DOLAVI Real-Life Study of Dolutegravir Plus Lamivudine in Naive HIV-1 Patients (48 Weeks)
Brief: Real-world data in naive HIV-1 patients demonstrate that dolutegravir plus lamivudine in a multiple tablet regimen is effective, safe, and satisfactory; it causes moderately increasing weight and abdominal circumference and is administrable on a test-and-treat strategy. Background: Our object...
| Autores: | , , , , , , , , , , , , , , , |
|---|---|
| Tipo de recurso: | artículo |
| Fecha de publicación: | 2022 |
| País: | España |
| Institución: | Conselleria de Salut i Consum del Govern de les Illes Balears |
| Repositorio: | Docusalut |
| Idioma: | inglés |
| OAI Identifier: | oai:docusalut.com:20.500.13003/19547 |
| Acceso en línea: | https://hdl.handle.net/20.500.13003/19547 |
| Access Level: | acceso abierto |
| Palabra clave: | Homosexuality, Male Viral Load Adult HIV Seropositivity Pyridones Humans Anti-HIV Agents Drug Therapy, Combination Heterocyclic Compounds, 3-Ring HIV Infections Male Female Piperazines HIV-1 Sexual and Gender Minorities Lamivudine Oxazines VIH-1 Femenino Infecciones por VIH Minorías Sexuales y de Género Masculino Piridonas Piperazinas Compuestos Heterocíclicos con 3 Anillos Quimioterapia Combinada Fármacos Anti-VIH Humanos Seropositividad para VIH Oxazinas Adulto Homosexualidad Masculina Carga Viral DOLAVI dolutegravir lamivudine real-world data HIV |
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DOLAVI Real-Life Study of Dolutegravir Plus Lamivudine in Naive HIV-1 Patients (48 Weeks)Hidalgo-Tenorio, CarmenPasquau, JuanVinuesa, DavidFerra, SergioTerron, AlbertoSanJoaquin, IsabelPayeras Cifre, AntonioMartinez, Onofre JuanLopez-Ruz, Miguel AngelOmar, Mohamedde la Torre-Lima, JavierLopez-Lirola, AnaPalomares, JesusBlanco, Jose RamonMontero, MartaGarcia-Vallecillos, CoralHomosexuality, MaleViral LoadAdultHIV SeropositivityPyridonesHumansAnti-HIV AgentsDrug Therapy, CombinationHeterocyclic Compounds, 3-RingHIV InfectionsMaleFemalePiperazinesHIV-1Sexual and Gender MinoritiesLamivudineOxazinesSexual and Gender MinoritiesVIH-1LamivudineFemeninoInfecciones por VIHMinorías Sexuales y de GéneroMasculinoPiridonasPiperazinasCompuestos Heterocíclicos con 3 AnillosQuimioterapia CombinadaFármacos Anti-VIHHumanosSeropositividad para VIHOxazinasAdultoHomosexualidad MasculinaCarga ViralDOLAVIdolutegravirlamivudinereal-world dataHIVBrief: Real-world data in naive HIV-1 patients demonstrate that dolutegravir plus lamivudine in a multiple tablet regimen is effective, safe, and satisfactory; it causes moderately increasing weight and abdominal circumference and is administrable on a test-and-treat strategy. Background: Our objectives were to determine the real-life effectiveness and safety of DT with dolutegravir (50 mg/QD) plus lamivudine (300 mg/QD) in a multiple-tablet regimen (MTR) in naive PLHIV followed up for 48 weeks and to evaluate the compliance and satisfaction of patients. Material and methods: An open, single-arm, multicenter, non-randomized clinical trial from May 2019 through September 2020 with a 48-week follow-up. Results: The study included 88 PLHIV patients (87.5% male) with a mean age of 35.9 years; 76.1% were MSM patients. The mean baseline CD4 was 516.4 cells/uL, with a viral load (VL) of 4.49 log(10), and 11.4% were in the AIDS stage. DT started within 7 days of first specialist consultation in all patients and the same day in 84.1%; 3.4% had baseline resistance mutations (K103N, V106I + E138A, and V108I); 12.5% were lost to follow-up. At week 48, 86.3% had VL < 50 cop/uL by intention-to-treat analysis and 98.7% by per-protocol (PP) analysis. Virological failure (VF) was recorded in 1.1%, with no resistance mutation. One blip was detected in 5.2% without VF. Three reported anxiety, dizziness, and cephalgia, respectively, at week 4 and one reported insomnia at week 24; none reported adverse events at week 48. The mean weight was 4 kg higher at 48 weeks (p = 0.0001) and abdominal circumference 3 cm larger at 24 weeks (p = 0.022). No forgetfulness occurred in 98.7% of patients. Patient satisfaction was 90/100 at 4, 24, and 48 