The Perfil-es study demonstrated that, while non-nucleoside reverse transcriptase inhibitor (NNRTI)-based initial antiretroviral therapy (ART) is more frequently used in human immunodeficiency virus (HIV)-infected naïve patients, ritonavir-boosted protease inhibitors (PI/r)-based regimens are the preferred option in patients with advanced infectious stages or high baseline viral load. The present analysis focused on the second phase of the Perfil-es study, where sociodemographic and clinical data were retrospectively collected from patients starting NNRTI- or PI/r-based regimens in order to identify factors that could influence the choice of initial ART. Patients' characteristics were compared by both bivariate and multivariate analyses. A total of 642 patients were evaluated. The main transmission group was men who have sex with men (MSM) (48%), and 24% of patients were coinfected with hepatitis B or C. Patients with cardiovascular risk accounted for 56%, and 15% had a neuropsychiatric history. Anxiolytics (29%), antidepressants (18%) and methadone (18%) were the most frequent concomitant medications. The use of PI/r-based regimens was more frequent in older patients, childbearing potential women patients coinfected with hepatitis B or C, and those with cardiovascular risk and a neuropsychiatric history. The presence of a neuropsychiatric disorder (OR: 1.912; CI 95%: 1.146-3.191; p < .05) and the use of concomitant medication (OR: 1.736; CI 95%: 1.204-2.502; p < .01) were identified as independent factors associated with the selection of PI/r-based regimens. MSM sexual conduct was the only independent factor related to the selection of NNRTI-based ART (OR: 0.699; CI 95%: 0.504-0.970; p < .05). Neither the physicians' characteristics nor the geographical area where HIV patients were attended influenced the choice of ART. In conclusion, patients' comorbidity, pregnancy potential and lifestyle seem to influence the choice of ART. Neuropsychiatric comorbidity and concomitant medication, mainly related to this condition, appear to be associated with the use of PI/r-based initial ART while MSM seem more likely to receive NNRTI-based regimens in Spain.
Purpose of the study: NNRTIs are commonly used to initiate HAART. Despite their demonstrated efficacy, tolerability and resistance issues could lead to a treatment change. The objective of the NEXT study was to evaluate the reasons for switching an initial non-nucleoside based regimen in the clinical setting, and the alternative regimen selected. Methods: A retrospective multicentre study was undertaken between April and October 2009. Patients from 38 Spanish centres who had changed the initial EFV or NVP-based regimen in the previous six-month period were included. Social-demographic and HIV-related data was collected from medical records. Responsible physicians were interviewed about reasons for switching the non-nucleoside and the alternative regimen of choice. Summary of results: A total of 391 HIV-1 infected patients had changed the initial EFV or NVP-based regimen in the previous six months. Data were available for 316 (80.8%) of them. 245/316 patients received EFV as first line (77.5%). Median time to switch the NNRTI regimen was 16.9 months, shorter in case of EFV-based regimen, 15.4 months, than NVP-based regimen, 20.8 months. Most of changes were observed in the first month after initiation, representing 51.3% of the discontinuations, especially in case of EFV (57.1% EFV; 31% NVP). 9.2% of the patients switched due to chronic toxicity (after the first month of treatment). CNS toxicity was the most common reason for switching therapy in the acute term in 63% of the patients. Other tolerability issues that led to treatment discontinuation in the short term were lipid abnormalities due to EFV (4.1%) and liver enzyme elevations related to NVP (7%). Rash led to a similar rate discontinuation with both NNRTIs (12%). The second reason to discontinue the first-generation NNRTI was virological/immunological failure in 40.5% of the patients (128/316). The new regimen selected was a boosted PI regimen in 52% of the cases, and was another NNRTI based regimen in 62.3%. Physicians marked safety/tolerability as the main reason for switching in 58.5% of cases (185/316). Conclusions: In the clinical setting, both acute and chronic intolerance/toxicity represents the main cause of the first line treatment change based on a first generation NNRTI, mainly EFV. CNS toxicity was the most common reason for switching therapy in the acute term. Therefore, the tolerability profile of the alternative regimen played a relevant role when switching regimens
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