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Título: | DOLAMA study. Effectiveness, safety and pharmacoeconoSequera, Sergio mic analysis of dual therapy with dolutegravir and lamivudine in virologically suppressed HIV-1 patients |
Autor: | Hidalgo-Tenorio, Carmen; López-Cortés, Luis Eduardo; Gutiérrez, Alicia R.; Santos, Jesús; Omar, Mohamed; Gálvez Contreras, María Carmen; Sequera, Sergio; Jesus, Samantha E. de; Téllez, Francisco; Fernández, Elisa; García, Coral; Pasquau-Liaño, Juan | Palabras clave: | DOLAMA Dolutegravir Dual therapy |
Fecha de publicación: | ago-2019 | Editor: | Lippincott Williams & Wilkins | Citación: | Medicine 98(32): e16813 (2019) | Resumen: | Dolutegravir (DTG) has shown effectiveness in combination with rilpivirine in with experience of antiretroviral therapy (ART) and with 3TC in naïve patients (GEMINI trial). The main objectives of this real-life study were to analyze the effectiveness and safety of 3TC plus DTG in virologically suppressed HIV-1 patients and to conduct a pharmacoeconomic analysis. We conducted an observational, retrospective and multicenter study of HIV+ patients pretreated for at least 6 months with ART that was then simplified to 3TC + DTG for any reason. We gathered data on viral loads (VLs) during exposure to the DT, calculating the rate with VL < 50 copies/mL at week 48, and on associated adverse effects. The 177 HIV+ patients were collected, 77.4% male, with average age of 48.5 years and mean count of 252.2cell/μL CD4+ nadir lymphocytes; 96.6% had VL < 50 copies/mL and 674 cells/μL CD4+ lymphocytes. Median time since HIV diagnosis was 15 years, and median ART duration was 13 years, and 34.5% of patients were on mono- or dual-therapy before the switch. At week 48, 82.4% of patients had VL < 50 cop/μL using an intention-to-treat (ITT) analysis, 89.6% according to mITT, and 96.7% according to Per-Protocol analysis. 3.3% patients had virological failure (VF). These effectiveness data and costs were compared with those for 2 reference triple therapies (DTG/ABC/3TC and EVG/cobi/FTC/TAF) in a cost minimization analysis, showing cost savings with administration of DTG+3TC (2741 €/year vs DTG/ABC/3TC and 4164 €/year vs EVG/cobi/FTC/TAF) and in a cost-effectiveness analysis, finding the DT to be the most cost-effective approach (ICER = −548 vs DTG/ABC/3TC and ICER = −4,627€ vs EVG/cobi/FTC/TAF) The combination of 3TC with DTG appears to be a safe and effective option for the simplification of ART in pretreated and virologically stable HIV-positive patients, being cost-effective and offering the same effectiveness as the triple therapy it replaces. | Versión del editor: | http://dx.doi.org/10.1097/MD.0000000000016813 | URI: | http://hdl.handle.net/10261/214317 | DOI: | 10.1097/MD.0000000000016813 | Identificadores: | doi: 10.1097/MD.0000000000016813 issn: 0025-7974 e-issn: 1536-5964 |
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