Efficacy and safety of oral alitretinoin as treatment for chronic hand eczema in France: a real-life open-label study.

BACKGROUND: Chronic hand eczema is an inflammatory dermatosis that results in a significant psychological and socio-economic burden. Alitretinoin (AL) is indicated in adults with severe chronic hand eczema (sCHE) unresponsive to potent topical corticosteroids. OBJECTIVES: To assess AL effectiveness and safety in patients with sCHE under real-life conditions based on a prospective observational study in France (2010-2014). MATERIALS & METHODS: Clinical severity was assessed using Physician Global Assessment (PGA) and Modified Total Lesion Symptom Score (mTLSS) and quality of life by Skindex and visual analogue scales. Patients were treated with AL for 12-24 weeks and followed for 24 months. Responders were patients with clear/almost clear skin based on PGA at the end of treatment and the primary outcome was remission (clear, almost clear, or mild skin) at one and two years after treatment. RESULTS: A total of 394 patients with severe or moderate PGA were included in the study by 109 dermatologists. AL treatment duration was 5.4 ± 4.1 months (mean ± SD) and 112/274 patients evaluated at the end of treatment were responders. Of the 112 responders, 41/51 evaluable patients were in remission after one year and 36/46 after two years. At the end of treatment, Skindex improved from 48.8 ± 18.1% to 27.1 ± 23.2%. Among the 112 responders, 68/84 did not relapse (mTLSS increased >75% from baseline). The most common adverse events were headache (24%) and dyslipidaemia (4%). CONCLUSIONS: This study supports a positive benefit/risk profile for AL for sCHE patients unresponsive to topical corticosteroids.

Cost-effectiveness of dolutegravir/abacavir/lamivudine in HIV-1 treatment-Naive (TN) patients in France.

BACKGROUND: To evaluate the cost-effectiveness of an integrase inhibitor (INI), dolutegravir (DTG), in combination with abacavir (ABC)/lamivudine (3TC) in France, in treatment-naive (TN) HIV adult patients. METHODS: The ARAMIS microsimulation Markov model, evaluates costs and effects of DTG vs. first-line ARVs options including INIs (raltegravir, elvitegravir/c), protease inhibitors (PIs) (darunavir/r, atazanavir/r, lopinavir/r), non-nucleoside reverse transcriptase inhibitors (efavirenz and rilpivirine). Efficacy and safety data were derived from phase III studies and network meta-analysis. Treatment algorithms were based on French guidelines and experts opinion. Costs included routine HIV and opportunistic infection care, and death. RESULTS: The model showed the fixed-dose combination DTG/ABC/3TC was more effective than all other recommended regimens: patients stayed longer on first-line, and lived longer and healthier. With the exception of EFV, DTG/ABC/3TC was more efficacious and less costly compared to all strategies. The cost per QALY gained (ICER) for DTG compared to EFV was €6,939. DTG/ABC/3TC was more efficacious and less costly compared to INIs and PIs in all deterministic sensitivity analyses. CONCLUSION: DTG/ABC/3TC was cost-effective in the management of HIV TN patients in France. These results are mainly explained by its lower price compared to other INIs and PIs, DTG's superior efficacy and high barrier to resistance.

Costs associated with hospitalization in HIV-positive patients in France.

OBJECTIVES: To estimate the number of patients hospitalized for HIV-related reasons in France, to describe their characteristics and to estimate hospitalization-associated costs. DESIGN: A retrospective analysis of the French hospital medical information database (Programme de médicalisation des systèmes d'information en médecine, chirurgie, obstétrique et odontologie database). METHODS: Patients hospitalized with HIV in France in 2013 and 2014 were identified in the database through International Classification of Diseases, 10th revision diagnostic codes as well as comorbidities and opportunistic infections. Hospital stays for each patient were extracted over a 12-month period following the initial index hospitalization. Costing was performed from the perspective of national health insurance. Direct costs were attributed from national tariffs for medical acts and expressed in 2016 Euros. RESULTS: During the study period, 70 180 stays, including day (80%) and overnight (20%) hospitalization, of patients with HIV were identified, of which 37 477 stays (by 20 126 patients) were directly related to HIV. In patients with overnight hospitalization, an opportunistic infection was documented in 50% of patients and at least one comorbidity were identified in 85% of patients. The overall estimated total annual cost of hospital stays was &OV0556; 64 126 616 (median annual cost per patient: &OV0556; 545). The median annual per capita cost was &OV0556; 541 for day hospitalization, &OV0556; 7664 for overnight stay with comorbidities and &OV0556; 9059 for overnight stay with opportunistic infections. CONCLUSION: Most patients hospitalized with HIV in France presented an opportunistic infection or at least one comorbidity that contributed to costs of hospitalization. The organization of interfaces between different healthcare providers in hospital and community practice needs to be organized so that comorbidities are identified and managed optimally.

