Asian population data: conversion B/F/TAF can sustainably suppress the virus at a high level, safe and well tolerated!

Antiretroviral therapy (ART) can bring life expectancy of HIV-infected people to a level similar to that of healthy people, but even if virological suppression has been achieved during lifelong medication, there is often a need
to optimize treatment regimens due to adverse drug reactions, drug interactions, pill burden, and the desire to improve treatment adherence and quality of life.

Bictegravir/emtricitabine/tenofovir propofovir (B/F/TAF) has a high resistance barrier, maintains high viral inhibition rates, and has a long-term safety and tolerability profile with few drug interactions and high patient adherence ^[1-3].

In multiple registries, clinical trials, and real-world studies involving virologic suppression of conversion therapy in HIV-infected patients, B/F/TAF has demonstrated its non-inferior efficacy and good safety profile
.

A recent study published in the journal HIV Medicine ^[4] pooled data from Asian or Asian participants in three international phase III clinical trials of B/F/TAF and reaffirmed the efficacy and safety
of B/F/TAF for viral suppression of conversion therapy in Asian adults with HIV infection.
In this issue, we specially invited Director Zhao Qingxia from Henan Provincial Infectious Disease Hospital to interpret
this study.

The three included clinical trials were GS-US-380-1844, GS-US-380-1961 and GS-US-380-1878, all of which were international multicentre non-inferiority trials
conducted at 48 weeks in adults with HIV infection.
Subjects achieved virologic suppression (HIV-1 RNA<50 copies/mL) for at least 3-6 months<b11>.

Figure Trial design of three clinical trials

Note: ABC, abacavir; 3TC, lamivudine; DTG, dolutegravir; TDF, tenofovir disoproxil fumarate; E/C, Ivereve/Cobistat; ATV, atazanavir; RTV, ritonavir; DRV, darunavir

*Two nucleotide reverse transcriptase inhibitors (NRTIs) are ABC/3TC or F/TDF

There were 136 Asian or Asian participants in the three trials (hereinafter collectively referred to as Asian participants), and the proportion of HIV-1 RNA ≥50 copies/mL in all treatment groups was low at 48 weeks, and 0% (-1.
4%, 95% CI: -7.
4 to 4.
6
) in the B/F/TAF and maintenance baseline regimen (SBR) groups in Asia.
The virological inhibition rates were similar in the B/F/TAF group and the SBR group, with virological inhibition rates of 100% and 95.
9%,
respectively, at 48 weeks.
There was no treatment-related resistance in either group
.

Figure 48 weeks of virological results: (a) virologic results based on the US Food and Drug Administration (FDA) snapshot algorithm; (b) Differences in the proportion of participants with HIV-1 RNA ≥ 50 copies/mL (complete set of analyses, including all randomized subjects who have received at least one dose of study drug).

In terms of safety and tolerability, among Asian subjects, 3 drug-related adverse events (AEs) occurred in the B/F/TAF group and SBR group, dyslipidemia, elevated blood glucose and gastritis in the b/f/TAF group, dyslipidemia, headache, diarrhea in the SBR group, and no serious drug-related AEs
of grade 3 or above.
No participants stopped taking the drug for AE and there were no deaths among Asian participants
.

From baseline to week 48, no significant difference
was observed between groups in median change in estimated glomerular filtration rate (eGFR) in either Asian or non-Asian participants.
Compared with SBR, the proportion of participants with tubular proteinuria at week 48 after switching from a TDF-containing regimen to B/F/TAF was significantly lower
than baseline.

Figure Change in eGFR and proteinuria compared to baseline: (a-b) change in eGFR from baseline at 48 weeks in Asian and non-Asian subjects; (c) Change in proteinuria from baseline in participants with baseline TDF-containing regimens

Among Asian participants, fasting triglyceride levels were significantly reduced at 48 weeks in the B/F/TAF group compared with the SBR group, with no significant changes in total cholesterol, low-density lipoprotein (LDL) and high-density lipoprotein (HDL), and total cholesterol/HDL ratios, consistent with
non-Asian participants.

Figures Showing changes in fasting lipids and body weight from baseline: (a) median changes in fasting lipids in Asian subjects in both treatment groups; (b) Median fasting lipid change in non-Asian participants in both treatment groups

At 48 weeks, the median weight gain in the B/F/TAF group and the SBR group was 1.
5 kg and 1.
0 kg, respectively, and there was no significant difference between the two groups (p-> 0.
05) at each follow-up point (except week 12)
during the follow-up period.

Figure Median change in weight over 48 weeks in Asian subjects

The study pooled data from Asian subjects from three international multicenter studies and showed that subjects converted to B/F/TAF were able to maintain higher rates of virologic inhibition and lower rates
of drug-related AEs similar to the original protocol.
There were no significant differences in safety measures such as kidney, lipid, and weight gain from the control group treated with the maintenance regimen, indicating that B/F/TAF is a safe and effective switching regimen
for virological suppression of adult HIV-infected patients in Asia.