Andrea De Vito, Alessandro Tavelli, Alessandro Cozzi-Lepri, Andrea Giacomelli, Roberto Rossotti, Giacomo Ponta, Nicoletta Bobbio, Alice Ianniello, Antonella Cingolani, Giordano Madeddu, Andrea Antinori, Antonella d'Arminio Monforte
{"title":"HIV患者双方案治疗后改用比替格拉韦/恩曲他滨/替诺福韦阿拉那胺的安全性和有效性：来自Icona队列的见解","authors":"Andrea De Vito, Alessandro Tavelli, Alessandro Cozzi-Lepri, Andrea Giacomelli, Roberto Rossotti, Giacomo Ponta, Nicoletta Bobbio, Alice Ianniello, Antonella Cingolani, Giordano Madeddu, Andrea Antinori, Antonella d'Arminio Monforte","doi":"10.1111/hiv.70037","DOIUrl":null,"url":null,"abstract":"<p><strong>Objectives: </strong>Most treatment switches are for simplification from three-drug (3DR) to dual regimens (2DR). However, a proportion of people with HIV may switch back to 3DR, like bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) after 2DR.</p><p><strong>Methods: </strong>We included people with HIV enroled in the Icona cohort who switched to B/F/TAF after 2DR INSTI-based (3TC/DTG, RPV/DTG, RPV/CAB, or DOR + DTG). Virological rebound (VR), virological suppression (VS), and treatment discontinuation (TD) due to toxicity or failure were evaluated using Kaplan-Meier curves. Random intercept and slopes before and after the switch were used to evaluate the trajectories of triglycerides, cholesterol, CD4, and CD4/CD8. Viro-immunological analyses were stratified according to HIV-RNA at switch.</p><p><strong>Results: </strong>Among the 3662 people with HIV who started a 2DR INSTI-based regimen, 71 (1.9%) switched to B/F/TAF; 60 had been followed up after the switch, for a median of 10.9 months (interquartile range: 3.6-24.7). Forty people with HIV switched with HIV-RNA <50 copies/mL (uVL), 20 with HIV-RNA ≥50 copies/mL (dVL). Among the uVL group, one participant experienced VR (HIV-RNA: 99, 71 followed by 29 copies/mL). Among the dVL group, the 1-year cumulative probability of undetectable VL was 75% (95% confidence interval [CI] 57.6-95.1). Fourteen people with HIV interrupted B/F/TAF for simplification (50.0%), toxicity (28.6%), VR (14.2%), and patient's choice (7.1); the 1-year cumulative probability of TD for toxicity/failure was 10.7% (95% CI 14.5-24.5). We observed an increase in the CD4/CD8 ratio (+0.02 CD4/CD8/month, p = 0.026) only in the dVL group.</p><p><strong>Conclusions: </strong>Switching from 2DR-INSTI to B/F/TAF is infrequent; this switch results in a low rate of toxicity and failure, along with a favourable immunovirological and lipid profile. CD4/CD8 gain is observed in those switching with detectable HIV-RNA.</p>","PeriodicalId":13176,"journal":{"name":"HIV Medicine","volume":" ","pages":""},"PeriodicalIF":2.8000,"publicationDate":"2025-04-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Safety and effectiveness of switch to bictegravir/emtricitabine/tenofovir alafenamide following dual regimen therapy in people with HIV: Insights from the Icona cohort.\",\"authors\":\"Andrea De Vito, Alessandro Tavelli, Alessandro Cozzi-Lepri, Andrea Giacomelli, Roberto Rossotti, Giacomo Ponta, Nicoletta Bobbio, Alice Ianniello, Antonella Cingolani, Giordano Madeddu, Andrea Antinori, Antonella d'Arminio Monforte\",\"doi\":\"10.1111/hiv.70037\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Objectives: </strong>Most treatment switches are for simplification from three-drug (3DR) to dual regimens (2DR). However, a proportion of people with HIV may switch back to 3DR, like bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) after 2DR.</p><p><strong>Methods: </strong>We included people with HIV enroled in the Icona cohort who switched to B/F/TAF after 2DR INSTI-based (3TC/DTG, RPV/DTG, RPV/CAB, or DOR + DTG). Virological rebound (VR), virological suppression (VS), and treatment discontinuation (TD) due to toxicity or failure were evaluated using Kaplan-Meier curves. Random intercept and slopes before and after the switch were used to evaluate the trajectories of triglycerides, cholesterol, CD4, and CD4/CD8. Viro-immunological analyses were stratified according to HIV-RNA at switch.