Advances in HIV management over the past 20 years have been striking. HIV-infected people receiving one of the many effective and available antiretroviral therapy (ART) regimens can achieve near-normal life expectancy. Despite this progress, nearly three-quarters of those with HIV infection in the US fail to realize the benefits f ART because they have not been tested, linked to and retained in care, or maintained on suppressive therapy. Together, these problems define the challenge of the HIV cascade of care; attrition in any area compromises individual health and leads to further HIV transmission. For those whose HIV is successfully treated, comorbidities, often related to tobacco use and depression, are major contributors to poor outcomes. Important clinical policy questions remain unanswered in all of these areas, and are particularly challenging in the face of increasingly limited resources for HIV care in the US. Beginning in 1997, NIAID has supported our research group in developing and expanding the Cost- Effectiveness of Preventing AIDS Complications (CEPAC) US Model, a computer simulation of the natural history, clinical management, outcomes, costs, and cost-effectiveness of HIV testing and treatment in the United States. This support was continued in 2001 and awarded R37 MERIT status in 2005, with continuation of that MERIT support in 2009. In the last five year cycle, the collaboration produced 27 original papers in peer-reviewed journals, with an additional five manuscripts submitted. In this competing continuation, we propose to expand upon the CEPAC US model, adding innovative modeling methodology and novel applications to address critical questions in HIV/AIDS care. We have three aims:
Specific Aim 1 : To assess the cost-effectiveness and budget impact of novel antiretroviral therapies for HIV-infected patients in care.
Specific Aim 2 : To determine the clinical impact, cost, and cost-effectiveness of strategies to increase the number of HIV-infected people entering and receiving effective care in the US.
Specific Aim 3 : To determine the outcomes and cost-effectiveness of interventions to reduce morbidity from smoking and depression in HIV-infected persons in the US. Our internationally-recognized, multidisciplinary team has an established record of producing leading, high-impact publications and advancing the methods of cost-effectiveness analysis in HIV research. This research has informed HIV care and guidelines, both in the US and internationally. By leveraging the team's achievements over past years and accomplishing the aims described above, the proposed studies clearly align with the 2014 research priorities of the NIH Office of AIDS Research to improve disease outcomes for people living with HIV and to reduce new infections in the US. This work will address critical HIV clinical research and policy questions in the United States over the next five years.

Public Health Relevance

Advances in HIV therapy have dramatically changed the face of the HIV epidemic in the United States. The work proposed here will expand the CEPAC US model, a detailed microsimulation of HIV disease and treatment, to provide an evidence base for evaluating new antiretroviral regimens, novel approaches to HIV testing and adherence to therapy, and management of comorbidities. This research will inform HIV care toward achieving optimal outcomes with available economic resources in the United States.

National Institute of Health (NIH)
National Institute of Allergy and Infectious Diseases (NIAID)
Research Project (R01)
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AIDS Clinical Studies and Epidemiology Study Section (ACE)
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Huebner, Robin E
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Massachusetts General Hospital
United States
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Hyle, Emily P; Fields, Naomi F; Fiebelkorn, Amy Parker et al. (2018) The Clinical Impact and Cost-effectiveness of MMR Vaccination to Prevent Measles Importations among US International Travelers. Clin Infect Dis :
Murray, Eleanor J; Robins, James M; Seage 3rd, George R et al. (2018) Using Observational Data to Calibrate Simulation Models. Med Decis Making 38:212-224
Neilan, Anne M; Dunville, Richard; Ocfemia, M Cheryl BaƱez et al. (2018) The Optimal Age for Screening Adolescents and Young Adults Without Identified Risk Factors for HIV. J Adolesc Health 62:22-28
Freedberg, Kenneth A; Sax, Paul E (2017) Improving on effective antiretroviral therapy: how good will a cure have to be? J Med Ethics 43:71-73
Koullias, Yiannis; Sax, Paul E; Fields, Naomi F et al. (2017) Should We Be Testing for Baseline Integrase Resistance in Patients Newly Diagnosed With Human Immunodeficiency Virus? Clin Infect Dis 65:1274-1281
Parker, Robert A; Rabideau, Dustin J; Sax, Paul E et al. (2017) Impact of Medication Adherence on Virologic Failure in A5202: A Randomized, Partially Blinded, Phase 3B Study. Clin Infect Dis 64:1612-1614
Reddy, Krishna P; Kong, Chung Yin; Hyle, Emily P et al. (2017) Lung Cancer Mortality Associated With Smoking and Smoking Cessation Among People Living With HIV in the United States. JAMA Intern Med 177:1613-1621
Levison, Julie H; Regan, Susan; Khan, Iman et al. (2017) Foreign-born status as a predictor of engagement in HIV care in a large US metropolitan health system. AIDS Care 29:244-251
Linas, Benjamin P; Morgan, Jake R; Pho, Mai T et al. (2017) Cost Effectiveness and Cost Containment in the Era of Interferon-Free Therapies to Treat Hepatitis C Virus Genotype 1. Open Forum Infect Dis 4:ofw266
Borre, Ethan D; Hyle, Emily P; Paltiel, A David et al. (2017) The Clinical and Economic Impact of Attaining National HIV/AIDS Strategy Treatment Targets in the United States. J Infect Dis 216:798-807

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