weeks. Conclusion: Real-world data demonstrate that dolutegravir plus lamivudine in MTR is effective, safe, and satisfactory, moderately increasing weight and abdominal circumference and administrable on a test-and-treat strategy.MDPI20222022-03-0120222022-03-01research articlehttp://purl.org/coar/resource_type/c_2df8fbb1info:eu-repo/semantics/articleapplication/pdfhttps://hdl.handle.net/20.500.13003/19547reponame:Docusalutinstname:Conselleria de Salut i Consum del Govern de les Illes BalearsInglésengopen accesshttp://purl.org/coar/access_right/c_abf2Attribution 4.0 Internationalhttp://creativecommons.org/licenses/by/4.0/info:eu-repo/semantics/openAccessoai:docusalut.com:20.500.13003/195472026-06-22T12:44:07Z |
| dc.title.none.fl_str_mv |
DOLAVI Real-Life Study of Dolutegravir Plus Lamivudine in Naive HIV-1 Patients (48 Weeks) |
| title |
DOLAVI Real-Life Study of Dolutegravir Plus Lamivudine in Naive HIV-1 Patients (48 Weeks) |
| spellingShingle |
DOLAVI Real-Life Study of Dolutegravir Plus Lamivudine in Naive HIV-1 Patients (48 Weeks) Hidalgo-Tenorio, Carmen Homosexuality, Male Viral Load Adult HIV Seropositivity Pyridones Humans Anti-HIV Agents Drug Therapy, Combination Heterocyclic Compounds, 3-Ring HIV Infections Male Female Piperazines HIV-1 Sexual and Gender Minorities Lamivudine Oxazines Sexual and Gender Minorities VIH-1 Lamivudine Femenino Infecciones por VIH Minorías Sexuales y de Género Masculino Piridonas Piperazinas Compuestos Heterocíclicos con 3 Anillos Quimioterapia Combinada Fármacos Anti-VIH Humanos Seropositividad para VIH Oxazinas Adulto Homosexualidad Masculina Carga Viral DOLAVI dolutegravir lamivudine real-world data HIV |
| title_short |
DOLAVI Real-Life Study of Dolutegravir Plus Lamivudine in Naive HIV-1 Patients (48 Weeks) |
| title_full |
DOLAVI Real-Life Study of Dolutegravir Plus Lamivudine in Naive HIV-1 Patients (48 Weeks) |
| title_fullStr |
DOLAVI Real-Life Study of Dolutegravir Plus Lamivudine in Naive HIV-1 Patients (48 Weeks) |
| title_full_unstemmed |
DOLAVI Real-Life Study of Dolutegravir Plus Lamivudine in Naive HIV-1 Patients (48 Weeks) |
| title_sort |
DOLAVI Real-Life Study of Dolutegravir Plus Lamivudine in Naive HIV-1 Patients (48 Weeks) |
| dc.creator.none.fl_str_mv |
Hidalgo-Tenorio, Carmen Pasquau, Juan Vinuesa, David Ferra, Sergio Terron, Alberto SanJoaquin, Isabel Payeras Cifre, Antonio Martinez, Onofre Juan Lopez-Ruz, Miguel Angel Omar, Mohamed de la Torre-Lima, Javier Lopez-Lirola, Ana Palomares, Jesus Blanco, Jose Ramon Montero, Marta Garcia-Vallecillos, Coral |
| author |
Hidalgo-Tenorio, Carmen |
| author_facet |
Hidalgo-Tenorio, Carmen Pasquau, Juan Vinuesa, David Ferra, Sergio Terron, Alberto SanJoaquin, Isabel Payeras Cifre, Antonio Martinez, Onofre Juan Lopez-Ruz, Miguel Angel Omar, Mohamed de la Torre-Lima, Javier Lopez-Lirola, Ana Palomares, Jesus Blanco, Jose Ramon Montero, Marta Garcia-Vallecillos, Coral |
| author_role |
author |
| author2 |
Pasquau, Juan Vinuesa, David Ferra, Sergio Terron, Alberto SanJoaquin, Isabel Payeras Cifre, Antonio Martinez, Onofre Juan Lopez-Ruz, Miguel Angel Omar, Mohamed de la Torre-Lima, Javier Lopez-Lirola, Ana Palomares, Jesus Blanco, Jose Ramon Montero, Marta Garcia-Vallecillos, Coral |
| author2_role |
author author author author author author author author author author author author author author author |
| dc.contributor.none.fl_str_mv |
|
| dc.subject.none.fl_str_mv |
Homosexuality, Male Viral Load Adult HIV Seropositivity Pyridones Humans Anti-HIV Agents Drug Therapy, Combination Heterocyclic Compounds, 3-Ring HIV Infections Male Female Piperazines HIV-1 Sexual and Gender Minorities Lamivudine Oxazines Sexual and Gender Minorities VIH-1 Lamivudine Femenino Infecciones por VIH Minorías Sexuales y de Género Masculino Piridonas Piperazinas Compuestos Heterocíclicos con 3 Anillos Quimioterapia Combinada Fármacos Anti-VIH Humanos Seropositividad para VIH Oxazinas Adulto Homosexualidad Masculina Carga Viral DOLAVI dolutegravir lamivudine real-world data HIV |
| topic |
