Outcomes of Nonvariceal Upper Gastrointestinal Bleeding in Patients With Cirrhosis: A National Analysis.

GOALS: We sought to evaluate hospital outcomes of cirrhosis patients with nonvariceal upper gastrointestinal bleeding (NVUGIB). BACKGROUND: NVUGIB is common in patients with cirrhosis. However, national outcome studies of these patients are lacking. STUDY: We utilized the 2014 Nationwide Readmission Database to evaluate NVUGIB in patients with cirrhosis, further stratified as no cirrhosis (NC), compensated cirrhosis (CC), or decompensated cirrhosis (DC). Validated International Classification of Diseases, Ninth Revision, Clinical Modification codes captured diagnoses and interventions. Outcomes included 30-day readmission rates, index admission mortality rates, health care utilization, and predictors of readmission and mortality using multivariable regression analysis. RESULTS: Overall, 13,701 patients with cirrhosis were admitted with NVUGIB. The 30-day readmission rate was 20.8%. Patients with CC were more likely to undergo an esophagogastroduodenoscopy (EGD) within 1 calendar day of admission (74.1%) than patients with DC (67.9%) or NC (69.4%). Patients with DC had longer hospitalizations (4.1 d) and higher costs of care ($11,834). The index admission mortality rate was higher in patients with DC (6.2%) than in patients with CC (1.7%, P <0.001) or NC (1.4%, P <0.001). Predictors of 30-day readmission included performing an EGD >1 calendar day from admission (OR: 1.21; 95% CI, 1.00 to 1.46) and DC (OR: 1.78; 95% CI, 1.54 to 2.06). DC was a predictor of index admission mortality (OR: 3.68; 95% CI, 2.67 to 5.05). CONCLUSIONS: NVUGIB among patients with DC is associated with higher readmission rates, mortality rates, and health care utilization compared with patients with CC and NC. Early EGD is a modifiable variable associated with reduced readmission rates. Early identification of high-risk patients and adherence to guidelines may improve clinical outcomes.

Optimizing HIV PrEP Persistence: Does Your Pharmacy Matter?

Persistence to human immunodeficiency virus (HIV) pre-exposure prophylaxis (PrEP) is integral to preventing new HIV infections. Previous studies have shown real-world PrEP persistence is low and insight is needed into PrEP delivery strategies that improve persistence. This single-center, retrospective, cohort study measured persistence in patients filling PrEP through an integrated health-system specialty pharmacy (HSSP) compared to those filling at external pharmacies. The Kaplan-Meier estimates for persistence probability at 6, 12, and 18 months were 0.87 (95% CI 0.79-0.95), 0.75 (95% CI 0.66-0.86), and 0.64 (95% CI 0.53-0.76) for the HSSP cohort compared to 0.65 (95% CI 0.51-0.83), 0.41 (95% CI 0.28-0.62), and 0.32 (95% CI 0.2-0.53), respectively, for the non-HSSP cohort (log-rank p < 0.001, [Formula: see text] = 11.2). Cox PH modeling showed that patients using a non-HSSP were 2.7 times more likely to be non-persistent than HSSP patients (HR 2.7, 95% CI 1.6-4.7, p < 0.001, [Formula: see text] = 12.61), demonstrating patients were better maintained on PrEP therapy when their prescriptions were filled with the HSSP.

Call for action: Increased healthcare utilization with growing use of percutaneous cholecystectomy tube over initial cholecystectomy in cirrhotics.

