Same-day testing with initiation of antiretroviral therapy or tuberculosis treatment versus standard care for persons presenting with tuberculosis symptoms at HIV diagnosis: A randomized open-label trial from Haiti.

BACKGROUND: Same-day HIV testing and antiretroviral therapy (ART) initiation is being widely implemented. However, the optimal timing of ART among patients with tuberculosis (TB) symptoms is unknown. We hypothesized that same-day treatment (TB treatment for those diagnosed with TB; ART for those not diagnosed with TB) would be superior to standard care in this population. METHODS AND FINDINGS: We conducted an open-label trial among adults with TB symptoms at initial HIV diagnosis at GHESKIO in Haiti; participants were recruited and randomized on the same day. Participants were randomized in a 1:1 ratio to same-day treatment (same-day TB testing with same-day TB treatment if TB diagnosed; same-day ART if TB not diagnosed) versus standard care (initiating TB treatment within 7 days and delaying ART to day 7 if TB not diagnosed). In both groups, ART was initiated 2 weeks after TB treatment. The primary outcome was retention in care with 48-week HIV-1 RNA <200 copies/mL, with intention to treat (ITT) analysis. From November 6, 2017 to January 16, 2020, 500 participants were randomized (250/group); the final study visit occurred on March 1, 2021. Baseline TB was diagnosed in 40 (16.0%) in the standard and 48 (19.2%) in the same-day group; all initiated TB treatment. In the standard group, 245 (98.0%) initiated ART at median of 9 days; 6 (2.4%) died, 15 (6.0%) missed the 48-week visit, and 229 (91.6%) attended the 48-week visit. Among all who were randomized, 220 (88.0%) received 48-week HIV-1 RNA testing; 168 had <200 copies/mL (among randomized: 67.2%; among tested: 76.4%). In the same-day group, 249 (99.6%) initiated ART at median of 0 days; 9 (3.6%) died, 23 (9.2%) missed the 48-week visit, and 218 (87.2%) attended the 48-week visit. Among all who were randomized, 211 (84.4%) received 48-week HIV-1 RNA; 152 had <200 copies/mL (among randomized: 60.8%; among tested: 72.0%). There was no difference between groups in the primary outcome (60.8% versus 67.2%; risk difference: -0.06; 95% CI [-0.15, 0.02]; p = 0.14). Two new grade 3 or 4 events were reported per group; none were judged to be related to the intervention. The main limitation of this study is that it was conducted at a single urban clinic, and the generalizability to other settings is uncertain. CONCLUSIONS: In patients with TB symptoms at HIV diagnosis, we found that same-day treatment was not associated with superior retention and viral suppression. In this study, a short delay in ART initiation did not appear to compromise outcomes. TRIAL REGISTRATION: This study is registered with ClinicalTrials.gov NCT03154320.

Improved Outcomes With High-dose Isoniazid in Multidrug-resistant Tuberculosis Treatment in Haiti.

We report outcomes for a cohort of patients with multidrug-resistant tuberculosis who received high-dose isoniazid in Haiti. Patients who received high-dose isoniazid had a faster time to culture conversion and higher odds of successful outcome, despite high-level isoniazid resistance. This suggests high-dose isoniazid may have effectiveness even with phenotypic resistance.

Same-day HIV testing with initiation of antiretroviral therapy versus standard care for persons living with HIV: A randomized unblinded trial.

