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

Abstract

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.

Twelve‐month effectiveness and safety of bictegravir/emtricitabine/tenofovir alafenamide in people with HIV: Real‐world insights from BICSTaR cohorts

“…A previous pooled analysis of the BICSTaR study suggested that people who have neuropsychiatric symptoms when starting treatment were less likely to have an undetectable viral load at 12 months [33]. Overall, our current findings add to the data supporting B/F/TAF as an effective option for a broad range of people, including those with late HIV diagnosis [27], women [34], older individuals [15,28,34,35], people of black race [36], and those with evidence of pre-existing viral resistance (mainly M184V/I) [30,37]. CD4 cell count and CD4/CD8 ratio were statistically significantly improved in TN participants and, to a lesser extent, in TE participants, consistent with the known benefits of ART [4,11,18,20], indicating a shift towards restoration of immunological function.…”

“…A previous pooled analysis of the BICSTaR study suggested that people who have neuropsychiatric symptoms when starting treatment were less likely to have an undetectable viral load at 12 months [33]. Overall, our current findings add to the data supporting B/F/TAF as an effective option for a broad range of people, including those with late HIV diagnosis [27], women [34], older individuals [15, 28, 34, 35], people of black race [36], and those with evidence of pre‐existing viral resistance (mainly M184V/I) [30, 37].…”

“…A growing number of real-world studies in a number of countries have evaluated B/F/TAF, providing evidence for its effectiveness, tolerability and safety in routine clinical practice [23][24][25][26][27][28][29][30]. Most of these data are from small and/or retrospective, country-specific studies.…”

Twelve-month effectiveness and safety of bictegravir/emtricitabine/tenofovir alafenamide in people with HIV from the Canadian cohort of the observational BICSTaR study

“…[3,8,[19][20][21] Several small real-world evidence (RWE) studies have shown the effectiveness and safety of B/F/TAF in routine clinical practice. [22][23][24][25][26][27][28][29][30][31][32] However, there is little RWE with B/F/TAF in the Canadian population. The only available evidence from Canada comes from specific population groups, such as TN migrant people in a Montreal-based multidisciplinary HIV care clinic receiving rapid cost-covered B/F/TAF initiation, [31,32] and a retrospective chart review in people with previously documented primary nucleoside reverse transcriptase inhibitor (NRTI) resistance at a single center in Alberta.…”

Tecovirimat Use in Combination With Fixed-Dose Bictegravir in a Person With HIV and Concurrent Monkeypox

“…Based on our case, if a PWH presents with MPV, has baseline HIV VL suppression and full ARV regimen activity (no significant nucleoside/tide reverse transcriptase inhibitor [NRTI] mutations), 11,12 or is treatment-naïve, then these authors recommend no bictegravir adjustment or alternative treatment strategy. If significant baseline NRTI resistance exists and/or a prolonged tecovirimat regimen is prescribed, then an empiric ARV switch (dolutegravir [metabolism primarily via UDG, no expected tecovirimat interaction] substitution) may be necessary to avoid a DDI with potential VL compromise for 14 days after the completed MPV treatment.…”