Potential relationship between cytomegalovirus and immunosenescence: Evidence from observational studies.

Immunosenescence (IS) occurs as a natural outcome of ageing and may be described as a decline in immune system flexibility and adaptability to sufficiently respond to new, foreign antigens. Potential factors that may precipitate IS include persistent herpesvirus infections, such as cytomegalovirus (CMV). Here, we conducted a review of the literature evaluating the potential association between CMV and IS. Twenty-seven epidemiologic studies that included direct comparisons between CMV-seropositive and CMV-seronegative immunocompetent individuals were analysed. The majority of these studies (n = 20) were conducted in European populations. The strength of evidence supporting a relationship between CMV, and various IS-associated immunologic endpoints was assessed. T-cell population restructuring was the most prominently studied endpoint, described in 21 studies, most of which reported a relationship between CMV and reduced CD4:CD8 T-cell ratio or modified CD8+ T-cell levels. Telomere length (n = 4) and inflammageing (n = 3) were less frequently described in the primary literature, and the association of these endpoints with CMV and IS was less pronounced. An emergent trend from our review is the potential effect modification of the CMV-IS relationship with both sex and age, indicating the importance of considering various effector variables when evaluating associations between CMV and IS. Our analysis revealed plausible mechanisms that may underlie the larger epidemiologic trends seen in the literature that support the indirect effect of CMV on IS. Future studies are needed to clarify CMV-associated and IS-associated immunologic endpoints, as well as in more diverse global and immunocompromised populations.

Prevalence and correlates of and a risk score to identify asymptomatic anorectal gonorrhoea and chlamydia infection among men who have sex with men in Kisumu, Kenya.

OBJECTIVES: In settings where laboratory capacity is limited, the WHO recommends presumptive treatment for Neisseria gonorrhoeae (NG) and Chlamydia trachomatis (CT) in asymptomatic men who have sex with men (MSM) at high risk for these infections. However, little is known about how best to target this intervention. We aimed to identify correlates of anorectal NG/CT infection in Kenyan MSM with and without anorectal symptoms and evaluate the performance of an empirical, model-based risk score to identify cases in asymptomatic men. METHODS: Anorectal NG/CT infections were diagnosed by the Abbott RealTime NG/CT nucleic acid amplification testamong 698 MSM at enrolment into the Anza Mapema study. Multivariable logistic regression was used to identify correlates of anorectal NG/CT infection in men with and without anorectal symptoms. Using coefficients from the final multivariable model for asymptomatic men, we calculated a risk score for each participant. Risk score performance was determined by calculating the sensitivity, specificity and number needed to treat (NNT) to identify one NG/CT infection. RESULTS: Overall anorectal NG/CT infection prevalence was 5.2% (n=36), of which 58.3% (n=21) were asymptomatic. Factors associated with anorectal NG/CT infection in asymptomatic men were aged 18-24 years (aOR=7.6; 95% CI: 1.7 to 33.2), HIV positive serostatus (aOR=6.9; 95% CI: 2.2 to 21.6) and unprotected anal sex in the past 3 months (aOR=3.8; 95% CI: 1.2 to 11.9). Sensitivity and specificity were optimal (81.0% and 66.1%, respectively) at a model-derived risk score cut-point ≥3, and the NNT was 12. CONCLUSIONS: A model-derived risk score based on correlates of anorectal NG/CT infection in asymptomatic participants would be sensitive and efficient (i.e, low NNT) for targeting presumptive treatment. If validated in other settings, this risk score could improve on the WHO algorithm and help reduce the burden of asymptomatic anorectal NG/CT infections among MSM in settings where diagnostic testing is not available.

Associations of urban greenness with asthma and respiratory symptoms in Mexican American children.