BACKGROUND: Acute calculous cholecystitis (ACC) is frequently seen in cirrhotics, with some being poor candidates for initial cholecystectomy. Instead, these patients may undergo percutaneous cholecystostomy tube (PCT) placement. We studied the healthcare utilization and predictors of cholecystectomy and PCT in patients with ACC. METHODS: The National Database was queried to study all cirrhotics and non-cirrhotics with ACC between 2010-2014 who underwent initial PCT (with or without follow-up cholecystectomy) or cholecystectomy. Cirrhotic patients were divided into compensated and decompensated cirrhosis. Independent predictors and outcomes of initial PCT and failure to undergo subsequent cholecystectomy were studied. RESULTS: Out of 919 189 patients with ACC, 13 283 (1.4%) had cirrhosis. Among cirrhotics, cholecystectomy was performed in 12 790 (96.3%) and PCT in the remaining 493 (3.7%). PCT was more frequent in cirrhotics (3.7%) than in non-cirrhotics (1.4%). Multivariate analyses showed increased early readmissions [odds ratio (OR) = 2.12, 95% confidence interval (CI): 1.43-3.13, P < 0.001], length of stay (effect ratio = 1.39, 95% CI: 1.20-1.61, P < 0.001), calendar-year hospital cost (effect ratio = 1.34, 95% CI: 1.28-1.39, P < 0.001) and calendar-year mortality (hazard ratio = 1.89, 95% CI: 1.07-3.29, P = 0.030) in cirrhotics undergoing initial PCT compared to cholecystectomy. Decompensated cirrhosis (OR = 2.25, 95% CI: 1.67-3.03, P < 0.001) had the highest odds of getting initial PCT. Cirrhosis, regardless of compensated (OR = 0.56, 95% CI: 0.34-0.90, P = 0.020) or decompensated (OR = 0.28, 95% CI: 0.14-0.59, P < 0.001), reduced the chances of getting a subsequent cholecystectomy. CONCLUSIONS: Cirrhotic patients undergo fewer cholecystectomy incurring initial PCT instead. Moreover, the rates of follow-up cholecystectomy are lower in cirrhotics. Increased healthcare utilization is seen with initial PCT amongst cirrhotic patients. This situation reflects suboptimal management of ACC in cirrhotics and a call for action.

HIV PrEP access and affordability: a multidisciplinary specialty pharmacy model.

BACKGROUND: Increasing the number of human immunodeficiency virus (HIV) pre-exposure prophylaxis (PrEP) providers expands PrEP access to more eligible patients to help end the HIV epidemic. Previous studies have noted providers perceive financial barriers as a limitation to prescribing PrEP. OBJECTIVE: This study aimed to describe PrEP medication access and affordability in patients seen at a multidisciplinary PrEP clinic. METHOD: We conducted a single-center, retrospective, cohort study of adults initiating tenofovir disoproxil fumarate/emtricitabine in the Vanderbilt PrEP Clinic between September 1, 2016, and March 31, 2019, with prescriptions filled by Vanderbilt Specialty Pharmacy. Data were gathered from the electronic health records and pharmacy claims. We evaluated 3 different time periods: initial evaluation to PrEP initiation, prescription of PrEP to insurance approval, and insurance approval to initiation. Treatment initiation was considered delayed when >7 days from initial evaluation, and reasons for delay were recorded. Continuous variables are presented as median (interquartile range [IQR]), and categorical variables are presented as percentages. RESULTS: We included 63 patients; most were male (97%), white (84%), and commercially insured (94%) with a median age of 38 years (IQR 29-47). Primary indication for PrEP was men who have sex with men at high risk of acquiring HIV (97%). Median time from initial appointment to treatment initiation was 7 days (IQR 4-8). Treatment delays occurred in 25% of patients and were mostly driven by patient preference (50%). Insurance prior authorization was required in 27% of patients; all were approved. Median total out-of-pocket medication costs for the entire study period were $0 (IQR $0-$0). Most patients (86%) used manufacturer copay cards. CONCLUSION: In this cohort of mostly commercially insured men, the majority were able to access PrEP with low out-of-pocket costs facilitated by manufacturer assistance. Although generalizability beyond this population is limited, these results contradict perceived financial barriers to PrEP access.

Trends and Health Care Outcomes Among Living Liver Donors: Are We Ready to Expand the Donor Pool With Living Liver Donations?

