Compliance with HIV treatment guidelines in the Spanish CoRIS cohort: impact on mortality and immunovirological response

Abstract

There is little evidence assessing compliance with clinical practice guidelines for antiretroviral treatment and its impact on clinical outcomes. The Spanish national guidelines for antiretroviral treatment are published by the Spanish AIDS Study Group (GeSIDA). The aim of this study was to assess compliance with national guidelines for the treatment of naïve patients from a multicentre Spanish cohort (CoRIS). The specific aims were to evaluate the proportion of patients treated according to the guidelines’ recommendations, to investigate factors associated with the prescription of a non‐recommended treatment, and to assess the impact of non‐recommended treatments on mortality and on virological and immunological response (defined as undetectable viral load and increase of 100 CD4/ml, respectively, after 1 year). Drug combinations were classified as recommended, alternative, or not recommended, according to the guidelines’ “what to start with” recommendations. 6225 naïve patients were included between the years 2004 and 2010. Among 4516 patients who started treatment, 3592 (79.5%), 540 (12%), and 384 (8.5%) started with a recommended, alternative and not‐recommended treatment, respectively. The use of a not‐recommended treatment was significantly associated with CD4 count >500/ml (OR: 2.03, 95% CI: 1.14–3.59), hepatitis B infection (OR: 2.23, 95% CI: 1.50–3.33), treatment in a hospital with <500 beds, and starting treatment in the years 2004 to 2006. There was no significant association of having a not‐recommended treatment with gender, route of transmission, hepatitis C infection, country of origin, education, or viral load. The use of a not‐recommended regimen was significantly associated with mortality (HR: 1.61, 95% CI: 1.03–2.52, p=0.035) and lack of virological response (OR: 0.65, 95% CI: 0.45–0.93, p=0.019), but it was not associated with immunological response (OR: 0.90, 95% CI: 0.75–1.08, p=0.273). In conclusion, compliance with “what to start with” recommendations of Spanish national guidelines was high. The use of not‐recommended regimens was more likely in patients with >500 CD4/ml, hepatitis B infection, and starting treatment in the years 2004–2006 and in small hospitals. Not‐recommended regimens were associated with higher mortality and lack of virological response.