Respiratory Syncytial Virus–Related Hospitalizations Among Infants Receiving Nirsevimab
1. In this large case-control study across 7 tertiary pediatric hospitals, receiving Nirsevimab (Beyfortus) among symptomatic infants with respiratory syncytial virus (RSV) significantly reduced the burden of severe disease and ICU visits.
Evidence Rating Level: 1 (Excellent)
Respiratory syncytial virus (RSV) is a major cause of emergency department visits and hospitalization in infants, and nirsevimab is a long-acting monoclonal antibody designed to prevent severe RSV disease during an infant’s first RSV season. This study evaluated the real-world effectiveness of nirsevimab against RSV-related emergency department (ED) visits, hospitalizations, and intensive care unit (ICU) admissions during the 2024–2025 RSV season in Ontario and Quebec. The investigators conducted a test-negative case-control study across 7 tertiary pediatric hospitals participating in the SPRINT-KIDS surveillance network. They included symptomatic infants younger than 12 months who underwent RSV testing between October 27, 2024, and March 1, 2025, with nirsevimab receipt at least 7 days before testing. Of 1,942 eligible infants, 683 (35.2%) were RSV-positive cases and 1,259 (64.8%) were RSV-negative controls, while 429 infants (22.1%) had received nirsevimab. Receiving nirsevimab was substantially less common among RSV-positive infants than RSV-negative infants (7.0% vs 30.3%; P < .001). After adjustment, estimated effectiveness against laboratory-confirmed RSV disease was 78% (95% CI, 68%-84%), with effectiveness of 77% (95% CI, 62%-86%) against ED visits, 79% (95% CI, 66%-87%) against hospitalization, and 97% (95% CI, 85%-100%) against ICU admission. Effectiveness remained high among premature infants (90%; 95% CI, 66%-98%) and infants with comorbidities (86%; 95% CI, 37%-98%). Overall, the findings suggest that nirsevimab was highly effective at preventing severe RSV disease requiring hospital-based care during the first season of universal publicly funded administration in Ontario and Quebec.
1. In this large randomized controlled trial, patients with HIV who received long-acting broadly neutralizing antibodies were able to delay HIV viral load rebound when off of antiretroviral therapy.
Evidence Rating Level: 1 (Excellent)
Long-acting broadly neutralizing antibodies (bNAbs) are being investigated as a strategy to maintain HIV suppression after discontinuation of antiretroviral therapy (ART), potentially providing a pathway toward prolonged ART-free viral control. This study reports secondary and exploratory analyses from the phase 2 RIO randomized, double-blind, placebo-controlled trial, which evaluated the long-acting bNAbs 3BNC117-LS and 10-1074-LS during analytical treatment interruption. Sixty-eight adult men living with HIV who had initiated ART during primary or early infection were randomized 1:1 to receive the two bNAbs (n=34) or placebo (n=34) before stopping ART. The investigators characterized the HIV reservoir using digital droplet polymerase chain reaction (ddPCR), assessed viral sensitivity to the antibodies, and examined viral rebound and evolution during treatment interruption. Early viral rebound before week 20 occurred in 8 participants in the bNAb group versus 30 in the placebo group (75% vs 11%; P < .001). Median time to ART restart was 45.4 weeks in the bNAb group compared with 4.6 weeks in the placebo group, and at 96 weeks, 7 of 29 participants (24%) receiving bNAbs remained off ART compared with 2 of 32 (6%) in the control group (P < .001). The investigators also found that greater baseline sensitivity of the viral reservoir to autologous antibodies and 10-1074 was associated with longer time to viral rebound. Overall, the findings suggest that long-acting bNAbs can substantially delay HIV rebound in selected individuals and that pre-existing host immunity and antibody sensitivity may influence the durability of ART-free viral control.
Accelerometer-Derived Real-World Sleep Stages and Risk of Incident Diseases
1. In a large cohort study, greater REM sleep was associated with lower risks of several chronic diseases including heart failure, dementia, atrial fibrillation, and Alzheimer’s disease.
