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Objective: To examine the association of clinic HIV-focused features and advanced HIV care experience with Pneumocystis carinii pneumonia (PCP) prophylaxis and development of PCP as the initial AIDS diagnosis.Design: Nonconcurrent prospective study.Setting: New York State Medicaid Program.Participants: Medicaid enrollees diagnosed with AIDS in 1990-1992.Measurements and Main Results: We collected patient clinical and health care data from Medicaid files, conducted telephone interviews of directors of 125 clinics serving as the usual source of care for study patients, and measured AIDS experience as the cumulative number of AIDS patients treated by the study clinics since 1986. Pneumocystis carinii pneumonia prophylaxis in the 6 months before AIDS diagnosis and PCP at AIDS diagnosis were the main outcome measures. Bivariate and multivariate analyses adjusted for clustering of patients within clinics. Of 1,876 HIV-infected persons, 44% had PCP prophylaxis and 38% had primary PCP. Persons on prophylaxis had 20% lower adjusted odds of developing PCP (95% confidence interval [CI] 0.64, 0.99). The adjusted odds of receiving prophylaxis rose monotonically with the number of HIV-focused features offered by the clinic, with threefold higher odds (95% CI 1.6, 5.7) for six versus two or fewer such features. Patients in clinics with three HIV-focused features had 36% lower adjusted odds of PCP than those in clinics with one or none. Neither clinic experience nor specialty had a significant association with prophylaxis or PCP.Conclusions: PCP prevention in our study cohort appears to be more successful in clinics offering an array of HIV-focused features. [ABSTRACT FROM AUTHOR]

Neglected tropical diseases (NTDs) receive relatively little research and development but have a tremendous impact on lifespan and livelihood. Here, we use existing data on the need for drugs, their efficacy, and their treatment percentages to estimate the impacts of various regimens on the global burden of several NTDs: schistosomiasis, onchocerciasis, lymphatic filariasis, and three soil-transmitted helminths (STHs) over time. For an interactive visualization of our models' results, see https://www.global-health-impact.org/. In 2015, our NTD models estimate that treatment averted 2,778,131.78 disability-adjusted life years (DALYs). Together, treatments targeting STHs together averted 51.05% of the DALYs averted from all NTD treatments, whereas schistosomiasis, lymphatic filariasis, and onchocerciasis medicines averted 40.21%, 7.56%, and 1.18%, respectively. Our models highlight the importance of focusing not just on the burden of these diseases but also on their alleviation in the effort to expand access to treatment.

Background: Contemporary vancomycin dosing schemes are designed to achieve an area under the curve (AUC) to minimum inhibitory concentration (MIC) ratio of ≥400. However, scant clinical data exist to support this target and available data relied on pharmacokinetic formulas based on daily vancomycin dose and estimated renal function (demographic pharmacokinetic model) to estimate AUCs., Methods: A cohort study of hospitalized, adult, nondialysis patients with methicillin-resistant Staphylococcus aureus bloodstream infections treated with vancomycin was performed to quantitatively evaluate the relationship between vancomycin exposure and outcomes. Bayesian techniques were used to estimate vancomycin exposure profile for day 1 and 2 of therapy for each patient based on their dosing schedule and collected concentrations. Classification and Regression Tree (CART) analysis was used to identify day 1 and 2 exposure thresholds associated with an increased risk of failure. Failure was defined as 30-day mortality, bacteremia was ≥7 days, or recurrence., Results: During the study period, 123 cases met criteria. Failure was uniformly less pronounced (approximately 20% less in absolute value) in patients who achieved the CART-derived day 1 and 2 thresholds for AUC/MIC by broth microdilution and AUC/MIC by Etest. In the multivariate analyses, all risk ratios were approximately 0.5 for all CART-derived AUC/MIC exposure thresholds, indicating that achievement of CART-derived AUC/MIC exposure thresholds was associated with a 2-fold decrease in failure., Conclusions: These findings establish the critical importance of daily AUC/MIC ratios during the first 2 days of therapy. As with all observational studies, these findings should be interpreted cautiously and validated in a multicenter randomized trial before adoption into practice., (© The Author 2014. Published by Oxford University Press on behalf of the Infectious Diseases Society of America. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.)

