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Clinical Trial
. 2024 Jun 1;38(7):983-991.
doi: 10.1097/QAD.0000000000003865. Epub 2024 Feb 21.

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

Chloe Orkin  1 , Andrea Antinori  2 , Jürgen K Rockstroh  3 , Santiago Moreno-Guillén  4 , Claudia T Martorell  5 , Jean-Michel Molina  6 , Adriano Lazzarin  7 , Franco Maggiolo  8 , Yazdan Yazdanpanah  9 , Kristen Andreatta  10 , Hailin Huang  10 , Jason T Hindman  10 , Hal Martin  10 , Anton Pozniak  11
Affiliations
Clinical Trial

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

Chloe Orkin et al. AIDS. .

Abstract

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 after switching, with diarrhea, weight gain, and headache occurring most commonly. There were no cases of proximal renal tubulopathy, drug-related Grade 4 adverse events, or serious adverse events. Two participants discontinued B/F/TAF due to treatment-related adverse events. 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.

Conclusion: 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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Conflict of interest statement

C.O. has received grants or contracts from Janssen, Gilead Sciences, ViiV Healthcare, MSD, and AstraZeneca (paid to institution); payment or honoraria for lectures, presentations, speakers’ bureaus, manuscript writing, or educational events from Janssen, Gilead Sciences, ViiV Healthcare, and MSD; and is President of the Medical Women's Federation (unpaid) and a governing council member of the International AIDS Society (unpaid). A.A. has received grants or contracts from Gilead Sciences, AstraZeneca, and ViiV Healthcare; consulting fees from Gilead Sciences, AstraZeneca, GSK, Merck, Janssen-Cilag, Moderna, Mylan, Pfizer, and ViiV Healthcare; and support for attending meetings and/or travel from Gilead Sciences. J.K.R. has received payment or honoraria for lectures, presentations, speakers’ bureaus, manuscript writing, or educational events from Gilead Sciences, Janssen, MSD, and ViiV Healthcare; and honoraria for consulting from Boehringer. S.-M.G. has received grants or contracts from Gilead Sciences, ViiV Healthcare, Janssen Pharmaceutical, and MSD; payment or honoraria for lectures, presentations, speakers’ bureaus, manuscript writing, or educational events from Gilead Sciences, ViiV Healthcare, Janssen Pharmaceutical, and MSD; support for attending meetings and/or travel from Gilead Sciences, ViiV Healthcare, Janssen Pharmaceutical, and MSD; and payment for participation on a data safety monitoring board or advisory board from Gilead Sciences, ViiV Healthcare, Janssen Pharmaceutical, and MSD. C.T.M. has received payments or honoraria for speakers’ bureaus from Gilead Sciences, ViiV Healthcare, Theratechnologies, and AbbVie. J.-M.M. has received grants or contracts from Gilead Sciences (paid to institution); consulting fees from Gilead Sciences, Merck, and ViiV Healthcare; and payment for participation on a data safety monitoring board or advisory board for Aelix. K.A., H.H., and J.T.H., are employees of Gilead Sciences and hold stocks. H.M. was an employee of Gilead Sciences at the time of the study and holds stocks in the company. A.P. has received grants or contracts from Gilead Sciences and ViiV Healthcare (paid to institution); payment or honoraria for lectures, presentations, or educational events from Gilead Sciences and ViiV Healthcare; support for attending meetings and/or travel from Gilead Sciences and ViiV Healthcare; and is President of NEAT ID and a member of guideline committees for BHIVA and EACS. A.L., F.M., and Y.Y. have nothing to disclose.

Figures

None
Graphical abstract
Fig. 1
Fig. 1
Participant disposition from baseline to Week 240 (OLE Week 96).
Fig. 2
Fig. 2
Proportion of participants with HIV-1 RNA <50 copies/ml to OLE Week 96. (a) M = E analysis and (b) M = F analysis.
Fig. 3
Fig. 3
Weight changes from baseline through Week 240 (OLE 96).
See this image and copyright information in PMC

References

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