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      Treatment discontinuation in HIV-1-infected individuals starting their first-line HAART after 2008: data from the ICONA Foundation Study Cohort

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          Abstract

          Introduction

          The aim of this study was to analyze the likelihood and the predictors of discontinuation of first-line regimen in the late HAART era.

          Methodology

          An observational multi-center analysis of HIV-positive patients enrolled in ICONA. Patients eligible were those starting a first-line HAART after 1 January 2008. Discontinuation was defined as stop and/or switch of at least one drug of the regimen. All causes of discontinuation, as reported by the treating physician, were evaluated and cumulative risk of stopping was investigated according to age, gender, co-morbidity, years since starting HAART, immuno-virological status, third drug and backbone of the first regimen. Kaplan Meier (KM) analysis and Cox proportional hazards model were used for the outcome discontinuation of ≥1 drug regardless of the reason. For the KM estimates a competing risk approach was used to estimate the contribution of each of the reasons over time to the cumulative risk of stopping over time.

          Results

          Data of 1759 patients who started first HAART and had at least one month of clinical follow-up were analyzed. The overall discontinuation risk was 33% over a median follow-up of 12 months. The likelihood of discontinuation by KM was 27% by one year (95% CI 25–29) and 41% by two years (95% CI 38–44). Main reason for stopping at least one drug in regimen was simplification (10%), followed by intolerance (7%), toxicity (5%), failure (2%) and other causes (8%). Estimates of the cumulative risk of discontinuation of ≥1 drug over time and according to reason are shown in Figure 1. In a multivariable Cox model independent predictors of discontinuation regardless of the reason were: longer time from HIV diagnosis to date of starting HAART (hazard ratio [HR] 0.96; 95% CI 0.93–1.00; p=0.039), regimens containing ZDV/3TC (HR 2.86; 95% CI 1.42–5.76; p=0.003 vs TDF/FTC) and an NNRTI-based regimen (HR 2.47; 95% CI 0.91–6.72; p=0.07 vs regimens not NNRTI-based).

          Conclusions

          In a previously reported analysis of the ICONA data [ 1], the overall risk of discontinuation of first-line HAART was 36% with 21% due to intolerance/toxicity. In this updated analysis, the main reason for stopping is simplification (accounting for 32% of stops), reflecting the recent changes in recommendations aimed to minimize drug toxicity, enhancing adherence and quality of life.

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          Most cited references 1

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          Insights into the reasons for discontinuation of the first highly active antiretroviral therapy (HAART) regimen in a cohort of antiretroviral naïve patients. I.CO.N.A. Study Group. Italian Cohort of Antiretroviral-Naïve Patients.

          To evaluate the frequency of discontinuation of the first highly active antiretroviral regimen (HAART) and the factors predictive of discontinuing for toxicity and failure in a population-based cohort of HIV-positive individuals in Italy, naïve from antiretrovirals at enrolment. The study population consisted of individuals who initiated HAART and had at least one follow-up visit. The primary end-points were discontinuation of any component of HAART for drug toxicity and discontinuation for failure. Survival analyses were performed to identify predictive factors for reaching the two end-points. Eight hundred and sixty-two individuals initiated HAART; in 727 of them (84.3%) this consisted of two nucleoside reverse transcriptase inhibitors (NRTI) and one protease inhibitor (PI). Over a median follow-up of 45 weeks, 312 patients (36.2%) discontinued therapy: 182 (21.1%) discontinued due to toxicity, 44 (5.1%) due to failure. The probability of discontinuing HAART at 1 year was 25.5% [95% confidence interval (CI), 21.9-28.9] due to toxicity and 7.6% (95% CI, 4.9-1 0.3) due to failure. Independent factors associated with discontinuation for toxicity were: gender [relative hazard (RH) = 0.51; 95% CI, 0.32-0.80 for men versus women], type of treatment (indinavir-containing regimens, RH = 1.94; 95% CI, 1.10-3.41 and ritonavir-containing regimens, RH = 3.83; 95% CI, 2.09-7.03 versus hard-gell saquinavir) and time spent on treatment (RH = 0.89; 95% CI, 0.80-0.98 for each additional month). Discontinuation due to failure was independently associated with the most recent HIV-RNA (RH = 3.20; 95% CI, 1.74-5.88 for log10 copies/ml higher), and with type of treatment (indinavir-containing regimens, RH = 0.21; 95% CI, 0.06-0.78 and ritonavir-containing regimens, RH = 0.23; 95% CI, 0.04-1.26 versus hard-gell saquinavir). If the current HAART regimen caused no toxicity, less than 10% of naïve patients discontinue their first HAART regimen because of failure after 1 year from starting therapy.
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            Author and article information

            Journal
            J Int AIDS Soc
            J Int AIDS Soc
            JIAS
            Journal of the International AIDS Society
            International AIDS Society
            1758-2652
            02 November 2014
            2014
            : 17
            : 4Suppl 3
            Affiliations
            [1 ]Department of Internal Medicine, San Martino Hospital, Genoa, Italy
            [2 ]Division of Population Health, Department of Infection and Population Health, Royal Free Campus, UCL Medical School, London, UK
            [3 ]Department of Internal Medicine, IRCCS AOU San Martino Hospital, Genoa, Italy
            [4 ]Infectious Diseases, University of Bari, Bari, Italy
            [5 ]Infectious Diseases, Hospital Monza, Monza, Italy
            [6 ]Infectious Diseases, Hospital Busto Arsizio, Busto Arsizio, Italy
            [7 ]Infectious Diseases, University of Siena, Siena, Italy
            [8 ]Infectious Diseases, University of Ancona, Ancona, Italy
            [9 ]Infectious Diseases, University of Modena, Modena, Italy
            [10 ]Infectious Diseases, Sacco Hospital, Milano, Italy
            [11 ]Infectious Diseases, INMI Lazzaro Spallaanzani, Roma, Italy
            [12 ]Infectious Diseases, University of Milan, San Paolo Hospital, Milano, Italy
            [13 ]Health Sciences, University of Milan, San Paolo Hospital, Milano, Italy
            Article
            19825
            10.7448/IAS.17.4.19825
            4225385
            © 2014 Di Biagio A et al; licensee International AIDS Society

            This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

            Categories
            Poster Sessions – Abstract P293

            Infectious disease & Microbiology

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