Recent Food and Drug Administration (FDA) guidance endorses the use of an early clinical response endpoint as the primary outcome for community-acquired bacterial pneumonia (CABP) trials. While antibiotics will now be approved for CABP, in practice they will primarily be used to treat patients with community-acquired pneumonia (CAP). More importantly, it is unclear how achievement of the new FDA CABP early response endpoint translates into clinically applicable real-world outcomes for patients with CAP. To address this, a retrospective cohort study was conducted among adult patients who received ceftriaxone and azithromycin for CAP of Pneumonia Outcomes Research Team (PORT) risk class III and IV at an academic medical center. The clinical response was defined as clinical stability for 24 h with improvement in at least one pneumonia symptom and with no symptom worsening. A classification and regression tree (CART) was used to determine the delay in response time, measured in days, associated with the greatest risk of a prolonged hospital length of stay (LOS) and adverse outcomes (in-hospital mortality or 30-day CAP-related readmission). A total of 250 patients were included. On average, patients were discharged 2 days following the achievement of a clinical response. In the CART analysis, adverse clinical outcomes were higher among day 5 nonresponders than those who responded by day 5 (22.4% versus 6.9%, P = 0.001). The findings from this study indicate that time to clinical response, as defined by the recent FDA guidance, is a reasonable prognostic indicator of real-world effectiveness outcomes among hospitalized PORT risk class III and IV patients with CAP who received ceftriaxone and azithromycin., (Copyright © 2014, American Society for Microbiology. All Rights Reserved.)

Data comparing the treatment outcomes of the two most frequently recommended empirical antibiotic regimens for community-acquired pneumonia (CAP)--combination therapy with an extended-spectrum beta-lactam and a macrolide (BL+M) or fluoroquinolone (F) monotherapy--for patients with severe CAP are sparse. The purpose of this study was to compare empirical BL+M combination therapy with F monotherapy for Veterans Affairs (VA) patients with severe CAP. This retrospective study included patients with CAP who received empirical therapy with BL+M or F between October 1999 and May 2003 in the Upstate New York VA Network. Outcome measures were 14-day mortality, 30-day mortality, and length of hospital stay (LOS). Severe CAP was defined as a class V pneumonia severity index (PSI). During the study period, 261 patients received BL+M and 254 received F. Disease severity was similar for the two treatment groups at admission, and the presence of tachycardia was the only difference noted. For PSI class V patients, there were lower 14-day and 30-day mortality rates with BL+M than with F (14-day rates, 8.2% versus 26.8% [P = 0.02]; 30-day rates, 18.4% versus 36.6% [P = 0.05]). No differences in mortality between treatment groups were noted for the lower PSI classes. The overall median LOS was significantly longer for the BL+M combination group than for the F monotherapy group (6.0 days versus 5.0 days, respectively [P = 0.01]), but no difference in LOS was noted among PSI class V patients. Our study showed that improved outcomes may be realized with BL+M in cases of severe CAP. A randomized clinical study is warranted based on these results.

Background: Medicare Part D excludes benzodiazepines from coverage, and numerous state government policies limit use of benzodiazepines. No data indicate that such policies have decreased the incidence of hip fracture., Objective: To assess whether a statewide policy that decreased the use of benzodiazepines among elderly persons by more than 50% has decreased the incidence of hip fracture., Design: A quasi-experiment comparing changes in outcomes before and after a policy change in a study U.S. state (New York) and a control state (New Jersey)., Setting: Two U.S. state Medicaid programs, 1988-1990., Patients: Medicaid enrollees in New York (n = 51 529) and New Jersey (n = 42 029) who received or did not receive a benzodiazepine., Measurements: Benzodiazepine prescribing and hazard ratios for hip fracture, adjusted for age and eligibility category., Intervention: A statewide policy, implemented in New York in 1989, that required triplicate forms for benzodiazepine prescribing to allow surveillance by health authorities., Results: The triplicate prescription policy immediately resulted in a 60.3% (95% CI, -66.3% to -54.2%) reduction in benzodiazepine use among women and 58.5% (-64.3% to -52.8%) among men. Benzodiazepine use in New Jersey remained stable. Hazard ratios for hip fracture that were adjusted for age and eligibility category did not change in New York or New Jersey when the periods before and after use of the triplicate prescription policy were compared (change from 1.2 to 1.1 among female benzodiazepine recipients [P = 0.70], 1.3 to 1.1 [P = 0.08] among female nonrecipients, 0.8 to 1.1 [P = 0.56] among male recipients, and 1.1 to 1.3 [P = 0.46] among male nonrecipients)., Limitations: Information was lacking on race, benzodiazepine dose, and other potential determinants of continued benzodiazepine prescribing., Conclusions: Policies that lead to substantial reductions in the use of benzodiazepines among elderly persons do not necessarily lead to decreased incidence of hip fracture. Limitations on coverage of benzodiazepines under Medicare Part D may not achieve this widely assumed clinical benefit.

