HIV Guidelines and Treatment Outcomes
HIV Guidelines and Treatment Outcomes
Objectives The aim of the study was to assess the adequacy of initial antiretroviral therapy (ART), in terms of its timing and the choice of regimens, according to the Spanish national treatment guidelines [Spanish AIDS Study Group–National Plan for AIDS (GeSIDA-PNS) Guidelines] for treatment-naïve HIV-infected patients.
Methods A prospective cohort study of HIV-positive ART-naïve subjects attending 27 centres in Spain from 2004 to 2010 was carried out. Regimens were classified as recommended, alternative or nonrecommended according to the guidelines. Delayed start of treatment was defined as starting treatment later than 12 months after the patient had fulfilled the treatment criteria. Multivariate logistic and Cox regression analyses were performed.
Results A total of 6225 ART-naïve patients were included in the study. Of 4516 patients who started treatment, 91.5% started with a recommended or alternative treatment. The use of a nonrecommended treatment was associated with a CD4 count > 500 cells/μL [odds ratio (OR) 2.03; 95% confidence interval (CI) 1.14–3.59], hepatitis B (OR 2.23; 95% CI 1.50–3.33), treatment in a hospital with < 500 beds, and starting treatment in the years 2004–2006. Fourteen per cent of the patients had a delayed initiation of treatment. Delayed initiation of treatment was more likely in injecting drug users, patients with hepatitis C, patients with higher CD4 counts and during the years 2004–2006, and it was less likely in patients with viral loads > 5 log HIV-1 RNA copies/ml. The use of a nonrecommended regimen was significantly associated with mortality [hazard ratio (HR) 1.61; 95% CI 1.03–2.52; P = 0.035] and lack of virological response.
Conclusions Compliance with the recommendations of Spanish national guidelines was high with respect to the timing and choice of initial ART. The use of nonrecommended regimens was associated with a lack of virological response and higher mortality.
Clinical guidelines are available for an increasing array of diseases. Despite this, physicians' adherence to clinical guidelines is highly variable and is influenced by multiple factors, such as guideline complexity, implementation strategies, physician characteristics, general workload, institutional support, and the patient's comorbidities.
Guidelines for the treatment of HIV infection are available in many countries; however, there is little evidence assessing compliance with clinical practice guidelines for antiretroviral treatment and its impact on clinical outcomes. Among the few studies that have investigated this issue, only two evaluated the relationship of adherence to treatment guidelines with immunovirological outcome. Most importantly, none of these studies has evaluated its relationship with mortality.
The Spanish health care system provides free-of-charge health care to all HIV-infected patients. The Spanish national guidelines for antiretroviral treatment are published by the Spanish AIDS Study Group (GeSIDA) and the National Plan for AIDS (PNS): they provide guidance on antiretroviral treatment of HIV-infected adults, and give recommendations on when to start treatment in naïve patients, as well as recommended antiretroviral regimens.
The aim of this study was to assess compliance with national guidelines for the treatment of naïve patients in a multicentre Spanish cohort [the Cohort of the Spanish AIDS Research Network (CoRIS)], and to investigate whether adherence to the guidelines is associated with better outcomes. The specific aims were to evaluate the proportion of patients treated according to the guidelines' recommendations in terms of initial antiretroviral regimens and appropriate timing of treatment initiation, to investigate factors associated with the prescription of a nonrecommended treatment and with a delayed initiation of treatment, and to assess the prognosis of patients receiving nonrecommended treatments in terms of mortality and of virological and immunological response.
*Data from this study were presented at the 11th International Congress on Drug Therapy in HIV Infection, November 2012, Glasgow, UK (P267) and published as an abstract in the Journal of the International AIDS Society 2012, 15 (Suppl 4): 18243.
†See Appendix.
Abstract and Introduction
Abstract
Objectives The aim of the study was to assess the adequacy of initial antiretroviral therapy (ART), in terms of its timing and the choice of regimens, according to the Spanish national treatment guidelines [Spanish AIDS Study Group–National Plan for AIDS (GeSIDA-PNS) Guidelines] for treatment-naïve HIV-infected patients.
Methods A prospective cohort study of HIV-positive ART-naïve subjects attending 27 centres in Spain from 2004 to 2010 was carried out. Regimens were classified as recommended, alternative or nonrecommended according to the guidelines. Delayed start of treatment was defined as starting treatment later than 12 months after the patient had fulfilled the treatment criteria. Multivariate logistic and Cox regression analyses were performed.
Results A total of 6225 ART-naïve patients were included in the study. Of 4516 patients who started treatment, 91.5% started with a recommended or alternative treatment. The use of a nonrecommended treatment was associated with a CD4 count > 500 cells/μL [odds ratio (OR) 2.03; 95% confidence interval (CI) 1.14–3.59], hepatitis B (OR 2.23; 95% CI 1.50–3.33), treatment in a hospital with < 500 beds, and starting treatment in the years 2004–2006. Fourteen per cent of the patients had a delayed initiation of treatment. Delayed initiation of treatment was more likely in injecting drug users, patients with hepatitis C, patients with higher CD4 counts and during the years 2004–2006, and it was less likely in patients with viral loads > 5 log HIV-1 RNA copies/ml. The use of a nonrecommended regimen was significantly associated with mortality [hazard ratio (HR) 1.61; 95% CI 1.03–2.52; P = 0.035] and lack of virological response.
Conclusions Compliance with the recommendations of Spanish national guidelines was high with respect to the timing and choice of initial ART. The use of nonrecommended regimens was associated with a lack of virological response and higher mortality.
Introduction
Clinical guidelines are available for an increasing array of diseases. Despite this, physicians' adherence to clinical guidelines is highly variable and is influenced by multiple factors, such as guideline complexity, implementation strategies, physician characteristics, general workload, institutional support, and the patient's comorbidities.
Guidelines for the treatment of HIV infection are available in many countries; however, there is little evidence assessing compliance with clinical practice guidelines for antiretroviral treatment and its impact on clinical outcomes. Among the few studies that have investigated this issue, only two evaluated the relationship of adherence to treatment guidelines with immunovirological outcome. Most importantly, none of these studies has evaluated its relationship with mortality.
The Spanish health care system provides free-of-charge health care to all HIV-infected patients. The Spanish national guidelines for antiretroviral treatment are published by the Spanish AIDS Study Group (GeSIDA) and the National Plan for AIDS (PNS): they provide guidance on antiretroviral treatment of HIV-infected adults, and give recommendations on when to start treatment in naïve patients, as well as recommended antiretroviral regimens.
The aim of this study was to assess compliance with national guidelines for the treatment of naïve patients in a multicentre Spanish cohort [the Cohort of the Spanish AIDS Research Network (CoRIS)], and to investigate whether adherence to the guidelines is associated with better outcomes. The specific aims were to evaluate the proportion of patients treated according to the guidelines' recommendations in terms of initial antiretroviral regimens and appropriate timing of treatment initiation, to investigate factors associated with the prescription of a nonrecommended treatment and with a delayed initiation of treatment, and to assess the prognosis of patients receiving nonrecommended treatments in terms of mortality and of virological and immunological response.
*Data from this study were presented at the 11th International Congress on Drug Therapy in HIV Infection, November 2012, Glasgow, UK (P267) and published as an abstract in the Journal of the International AIDS Society 2012, 15 (Suppl 4): 18243.
†See Appendix.
Source...