Person: Caniglia, Ellen
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Caniglia
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Ellen
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Caniglia, Ellen
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Publication Efavirenz versus boosted atazanavir-containing regimens and immunologic, virologic, and clinical outcomes: A prospective study of HIV-positive individuals(Wolters Kluwer Health, 2016) Cain, Lauren; Caniglia, Ellen; Phillips, Andrew; Olson, Ashley; Muga, Roberto; Pérez-Hoyos, Santiago; Abgrall, Sophie; Costagliola, Dominique; Rubio, Rafael; Jarrín, Inma; Bucher, Heiner; Fehr, Jan; van Sighem, Ard; Reiss, Peter; Dabis, François; Vandenhende, Marie-Anne; Logan, Roger; Robins, James; Sterne, Jonathan A. C.; Justice, Amy; Tate, Janet; Touloumi, Giota; Paparizos, Vasilis; Esteve, Anna; Casabona, Jordi; Seng, Rémonie; Meyer, Laurence; Jose, Sophie; Sabin, Caroline; Hernan, MiguelAbstract Objective: To compare regimens consisting of either ritonavir-boosted atazanavir or efavirenz and a nucleoside reverse transcriptase inhibitor (NRTI) backbone with respect to clinical, immunologic, and virologic outcomes. Design: Prospective studies of human immunodeficiency virus (HIV)-infected individuals in Europe and the United States included in the HIV-CAUSAL Collaboration. Methods: HIV-positive, antiretroviral therapy-naive, and acquired immune deficiency syndrome (AIDS)-free individuals were followed from the time they started an atazanavir or efavirenz regimen. We estimated an analog of the “intention-to-treat” effect for efavirenz versus atazanavir regimens on clinical, immunologic, and virologic outcomes with adjustment via inverse probability weighting for time-varying covariates. Results: A total of 4301 individuals started an atazanavir regimen (83 deaths, 157 AIDS-defining illnesses or deaths) and 18,786 individuals started an efavirenz regimen (389 deaths, 825 AIDS-defining illnesses or deaths). During a median follow-up of 31 months, the hazard ratios (95% confidence intervals) were 0.98 (0.77, 1.24) for death and 1.09 (0.91, 1.30) for AIDS-defining illness or death comparing efavirenz with atazanavir regimens. The 5-year survival difference was 0.1% (95% confidence interval: −0.7%, 0.8%) and the AIDS-free survival difference was −0.3% (−1.2%, 0.6%). After 12 months, the mean change in CD4 cell count was 20.8 (95% confidence interval: 13.9, 27.8) cells/mm3 lower and the risk of virologic failure was 20% (14%, 26%) lower in the efavirenz regimens. Conclusion: Our estimates are consistent with a smaller 12-month increase in CD4 cell count, and a smaller risk of virologic failure at 12 months for efavirenz compared with atazanavir regimens. No overall differences could be detected with respect to 5-year survival or AIDS-free survival.Publication When to Monitor CD4 Cell Count and HIV RNA to Reduce Mortality and AIDS-Defining Illness in Virologically Suppressed HIV-Positive Persons on Antiretroviral Therapy in High-Income Countries: A Prospective Observational Study(JAIDS Journal of Acquired Immune Deficiency Syndromes, 2016) Caniglia, Ellen; Sabin, Caroline; Robins, James; Logan, Roger; Cain, Lauren; Abgrall, Sophie; Mugavero, Michael J.; Hernandez-Diaz, Sonia; Meyer, Laurence; Seng, Remonie; Drozd, Daniel R.; Seage, George; Bonnet, Fabrice; Dabis, Francois; Moore, Richard R.; Reiss, Peter; van Sighem, Ard; Mathews, William C.; del Amo, Julia; Moreno, Santiago; Deeks, Steven G.; Muga, Roberto; Boswell, Stephen L.; Ferrer, Elena; Eron, Joseph J.; Napravnik, Sonia; Jose, Sophie; Phillips, Andrew; Olson, Ashley; Justice, Amy C.; Tate, Janet P.; Bucher, Heiner C.; Egger, Matthias; Touloumi, Giota; Sterne, Jonathan A.; Costagliola, Dominique; Saag, Michael; Hernan, MiguelObjective: To illustrate an approach to compare CD4 cell count and HIV-RNA monitoring strategies in HIV-positive individuals on antiretroviral therapy (ART). Design: Prospective studies of HIV-positive individuals in Europe and the USA in