BACKGROUND: Evidence on the association between residential surrounding greenness (RSG) in urban areas with asthma and asthma symptoms is inconsistent. OBJECTIVE: To examine the association of RSG with respiratory outcomes in a sample of Mexican American children living in inner-city Chicago, Illinois. METHODS: This study is based on parent-reported data on 1915 Mexican American children. We calculated RSG using the normalized difference vegetation index based on satellite imagery within buffers of 100, 250, and 500 m of each child's residence. Multivariable multilevel mixed-effect logistic regression was used to estimate adjusted odds ratios (aORs) for the effect of a 1-interquartile range increase in greenness. RESULTS: In adjusted analyses, a protective effect of greenness within 100 m was observed for lifetime wheezing (aOR, 0.82; 95% CI, 0.69-0.96). Environmental tobacco smoke (ETS) exposure modified the association of RSG with lifetime asthma and current dry cough at night. For all buffer distances, increased greenness was associated with lower odds of lifetime asthma among children with current ETS exposure (100 m: aOR, 0.43; 95% CI, 0.22-0.87; 250 m: aOR, 0.39; 95% CI, 0.18-0.84; 500 m: aOR, 0.48; 95% CI, 0.26-0.90) and lower odds of current dry cough at night among children with perinatal ETS exposure (100 m: aOR, 0.53; 95% CI, 0.31-0.92; 250 m: aOR, 0.55; 95% CI, 0.31-0.98; 500 m: aOR, 0.55; 95% CI, 0.35-0.87). CONCLUSION: Our results suggest inverse associations of urban greenness with respiratory outcomes, especially in children exposed to ETS. Further research is needed to examine the mechanisms through which RSG may be associated with the risk of asthma and contribute to health.

Depressive Symptoms, Alcohol and Drug Use, and Physical and Sexual Abuse Among Men Who Have Sex with Men in Kisumu, Kenya: The Anza Mapema Study.

Men who have sex with men (MSM) are disproportionately burdened by depressive symptoms and psychosocial conditions including alcohol and substance abuse as well as physical and sexual abuse. We examined sociodemographic and psychosocial factors associated with depressive symptoms at baseline among a cohort of MSM in Kisumu, Kenya. Depressive symptoms were assessed via the Personal Health Questionnaire 9 instrument and examined dichotomously. We performed multivariable modified Poisson regression with robust standard errors for the binary outcome. Among 711 participants: 11.4% reported severe depressive symptoms; 50.1% reported harmful alcohol abuse; 23.8% reported moderate substance abuse; 80.9% reported any childhood physical or sexual abuse; and 39.1% experienced recent trauma due to same-sex behaviors. In the final multivariable model, severe depressive symptoms were more common for men who were ≥ 30 years old, had completed ≤ 8 years of education, had experienced childhood physical or sexual abuse, and had recently experienced trauma due to same-sex behaviors. Our results demonstrate that comprehensive services capable of identifying and addressing depressive symptoms, alcohol and substance abuse, and physical and sexual abuse must be expanded within this sample of MSM.

Factors associated with viral suppression among HIV-positive Kenyan gay and bisexual men who have sex with men.

The UNAIDS 90-90-90 target has prioritized achieving high rates of viral suppression. We identified factors associated with viral suppression among HIV-positive gay, bisexual, and other men who have sex with men (GBMSM) in Kisumu, Kenya. HIV-positive participants in the Anza Mapema study were offered antiretroviral therapy (ART) regardless of CD4 count. HIV viral load was assessed at baseline and after 6 and 12 months of follow-up. Viral suppression was defined as <1,000 copies/mL. Sociodemographic, sexual behaviors, and psychosocial characteristics were assessed via audio computer-assisted self interview. We used generalized estimating equations to estimate the associations between baseline and time-dependent predictors and viral suppression at 6 and 12 months. Seventy-five HIV-positive men were enrolled in the Anza Mapema study, of which 63 had at least one viral load measured during follow-up. Among 52 men with a viral load measure at month 6, 37 (71%) were on ART and virally suppressed. Among 59 men with a viral load measure at month 12, 37 (63%) were on ART and virally suppressed. In the final multivariable model, men who reported receptive or versatile sexual position during anal intercourse with a male partner had reduced odds of viral suppression (aOR = 0.20; 95% CI: 0.08-0.50). Greater levels of coping self-efficacy were associated with increased odds of viral suppression (aOR = 1.10; 95% CI: 1.03-1.16). Despite extensive initiation, retention, and adherence support, the rate of viral suppression in this population did not meet the UNAIDS 90-90-90 target (81% for individuals aware of their HIV status). Pervasive stigma against male-male sex, especially men who practice receptive anal sex, may underlie our findings, which highlight the need for advocacy and stigma reduction efforts. Because coping self-efficacy was a protective factor, efforts to promote resilience in addition to healthy sexual identity development may lead to improved care outcomes among GBMSM in this area.

