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

Abstract

To date, therapeutic switches are performed to reduce and prevent toxicity, improve adherence, promote virological control, and save costs. Drug switches are a daily challenge in the management of people living with HIV (PLWH), especially in those with multiple comorbidities and on polypharmacy. The objectives of this prospective analysis were: (I) to evaluate the viro-immunological efficacy of BIC/FTC/TAF in a cohort of PLWH who switched to this regimen from any other previous, at the Infectious and Tropical Diseases Unit of the Padua University Hospital; (II) to assess the impact on body weight, lipids, and renal function parameters at week 48; and (III) to evaluate daily costs changes, adherence, and the rate and causes of discontinuation of the regimen. We included all adult PLWH who switched to BIC/FTC/TAF from 1 February 2020 to 31 October 2021. We collected demographic, clinical, and laboratory data at baseline and week 48 after the switch. In addition, the estimated cART-related cost changes over the follow-up period were calculated. Over the study period, 290 individuals who switched to BIC/FTC/TAF, 76.9% were males, with a median age of 52 years, and 94.8% had an undetectable baseline HIV viremia. After a median time of 35 days (IQR: 1–55), 41 (14.1%) individuals discontinued the regimen. Factors significantly associated with discontinuation were switching from dual regimens, and neurological disorders. At week 48, we detected a significant increase in body weight, BMI, CD4 T-cell count, and CD4/CD8 ratio, and a significant reduction in triglycerides and costs; all patients had undetectable HIV RNA. Our results showed that switching to BIC/FTC/TAF may favor slightly immunological recovery and cost saving (−4.2 EUR/day from baseline to week 48, equivalent to a mean saving of 1533 EUR/year/person). The reduction in triglycerides does not appear to be clinically relevant, even if statistically significant, nor do both the increase in body weight and BMI (+1 kg and +0.29 BMI, respectively) and the increase in CD4 T-cell count (+45 cells/mmc). Further studies are needed to confirm our results.

Clinical efficacy, safety, and subjective experience based on ePRO in HIV‐infected individuals administered Bictegravir/Emtricitabine/Tenofovir Alafenamide in southwest China

“…[12][13][14][15] After starting ART, CD4 count increased while CD8 count decreased. 16 In this study, at Week 24 of BIC/FTC/ TAF treatment, CD4 count in patients increased, indicating improved immune function after ART with BIC/FTC/TAF, corroborating previous studies. [12][13][14][15]17 In patients with HIV and associated comorbidities, simplified medication regimens can reduce drug interactions and decrease the risk of renal dysfunction.…”

“…After starting ART, CD4 count increased while CD8 count decreased. 16 In this study, at Week 24 of BIC/FTC/TAF treatment, CD4 count in patients increased, indicating improved immune function after ART with BIC/FTC/TAF, corroborating previous studies. 12 , 13 , 14 , 15 , 17 …”

Rildo: Real-World Multicenter Study on the Effectiveness and Safety of Single-Tablet Regimen of Dolutegravir plus Rilpivirine in Treatment-Experienced People Living with HIV

“…A pharmacoeconomic analysis was performed, comparing therapy with RPV/DTG vs. BIC/TAF/FTC, DRV/c/TAF/FTC, and DTG/3TC. Data obtained from published research in study populations with similar characteristics [16][17][18] were compared with the effectiveness of RPV/DTG STR by modified ITT analysis (excluding individuals lost to follow-up). Treatment-cost calculations were based on the laboratory price list for February 2022, without VAT and without considering state discounts.…”

Real-world weight changes in people with HIV-1 at risk of weight gain (female, Black or Hispanic) switching from integrase strand transfer inhibitors

“…Previous research has noted that initiation of INSTI-based ART in many populations of treatment-naive PLWH leads to higher weight gain [ 18 , 24 , 25 ]. Other studies have also noted trends toward weight increase upon a switch to an INSTI, including BIC/FTC/TAF [ 20 , 26 , 27 ]. Furthermore, the DHHS outlines the weight gain potential of INSTIs in its guidelines and notes that further questions about the regional distribution, association with cardiometabolic risk and reversibility of weight gain after discontinuation remain [ 14 ].…”