Efecto de la terapia antiretroviral de gran actividad (TARGA) en pacientes enrolados en un Hospital Público en Lima-Perú.  <span class="so-article-trans-title" dir="auto"> Translated title: Effectiveness of highly active antiretroviral therapy (HAART) on HIV patients treated in a public hospital in Lima, Peru. </span>

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Abstract

Introducción: En mayo del 2004, el Ministerio de Salud (MINSA) en colaboración con el Fondo Global de lucha contra el SIDA, la tuberculosis y la malaria implementó el programa nacional (PN) para brindar terapia antiretroviral en forma gratuita a todos los pacientes infectados con el VIH con indicación de tratamiento de acuerdo a la guía del PN. Objetivos: Describir las características pre-tratamiento antiretroviral, respuesta a la terapia antiretroviral de gran actividad (TARGA), toxicidad y tasa de mortalidad de la población de pacientes que iniciaron TARGA a través del PN en un hospital general. Material y Métodos: Revisamos las historias clínicas, fichas médicas, resultados de laboratorio y tarjetas de TARGA de todos los pacientes enrolados en el PN en el Hospital Nacional Cayetano Heredia (HNCH) y describimos las características pre-tratamiento antiretroviral, respuesta a la TARGA, toxicidad y tasa de mortalidad. Los pacientes seleccionados para este estudio fueron sujetos infectados con el VIH que: (i) tenían 18 años o más; (ii) iniciaron TARGA en el PN entre mayo 2004 y abril 2006; y (iii) no habían recibido terapia antiretroviral anteriormente (naïve). Se consideró como éxito virológico a la presencia de por lo menos un valor de carga viral indetectable (VIH-1 ARN < 400 copias/mL) entre los 3-6 meses posteriores al inicio de la TARGA. Resultados: Se incluyeron en el estudio a 453 pacientes: 68% fueron varones, la edad promedio fue 35,7 ± 9,5 años y el peso fue 55,6 ± 10,8 Kg. El valor medio de CD4 pre-tratamiento fue 98 células/mm3 y el de carga viral fue 278 438 VIH-1 ARN copias/mL. Descontinuaron el tratamiento 84 pacientes (22 abandonaron, 59 fallecieron y 3 fueron transferidos a otra institución). Aquellos que continuaron fueron seguidos en promedio 337 días; el 38% (142/369) interrumpió temporalmente la TARGA, principalmente debido a toxicidad medicamentosa (82%). Se obtuvo éxito virológico en 85% de los pacientes. La mortalidad fue 13% y el 74% de las muertes ocurrió antes de los 3 meses de tratamiento. Conclusión: A pesar de una elevada frecuencia de interrupción del tratamiento, nuestros resultados muestran que la respuesta a las medicinas distribuidas por el PN es comparable a la reportada por programas de otros países. Es necesario realizar más estudios que evalúen la respuesta al tratamiento antiretroviral a largo plazo en el Perú. (Rev Med Hered 2007;18:184-191).

Translated abstract

In May 2004, the Peruvian Ministry of Health in collaboration with the Global Fund to fight AIDS, tuberculosis and malaria, implemented a national program (NP) to provide highly active antiretroviral therapy (HAART) free of charge to all HIV-infected patients who fulfilled the NP’s guidelines. Objective: To evaluate the efficacy, safety and impact on mortality of HAART on HIV patients of a public hospital. Material and methods: We reviewed medical records, medical files, laboratory results and HAART charts of all patients enrolled within the NP at the Hospital Nacional Cayetano Heredia and described pre-treatment characteristics, response to HAART, toxicity and mortality rates. Study subjects were confirmed HIV-infected individuals who: (i) were > 18 years of age; (ii) started HAART under the NP between May 2004 and April 2006, and (iii) were naïve for antiretroviral treatment. Successful virological response was defined as at least one undetectable viral load (HIV-1 RNA < 400 copies/mL) determination 3 to 6 months after the initiation of HAART. Results: A total of 453 patients were included in the study: 68% were male; the mean age was 35.7 ±9.5 years and mean body weight was 55.6±10.8 Kg. Mean baseline CD4 cell count was 98 cells/mm3 and viral load was 278,438 copies/mL. Eighty-four patients discontinued HAART (22 abandoned treatment, 59 died and 3 were transferred to another institution). For those who continued HAART, the mean follow-up time was 337 days; 38% (142/369) temporarily interrupted HAART mainly due to drug toxicity (82%). Successful virological response was achieved in 85% of patients. Overall mortality was 13% and 74% of deaths occurred within the first 3 months of treatment. Conclusion: Despite of a high frequency of treatment interruption, our results show that the response to drugs provided by the NP is comparable to that reported by programs in other countries. Further studies should be performed to evaluate long-term outcome of HAART in Peru. (Rev Med Hered 2007;18:184-191).