Association of neighborhood crime with asthma and asthma morbidity among Mexican American children in Chicago, Illinois.

BACKGROUND: There is increasing evidence that neighborhood-level factors, in addition to individual-level factors, may contribute directly or indirectly to childhood asthma by affecting environmental and lifestyle factors. Exposure to neighborhood crime and violence has been associated with poor health outcomes, especially among underserved and minority populations, and its effect on respiratory health is an area of active research. OBJECTIVE: To examine the association of residential neighborhood crime with asthma and asthma-related outcomes among Mexican American children. METHODS: This cross-sectional study was conducted with parents of 2,023 Mexican American children. We derived measures of neighborhood (census tract) violent, property, and drug abuse crime and used multilevel generalized estimating equations to test associations of neighborhood crime counts with respiratory conditions. RESULTS: In multiple regression models, a 1-SD increase in neighborhood property crimes significantly increased the odds of lifetime asthma, lifetime wheezing, lifetime emergency department (ED) visits attributable to asthma or wheezing, and lifetime hospitalization attributable to asthma or wheezing by 25%, 18%, 44%, and 62%, respectively. A 1-SD elevation in neighborhood violent crime was positively and significantly associated with 21% and 57% higher odds of lifetime wheezing and ED visits, respectively. We also observed 13% and 44% significantly increased odds of lifetime wheezing and ED visits, respectively, for a 1-SD increase in drug abuse crime. These findings were not explained or modified by individual- and neighborhood-level covariates. CONCLUSION: Higher neighborhood crime was associated with greater odds of asthma and asthma morbidity in Mexican American children.

In utero exposure to pets is associated with asthma and wheezing in Mexican American children.

OBJECTIVE: To examine the associations of in utero and early life exposure to cats/dogs and birds with the risk of lifetime doctor-diagnosed asthma and other respiratory conditions in a sample of Mexican American (MA) children 4-18 years of age. METHODS: This study is a population-based cross-sectional investigation of 1816 MA children. We conducted multiple logistic models examining the relationship of asthma and wheezing with exposures to cats/dogs and birds in utero, infancy and at the time of the survey adjusted for country of birth, family history of asthma/allergies, antibiotics use in infancy and other covariates. RESULTS: In adjusted analyses, in utero exposure to cats/dogs and birds jointly was associated with increased odds of asthma (adjusted odds ratio (aOR): 2.89; 95% confidence interval (CI): 1.34-6.23), ever wheezing (aOR: 1.96; 95% CI: 1.11-3.46) and current exercise-induced wheezing (aOR: 3.16; 95% CI: 1.27-7.85) compared to children not exposed to these pets in utero. Children who were exposed to both cats/dogs and birds in utero had an elevated, albeit statistically non-significant, odds of current wheezing. Exposures in infancy and at the time of the survey to cats/dogs and birds were not associated with asthma or wheezing. CONCLUSIONS: In utero exposure to pets might be associated with an increased risk of asthma and respiratory conditions in a sample of non-affluent MA children.

Antibiotic use in infancy and the risk of asthma in Mexican American children.

