From TRIO to one: simplification to bictegravir/emtricitabine/tenofovir alafenamide in highly treatment-experienced people living with MDR HIV.

Abstract

Background: We evaluated the maintenance of virological suppression in people living with multidrug resistance (MDR) HIV (PLWH), who simplified to bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF).

Methods: We conducted a prospective, observational study of 62 PLWH with MDR who switched therapy because of drug-drug interactions (DDIs), non-adherence or toxicity. Survival analysis was used to assess the probability of virological failure (VF). Cumulative genotypic susceptibility score to BIC/FTC/TAF (cGSS; maximum 3 points) was evaluated.

Results: Before the switch, PLWH were virologically suppressed for a median of 7.95 years (interquartile range, IQR, 2.5-9.7), 60% and 37% had resistance to two and three classes of antiretrovirals respectively (median cGSS = 2), and the mutation M184V/I was observed in 34 cases (68%). The main reason for switching was DDIs (61%). At Week 48, there were no VFs, three patients (5%) discontinued early due to mild neuropsychiatric events, and two showed transient detectable HIV RNA levels (1.8 and 1.85 log copies/mL). Thus, the efficacy was 91% (95% CI, 81%-99%, intention-to-treat analysis) and 94% (95% CI, 87%-100%, on-treatment). Total cholesterol and LDL cholesterol decreased significantly after the switch, and estimated glomerular filtration rate and tubular parameters remained stabilized. Excluding two diabetic PLWH with progressive renal deterioration, there were no VFs or additional discontinuations for 32.5 months (IQR, 14.1-48.5; follow-up, 199 person-years). By survival analysis, the probability of remaining on BIC/FTC/TAF was 91% at 5 years.

Conclusions: In highly treatment-experienced PLWH harbouring MDR strains, who were virologically suppressed, switching to BIC/FTC/TAF was well tolerated with maintenance of virological control.