Switching to Dolutegravir/lamivudine or Bictegravir/Emtricitabine/Tenofovir alafenamide. A comparative real-world study

Abstract

Background

This real-world study compared the safety and effectiveness of Dolutegravir/lamivudine (D/L) and Bictegravir/Emtricitabine/Tenefovir alafenamide (B/F/T) switch therapy regimens for people living with HIV (PLWH)

Methods

The retrospective study conducted from April 2019 to November 2022, included PLWH with < 50 copies/mL of HIV-RNA prior to recruitment who initiated either D/L or B/F/T switching therapy. The primary objective was to evaluate treatment discontinuation rates; safety and virologic outcomes were also evaluated.

Results

690 PLWH were included, 358 in the D/L and 332 in the B/F/T, and a median follow-up of 728 and 1013 days, respectively. The discontinuation proportions were 8.7% (31 participants, incidence rate of 4.44 per 100 PYFU in the D/L group and 15.3% (51 participants, incidence rate of 6.25 per 100 PYFU) in the B/F/T group. The adjusted hazard ratio for B/F/T discontinuation compared to D/L was 1.20 (95% CI: 0.71;2.0; p = 0.494). Virologic failure (VL > 200 copies/mL in two consecutive measurements) occurred in 1.1% and 0.9% of patients in the D/L and B/F/T groups, respectively. Notably, one patient in D/L group with severe non-adherence and virologic failure developed resistance mutations.

Conclusions

Switching to either B/T/F or D/L treatment for PLWH was effective and well tolerated in this real-world study. Treatment discontinuation rates did not significantly differ between the two regimens.

Keywords:

• Switching antiretroviral therapy
• optimizing antiretroviral therapy
• Dolutegravir/lamivudine
• Bictegravir/Emtricitabine/Tenofovir alafenamide
• real-world data

Authors’ contributions

H.K: Participate in the design of the work; the analysis of data; and drafted the work. E.C-R: Participate in the interpretation of data and substantively revised the final document. A.G: Participate in the acquisition of the data. P.K: Participate in the analysis of the data and substantively revised the final document. J.V-G: Participate in the acquisition of the data. A.G-M: Participate in the acquisition of the data. C.C: Participate in the acquisition of the data. I. A-A: Participate in the acquisition of the data. A.M: Participate in the acquisition of the data. A.A-T: Participate in the acquisition of the data. R.G-F: Participate in the interpretation of data and substantively revised the final document. All the authors have read and approved the submitted version of the article.

Disclosure statement

H.K has received financial compensation for consulting and speaking engagements from Gilead Sciences, Janssen-Cilag, MSD, and ViiV Healthcare. R.G-F has received financial compensation for consulting and speaking engagements from Gilead Sciences, Janssen-Cilag, and ViiV Healthcare. The rest of the authors declare that they have no competing interests

Data availability statement

The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.

Additional information

Funding

The author(s) reported there is no funding associated with the work featured in this article.