were defined as the numbers of episodes per 1,000 person-years (PY). Annual IRs were stratified by age groups (< 2, 2-4, and 5-17), and reported separately for CCAE and Medicaid databases. Results AOM IRs declined over time among commercially and Medicaid-insured children in all age groups < 18 years old. In particular, among children < 2 years, AOM IRs declined from 1,111 in 1998 to 727/1,000 PY in 2018 in commercially plans and from 895 in 2001 to 656/1,000 PY in 2018 in Medicaid (Figure 1). In children 2-4 years, AOM IRs declined from 517 in 1998 to 400/1,000 PY in 2018 in commercial plans and from 385 in 2001 to 329/1,000 PY in 2018 in Medicaid (Figure 2). In children 5-17 years, AOM IRs declined from 112 in 1998 to 87/1,000 PY in 2018 in commercial plans and from 98 in 2001 to 87/1,000 in 2018 in Medicaid (Figure 3). Figure 1. AOM incidence in commercially and Medicaid-insured children ages 0 - 1 years, episodes per 100,000 patient-years (1998 - 2018) Figure 2. AOM incidence in commercially and Medicaid-insured children ages 2 - 4 years, episodes per 100,000 patient-years (1998 - 2018) Figure 3. AOM incidence in commercially and Medicaid-insured children ages 5 - 17 years, episodes per 100,000 patient-years (1998 - 2018) Conclusion AOM IRs declined following the introduction of PCV7 and PCV13; however, disease burden remains substantial in younger children. The impact of future PCVs on AOM will depend on the proportion of AOM caused by S. pneumoniae and vaccine-type serotypes. Disclosures Tianyan Hu, PhD, Merck (Employee, Shareholder) Yan Song, PhD, Merck (Consultant) Nicolae Done, PhD, Merck & Co., Inc. (Consultant) Eli Orvis, BA, Merck (Consultant) James Signorovitch, PhD, Merck & Co., Inc. (Consultant) Tanaz Petigara, PhD, Merck & Co., Inc. (Employee, Shareholder)
Background To describe trends in emtricitabine and tenofovir disoproxil fumarate (FTC/TDF) PrEP uptake in 2012-2018 and characterize high risk individuals who use PrEP. Methods The study identified individuals aged ≥ 15 years old with claims suggesting high risk for HIV infection in the IBM MarketScan® Commercial Claims and Multi-state Medicaid Databases. High risk was defined using ICD codes indicating high risk sexual behavior or rectal/repeated bacterial sexually transmitted infection (STI). The index date was defined as the earliest of the first high risk sexual behavior diagnosis, the first rectal bacterial STI diagnosis, or the second non-rectal bacterial STI diagnosis within 12 months. Individuals were considered PrEP users if they had at least one FTC/TDF PrEP prescription within 12 months of index date. Individuals with evidence of HIV prior to or within 30 days after PrEP initiation/index date were excluded. Comorbidities were assessed using a modified Charlson Comorbidity Index that excluded HIV/AIDS. Results FTC/TDF PrEP uptake increased from 0.1% to 7.3% among commercially insured individuals between 2012-2018, and from 0.01% to 0.5% among Medicaid insured individuals between 2012-2017. Individuals ≥ 35 years old had the largest increase in PrEP uptake (0.1% to 13.0%), while those 16-25 years old had the smallest increase (0.03% to 2.3%). The largest proportion of PrEP users across all years were aged 25-34 while the largest proportion of non-PrEP users were aged 18-24. Compared to PrEP users, a larger proportion of PrEP non-users were female (62.9% vs. 1.4%, p < 0.05) and blacks/African American (49.1% vs. 40.3%, p < 0.05). A larger proportion of PrEP users had a risk status of homosexual (46.6% vs. 1.5%, p < 0.05) or bisexual (3.9% vs. 0.8%, p < 0.05) behavior than non-PrEP users. PrEP users also had more comorbidities than non-users among individuals with Medicaid and were less likely to have fee-for-service insurance plans overall (p < 0.05). Table 1. Characteristics of people at high-risk for HIV who do vs. do not use FTC/TDF PrEP measured during the follow-up period Conclusion Despite an increase in FTC/TDF PrEP initiations, uptake was low, especially among young adults, women, heterosexuals and blacks/African Americans. Low initiation rates in these groups may illustrate that FTC/TDF PrEP is not meeting the needs of all high-risk individuals. Disclosures Mo Zhou, PhD, Merck & Co., Inc. (Consultant) Yan Song, PhD, Merck & Co., Inc. (Consultant) Emily Gao, MS, MPH, Merck & Co., Inc. (Consultant) Yohance Whiteside, PhD, MSPH, Merck & Co., Inc. (Employee) Emma Billmyer, BA, Merck & Co., Inc. (Consultant) James Signorovitch, PhD, Merck & Co., Inc. (Consultant)
733 Background: VHL disease is a rare hereditary condition that causes abnormal tumor growth in multiple organs, including renal cell carcinoma (RCC), central nervous system (CNS) hemangioblastomas (Hb), pancreatic neuroendocrine tumors (pNET), and other tumors. Repeated surgeries are often required due to ongoing tumor recurrences and can lead to complications such as chronic kidney disease, pancreatic insufficiency, and neurological deficit. Belzutifan is a hypoxia-inducible factor inhibitor approved in the US for the treatment of VHL-associated RCC, CNS Hb, or pNET not requiring immediate surgery. This study aimed to quantify the annual rate and costs of VHL-related surgeries and surgical complications before and after belzutifan initiation. Methods: Surgeries were observed during the periods before and after belzutifan initiation in the single-arm phase 2 LITESPARK-004 trial (NCT03401788) among adults with VHL-RCC. Rates of RCC surgeries were obtained by fitting exponential survival models to: time from treatment initiation to the next renal surgery; and time (looking backward) from treatment initiation to the most recent renal surgery before treatment. Rates of surgeries related to other VHL manifestations were calculated as number of surgeries divided by person-years at risk, using all available post-treatment follow up (151 person-years; median [range] per patient: 29.2 [4.2-37.5] months) and equivalent person-years in the pre-treatment period. Complication risks per surgery and unit costs of surgeries and complications were obtained from a retrospective study on VHL within the Optum Clinformatics Data Mart (2000-2020). Annual per-patient costs of surgeries and complications were estimated in 2020 US dollars over the pre- and post-treatment periods from a US third-party payer perspective. Results: Among trial participants (N=61), the rate of RCC surgeries (surgeries/person-year) decreased 87% (0.108 to 0.014) after belzutifan initiation. The rate of other surgeries decreased 98% (0.265 to 0.007), with CNS Hb surgeries decreasing from 0.185 to 0.007, pNET surgeries from 0.013 to 0, adrenal lesion surgeries from 0.007 to 0, and retinal Hb surgeries from 0.060 to 0. Belzutifan was accordingly estimated to reduce per-patient average annual costs of surgeries and complications from $57,259 to $2,536. Conclusions: Healthcare costs of surgeries and surgical complications are substantial among patients with VHL-RCC. In a trial-based cost-consequence analysis, belzutifan was estimated to decrease annual surgery and complication costs by 96%, based on observed reductions in VHL-related surgeries. [Table: see text]
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.
hi@scite.ai
10624 S. Eastern Ave., Ste. A-614
Henderson, NV 89052, USA
Copyright © 2024 scite LLC. All rights reserved.
Made with 💙 for researchers
Part of the Research Solutions Family.