Bictegravir/emtricitabine/tenofovir alafenamide as initial treatment for HIV-1: five-year follow-up from two randomized trials

Sax, Paul E.; Arribas, José Ramón; Orkin, Chloe; Lazzarin, Adriano; Pozniak, Anton; DeJesus, Edwin; Maggiolo, Franco; Stellbrink, Hans‐Jürgen; Yazdanpanah, Yazdan; Acosta, Rima; Huang, Hailin; Hindman, Jason; Martin, Hal David; Baeten, Jared M.; Wohl, David A.

doi:10.1016/j.eclinm.2023.101991

Cited by 30 publications

(14 citation statements)

References 18 publications

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“…Consistent with findings seen in other clinical trials [ 15 ], there were no cases of treatment-emergent resistance with B/F/TAF. These data confirm and extend the previous 144- and 240-week follow-up results of B/F/TAF in the blinded and open-label phases, respectively [ 6 , 10 ], and 48-week follow-up results of B/F/TAF switch from DTG/ABC/3TC [ 5 ].…”

Section: Discussionsupporting

confidence: 88%

“…During the follow-up, adults who switched from DTG-based treatment to B/FTAF in studies 1489 and 1490 maintained high rates of virologic suppression with no treatment-emergent resistance to B/F/TAF during 96 weeks of treatment [ 10 ]. Two participants with M184 V had HIV-1 RNA of at least 200 copies/ml at the time of switching from DTG/ABC/3TC.…”

Section: Discussionmentioning

confidence: 99%

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Switch to bictegravir/emtricitabine/tenofovir alafenamide from dolutegravir-based therapy

Orkin,

Antinori,

Rockstroh

et al. 2024

Aids

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Objective: To evaluate the efficacy and safety of 96 weeks of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) treatment in participants switching from dolutegravir (DTG)-based therapy. Design: Studies 1489 (NCT02607930) and 1490 (NCT02607956) were phase 3 randomized, double-blind, active-controlled, first-line therapy trials in people with HIV-1. After 144 weeks of DTG-based or B/F/TAF treatment, participants could enter a 96-week open-label extension (OLE) of B/F/TAF. Methods: A pooled analysis evaluated viral suppression (HIV-1 RNA <50 copies/mL) and changes in CD4+ cell count at OLE Weeks 48 and 96, treatment-emergent resistance, safety and tolerability after switch from a DTG-based regimen to B/F/TAF. Outcomes by prior treatment were summarized using descriptive statistics and compared by two-sided Wilcoxon rank sum test. Results: At OLE Week 96, participants who switched to B/F/TAF (N=519) maintained high levels of virologic suppression (99.5% and 99.1% in those switching from DTG/abacavir/lamivudine and DTG+F/TAF, respectively) and CD4+ cell count, with no treatment-emergent resistance to B/F/TAF. Twenty-one participants experienced drug-related adverse events (AEs) after switching, with diarrhea, weight gain and headache occurring most commonly. There were no cases of proximal renal tubulopathy, drug-related Grade 4 AEs or serious AEs. Two participants discontinued B/F/TAF due to treatment-related AEs. Participants who switched from DTG/abacavir/lamivudine experienced statistically significant greater weight gain than those who switched from DTG+F/TAF; however, median weight change from the blinded phase baseline to OLE Week 96 was numerically similar across treatment groups. Conclusions: This medium-term analysis demonstrates the safety and efficacy of switching to B/F/TAF from a DTG-containing regimen in people with HIV-1.

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Section: Discussionsupporting

confidence: 88%

Section: Discussionmentioning

confidence: 99%

Switch to bictegravir/emtricitabine/tenofovir alafenamide from dolutegravir-based therapy

Orkin,

Antinori,

Rockstroh

et al. 2024

Aids

Self Cite

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“…This potentially indicates that participants can experience viral suppression efficiently and effectively once they are enrolled in this model of care and initiate B/F/TAF. The use of B/F/TAF as the primary line of treatment may also have contributed to this finding, given its high efficacy, tolerability, and simplicity [21].…”

Section: Discussionmentioning

confidence: 99%

Impact of social determinants of health on time to antiretroviral therapy initiation and HIV viral undetectability for migrants enrolled in a multidisciplinary HIV clinic with rapid, free, and onsite B/F/TAF: ‘The ASAP study’

