Background ART is typically begun weeks after HIV diagnosis. We assessed the acceptability, feasibility, safety and efficacy of initiating ART on the same day as diagnosis. Methods We studied a clinic-based cohort consisting of consecutive patients who were referred with new HIV diagnosis between June 2013 and December 2014. A subset of patients with acute or recent infection (<6 months) or CD4<200 were managed according to a “RAPID” care initiation protocol. An intensive, same-day appointment included social needs assessment; medical provider evaluation; and a first ART dose offered after labs were drawn. Patient acceptance of ART, drug toxicities, drug resistance and time to viral suppression outcomes were compared between RAPID participants and contemporaneous patients (who were not offered the program), as well as with an historical cohort. Results Among 86 patients, 39 were eligible and managed on the RAPID protocol. 37 (94.9%) of 39 in RAPID began ART within 24 hours. Minor toxicity with the initial regimen occurred in two (5.1%) of intervention patients versus none in the non-intervention group. Loss to follow-up was similar in intervention (10.3%) and non-intervention patients (14.9%) during the study. Time to virologic suppression (<200 copies HIV RNA/mL) was significantly faster (median 1.8 months) among intervention-managed patients when compared with patients treated in the same clinic under prior recommendations for universal ART (4.3 months; p=0.0001). Conclusions Treatment for HIV infection can be started on the day of diagnosis without impacting the safety or acceptability of ART. Same-day ART may shorten the time to virologic suppression.

Consistent with findings from adult patient populations, trait anxiety levels and recent experiences with hypoglycemia predict FOH in adolescents with T1DM. In parents, however, beliefs about their adolescents' ability to cope with hypoglycemic episodes predicted FOH. FOH in adolescents with T1DM and their parents is a complex construct influenced by multiple personality and situational and behavioral factors, and its impact on diabetes management remains unclear.

Background/Aims Risks and benefits of simeprevir plus sofosbuvir in patients with advanced cirrhosis are unknown. We assessed the safety and sustained virologic responses (SVR) of simeprevir plus sofosbuvir with and without ribavirin in patients with Child-Pugh (CP)-B/C vs. CP-A cirrhosis and compared to matched untreated controls. Methods Multicenter cohort of adults with HCV genotype 1 and cirrhosis treated with simeprevir plus sofosbuvir with/without ribavirin for 12 weeks. Controls were matched on treatment center, age, CP class and model for end-stage liver disease (MELD) score. Results Of 160 patients treated with simeprevir plus sofosbuvir with/without ribavirin, 35% had CP-B/C and 64% had CP-A, with median baseline MELD 9 (IQR 8–11). SVR12 was achieved by 73% of CP-B/C vs. 91% of CP-A (p<0.01). CP-B/C vs. CP-A had more early treatment discontinuations (11% vs. 1%), adverse events requiring hospitalization (22% vs. 2%), infections requiring antibiotics (20% vs. 1%) and hepatic decompensating events (20% vs. 3%) (all p<0.01). There were 2 deaths: 1 CP-B/C (liver-related) and 1 CP-A (not liver-related). In multivariate analysis, CP-B/C independently predicted lack of SVR12 (OR 0.27, 95% CI 0.08–0.92). In comparing simeprevir plus sofosbuvir treated patients vs. matched untreated controls, adverse events requiring hospitalization (9% vs. 13%, p=0.55), infections (8% vs. 6%, p=0.47) and events of decompensation (9% vs. 10%, p=0.78) occurred at similar frequency. Conclusions Simeprevir plus sofosbuvir with/without ribavirin has lower efficacy and higher rates of adverse events in patients with CP-B/C cirrhosis compared to CP-A. The frequency of adverse safety outcomes were similar to matched untreated controls, suggesting safety events reflect the natural history of cirrhosis and are not related to treatment.

Immune checkpoint inhibitor (ICI) therapies are now first-line therapy for many advanced malignancies in adults, with emerging use in children. With increasing ICI use, prompt recognition and optimal management of ICI-associated immune-related adverse events (IRAEs) are critical. Nearly 60% of ICI-treated adults develop IRAEs, which commonly manifest as autoimmune skin, gastrointestinal, and endocrine disease and can be life-threatening. The incidence, presentation, and disease course of spontaneous autoimmune diseases differ between adults and children, but the pattern of pediatric IRAEs is currently unclear. We report a case of a pediatric patient presenting with new onset autoimmune diabetes mellitus and diabetic ketoacidosis during ICI treatment of fibrolamellar hepatocellular carcinoma (FLC). Distinct from spontaneous type 1 diabetes mellitus (T1DM), this patient progressed rapidly and was negative for known β cell autoantibodies. Additionally, the patient was positive for 21-hydroxylase autoantibodies, suggesting development of concomitant adrenal autoimmunity. Current guidelines for the management of IRAEs in adults may not be appropriate for the management of pediatric patients, who may have different autoimmune risks in a developmental context.