the HIV-CAUSAL Collaboration and The Center for AIDS Research Network of Integrated Clinical Systems. Methods: Antiretroviral-naive individuals who initiated ART and became virologically suppressed within 12 months were followed from the date of suppression. We compared 3 CD4 cell count and HIV-RNA monitoring strategies: once every (1) 3 ± 1 months, (2) 6 ± 1 months, and (3) 9–12 ± 1 months. We used inverse-probability weighted models to compare these strategies with respect to clinical, immunologic, and virologic outcomes. Results: In 39,029 eligible individuals, there were 265 deaths and 690 AIDS-defining illnesses or deaths. Compared with the 3-month strategy, the mortality hazard ratios (95% CIs) were 0.86 (0.42 to 1.78) for the 6 months and 0.82 (0.46 to 1.47) for the 9–12 month strategy. The respective 18-month risk ratios (95% CIs) of virologic failure (RNA >200) were 0.74 (0.46 to 1.19) and 2.35 (1.56 to 3.54) and 18-month mean CD4 differences (95% CIs) were −5.3 (−18.6 to 7.9) and −31.7 (−52.0 to −11.3). The estimates for the 2-year risk of AIDS-defining illness or death were similar across strategies. Conclusions: Our findings suggest that monitoring frequency of virologically suppressed individuals can be decreased from every 3 months to every 6, 9, or 12 months with respect to clinical outcomes. Because effects of different monitoring strategies could take years to materialize, longer follow-up is needed to fully evaluate this question.Publication Dynamic Monitoring Strategies for HIV-Positive Individuals(2016-04-25) Caniglia, Ellen; Hernan, Miguel A.; Robins, James M.; Seage III, George R.; Hernandez-Diaz, SoniaThe benefits of immunologic and virologic monitoring for the management of HIV-positive individuals are well established. However, the optimal frequency with which CD4 cell count and HIV RNA should be monitored remains unknown. In this dissertation, we use observational data from two collaborations of prospective cohort studies from high-income countries to estimate the effect of CD4 cell count and HIV RNA monitoring strategies on clinical, virologic, and immunologic outcomes in virologically suppressed HIV-positive patients. In Chapter 1, we compare three CD4 cell count and HIV-RNA monitoring strategies applied to virologically suppressed individuals on combined antiretroviral therapy (cART) without AIDS: once every (i) 3±1 months, (ii) 6±1 months, and (iii) 9-12 ±1 months. We find that monitoring frequency can be decreased from every 3 months to every 6, 9, or 12 months in the short term with respect to clinical outcomes. In Chapter 2, we compare strategies corresponding to three CD4 cell count thresholds at which monitoring frequency is decreased from every 3-6 months to every 9-12 months: 200 cells/µl, 350 cells/µl, and 500 cells/µl. We find that decreasing monitoring from every 3-6 months to every 9-12 months while CD4 cell count>200 cells/µl does not worsen the short-term clinical and immunologic outcomes of HIV-positive, virologically suppressed individuals on cART without AIDS. Our estimates also suggest that decreasing monitoring frequency when CD4 cell count>200 cells/µl compared with when CD4 cell count>500 cells/µl may result in an increased risk of virologic failure at 24 months of follow-up. In Chapter 3, we compare joint monitoring and treatment switching strategies. The strategies expand on those described in Chapter 2 by including two HIV-RNA threshold at which individuals should switch to a new antiretroviral regimen: 200 copies/ml and 1,000 copies/ml. We find that the studied monitoring-switching strategies have little impact on the short-term clinical outcomes of HIV-positive individuals on cART. In summary, we illustrate an approach to compare monitoring strategies in HIV-positive individuals, and provide estimates of the comparative effectiveness of strategies used in clinical practice. Since effects of different monitoring strategies could take years to materialize, longer follow-up is needed to fully evaluate this question.