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Efficacy of ARV treatment provided through randomized
clinical trials compared to standard of care in Mexico: ideal or real results?
A. López Martínez1, N. O'Brien2, Y. Caro-Vega3, J. Sierra-Madero1, B. Crabtree-Ramírez1
1Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Infectious Diseases Department, Mexico City, Mexico, 2Vanderbilt University School of Medicine, Nashville, United States, 3Instituto Nacional de Salud Pública de México, Cuernavaca, Mexico
Background: The
efficacy of antiretroviral therapy (ARV) is established through clinical trials
(CT), however it is widely recognized that selection bias can favor the results
of such trials and thus limit their applicability to the general HIV
population. Information comparing the efficacy of ARVs in CT vs. standard of
care in constrained resource settings is lacking.
Methods: All
HIV-infected ARV-näive patients who started therapy from 2000- 2008 at the INCMNSZ
HIV clinic were divided into those who started ARV through a clinical trial (CT
group) and through standard of care (NCT group). The main outcome was the proportion
of patients with virologic failure(VF) at week 48; secondary outcomes were
mortality and probability of retention in care. Risk factors associated with VF
and death were analyzed.
Results: Baseline characteristics were different between
CT and NCT respectively: women (5.7 vs. 14.2 %, p=0.005); median age (33 vs. 35
years, p=0.05); weight (64 vs. 62 kg, p=0.04); hemoglobin (14.7 vs. 13.6 gr/dL,
p< 0.01) and CD4+ count (158 vs. 97 cells/mm3,
p=< 0.01). There was a trend toward higher proportion of patients with AIDS
or CD4< 200 cells/mm3 in NCT group (66 vs. 73.7%, p=0.07).
Proportion of patients with VF at year one was similar between groups (CT 22.01
vs. NCT 22.03%, p= 0.99). Death rate during the first year of HAART was 5.6 and
13.6 per 1000 person-days in the CT and NCT group, respectively. There were no differences in the probability
of retention to care at the HIV Clinic between groups.
Conclusions: In our population ARV treatment provided through CT and NCT had similar
rates of virologic failure and retention to care. Patients selected to CT showed
better baseline clinical and immunologic parameters, which may explain a higher
mortality among NCT patients.
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