RESUMEN
OBJECTIVE: To improve neonatal outcomes through the implementation of an eat, sleep, console (ESC) assessment and change in hospital policy regarding the monitoring requirements for pharmacologic treatment of neonates with neonatal abstinence syndrome (NAS). DESIGN: Retrospective chart review and descriptive survey design. SETTING/LOCAL PROBLEM: A hospital in Northwestern Ontario decided to implement an evidence-informed practice change to better care for neonates with NAS. PARTICIPANTS: Neonates being screened for NAS during the Modified Finnegan Neonatal Abstinence Syndrome Scoring System (MFNASSS) protocol (n = 75) and ESC protocol (n = 40). Nurses working in the departments after the implementation of ESC were surveyed. MEASUREMENTS: Length of stay (LOS) and morphine administration by intervention status using unadjusted hazard and risk ratios, respectively. Descriptive statistics are also presented. A one-sample t test was completed for the nurses' perspectives survey questions. RESULTS: Reduced rate of LOS (HR = 1.66, 95% confidence interval [1.1, 2.51]) was observed for participants receiving the ESC intervention (4.53, SD = 1.94), compared to the MFNASSS control (7.45, SD = 6.35). Although the ESC group appeared to have a greater proportion of neonates administered morphine (42.5% ESC vs. 26.7% MFNASSS), the relative risk was not statistically significant (RR = 1.28, 95% confidence interval [0.95, 1.72]). Morphine doses per day were reduced in the ESC group (0.37, SD = 1.50) compared to the MFNASSS group (5.16, SD = 1.02). Overall, the nurses had a positive perspective on the policy change. CONCLUSION: ESC was successfully implemented in a Northwestern Ontario hospital. The overall LOS of neonates with NAS decreased. Nurses found the policy change to be safe and attainable.
RESUMEN
Background & Aims: In France, bulevirtide (BLV) became available in September 2019 through an early access program to treat patients with HDV. The aim of this analysis was to evaluate the efficacy and safety of BLV in patients with HIV and HDV coinfection. Methods: Patients received BLV 2 mg ± pegylated interferon-α (pegIFNα) according to the physician's decision. The primary endpoint (per-protocol analysis) was the virological response rate at Week 48, defined as the proportion of patients with undetectable serum HDV RNA or a HDV RNA decline >2 log10 IU/ml from baseline. Results: The characteristics of the 38 patients were as follows: 28 male, mean age 47.7 years, and mean baseline HDV RNA viral load 5.7 ± 1.2 log10 IU/ml. Median HIV viral load and mean CD4 count were 32 (30-65) copies/ml and 566 ± 307/mm3, respectively. Eight patients stopped treatment before Week 48. At Week 48, 10 of 19 patients (52.6%) in the 2 mg BLV group and five of seven patients (71.4%) in the 2 mg BLV + pegIFNÉ group had reached virological response (no HDV RNA available in four patients). At Week 48, seven of 19 patients in the 2 mg BLV group and three of six patients in the 2 mg BLV + pegIFNÉ group had a combined response (virological response and normal alanine aminotransferase level). Conclusions: Adults living with HIV coinfected with HDV can be treated by BLV with a virological response in more than 50% of patients. The combination of BLV and pegIFNÉ showed a strong virological response. Impact and implications: Bulevirtide is the only EMA-approved drug for HDV treatment, and we showed that it can be used in adults living with HIV, with an overall good tolerability. Bulevirtide induces a virological response in more than 50% of patients, suggesting that bulevirtide should be considered as a first-line therapy in this specific population. Bulevirtide in combination with pegIFNα could be used in patients without pegIFNα contraindication. No specific drug-drug interaction is reported. Bulevirtide is the only EMA-approved drug for HDV treatment, and we showed that it can be used in adults living with HIV, with an overall good tolerability. Bulevirtide induces a virological response in more than 50% of patients, suggesting that bulevirtide should be considered as a first-line therapy in this specific population. Bulevirtide in combination with pegIFNα could be used in patients without pegIFNα contraindication. No specific drug-drug interaction is reported. Bulevirtide is the only EMA-approved drug for HDV treatment, and we showed that it can be used in adults living with HIV, with an overall good tolerability. Bulevirtide induces a virological response in more than 50% of patients, suggesting that bulevirtide should be considered as a first-line therapy in this specific population. Bulevirtide in combination with pegIFNα could be used in patients without pegIFNα contraindication. No specific drug-drug interaction is reported.