OBJECTIVE: This study examined the associations of antibiotic use in infancy with lifetime doctor-diagnosed asthma and current wheeze among Mexican American children. METHODS: In a population-based, cross-sectional investigation, parents of 2023 children 4-18 years of age completed a questionnaire/interview addressing respiratory conditions, antibiotic use, and covariates. RESULTS: In adjusted analyses, among children without history of ear infections in infancy, children who used antibiotics ≥3 times and 1-2 times were more likely to report doctor-diagnosed asthma compared with their peers who did not use antibiotics in infancy [adjusted odds ratio (aOR) = 5.14, 95% confidence interval (CI): 2.88-9.17, and aOR = 2.15, 95% CI: 1.26-3.69, respectively, p trend < 0.0001]. The respective aORs for current wheeze were 3.67 (95% CI: 1.95-6.89) and 1.63 (95% CI: 0.91-2.95). Antibiotic use in infancy was not associated with asthma or current wheeze in children who had ear infections in infancy. In additional analyses, antibiotic use in infancy was associated with asthma in children without parental history of asthma or allergies (aOR = 2.73, 95% CI: 1.70-4.39) but not in those with parental history of asthma or allergies. Among Mexico-born participants born in rural areas, antibiotic use in infancy was associated with a seven-fold increase in risk of asthma (aOR = 7.21, 95% CI: 1.46-35.65), while the association was non-significant in Mexico-born children born in urban areas in Mexico. CONCLUSIONS: Antibiotic use in infancy may increase the risk of asthma and wheezing, but these associations were limited to subgroups of children.

Dosing Patterns of Patients with Paroxysmal Nocturnal Hemoglobinuria Treated with Ravulizumab in the United States: A Retrospective Claims-Based Analysis.

INTRODUCTION: Complement factor 5 inhibitors eculizumab and, recently, ravulizumab are standard therapies for paroxysmal nocturnal hemoglobinuria (PNH). However, some patients experience suboptimal response and may benefit from dosage adjustments. Ravulizumab is administered less frequently than eculizumab on the basis of patient's body weight. This retrospective analysis of insurance claims investigated ravulizumab dosing patterns among patients with PNH from the USA. METHODS: Patients aged ≥ 12 years with ≥ 2 ravulizumab infusions between June 21, 2019 and May 6, 2021, and ≥ 6 months of continuous clinical activity prior to first ravulizumab infusion (index date) were identified from the Symphony Health Integrated Dataverse (IDV®) database. Observed mean (standard deviation, SD) ravulizumab doses administered were reported and stratified by previous eculizumab use. Scenarios adjusting for patients' body weights (unavailable in Symphony Health IDV) based on the US general population distribution were performed to estimate percentages of patients receiving label-recommended doses. RESULTS: Among 433 patients (mean [SD] age 47 [17] years), the mean (SD) loading dose was 3316.3 (2931.7) mg, greater than the maximal label-recommended loading dose (3000 mg for patients ≥ 100 kg). The mean (SD) loading doses were 3581.3 (3673.7) mg for eculizumab-naive versus 3093.1 (2096.8) mg for eculizumab-experienced patients. Over a mean (SD) treatment period of 11.8 (6.9) months, the mean (SD) average maintenance dose was 3403.7 (1024.4) mg, falling between label-recommended maintenance dose categories (3300 mg for ≥ 60 to < 100 kg; 3600 mg for ≥ 100 kg). Estimated percentages of patients receiving label-recommended loading and maintenance doses were 23.1% and 39.2%, respectively; 59.1% and 28.4% were estimated to receive above label-recommended loading and average maintenance doses, respectively. CONCLUSION: Although limited by missing clinical characteristics including body weight, this study of ravulizumab dosing patterns in patients with PNH identified potential deviations from label-recommended dosing, warranting further investigations of treatment response to complement inhibitors in PNH.

Paroxysmal nocturnal hemoglobinuria (PNH) is a rare blood disease. Complement factor 5 (C5) inhibitors can help treat PNH symptoms; health care providers administer C5 inhibitors to patients during clinic or office visits. Eculizumab was the first C5 inhibitor approved for PNH. Some patients still experience symptoms with approved eculizumab doses and may need to receive larger or more frequent doses than recommended. The new C5 inhibitor ravulizumab offers reduced dosing frequency and is dosed on the basis of patients' body weights. This study assessed ravulizumab doses administered to patients with PNH in the USA using insurance claim records. Studied patients were 12 years or older and received two or more ravulizumab doses between June 21, 2019 and May 6, 2021. Researchers assessed ravulizumab doses administered to patients on the basis of body weight distribution of the US general population. The average first (loading) ravulizumab dose administered to 433 patients was 3316 mg. This was above the largest recommended loading dose of 3300 mg for patients weighing 100 kg (220 pounds) or more. Over nearly 12 months on average, the average maintenance dose administered was 3403 mg. Researchers estimated that larger loading doses than recommended were administered to almost 6 out of 10 patients and larger maintenance doses than recommended were administered to almost 3 out of 10 patients. This study found that larger than recommended ravulizumab doses may have been administered to some patients with PNH. More studies are needed to evaluate treatment response to complement inhibitors in patients with PNH.

