Outcomes After Switching to BIC/FTC/TAF in Patients with Virological Failure to Protease Inhibitors or Non-Nucleoside Reverse Transcriptase Inhibitors: A Real-World Cohort Study

Chang, Hyo Sik; Chou, Pei-Yun; Chou, Cheng‐Jen; Tsai, Hung-Chin

doi:10.2147/idr.s331647

Cited by 15 publications

(15 citation statements)

References 28 publications

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“…No patients discontinued the regimen due to VF during the time of observation, and viral suppression was maintained also in individuals with virological failure at baseline regardless of the pre-existing NRTI resistance such as M184V and K65R. These results further support the high resistance barrier of bictegravir as previously demonstrated in both in vitro and clinical studies [ 16 , 24 , 25 ]. In addition, BIC/FTC/TAF was successful in maintaining an excellent immunological efficacy as a switch regimen; at week 48, the median CD4 increased to 610 (450–780) cells/mL, and the CD4+/CD8+ ratio slightly improved, confirming the persistence and further mild amelioration of immune recovery after switching.…”

Section: Discussionsupporting

confidence: 83%

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

et al. 2022

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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.

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Section: Discussionsupporting

confidence: 83%

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

et al. 2022

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“…This retrospective cohort study showed that the virological inhibition rate of ART-naïve was 86.3% after 24 weeks. Previous studies have shown that high viral load at baseline leads to delayed virus suppression and increased chances of virology failure [11,12]. The same trend was observed in this study.…”

Section: Discussionsupporting

confidence: 90%

“…In addition, no patients stopped taking drugs because of adverse events, and most patients had very good tolerance. In 80 patients, the most common AE was skin rash (7.5%), skin pruritus (5.0%), and digestive tract reactions (2.5%), which was consistent with Chang et al [11] and Hayes et al [26]. During the follow-up, we found 2 patients had SAE (hospitalization); however, none were related to drugs.…”

Section: Discussionsupporting

confidence: 89%

“…Compared with weight, clinicians should pay more attention to patients' blood lipids, as dyslipidemia is an independent risk factor for the occurrence and development of cardiovascular diseases [25]. This study con rmed that BIC/FTC/TAF had no signi cant effect on blood lipid, which was consistent with a previous real-world study [11]. This also explains the safety of BIC/FTC/TAF as ART drugs.…”

Section: Discussionsupporting

confidence: 89%

“…After starting antiviral therapy, their weight gain is large, that is, the phenomenon of health recovery. Studies have con rmed that BIC/FTC/TAF can lead to weight gain among patients [11,20], but the weight increase is the result of comprehensive factors. For HIV-1 patients, the possible mechanism includes the phenomenon of health recovery of patients with advanced AIDS, and the mechanism of health recovery may be the result of the alleviation of HIV-related in ammation and the acceleration of catabolism [21].…”

Section: Discussionmentioning

confidence: 99%

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Study on the effectiveness and safety of BIC/FTC/TAF in adult HIV-1 patients in China: A retrospective real-world cohort study

Xie

Gan

et al. 2022

Preprint

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Background To evaluate the therapeutic effect and tolerance of BIC/FTC/TAF used for 24-week in ART-naïve in China. Methods This single-center retrospective cohort study included ART-naïve who received BIC/FTC/TAF from July 2021 to April 2022. The proportion of patients with HIV RNA < 50 cp/ml at the end point of 24-week (virological inhibition rate) was the primary outcome, and the changes of CD4 cell count, CD4/CD8, weight, blood lipid, and safety were secondary outcomes. Results A total of 80 ART-naïve were enrolled. The inhibition rate of virology was 86.3% 24-week. The median CD4 cell count increased from 212 cells/µL (90.3-398.3) at baseline to 348 cells/µL (219.8–541.0) at 24-week. The median CD4/CD8 ratio increased from 0.25 (0.13–0.37) at baseline to 0.40 (0.26–0.66) at 24-week. During the follow-up of 80 ART-naïve using BIC/FTC/TAF, 16 patients had adverse events; however, no drug withdrawal was caused by adverse events. Conclusion This real-world cohort study showed that BIC/FTC/TAF could achieve good immunological and virological responses in ART-naïve. In addition, this study also shows good safety.

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

Kong,

Xie,

et al. 2023

Immunity Inflam & Disease

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BackgroundProspective studies examining long‐term therapeutic outcomes of the Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) regimen in human immunodeficiency virus (HIV) infection remain limited. This study assessed the actual efficacy and safety of BIC/FTC/TAF in HIV‐infected individuals in southwest China.MethodsThis was a single‐center, prospective study enrolling ART‐naïve (n = 32) and ART‐experienced (n = 177) HIV‐infected patients administered BIC/FTC/TAF treatment between March 2022 and August 2022. The data were collected until February 28, 2023. Virological reactions and adverse events to the treatment were recorded, and patient subjective feelings in the form of Electronic Patient Reporting Outcome (ePRO) were collected. The primary endpoint was the rate of patients with HIV viral load <50 copies/mL at Week 24.ResultsAt Week 24, 87.5% and 95.5% of ART‐naïve and ART‐experienced HIV patients had a viral load <50 copies/mL, respectively. CD4 cell counts in ART‐naïve and ART‐experienced patients increased significantly by 163.5 cells/μL (p = .002) and 55.0 cells/μL (p = .022), respectively. By Week 24, no patients had discontinued the BIC/FTC/TAF treatment due to adverse events. Based on ePRO data, ART‐naïve and ART‐experienced patients at Week 24 had stable disease symptom burden, quality of life, and depression level after treatment with BIC/FTC/TAF.ConclusionBIC/FTC/TAF reduces the viral load in ART‐naïve patients with high viral load as well as ART‐experienced patients with residual viremia. The patient's subjective experience was maintained stable after treatment with BIC/FTC/TAF. This study also revealed a very low incidence for BIC/FTC/TAF drug‐related side effects.

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Outcomes After Switching to BIC/FTC/TAF in Patients with Virological Failure to Protease Inhibitors or Non-Nucleoside Reverse Transcriptase Inhibitors: A Real-World Cohort Study

Cited by 15 publications

References 28 publications

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

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

Study on the effectiveness and safety of BIC/FTC/TAF in adult HIV-1 patients in China: A retrospective real-world cohort study

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

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