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BACKGROUND: Reduction of waste and carbon footprint can be optimized. Awareness of carbon sources and quantification of the waste are two key parameters. To our knowledge, there is no study in France on waste production by the surgical team during the operation in orthopedic surgery, in a global scope. Therefore, we performed an observational investigation aiming to: (1) quantify and characterize the weight of the wastes generated after a panel of orthopedic procedures, (2) calculate the CO2 footprint generated by these wastes and extrapolate the figure at the national scale. HYPOTHESIS: Waste production is highly variable according to the types of procedures and infectious clinical waste is still a predominant source of waste and CO2 emission. MATERIALS AND METHODS: It is a comparative and prospective study in which a total of 14 procedures were selected as a representative panel: arthroplasties (hip, knee), spine fusions, arthroscopic procedures (shoulder, knee), nerve release, forefoot osteotomies, trauma procedures. The main outcome was the average total weight of waste for each of the fourteen categories (280 measurements: 140 times 2, at the end of each procedure), expressed in kilograms (kg), and the proportions of infectious clinical waste (ICW) and household wastes (HW), expressed in percentages. Ten measures were prospectively recorded for each type of procedure in a single teaching hospital from January to September 2022. The theoretical carbon footprint generated by the treatment of the wastes was estimated in kilograms of CO2 equivalent (KgEqCO2). The national extrapolation of the carbon footprint was performed by collecting the total number of procedures in France in 2021 using the VisuChir tool. RESULTS: A total of 937kg of waste were produced for the 140 procedures, amongst which 514kg of ICW (54.8%) and 423kg of HW (45.2%). The overall median waste weight was 5.9kg (Q1: 4.4, Q3: 8.1), ranging from 1.8kg to 18.3kg. The overall median waste weight for HW was 2.8kg (Q1: 2.5, Q3: 3.4), ranging from 1.8kg to 17.8kg. The overall median waste weight for ICW was 3.8kg (Q1: 2.7, Q3: 4.8), ranging from 0.8kg to 7.2kg. The knee surgeries were responsible for the heaviest waste weight; the least waste-productive procedures were the foot and the carpal tunnel release. The median proportions of ICW varied from 39% for the total knee replacements to 72% for the femoral nails. There was a significant inverse correlation between the total waste weight and the proportion of ICW: r=-0.47, p<10-4. The total median estimated carbon footprint was 4.3KgCO2Eq (Q1: 3.1, Q3: 5.8), ranging from 1.59KgCO2Eq (Q1: 1.5, Q3: 1.8) and 7.07KgCO2Eq (Q1: 6.7, Q3: 8.17). The total median estimated carbon footprint was 3.5KgCO2Eq for ICW (Q1: 2.5, Q3: 4.5) and 0.76KgCO2Eq (Q1: 0.54, Q3: 1.3) for HW. The national median estimated carbon footprint was 10.1 million KgEqCO2 in 2021 for orthopedic surgery. CONCLUSION: Our study revealed that in most cases more than half of the wastes were ICW. The total estimated national carbon footprint for orthopedic procedures was 10 million kilograms. The reduction of the ICW constitutes a cornerstone, as they are responsible for more carbon emissions. LEVEL OF EVIDENCE: III; prospective comparative observational in vivo study.