BACKGROUND: Attrition during the period from HIV testing to antiretroviral therapy (ART) initiation is high worldwide. We assessed whether same-day HIV testing and ART initiation improves retention and virologic suppression. METHODS AND FINDINGS: We conducted an unblinded, randomized trial of standard ART initiation versus same-day HIV testing and ART initiation among eligible adults ≥18 years old with World Health Organization Stage 1 or 2 disease and CD4 count ≤500 cells/mm3. The study was conducted among outpatients at the Haitian Group for the Study of Kaposi's Sarcoma and Opportunistic infections (GHESKIO) Clinic in Port-au-Prince, Haiti. Participants were randomly assigned (1:1) to standard ART initiation or same-day HIV testing and ART initiation. The standard group initiated ART 3 weeks after HIV testing, and the same-day group initiated ART on the day of testing. The primary study endpoint was retention in care 12 months after HIV testing with HIV-1 RNA <50 copies/ml. We assessed the impact of treatment arm with a modified intention-to-treat analysis, using multivariable logistic regression controlling for potential confounders. Between August 2013 and October 2015, 762 participants were enrolled; 59 participants transferred to other clinics during the study period, and were excluded as per protocol, leaving 356 in the standard and 347 in the same-day ART groups. In the standard ART group, 156 (44%) participants were retained in care with 12-month HIV-1 RNA <50 copies, and 184 (52%) had <1,000 copies/ml; 20 participants (6%) died. In the same-day ART group, 184 (53%) participants were retained with HIV-1 RNA <50 copies/ml, and 212 (61%) had <1,000 copies/ml; 10 (3%) participants died. The unadjusted risk ratio (RR) of being retained at 12 months with HIV-1 RNA <50 copies/ml was 1.21 (95% CI: 1.04, 1.38; p = 0.015) for the same-day ART group compared to the standard ART group, and the unadjusted RR for being retained with HIV-1 RNA <1,000 copies was 1.18 (95% CI: 1.04, 1.31; p = 0.012). The main limitation of this study is that it was conducted at a single urban clinic, and the generalizability to other settings is uncertain. CONCLUSIONS: Same-day HIV testing and ART initiation is feasible and beneficial in this setting, as it improves retention in care with virologic suppression among patients with early clinical HIV disease. TRIAL REGISTRATION: This study is registered with ClinicalTrials.gov number NCT01900080.

Can social media data lead to earlier detection of drug-related adverse events?

PURPOSE: To compare the patient characteristics and the inter-temporal reporting patterns of adverse events (AEs) for atorvastatin (Lipitor® ) and sibutramine (Meridia® ) in social media (AskaPatient.com) versus the FDA Adverse Event Reporting System (FAERS). METHODS: We identified clinically important AEs associated with atorvastatin (muscle pain) and sibutramine (cardiovascular AEs), compared their patterns in social media postings versus FAERS and used Granger causality tests to assess whether social media postings were useful in forecasting FAERS reports. RESULTS: We analyzed 998 and 270 social media postings between 2001 and 2014, 69 003 and 7383 FAERS reports between 1997 and 2014 for atorvastatin and sibutramine, respectively. Social media reporters were younger (atorvastatin: 53.9 vs. 64.0 years, p < 0.001; sibutramine: 36.8 vs. 43.8 years, p < 0.001). Social media reviews contained fewer serious AEs (atorvastatin, pain: 2.5% vs. 38.2%; sibutramine, cardiovascular issues: 7.9% vs. 63.0%; p < 0.001 for both) and concentrated on fewer types of AEs (proportion comprising the top 20 AEs: atorvastatin, 88.7% vs. 55.4%; sibutramine, 86.3% vs. 65.4%) compared with FAERS. While social media sibutramine reviews mentioning cardiac issues helped predict those in FAERS 11 months later (p < 0.001), social media atorvastatin reviews did not help predict FAERS reports. CONCLUSIONS: Social media AE reporters were younger and focused on less-serious and fewer types of AEs than FAERS reporters. The potential for social media to provide earlier indications of AEs compared with FAERS is uncertain. Our findings highlight some of the promises and limitations of online social media versus conventional pharmacovigilance sources and the need for careful interpretation of the results. © 2016 The Authors. Pharmacoepidemiology and Drug Safety published by John Wiley & Sons Ltd.

Predictors of Clinical Outcomes among People with HIV and Tuberculosis Symptoms after Rapid Treatment Initiation in Haiti.

