Real-life experience with bictegravir/emtricitabine/tenofovir alafenamide in a large reference clinical centre

Abstract

Background The use of bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) is mainly based on robust, pivotal clinical trials. Objectives To provide data on clinical use of BIC/FTC/TAF in real life. Patients and methods This was an observational, retrospective and single-centre study. We included all adult, treatment-naive (TN) and treatment-experienced (TE) people living with HIV (PLWH) starting BIC/FTC/TAF from 8 June 2018. We evaluated effectiveness [on treatment (OT), modified intention-to-treat (mITT) and intention-to-treat (ITT)], tolerability and safety in those patients who reached 6 months of follow-up (M6). Results We included 1584 PLWH [213 TN (13%) and 1371 TE (87%)]. The median (IQR) follow-up was 16 (7–21) months, with 81% and 53% of PLWH reaching M6 and M12, respectively. By OT, mITT and ITT, HIV-RNA <50 copies/mL was 77%, 70% and 62% at M6 and 92%, 77% and 63% at M12 for TN PLWH and 94%, 89% and 83% at M6 and 93%, 85% and 78% at M12 for TE PLWH, respectively. In PLWH carrying an M184V/I substitution, OT RNA <50 copies/mL was 89.5% at M6. The median CD4 cell count increased from 329 to 511/μL in TN PLWH and from 630 to 683/μL in TE PLWH at M6. Of the total, 1148 (88%) PLWH continued on BIC/FTC/TAF at M6. The most frequent known reason for discontinuation was toxicity [42 (69%) cases]; only 7 cases were considered virological failures (0.6% of the total OT cohort at M6), with no emerging resistance substitutions. Conclusions In real life, BIC/FTC/TAF showed high rates of virological suppression and also in PLWH carrying lamivudine/emtricitabine resistance substitutions. The tolerability and safety of BIC/FTC/TAF were good, with high persistence observed for patients on this regimen at M6.

Impact of preexisting nucleos(t)ide reverse transcriptase inhibitor resistance on the effectiveness of bictegravir/emtricitabine/tenofovir alafenamide in treatment experience patients

“…Similarly, in a large cohort of patients treated in Barcelona (Spain), 93% of 695 PWH achieved viral load less than 50 copies/ ml at week 48. In this cohort, like ours, M184V was not associated with lower risk of virological failure [10]. Dolutegravir combined with two NRTI has also demonstrated high rates of virological suppression in patients with preexisting or current resistance mutations [13,14].…”

Treatment persistence of bictegravir/emtricitabine/tenofovir alafenamide and efavirenz+lamivudine+tenofovir disoproxil among HIV-1 patients newly starting treatment in China

“…To our knowledge, this is the rst study to evaluate the persistence of BIC/FTC/TAF and EFV + 3TC + TDF in real-world setting in China. Our study showed that after excluding the economic burden between ARTs, BIC/FTC/TAF had signi cant better persistence compared with EFV + 3TC + TDF, which is consistent with previous real-world studies in western countries [10,11]. The treatment discontinuation of EFV + 3TC + TDF group is mainly due to safety reason, which is also shown in other studies reporting the neuropsychiatric side effects related with EFV [14][15][16].…”

“…Previous studies have shown that STRs had higher adherence and persistence compared with MTRs [10][11][12][13]. Nevertheless, limited studies have explored the persistence difference between STR and MTR in the real-world clinical practice in China.…”

Viro-Immunological, Clinical Outcomes and Costs of Switching to BIC/TAF/FTC in a Cohort of People Living with HIV: A 48-Week Prospective Analysis

“…Adverse events and lost to follow-up almost equally contributed to the discontinuation rate in our cohort of individuals. Recently, results from a Spanish cohort, with a shorter follow-up, and including also naïve individuals, showed that at the end of the study, 88% of subjects remained on the study regimens; 42/1584 (2.6%) discontinued treatment for toxicities, and 7/1584 (0.4%) experienced virological failure [ 26 ].…”