Caution in Interpreting Equivalence From Nonsignificant Findings in Antiretroviral Switch Studies

To the Editor,We read with great interest the article by .The study is carefully conducted and addresses an important clinical question.However, several aspects of its rationale, design, and interpretation warrant reconsideration.When this study was conducted, dual therapy with dolutegravir/lamivudine (DTG/3TC) was not yet widely implemented or available as a fixed -dose combination.Although INSTINCT was registered in 2019, Dovato was not marketed in Spain until early 2020 (2).Participants likely received dolutegravir and lamivudine as separate agents, prescribed for specific clinical reasons rather than as standard care.Consequently, the findings may not fully reflect current real-world use of DTG/3TC and have limited generalizability.The biological rationale for expecting differences in inflammation between these regimens is weak.Both DTG/3TC and bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) are potent, well-tolerated therapies expected to yield similar immunologic effects once viral suppression is achieved.Indeed, recent studies comparing these combinations have reported no

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Publication Details

Journal
Clinical Infectious Diseases
Published
2025-12-07
DOI
https://doi.org/10.1093/cid/ciaf675
Primary Topic
HIV/AIDS drug development and treatment
Type
article
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article

Caution in Interpreting Equivalence From Nonsignificant Findings in Antiretroviral Switch Studies

Estebán Martínez
Clinical Infectious Diseases
HIV/AIDS drug development and treatment
article

Caution in Interpreting Equivalence From Nonsignificant Findings in Antiretroviral Switch Studies

Estebán Martínez
article en

Abstract

To the Editor,We read with great interest the article by .The study is carefully conducted and addresses an important clinical question.However, several aspects of its rationale, design, and interpretation warrant reconsideration.When this study was conducted, dual therapy with dolutegravir/lamivudine (DTG/3TC) was not yet widely implemented or available as a fixed -dose combination.Although INSTINCT was registered in 2019, Dovato was not marketed in Spain until early 2020 (2).Participants likely received dolutegravir and lamivudine as separate agents, prescribed for specific clinical reasons rather than as standard care.Consequently, the findings may not fully reflect current real-world use of DTG/3TC and have limited generalizability.The biological rationale for expecting differences in inflammation between these regimens is weak.Both DTG/3TC and bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) are potent, well-tolerated therapies expected to yield similar immunologic effects once viral suppression is achieved.Indeed, recent studies comparing these combinations have reported no

Clinical Infectious Diseases
Real Academia Española (ES), Instituto de Salud Carlos III (ES), Centro de Investigación Biomédica en Red (ES), Hospital Clínic de Barcelona (ES), Universitat de Barcelona (ES)
Openalex Percentile: Top 54%
HIV/AIDS drug development and treatment
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