Effectiveness and safety of integrase strand transfer inhibitors in Spain: a prospective real-world study.
INTRODUCTION: Second-generation integrase strand transfer inhibitors (INSTIs) are preferred treatment options worldwide, and dolutegravir (DTG) is the treatment of choice in resource-limited settings. Nevertheless, in some resource-limited settings, these drugs are not always available. An analysis...
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| Format: | Article |
| Status: | Published version |
| Publication date: | 2023 |
| Country: | España |
| Institution: | Instituto de Investigación Biomédica y Sanitaria de Alicante (ISABIAL) |
| Repository: | r-ISABIAL. Repositorio Institucional de Producción Científica del Instituto de Investigación Biomédica y Sanitaria de Alicante |
| OAI Identifier: | oai:isabial.fundanetsuite.com:p9836 |
| Online Access: | https://isabial.portalinvestigacion.com/publicaciones9836 https://www.frontiersin.org/articles/10.3389/fcimb.2023.1187999/full |
| Access Level: | Open access |
| Keyword: | HIV dolutegravir elvitegravir integrase strand transfer inhibitors (INSTI) raltegravir real-world study |
| _version_ | 1878738521071550465 |
|---|---|
| author | Santos JR |
| author2 | Casadellà M Noguera-Julian M Micán-Rivera R Domingo P Antela A Portilla J Sanz J Montero-Alonso M Navarro J Masiá M Valcarce-Pardeiro N Ocampo A Pérez-Martínez L García-Vallecillos C Vivancos MJ Imaz A Iribarren JA Hernández-Quero J Villar-García J Barrufet P Paredes R |
| author2_role | author author author author author author author author author author author author author author author author author author author author author |
| author_browse | Antela A Barrufet P Casadellà M Domingo P García-Vallecillos C Hernández-Quero J Imaz A Iribarren JA Masiá M Micán-Rivera R Montero-Alonso M Navarro J Noguera-Julian M Ocampo A Paredes R Portilla J Pérez-Martínez L Santos JR Sanz J Valcarce-Pardeiro N Villar-García J Vivancos MJ |
| author_facet | Santos JR Casadellà M Noguera-Julian M Micán-Rivera R Domingo P Antela A Portilla J Sanz J Montero-Alonso M Navarro J Masiá M Valcarce-Pardeiro N Ocampo A Pérez-Martínez L García-Vallecillos C Vivancos MJ Imaz A Iribarren JA Hernández-Quero J Villar-García J Barrufet P Paredes R |
| author_role | author |
| collection | r-ISABIAL. Repositorio Institucional de Producción Científica del Instituto de Investigación Biomédica y Sanitaria de Alicante |
| description | INTRODUCTION: Second-generation integrase strand transfer inhibitors (INSTIs) are preferred treatment options worldwide, and dolutegravir (DTG) is the treatment of choice in resource-limited settings. Nevertheless, in some resource-limited settings, these drugs are not always available. An analysis of the experience with the use of INSTIs in unselected adults living with HIV may be of help to make therapeutic decisions when second-generation INSTIs are not available. This study aimed to evaluate the real-life effectiveness and safety of dolutegravir (DTG), elvitegravir/cobicistat (EVG/c), and raltegravir (RAL) in a large Spanish cohort of HIV-1-infected patients. METHODS: Real-world study of adults living with HIV who initiated integrase INSTIs DTG, EVG/c, and RAL-based regimens in three settings (ART-naïve patients, ART-switching, and ART-salvage patients). The primary endpoint was the median time to treatment discontinuation after INSTI-based regimen initiation. Proportion of patients experiencing virological failure (VF) (defined as two consecutive viral loads (VL) =200 copies/mL at 24 weeks or as a single determination of VL =1,000 copies/mL while receiving DTG, EVG/c or RAL, and at least 3 months after INSTI initiation) and time to VF were also evaluated. RESULTS: Virological effectiveness of EVG/c- and RAL-based regimens was similar to that of DTG when given as first-line and salvage therapy. Treatment switching for reasons other than virological failure was more frequent in subjects receiving EVG/c and, in particular, RAL. Naïve patients with CD4+ nadir <100 cells/µL were more likely to develop VF, particularly if they initiated RAL or EVG/c. In the ART switching population, initiation of RAL and EVG/c was associated with both VF and INSTI discontinuation. There were no differences in the time to VF and INSTI discontinuation between DTG, EVG/c and RAL. Immunological parameters improved in the three groups and for the three drugs assessed. Safety and tolerability were consistent with expected safety profiles. DISCUSSION: Whereas second-generation INSTIs are preferred treatment options worldwide, and DTG is one of the treatment of choices in resource-limited settings, first-generation INSTIs may still provide high virological and immunological effectiveness when DTG is not available. |
| eu_rights_str_mv | openAccess |
| format | article |
| id | ES_b05abd44f1fd1a5fcad86d34a5c58bb8 |