Time and personnel costs associated with adverse event (AE) management among patients with chronic lymphocytic leukemia (CLL).

OBJECTIVES: Novel therapies improve clinical outcomes in chronic lymphocytic leukemia (CLL), although adverse event (AE) profiles differ. This study evaluated time and personnel costs of AE management among healthcare professionals (HCPs) treating patients with CLL with novel therapies. METHODS: A non-interventional prospective survey was conducted over 2 months. Eligible HCPs reported the time per day spent performing AE management activities for CLL patients treated with acalabrutinib, ibrutinib, or venetoclax. Mean time and personnel costs (USD) per activity were summarized and used to estimate the total annual costs of AE management for an average-sized oncology practice. RESULTS: For an average-sized practice (28 HCPs with an average of 56 CLL patients), the mean annual personnel cost of AE management for CLL patients on novel agents was estimated at $115,733. The personnel cost associated with acalabrutinib ($20,912) was less than half that of ibrutinib ($53,801) and venetoclax ($41,884), potentially due to fewer severe AEs and less time spent by oncologists managing AEs compared to other HCP types. CONCLUSION: The substantial burden of AE management for patients with CLL may vary by treatment used. Acalabrutinib was associated with lower annual costs of AE management at an oncology practice level compared to ibrutinib and venetoclax.

Literature Review of Fatigue Scales and Association with Clinically Meaningful Improvements in Outcomes Among Patients With and Without Paroxysmal Nocturnal Hemoglobinuria.

INTRODUCTION: Paroxysmal nocturnal hemoglobinuria (PNH) is a rare blood disorder characterized by anemia and debilitating fatigue. Limited evidence characterizes the association between hemoglobin, an indicator of anemia and disease activity, and patient-reported fatigue scales. This review identifies benchmarks for clinically meaningful improvements in patients with and without PNH. METHODS: MEDLINE, Embase, Cochrane, and PsycINFO databases were searched along with Google Scholar to identify publications for patients with and without PNH. Full-text articles and conference abstracts of clinical trials or observational studies that examined patient-reported fatigue or associations between fatigue and hemoglobin were included. RESULTS: Fourteen publications were included in this study. Four clinical trials conducted in patients with PNH reported that patients achieved and sustained clinically meaningful improvements in fatigue. However, these studies did not examine the association between fatigue and hemoglobin. Ten studies conducted in patients with cancer and anemia (with or without chemotherapy) demonstrated an association between increased hemoglobin and improvements in fatigue (P < 0.05). The greatest incremental gain in fatigue improvement was observed when hemoglobin increased from 11 to 12 g/dL. CONCLUSION: Evidence among patients with cancer without PNH demonstrates that increased hemoglobin levels are associated with clinically significant improvements in fatigue. Future studies should validate this relationship among patients with PNH.

Real-World Eculizumab Dosing Patterns Among Patients with Paroxysmal Nocturnal Hemoglobinuria in a US Population.

