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Preventing Hepatitis B Reactivation During Anti-CD20 Antibody Treatment in the Veterans Health Administration.

ABSTRACT: Hepatitis B virus (HBV) reactivation may occur with high risk immunosuppression, such as anti-cluster of differentiation (CD)20 antibodies (Abs). Appropriate HBV prophylaxis during anti-CD20 Ab therapy averts hepatitis, chemotherapy disruption, and death. Serologic evidence of prior HBV exposure is present in one in nine veterans in the Veterans Health Administration (VHA). In 2014, most (61%-73%) patients in the VHA who were receiving anti-CD20 Ab treatment underwent HBV testing, yet <20% of eligible patients received HBV antiviral prophylaxis. We aimed to prevent HBV reactivation by increasing HBV testing and antiviral treatment rates among anti-CD20 Ab recipients through prospective interventions. A multidisciplinary team of clinicians, pharmacists, and public health professionals developed comprehensive prevention systems, including national seminars/newsletters/websites; pharmacy criteria for HBV screening/treatment prior to anti-CD20 Ab use; changes to national formulary restrictions to expand HBV prophylaxis prescribing authority; Medication Use Evaluation Tracker to identify omissions; national e-mail alert to all VHA oncology providers detailing specific testing and HBV antiviral treatment needs; and a voluntary electronic medical record "order check" used at interested facilities (n = 11) to automatically assess pretreatment HBV testing and antiviral treatment and only generate a reminder to address deficiencies. Analysis of monthly data from June 2016 through September 2017 among anti-CD20 Ab recipients revealed pre-anti-CD20 Ab treatment HBV testing increased to 91%-96% and appropriate HBV antiviral prophylaxis to 76%-85% nationally following implementation of the intervention. Medical centers using the voluntary electronic medical record order check increased HBV testing rates to 93%-98% and HBV antiviral prophylaxis rates to 99%. Conclusion: Multimodal intervention systems to prevent HBV reactivation among VHA patients receiving anti-CD20 Ab therapies increased national rates of HBV testing to >90% and antiviral prophylaxis to >80%.

SUBMITTER: Jasmine Bullard A

PROVIDER: S-EPMC6128236 | biostudies-literature | 2018 Sep

REPOSITORIES: biostudies-literature

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Preventing Hepatitis B Reactivation During Anti-CD20 Antibody Treatment in the Veterans Health Administration.

Jasmine Bullard A A Cunningham Francesca E FE Volpp Bryan D BD Lowy Elliott E Beste Lauren A LA Heron Bernadette B BB Geraci Mark M Hammond Julia M JM LaPlant Kourtney K Stave Elise A EA Turner Marsha J MJ O'Leary Meghan C MC Kelley Michael J MJ Hunt Christine M CM

Hepatology communications 20180828 9

Hepatitis B virus (HBV) reactivation may occur with high risk immunosuppression, such as anti-cluster of differentiation (CD)20 antibodies (Abs). Appropriate HBV prophylaxis during anti-CD20 Ab therapy averts hepatitis, chemotherapy disruption, and death. Serologic evidence of prior HBV exposure is present in one in nine veterans in the Veterans Health Administration (VHA). In 2014, most (61%-73%) patients in the VHA who were receiving anti-CD20 Ab treatment underwent HBV testing, yet <20% of el ...[more]

PMID: 30202826

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Project description:The humanized anti-CD22 antibody, epratuzumab, has demonstrated therapeutic activity in clinical trials of lymphoma, leukemia and autoimmune diseases, treating currently over 1500 cases of non-Hodgkin lymphoma, acute lymphoblastic leukemias, Waldenström's macroglobulinemia, Sjögren's syndrome, and systemic lupus erythematosus. Because epratuzumab reduces on average only 35% of circulating B cells in patients, and has minimal antibody-dependent cellular cytotoxicity and negligible complement-dependent cytotoxicity when evaluated in vitro, its therapeutic activity may not result completely from B-cell depletion. We reported recently that epratuzumab mediates Fc/FcR-dependent membrane transfer from B cells to effector cells via trogocytosis, resulting in a substantial reduction of multiple BCR modulators, including CD22, CD19, CD21, and CD79b, as well as key cell adhesion molecules, including CD44, CD62L, and β7 integrin, on the surface of B cells in peripheral blood mononuclear cells obtained from normal donors or SLE patients. Rituximab has clinical activity in lupus, but failed to achieve primary endpoints in a Phase III trial. This is the first study of trogocytosis mediated by bispecific antibodies targeting neighboring cell-surface proteins, CD22, CD20, and CD19, as demonstrated by flow cytometry and immunofluorescence microscopy. We show that, compared to epratuzumab, a bispecific hexavalent antibody comprising epratuzumab and veltuzumab (humanized anti-CD20 mAb) exhibits enhanced trogocytosis resulting in major reductions in B-cell surface levels of CD19, CD20, CD21, CD22, CD79b, CD44, CD62L and β7-integrin, and with considerably less immunocompromising B-cell depletion that would result with anti-CD20 mAbs such as veltuzumab or rituximab, given either alone or in combination with epratuzumab. A CD22/CD19 bispecific hexavalent antibody, which exhibited enhanced trogocytosis of some antigens and minimal B-cell depletion, may also be therapeutically useful. The bispecific antibody is a candidate for improved treatment of lupus and other autoimmune diseases, offering advantages over administration of the two parental antibodies in combination.