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Most cited references 28

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Patrice Sévère, Paul S Leger, Macarthur Charles … (2005)

The one-year survival rate of adults and children with the acquired immunodeficiency syndrome (AIDS), without antiretroviral therapy, has been about 30 percent in Haiti. Antiretroviral therapy has recently become available in Haiti and in other developing countries. Data on the efficacy of antiretroviral therapy in developing countries are limited. High rates of coinfection with tropical diseases and tuberculosis, along with malnutrition and limited laboratory monitoring of therapy, may decrease the efficacy of antiretroviral therapy in these countries. We studied the efficacy of antiretroviral therapy in the first 1004 consecutive patients with AIDS and without previous antiretroviral therapy who were treated beginning in March 2003 in Port-au-Prince, Haiti. During a 14-month period, three-drug antiretroviral therapy was initiated in 1004 patients, including 94 children under 13 years of age. At enrollment, the median CD4 T-cell count in adults and adolescents was 131 per cubic millimeter (interquartile range, 55 to 211 per cubic millimeter); in children, a median of 13 percent of T cells were CD4-positive (interquartile range, 8 to 20 percent). According to a Kaplan-Meier survival analysis, 87 percent of adults and adolescents and 98 percent of children were alive one year after beginning treatment. In a subgroup of 100 adult and adolescent patients who were followed for 48 to 56 weeks, 76 patients had fewer than 400 copies of human immunodeficiency virus RNA per milliliter. In adults and adolescents, the median increase in the CD4 T-cell count from baseline to 12 months was 163 per cubic millimeter (interquartile range, 77 to 251 per cubic millimeter). In children, the median percentage of CD4 T cells rose from 13 percent at baseline to 26 percent (interquartile range, 22 to 36 percent) at 12 months. Treatment-limiting toxic effects occurred in 102 of the 910 adults and adolescents (11 percent) and 5 of the 94 children (5 percent). This report documents the feasibility of effective antiretroviral therapy in a large number of patients in an impoverished country. Overall, the outcomes are similar to those in the United States. These results provide evidence in support of international efforts to make antiretroviral therapy available to patients with AIDS in developing countries. Copyright 2005 Massachusetts Medical Society.

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Mortality of HIV-1-infected patients in the first year of antiretroviral therapy: comparison between low-income and high-income countries.

Paolo Miotti, Mauro Schechter, David R Bangsberg … (2006)

Highly active antiretroviral therapy (HAART) is being scaled up in developing countries. We compared baseline characteristics and outcomes during the first year of HAART between HIV-1-infected patients in low-income and high-income settings. 18 HAART programmes in Africa, Asia, and South America (low-income settings) and 12 HIV cohort studies from Europe and North America (high-income settings) provided data for 4810 and 22,217, respectively, treatment-naïve adult patients starting HAART. All patients from high-income settings and 2725 (57%) patients from low-income settings were actively followed-up and included in survival analyses. Compared with high-income countries, patients starting HAART in low-income settings had lower CD4 cell counts (median 108 cells per muL vs 234 cells per muL), were more likely to be female (51%vs 25%), and more likely to start treatment with a non-nucleoside reverse transcriptase inhibitor (NNRTI) (70%vs 23%). At 6 months, the median number of CD4 cells gained (106 cells per muL vs 103 cells per muL) and the percentage of patients reaching HIV-1 RNA levels lower than 500 copies/mL (76%vs 77%) were similar. Mortality was higher in low-income settings (124 deaths during 2236 person-years of follow-up) than in high-income settings (414 deaths during 20,532 person-years). The adjusted hazard ratio (HR) of mortality comparing low-income with high-income settings fell from 4.3 (95% CI 1.6-11.8) during the first month to 1.5 (0.7-3.0) during months 7-12. The provision of treatment free of charge in low-income settings was associated with lower mortality (adjusted HR 0.23; 95% CI 0.08-0.61). Patients starting HAART in resource-poor settings have increased mortality rates in the first months on therapy, compared with those in developed countries. Timely diagnosis and assessment of treatment eligibility, coupled with free provision of HAART, might reduce this excess mortality.