Addition of Maraviroc Versus Placebo to Standard Antiretroviral Therapy for Initial Treatment of Advanced HIV Infection

Autor: Lévy, Yves, Lelièvre, Jean-Daniel, Assoumou, Lambert, Aznar, Esther, Pulido, Federico, Tambussi, Giuseppe, Crespo, Manuel, Meybeck, Agnès, Molina, Jean-Michel, Delaugerre, Constance, Izopet, Jacques, Peytavin, Gilles, Cardon, Fanny, Diallo, Alpha, Lancar, Rémi, Béniguel, Lydie, Costagliola, Dominique
Přispěvatelé: Vaccine Research Institute (VRI), Université Paris-Est Créteil Val-de-Marne - Paris 12 (UPEC UP12), Institut Pierre Louis d'Epidémiologie et de Santé Publique (iPLESP), Institut National de la Santé et de la Recherche Médicale (INSERM)-Sorbonne Université (SU), Sociedad Española de Enfermedades Infecciosas y Microbiología Clínica = Spanish Society of Infectious Diseases and Clinical Microbiology (SEIMC), Hospital Universitario 12 de Octubre [Madrid], Universidad Complutense de Madrid = Complutense University of Madrid [Madrid] (UCM), Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS San Raffaele Pisana), Vall d'Hebron University Hospital [Barcelona], Centre Hospitalier de Tourcoing, Hopital Saint-Louis [AP-HP] (AP-HP), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Centre de Physiopathologie Toulouse Purpan (CPTP), Université Toulouse III - Paul Sabatier (UT3), Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), CHU Toulouse [Toulouse], AP-HP - Hôpital Bichat - Claude Bernard [Paris], Agence Nationale de Recherches sur le Sida et les Hépatites Virales (ANRS)
Jazyk: angličtina
Rok vydání: 2020
Předmět:
Zdroj: Annals of Internal Medicine
Annals of Internal Medicine, American College of Physicians, 2020, 172 (5), pp.297-305. ⟨10.7326/M19-2133⟩
ISSN: 0003-4819
1539-3704
DOI: 10.7326/M19-2133⟩
Popis: International audience; Background: Patients diagnosed with advanced HIV infection have a poor prognosis despite initiation of combined antiretroviral therapy (c-ART). Objective : To assess the benefit of adding maraviroc, an antiretroviral drug with immunologic effects, to standard c-ART for patients with advanced disease at HIV diagnosis. Design : Randomized controlled trial. (ClinicalTrials.gov: NCT01348308). Setting : Clinical sites in France (n = 25), Italy (n = 5), and Spain (n = 20). Participants : 416 HIV-positive, antiretroviral-naive adults with CD4 counts less than 0.200 × 109 cells/L and/or a previous AIDS-defining event (ADE). Intervention : C-ART plus placebo or maraviroc (300 mg twice daily with dose modification) for 72 weeks. Measurements : The primary end point was first occurrence of severe morbidity (new ADE, selected serious infections, serious non-ADE, immune reconstitution inflammatory syndrome, or death). Prespecified secondary outcomes included primary outcome components, biological and pharmacokinetic measures, and adverse events graded 2 or higher. Results : 409 randomly assigned participants (207 in the placebo group and 202 in the maraviroc group) who received more than 1 dose were included in the analysis. During 72 weeks of follow-up, incidence of severe morbidity was 11.1 per 100 person-years in the maraviroc group and 11.2 per 100 person-years in the placebo group (hazard ratio, 0.97 [95% CI, 0.57 to 1.67]). Incidence of adverse events graded 2 or higher was 36.1 versus 41.5 per 100 person-years (incidence rate ratio, 0.87 [CI, 0.65 to 1.15]). Limitations : Sixty-four participants discontinued therapy during follow-up. The study was not designed to evaluate time-dependent outcomes or effect modification. Conclusion : Addition of maraviroc to standard c-ART does not improve clinical outcomes of patients initiating therapy for advanced HIV infection.
Databáze: OpenAIRE
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