Project description:BackgroundPhysician responsiveness to patient preferences for depression treatment may improve treatment adherence and clinical outcomes.ObjectiveTo examine associations of patient treatment preferences with types of depression treatment received and treatment adherence among Veterans initiating depression treatment.DesignPatient self-report surveys at treatment initiation linked to medical records.SettingVeterans Health Administration (VA) clinics nationally, 2018-2020.ParticipantsA total of 2582 patients (76.7% male, mean age 48.7 years, 62.3% Non-Hispanic White) MAIN MEASURES: Patient self-reported preferences for medication and psychotherapy on 0-10 self-anchoring visual analog scales (0="completely unwilling"; 10="completely willing"). Treatment receipt and adherence (refilling medications; attending 3+ psychotherapy sessions) over 3 months. Logistic regression models controlled for socio-demographics and geographic variables.Key resultsMore patients reported strong preferences (10/10) for psychotherapy than medication (51.2% versus 36.7%, McNemar χ21=175.3, p<0.001). A total of 32.1% of patients who preferred (7-10/10) medication and 21.8% who preferred psychotherapy did not receive these treatments. Patients who strongly preferred medication were substantially more likely to receive medication than those who had strong negative preferences (odds ratios [OR]=17.5; 95% confidence interval [CI]=12.5-24.5). Compared with patients who had strong negative psychotherapy preferences, those with strong psychotherapy preferences were about twice as likely to receive psychotherapy (OR=1.9; 95% CI=1.0-3.5). Patients who strongly preferred psychotherapy were more likely to adhere to psychotherapy than those with strong negative preferences (OR=3.3; 95% CI=1.4-7.4). Treatment preferences were not associated with medication or combined treatment adherence. Patients in primary care settings had lower odds of receiving (but not adhering to) psychotherapy than patients in specialty mental health settings. Depression severity was not associated with treatment receipt or adherence.ConclusionsMismatches between treatment preferences and treatment type received were common and associated with worse treatment adherence for psychotherapy. Future research could examine ways to decrease mismatch between patient preferences and treatments received and potential effects on patient outcomes.

Project description:ImportanceThe Veterans Health Administration (VHA) serves a population of veterans with a high prevalence of comorbid health conditions and increased risk for suicide.ObjectiveTo replicate the findings of a previous study and assess whether exposure to angiotensin receptor blockers (ARBs) is associated with differential suicide risk compared with angiotensin-converting enzyme inhibitors (ACEIs) among veterans receiving VHA care.Design, setting, and participantsThis nested case-control design included all suicide decedents from 2015 to 2017 with a VHA inpatient or outpatient encounter in the prior year and with either an active ACEI or ARB prescription in the 100 days prior to death. Using a 4:1 ratio, controls were matched to cases by age, sex, and hypertension and diabetes diagnoses. Controls were alive at the time of the death of the matched case, had a VHA encounter within the previous year, and had either an active ACEI or ARB medication fill within 100 days before the death of the matched case.ExposuresAn active ACEI or ARB prescription within 100 days before the death of the case.Main outcomes and measuresCases were suicide decedents from 2015 to 2017 per National Death Index search results included in the Veteran Affairs/Department of Defense Mortality Data Repository.ResultsAmong 1309 cases, the median (interquartile range [IQR]) age was 68 (60-76) years and among 5217 controls, the median (IQR) age was 67 (60-76) years, and 1.9% of veterans in both groups were female. ARBs were received by 20.2% of controls and 19.6% of cases; ACEIs were received by 79.8% of controls and 80.4% of cases. The crude suicide odds ratio for ARBs vs ACEIs was 0.966 (95% CI, 0.828-1.127). Controlling for covariates, the adjusted odds ratio for ARBs was 0.985 (95% CI, 0.834-1.164). Sensitivity analyses using only those covariates that differed significantly between groups, restricting to veterans ages 65 and older, dropping matching criteria, and adjusting for the quantity and temporal proximity of ACEI and ARB exposure in the 100 days prior to the index date, had consistent findings.Conclusions and relevanceThis case-control study did not identify differences in suicide risk by receipt of ARBs vs ACEIs in analyses specific to veterans receiving VHA care in contrast with findings from the referent study.