Background: Benzodiazepines (BZD) effectively treat anxiety and insomnia accompanying major health events, including hospitalizations. Prescribing regulations to decrease BZD misuse may negatively impact therapeutic uses., Objective: To assess the impact of a Triplicate Prescription Program (TPP) on initiation of post-hospitalization BZD prescribing, both overall and among cardiac and cancer patients in the United States., Design: Interrupted time-series of post-hospitalization BZD dispensing events to enrollees in the US Medicaid program in the states of New York (intervention group) and New Jersey (control group), before and after implementation of a TPP., Study Participants: Community-dwelling Medicaid enrollees in New York State (n = 67 962) and New Jersey (n = 71 701), hospitalized between 1 January 1988 and 30 November 1990., Intervention: The New York State TPP, implemented on 1 January 1989, requires physicians to prescribe BZD on triplicate prescription forms for state surveillance., Outcome Measures: Rates and duration of new post-hospitalization use of BZD and substitute medications., Results: Overall, a sudden and sustained 63.5% decrease [95% confidence interval (CI) -58.6% to -68.3%] in new post-hospitalization BZD dispensing-from a baseline rate of 44 discharges with BZD dispensing per 1000 discharges per month-followed the TPP in New York State, without discontinuity in the control state. Patients hospitalized for acute ischemic cardiac events experienced a 72.5% reduction (95% CI -55.5% to -89.4%), and cancer patients a 69.4% reduction (95% CI -36.7% to -100.0%). The TPP did not preferentially reduce BZD use lasting >2 months. Increased substitute use did not offset reductions in BZD use., Conclusions: By decreasing new short-term post-hospitalization BZD use, the New York State TPP also had unintended effects.

Background: Antiretroviral adherence is worse in women than in men, and depression can influence medication adherence., Objective: To evaluate the relationship of gender, depression, medical care, and mental health care to adherence in HIV-infected drug users., Design: Retrospective cohort study., Setting: New York State Medicaid program., Participants: One thousand eight hundred twenty-seven female and 3,246 male drug users on combination antiretroviral therapy for more than 2 months in 1997., Main Measures: A pharmacy-based measure of adherence was defined as > or =95% days covered by at least 2 prescribed antiretroviral drugs. Independent variables were: depression, regular drug treatment (> or =6 months), regular medical care (2+ and >35% of visits), HIV-focused care (2+ visits), psychiatric care (2+ visits), and antidepressant therapy., Results: Women were less adherent than men (18% vs 25%, respectively,P <.001) and more likely to be diagnosed with depression (34% vs 29%). In persons with depression, the adjusted odds ratio (AOR) for adherence was greater for those with psychiatric care alone (AOR 1.52; 95% confidence interval [95% CI], 1.03 to 2.26) or combined with antidepressants (AOR 1.49; 95% CI, 1.04 to 2.15). In separate models by gender in persons with depression, psychiatric care plus antidepressants had a slightly stronger association with adherence in women (AOR 1.92; 95% CI, 1.00 to 3.68) than men (AOR, 1.26; 95% CI, 0.81 to 1.98). In drug users without depression, antidepressants alone were associated with greater adherence (AOR, 1.23; 95% CI, 1.02 to 1.49) with no difference by gender. Regular drug treatment was positively associated with adherence only in men., Conclusions: In this drug-using cohort, women had worse pharmacy-measured antiretroviral adherence than men. Mental health care was significantly associated with adherence in women, while regular drug treatment was positively associated with adherence in men.

Objective: To examine the relative role of ethnicity and maternal birthplace on small-for-gestational-age (SGA) deliveries of a cohort of mothers in New York who were infected with human immunodeficiency virus., Methods: Medicaid claims and linked vital statistics records were examined for 2,525 singleton deliveries to HIV-infected women from 1993 through 1996. We estimated adjusted odds ratios (AORs) and 95% confidence intervals (CIs) of SGA delivery associated with ethnicity (i.e., white, white-Latina, black, and black-Latina) and maternal birthplace (i.e., native US/Puerto Rican vs. foreign born) in a series of multivariate regression models to which we sequentially added demographic, health services, and lifestyle factors (i.e., alcohol, tobacco, and illicit drug use)., Results: Of the deliveries, 10% were SGA. The odds of SGA infants for black and white women did not differ by maternal birthplace. Foreign-born white-Latinas and black-Latinas had lower unadjusted odds of a SGA delivery than their US-born counterparts (OR 0.29, CI 0.14, 0.61 and OR 0.22, CI 0.07, 0.71, respectively). After adjustment for maternal lifestyle characteristics, the odds of SGA delivery were 0.50 (CI 0.23, 1.09) for white-Latina mothers and 0.60 (CI 0.17, 2.08) for black-Latina mothers., Conclusions: SGA outcomes did not differ by maternal birthplace for black and white women. Differences in lifestyle factors appear to contribute to lower odds of SGA delivery for foreign-born versus US-born white- and black-Latina HIV-infected women.