We studied the trends and various outcomes, including the readmission rates, health care utilization, and complications among living liver donors (LLDs) in the United States. We queried the National Database for data from 2010 to 2017 for all LLDs. The primary outcomes were 30-day and 90-day readmission rates. The secondary outcomes included health care use (length of stay [LOS], cost of care), index admission, and calendar-year mortality. Logistic regression models were fit for various outcomes. A total of 1316 LLDs underwent hepatectomy during the study period. The median donor age was 35.0 years (interquartile range, 27.4-43.6), and donors were predominantly women (54.2%). The trend of LLD surgeries remained stable at large medical centers (85.3%). The 30-day and 90-day readmission rates were low at 5% and 5.9%, respectively. Older age (50 years and older; 8%; confidence interval [CI], 0.6%-15.9%; P = 0.03) and hepatectomy at small to medium-sized hospitals were associated with increased index LOS (13.4%; 95% CI, 3.1%-24.7%; P = 0.01). Moreover, older age of donor (-11.3%; 95% CI, -20.3% to -1.4%; P = 0.03), Elixhauser score ≥3 (17%; 95% CI, 1.2%-35.3%; P = 0.03), and Medicaid insurance (24.5%; 95% CI, 1.2%-53.1%; P = 0.04) were also associated with increased cost. The overall rate of any complications during index admission was 42.8%. Male sex (odds ratio [OR], 1.63; 95% CI, 1.19-2.23) was an independent predictor of post-LLD complications. There was no index admission or calendar-year mortality reported during the study period. This is the largest national report of LLDs to date, showing that the trend of LLD surgeries is stable in the United States. With established safety, fewer complications, and less health care utilization, LLDs can be a potential source of continuation of liver transplantation in the context of changing liver allocation policies in the United States.

Cannabis use may reduce healthcare utilization and improve hospital outcomes in patients with cirrhosis.

INTRODUCTION AND OBJECTIVES: Previous studies reveal conflicting data on the effect of cannabis use in patients with cirrhosis. This research evaluates the impact of cannabis on hepatic decompensation, health care utilization, and mortality in patients with cirrhosis. MATERIAL AND METHODS: A retrospective analysis of the State Inpatient Database (SID) was performed evaluating patients from Colorado and Washington in 2011 to represent pre-cannabis legalization and 2015 to represent post-cannabis legalization. Multivariable analysis was performed to study the impact of cannabis on the rate of admissions with hepatic decompensations, healthcare utilization, and mortality in patients with cirrhosis. RESULTS: Cannabis use was detected in 370 (2.1%) of 17,520 cirrhotics admitted in 2011 and in 1162 (5.3%) of 21,917 cirrhotics in 2015 (p-value <0.001). On multivariable analysis, cirrhotics utilizing cannabis after its legalization experienced a decreased rate of admissions related to hepatorenal syndrome (Odds Ratio (OR): 0.51; 95% Confidence Interval (CI): 0.34-0.78) and ascites (OR: 0.73; 95% CI: 0.63-0.84). Cirrhotics with an etiology of disease other than alcohol and hepatitis C had a higher risk of admission for hepatic encephalopathy if they utilized cannabis [OR: 1.57; 95% CI: 1.16-2.13]. Decreased length of stay (-1.15 days; 95% CI: -1.62, -0.68), total charges (-$15,852; 95% CI: -$21,009, -$10,694), and inpatient mortality (OR: 0.68; 95% CI: 0.51-0.91) were also observed in cirrhotics utilizing cannabis after legalization compared to cirrhotics not utilizing cannabis or utilizing cannabis prior to legalization. CONCLUSION: Cannabis use in patients with cirrhosis resulted in mixed outcomes regarding hospital admissions with hepatic decompensation. A trend towards decreased hospital utilization and mortality was noted in cannabis users after legalization. These observations need to be confirmed with a longitudinal randomized study.

Outcomes of hepatitis C virus seropositive donors to hepatitis C virus seronegative liver recipients: A large single center analysis.

