Faculty Bibliography

Prior international studies have shown mixed results regarding the association of hepatitis B and hepatitis C with adverse pregnancy outcomes. We performed an updated evaluation of the prevalence of associated adverse pregnancy outcomes and evaluated trends over time of diagnosis of chronic hepatitis B (HBV) and chronic hepatitis C (HCV) in pregnant women in a national database. All pregnant women with HBV and HCV were identified from the National Inpatient Sample database 2012 to 2018. Multivariate logistic regression analyses were performed to compare pregnancy-related complications, including rates of preeclampsia/eclampsia, gestational diabetes, intrauterine growth restriction, antepartum/intrapartum hemorrhage, preterm labor, and Cesarean section. We evaluated all-cause in-hospital mortality, length of stay, and total cost of hospitalizations. A total of 28.7 million pregnancy-related hospitalizations that met our eligibility criteria were identified, including 51,200 with HBV and 131,695 with HCV. In comparison with the uninfected controls, the HBV group was significantly more likely to develop gestational diabetes (12.94% vs. 6.94%, p < 0.001). The HCV group was more likely to have preterm labor (9.63% vs. 6.27%, p < 0.001), intrauterine growth restriction (6.04% vs. 2.89%, p < 0.001), longer length of stay (3.4 days vs. 2.7 days, p < 0.001), and higher hospitalization cost (15,052 dollars vs. 14,258 dollars, p < 0.001). These findings should inform counseling of women who are found to have HBV or HCV during pregnancy regarding the risk of adverse pregnancy outcomes and support the need for an interdisciplinary approach to optimize maternal and neonatal outcomes.

PURPOSE/OBJECTIVE:The prospective Neoadjuvant Breast Registry Symphony Trial compared the 80-gene molecular subtyping signature with clinical assessment by immunohistochemistry and/or fluorescence in situ hybridization in predicting pathologic complete response (pCR) and 5-year outcomes in patients with early-stage breast cancer. METHODS:Standard-of-care neoadjuvant chemotherapy combined with trastuzumab or trastuzumab plus pertuzumab was given to patients with human epidermal growth factor receptor 2 (HER2)-positive tumors (n = 295). pCR was the primary end point, with secondary end points of distant metastasis-free survival and overall survival at 5 years. RESULTS:= .010), with similar corresponding overall survival differences. CONCLUSION/CONCLUSIONS:The 80-gene assay identified meaningful genomic diversity in patients with cHER2 disease. Patients with cHER2/gHER2 tumors, who benefitted most from dual HER2-targeted therapy, accounted for approximately half of the cHER2 cohort. Genomically Luminal tumors had low pCR rates but good 5-year outcomes. cHER2/gBasal tumors derived no benefit from dual therapy and had significantly worse 5-year prognosis; these patients merit special consideration in future trials.

Although upfront autologous stem cell transplantation (ASCT) generally improves progression-free survival (PFS) in newly diagnosed multiple myeloma (NDMM), the overall survival (OS) benefit and optimal timing of ASCT are not well established. Patients with early response may be able to safely continue induction and avoid ASCT without compromised outcomes. We report an extended follow-up analysis of a phase 2 trial that randomized transplant-eligible patients with NDMM who responded to induction (50/65 patients) to continued induction or ASCT; median follow-up was 8.0 years. Patients had similar 8-year PFS (55% vs. 43%), 8-year OS (83% vs. 72%), and rates of at least very good partial response (72% vs. 84%) whether continuing induction of lenalidomide and dexamethasone (Ld arm) or receiving ASCT (Ld + ASCT arm) (p = 0.5). Notably, over 50% of patients receiving continuous Ld had PFS of 5-10 years. These results suggest the need for prospective trials incorporating response-adapted therapeutic approaches to NDMM.STATEMENT OF PRIOR PRESENTATIONPresented in abstract form (interim analysis) at the 56th annual meeting of the American Society of Hematology (San Francisco, CA, 6 December 2014) and at the 57th annual meeting of the American Society of Hematology (Orlando, FL, 3 December 2015).