Objective: We explored the effect of patient and provider factors on the type of antiretroviral regimen among women receiving therapy., Patients: Five hundred ninety-five New York State nonpregnant HIV+ women with full Medicaid eligibility and at least 1 month of a prescribed antiretroviral regimen in federal fiscal years (FFY) 1997-1998 and intervals in FFY 1997-1998, who had delivered a liveborn baby within 5 years., Measurements: From pharmacy claims in 4 6-month intervals in FFY 1997-1998, data were extracted on (1) an acceptable > or = 2 antiretroviral combination regimen per expert guidelines; and (2) a highly active regimen, including a protease inhibitor or nonnucleoside analog (highly active antiretroviral therapy [HAART])., Results: Of 1514 woman-6-month intervals with filled antiretroviral prescriptions, 82% had an acceptable regimen, and of 1246 woman-6-month intervals on acceptable antiretroviral therapy, half demonstrated the use of HAART. Adjusted odds ratios (AORs) of acceptable antiretroviral therapy were higher (p < .05) for HIV specialty care (AOR = 1.71 for one or two visits; AOR = 2.10 for 3+ visits) or HIV clinical trials site care (AOR = 1.43; 95% confidence interval [CI]: 1.01, 2.04). Among women on acceptable antiretroviral regimens, those aged older than 25 years (AOR = 1.69; CI: 1.13, 2.53) or who were high school graduates (AOR = 1.50; CI: 1.09, 2.06) had higher odds of HAART. Methadone-treated women had twofold and nearly threefold higher AORs of acceptable antiretroviral regimens and HAART, respectively, than current drug users., Conclusion: Provider HIV expertise is associated with receipt of an acceptable antiretroviral regimen in women, although receipt of HAART is affected more by age, education, and current drug abuse. Methadone treatment seems to improve access to acceptable antiretroviral regimens as well as to HAART.

We evaluated factors associated with low birth weight (LBW) in an HIV-infected cohort (n = 772) and a general sample (n = 2,377) of women delivering a live singleton in federal fiscal years 1989 and 1990 while enrolled in New York State Medicaid. The association of LBW and HIV infection was studied in logistic models, controlling for illicit drug use, demographic characteristics, adequacy of prenatal care, and medical risk factors. Overall, 29% of the HIV-infected women had a LBW infant compared to 9.3% of the general sample (p < 0.001). The adjusted odds of LBW for HIV-infected women were twofold higher than for uninfected women [odds ratio (OR) = 2.04 and 95% confidence interval (Cl) = 1.54, 2.69]. Odds of LBW were also increased for illicit drug users (OR = 2.16; 95% CI = 1.59, 2.94), cigarette smokers (OR = 1.81; 95% CI = 1.37, 2.39), and African-American versus non-Hispanic white women (OR = 1.89; 95% CI = 1.31, 2.72). Lower odds appeared for women with adequate prenatal care (OR = 0.54; 95% CI = 0.42, 0.68). Among only women with full-term deliveries, the association of HIV with LBW remained strong as we found nearly threefold greater odds of LBW for HIV-infected women. This study indicates that HIV-infected women have an increased risk of bearing a L.BW infant, even after adjusting for the effects of drug use, health care delivery, and other social and medical risk factors.

Objective: To examine the association of clinical complications and age at diagnosis with survival for a cohort of children and adults with AIDS., Design: A population-based analysis of 734 children and 5584 adults diagnosed with AIDS from 1985 to 1990 in New York State., Results: The initial AIDS-defining diagnoses for 68% of children were lymphoid interstitial pneumonitis or infections specified in the Centers for Disease Control and Prevention's (CDC) pediatric AIDS case definition but not the CDC's 1987 adult AIDS case definition. Of opportunistic infections in both case definitions, Pneumocystis carinii pneumonia (PCP) was the most common initial AIDS diagnosis, occurring in 53% of adults, 47% of children aged < 6 months at diagnosis (n = 122) and 14% aged > or = 6 months at diagnosis (n = 612). Median survival after AIDS diagnosis was 62 months for all children compared with 11 months for adults. For children initially diagnosed with conditions only in the pediatric case definition, median survival ranged from 27 to 62 months compared with less than 12 months for children and adults with PCP. Compared with children aged 6-54 months, the estimated hazards of death for younger and older children were 2.06 [95% confidence interval (CI), 1.48-2.86] and 1.54 (95% CI, 1.10-2.16), respectively., Conclusion: Children survived significantly longer than adults after AIDS diagnosis, but their survival varied by age at diagnosis. Differences in the types of common initial AIDS-defining diagnoses appear to contribute to the observed differences in survival.