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INTRODUCTION: The use of cemented stems in elderly patients is associated with the risk of intraoperative embolic complications. Uncemented stems eliminate this risk, but their use is controversial because of the risk of mechanical complications, with estimated subsidence between 3.6 and 30% and periprosthetic fractures between 2.1 and 11% at 6 weeks. A retrospective multicenter comparative study was conducted using a propensity score analysis to evaluate mechanical performances of uncemented stems in femoral neck fractures in elderly patients to (1) compare the risk of mechanical complications and (2) assess the use of metaphyseal-anchored stems for this indication. HYPOTHESIS: There is no difference in the risk of mechanical complications, intraoperatively or postoperatively, between these stems. MATERIALS AND METHODS: We conducted a multicenter retrospective comparative study including 358 uncemented and 313 cemented stems. The mean age was 84.5 years [83.9-85.1]. The inclusion criteria were patients 70 years and older and a follow-up of at least 6 weeks. The primary endpoint was a composite endpoint comprised of stem subsidence≥2mm or periprosthetic fracture (up to 3 months postoperatively). The secondary endpoints were infection, stem subsidence≥2mm, and operative time. These endpoints were analyzed using a propensity score to control confounding factors. A secondary analysis used the same endpoints to compare metaphyseal-anchored (short stems) versus Corail-like stems. RESULTS: After adjusting for the propensity score, we found 11.17% mechanical complications in the uncemented group (n=40, 5.59% subsidence, and 5.59% fractures) versus 13.42% for the cemented group (n=42, 7.99% subsidence, and 5.43% fractures). There was no statistically significant difference between the 2 values (Odds Ratio [OR]=0.64 [95% Confidence Interval [CI]: 0.14-2.85] [p=0.7]). The mortality rate due to cement embolism was 1%. There was no difference in the rate of subsidence (OR=0.55 [95% CI: 0.02-12.5] [p=0.7]), periprosthetic fracture (OR=0.65 [95% CI: 0.13-3.12] [p=0.7]) or infection (OR=0.71 [95% CI: 0.32-1.55] [p=0.4]). However, the operative times were longer in the cemented group (p=0.03 for hemiarthroplasties [mean additional time 16minutes] and p=0.02 for total hip arthroplasties [mean additional time 22minutes]). No difference was observed between the metaphyseal-anchored (short stems) and Corail-like stems regarding operative time, rate of infection, and rate of stem subsidence or periprosthetic fractures. DISCUSSION: This is one of the first studies to highlight cemented stem subsidence when used for femoral neck fractures in elderly patients. Using uncemented stems in this indication is still warranted, especially since they do not bring about more mechanical complications in the first few months. Metaphyseal-anchored short stems seem to give the same results as "standard" stems. However, these findings need to be assessed in the longer term. LEVEL OF EVIDENCE: III; retrospective comparative study.
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Artroplastia de Quadril , Fraturas do Colo Femoral , Prótese de Quadril , Desenho de Prótese , Humanos , Estudos Retrospectivos , Masculino , Feminino , Idoso de 80 Anos ou mais , Fraturas do Colo Femoral/cirurgia , Artroplastia de Quadril/métodos , Idoso , Pontuação de Propensão , Cimentos Ósseos , Cimentação , Fraturas Periprotéticas/cirurgia , Complicações Pós-Operatórias/epidemiologia , Resultado do Tratamento , SeguimentosRESUMO
BACKGROUND: Long-acting antipsychotics (e.g. 1-monthly (PP1M) / 3-monthly (PP3M) injection forms of paliperidone palmitate) have been developed to improve treatment continuation in schizophrenia patients. We aim to assess risk factors of treatment discontinuation of patients on paliperidone palmitate and risperidone microsphere. Additionally, treatment discontinuation between patients with PP1M and PP3M was compared. METHODS: The IQVIA Longitudinal Prescription databases were used. Risk factors of treatment discontinuation were identified by a multilevel survival regression using Cox proportional hazards model. Kaplan Meier analyses were performed by identified significant risk factors. RESULTS: Twenty-five thousand three hundred sixty-one patients (France: 9,720; Germany: 14,461; Belgium: 1,180) were included. Over a one-year follow-up period, a significant lower treatment discontinuation was observed for patients newly initiated on paliperidone palmitate (53.8%) than those on risperidone microspheres (85.4%). Additionally, a significantly lower treatment discontinuation was found for 'stable' PP3M patients (19.2%) than 'stable' PP1M patients (37.1%). Patients were more likely to discontinue when drugs were prescribed by GP only (HR = 1.68, p < 0.001 vs. psychiatrist only) or if they were female (HR = 1.07, p < 0.001), whereas discontinuation decreased with age (31-50 years: HR = 0.95, p = 0.006 and > 50 years: HR = 0.91, p < 0.001 vs. 18-30 years). CONCLUSIONS: This study demonstrates that patients stay significantly longer on treatment when initiated on paliperidone palmitate as compared to risperidone microspheres. It also indicated a higher treatment continuation of PP3M over PP1M. Treatment continuation is likely to be improved by empowering GPs with mental health knowledge and managing patients by a collaborative primary care-mental health model. Further research is needed to understand why females and younger patients have more treatment discontinuation.