Introduction: Few studies have evaluated baseline predictors of clinical outcomes among people with HIV starting antiretroviral therapy (ART) in the modern era of rapid ART initiation. Methods: We conducted a secondary analysis of a randomized controlled trial of two rapid treatment initiation strategies for people with treatment-naïve HIV and tuberculosis symptoms at an urban clinic in Haiti. We used logistic regression models to assess associations between baseline characteristics and (1) retention in care at 48 weeks, (2) HIV viral load suppression at 48 weeks (among participants who underwent viral load testing), and (3) all-cause mortality. Results: 500 participants were enrolled in the study 11/2017-1/2020. Eighty-eight (18%) participants were diagnosed with tuberculosis, and ART was started in 494 (99%). After adjustment, less than secondary education (adjusted odds ratio [AOR] 0.21, 95% CI 0.10-0.46), dolutegravir initiation (AOR 2.57, 95% CI 1.22-5.43), age (AOR 1.42 per 10-year increase, 95% CI 1.01-1.99), and tuberculosis diagnosis (AOR 3.92, 95% CI 1.36-11.28) were significantly associated with retention. Age (AOR 1.36, 95% CI 1.05-1.75), dolutegravir initiation (AOR 1.75, 95% CI 1.07-2.85), and tuberculosis diagnosis (AOR 0.50, 95% CI 0.28-0.89) were associated with viral suppression. Higher CD4 cell count at enrollment (unadjusted odds ratio [OR] 0.69, 95% CI 0.55-0.87) and anemia (OR 4.86, 95% CI 1.71-13.81) were associated with mortality. Conclusions: We identified sociodemographic, treatment-related, clinical, and laboratory-based predictors of clinical outcomes. These characteristics may serve as markers of sub-populations that could benefit from additional interventions to support treatment success after rapid treatment initiation.

Potential Utility of C-reactive Protein for Tuberculosis Risk Stratification among Patients with Non-Meningitic Symptoms at HIV Diagnosis in Low- and Middle-Income Countries.

Article Summary: We assessed the association between C-reactive protein (CRP) and Mycobacterium tuberculosis (TB) diagnosis in symptomatic patients at HIV diagnosis. We found that CRP concentrations can improve tuberculosis risk stratification, facilitating decision making about whether (specific) tuberculosis testing is indicated before antiretroviral therapy initiation. Background: The World Health Organization recommends initiating same-day ART while tuberculosis testing is underway for patients with non-meningitic symptoms at HIV diagnosis, though safety data are limited. C-reactive protein (CRP) testing may improve tuberculosis risk stratification in this population. Methods: In this baseline analysis of 498 adults (>18 years) with tuberculosis symptoms at HIV diagnosis who were enrolled in a trial of rapid ART initiation in Haiti, we describe test characteristics of varying CRP thresholds in the diagnosis of TB. We also assessed predictors of high CRP (≥3 mg/dL) using generalized linear models. Results: Eighty-seven (17.5%) patients were diagnosed with baseline TB. The median CRP was 33.0 mg/L (IQR: 5.1, 85.5) in those with TB, and 2.6 mg/L (IQR: 0.8, 11.7) in those without TB. As the CRP threshold increased from ≥1 mg/L to ≥10 mg/L, the positive predictive value for TB increased from 22.4% to 35.4%, and negative predictive value decreased from 96.9% to 92.3%. With CRP thresholds varying from <1 to <10 mg/L, a range from 25.5% to 64.9% of the cohort would have been eligible for same-day ART, and 0.8% to 5.0% would have untreated TB at ART initiation. Conclusions: CRP concentrations can be used to improve TB risk stratification, facilitating same-day decisions about ART initiation. Depending on the CRP threshold, one-quarter to two-thirds of patients could be eligible for same-day ART, with a reduction of 3-fold to 20-fold in the proportion with untreated TB, compared with a strategy of same-day ART while awaiting TB test results.

Exact and efficient inference procedure for meta-analysis and its application to the analysis of independent 2 x 2 tables with all available data but without artificial continuity correction.

