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Randomized Controlled Trial to Evaluate the Impact of Pharmaceutical Care on Therapeutic Success in HIV-Infected Patients in Southern Brazil

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Abstract

A non-blinded randomized controlled trial evaluated efficacy of pharmaceutical care (PC) (Dáder method) on self-reported antiretroviral adherence and undetectable plasma viral load (UPVL), compared with usual care (UC) in HIV-positive patients in Brazil. Most were male (63 %), mean age 40.3 years (SD = 10). After 12 months, 79.8 % of those receiving PC versus 73.8 % in UC were adherent (RR 1.05, 95 % CI 0.95–1.15, P = 0.35), and 50.3 versus 49.8 % (PC vs. UC, respectively) had UPVL (RR 1.08, 95 % CI 0.97–1.20, P = 0.15). Factors associated with self-reported adherence were regular employment, UPVL, no depressive symptoms, and lower pill load in the treatment regimen. Older age, education, CD4 count <200 cells/mm3, and shorter treatment duration were associated with UPVL. Of 94 reported drug-related problems, 43 % resolved. In subgroup analyses of patients who experienced therapeutic failure and who were non-adherent at the beginning of the trial (N = 50), no differences were found in UPVL (HR 1.35, 95 % CI 0.57–3.19). Only education level (>12 years) was independently predictive of viral suppression (HR 7.47, 95 % CI 1.69–32.91). In conclusion, PC was not associated with increased self-reported adherence to ART or UPVL in patients treated at a health care facility in southern Brazil. The study suggests, however, that PC could be effective for the subgroup of patients with poor adherence.

Resumen

Se evalúo, a través de ensayo clínico abierto, la eficacia de la Atención Farmacéutica (AF) (Método Dáder) sobre la adherencia auto-reportada a la terapia antirretroviral y obtención de carga viral indetectable (CVi), comparada con cuidado habitual (CH), en pacientes HIV-positivos en Brazil. La mayoría fue hombres (63 %), edad media de 40.3 (DP = 10) años. Después de 12 meses, 79.8 % del grupo AF frente 73.8 % en CH estaban adherentes (RR = 1.05, 95 % CI 0.95–1.15, P = 0.35), y 50.3 frente 49.8 % (AF vs. CH, respectivamente) tenían CVi (RR = 1.08, 95 % CI 0.97–1.20, P = 0.15). Los factores asociados con adherencia auto-reportada fueron empleo regular, CVi, sin síntomas depresivos y menor número de comprimidos. Ser mayor, educación, CD4 <200 cel/mm3 y menor duración de tratamiento, se asociaron con CVi. De los 94 problemas relacionados a los medicamentos encontrados, 43 % fueron resueltos. En la análisis de subgrupo con pacientes que habían experimentado fracaso terapéutico y no adhesión al principio del ensayo (N = 50), tampoco se encontró diferencia (HR 1.35, 95 % CI 0.57–3.19). Apenas educación >12 años fue preditor independiente de CVi (HR 7.47, 95 % CI 1.69–32.91). En conclusión, AF no se mostro asociada con aumento de la adherencia auto-reportada o CVi entre los pacientes de este estudio. Entretanto, los resultados sugieren que AF puede ser efectiva para un subgrupo de pacientes con poca adherencia.

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Acknowledgments

This study and its authors (MPTS, AM, KP) received support through the University of California San Francisco from the following grants by the US National Institutes of Health (NIH): Fogarty International Center (FIC) D43TW005799; National Institute for Mental Health (NIMH) P30MH062246, R25MH064712; and the FIC AIDS International Training and Research Program (AITRP) D43TW000003. The content is solely the responsibility of the authors and does not necessarily represent the official views of NIH, NIMH, or FIC. The authors would like to acknowledge the helpful comments from Dr. George Rutherford at UCSF during the preparation of this manuscript. We also wish to thank Dr. Ali Mirzazadeh (Regional Knowledge Hub for HIV/AIDS Surveillance, Kerman University of Medical Sciences, Kerman, Iran), who was a visiting scholar at UCSF Global Health Sciences in 2012 and assisted with the subgroup analyses. In addition, we thank the staff and patients at Serviço de Assistência Especializada em HIV/AIDS de Pelotas, the students at Curso de Farmácia da Universidade Católica de Pelotas who worked on this project, Centro de Estudos em Aids do Rio Grande do Sul (CEARGS), and the Federal University of Bahia (UFBA).

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Authors and Affiliations

  1. Departamento de Fisiologia e Farmacologia, Instituto de Biologia, Universidade Federal de Pelotas (UFPel), Campus Universitário, Capão do Leão, S/N, Caixa Postal 354, Pelotas, Rio Grande do Sul, CEP 96010900, Brazil

    Marysabel Pinto Telis Silveira

  2. Post-graduate Program in Epidemiology, Universidade Federal de Pelotas (UFPel), Pelotas, Brazil

    Marília Cruz Guttier

  3. University of California San Francisco, San Francisco, CA, USA

    Kimberly Page

  4. Department of Pharmacology, Federal University of Rio Grande do Sul, Porto Alegre, Brazil

    Leila Beltrami Moreira

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  1. Marysabel Pinto Telis Silveira
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  2. Marília Cruz Guttier
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  3. Kimberly Page
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  4. Leila Beltrami Moreira
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Correspondence to Marysabel Pinto Telis Silveira.

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Silveira, M.P.T., Guttier, M.C., Page, K. et al. Randomized Controlled Trial to Evaluate the Impact of Pharmaceutical Care on Therapeutic Success in HIV-Infected Patients in Southern Brazil. AIDS Behav 18 (Suppl 1), 75–84 (2014). https://doi.org/10.1007/s10461-013-0596-8

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