Arora,

Vicente,

Engler

et al. 2024

HIV Medicine

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ObjectiveMultidisciplinary care with free, rapid, and on‐site bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) dispensation may improve health outcomes among migrants living with HIV. However, models for rapid B/F/TAF initiation are not well studied among migrants living with HIV, and an understanding of how social determinants of health (SDH) may affect HIV‐related health outcomes for migrants enrolled in such care models is limited.MethodsWithin a 96‐week pilot feasibility prospective cohort study at a multidisciplinary HIV clinic, participants received free B/F/TAF rapidly after care linkage. The effects of SDH (i.e., birth region, sexual orientation, living status, education, employment, French proficiency, health coverage, use of a public health facility outside our clinic for free blood tests, and time in Canada) and other covariates (i.e., age, sex) on median time to antiretroviral therapy (ART) initiation and HIV viral undetectability from care linkage were calculated via survival analyses.ResultsThirty‐five migrants were enrolled in this study. Median time to ART initiation and HIV undetectability was 5 days (range 0–50) and 57 days (range 5–365), respectively. Those who took significantly longer to initiate ART were aged <35 years, identified as heterosexual, had less than university‐level education, or were unemployed. No factor was found to significantly affect time to undetectability.ConclusionDespite the provision of free B/F/TAF, several SDH were linked to delays in ART initiation. However, once initiated and engaged, migrants living with HIV reached HIV undetectability efficiently. Findings provide preliminary support for adopting this care model with migrants living with HIV and suggest that SDH should be considered when designing clinical interventions for more equitable outcomes.

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“…Here, infection was initiated in the periphery. To model a commonly prescribed ART regimen, the current study used a daily combination treatment with bictegravir (B) – a recommended integrase strand transfer inhibitor (INSTI) -, emtricitabine (F) and tenofovir alafenamide (TAF) – nucleoside reverse transcriptase inhibitors (NRTIs) -, in accordance with recommended initial ART regimens that show high rates of viral suppression in PLWH (Havens et al, 2023; Sax et al, 2023).…”

Section: Introductionmentioning

confidence: 99%

Effects of antiretroviral treatment on central and peripheral immune response in mice with EcoHIV infection

Xie,

Namba,

Buck

et al. 2024

Preprint

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HIV infection is an ongoing global health issue despite increased access to antiretroviral therapy (ART). People living with HIV (PLWH) who are virally suppressed through ART still experience negative health outcomes, including neurocognitive impairment. It is increasingly evident that ART may act independently or in combination with HIV infection to alter immune state, though this is difficult to disentangle in the clinical population. Thus, these experiments used multiplexed chemokine/cytokine arrays to assess peripheral (plasma) and brain (nucleus accumbens; NAc) expression of immune targets in the presence and absence of ART treatment in the EcoHIV mouse model. The findings identify effects of EcoHIV infection and of treatment with bictegravir (B), emtricitabine (F) and tenofovir alafenamide (TAF) on expression of numerous immune targets. In the NAc, this included EcoHIV-induced increases in IL-1α and IL-13 expression and B/F/TAF-induced reductions in KC/CXCL1. In the periphery, EcoHIV suppressed IL-6 and LIF expression, while B/F/TAF reduced IL-12p40 expression. In absence of ART, IBA-1 expression was negatively correlated with CX3CL1 expression in the NAc of EcoHIV-infected mice. These findings identify distinct effects of ART and EcoHIV infection on peripheral and central immune factors and emphasize the need to consider ART effects on neural and immune outcomes.

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Bictegravir/emtricitabine/tenofovir alafenamide as initial treatment for HIV-1: five-year follow-up from two randomized trials

Cited by 30 publications

References 18 publications

Switch to bictegravir/emtricitabine/tenofovir alafenamide from dolutegravir-based therapy

Switch to bictegravir/emtricitabine/tenofovir alafenamide from dolutegravir-based therapy

Impact of social determinants of health on time to antiretroviral therapy initiation and HIV viral undetectability for migrants enrolled in a multidisciplinary HIV clinic with rapid, free, and onsite B/F/TAF: ‘The ASAP study’

Effects of antiretroviral treatment on central and peripheral immune response in mice with EcoHIV infection

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