Original article
Reasons for noncompliance with the national guidelines for initial antiretroviral therapy of HIV-infected patients in Spain, 2010–2015Razones para no cumplir las recomendaciones de las guías de práctica clínica en el tratamiento antirretroviral inicial de pacientes con infección por VIH en España, 2010-2015

https://doi.org/10.1016/j.eimc.2019.02.007Get rights and content

Abstract

Introduction

Our aims were to investigate the adherence to national guidelines of initial antiretroviral therapy (ART) in the Spanish multicenter CoRIS cohort during the years 2010–2015, to identify the reasons for the prescription of nonrecommended treatments, and to explore the role of institutional constraints to guideline compliance.

Methods

ART regimens were classified as recommended, alternative or nonrecommended according to the guidelines. Physicians were asked the reasons for prescribing nonrecommended regimens. Factors associated with the prescription of non recommended regimens were assessed using multivariable logistic regression.

Results

During the study period, 586 (10.7%) of 5479 patients who started ART were given a regimen not recommended in the guidelines. The most frequent reasons for prescribing nonrecommended regimens were: enrolment in clinical trials (43.3%), comorbidities and/or interactions (10.2%), pregnancy (8.7%), and cost (7.7%). Among 37 participating centers, 16 (43%), treating 3561 patients, reported limitations related with the cost of ART, and 20 (54%), treating 1365 patients, reported restrictions for prescribing at least one recommended antiretroviral. In multivariable analysis, a higher risk of receiving nonrecommended regimens was associated with male gender, HIV acquisition by heterosexual transmission, low viral loads, initiation of treatment during the years 2011 to 2015, and initiation of treatment in a center with restricted access to at least one antiretroviral drug.

Conclusions

Compliance to clinical guidelines was high. A high proportion of centres reported cost limitations for ART or restricted access to at least one recommended antiretroviral drug, with a significant impact on the choice of initial regimens.

Resumen

Introducción

Nuestros objetivos fueron investigar la adecuación del tratamiento antirretroviral (TAR) inicial a las guías nacionales en la cohorte multicéntrica española CoRIS durante los años 2010-2015, identificar las razones para la prescripción de pautas no recomendadas y estudiar la influencia de limitaciones institucionales en el cumplimiento de las guías.

Métodos

Se clasificaron las pautas de TAR en recomendadas, alternativas o no recomendadas según las guías de GeSIDA/Plan Nacional sobre el sida. Se preguntaron las razones para haber prescrito pautas no recomendadas a los médicos prescriptores. Se evaluaron los factores asociados a la prescripción de pautas no recomendadas mediante regresión logística multivariable.

Resultados

Durante el periodo de estudio 586 (10,7%) de 5.479 pacientes que iniciaron TAR recibieron una pauta no recomendada. Las razones más frecuentes para prescribir pautas no recomendadas fueron: participación en ensayo clínico (43,3%), comorbilidades y/o interacciones (10,2%), embarazo (8,7%) y coste (7,7%). Entre los 37 centros participantes 16 (43%), que incluían 3.561 pacientes, referían limitaciones en el coste del TAR y 20 (54%), que incluían 1.365 pacientes, referían restricciones para la prescripción de al menos un fármaco recomendado. En el análisis multivariable el riesgo de recibir una pauta no recomendada se asoció a ser varón, adquisición del VIH por vía heterosexual, carga viral baja, inicio del tratamiento durante los años 2011 a 2015 e inicio del tratamiento en un centro con acceso restringido al menos a un antirretroviral.

Conclusiones

El cumplimiento de las guías de TAR fue elevado. Una alta proporción de centros refirieron limitaciones de coste para el TAR o acceso restringido al menos a uno de los fármacos antirretrovirales recomendados; esto último influyó en la elección de pautas no recomendadas.

Introduction

Clinical guidelines for the treatment of HIV-infected patients are developed by many scientific societies and institutional boards and are widely available.1, 2, 3 Despite this, there is little information on the compliance to HIV treatment guidelines and the factors that might influence it.

