Switching to coformulated bictegravir, emtricitabine, and tenofovir alafenamide maintained viral suppression in adults with historical virological failures and K65N/R mutation

Tsai, Mao‐Song; Sun, Hsin‐Yun; Chen, Cheng-Pin; Lee, Chen‐Hsiang; Lee, Chun-Yuan; Liu, Chun-Eng; Tang, Hung‐Jen; Hung, Tung-Che; Li, Chia‐Wen; Lee, Yuan‐Ti; Liou, Bo-Huang; Yang, Chia‐Jui; Hung, Chien‐Ching

doi:10.1016/j.ijid.2022.11.012

Cited by 11 publications

(5 citation statements)

References 39 publications

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“…The data from our study, combined with the post hoc analysis of five clinical trials [7,8], provides evidence that B/F/TAF can be effective in treating PLHIV who have historical NRTI RAMs, thereby reducing pill burden and reducing the risk of drug-drug interactions. Further 'real world' data in support of the efficacy of B/F/TAF in patients with historical NRTI RAMs comes from other cohort studies from Spain [11], Italy [12] and Taiwan [13]. Only one patient in our cohort had a K65R RAM, but the cohort study from Taiwan included 71 PLHIV with K65R/ N, of whom 36 also had M184V/I and nine had at least one TAM, and plasma HIV RNA remained at < 50 copies/ mL in all patients after switching to B/F/TAF.…”

Section: Discussionmentioning

confidence: 99%

“…We only had one patient with a K65R/E/M RAM, who had K65R, K70R, Y115F and M184V, but that patient remained suppressed after a switch to B/F/TAF. However, the cohort study from Taiwan provides reassuring data on the efficacy of B/F/TAF in virologically suppressed patients with K65R/N RAMs, half of whom also had M184V/I [13]. We had limited numbers of patients with three or more NRTI RAMs, which could be due to the low prevalence of such patients, but could also be explained by a patient selection bias; clinicians may be hesitant to treat such patients with B/F/TAF.…”

Section: Discussionmentioning

confidence: 99%

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Bictegravir/emtricitabine/tenofovir alafenamide in patients with genotypic NRTI resistance

Shafran

Hughes

2022

HIV Medicine

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Background: Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) is approved for treatment of HIV without known resistance to its components.Several studies have demonstrated efficacy of B/F/TAF in patients with nucleoside reverse transcriptase inhibitor (NRTI) resistance-associated mutations (RAMs), mainly identified by proviral DNA testing, but data on the efficacy of B/F/TAF in patients with NRTI RAMs identified in viraemic plasma are limited.Methods: We used a retrospective analysis of patients receiving B/F/TAF identified by searching electronic health records with eligibility confirmed by review of individual patient records. Patients included were ≥ 18 years, had 2019 International Antiviral Socitey-USA (IAS-USA) major RAMs affecting NRTIs detected in viraemic plasma prior to starting B/F/TAF and one or more HIV viral load (VL) after starting B/F/TAF. Results: In all, 50 patients met the study criteria: mean age of 54 years, mean proximal CD4 count of 609 cells/μL, 64% male. A total of 46 were virologically suppressed (< 200 copies/mL) when B/F/TAF was initiated, two were treatmentnaïve, one stopped prior antiretroviral therapy (ART) and one had a VL of 961 HIV-1 RNA copies/mL on ART. Twenty-nine had one NRTI RAM (24 were M184V/I), nine had two NRTI RAMs, three had three NRTI RAMs, four had four NRTI RAMs, two had five NRTI RAMs, one had six NRTI RAMs, one had seven RAMs and one had eight NRTI RAMs. At the last VL on B/F/TAF, a mean of 18.6 months after starting B/F/TAF, 49 out of 50 had VL < 100 copies/mL and one had a VL of 208 copies/mL at 11 months but only filled 5 months of B/F/TAF.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Bictegravir/emtricitabine/tenofovir alafenamide in patients with genotypic NRTI resistance

