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Title: Long-term efficacy and safety of atazanavir/ritonavir treatment in a cohort of treatment-naïve HIV patients: An interim analysis of the REMAIN study.
Authors: Teófilo, E
Knechten, H
Antela, A
Aleixo, M
Santos, J
Barlet, M
Jiménez-Expósito, M
metadata.dc.contributor.authoraffiliation: [Teófilo,E] Hospital Dos Capuchos, Department of Internal Medicine, Lisbon, Portugal. [ Knechten,H] HIV Schwerpunktpraxis Dr. Heribert Knechten, Aachen, Germany. [Antela,A] Hospital Clínico Universitario de Santiago, Infectious Disease Service, Santiago de Compostela, Spain. [Aleixo,M] Hospital García de Orta, Infectious Diseases Service, Almada, Portugal. [Santos,J] Hospital Virgen de la Victoria, Infectious Disease Unit, Málaga, Spain. [Barlet,M] Altigapharma, Boulogne-Billancourt, France. [Jiménez-Expósito,M] Bristol-Myers Squibb, Medical Department, Paris, France.
Keywords: Infecciones por VIH;Hepatitis;Hiperbilirrubinemia;Inhibidores de Proteasas;VIH;Quimioterapia;España;Portugal;Alemania;Estimación de Kaplan-Meier
metadata.dc.subject.mesh: Medical Subject Headings::Diseases::Immune System Diseases::Immunologic Deficiency Syndromes::HIV Infections
Medical Subject Headings::Diseases::Digestive System Diseases::Liver Diseases::Hepatitis
Medical Subject Headings::Diseases::Pathological Conditions, Signs and Symptoms::Pathologic Processes::Hyperbilirubinemia
Medical Subject Headings::Chemicals and Drugs::Chemical Actions and Uses::Pharmacologic Actions::Therapeutic Uses::Anti-Infective Agents::Antiviral Agents::Anti-Retroviral Agents::Anti-HIV Agents
Medical Subject Headings::Chemicals and Drugs::Chemical Actions and Uses::Pharmacologic Actions::Molecular Mechanisms of Pharmacological Action::Enzyme Inhibitors::Protease Inhibitors
Medical Subject Headings::Organisms::Viruses::RNA Viruses::Retroviridae::Lentivirus::Lentiviruses, Primate::HIV
Medical Subject Headings::Analytical, Diagnostic and Therapeutic Techniques and Equipment::Therapeutics::Drug Therapy
Medical Subject Headings::Geographicals::Geographic Locations::Europe::Spain
Medical Subject Headings::Geographicals::Geographic Locations::Europe::Portugal
Medical Subject Headings::Geographicals::Geographic Locations::Europe::Germany
Medical Subject Headings::Analytical, Diagnostic and Therapeutic Techniques and Equipment::Investigative Techniques::Epidemiologic Methods::Statistics as Topic::Survival Analysis::Kaplan-Meier Estimate
Medical Subject Headings::Disciplines and Occupations::Human Activities::Survival
Issue Date: 11-Nov-2012
Publisher: BioMed Central
Citation: Teófilo E., Knechten H., Antela A., Aleixo M., Santos J., Barlet M. et al. Long-term efficacy and safety of atazanavir/ritonavir treatment in a cohort of treatment-naïve HIV patients: An interim analysis of the REMAIN study. Journal of the International AIDS Society. 2012;15(Suppl. 4):18248.
Abstract: Purpose: Combined antiretroviral therapy has dramatically improved HIV-infected individuals survival. Long-term strategies are currently needed to achieve the goal of durable virologic suppression. However, long-term available data for specific antiretrovirals (ARV) are limited. In clinical trials, boosted atazanavir (ATV/r) regimens has shown good efficacy and tolerability in ARV-naïve patients for up to 4 years. The REMAIN study aimed to evaluate the long-term outcomes of ATV/r regimens in ARV-naïve patients in a real life setting. Methods: Non-comparative, observational study conducted in Germany, Portugal and Spain. Historical and longitudinal follow-up data was extracted six monthly from the medical record of HIV-infected, treatment-naïve patients, who initiated an ATV/r-regimen between 2008 and 2010. The primary endpoint was the proportion of patients remaining on ATV treatment over time. Secondary endpoints included virologic response (HIV-1 RNA <50 c/mL and <500 c/mL), reasons for discontinuation and long-term safety. The duration of treatment and time to virologic failure (VF) were analyzed using the Kaplan- Meier method. Data from an interim analysis including patients with at least one year of follow-up are reported here. Results: A total of 411 patients were included in this interim analysis [median (Q1, Q3) follow-up: 23.42 (16.25, 32.24) months≥: 77% male; median age 40 years [min, max: 19, 78≥; 16% IDUs; 18% CDC C; 18% hepatitis C. TDF/FTC was the most common backbone (85%). At baseline, median (Q1, Q3) HIV-RNA and CD4 cell count were 4.91 (4.34, 5.34) log10 c/mL and 256 (139, 353) cells/mm3, respectively. The probability of remaining on treatment was 0.84 (95% CI: 0.80, 0.87) and 0.72 (95% CI: 0.67, 0.76) for the first and second year, respectively. After 2 years of follow-up, 84% (95% CI: 0.79, 0.88) of patients were virologically suppressed (<50 c/mL). No major protease inhibitors mutations were observed at VF. Overall, 125 patients (30%) discontinued ATV therapy [median (Q1, Q3) time to discontinuation: 11.14 (6.24, 19.35) months]. Adverse events (AEs) were the main reason for discontinuation (n =47, 11%). Hyperbilirubinaemia was the most common AE leading to discontinuation (14 patients). No unexpected AEs were reported. Conclusions: In a real life clinical setting, ATV/r regimens showed durable virologic efficacy with good tolerability in an ARV-naïve population. Data from longer follow-up will provide additional valuable information.
metadata.dc.identifier.doi: 10.7448/IAS.15.6.18248
ISSN: 1758-2652 (Online)
Appears in Collections:01- Artículos - Hospital Virgen de la Victoria

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