Suchergebnisse

Purpose of the studyTo identify the proportion of patients starting ARV treatment with NNRTIs or with a PI/r and to explore and compare their clinical profile establishing different factors whereby physicians select the initial ARV treatment in a Spanish clinical setting.MethodsAn observational study was conducted in two different phases. In Phase I a cross‐sectional registration was conducted for patients who initiated ARV treatment in a 6‐month period in 65 Spanish hospitals. In Phase II clinical and social‐demographic features were collected retrospectively of patients who visited HIV clinics between August and November 2010 who had started ARV treatment containing an NNRTIs or a PI/r in Phase I.Summary of resultsIn Phase I, 1,687 subjects who initiated ARV treatment were registered, of which 53% started with an NNRTI‐based regimen whereas 42% started with a PI/r‐based regimen. Two percent of the treatment initiations occurred in a clinical trial. In Phase II, 642 patients were paired consecutively and retrospectively. The group of patients was composed of predominantly male subjects (81% vs 19%). The median time between diagnosis and the start of ARV treatment was 3.6±5.3 years. At the initiation of treatment, 72% of patients had a CD4 count below 350 cells/µl. Although treatment based on NNRTIs in naïve patients is the most frequent option in Spain, the analysis of clinical profiles shows that PI/r‐based therapy is more often used than NNRTIs with statistical significance in patients with high viral load, Fig. A (≥100.000 copies/ml) (58% vs 42%; OR:1,75; 95% CI: 1,26–2,43; p<0,01), with CD4 cell counts <200 cells/µl, Fig. B (68% vs 31%; OR: 2,92; 95% CI: 1,99–4,27; p<0,01), and in patients at CDC stage C (65% vs 35%; OR: 2,05; CI: 1,27–3,31; p<0,01).imageConclusionsIn Spain, HIV is still diagnosed late (as measured by CD4 count<350 cells/µl). Treatment based on NNRTIs are more frequently used in naïve patients, although PIs/r‐based regimens play an important role being the preferred option in patients with high viral load (≥100.000 copies/ml) and low CD4 cell count (<200 cells/µl).

BackgroundUntil the past decade, immune/viral failure was the main reason for antiretroviral treatment changes. After HAART generalization the management of antiretroviral treatment toxicities was the most prevalent reason for treatment modification. Today, with the advent of new more potent and less toxic drugs as well as more convenient combinations may have changed the situation. We aim to describe the main reasons that today leads to ART changes in HIV+ patients in Spain in the current clinical practice.MethodsMulticentre, national, cross‐sectional epidemiological study. Eligible patients had to be HIV+, >18 years old and under current ART that was going to be changed by any reason. Patients did sign inform consent. The study consisted in a single visit (change of treatment) in which data on social and demographic characteristics, HIV disease and ARV treatment were collected.Results349 patients were included; mean age: 43.7±8.9 y, 70.5% male and 89.1% Caucasian. Main transmission categories were IVDU (36.4%) and heterosexual (36.4%). Mean time from HIV diagnosis was 11.3±7.6 y. 59.5% were CDC C category. Median CD4 nadir was: 155 cells/mm3 and median CD4 at the time of switching was 467 cells/mm3. 64.1% had undetectable viral load (<50 copies/ml); 40.1% had HCV or HBV co‐infection. Main reasons for treatment change were simplification (40.2%), treatment toxicities (29.2%) and immune/viral failure (20.1%). No significant correlations were found between reason for changing treatment and age, gender, race, nationality and level of education. Simplification was significantly the main reason both in employed and unemployed patients (p<0.01).ConclusionsCurrently, treatment simplification was the most prevalent reason for a change of treatment even in advanced lines of treatment. This is so probably because of the advent of ARV drugs that are more potent and effective, with less toxicity and more convenient. Treatment simplification was significantly the first cause of treatment change in those patients who are currently working or seeking for a job. This highlights the need for simpler regimens that can adapt to an active life.

7‐11 November 2010, Tenth International Congress on Drug Therapy in HIV Infection, Glasgow, UK

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.