Recently, meta-analysis has been widely utilized to combine information across comparative clinical studies for evaluating drug efficacy or safety profile. When dealing with rather rare events, a substantial proportion of studies may not have any events of interest. Conventional methods either exclude such studies or add an arbitrary positive value to each cell of the corresponding 2 x 2 tables in the analysis. In this article, we present a simple, effective procedure to make valid inferences about the parameter of interest with all available data without artificial continuity corrections. We then use the procedure to analyze the data from 48 comparative trials involving rosiglitazone with respect to its possible cardiovascular toxicity.

Do drugs reduce utilisation of other healthcare resources?

BACKGROUND: Drug expenditures per capita have drastically increased over the last quarter century in Canada, with a share of overall healthcare costs rising from 8.8% in 1980 to 16.8% in 2002. Pressure to curb expenditure on drugs has increased accordingly, but containing drug expenditure might increase costs elsewhere in the healthcare sector. OBJECTIVE: To measure substitution patterns between drugs and other healthcare resources over the last 25 years and thus assess whether containing drug costs might result in higher expenditure elsewhere in the healthcare system. METHODS AND DATA: A production function approach was used, in which life expectancy was modelled as a function of per capita drugs and non-drug healthcare resources, among other factors. Estimates are used to calculate a marginal rate of substitution, or trade-off, between drugs and non-drug healthcare resources, for a given level of life expectancy in the population. The model is estimated from a societal perspective, with panel data techniques using Canadian provincial-level data on health expenditure and spending on physicians per capita for the period 1980-2002, as well as individual survey data on lifestyle habits such as cigarette consumption and body mass index. RESULT: Using life expectancy at birth for males as the production function, increasing drug spending by Can 1.00 dollars (constant 2003 values) was accompanied by a decrease of Can 1.48 dollars in non-drug, non-physician healthcare resources over the study period, without affecting life expectancy at birth. Results using life expectancy at birth for females as the production function showed a decrease of Can 1.05 dollars in non-drug, non-physician healthcare resources over the same period. CONCLUSION: Using life expectancy as a general health indicator, results suggest that increases in drug spending could be more than offset by decreases in other healthcare spending without affecting the health of the population. This suggests that better access to drugs may be an effective strategy to decrease overall healthcare costs. Freeing up healthcare dollars by reallocating spending towards drugs could provide opportunities for overall healthcare cost savings without negatively impacting the health of the population.

The economic consequences of generic substitution for antiepileptic drugs in a public payer setting: the case of lamotrigine.

Generic substitution of antiepileptic drugs (AEDs) may increase pharmacy utilization, thus counterbalancing per-pill savings. The purpose of our study was to analyze the economic impact of government-mandated switching from branded to generic lamotrigine. Patients in a Canadian public pharmacy claims database using branded lamotrigine (Lamictal GlaxoSmithKline, UK) in 2002 converted to generic lamotrigine in 2003 and were observed from July 2002 to March 2006. Patients used branded lamotrigine for >or=90 days pre-generic entry and had >or=1 claim for generic lamotrigine post-generic entry. For the generic period, observed per-patient monthly drug costs were calculated as the sum of costs for lamotrigine, other AEDs, and non-AEDs. Expected per-patient drug costs were estimated assuming lamotrigine dose and other prescription drug utilization in the generic period were identical to those observed during the brand period. Differences between observed and expected costs were compared. Among 1,142 branded lamotrigine users, overall average monthly drug costs per person were expected to decrease by $30.55 due to lower pill costs. Instead, they fell by $11.98 from the brand to the generic periods (p < 0.001). Because of dosage changes, lamotrigine costs decreased by $29.92 instead of the anticipated $33.87 (p < 0.001). Increased pharmacy utilization caused other AED costs to rise by $6.29 versus the expected $0.36 (p < 0.001), while non-AED drug cost increased by $11.64 rather than by $2.95 (p < 0.001). We concluded that conversion to generic lamotrigine resulted in lower than expected cost savings. Further research is necessary to determine whether this is due to reduced effectiveness and/or tolerability. Payers may weigh smaller-than-expected cost reductions against a possible decrease in effectiveness to assess the relevance of mandatory generic switching of lamotrigine.