Purpose: Current pharmacologic management of paroxysmal nocturnal hemoglobinuria (PNH) consists of C5 inhibitors, eculizumab and ravulizumab; however, because patients experience incomplete symptom control, off-label doses may be utilized. We conducted a retrospective, longitudinal cohort study of provider-based claims data to assess the real-world eculizumab dosing patterns in PNH patients. Patients and Methods: Patients were ≥12 years, received ≥2 eculizumab infusions between January 1, 2015 and September 30, 2019, and had ≥3 months of continuous clinical activity prior to index. The index date was the first claim for eculizumab. Patients with ≥1 diagnosis of another indication for eculizumab were excluded. Treatment patterns including the proportion with high, label-recommended, and low dosages during induction (first 28 days) and maintenance (beginning day 29) phases were described. The proportion and time-to-first dose escalation, defined as an increase in dose or frequency of infusion, were assessed among a subset of patients (ie, escalation analysis cohort). Results: A total of 707 patients were examined. Mean (standard deviation [SD]) starting dose was 862mg (412mg) and was higher than label-recommended 600mg for 64% of the patients. Mean (SD) dose per infusion was 859mg (391mg) during the induction phase; average dose was higher than label-recommended 600mg for 68%. Mean (SD) dose per infusion during the maintenance phase was 1005mg (335mg); average dose was higher than label-recommended 900mg for 43%. Dose escalation occurred in 40/121 escalation analysis cohort patients. Median time-to-first dose escalation was ~12 months. Conclusion: Results suggest that deviations from label-recommended dosing patterns were common. Future budget impact assessments of eculizumab should account for real-world dosing patterns to comprehensively assess costs and benefits.

Retrospective analysis of adherence to HIV treatment and healthcare utilization in a commercially insured population.

AIMS: Single-tablet regimens (STRs) can improve antiretroviral therapy (ART) adherence; however, the relationship between long-term adherence and patient healthcare resource utilization (HRU) is unclear. The objective of this study was to assess long-term ART adherence among people living with HIV (PLHIV) using STRs and multi-tablet regimens (MTRs) and compare HRU over time by adherence. MATERIALS AND METHODS: This retrospective study analyzed medical and pharmacy claims (Optum Clinformatics Data Mart Database). Included PLHIV were aged ≥18 years, had ≥1 medical claim with an HIV diagnosis, and had pharmacy claims for a complete STR or MTR. Adherence was analyzed as the proportion of days covered (PDC), stratified as ≥95%, very high; 90-95%, high; 80-90%, moderate; <80%, low. Cumulative all-cause and HIV-related HRU were calculated across 4 years. Among PLHIV with ≥4-year follow-up, HRU was assessed by adherence. RESULTS: Among 15,153 PLHIV included, 63% achieved PDC ≥90% during Year 1. Among the subgroup of PLHIV with ≥4-year follow-up (N = 3,818), the proportion maintaining PDC ≥90% fell from 67% in Year 1 to 54% by Year 4. The difference from Years 1 to 4 in the proportion of PLHIV with PDC ≥90% was 13% and 17% in the STR and MTR groups, respectively. Cumulative HRU across the 4-year follow-up was higher in PLHIV with low vs high adherence (27% with low adherence had ≥1 emergency room visit vs 17% for very high, p < .0001; 15% with low adherence had ≥1 inpatient stay vs 7% for very high, p < .0001). CONCLUSIONS: ART adherence showed room for improvement, particularly over the long term. PLHIV receiving STRs exhibited higher adherence vs those receiving MTRs; this difference increased over time. The proportion of PLHIV with higher HRU was significantly higher among those with lower adherence and became greater over time. Interventions and alternative therapies to improve adherence among PLHIV should be explored.

Comparative effectiveness of pegcetacoplan versus ravulizumab in patients with paroxysmal nocturnal hemoglobinuria previously treated with eculizumab: a matching-adjusted indirect comparison.