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Antipsicóticos , Palmitato de Paliperidona , Adulto , Antipsicóticos/uso terapêutico , Bélgica , Preparações de Ação Retardada/uso terapêutico , Feminino , Humanos , Masculino , Microesferas , Pessoa de Meia-Idade , Fatores de Risco , Risperidona/uso terapêuticoRESUMO
INTRODUCTION: Few studies have examined the relationship between the indication of total hip arthroplasty (THA) and the quality of its technical achievement. Implants mispositioning could happen more frequently while THA is performed on acute proximal femur fracture cases. The purpose of this study was to compare the frontal inclination (FTA) of double-mobility cups (DMC) in patients undergoing THA for hip osteoarthritis or fracture. MATERIALS AND METHODS: This retrospective study included all patients undergoing THA for hip fracture or hip osteoarthritis. The surgical protocol was identical in all patients and included a systematic DMC implantation. In the postoperative period, the FTA was measured on anteroposterior pelvic radiographs and compared between groups. Malposition was defined for FTA values outside the 35°-55° range. RESULTS: The study included 97 patients: 33 men, mean age: 78.8 years, 45 fractures. The misalignment rate was 55% after THA for fracture versus 33% for hip osteoarthritis (p = 0.02). The mean FTA value was 39° for "fracture" and 43° for "hip osteoarthritis" groups (p = 0.052). The risk for hip dislocation, surgical revision for mechanical or infectious cause was identical in both groups. DISCUSSION: Misalignment was more frequent when THA was achieved for an acute proximal femur fracture. Several explanations can be proposed: lesser bone quality, incomplete removal of upper acetabular osteophytes which can lead to excessive horizontalization of the cup and surgical procedure performed by younger surgeons in "fracture group". These misalignments don't cause more mechanical complications in the first months after surgery.
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Artroplastia de Quadril/métodos , Fraturas do Colo Femoral/cirurgia , Prótese de Quadril , Idoso , Idoso de 80 Anos ou mais , Artroplastia de Quadril/efeitos adversos , Artroplastia de Quadril/instrumentação , Feminino , Prótese de Quadril/efeitos adversos , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Resultado do TratamentoRESUMO
OBJECTIVE: Antipsychotics exhibit different profiles of efficacy and safety in patients with schizophrenia. It has recently been reported that the risk of rehospitalization was the lowest with paliperidone palmitate (PP), a long-acting injectable (LAI), when compared with other LAIs (of zuclopenthixol, perphenazine, and olanzapine). We aimed to investigate whether treating patients with PP was also associated with improved real-life treatment persistence. MATERIALS AND METHODS: We conducted a retrospective observational study of the LAI antipsychotics (LAIAs) dispensed in French retail pharmacies. Treatment persistence was defined as the non-discontinuation of LAIAs for ≥ 5 months after LAIA initiation (and was also analyzed by Kaplan-Meier persistence curves). RESULTS: A total of 4,492 patients were included in the study. The persistence rate was significantly greater for LAI-PP (64.5%) than for either LAI haloperidol decanoate (HD) or LAI risperidone microspheres (R) (46.4% and 35.4%, respectively). Multivariate Cox analyses illustrated that LAIA initiation with HD or R significantly increased the risk of discontinuation when compared with PP. CONCLUSION: PP demonstrated a significantly higher persistence rate than HD or R. Moreover, LAIA initiation with HD or R significantly increased the risk of treatment discontinuation relative to PP. Further comparative studies are required to comprehensively determine whether PP has a better efficacy and/or safety profile than other LAIs.
