[First antiretroviral therapy regimen in HIV-infected patients. Durability and factors associated with therapy changes]. / Primera pauta de tratamiento antirretroviral en pacientes con infección por el virus de la inmunodeficiencia humana. Durabilidad y factores asociados a su modificación.

AIM: To analyze the durability of the first highly active antiretroviral therapy (HAART) regimen used in naïve HIV-infected patients and the factors leading to therapy changes. METHODS: Multicenter, retrospective study of naïve HIV-infected patients from 5 hospitals in Málaga (southeast Spain), who started HAART between January 1997 and December 2003. The main outcome measure was median time to the first change in the antiretroviral regimen. A descriptive analysis was performed and Kaplan-Meier curves were used to assess durability of the first HAART used. Independent factors associated with durability were evaluated with a Cox multiple regression model. RESULTS: A total of 603 patients started HAART, and 130 (21.6%) remained under the same treatment at the latest evaluation point. Median time on the same HAART was 17.5 months, and reached 24 months when cases of simplification or structured intermittent treatment interruption were excluded from the analysis. HAART had been interrupted in 36% by one-year of follow-up. Toxicity was the main cause of switching therapy (25%), followed by simplification (19%), and virologic failure (15%). Longer durability of HAART was observed in non-nucleoside reverse transcriptase inhibitor (NNRTI) regimens, (P < 0.046; HR, 1.58) and in those with less than 5 pills (P < 0.001; HR, 2.05). CONCLUSION: Median durability of the first HAART was almost one year and a half, and discontinuation was mainly due to toxicity. NNRTI regimens showed longer durability, which could be attributable to a lower pill burden, at least in part.

Primera pauta de tratamiento antirretroviral en pacientes con infección por el virus de la inmunodeficiencia humana. Durabilidad y factores asociados a su modificación / First antiretroviral therapy regimen in HIV-infected patients. Durability and factors associated with therapy changes

OBJETIVOS. Se evaluó la durabilidad de la primera pauta de tratamiento antirretroviral de gran actividad (TARGA) en pacientes sin tratamiento antirretroviral previo infectados por el virus de la inmunodeficiencia humana (VIH) y los factores asociados a su modificación. MÉTODOS. Estudio multicéntrico, retrospectivo, de pacientes con infección por el VIH que iniciaron su primer TARGA entre 1997 y 2003. La variable principal medida fue la durabilidad de la primera pauta de TARGA hasta su cambio. Se realizó estadística descriptiva, curvas de Kaplan-Meier para evaluar la durabilidad y se construyó un modelo de regresión múltiple de Cox para valorar los factores asociados a la durabilidad. RESULTADOS. Iniciaron su primer TARGA 603 pacientes y 130 (21,6%) lo mantuvieron hasta la visita final, con una mediana de duración de 17,5 meses. Un 36% de los pacientes interrumpió el tratamiento antes del año. Cuando se excluyeron las causas “no desfavorables”(simplificación/interrupción estructurada), la mediana de duración aumentó hasta los 2 años. La causa principal del cambio fue la toxicidad (25%), seguida de la simplificación(19%) y el fracaso virológico (15%). Se encontró una mayor durabilidad de las pautas con un inhibidor de la transcriptasa inversa no análogo de nucleósidos (ITINAN)(p < 0,046; hazard ratio [HR], 1,58) y de aquellas con menos de cinco comprimidos (p < 0,001; HR, 2,05).CONCLUSIÓN. La mediana de duración del primer TARGA fue algo menor de 1,5 años y la causa principal del cambio fue la toxicidad. Se constata una mayor durabilidad de las pautas con ITINAN que, al menos en parte, podría explicarse por su menor número de comprimidos (AU)

AIM. To analyze the durability of the first highly active antiretroviral therapy (HAART) regimen used in naïve HIV-infected patients and the factors leading to therapy changes. METHODS. Multicenter, retrospective study of naïve HIV-infected patients from 5 hospitals in Málaga(southeast Spain), who started HAART between January 1997 and December 2003. The main outcome measure was median time to the first change in the antiretroviral regimen. A descriptive analysis was performed and Kaplan-Meier curves were used to assess durability of the first HAART used. Independent factors associated with durability were evaluated with a Cox multiple regression model. RESULTS. A total of 603 patients started HAART, and130 (21.6%) remained under the same treatment at the latest evaluation point. Median time on the same HAART was 17.5 months, and reached 24 months when cases of simplification or structured intermittent treatment interruption were excluded from the analysis. HAART had been interrupted in 36% by one-year of follow-up. Toxicity was the main cause of switching therapy (25%), followed by simplification (19%), and virologic failure (15%). Longer durability of HAART was observed in non-nucleoside reverse transcriptase inhibitor (NNRTI) regimens, (P < 0.046; HR, 1.58) and in those with less than 5 pills (P < 0.001; HR, 2.05).CONCLUSION. Median durability of the first HAART was almost one year and a half, and discontinuation was mainly due to toxicity. NNRTI regimens showed longer durability, which could be attributable to a lower pill burden, at least in part (AU)