Document Detail


Using mechanistic models to simulate comparative effectiveness trials of therapy and to estimate long-term outcomes in HIV care.
MedLine Citation:
PMID:  20473184     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND: In HIV care, it is difficult to decide when to initiate therapy, which drugs to use for initial treatment, and which drugs to use if drug resistance develops. With hundreds of possible drug regimens available and variable patterns of drug resistance, randomized controlled trials cannot answer all HIV treatment decisions. Mechanistic models of HIV infection can be used to conduct virtual therapeutic trials with the goal of predicting outcomes, some of which are long-term and may not fall within the time frame of a typical therapeutic trial. METHODS: We used a previously developed and validated model of HIV infection to replicate 2 arms of an HIV initial treatment trial (ACTG A5142) and predict long-term outcomes. The model incorporated data about biologic processes involved in the development of drug resistance. RESULTS: The model reproduced the proportion that developed AIDS (0.04 and 0.05 for the efavirenz arm and lopinavir arms, respectively, vs. 0.04 and 0.06 for the trial), the development of virologic failure (0.27 and 0.33 for the Efavirenz arm and lopinavir arms, respectively, vs. 0.24 and 0.37 for the trial), and drug resistance. The hazard ratio for the time to treatment failure, a combination of resistance and other causes (0.96 for the model vs. 0.75 for the trial; 95% confidence interval, 0.57-0.98), and changes in CD4 cell count, were less accurate. The model estimated longer-term life expectancy, quality-adjusted life expectancy, and HIV-related deaths. CONCLUSIONS: Mechanistic models of HIV infections have the potential to be useful in comparative effectiveness research.
Authors:
Mark S Roberts; Kimberly A Nucifora; R Scott Braithwaite
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Publication Detail:
Type:  Journal Article; Research Support, N.I.H., Extramural    
Journal Detail:
Title:  Medical care     Volume:  48     ISSN:  1537-1948     ISO Abbreviation:  Med Care     Publication Date:  2010 Jun 
Date Detail:
Created Date:  2010-05-20     Completed Date:  2010-06-18     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  0230027     Medline TA:  Med Care     Country:  United States    
Other Details:
Languages:  eng     Pagination:  S90-5     Citation Subset:  IM    
Affiliation:
Department of Health Policy and Management, Graduate School of Public Health, University of Pittsburgh, Pittsburgh, Pennsylvania 15261, USA. mroberts@pitt.edu
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MeSH Terms
Descriptor/Qualifier:
Acquired Immunodeficiency Syndrome / drug therapy,  mortality
Anti-Retroviral Agents / therapeutic use*
CD4 Lymphocyte Count
Clinical Trials as Topic
Comparative Effectiveness Research / methods*,  statistics & numerical data*
Computer Simulation*
Drug Resistance, Viral
HIV Infections / drug therapy*,  mortality
Humans
Life Expectancy
Models, Statistical*
Quality of Life
Time Factors
Treatment Outcome
Grant Support
ID/Acronym/Agency:
R01 AA017385-01/AA/NIAAA NIH HHS; U01 AA013566-06/AA/NIAAA NIH HHS
Chemical
Reg. No./Substance:
0/Anti-Retroviral Agents

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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