Expanded European AIDS case definition

“…Family history of diabetes 17.0 [11] Table I. Baseline characteristics of the cohort simulated in the model 1 If not otherwise specified, standard deviation was calculated to be 10% of the average value 2 N1: Fitted mean and SD to more accurately fit median and IQR; N2: Mean and SD calculated starting from mean and SD subgroups; N3: Fitted mean and SD to more accurately fit median and %<18. …”

Section: Initial Comorbidities (%)mentioning

confidence: 99%

“…-The cost of disease-related adverse events (OIs, neoplasms and TRAEs) was varied by ± 10%. -Two alternative adherence scenarios were considered in the sensitivity analysis: -The increase in adherence due to the STR was set to zero -For adherence data [1], an alternative source was used for the Italian context: 92.4% for patients in suppression, 38.4% for patients who do not achieve suppression and increase in adherence due to the STRs equal to 6.6 % results…”

Section: Sensitivity Analysismentioning

confidence: 99%

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A cost-effectiveness analysis of E/C/F/TAF vs three boosted regimens in the Italian context

Pradelli¹,

Perri

Rizzardini

et al. 2017

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BACKGROUND: Highly Active Antiretroviral Therapy (HAART) has transformed HIV into a lifelong condition. Following the chronicity of the disease, and significant increase in lifespan -the prevalence of comorbidities increased in HIV+ subjects that are exposed both to a higher risk of developing cardiovascular disease, renal disease, osteopenia/osteoporosis and diabetes, and to the risk of developing them early. Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Fumarate (E/C/F/TAF), a complete, Single-Tablet antiretroviral Regimen (STR) that combines the effectiveness and tolerability of integrase inhibitors with an innovative backbone was recently introduced in Italy. Compared to Tenofovir Disoproxil Fumarate (TDF), TAF reaches the sites of action more efficiently, reducing tenofovir plasma concentration to more than 90% and the risk of off-target effects. OBJECTIVE: A patient-level micro-simulation model was adapted to the Italian context to evaluate E/C/F/TAF costeffectiveness vs three boosted regimens for HIV+ patients treatment. METHODS: A Markov micro-simulation model was adapted to the Italian context for the evaluation of the cost-effectiveness in patients with HIV. The total cost per patient accounts for drug therapies and the management of adverse events and comorbidities. The quality-adjusted life expectancy (in QALYs) is calculated by weighing the years of life lived by the utility weights. A 70-year time horizon was adopted to simulate a lifetime analysis; shorter time horizons were considered in the sensitivity analyses. 3.5% discount rate was applied both for costs and future benefits. The rate of virologic suppression at 48 weeks with E/C/F/TAF is 92.3%; for the other treatments such proportion is calculated by applying to the reference rate the relative risks, as calculated in a recent network meta-analysis (NMA). Alternative treatments considered in this analysis are three boosted regimens commonly used in Italy: tenofovir disoproxil fumarate/emtricitabine/elvitegravir/ cobicistat in STR; tenofovir disoproxil fumarate/emtricitabine + darunavir/ritonavir; tenofovir disoproxil fumarate/emtricitabine + atazanavir/ritonavir. RESULTS: E/C/F/TAF improves survival and quality of life (20.17 LY and 14.89 QALY), with the lowest total cost (€ 280,528), thus resulting dominant over three comparators considered as starting therapy. The sensitivity analysis confirms the results of the base case: at a willingness-to-pay threshold of € 30,000 per QALY, the E/C/F/TAF strategy is the most cost-effective, with a 90% probability and it is the most cost-effective even with a threshold of € 10,000 per QALY, with a 50% probability. CONCLUSION: E/C/F/TAF can be a sustainable alternative to currently available treatments, combining the advantage of the STR to lower risks of kidney and bone damage than observed in regimens based on TDF.

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“…Our analysis was restricted to the 4,237 HIV-infected individuals who met the following eligibility criteria: age 18 years or older, antiretroviral therapynaïve, no history of AIDS-defining illness (Ancelle-Park et al, 1993;CDC, 1992), no pregnancy, HIV-RNA >500 copies/mL, CD4 cell count and HIV-RNA measurements within six months of each other, and CD4 cell count between 200 and 500 cells/mm 3 with no history of CD4 cell count less than 500 cells/mm 3 . All analyses were conducted with SAS 9.2 (Cary, North Carolina).…”

Section: Data and Notationmentioning

confidence: 99%

When to Start Treatment? A Systematic Approach to the Comparison of Dynamic Regimes Using Observational Data

Cain¹,

Robins²,

Lanoy³

et al. 2010

The International Journal of Biostatistics

184

259

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Recommended Citation: Cain, Lauren E.; Robins, James M.; Lanoy, Emilie; Logan, Roger; Costagliola, Dominique; and Hernán, Miguel A. (2010) an approach for using observational data to emulate randomized clinical trials that compare dynamic regimes of the form "initiate treatment within a certain time period of some time-varying covariate first crossing a particular threshold." We applied this method to data from the French Hospital database on HIV (FHDH-ANRS CO4), an observational study of HIV-infected patients, in order to compare dynamic regimes of the form "initiate treatment within m months after the recorded CD4 cell count first drops below x cells/mm 3 " where x takes values from 200 to 500 in increments of 10 and m takes values 0 or 3. We describe the method in the context of this example and discuss some complications that arise in emulating a randomized experiment using observational data.

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Expanded European AIDS case definition

Cited by 173 publications

References 1 publication

Differential improvement in survival among patients with AIDS after the introduction of HAART

Differential improvement in survival among patients with AIDS after the introduction of HAART

A cost-effectiveness analysis of E/C/F/TAF vs three boosted regimens in the Italian context

When to Start Treatment? A Systematic Approach to the Comparison of Dynamic Regimes Using Observational Data

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