Background: The lag time for adoption of new acquired immunodeficiency syndrome (AIDS) therapies into the clinical practices of different types of ambulatory care providers can be estimated from patient use of zidovudine therapy during the first few years after approval by the Food and Drug Administration., Methods: We analyzed receipt of zidovudine therapy from April 1987 through March 1990 by 3643 patients with a diagnosis of AIDS. The study group was continuously enrolled in the New York State Medicaid program for at least 6 months after diagnosis. For each patient, the dominant providers of ambulatory care, receipt of zidovudine therapy, and consultation with a human immunodeficiency virus-AIDS specialist within 6 months after diagnosis were determined from Medicaid claims. AIDS specialists included physicians or clinics specializing in infectious disease or hematology/oncology or specific clinics within designated AIDS centers., Results: In 1987, 55% of those who had an AIDS specialist as their dominant care provider received zidovudine therapy, compared with only 36% of patients with a primary care clinic as their dominant care provider. It was not until 1990, 3 years after approval by the Food and Drug Administration, that the percentage of patients receiving zidovudine therapy (77% to 78%) was comparable for patients of primary care clinics and AIDS specialists. In logistic regression analysis, zidovudine use did not differ between patients of AIDS specialists and patients with other types of dominant providers when the latter group had consulted with an AIDS specialist (adjusted odds ratio, 1.38; 95% confidence interval, 0.99 to 1.95)., Conclusions: In our AIDS study population, there was at least a 3-year lag before patients of primary care clinics received zidovudine therapy at the same rate as patients of AIDS specialists. Conditions such as AIDS with rapid changes in treatment options may require a close relationship between generalists and specialists to increase access to new therapies.

This study used a longitudinal data set of 4,957 patients and 39,455 patient-months of observation, drawn from 17 months of data on patients with symptomatic HIV disease identified from the New York State Medicaid Program. Multivariate regression analysis was used to evaluate the effect of AZT on the use of several medical services. The results show that AZT produced substantial reductions in resource use. Patients who took AZT were hospitalized fewer days per month and, including the cost of the drug, had Medicaid expenditures that were several hundred dollars lower per month. The reduction in total expenditures is largely accounted for by a reduction in inpatient expenditures and an increase in pharmacy expenditures. These effects were temporary, however, as the impact of the drug decreased with each month of use. There were no declines in expenditures and utilization after approximately 7 to 9 months of AZT use.

An epidemiological analysis of the impact of AIDS on the New York and California Medicaid programs was conducted for 1983-1986. The epidemic affected the New York and California Medicaid programs in several similar ways. The total number of cases grew rapidly over the study time period. In both states, the epidemic was mostly confined to the young adult (21-44 years) age group. Cases were geographically concentrated and highly localized even within counties, but evidence of geographic dispersion to counties outside of the urban centers was also evident. Some dramatic differences were also found between California and New York. Patients with claims histories of drug use were far more likely to be found in the New York population and the proportion of other adult males (our proxy for the homosexual risk group) was higher in California. A much higher proportion of New York's population was female (30 vs. 5%). New York also had many more pediatric cases. Most importantly, New York's raw number of cases was substantially higher than California, with approximately three times as many cases during the time period (1983-1986). There is also substantial evidence that transmission of the disease to heterosexual partners of drug users places heterosexual urban minorities at grave risk of contracting the disease through interaction with infected persons.

The purposes of this study were to: (1) determine consumer preferences for personal drug information sources, and (2) determine if preference for information source is affected by perceived drug importance. A telephone survey of 204 metropolitan subjects was conducted using a systematic sampling design. Pharmacists and physicians were preferred over lay sources for all drug categories. Pharmacists and physicians were preferred equally for drugs perceived of low to moderate importance, but not for drugs perceived of highest importance. Perceived drug importance, which has not been examined previously, appears to be an important factor in consumers' preference for personal drug information sources.