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Antipsicóticos/farmacocinética , Esquizofrenia/tratamento farmacológico , Preparações de Ação Retardada , França , Haloperidol/análogos & derivados , Haloperidol/farmacocinética , Humanos , Injeções , Palmitato de Paliperidona/farmacocinética , Estudos Retrospectivos , Risperidona/farmacocinéticaRESUMO
BACKGROUND: Screw-plates disassembly incidence after pertrochanteric fracture (PF) amounts to 1 and 16% among the elderly population. The main occurrence is early cervical screw cut-out. The population at highest risk of disassembly remains difficult to identify. The correlation between femoral offset loss and disassembly occurrence has never been surveyed. OBJECTIVES: A radiological prognosis score for screw plate disassembly was defined to reflect trochanteric impaction (TI); it was based on a femoral offset ratio. STUDY DESIGN AND METHODS: Our single-centre retrospective case-control study surveyed patients suffering from Dynamic Hip Screw (DHS, Synthes®) disassembly following osteosynthesis of non-pathological osteoporotic PF between 2004 and 2014. All cases were categorised by age and gender and paired to three patients in the control group. The primary endpoint was TI measurement, corresponding to offset loss on the operated hip compared to healthy hip offset and expressed as a percentage. The measurement was done on an immediate postoperative X-ray. The secondary endpoints were tip apex distance (TAD) measurement, Ender and AO classifications, as well as postoperative weight-bearing prescription. RESULTS: Twenty-three cases and 69 controls were surveyed. The case group's average age was 87; 70% of the cases were women. The main disassembly occurrence delay was after 27 days. Average TI was 26% within the patients global group and 12% within the control group (p < 10-5). Over a 21% impaction percentage, disassembly occurrence represents a greater risk: OR = 21.95% CI [5.4-104.3], p < 10-5. Ender 3 type fractures were the most frequent indication for surgery within the case group. Average TAD was 20 mm within the case group, and 17 mm within the control group (p = 0.03). The weight-bearing prescription rate was 52% within the control group and 21% within the case group (p = 0.014). 14.5% of the control group had a TI > 21%. CONCLUSIONS: Using the offset ratio tool, TI measurement was associated with a greater risk of DHS disassembly when it was higher than 21%. The exclusive use of a DHS device does not seem optimal for a TI > 21%. Weight-bearing may be prescribed for all the patients with a TI < 21%, provided good implant positioning is secured.
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Placas Ósseas/efeitos adversos , Parafusos Ósseos/efeitos adversos , Fixação Interna de Fraturas/efeitos adversos , Fraturas do Quadril/cirurgia , Fraturas por Osteoporose/cirurgia , Idoso , Idoso de 80 Anos ou mais , Feminino , Fraturas do Quadril/diagnóstico por imagem , Humanos , Masculino , Fraturas por Osteoporose/diagnóstico por imagem , Prognóstico , Falha de Prótese , Estudos RetrospectivosRESUMO
INTRODUCTION: We have studied the early C-reactive protein (CRP) kinetics after proximal femoral fracture (PFF) surgery and defined a chart of CRP threshold values beyond which early postoperative complications are likely. MATERIALS AND METHODS: We have prospectively followed up a 42-patient cohort for surgical treatment by osteosynthesis or hip arthroplasty, and CRP was dosed at admission, on day 1, day 3, day 5 and then twice weekly for 30 days at the same time as a platelet count control of low molecular weight heparins. Then, we identified postoperative complications (medical complications like infections other than the surgical site, thromboembolic complications, death and surgical complications like surgical site infections, dislocation, haematoma) and established the evolutive profile of CRP in a 'complication' group and a 'no complication' group. We developed a threshold value model for complications detection from our results and compared with Chapman's 500/d formula (d being the postoperative day). RESULTS: CRP in the 'complication' group (20 patients) is on average 19 points higher than the 'no complication' group (22 patients) (p = 0.007). Our model, which corresponds to the formula CRP(d) = e(4.71 - 0.06*d), is valid from day 1 to day 30 and has a threshold value of 105 mg/L at day 1. From day 5, the correlation between our chart and the 500/d chart is 0.84 (p < 10-5). Two successive CRP values strictly above our chart at a 48-h interval have a sensitivity of 65% and a specificity of 85% to detect a postoperative complication while only one CRP value above the chart has a sensitivity and a specificity of 48%. DISCUSSION/CONCLUSION: Early postoperative CRP kinetics of PFF surgical patients can be modelled as a threshold value scale valid between day 1 and day 30. This can be an additional tool in the early detection of postoperative complications, if two CRP values are above the threshold values, without replacing the clinical examination, which remains the 'gold standard'. LEVEL OF EVIDENCE: Prospective observational study.