Shafran

Hughes

2022

HIV Medicine

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“…They also demonstrated that only patients who had previously experienced INIs failures were at risk of losing virological control under BIC-STR [13]. Other studies confirmed that previous resistance-associated mutations to nucleoside reverse transcriptase inhibitors (such as M184V and K65N/R) are not associated with virological failure after the switch to BIC-STR in virological suppressed PLWH [14,15]. Furthermore, no differences between DTG and BIC regimens have been observed regarding low-level viremia or virological failure onset [15].…”

Section: Discussionmentioning

confidence: 90%

Bictegravir/Tenofovir Alafenamide/Emtricitabine: A Real-Life Experience in People Living with HIV (PLWH)

Gidari,

Benedetti,

Tordi

et al. 2023

Infectious Disease Reports

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Background: Bictegravir (BIC), a recently introduced integrase inhibitor, is available in a single tablet regimen with tenofovir alafenamide (TAF) and emtricitabine (FTC) (BIC-STR). This study aimed to describe a real-life experience with BIC-STR. Methods: We retrospectively analyzed the data of people living with HIV (PLWH) on antiretroviral therapy (ART) with BIC-STR followed by the Clinic of Infectious Diseases of Perugia (Perugia, Italy) from September 2019 to February 2023. Results: 270 PLWH were enrolled with a median follow-up time on BIC-STR of 2.2 years (IQR 1.2–2.7). In the overall population, in treatment-experienced (N = 242), in treatment-naïve (N = 28), and in population with age > 60 years old (N = 86), we observed that CD4 cell count improved in absolute number, percentage and CD4/CD8 ratio, under BIC-STR. Patients with viremia < 50 cp/mL increased in all groups. In the overall population, previous ART with TAF and nadir CD4 cell count favored immunological recovery. In the ART-experienced group, time in therapy with BIC-STR was associated with HIV-RNA undetectability. In the older group, previous opportunistic infection and advanced age were associated with lower CD4 count. Conclusions: BIC-STR was demonstrated, in real-life, to be a valid option for a switch, such as initial ART.

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“…Participants on DTG‐based ART had higher rates of viral suppression at 1 year than those on NNRTIs‐based ART [66]. In addition, BIC/FTC/TAF could be a simplified option after viral suppression, although some patients developed K65N/R +/− M184V/I after VF [67].…”

Section: Impact Of Instis On Llvmentioning

confidence: 99%

Clinical significance and management of low‐level HIV viremia in the era of integrase strand transfer inhibitors

Shi,

Ying,

Zheng

et al. 2023

HIV Medicine

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BackgroundPeople living with HIV (PLWH) and receiving antiretroviral therapy (ART) have a goal of achieving and maintaining viral suppression; however, the existence of PLWH that show events of low‐level viremia (LLV) between 50 and 1000 copies/mL and with different virological consequences have been observed. Moreover, some reports indicate that LLV status can lead to residual immune activation and inflammation, leading to a higher occurrence of non‐AIDS‐defining events (nADEs) and other adverse clinical outcomes. Until now, however, published data have shown controversial results that hinder understanding of this phenomenon's actual cause(s) and origin(s). Integrase strand transfer inhibitors (INSTIs)‐based therapies could lead to lower LLV over time and, therefore, more effective virological control.ObjectivesThis review aims to assess recent findings to provide a view of the clinical significance and management of low‐level HIV viremia in the era of INSTIs.

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Switching to coformulated bictegravir, emtricitabine, and tenofovir alafenamide maintained viral suppression in adults with historical virological failures and K65N/R mutation

Cited by 11 publications

References 39 publications

Bictegravir/emtricitabine/tenofovir alafenamide in patients with genotypic NRTI resistance

Bictegravir/emtricitabine/tenofovir alafenamide in patients with genotypic NRTI resistance

Bictegravir/Tenofovir Alafenamide/Emtricitabine: A Real-Life Experience in People Living with HIV (PLWH)

Clinical significance and management of low‐level HIV viremia in the era of integrase strand transfer inhibitors

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