The economic impact of a partnership-measurement model of disease management: Improving Cardiovascular Outcomes in Nova Scotia (ICONS).

Improving Cardiovascular Outcomes in Nova Scotia (ICONS) was a five-year, community partnership-based disease-management project that sought, as a primary goal, to improve the care and outcomes of patients with heart disease in Nova Scotia. This program, based on a broad stakeholder partnership, provided repeated measurement and feedback on practices and outcomes as well as widespread communication and education among all partners. From a clinical viewpoint, ICONS was successful. For example, use of proven therapies for the target diseases improved and re-hospitalization rates decreased. Stakeholders also perceived a sense of satisfaction because of their involvement in the partnership. However, the universe of health stakeholders is large, and not many have had an experience similar to ICONS. These other health stakeholders, such as decision-makers concerned with the cost of care and determining the value for cost, might, nonetheless, benefit from knowledge of the ICONS concepts and results, particularly economic analyses, as they determine future health policy. Using budgetary data on actual dollars spent and a robust input-output methodology, we assessed the economic impact of ICONS, including trickle-down effects on the Canadian and Nova Scotian economies. The analysis revealed that the $6.22 million invested in Nova Scotia by the private sector donor generated an initial net increase in total Canadian wealth of $5.32 million and a global net increase in total Canadian wealth of $10.23 million, including $2.27 million returned to the different governments through direct and indirect taxes. Thus, the local, provincial and federal governments are important beneficiaries of health project investments such as ICONS. The various government levels benefit from the direct influx of private funds into the publicly funded healthcare sector, from direct and indirect tax revenues and from an increase in knowledge-related employment. This, of course, is in addition to the clinical benefits associated with the partnership-measurement disease-management model. Because of their uniquely simultaneous roles as beneficiary and major resource provider, the public payer can play an early and active role in such partnerships to enhance its efficiencies and increase the likelihood of sustainability if the original concepts are proven of value.

Health Services Utilization Among Fee-for-Service Medicare and Medicaid Patients Under Age 65 with Behavioral Health Illness at an Urban Safety Net Hospital.

BACKGROUND: In 2011, fee-for-service patients with both Medicare and Medicaid (dual eligible) sustained $319.5 billion in health care costs. OBJECTIVE: To describe the emergency department (ED) use and hospital admissions of adult dual eligible patients aged under 65 years who used an urban safety net hospital. METHODS: This was a retrospective database analysis of patients aged between 18 and 65 years with Medicare and Medicaid, who used an urban safety net academic health center between January 1, 2011, and December 31, 2011. We compared patients with and without behavioral health illness. The main outcome measures were hospital admission and ED use. Chi-square and Wilcoxon rank-sum tests were used for descriptive statistics on categorical and continuous variables, respectively. Greedy propensity score matching was used to control for confounding factors. Rate ratios (RR) and 95% confidence intervals (CI) were determined after matching and after adjusting for those variables that remained significantly different after matching. RESULTS: In 2011, 10% of all fee-for-service dual eligible patients aged less than 65 years in Massachusetts were seen at Boston Medical Center. Data before propensity score matching showed significant differences in age, sex, race/ethnicity, marital status, education, employment, physical comorbidities, and Charlson Comorbidity Index score between patients with and without behavioral health illness. Analysis after propensity score matching found significant differences in sex, Hispanic race, and other education and employment status. Compared with patients without behavioral health illness, patients with behavioral health illness had a higher RR for hospital admissions (RR = 2.07; 95% CI = 1.81-2.38; P < 0.001) and ED use (RR = 1.61; 95% CI = 1.46-1.77; P < 0.001). Results were robust after adjusting for characteristics that remained statistically significantly different after propensity score matching. CONCLUSIONS: Adult dual eligible patients aged less than 65 years with behavioral health illness in the Medicaid fee-for-service plan had significantly higher rates of hospital admission and ED use compared with dual eligible patients without behavioral health illness at the largest urban safety net medical center in New England. Safety net hospitals care for a large proportion of dual eligible patients with behavioral health illness. Further research is needed to elucidate the systems-related and patient-centered factors contributing to the utilization behaviors of this patient population. DISCLOSURES: This research was funded in part by a National Research Service Award (T3HP10028-14-01). The authors have no conflicts of interests to disclose. Cancino had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. Study concept and design were contributed by Cancino, Jack, and Burgess, with assistance from Cremieux. Cancino and Cremieux took the lead in data collection, along with Jack and Burgess, and data interpretation was performed by Jarvis, Cummings, and Cooper, along with the other authors. The manuscript was written primarily by Cancino, along with Jack and Burgess, and revised primarily by Cancino, along with the other authors.