Durability and Effectiveness of Maraviroc-Containing Regimens in HIV-1-Infected Individuals with Virological Failure in Routine Clinical Practice.

INTRODUCTION: Limited data are available on the durability and effectiveness of maraviroc in routine clinical practice. We assessed the durability of maraviroc-containing regimens during a 30-month period, as well as their immunovirological and clinical efficacy, according to viral tropism in treatment-experienced individuals with viral load (VL) >50 copies/ml in the French Hospital Database on HIV. METHODS: Virological success was defined as VL<50 copies/ml, immunological success as a confirmed increase of at least 100 CD4 cells/mm3 measured twice at least one month apart, and clinical failure as hospitalization for a non-AIDS event, an AIDS event, or death. Multivariable Cox regression models adjusted for potential confounders were used to assess the influence of viral tropism on durability, the immunovirological responses, and clinical outcome. RESULTS: 356 individuals started maraviroc with VL>50 copies/ml of whom 223 harbored R5 viruses, 44 non-R5 viruses and 89 viruses of unknown tropism. Individuals with non-R5 viruses were more likely than individuals with R5 viruses to discontinue maraviroc (75% vs 34%, p<0.0001). At 30 months, the estimated rates of virological and immunological success were respectively 89% and 51% in individuals with R5 viruses and 48% and 23% in individuals with non-R5 viruses. In multivariable analysis, non-R5 viruses were associated with a lower likelihood of both virological success (hazard ratio (HR): 0.42; 95% confidence interval (CI), 0.25-0.70) and immunological success (HR: 0.37; 95% CI, 0.18-0.77). No difference in clinical outcome was found between individuals with R5 and non-R5 viruses. The effectiveness of maraviroc-containing regimens in individuals with unknown viral tropism was not significantly different from that in individuals with R5 viruses. A limitation of the study is the absence of genotypic susceptibility score. CONCLUSION: In this observational study, maraviroc-containing regimens yielded high rates of viral suppression and immunological responses in individuals with R5 viruses in whom prior regimens had failed.

Cost-Effectiveness of Dolutegravir in HIV-1 Treatment-Experienced (TE) Patients in France.

OBJECTIVES: To evaluate the cost-effectiveness of a new generation integrase inhibitor (INI), dolutegravir (DTG), in France, in treatment-experienced (TE) and INI-naïve HIV-infected adults with at least two classes resistance compared to raltegravir (RAL), by adapting previously published Anti-Retroviral Analysis by Monte Carlo Individual Simulation (ARAMIS) model. METHODS: ARAMIS is a microsimulation Markov model with a lifetime time horizon and a monthly cycle length. Health states are defined as with or without opportunistic infection and death. In the initial cohort, efficacy and safety data were derived from a phase III study comparing DTG to RAL. Antiretroviral treatment algorithms, accounting for patient history, were based on French guidelines and experts opinion. Costs are mainly including treatment costs, routine HIV and opportunistic infection care, and death. Utilities depend on CD4+ cell count and the occurrence of opportunistic infections. RESULTS: The ARAMIS model indicates in the TE population that DTG compared to RAL over a life time is associated with 0.35 additional quality-adjusted life years (QALY; 10.75 versus 10.41) and additional costs of €7,266 (€390,001 versus €382,735). DTG increased costs are mainly related to a 9.1-month increase in life expectancy for DTG compared with RAL, and consequently a longer time spent on ART. The incremental cost-effectiveness ratio (ICER) for DTG compared with RAL is €21,048 per QALY gained. About 83% and 14% of total lifetime costs are associated with antiretroviral therapy and routine HIV care respectively. Univariate deterministic sensitivity analyses demonstrate the robustness of the model. CONCLUSION: DTG is cost-effective in the management of TE INI naive patients in France, from a collective perspective. These results could be explained by the superior efficacy of DTG in this population and its higher genetic barrier to resistance compared to RAL. These data need to be confirmed with longer-term real life data.