Intimate Partner Violence (IPV) has been linked to poor health. Economic position may be an important risk factor for IPV. We examined the association between economic position and IPV at country and individual levels. We analyzed Demographic and Health Surveys data of 187,716 ever-partnered women between ages 10 and 59 from 20 low- and middle-income countries. We calculated direct age-standardized 12-month prevalence of physical IPV and performed ecological analysis using Gini coefficients and Concentration indexes to assess correlation with 12-month prevalence of physical IPV. We conducted multivariable logistic regression for each country to assess the association between wealth status and physical IPV and a meta-analysis of the regression model to present results across countries. Compared to the Poorest quintile, odds of IPV among wealthier quintiles varied by country. In the Middle quintile, India had significantly reduced IPV (OR 0.75, 95%CI: 0.68-0.83). In the Richer and Richest quintiles, 4 and 6 countries had significant reductions in IPV, respectively. Only Mozambique was found to have significant increased IPV in the wealthiest quintile (OR 2.51, 95%CI: 1.45-4.38). Gini coefficient and physical IPV had a correlation coefficient of 0.502 (p value 0.033), while Concentration index had -0.276 (p value .253). Standardized prevalence for physical IPV ranged from 1.58% to 18.91%. Findings suggest that the relationship between wealth and IPV vary considerably in the included low- and middle-income countries, and that risk of IPV may not necessarily be higher among women in lower wealth brackets. Mozambique was the only country with increased odds of IPV among the Richest group as compared to the Poorest group. This study provides evidence IPV may transcend economic boundaries, and that studies looking at the link between inequality and IPV are paramount for designing adequate preventative policies.

BACKGROUND AND OBJECTIVES/OBJECTIVE:Contrast-associated AKI may result in higher morbidity and mortality. Intravenous fluid administration remains the mainstay for prevention. There is a lack of consensus on the optimal administration strategy. We studied the association of periprocedure fluid administration with contrast-associated AKI, defined as an increase in serum creatinine of at least 25% or 0.5 mg/dl from baseline at 3-5 days after angiography, and 90-day need for dialysis, death, or a 50% increase in serum creatinine. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS/METHODS:We conducted a secondary analysis of 4671 PRESERVE participants who underwent angiographic procedures. Although fluid type was randomized, strategy of administration was at the discretion of the clinician. We divided the study cohort into quartiles by total fluid volume. We performed multivariable logistic regression, adjusting for clinically important covariates. We tested for the interaction between fluid volume and duration of fluid administration, categorized as <6 or ≥6 hours. RESULTS:. The range of fluid administered was 89-882 ml in quartile 1 and 1258-2790 ml in quartile 4. Compared with the highest quartile (quartile 4) of fluid volume, we found a significantly higher risk of the primary outcome in quartile 1 (adjusted odds ratio, 1.58; 95% confidence interval, 1.06 to 2.38) but not in quartiles 2 and 3 compared with quartile 4. There was no difference in the incidence of contrast-associated AKI across the quartiles. The interaction between volume and duration was not significant for any of the outcomes. CONCLUSIONS:We found that administration of a total volume of 1000 ml, starting at least 1 hour before contrast injection and continuing postcontrast for a total of 6 hours, is associated with a similar risk of adverse outcomes as larger volumes of intravenous fluids administered for periods >6 hours. Mean fluid volumes <964 ml may be associated with a higher risk for the primary outcome, although residual confounding cannot be excluded.

COVID-19 symptom definitions rarely include symptom severity. We collected daily nasal swabs and symptom diaries from contacts of SARS-CoV-2 cases. Requiring ≥1 moderate or severe symptom reduced sensitivity to predict SARS-CoV-2 shedding from 60.0% (CI: 52.9-66.7%) to 31.5% (CI: 25.7-38.0%), but increased specificity from 77.5% (CI:75.3-79.5%) to 93.8% (CI: 92.7-94.8%).

BACKGROUND:Transmission rates after exposure to a severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)-positive individual within households and healthcare settings varies significantly between studies. Variability in the extent of exposure and community SARS-CoV-2 incidence may contribute to differences in observed rates. METHODS:We examined risk factors for SARS-CoV-2 infection in a randomized controlled trial of hydroxychloroquine as postexposure prophylaxis. Study procedures included standardized questionnaires at enrollment and daily self-collection of midturbinate swabs for SARS-CoV-2 polymerase chain reaction testing. County-level incidence was modeled using federally sourced data. Relative risks and 95% confidence intervals were calculated using modified Poisson regression. RESULTS:Eighty-six of 567 (15.2%) household/social contacts and 12 of 122 (9.8%) healthcare worker contacts acquired SARS-CoV-2 infection. Exposure to 2 suspected index cases (vs 1) significantly increased risk for both household/social contacts (relative risk [RR], 1.86) and healthcare workers (RR, 8.18). Increased contact time also increased risk for healthcare workers (3-12 hours: RR, 7.82, >12 hours: RR, 11.81, vs ≤2 hours), but not for household/social contacts. County incidence did not impact risk. CONCLUSIONS:In our study, increased exposure to SARS-CoV-2 within household or healthcare settings led to higher risk of infection, but elevated community incidence did not. This reinforces the importance of interventions to decrease transmission in close contact settings.