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Artroplastia de Quadril/efeitos adversos , Proteína C-Reativa/análise , Fixação Interna de Fraturas/efeitos adversos , Fraturas do Quadril/cirurgia , Idoso de 80 Anos ou mais , Proteína C-Reativa/biossíntese , Feminino , Humanos , Masculino , Complicações Pós-Operatórias/sangue , Complicações Pós-Operatórias/metabolismo , Valor Preditivo dos Testes , Estudos ProspectivosRESUMO
PURPOSE/BACKGROUND: The study objective was to compare the impact of being treated by paliperidone palmitate (PP) or risperidone long-acting injection (RLAI) on the length of stay on initial hospitalization, rehospitalization risk, and treatment duration in schizophrenic patients. METHODS: We conducted an observational retrospective cohort study in 43 centers in France, including schizophrenic patients who initiated a treatment by PP or RLAI during initial hospitalization. The follow-up periods started in September 2012 for the RLAI group (median follow-up duration, 233 days) and in June 2013 for the PP group (259 days). Statistical analyses were based on Cox regression models, with propensity score weighting to account for differences in patients' characteristics. FINDINGS/RESULTS: The analysis included 347 patients: 197 in the PP treatment group and 150 in the RLAI group. Compared with patients on RLAI, patients on PP were significantly more likely to have nonpsychiatric comorbidities, to have been on previous antipsychotic therapy, or to have been hospitalized for psychiatric care in the previous year. With regard to length of stay on initial hospitalization, there was no statistically significant difference between both groups (hazard ratio, 1.13 [0.97; 1.31]). Being on PP was associated with similar times to first rehospitalization compared with RLAI (hazard ratio, 0.92 [0.65; 1.30]). IMPLICATIONS/CONCLUSIONS: We observed nonsignificant differences in initial hospitalization duration and time to rehospitalization between PP and RLAI, potentially due to lack of statistical power. A trend was observed in favor of PP with regard to time to treatment discontinuation, although this result was compromised by patients who switched between RLAI and PP.
