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01-10-2016 | Original Paper

Randomized Controlled Trial: 4 Month versus 6 Month Monitoring of HIV-infected Patients on Highly Active Antiretroviral Therapy

Authors: Sharon Weissman, Sarah Singh, Shana Dykema, R. David Parker

Published in: Journal of Community Health | Issue 5/2016

Abstract

As HIV treatment becomes more widely available and efficacious, and persons with HIV live longer, considerations for the financial and healthcare impact are of important. The best interval for routine HIV monitoring has been identified as area in which gaps in knowledge exist. The goal of this study is to determine the impact of changing scheduled follow up care for persons with HIV from a 4 to 6 months interval. HIV infected adults with a CD4 count ≥250 cells/μl, and an undetectable HIV viral load (VL) by an ultrasensitive assay for at least 1 year were randomized to routine HIV care at either a 4 or 6 months interval. Subjects were monitored for virological failure, adherence and quality of life (QOL). 142 subjects were enrolled and completed study protocol. Two subjects in the 6 months arm developed virological failure, p value = 0.5. There was no difference in adherence, or QOL scores. Subjects in the 4 months arm had higher rates of HIV visits (8.5/100 vs. 5.2/100 person months, p = 0.01) and non-HIV related visits (9.4/100 vs. 6.0/100 person months, p = 0.01) and were more likely to change antiretroviral regimen (34.8 vs. 15.8 %, p = 0.01). Despite strict inclusion criteria in this relatively short follow up time, 2/142 (1.4 %) subjects developed virological failure and many more had transient detectable VL. While not statistically significant a larger study with longer follow up is needed.

Palella, F. J., Delaney, K. M., Moorman, A. C., et al. (1998). Declining morbidity and mortality among patients with advanced human immunodeficiency virus infection. New England Journal of Medicine, 338, 853–860.CrossRefPubMed

Centers for Disease Control and Prevention. HIV Surveillance Report, 2012, Vol. 24. http://www.cdc.gov/hiv/library/reports/surveillance. Published November 2014. Accessed 22 Jan 2015.

Harrison, K. M., Song, R., & Zhang, X. (2010). Life expectancy after HIV diagnosis based on national HIV surveillance data from 25 states, United States. Journal of Acquired Immune Deficiency Syndromes, 53, 124–130.CrossRefPubMed

The Antiretroviral Therapy Cohort Collaboration. (2008). Life expectancy of individuals on combination antiretroviral therapy in high-income countries: A collaborative analysis of 14 cohort studies. Lancet, 372, 293–299.CrossRefPubMedCentral

Cooper, D. A. (2008). Life and death in the cART era. Lancet, 372, 266–267.CrossRefPubMed

Antiretroviral Therapy Cohort Collaboration, Zwahlen, M., Harris, R., May, M., Hogg, R., Costagliola, D., et al. (2009). Mortality of HIV-infected patients starting potent antiretroviral therapy: Comparison with the general population in nine industrialized countries. International Journal of Epidemiology, 38(6), 1624–1633. doi:10.1093/ije/dyp306.

Lohse, N., Hansen, A. E., Pedersen, G., Kronborg, G., et al. (2007). Survival of persons with and without HIV infection in Denmark, 1995–2005. Annals of Internal Medicine, 146, 87–95.CrossRefPubMed

Aberg, J. A., Gallant, J. E., Ghanem, K. G., Emmanuel, P., Zingman, B. S., & Horberg, M. A. (2013). Primary care guidelines for the management of persons infected with HIV: 2013 update by the HIV medicine association of the infectious diseases society of America. Clinical Infectious Diseases, 2014(58), e1–e34.

Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents. Department of Health and Human Services. https://aidsinfo.nih.gov/guidelines/html/1/adult-and-adolescent-treatment-guidelines/0. Accessed 7 July 2015.

10.

Günthard, H. F., Aberg, J. A., Eron, J. J., Hoy, J. F., Telenti, A., Benson, C. A., et al. (2014). Antiretroviral treatment of adult HIV infection: 2014 recommendations of the International Antiviral Society-USA Panel. JAMA, 312, 410–425.CrossRefPubMed

11.

Walensky, R. P., Freedberg, K. A., Weinstein, M. C., & Paltiel, A. D. (2007). Cost-effectiveness of HIV testing and treatment in the United States. Clinical Infectious Diseases, 45(Suppl 4), S248–S254.CrossRefPubMedPubMedCentral

12.

Schackman, B. R., Gebo, K. A., Walensky, R. P., Losina, E., Muccio, T., Sax, P. E., et al. (2006). The lifetime cost of current human immunodeficiency virus care in the United States. Medical Care, 44(11), 990–997.CrossRefPubMed

13.

Buscher, A. L., & Giordano, T. P. (2010). Gaps in knowledge in caring for HIV survivors long-term. JAMA, 304, 340–341.CrossRefPubMed

14.

Reekie, J., Mocroft, A., Sambatakou, H., EuroSIDA Study Group, et al. (2008). Does less frequent routine monitoring of patients on a stable, fully suppressed cART regimen lead to an increased risk of treatment failure? AIDS, 22, 2381–2390.CrossRefPubMed

15.

Goetz, M. B., Ferguson, M. R., Han, X., McMillian, G., et al. (2006). Evolution of HIV resistance mutations in patients maintained on a stable treatment regimen after virologic failure. Journal of Acquired Immune Deficiency Syndromes, 43, 541–549.PubMedPubMedCentral

16.

Kendall, M. A., Andersen, J. W., & van Der, H. C. (2006). A reduced frequency visit schedule underreports adverse events that resulted in dose modification or treatment discontinuations in HIV/AIDS clinical trials: ACTG DACS 207. Contemporary Clinical Trials, 27, 287–294.CrossRefPubMed

17.

Julian, F. S., Martin, P., & Erickson, S. R. (2010). Validation of the special projects of national significance adherence tool in HIV/AIDS patients. The Annals of Pharmacotherapy, 44, 1003–1009.CrossRefPubMed

18.

Medical outcomes study HIV health survey (MOS-HIV). John Hopkins Bloomberg School of Public Health. http://www.jhsph.edu/mos-hiv/scoring.html.

19.

Norman, P., Bennett, P., Smith, C., & Murphy, S. (1998). Health locus of control and health behaviour. Journal of Health Psychology, 3(2), 171–180.CrossRefPubMed

20.

Bonner, K., Mezochow, A., Roberts, T., Ford, N., & Cohn, J. (2013). Viral load monitoring as a tool to reinforce adherence: A systematic review. JAIDS Journal of Acquired Immune Deficiency Syndromes, 64(1), 74–78.CrossRefPubMed

Title: Randomized Controlled Trial: 4 Month versus 6 Month Monitoring of HIV-infected Patients on Highly Active Antiretroviral Therapy
Authors: Sharon Weissman
Sarah Singh
Shana Dykema
R. David Parker
Publication date: 01-10-2016
Publisher: Springer US
Published in: Journal of Community Health / Issue 5/2016
Print ISSN: 0094-5145
Electronic ISSN: 1573-3610
DOI: https://doi.org/10.1007/s10900-016-0188-4

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Randomized Controlled Trial: 4 Month versus 6 Month Monitoring of HIV-infected Patients on Highly Active Antiretroviral Therapy

Abstract

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Abstract

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