Background: Vaso-occlusive pain leads to high acute care utilization among patients with sickle cell disease (SCD). Data suggest that clinical pathways (CPWs) reduce variation in the management of vaso-occlusive pain and improve clinical outcomes. Methods: We implemented and evaluated a CPW for vaso-occlusive pain at our institution using a before and after study design. The primary objective was to decrease acute care utilization among patients with SCD, which was assessed by the primary outcome measures of hospital length of stay (LOS), 30-day readmission rate, and total hospitalizations annually per patient. Secondary outcome measures were packed red blood cell transfusions, and acute chest syndrome incidence. Patient-controlled analgesia use and promethazine use were assessed to estimate CPW use. Results: Three hundred fourty-four admissions in 112 patients were analyzed, of which 193 admissions occurred pre-CPW and 151 admissions occurred post-CPW implementation. Post-CPW implementation, we observed a significant decrease in hospital admissions annually per patient, an increase in patient-controlled analgesia use, and a decrease in intravenous promethazine use. We observed trends toward decreased 30-day readmission rate and increased acute chest syndrome incidence, which were not statistically significant. No effect was found on hospital LOS. Conclusions: Clinical pathway implementation at our institution reduced variation in management and decreased hospital admissions for vaso-occlusive pain.

Vaso-occlusive pain, a primary feature of sickle cell disease (SCD), leads to high acute care utilization, including frequent hospital admission. Though limited by a paucity of high quality evidence, guideline recommendations for the inpatient management of vaso-occlusive pain include rapid and continual pain assessment, early and individualized pain control, and intravenous fluid resuscitation (Yawn et. al. JAMA). However, research suggests that inpatient vaso-occlusive pain management varies significantly within institutions (Co et. al. Jt Comm J Qual Saf). Clinical pathways, which are a mechanism for increasing evidence-based management within an institution to standardize and improve quality of care, have been shown to reduce variation in vaso-occlusive pain management (Morrisey et. al. Pediatr Blood Cancer). We developed and implemented a clinical pathway for the management of vaso-occlusive pain using evidence-based interventions and expert consensus guidelines and hypothesized that it would improve clinical outcomes. The pathway was implemented as an electronic orderset and providers were educated on its use, which was voluntary. A retrospective chart review was then performed of adult patients admitted to Tulane Hospital for vaso-occlusive pain during one year prior to and following pathway implementation (344 total admissions, 112 total patients). Outcome measures were hospital length of stay (LOS), rate of 30-day readmission, median number of hospitalizations over one year prior to and after pathway implementation, and incidence of acute chest syndrome. Use of patient-controlled analgesia (PCA) and intravenous (IV) promethazine were used as surrogate measures of pathway utilization. Data were summarized in terms of medians (IRQ) for continuous outcomes (analyzed with the Wilcoxon Rank Sum Test) and percentages for categorical variables (analyzed with the Pearson's Chi-Squared Test). Following pathway implementation, we observed a statistically significant decrease in median number of admissions per patient (2 vs. 1, p=0.0027), an increase in PCA use (3.6% vs. 87.3%, p<0.0001), and a decrease in IV promethazine use (78% vs. 36%, p<0.0001). We observed trends toward decreased 30-day readmission (26% vs 20%, p=0.6105) and increased acute chest syndrome incidence (12% vs 18%, p=0.157), but these trends were not statistically significant. No effect was found on hospital LOS. Increased PCA use and decreased IV promethazine use suggest high pathway utilization among providers. We suspect the decrease in median admissions occurred due to improved discharge planning, primarily arranging close followup, given that lack of an outpatient provider is a known risk factor for hospital admission for vaso-occlusive pain (Brodsky Am J Med). Despite the reduction in median admissions, the observed decrease in readmission rates was not statistically significant, possibly due to insufficient study power. A nonsignificant change in readmission rates may also suggest that additional interventions need to be developed and evaluated to address socioeconomic barriers to outpatient healthcare access, such as financial insecurity and missed appointments, which have also been identified as modifiable risk factors for readmission (Cronin et. al. Hematology). The lack of an effect on hospital LOS may be due to the confounding variable of pain episode severity, which is difficult to control for given the absence of a biomarker for vaso-occlusive disease severity. Thus, we suggest 30-day readmission and total hospital days be used as primary outcome measures in future studies. By increasing evidence-based and expert consensus management of vaso-occlusive pain, clinical pathways may decrease hospital admissions for SCD patients. More research is needed to evaluate interventions to mitigate socioeconomic risk factors for readmission, which may then be incorporated into future clinical pathways to reduce readmission rates. Disclosures Debord: Stryker Orthopaedics: Consultancy, Other: ceives salary as well as is a stock holder with Stryker.

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