OBJECTIVE: In the absence of a head-to-head study, we assessed the comparative effectiveness of pegcetacoplan, a targeted C3 complement inhibitor, vs. ravulizumab, a C5 complement inhibitor, among patients with paroxysmal nocturnal hemoglobinuria (PNH) previously treated with eculizumab using matching-adjusted indirect comparison methodology. METHODS: Individual patient data from the PEGASUS study (NCT03500549) comparing pegcetacoplan and eculizumab enabled adjustment for baseline differences compared with published results from the ALXN1210-PNH-302 study (NCT03056040), comparing ravulizumab and eculizumab. Adjusted differences and 95% confidence intervals (CIs) were computed via weighted Wald tests for comparisons of pegcetacoplan vs. ravulizumab, anchored to the common comparator eculizumab. RESULTS: Sixty-eight patients from PEGASUS (36 pegcetacoplan; 32 eculizumab) and 195 from ALXN1210-PNH-302 (97 ravulizumab; 98 eculizumab) were included. Compared with ravulizumab, treatment with pegcetacoplan was associated with more transfusion avoidance (adjusted difference [95% CI] = +71.4% [53.5%, 89.3%]), hemoglobin level stabilization (+75.5% [56.4%, 94.6%]), lactate dehydrogenase (LDH) level normalization (+64.0% [41.8%, 86.1%]), and fewer blood transfusions (-5.7 units [-7.2, -4.2]). Additionally, patients who received pegcetacoplan experienced clinically meaningful improvements in fatigue (+8.2 points [3.8, 12.6]), global health status (+9.6 points [0.1, 19.0]), physical functioning (+11.5 points [3.6, 19.5]), and fatigue symptoms (-13.3 points [-23.7, -3.0]), compared with ravulizumab. Mean change from baseline in LDH level was not significantly different for pegcetacoplan vs. ravulizumab. CONCLUSIONS: Results suggest that among patients previously treated with eculizumab, clinical, hematological, and quality of life endpoints were better for patients who received the C3 complement inhibitor pegcetacoplan vs. patients who received ravulizumab, a C5 complement inhibitor.

Increased Health Care Resource Utilization and Costs Associated with Herpes Zoster Among Patients Aged ≥50 Years with Chronic Obstructive Pulmonary Disease in the United States.

BACKGROUND: Patients with chronic obstructive pulmonary disease (COPD) are potentially at increased risk of herpes zoster (HZ). Little is known about the impact of an HZ episode on health care resource utilization (HRU) and costs among patients with COPD. METHODS: This retrospective cohort study of individuals aged ≥50 years in the United States (US) used administrative claims data from Optum's de-identified Clinformatics Data Mart Database for commercially insured and Medicare Advantage members (2013-2018). Two cohorts of patients with COPD, with HZ (COPD+/HZ+) and without HZ (COPD+/HZ-), were identified. All-cause and COPD-related HRU rates and costs (2018 US dollars) were compared between cohorts for up to 12 months of follow-up. Comparisons were controlled for baseline differences through propensity score adjustment. RESULTS: A total of 3415 COPD+/HZ+ and 35,360 COPD+/HZ- patients (mean ages 73.2 ± 9.0 and 72.4 ± 9.4 years, respectively) were identified. Patients in the COPD+/HZ+ versus COPD+/HZ- cohort had increased use of all-cause (adjusted incidence rate ratio [aIRR] 1.17; 95% confidence interval [CI] 1.14, 1.21) and COPD-related (aIRR 1.27; 95% CI 1.21, 1.34) medical services (both P<0.001) and higher mean total all-cause ($4140 versus $3749 per person per month [PPPM]; adjusted cost difference +$313 PPPM) and COPD-related ($1541 versus $1231 PPPM; +$152 PPPM) costs (both P<0.004) in the year after HZ. CONCLUSIONS: HRU and cost burden is higher in patients with COPD with vs without HZ. These results could help to estimate the potential cost benefits of HZ vaccination among patients with COPD.

Enrolment characteristics associated with retention among HIV negative Kenyan gay, bisexual and other men who have sex with men enrolled in the Anza Mapema cohort study.