INTRODUCTION AND OBJECTIVES: The success of direct-acting antivirals (DAA) has transformed the management of hepatitis C virus (HCV) infection and has led to the expansion of the deceased donor organ pool for liver transplantation. MATERIAL AND METHODS: We present a single center retrospective review of liver transplantations performed on HCV-seronegative recipients from HCV-seropositive organs from 11/2017 to 05/2020. HCV nucleic acid testing (NAT) was performed on HCV-seropositive donors to assess active HCV infection. RESULTS: 42 HCV-seronegative recipients underwent a liver transplant from a HCV-seropositive donor, including 21 NAT negative (20 liver, 1 simultaneous liver kidney transplant) and 21 NAT positive liver transplants. Two (9.5%) HCV antibody positive/NAT negative recipients developed HCV viremia and achieved sustained virologic response with DAA therapy. The remaining patients with available data (19 patients) remained polymerase chain reaction (PCR) negative at 6 months. 20 (95%) of HCV antibody positive/NAT positive recipients had a confirmed HCV viremia. 100% of patients with available data (15 patients) achieved SVR. Observed events include 1 mortality and graft loss and equivalent rates of post-transplant complications between NAT positive and NAT negative recipients. CONCLUSIONS: HCV-seropositive organs can be safely transplanted into HCV-seronegative patients with minimal complications post-transplant.

Multisystem Inflammatory Syndrome in an Adult With COVID-19.

Multisystem inflammatory syndrome (MIS) in children is a severe illness characterized by fever, laboratory evidence of inflammation, and multisystem organ dysfunction resulting from severe acute respiratory syndrome coronavirus 2 infection in a patient younger than 21 years. We present the case of a 39-year-old man with evidence of prior COVID-19 who seemed to meet all non-age-related criteria for MIS in children as well as criteria for the working definition of MIS in adults, and who improved after treatment with aspirin, corticosteroids, and intravenous immunoglobulin. Clinicians should be aware of this new inflammatory illness, not only in children but potentially also in adults with antecedent or concurrent COVID-19.

Frailty Is an Independent Risk Factor for Mortality, Cardiovascular Disease, Bone Disease, and Diabetes Among Aging Adults With Human Immunodeficiency Virus.

BACKGROUND: We characterized associations between frailty and incident cardiovascular disease (CVD), diabetes mellitus (DM), bone disease, and mortality within a cohort of aging persons with human immunodeficiency virus (PWH). METHODS: Participants underwent frailty evaluations using the Fried frailty assessment (baseline and annually). Frailty was defined as having ≥3 frailty criteria. Clinical outcomes of mortality, CVD events, DM, and bone disease events were recorded throughout the study period (baseline to most recent study or clinic visit, or date of clinical outcome, whichever came first). Poisson regression models were used to evaluate associations between baseline frailty, change in frailty score over 48 weeks, and each clinical outcome. RESULTS: Among 821 men and 195 women (median age 51 years), 62 (6%) were frail at baseline. Frailty scores increased by ≥1 component among 194 participants (19%) from baseline to 48 weeks. Baseline frailty was associated with an increased risk of incident CVD and DM, with a trend toward a significant association with bone events. Among frailty components, slow gait speed was associated with incident DM and borderline associated with incident CVD. An increase in frailty from baseline to week 48 was associated with mortality but not with the other clinical outcomes. CONCLUSIONS: Baseline frailty was associated with multiple adverse health outcomes (incident CVD, DM, and bone disease), while increase in frailty score was associated with mortality among PWH engaged in care. Incorporation of frailty assessments into the care of PWH may assist in improvement of functional status and risk stratification for age-related chronic diseases.

Long-Acting Antiretrovirals: Where Are We now?

PURPOSE OF REVIEW: Current HIV treatment options require daily use of combination antiretroviral drugs. Many persons living with HIV experience treatment fatigue and suboptimal adherence as a result. Long-acting antiretroviral drugs are being developed to expand options for HIV treatment. Here, we review the agents in development, and evaluate data from recent clinical trials. In addition, we anticipate challenges to successful widespread use of long-acting antiretrovirals. RECENT FINDINGS: Parenteral nanosuspensions of cabotegravir and rilpivirine, and dapivirine vaginal ring are the farthest in clinical development. Long-acting modalities in earlier development stages employ drug-loaded implants, microparticles, or targeted mutagenesis, among other innovations. Long-acting antiretroviral drugs promise new options for HIV prevention and treatment, and ways to address poor adherence and treatment fatigue. Further studies will identify the long-acting agents or combinations that are suitable for routine use. Creative solutions will be needed for anticipated implementation challenges.