</p><p><strong>Results: </strong>Among the 3662 people with HIV who started a 2DR INSTI-based regimen, 71 (1.9%) switched to B/F/TAF; 60 had been followed up after the switch, for a median of 10.9 months (interquartile range: 3.6-24.7). Forty people with HIV switched with HIV-RNA <50 copies/mL (uVL), 20 with HIV-RNA ≥50 copies/mL (dVL). Among the uVL group, one participant experienced VR (HIV-RNA: 99, 71 followed by 29 copies/mL). Among the dVL group, the 1-year cumulative probability of undetectable VL was 75% (95% confidence interval [CI] 57.6-95.1). Fourteen people with HIV interrupted B/F/TAF for simplification (50.0%), toxicity (28.6%), VR (14.2%), and patient's choice (7.1); the 1-year cumulative probability of TD for toxicity/failure was 10.7% (95% CI 14.5-24.5). We observed an increase in the CD4/CD8 ratio (+0.02 CD4/CD8/month, p = 0.026) only in the dVL group.</p><p><strong>Conclusions: </strong>Switching from 2DR-INSTI to B/F/TAF is infrequent; this switch results in a low rate of toxicity and failure, along with a favourable immunovirological and lipid profile. CD4/CD8 gain is observed in those switching with detectable HIV-RNA.</p>\",\"PeriodicalId\":13176,\"journal\":{\"name\":\"HIV Medicine\",\"volume\":\" \",\"pages\":\"\"},\"PeriodicalIF\":2.8000,\"publicationDate\":\"2025-04-28\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"HIV Medicine\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1111/hiv.70037\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q2\",\"JCRName\":\"INFECTIOUS DISEASES\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"HIV Medicine","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1111/hiv.70037","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"INFECTIOUS DISEASES","Score":null,"Total":0}
Safety and effectiveness of switch to bictegravir/emtricitabine/tenofovir alafenamide following dual regimen therapy in people with HIV: Insights from the Icona cohort.
Objectives: Most treatment switches are for simplification from three-drug (3DR) to dual regimens (2DR). However, a proportion of people with HIV may switch back to 3DR, like bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) after 2DR.
Methods: We included people with HIV enroled in the Icona cohort who switched to B/F/TAF after 2DR INSTI-based (3TC/DTG, RPV/DTG, RPV/CAB, or DOR + DTG). Virological rebound (VR), virological suppression (VS), and treatment discontinuation (TD) due to toxicity or failure were evaluated using Kaplan-Meier curves. Random intercept and slopes before and after the switch were used to evaluate the trajectories of triglycerides, cholesterol, CD4, and CD4/CD8. Viro-immunological analyses were stratified according to HIV-RNA at switch.
Results: Among the 3662 people with HIV who started a 2DR INSTI-based regimen, 71 (1.9%) switched to B/F/TAF; 60 had been followed up after the switch, for a median of 10.9 months (interquartile range: 3.6-24.7). Forty people with HIV switched with HIV-RNA <50 copies/mL (uVL), 20 with HIV-RNA ≥50 copies/mL (dVL). Among the uVL group, one participant experienced VR (HIV-RNA: 99, 71 followed by 29 copies/mL). Among the dVL group, the 1-year cumulative probability of undetectable VL was 75% (95% confidence interval [CI] 57.6-95.1). Fourteen people with HIV interrupted B/F/TAF for simplification (50.0%), toxicity (28.6%), VR (14.2%), and patient's choice (7.1); the 1-year cumulative probability of TD for toxicity/failure was 10.7% (95% CI 14.5-24.5). We observed an increase in the CD4/CD8 ratio (+0.02 CD4/CD8/month, p = 0.026) only in the dVL group.
Conclusions: Switching from 2DR-INSTI to B/F/TAF is infrequent; this switch results in a low rate of toxicity and failure, along with a favourable immunovirological and lipid profile. CD4/CD8 gain is observed in those switching with detectable HIV-RNA.
期刊介绍：
HIV Medicine aims to provide an alternative outlet for publication of international research papers in the field of HIV Medicine, embracing clinical, pharmocological, epidemiological, ethical, preclinical and in vitro studies. In addition, the journal will commission reviews and other feature articles. It will focus on evidence-based medicine as the mainstay of successful management of HIV and AIDS. The journal is specifically aimed at researchers and clinicians with responsibility for treating HIV seropositive patients.
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