Homosexuality, Male Viral Load Adult HIV Seropositivity Pyridones Humans Anti-HIV Agents Drug Therapy, Combination Heterocyclic Compounds, 3-Ring HIV Infections Male Female Piperazines HIV-1 Sexual and Gender Minorities Lamivudine Oxazines Sexual and Gender Minorities VIH-1 Lamivudine Femenino Infecciones por VIH Minorías Sexuales y de Género Masculino Piridonas Piperazinas Compuestos Heterocíclicos con 3 Anillos Quimioterapia Combinada Fármacos Anti-VIH Humanos Seropositividad para VIH Oxazinas Adulto Homosexualidad Masculina Carga Viral DOLAVI dolutegravir lamivudine real-world data HIV |
| description |
Brief: Real-world data in naive HIV-1 patients demonstrate that dolutegravir plus lamivudine in a multiple tablet regimen is effective, safe, and satisfactory; it causes moderately increasing weight and abdominal circumference and is administrable on a test-and-treat strategy. Background: Our objectives were to determine the real-life effectiveness and safety of DT with dolutegravir (50 mg/QD) plus lamivudine (300 mg/QD) in a multiple-tablet regimen (MTR) in naive PLHIV followed up for 48 weeks and to evaluate the compliance and satisfaction of patients. Material and methods: An open, single-arm, multicenter, non-randomized clinical trial from May 2019 through September 2020 with a 48-week follow-up. Results: The study included 88 PLHIV patients (87.5% male) with a mean age of 35.9 years; 76.1% were MSM patients. The mean baseline CD4 was 516.4 cells/uL, with a viral load (VL) of 4.49 log(10), and 11.4% were in the AIDS stage. DT started within 7 days of first specialist consultation in all patients and the same day in 84.1%; 3.4% had baseline resistance mutations (K103N, V106I + E138A, and V108I); 12.5% were lost to follow-up. At week 48, 86.3% had VL < 50 cop/uL by intention-to-treat analysis and 98.7% by per-protocol (PP) analysis. Virological failure (VF) was recorded in 1.1%, with no resistance mutation. One blip was detected in 5.2% without VF. Three reported anxiety, dizziness, and cephalgia, respectively, at week 4 and one reported insomnia at week 24; none reported adverse events at week 48. The mean weight was 4 kg higher at 48 weeks (p = 0.0001) and abdominal circumference 3 cm larger at 24 weeks (p = 0.022). No forgetfulness occurred in 98.7% of patients. Patient satisfaction was 90/100 at 4, 24, and 48 weeks. Conclusion: Real-world data demonstrate that dolutegravir plus lamivudine in MTR is effective, safe, and satisfactory, moderately increasing weight and abdominal circumference and administrable on a test-and-treat strategy. |
| publishDate |
2022 |
| dc.date.none.fl_str_mv |
2022 2022-03-01 2022 2022-03-01 |
| dc.type.none.fl_str_mv |
research article http://purl.org/coar/resource_type/c_2df8fbb1 |
| dc.type.openaire.fl_str_mv |
info:eu-repo/semantics/article |
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article |
| dc.identifier.none.fl_str_mv |
https://hdl.handle.net/20.500.13003/19547 |
| url |
https://hdl.handle.net/20.500.13003/19547 |
| dc.language.none.fl_str_mv |
Inglés eng |
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Inglés |
| language |
eng |
| dc.rights.none.fl_str_mv |
open access http://purl.org/coar/access_right/c_abf2 Attribution 4.0 International http://creativecommons.org/licenses/by/4.0/ |
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info:eu-repo/semantics/openAccess |
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open access http://purl.org/coar/access_right/c_abf2 Attribution 4.0 International http://creativecommons.org/licenses/by/4.0/ |
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openAccess |
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application/pdf |
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MDPI |
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MDPI |
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reponame:Docusalut instname:Conselleria de Salut i Consum del Govern de les Illes Balears |
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Conselleria de Salut i Consum del Govern de les Illes Balears |
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Docusalut |
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15,811543 |