Project description:BACKGROUND:In response to the development of highly effective but expensive new medications, policymakers, payors, and health systems are considering novel and pragmatic ways to provide these medications to patients. One approach is to target these treatments to those most likely to benefit. However, to maximize the fairness of these policies, and the acceptance of their implementation, the values and beliefs of patients should be considered. The provision of treatments for chronic hepatitis C (CHC) in the resource-constrained context of the Veterans Health Administration (VHA) offered a real-world example of this situation, providing the opportunity to test the value of using Democratic Deliberation (DD) methods to solicit the informed opinions of laypeople on this complex issue. METHODS:We recruited Veterans (n?=?30) from the VHA to attend a DD session. Following educational presentations from content experts, participants engaged in facilitated small group discussions to: 1) identify strategies to overcome CHC treatment barriers and 2) evaluate, vote on, and modify/improve two CHC treatment policies - "first come, first served" (FCFS) and "sickest first" (SF). We used transcripts and facilitators' notes to identify key themes from the small group discussions. Additionally, participants completed pre- and post-DD surveys. RESULTS:Most participants endorsed the SF policy over the FCFS policy, emphasizing the ethical and medical appropriateness of treating the sickest first. Concerns about SF centered on the difficulty of implementation (e.g., how is "sickest" determined?) and unfairness to other Veterans. Proposed modifications focused on: 1) the need to consider additional health factors, 2) taking behavior and lifestyle into account, 3) offering education and support, 4) improving access, and 5) facilitating better decision-making. CONCLUSIONS:DD offered a robust and useful method for addressing the allocation of the scarce resource of CHC treatment. Participants were able to develop a modified version of the SF policy and offered diverse recommendations to promote fairness and improve quality of care for Veterans. DD is an effective approach for incorporating patient preferences and gaining valuable insights for critical healthcare policy decisions in resource-limited environments.

Project description:BackgroundWhile few countries and healthcare systems are on track to meet the World Health Organization's hepatitis C virus (HCV) elimination goals, the US Veterans Health Administration (VHA) has been a leader in these efforts. We aimed to determine which implementation strategies were associated with successful national viral elimination implementation within the VHA.MethodsWe conducted a five-year, longitudinal cohort study of the VHA Hepatic Innovation Team (HIT) Collaborative between October 2015 and September 2019. Participants from 130 VHA medical centers treating HCV were sent annual electronic surveys about their use of 73 implementation strategies, organized into nine clusters as described by the Expert Recommendations for Implementing Change taxonomy. Descriptive and nonparametric analyses assessed strategy use over time, strategy attribution to the HIT, and strategy associations with site HCV treatment volume and rate of adoption, following the Theory of Diffusion of Innovations.ResultsBetween 58 and 109 medical centers provided responses in each year, including 127 (98%) responding at least once, and 54 (42%) responding in all four implementation years. A median of 13-27 strategies were endorsed per year, and 8-36 individual strategies were significantly associated with treatment volume per year. Data warehousing, tailoring, and patient-facing strategies were most commonly endorsed. One strategy-"identify early adopters to learn from their experiences"-was significantly associated with HCV treatment volume in each year. Peak implementation year was associated with revising professional roles, providing local technical assistance, using data warehousing (i.e., dashboard population management), and identifying and preparing champions. Many of the strategies were driven by a national learning collaborative, which was instrumental in successful HCV elimination.ConclusionsVHA's tremendous success in rapidly treating nearly all Veterans with HCV can provide a roadmap for other HCV elimination initiatives.

