Associated factors to virologic result on Highly Active Antiretroviral Therapy (HAART) in 340 naive patients. Medellín - Colombia, 1997 - 2000
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Abstract
Context: Most studies supporting guidelines on HIV/AIDS have been conducted in developed countries. Nevertheless, their applicability on effectiveness of therapies may vary in developing countries, because of different socioeconomic characteristics which can affect therapy responses.
Objective: To measure HAART effectiveness and factors associated with favorable virologic responses after six months of treatment.
Study design: Historical Cohort.
Place: Public Hospital with ambulatory service for HIV/AIDS patients in a developing country (Medellín, Colombia). May 1997 trough May 2000.
Patients: 340 naive patients, over 13 years of age, which began HAART theraphy.
Measurements: The dependent variable was the viral load after six months of therapy, classified as a result either over or below 500 copies/ml. Univariate analysis was conducted using odds ratios for categorical variables and student – t test for quantitative ones. Logistic regression was used in order to identify adjusted risk factors of confounding factors.
Results: 56% of patients reached a viral load of less than 500 copies/ml after six months of therapy. This effectiveness level was obtained for HIV positive and AIDS patients (56.3% and 59.5% respectively) and independently of CD4 T cells level and viral load level before the beginning of the therapy. In the multivariate analysis no – adherence to therapy (OR 51.73 95% CI 21.22 – 126.11) and age below 34 years (OR 3.13 95% CI 1.47 – 6.66) were associated with a viral load higher than 500 copies/ml after six months of therapy. 66.8% of patients reported adherence to therapy and 80.2% of them succeeded with therapy, in non adherent patients 89.9% failed to reach viral load control. Median of CD4 T cells increase was 95 cells/ml and the reduction of viral load was -1.52 Log10 after 6 months of therapy.
Conclusions: Viral load control in naive patients after 6 months of therapy is comparable with cohorts from developed countries and this effect was independent of clinical stage (AIDS or Asymptomatic), CD4 T cells level, or viral load previous to therapy. Ages higher than 34 years and therapy adherence were factors positively associated with viral load control. This study suggests different effect of therapy, than cohorts with a mix of naive and experimented patients. Self reported adherence is associated with virologic load control, for that reason, efforts can be directed to improve this response.
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References
Department of Health and Human Services (DHHS). Guidelines for the use of antiretroviral agents in HIV-infected adults and adolescents. Panel on clinical practices for treatment of HIV infection; Ago 13, 2001 www.hivatis.org
Gulick, R; Mellors,J; Havlir, D; et al. Treatment with indinavir, zidovudine, and lamivudine in adults with HIV infection and prior antiretroviral therapy. N Engl J Med 1997;337:734-39.
Hammer, S; Squires, K; Hughes, M, et al. A controlled trial of two nucleoside analogues plus indinavir in persons with HIV infection and CD4+ cell counts of 200 per cubic millimeter or less. N Engl J Med 1997;337:725-33.
Cameron, DW; Heath-Chiozzi, M; Danner, S; et al. Randomized placebo-controlled trial of ritonavir in advanced HIV-1 disease. The advanced HIV disease ritonavir study group. Lancet 1998;351:543-49.
Murphy E; Collier A; Kalish L; et al. Highly Active Antiretroviral Therapy decrease mortality and morbility in patients with advanced HIVDisease. Ann Intern Med. 2001;135:17-26.
Yamashita T, Phair J, Muñoz A, Margolick J, Detels R, O´Brien S, Mellors J, Wolinsky S, Jacobson L. Immunologic and Virologic response to highly active antiretroviral therapy in the Multicenter AIDS Cohort Study. AIDS 2001,15:735-46.
Mellors JW, Muñoz A, Giorgi JV, et al., Plasma viral load and CD4+ lymphocytes as prognostic markers of HIV-1 infection. Ann Intern Med 1997;126:946-54.
Powderly WG, Saag MS, Chapman S, et al., Predictors of optimal virological response to potent antiretroviral therapy. AIDS 1999;13:1873-80.
Lucas GM, Chaisson RE, Moore RD. Highly active antiretroviral therapy in a large urban clinic: Risk factors for virologic failure and adverse drug reactions. Ann Intern Med 1999;131:81-7.
Ledergerber B, Egger M, Opravil M, et al. Clinical progression and virological failure on highly active antiretroviral therapy in HIV1 patients: A prospective cohort study. Swiss HIV Cohort Study. Lancet 1999;353:863- 68.