Retention in Care among Patients with Early HIV Disease in Haiti.

In September 2015, the World Health Organization updated their guidelines to recommend antiretroviral therapy (ART) for all people living with HIV. Countries are now in the process of implementing strategies to provide universal HIV treatment. We analyzed the rate of retention and time to ART eligibility (according to 2013 WHO guidelines) among 3,345 adult patients receiving positive HIV test results between February 1, 2003 and March 31, 2013 at the GHESKIO Clinic in Haiti, with WHO stage 1 or 2 disease and initial CD4 cell count >500 cells/mm3. Among the 3,345 patients, 2,423 (72%) were female, the median age was 33 years, 3,089 (92%) lived in Port-au-Prince, and 1,944 (58%) had attended no school or primary school only. The median initial CD4 cell count was 668 cells/mm3 (IQR: 572-834); over the subsequent 2 years, 1,485 patients (44%) were lost to follow-up and 7 (<1%) died pre-ART, 1,041 (31%) were retained in pre-ART care, and 819 (24%) initiated ART. In multivariate analysis, secondary education (aOR 1.27; 95% CI: 1.10-1.47), female gender (aOR: 1.28; 95% CI: 1.09-1.50), co-habitation (aOR: 1.31; 95% CI: 1.09-1.57), and residence in Port-au-Prince (aOR: 1.43; 95% CI: 1.09-1.88) were associated with retention in care. The median time from baseline CD4 count to ART eligibility was 1.7 years. Prior to the implementation of universal treatment, pre-ART attrition was high among patients who did not qualify for ART at presentation. Though implementing WHO recommendations for universal ART will require service expansion, it will likely result in improved retention for those at risk of being lost to follow-up.

Dose conversion and cost effectiveness of erythropoietic therapies in chemotherapy-related anaemia : a meta-analysis.

OBJECTIVE: To estimate a dose-conversion ratio (DCR) between epoetin alfa (EPO) and darbepoetin alfa (DARB) and compare the costs of both drugs at the estimated DCRs using average wholesale prices (AWPs). METHODS: A search of PUBMED, CANCERLIT and references for papers and abstracts reporting on clinical trials of DARB or EPO for chemotherapy-related anaemia (CRA) identified 56 publications. A meta-analysis was conducted on the 12 eligible papers to estimate a DCR at which the two drugs were equally effective as measured by the area under the curve of haemoglobin (Hb) change (Hb AUC) at weeks 4 and 13. The DCR is based on the ratio of the coefficients of DARB and EPO doses in a regression of Hb AUC on those two variables, baseline Hb, Hb change calculation method, tumour type, and dosing frequency. Studies were frequency-weighted by the number of subjects. DCRs with confidence intervals (CIs) were calculated using a Monte-Carlo approach. Results from the regression were used to calculate DCRs for different dosing regimen comparisons - EPO three times weekly (TIW) versus DARB once weekly (QW), EPO TIW versus DARB once every 2 weeks (Q2W), EPO QW versus DARB QW, and EPO QW versus DARB Q2W. Relative cost effectiveness (RCE) was assessed by comparing drug costs at the estimated DCRs at $US 2003 AWPs [RCE = DCR . ($/U EPO)/($/mug DARB)]. RESULTS: The regression results suggest an EPO QW : DARB QW DCR of 187 (95% CI 183, 191). Depending on the assumed starting dose, the DCR ranges from 126 to 137 for EPO TIW : DARB QW; from 128 to 139 for EPO TIW : DARB Q2W; and equals 191 for EPO QW : DARB Q2W. RCE was 2.0 for the main regression. CONCLUSION: The DCR of 330 : 1 estimated for the 2004 Hospital Outpatient Prospective Payment System by the Centers for Medicare and Medicaid Services is greater than the DCRs estimated based on Hb AUC. The DCR estimated in the primary regression suggests that based on AWPs, EPO is 2.0 times more cost effective than DARB.