Evidence Rating Level: 2 (Good)
Sleep duration and quality have been associated with numerous chronic diseases, but much of the existing epidemiologic literature relies on self-reported sleep rather than objectively measured sleep patterns. This study investigated whether objectively measured sleep stages, duration, irregularity, and fragmentation were associated with subsequent development of a broad range of diseases. The investigators conducted a prospective cohort study using 95,559 UK Biobank participants who had worn wrist-based accelerometers for 7 days, with sleep stages estimated using the SleepNet algorithm. Participants had a mean age of 56.2 years, 43.7% were male, and median follow-up was 8.9 years. The researchers performed a phenome-wide association analysis examining associations between sleep characteristics and 1,049 incident health outcomes, using Cox proportional hazards models adjusted for demographic, lifestyle, and environmental factors. After Bonferroni correction, 156 disease associations remained significant, including 83 associated with REM sleep and 7 with deep sleep. Greater REM sleep was associated with lower risk of heart failure (HR 0.74, 95% CI 0.68-0.80; P<.001), atrial fibrillation (HR 0.83, 95% CI 0.79-0.86; P<.001), dementia (HR 0.54, 95% CI 0.47-0.62; P<.001), and Alzheimer disease (HR 0.69, 95% CI 0.57-0.81; P<.001). Greater deep sleep was also associated with lower risk of type 2 diabetes (HR 0.89, 95% CI 0.85-0.93; P<.001) and Parkinson disease (HR 0.70, 95% CI 0.62-0.80; P<.001), whereas greater sleep irregularity and wakefulness after sleep onset were associated with increased disease risk. Sleep duration demonstrated significant nonlinear associations with 86 disease phenotypes (P for nonlinearity <.05), with the lowest observed risks for 69 phenotypes concentrated around 6–8 hours of sleep. Overall, longer uninterrupted sleep was measured to decrease the risk of several chronic diseases, while interruptions and wakefulness after sleep onset is associated with increased disease risk.
Program-Level Neoadjuvant Chemotherapy Use and 10-Year Survival in Advanced Ovarian Cancer
1. In this comparative study, patients with advanced epithelial ovarian cancer who received neoadjuvant chemotherapy were found to have reduced early morbidity or mortality.
Evidence Rating Level: 2 (Good)
The optimal sequencing of surgery and chemotherapy for advanced epithelial ovarian cancer remains an important clinical question, particularly regarding whether increased use of neoadjuvant chemotherapy (NACT) affects long-term survival. This comparative effectiveness study examined whether cancer programs that adopted NACT more extensively after publication of randomized trial evidence experienced differences in 10-year overall survival compared with programs with little change in NACT use. The investigators used the National Cancer Database to identify patients with stage IIIC or IV epithelial ovarian cancer diagnosed between 2004 and 2015, with follow-up through December 2023. The analysis included 17,004 patients treated at 319 low-NACT-use programs and 17,611 patients at 319 high-use programs, with a mean age of 63.8 years. A difference-in-differences design compared programs with large versus minimal increases in NACT utilization before and after publication of an RCT supporting NACT as a noninferior treatment strategy. NACT use increased from 21.5% to 42.8% at high-use programs compared with only 20.3% to 22.7% at low-use programs, producing a difference-in-differences estimate of 18.9 percentage points (95% CI, 16.6-21.2). Despite this divergence in treatment strategy, standardized 10-year survival increased similarly in both groups, from 15.6% to 20.0% at high-use programs and from 15.1% to 19.1% at low-use programs. The corresponding difference-in-differences estimate for 10-year survival was only 0.3 percentage points (95% CI, −0.8 to 1.6), while the difference in 10-year restricted mean survival time was 0.7 months (95% CI, −0.8 to 2.1). Thus, greater program-level adoption of NACT was not associated with either better or worse 10-year survival in this analysis. The authors concluded that these findings extend previous evidence suggesting that increased use of NACT can reduce early morbidity or mortality without compromising long-term survival.
1. In this observational case-control study, children who received a complete ROTASIIL vaccination series had significantly reduced hospitalization rates for rotavirus gastroenteritis.
Evidence Rating Level: 2 (Good)
Rotavirus remains an important cause of severe gastroenteritis and hospitalization among young children, particularly in countries with substantial pediatric diarrheal disease burden. This study assessed the real-world effectiveness of ROTASIIL, a pentavalent oral rotavirus vaccine introduced into India’s Universal Immunization Program in 2018. The investigators pooled data from two multicentre observational studies conducted across 32 hospitals in 7 Indian states between July 2019 and December 2023. Using a test-negative case-control design, they evaluated children aged 3–23 months who were hospitalized with acute gastroenteritis and compared vaccine receipt between children with and without laboratory-confirmed rotavirus gastroenteritis. Among 2,243 hospitalized children, 638 were positive for rotavirus by ELISA. For children who had received the complete 3-dose series, adjusted vaccine effectiveness against hospitalization for rotavirus gastroenteritis was 52% (95% CI, 32%-66%). Effectiveness was particularly high among infants aged 3–5 months, reaching 88% (95% CI, 53%-97%). The adjusted effectiveness was 56% (95% CI, 11%-79%) against moderate rotavirus gastroenteritis and 54% (95% CI, 31%-70%) against severe disease. Genotype-specific effectiveness was highest against G1P rotavirus at 62% (95% CI, 29%-80%), while receipt of at least one vaccine dose provided 45% effectiveness (95% CI, 26%-60%) among children aged 1–23 months. The study therefore provides real-world evidence that completing the ROTASIIL series reduces hospitalization for rotavirus gastroenteritis, with particularly strong protection when vaccination occurs early in infancy.
Image: PD
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