Chaisson RE, Keruly JC, Moore RD, Association of initial CD4 cell count and viral load with response to highly active antiretroviral therapy. J Am Med Assoc 2000;284:3128-9.
H. Valdez, M. Lederman, I Woolley, C. Walker, L Vernon, A. Hise, B Gripshover. Human Immunodeficiency Virus 1 Protrease Inhibitors in Clinical Practice. Predictors of virological outcome. Arch Intern Med 1999;159:1771-6.
Grabar S, Le Moing V, Goujard C, et al. Clinical Outcomeome Of Patients With HIV-1 Infection According To Immunologic And Virologic Response After 6 Months Of Highly Active Antiretroviral Therapy. Ann Intern Med. 2000;133:401-10.
Paredes R, Mocrof A, Kirk O. Predictors of virological success and ensuing failure in HIV- Positive Patients Starting Highly Active Antiretroviral Therapy in Europe. Results from the Eurosida study. Arch Intern Med. 2000;160:1123-32.
Mocroft A, Gill Mj, Davidson W, et al. Predictors of a viral response and subsequent virological failure in patients with HIV starting a protease inhibitor. AIDS. 1998;12:2161- 7.
Erb P, Battegay M, Zimmerli W, et al. Effect of antiretroviral therapy on viral load, CD4 cell count, and Progression to Acquired Immunodeficiency Syndrome in a Community Human Immunodeficiency Virus-Infected Cohort. Arch Intern Med 2000;160:1134-40.
Levitz SM. Improvement in CD4 cell count despite persistently detectable HIV load (Letter). N Engl J Med 1998;338:1074-5.
Lepri AC, Miller V, Phillips AN, et al. The virological response to highly active antiretroviral therapy over the first 24 weeks of therapy according to the pre-therapy viral load and the weeks 4-8 viral load. AIDS 2001;15:47-54.
Moreno A, Pérez-Elías MJ, Casado JL, et al. Effectiveness and pitfalls of initial highly active antiretroviral therapy in HIV-infected patients in routine clinical practice. Antiviral Therapy 2000;5:243-8.
Piketty C, Weiss L, Thomas F, et al. Long-term clinical outcome of human immunodeficiency virus-infected patients with discordant immunologic and virologic responses to a protease inhibitor-containing regimen. Journal of Infectious Diseases 2001;183:1328-35.
Paris D, Ledergerber B, Weber R, et al. Incidence and predictors of virologic failure of antiretroviral trple-drug therapy in a community-based cohort. AIDS Research and Human Retroviruses 1999;15:1631-8.
Nieuwkerk PT, Sprangers MA, Burger DM, et al. Limited Patient Adherence to Highly Active Antiretroviral Therapy for HIV-1 Infection in an Observational Cohort Study. Arch Intern Med. 2001;161:1962-8.
Paterson D; Swindells S, Mohr J et al. Adherence to protease inhibitor therapy and outcomes in patients with HIV infection. Annals of Internal Medicine. 2000;133:21- 30.
Liu H, Golin CE, Miller LG, et al. A Comparison Study of Adherence to HIV Protease Inhibitors. Ann Intern Med. 2001;134:968- 77.
Turner BJ, Hecht FM. Improving on a Coin Toss To Predict Patient Adherence to Medications. Ann Intern Med 2001;134:1004- 6.
Havlir DV, Basset R, Levitan D, et al. Prevalence and Predictive Value of Intermittent Viremia with Combination HIV Therapy. JAMA 2001;286:171-9.
Deeks SG. Durable HIV Treatment Benefit Despite Low-Level Viremia. JAMA 2001;286:224-6.
Girard PM, Guiguet M, Bolens D, et al. Long- Term Outcome and Treatment Modifications in a Prospective Cohort of Human Immunodeficiency Virus Type-1- Infected Patients on Triple-Drug Antiretroviral Regimens. Clinical Infectious Diseases 2000;31:987-94.
Deeks SG, Hecht FM, Swanson M, et al. HIV RNA and CD4 cell count response to protease inhibitor therapy in an urban AIDS clinic: response to both initial and salvage therapy. AIDS. 1999;13:35-43.
Tseng AL. Compliance issues in the treatment of HIV infection. American Journal of Health-System Pharmacy 1998;55:1817- 1824.