Studies in different populations have found variable adherence to ART guidelines, ranging from 53 to 83% in the United States4, 5, 6 to over 90% in several European countries.7, 8, 9, 10 The reasons why physicians prescribe antiretroviral drug regimens that are not recommended by the guidelines are not well known. Some studies have tried to identify factors associated with the prescription of nonrecommended regimens.4, 5, 7, 9, 10, 11 However, none of these studies, with the exception of one,9 specifically investigated the reasons for noncompliance to the guidelines among the prescribing physicians.

The Spanish national guidelines for HIV treatment are published jointly by the Spanish AIDS Study Group (GeSIDA) and the National Plan for AIDS (PNS); they are updated annually and are widely known in Spain.12 Only two studies have assessed the adherence to antiretroviral treatment (ART) guidelines in our country in earlier years10, 11: both found a high percentage (over 90%) of compliance to the guidelines for initial ART. However, since both studies were published treatment guidelines have changed substantially, and during the later years cost-containment policies have been implemented in the Spanish healthcare system.13, 14, 15 Whether these changes could have influenced the adherence to the guidelines is not known.

The aims of this study were to investigate the adherence to national guidelines of initial ART in the Spanish CoRIS cohort during the years 2010–2015, to identify the reasons why physicians prescribe treatments that are not recommended by the guidelines, and to explore possible institutional constraints to guideline compliance.

Section snippets

Patients and data collection

Patients were selected from the Cohort of the Spanish AIDS Research Network (CoRIS), which has been described in detail elsewhere.16, 17 CoRIS is a prospective multicentre cohort of HIV-positive treatment-naïve patients aged >13 years, recruited from 42 centres from 13 Autonomous Regions in the Spanish public healthcare system. We included patients who started their first ART from January 2010 to November 2015. Five of the centres did not have any patients starting treatment during the study

Results

During the study period, 5479 patients initiated ART. The clinical and demographic characteristics of the study population are shown in Table 2. Of these patients, 586 (10.7%) received a nonrecommended treatment.

The number and proportion of patients starting ART with a preferred, alternative, and nonrecommended treatment by year of treatment initiation are shown in Fig. 1. The category “alternative treatments” was only used in the guidelines during the years 2010, 2011, 2014 and 2015. Compared

Discussion

In this multicenter Spanish cohort, we have investigated the compliance to the national guidelines for the initial ART during the years 2010 and 2015, and we have explored factors associated with the prescription of nonrecommended treatments. As found in two previous studies in Spain in earlier periods,10, 11 the compliance to the guidelines continues to be high in our cohort, and even higher (over 95%) if we consider patients enrolled in a clinical trial and pregnant women as receiving

Conclusions

In conclusion, our results show a high proportion of initial antiretroviral treatments that comply with national guidelines in recent years in Spain. However, some groups of patients were more likely to receive treatments that were not recommended by the guidelines, such as male patients, those who acquired HIV by heterosexual transmission, those who had low viral loads and those who were treated in hospitals with restricted access to some antiretrovirals. Although we found a high proportion of

Funding

The RIS cohort (CoRIS) is supported by the Instituto de Salud Carlos III through the Red Temática de Investigación Cooperativa en Sida (RD06/006, RD12/0017/0018 and RD16/0002/0006) as part of the Plan Nacional I+D+i and cofinanced by ISCIII-Subdirección General de Evaluación and the Fondo Europeo de Desarrollo Regional (FEDER)”.

Authorship

All authors were involved in the setting up of the cohort and contributed to its design. All authors were involved in data collection. ISG and IJ asked the research question presented in this paper and designed the study. IJ performed the statistical analyses. ISG wrote the first draft of the paper, which was supervised by IJ and SM. All authors were involved in interpretation of the data and commented on interim drafts. All authors have read and approved the final draft.

Conflict of interest

All authors declare that they have no conflict of interest related to this work.

Acknowledgements

This study would not have been possible without the collaboration of all patients, medical and nursery staff and data mangers who have taken part in the Project.

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