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Individual patient data meta-analysis of randomized controlled trials of dual therapy with a boosted PI plus lamivudine for maintenance of virological suppression: GeSIDA study 9717.
Perez-Molina, J A; Pulido, F; Di Giambenedetto, S; Ribera, E; Moreno, S; Zamora, J; Coscia, C; Alejos, B; Pitch, J; Gatell, J M; De Luca, A; Arribas, J R.
Afiliación
  • Perez-Molina JA; Infectious Diseases Department, Hospital Universitario Ramón y Cajal, IRYCIS, Madrid, Spain.
  • Pulido F; HIV Unit, Hospital Universitario Doce de Octubre, imas12, UCM, Madrid, Spain.
  • Di Giambenedetto S; Institute of Clinical Infectious Diseases, Catholic University of Sacred Heart, Rome, Italy.
  • Ribera E; Infectious Diseases Department, Hospital Universitari Vall d'Hebron, Barcelona, Spain.
  • Moreno S; Infectious Diseases Department, Hospital Universitario Ramón y Cajal, IRYCIS, Madrid, Spain.
  • Zamora J; Clinical Biostatistics Unit and CIBERESP, Hospital Ramón y Cajal, IRYCIS, Madrid, Spain.
  • Coscia C; Queen Mary University, London, UK.
  • Alejos B; Clinical Biostatistics Unit and CIBERESP, Hospital Ramón y Cajal, IRYCIS, Madrid, Spain.
  • Pitch J; Centro Nacional de Epidemiología, Instituto Carlos III, Madrid, Spain.
  • Gatell JM; Hospital Clínic/Institut d'Investigacions Biomèdiques August Pi i Sunyer, University of Barcelona, Barcelona, Spain.
  • De Luca A; Hospital Clínic/Institut d'Investigacions Biomèdiques August Pi i Sunyer, University of Barcelona, Barcelona, Spain.
  • Arribas JR; UOC Malattie Infettive, Azienda Ospedaliera Universitaria Senese, and Department of Medical Biotechnologies, University of Siena, Siena, Italy.
J Antimicrob Chemother ; 73(11): 2927-2935, 2018 11 01.
Article en En | MEDLINE | ID: mdl-30085184
Background: Dual therapy (DT) with a ritonavir-boosted PI (PI/r) plus lamivudine has proven non-inferior (12% margin) to triple therapy (TT) with PI/r plus two nucleos(t)ide reverse transcriptase inhibitors [N(t)RTIs] in four clinical trials. It remains unclear whether DT is non-inferior based on the US FDA endpoint (virological failure with a margin of 4%) or in specific subgroups. Methods: We performed a systematic search (January 1990 to March 2017) of randomized controlled trials that compared switching of maintenance ART from TT to DT. The principal investigators were contacted and agreed to share study databases. The primary endpoint was non-inferiority of DT to TT based on the current FDA endpoint (4% non-inferiority margin for virological failure at week 48). We also analysed whether efficacy was modified by gender, active HCV infection and type of PI. Effect estimates and 95% CIs were calculated using generalized estimating equation-based models. Results: We found 881 references that yielded eight articles corresponding to four clinical trials (1051 patients). At week 48, 4% of patients on DT versus 3.04% on TT had experienced virological failure (difference 0.9%; 95% CI -1.2% to 3.1%), and 84.7% of patients on DT versus 83.2% on TT had <50 copies of HIV RNA/mL (FDA snapshot algorithm) (difference 1.4%; 95% CI -2.8% to 5.8%). Gender, active HCV infection and type of PI had no effect on differences in treatment efficacy between DT and TT. Conclusions: DT was non-inferior to TT using both current and past FDA endpoints. The efficacy of DT was not influenced by gender, active HCV infection status, or type of PI.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Infecciones por VIH / Inhibidores de la Proteasa del VIH / Ritonavir / Lamivudine / Carga Viral Tipo de estudio: Clinical_trials / Systematic_reviews Límite: Humans Idioma: En Revista: J Antimicrob Chemother Año: 2018 Tipo del documento: Article País de afiliación: España Pais de publicación: Reino Unido
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Infecciones por VIH / Inhibidores de la Proteasa del VIH / Ritonavir / Lamivudine / Carga Viral Tipo de estudio: Clinical_trials / Systematic_reviews Límite: Humans Idioma: En Revista: J Antimicrob Chemother Año: 2018 Tipo del documento: Article País de afiliación: España Pais de publicación: Reino Unido