Gap Between Evidence and Patient Access: Policy Implications for Bariatric and Metabolic Surgery in the Treatment of Obesity and its Complications.

Despite consistently supportive evidence of clinical effectiveness and economic advantages compared with currently available non-surgical obesity treatments, patient access to bariatric and metabolic surgery (BMS) is impeded. To address this gap and better understand the relationship between value and access, the objectives of this study were twofold: (i) identify the multidimensional barriers to adoption of BMS created by clinical guidelines, public policies, and health technology assessments; and, most importantly, (ii) develop recommendations for stakeholders to improve patient access to BMS. Updated public policies focused on treatment and clinical guidelines that reflect the demonstrated advantages of BMS, patient education on safety and effectiveness, updated reimbursement policies, and additional data on long-term BMS effectiveness are needed to improve patient access.

A Second Look at the Association between Gender and Mortality on Antiretroviral Therapy.

OBJECTIVE: We assessed the association between gender and mortality on antiretroviral therapy (ART) using identical models with and without sex-specific categories for weight and hemoglobin. DESIGN: Cohort study of adult patients on ART. SETTING: GHESKIO Clinic in Port-au-Prince, Haiti. PARTICIPANTS: 4,717 ART-naïve adult patients consecutively enrolled on ART at GHESKIO from 2003 to 2008. MAIN OUTCOME MEASURE: Mortality on ART; multivariable analyses were conducted with and without sex-specific categories for weight and hemoglobin. RESULTS: In Haiti, male gender was associated with mortality (OR 1.61; 95% CI: 1.30-2.00) in multivariable analyses with hemoglobin and weight included as control variables, but not when sex-specific interactions with hemoglobin and weight were used. CONCLUSIONS: If sex-specific categories are omitted, multivariable analyses indicate a higher risk of mortality for males vs. females of the same weight and hemoglobin. However, because males have higher normal values for weight and hemoglobin, the males in this comparison would generally have poorer health status than the females. This may explain why gender differences in mortality are sometimes observed after controlling for differences in baseline variables when gender-specific interactions with weight and hemoglobin are omitted.

Cost-minimization analysis of once-weekly versus thrice-weekly epoetin alfa for chemotherapy-related anemia.

BACKGROUND: For individuals with chemotherapy-related anemia, the clinical effectiveness of epoetin alfa (EPO) dosed once weekly ([QW], 40,000 units per dose) has been demonstrated to be indistinguishable from that observed with thrice-weekly dosing ([TIW], 10,000 units per dose). Whether the advantage of less-frequent administration justifies the higher EPO dosage used in the weekly regimen in terms of overall cost of care is unknown. OBJECTIVE: To conduct a cost-minimization analysis comparing QW and TIW EPO dosing from a societal perspective. METHODS: Direct and indirect medical cost data were calculated for a 16-week period for 2 large, prospective, multicenter, community-based studies. Costs measured included EPO, transfusions, laboratory tests, office visits, and opportunity cost of patient time. RESULTS: The average total costs in 2002 (first half) dollars were nearly equivalent across the 2 groups (QW: 9,204 dollars; 95% confidence interval [CI], 9,057 dollars-9,350 dollars. TIW: 9,265 dollars; 95% CI, 9,083 dollars-9,447 dollars. P=0.60). QW incurred mean drug acquisition costs that were 23% higher (QW: 6,725 dollars; 95% CI, 6,611 dollars-6,838 dollars. TIW: 5,474 dollars; 95% CI, 5,350 dollars-5,598 dollars. P<0.001). However, QW patients can avoid the resource use and time cost associated with 2 additional office visits incurred each week (QW: 592 dollars [583 dollars-600 dollars]; TIW: 1,709 dollars [1,678 dollars-1,740 dollars]; P<0.001). Transfusion and laboratory test costs were slightly higher in the TIW group (QW: 1,888 dollars [1,837 dollars-1,940 dollars]; TIW: 2,082 dollars [2,020 dollars-2,144 dollars]; P<0.001). CONCLUSION: Total anemia treatment costs over a 16-week period with EPO QW were similar to those of TIW dosing. In the absence of cost differences between regimens, the noneconomic advantages of less-frequent dosing intervals should make weekly dosing increasingly attractive to patients, clinicians, and payers.