INTRODUCTION: Most gay, bisexual and other men who have sex with men (GBMSM) live in rights-constrained environments making retaining them in research to be as hard as recruiting them. To evaluate Anza Mapema, an HIV risk-reduction programme in Kisumu, Kenya, we examined the enrolment sociodemographic, behavioural, psychosocial and clinical factors associated with missing two or more follow-up visits for GBMSM participating in Anza Mapema. METHODS: Between August 2015 and November 2017, GBMSM were enrolled and followed in a prospective cohort study with quarterly visits over 12 months. At enrolment, men were tested for HIV and sexually transmitted infections and completed questionnaires via audio computer-assisted self-interview. Because the Kenya Ministry of Health recommends HIV testing every three to six months for GBMSM, the retention outcome in this cross sectional analysis was defined as missing two consecutive follow-up visits (vs. not missing two or more consecutive visits). Multivariable logistic regression estimated the adjusted odds ratios (aOR) and 95% confidence intervals (CI) for the associations of the enrolment characteristics with the binary outcome of retention. RESULTS AND DISCUSSION: Among 609 enrolled HIV-negative GBMSM, the median age was 23 years (interquartile range, 21 to 28 years), 19.0% had completed ≤8 years of education and 4.1% had resided in the study area <1 year at enrolment. After enrolment, 19.7% missed two consecutive follow-up visits. In the final multivariable model, the odds of missing two consecutive follow-up visits were higher for men who: resided in the study area <1 year at enrolment (aOR, 4.14; 95% CI: 1.77 to 9.68), were not living with a male sexual partner (aOR, 1.59; 95% CI: 1.01 to 2.50), and engaged in transactional sex during the last three months (aOR, 1.70; 95% CI: 1.08 to 2.67). CONCLUSIONS: One in five men missed two consecutive follow-up visits during this HIV prevention study despite intensive retention efforts and compensation for travel and participation. Participants with recent community arrival may require special support to optimize their retention in HIV prevention activities. Live-in partners of participants may be enlisted to support greater engagement in prevention programmes, and men who engage in transactional sex will need enhanced counselling and support to stay in longitudinal studies.

Using HIV Surveillance and Clinic Data to Optimize Data to Care Efforts in Community Health Centers in Massachusetts: The Massachusetts Partnerships for Care Project.

BACKGROUND: We describe Data to Care processes of the Massachusetts Partnerships for Care (MA P4C) project and identify factors associated with engagement, retention, and viral suppression outcomes. METHODS: The Massachusetts Department of Public Health and participating community health centers generated lists of patients not in care based on a temporal gap in laboratory results, missed clinic visits, and provider concern regarding engagement. The Massachusetts Department of Public Health and community health centers reviewed the lists monthly and identified out-of-care patients in need of linkage or re-engagement. RESULTS: Between October 2015 and June 2017, of 1418 patients potentially out of care, 83 (5.9%) were confirmed to be out of care. Forty-four of those out of care (53%) received services or were re-engaged in care within 90 days, 45 (54%) were retained in care, and 40 (48%) were virally suppressed. The odds of being re-engaged or retained were lower for patients who were 6 months out-of-care (vs. those newly diagnosed). Patients with an AIDS-defining condition had increased odds of retention and viral suppression. The odds of viral suppression were reduced for patients who reported exposure categories other than men who have sex with men and were younger (30-49 years vs. ≥50 years). CONCLUSIONS: Although rates of re-engagement, retention, and viral suppression were low, the MA P4C Data to Care procedures provided a means for accurate ascertainment of out-of-care status. Future Data to Care programs should investigate the factors that contribute to disengagement from care.

Factors Associated With Prevalent HIV Infection Among Kenyan MSM: The Anza Mapema Study.

BACKGROUND: To inform future HIV treatment and care programs for men who have sex with men (MSM), we assessed the prevalence of and factors associated with previously diagnosed HIV-positive and out-of-care (PDOC) or newly diagnosed HIV-positive and out-of-care (NDOC) HIV infection among MSM enrolled in the prospective Anza Mapema cohort study. METHODS: Participants were aged 18 years and older, reported oral or anal sex with a man in the past 6 months and were not already in HIV care or taking antiretroviral therapy in the past 3 months. At enrollment, men were tested for HIV infection and completed questionnaires through audio computer-assisted self-interview. Multinomial logistic regression was used to identify associations with PDOC or NDOC HIV infection, relative to HIV-negative status. RESULTS: Among 711 enrolled men, 75 (10.5%) were seropositive including 21 PDOC and 54 NDOC men. In multivariable modeling, PDOC status was more likely than HIV-negative status among men who had experienced upsetting sexual experiences during childhood, had recently experienced MSM trauma, and did not report harmful alcohol use. NDOC infection status was more common among men aged 30 years and older and who had completed ≤8 years of education, relative to HIV-negative status. CONCLUSIONS: Most HIV-positive men were unaware of their infection, indicating that HIV testing and counseling services tailored to this population are needed. To improve linkage to and retention in care, HIV testing and care services for MSM should screen and provide support for those with hazardous alcohol use and those who have experienced childhood sexual abuse or MSM trauma.