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Antipsicóticos/uso terapêutico , Palmitato de Paliperidona/uso terapêutico , Risperidona/uso terapêutico , Esquizofrenia/tratamento farmacológico , Adulto , Antipsicóticos/administração & dosagem , Estudos de Coortes , Preparações de Ação Retardada , Feminino , Seguimentos , França , Hospitalização/estatística & dados numéricos , Humanos , Injeções , Tempo de Internação , Masculino , Pessoa de Meia-Idade , Palmitato de Paliperidona/administração & dosagem , Estudos Retrospectivos , Risperidona/administração & dosagem , Resultado do TratamentoRESUMO
BACKGROUND: French clinical recommendations suggest prescribing long-acting injectable (LAI) antipsychotics to patients with a maintenance treatment indication in schizophrenia. Despite this, and due to their relatively high acquisition and administration costs, LAIs are still underused in clinical practice in France, thus highlighting the need for pharmacoeconomic evaluations. OBJECTIVE: Our objective was to estimate the cost effectiveness of paliperidone LAI (or paliperidone palmitate), a once-monthly second-generation LAI antipsychotic, compared with the most common antipsychotic medications for the maintenance treatment of schizophrenia in France. METHODS: A Markov model was developed to simulate the progression of a cohort of schizophrenic patients through four health states (stable treated, stable non-treated, relapse and death) and to consider up to three lines of treatment to account for changes in treatment management. Paliperidone LAI was compared with risperidone LAI, aripiprazole LAI, olanzapine LAI, haloperidol LAI (or haloperidol decanoate) and oral olanzapine. Costs, quality-adjusted life-years (QALYs) and number of relapses were assessed over 5 years based on 3-month cycles with a discount rate of 4% and from a French health insurance perspective. Patients were considered to be stabilised after a schizophrenic episode and would enter the model at an initiation phase, followed by a prevention of relapse phase if successful. Data (e.g. relapse or discontinuation rates) for the initiation phase came from randomised clinical trials, whereas relapse rates in the prevention phase were derived from hospitalisation risks based on real-life French data to capture adherence effects. Safety and utility data were derived from international publications. Additionally, costs were retrieved from French health insurance databases and publications. Finally, expert opinion was used for validation purposes or in case of gaps in data. The robustness of results was assessed through deterministic and probabilistic sensitivity analyses. RESULTS: All LAI antipsychotics were found to have similar costs over 5 years: approximatively 55,000, except for paliperidone LAI which had a discounted cost of 50,880. Oral olanzapine was less costly than LAIs (i.e. 50,379 after 5 years) but was associated with fewer QALYs gained and relapses avoided. Paliperidone LAI dominated aripiprazole LAI, olanzapine LAI and haloperidol LAI in terms of costs per QALY, and it was associated with slightly fewer QALYs when compared with risperidone LAI (i.e. 3.763 vs 3.764). This resulted in a high incremental cost-effectiveness ratio (ICER) (i.e. 4,770,018 per QALY gained) for risperidone LAI compared with paliperidone LAI. Paliperidone LAI was more costly than olanzapine oral but associated with more QALYs (i.e. ICER of 2411 per QALY gained for paliperidone LAI compared with oral olanzapine). Paliperidone LAI had a probability of being the optimal strategy in more than 50% of cases for a willingness-to-pay threshold of 8000 per QALY gained. CONCLUSION: This analysis, to the best of our knowledge, is the first of its kind to assess the cost effectiveness of antipsychotics based on French observational data. Paliperidone LAI appeared to be a cost-effective option in the treatment of schizophrenia from the French health insurance perspective.
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Análise Custo-Benefício , Palmitato de Paliperidona/economia , Palmitato de Paliperidona/uso terapêutico , Esquizofrenia/tratamento farmacológico , Esquizofrenia/economia , Antipsicóticos/efeitos adversos , Antipsicóticos/economia , Antipsicóticos/uso terapêutico , Preparações de Ação Retardada/efeitos adversos , Preparações de Ação Retardada/economia , Preparações de Ação Retardada/uso terapêutico , Custos de Medicamentos , França , Custos de Cuidados de Saúde/estatística & dados numéricos , Humanos , Cadeias de Markov , Modelos Estatísticos , Palmitato de Paliperidona/efeitos adversos , Anos de Vida Ajustados por Qualidade de Vida , RecidivaRESUMO
BACKGROUND: Highly active antiretroviral therapy (HAART) has greatly enhanced HIV management, lowering the risk of clinical disease progression and death by substantially improving HIV-induced immune deficiency. Lower CD4 cell counts have consistently been associated with higher direct costs of HIV patient care. The aim of this study was to analyze HIV costs of care in France at different levels of HIV-induced immune deficiency (as measured by the CD4 cell count) using recent data from treatment-experienced patients. METHODS: This analysis used data from the French Hospital Database in HIV, containing data on approximately 50% of the French HIV population. Patients were included in the analysis if they had visited a participating centre from 2003 to 2005, had CD4 cell counts determined at least twice during the study period, and had been prescribed at least two nucleoside reverse transcriptase inhibitors, one non-nucleoside reverse transcriptase inhibitor and two protease inhibitors since their first consultation. Resources consumed were counted and aggregated according to the CD4 cell count level. Standard costs were applied. RESULTS: Periods with the lowest CD4 cell counts were associated with increased prescription rates of antiviral agents (other than anti-HIV agents), antiparasitic drugs and antimycobacterial agents. Antiretroviral treatments accounted for 80% of all medications prescribed during the study period. Hospitalization rates decreased with increasing CD4 cell counts, with 0.72 hospitalizations per patient-year for those with CD4 cell counts of 50 cells/mm³ or less compared with 0.05 per patient-year for patients with CD4 cell counts greater than 500 cells/mm³. There was a clear trend towards lower mean healthcare costs per patient-year with decreasing immune deficiency; from 34,286 to 12,361. CONCLUSIONS: Our study showed an association between the degree of HIV-induced immune deficiency (measured by CD4 cell count) and the costs of managing HIV infection among highly pre-treated, HIV-infected individuals in France in the HAART era.