Superior outcomes and lower outpatient costs with scale-up of antiretroviral therapy at the GHESKIO clinic in Port-au-Prince, Haiti.

BACKGROUND: Treatment protocols and prices of antiretroviral therapy (ART) have changed over time. Yet, limited data exist to evaluate the impact of these changes on patient outcomes and treatment costs in resource-poor settings. METHODS: We compared patient-level data on outcomes, utilization, and cost for the first 2 years of ART for a cohort of adult patients initiating ART in 2003-2004 and a cohort initiating ART in 2006-2008 at the Haitian Group for the Study of Kaposi's Sarcoma and Opportunistic Infections clinic (GHESKIO) in Port-au-Prince, Haiti. Costs were measured from the health center perspective. Multivariate analyses were conducted to account for the potential impact of differences in disease severity at baseline. RESULTS: With the exclusion of patients who transferred care, 92% (167/181) of patients in the 2006-2008 cohort and 75% (150/200) in the 2003-2004 cohort were alive and in care at the end of the study period. The mean cost per patient for the 2-year study period was US$723 for the 2006-2008 cohort vs. US$1191 for the 2003-2004 cohort, a cost difference of US$468 (P < 0.0001). The mean cost per patient alive and in care at the end of the 2-year study period was US$744 for the 2006-2008 cohort vs. US$1489 for the 2003-2004 cohort (P < 0.0001). CONCLUSIONS: HIV treatment outcomes in Haiti have improved over time while treatment costs declined by over 50% per patient alive and in care at the end of the 2-year study period. The major drivers in the reduction of treatment costs were the lower price of ART, lower costs for laboratory testing, and lower overhead costs.

Economic impact of the clinical benefits of bariatric surgery in diabetes patients with BMI ≥35 kg/m².

The medical costs for a type 2 diabetes patient are two to four times greater than the costs for a patient without diabetes. Bariatric surgery is the most effective weight-loss therapy and has marked therapeutic effects on diabetes. We estimate the economic effect of the clinical benefits of bariatric surgery for diabetes patients with BMI ≥ 35 kg/m². Using an administrative claims database of privately insured patients covering 8.5 million lives 1999-2007, we identify obese patients with diabetes, aged 18-65 years, who were treated with bariatric surgery identified using Healthcare Common Procedure Coding System codes. These patients were matched with nonsurgery control patients on demographic factors, comorbidities, and health-care costs. The overall return on investment (RoI) associated with bariatric surgery was calculated using multivariate analysis. Surgery and control patients were compared postindex with respect to diagnostic claims for diabetes, diabetes medication claims, and adjusted diabetes medication and supply costs. Surgery costs were fully recovered after 26 months for laparoscopic surgery. At month 6, 28% of surgery patients had a diabetes diagnosis, compared to 74% of control patients (P < 0.001). Among preindex insulin users, insulin use dropped to 43% by month 3 for surgery patients, vs. 84% for controls (P < 0.001). By month 1, medication and supply costs were significantly lower for surgery patients (P < 0.001). The therapeutic benefits of bariatric surgery on diabetes translate into considerable economic benefits. These data suggest that surgical therapy is clinically more effective and ultimately less expensive than standard therapy for diabetes patients with BMI ≥ 35 kg/m².