Original articleReasons 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
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.
References (30)
[Cuts, austerity and health SESPAS report 2014]
Gac Sanit
(2014)- et al.
[Healthcare resources restrictions and human immunodeficiency virus infection]
Med Clin (Barc)
(2013) - et al.
[Spanish cohort of naive HIV-infected patients (CoRIS): rationale, organization and initial results]
Enferm Infecc Microbiol Clin
(2007) - et al.
[The Cohort of the Spanish HIV Research Network (CoRIS) and its associated biobank; organizational issues, main findings and losses to follow-up]
Enferm Infecc Microbiol Clin
(2011) - et al.
Costs and cost-effectiveness analysis of 2015 GESIDA/Spanish AIDS National Plan recommended guidelines for initial antiretroviral therapy in HIV-infected adults
Enferm Infecc Microbiol Clin
(2016) - et al.
[Choice of initial regimen for antiretroviral-naive HIV patients: analysis of motivation]
Rev Med Int
(2016) - et al.
Intensive five-drug antiretroviral therapy regimen versus standard triple-drug therapy during primary HIV-1 infection (OPTIPRIM-ANRS 147): a randomised, open-label, phase 3 trial
Lancet Infect Dis
(2015) - et al.
[Social inequalities in health and primary care SESPAS Report 2012]
Gac Sanit
(2012) Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents
(2016)[Recommendations from the GESIDA/Spanish AIDS Plan regarding antiretroviral treatment in adults with human immunodeficiency virus infection (update January 2007)]
Enferm Infecc Microbiol Clin
(2007)
Documento de consenso de GeSIDA/Plan Nacional sobre el Sida respecto al tratamiento antirretroviral en adultos infectados por el virus de la inmunodeficiencia humana (Actualización enero 2018)
Relationship between antiretroviral prescribing patterns and treatment guidelines in treatment-naive HIV-1-infected US veterans (1992–2004)
J Acquir Immune Defic Syndr
Consistency of initial antiretroviral therapy with HIV treatment guidelines in a US cohort of HIV-infected women
J Acquir Immune Defic Syndr
Medical treatment of women and adherence to HIV guidelines at an urban university-staffed public clinic
J Womens Health (Larchmt)
A comparison of initial antiretroviral therapy in the Swiss HIV Cohort Study and the recommendations of the International AIDS Society-USA
PLoS One
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