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Fármacos Anti-HIV/economia , Custos de Medicamentos , Infecções por HIV/tratamento farmacológico , Infecções por HIV/economia , Recursos em Saúde , Síndrome da Imunodeficiência Adquirida/tratamento farmacológico , Síndrome da Imunodeficiência Adquirida/economia , Síndrome da Imunodeficiência Adquirida/virologia , Adulto , Fármacos Anti-HIV/uso terapêutico , Terapia Antirretroviral de Alta Atividade , Contagem de Linfócito CD4 , Progressão da Doença , Feminino , França , HIV/fisiologia , Infecções por HIV/imunologia , Infecções por HIV/virologia , Humanos , Masculino , Carga ViralRESUMO
BACKGROUND: A key element for payers in the assessment of the economic profile of a medication is its anticipated impact on the evolution of healthcare budgets. OBJECTIVES: To forecast the impact of the use of darunavir with low-dose ritonavir 600/100 mg twice a day (bid) in highly treatment-experienced, HIV-infected adults who have failed one or more protease inhibitor (PI)-containing regimen on the budget of the French Sickness Fund (French healthcare system) over a 3-year time horizon. METHODS: A transition state model based on disease severity was developed that compared the evolution of antiretroviral and non-antiretroviral-related direct costs of care in the target population over 3 years (2007-2009) under two scenarios: (1) darunavir enters the French market in year 1; (2) darunavir is not available to the target population during 2007-2009. Model inputs were derived from a targeted analysis of the French hospital database in HIV, the darunavir POWER 1 and 2 trials and other relevant clinical studies. RESULTS: In the scenario where darunavir was available from year 1, the proportion of patients in the lower, more costly CD4 cell count strata (≤ 100 cells per mm³) was consistently lower than in the scenario without darunavir in each year of the model (17.0% vs 19.2%, 13.9% vs 18.3% and 10.8% vs 16.8% for years 1, 2 and 3, respectively). As a result, over the entire 3-year period, the net increase of antiretroviral drug costs (+ 5.6 million Euros; ), resulting from the substitution of older, cheaper PIs by darunavir, is expected to be fully compensated by savings in hospitalization costs (-9.7 million) and expenditures for other HIV-related (non-antiretroviral) medications (-7.3 million), leading to a net saving of 11.4 million or 2.9% of the total budget in the scenario without darunavir. Various sensitivity analyses confirmed these projected savings. CONCLUSION: The use of darunavir/ritonavir (DRV/r) 600/100 mg bid, in combination with other antiretroviral agents, in highly pre-treated, HIV-infected adults who have failed one or more PI-containing highly active antiretroviral therapy regimen is not expected to increase the budget of the French healthcare system, in comparison with a scenario without darunavir. Further research is needed to estimate the budget impact of the use of DRV/r in less treatment-experienced, HIV-infected individuals in France.