| institution | Instituto de Investigación Biomédica y Sanitaria de Alicante (ISABIAL) |
| instname_str | Instituto de Investigación Biomédica y Sanitaria de Alicante (ISABIAL) |
| network_acronym_str | ES |
| network_name_str | España |
| oai_identifier_str | oai:isabial.fundanetsuite.com:p9836 |
| publishDate | 2023 |
| publishDateSort | 2023 |
| publisher | FRONTIERS MEDIA SA |
| publisherStr | FRONTIERS MEDIA SA |
| reponame_str | r-ISABIAL. Repositorio Institucional de Producción Científica del Instituto de Investigación Biomédica y Sanitaria de Alicante |
| spelling | Effectiveness and safety of integrase strand transfer inhibitors in Spain: a prospective real-world study. Santos JR Casadellà M Noguera-Julian M Micán-Rivera R Domingo P Antela A Portilla J Sanz J Montero-Alonso M Navarro J Masiá M Valcarce-Pardeiro N Ocampo A Pérez-Martínez L García-Vallecillos C Vivancos MJ Imaz A Iribarren JA Hernández-Quero J Villar-García J Barrufet P Paredes R HIV dolutegravir elvitegravir integrase strand transfer inhibitors (INSTI) raltegravir real-world study INTRODUCTION: Second-generation integrase strand transfer inhibitors (INSTIs) are preferred treatment options worldwide, and dolutegravir (DTG) is the treatment of choice in resource-limited settings. Nevertheless, in some resource-limited settings, these drugs are not always available. An analysis of the experience with the use of INSTIs in unselected adults living with HIV may be of help to make therapeutic decisions when second-generation INSTIs are not available. This study aimed to evaluate the real-life effectiveness and safety of dolutegravir (DTG), elvitegravir/cobicistat (EVG/c), and raltegravir (RAL) in a large Spanish cohort of HIV-1-infected patients. METHODS: Real-world study of adults living with HIV who initiated integrase INSTIs DTG, EVG/c, and RAL-based regimens in three settings (ART-naïve patients, ART-switching, and ART-salvage patients). The primary endpoint was the median time to treatment discontinuation after INSTI-based regimen initiation. Proportion of patients experiencing virological failure (VF) (defined as two consecutive viral loads (VL) =200 copies/mL at 24 weeks or as a single determination of VL =1,000 copies/mL while receiving DTG, EVG/c or RAL, and at least 3 months after INSTI initiation) and time to VF were also evaluated. RESULTS: Virological effectiveness of EVG/c- and RAL-based regimens was similar to that of DTG when given as first-line and salvage therapy. Treatment switching for reasons other than virological failure was more frequent in subjects receiving EVG/c and, in particular, RAL. Naïve patients with CD4+ nadir <100 cells/µL were more likely to develop VF, particularly if they initiated RAL or EVG/c. In the ART switching population, initiation of RAL and EVG/c was associated with both VF and INSTI discontinuation. There were no differences in the time to VF and INSTI discontinuation between DTG, EVG/c and RAL. Immunological parameters improved in the three groups and for the three drugs assessed. Safety and tolerability were consistent with expected safety profiles. DISCUSSION: Whereas second-generation INSTIs are preferred treatment options worldwide, and DTG is one of the treatment of choices in resource-limited settings, first-generation INSTIs may still provide high virological and immunological effectiveness when DTG is not available. FRONTIERS MEDIA SA https://isabial.portalinvestigacion.com/publicaciones9836 https://www.frontiersin.org/articles/10.3389/fcimb.2023.1187999/full |
| spellingShingle | Effectiveness and safety of integrase strand transfer inhibitors in Spain: a prospective real-world study. Santos JR HIV dolutegravir elvitegravir integrase strand transfer inhibitors (INSTI) raltegravir real-world study |
| status_str | publishedVersion |
| title | Effectiveness and safety of integrase strand transfer inhibitors in Spain: a prospective real-world study. |
| title_full | Effectiveness and safety of integrase strand transfer inhibitors in Spain: a prospective real-world study. |
| title_fullStr | Effectiveness and safety of integrase strand transfer inhibitors in Spain: a prospective real-world study. |
| title_full_unstemmed | Effectiveness and safety of integrase strand transfer inhibitors in Spain: a prospective real-world study. |
| title_short | Effectiveness and safety of integrase strand transfer inhibitors in Spain: a prospective real-world study. |
| title_sort | Effectiveness and safety of integrase strand transfer inhibitors in Spain: a prospective real-world study. |
| topic | HIV dolutegravir elvitegravir integrase strand transfer inhibitors (INSTI) raltegravir real-world study |
| topic_facet | HIV dolutegravir elvitegravir integrase strand transfer inhibitors (INSTI) raltegravir real-world study |
| url | https://isabial.portalinvestigacion.com/publicaciones9836 https://www.frontiersin.org/articles/10.3389/fcimb.2023.1187999/full |