Project description:ImportanceThe Veterans Health Administration (VHA) implemented a national clinical program using a suicide risk prediction algorithm, Recovery Engagement and Coordination for Health-Veterans Enhanced Treatment (REACH VET), in which clinicians facilitate care enhancements for individuals identified in local top 0.1% suicide risk tiers. Evaluation studies are needed.ObjectiveTo determine associations with treatment engagement, health care utilization, suicide attempts, safety plan documentation, and 6-month mortality.Design, setting, and participantsThis cohort study used triple differences analyses comparing 6-month changes in outcomes after vs before program entry for individuals entering the REACH VET program (March 2017-December 2018) vs a similarly identified top 0.1% suicide risk tier cohort from prior to program initiation (March 2014-December 2015), adjusting for trends across subthreshold cohorts. Subcohort analyses (including individuals from March 2017-June 2018) evaluated difference-in-differences for cause-specific mortality using death certificate data. The subthreshold cohorts included individuals in the top 0.3% to 0.1% suicide risk tier, below the threshold for REACH VET eligibility, from the concurrent REACH VET period and from the pre-REACH VET period. Data were analyzed from December 2019 through September 2021.ExposuresREACH VET-designated clinicians treatment reevaluation and outreach for care enhancements, including safety planning, increased monitoring, and interventions to enhance coping.Main outcomes and measuresProcess outcomes included VHA scheduled, completed, and missed appointments; mental health visits; and safety plan documentation and documentation within 6 months for individuals without plans within the prior 2 years. Clinical outcomes included mental health admissions, emergency department visits, nonfatal suicide attempts, and all-cause, suicide, and nonsuicide external-cause mortality.ResultsA total of 173 313 individuals (mean [SD] age, 51.0 [14.7] years; 161 264 [93.1%] men and 12 049 [7.0%] women) were included in analyses, including 40 816 individuals eligible for REACH VET care and 36 604 individuals from the pre-REACH VET period in the top 0.1% of suicide risk. The REACH VET intervention was associated with significant increases in completed outpatient appointments (adjusted triple difference [ATD], 0.31; 95% CI, 0.06 to 0.55) and proportion of individuals with new safety plans (ATD, 0.08; 95% CI, 0.06 to 0.10) and reductions in mental health admissions (ATD, -0.08; 95% CI, -0.10 to -0.05), emergency department visits (ADT, -0.03; 95% CI, -0.06 to -0.01), and suicide attempts (ADT, -0.05; 95% CI, -0.06 to -0.03). Subcohort analyses did not identify differences in suicide or all-cause mortality (eg, age-and-sex-adjusted difference-in-difference for suicide mortality, 0.0007; 95% CI, -0.0006 to 0.0019).Conclusions and relevanceThese findings suggest that REACH VET implementation was associated with greater treatment engagement and new safety plan documentation and fewer mental health admissions, emergency department visits, and suicide attempts. Clinical programs using risk modeling may be effective tools to support care enhancements and risk reduction.

Project description:BackgroundPsychiatric comorbidities may complicate depression treatment by being associated with increased role impairments. However, depression symptom severity might account for these associations. Understanding the independent associations of depression severity and comorbidity with impairments could help in treatment planning. This is especially true for depressed Veterans, who have high psychiatric comorbidity rates.Methods2,610 Veterans beginning major depression treatment at the Veterans Health Administration (VHA) were administered a baseline self-report survey that screened for diverse psychiatric comorbidities and assessed depression severity and role impairments. Logistic and generalized linear regression models estimated univariable and multivariable associations of depression severity and comorbidities with impairments. Population attributable risk proportions (PARPs) estimated the relative importance of depression severity and comorbidities in accounting for role impairments.ResultsNearly all patients (97.8%) screened positive for at least one comorbidity and half (49.8%) for 4+ comorbidities. The most common positive screens were for generalized anxiety disorder (80.2%), posttraumatic stress disorder (77.9%), and panic/phobia (77.4%). Depression severity and comorbidities were significantly and additively associated with impairments in multivariable models. Associations were attenuated much less for depression severity than for comorbidities in multivariable versus univariable models. PARPs indicated that 15-60% of role impairments were attributable to depression severity and 5-32% to comorbidities.LimitationsThe screening scales could have over-estimated comorbidity prevalence. The cross-sectional observational design cannot determine either temporal or causal priorities.ConclusionsAlthough positive screens for psychiatric comorbidity are pervasive among depressed VHA patients, depression severity accounts for most of the associations of these comorbidities with role impairments.

Dataset Information

Preventing Hepatitis B Reactivation During Anti-CD20 Antibody Treatment in the Veterans Health Administration.

Publications

Preventing Hepatitis B Reactivation During Anti-CD20 Antibody Treatment in the Veterans Health Administration.

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