Reasons, Safety, and Efficacy Analysis for Conversion of HAART to TAF/FTC/BIC Among HIV-Infected Patients
The introduction of highly active antiretroviral therapy (HAART) has significantly transformed the management of human immunodeficiency virus (HIV) infection, leading to a dramatic reduction in HIV-associated mortality and morbidity. However, long-term HAART is associated with adverse effects (AEs) and non-AIDS-defining events (NADEs), which impact patient adherence and quality of life. In China, the National Free Antiretroviral Treatment Program (NFATP) recommends a combination of two nucleotide reverse transcriptase inhibitors (NRTIs) and a non-nucleotide reverse transcriptase inhibitor (NNRTI) or a boosted protease inhibitor as the preferred regimen. Despite its efficacy, the side effects of these regimens, including bone mineral density (BMD) loss, liver dysfunction, and metabolic changes, have necessitated the exploration of alternative treatments.
Tenofovir alafenamide/emtricitabine/bictegravir sodium (TAF/FTC/BIC) is a single-tablet co-formulated regimen that offers a higher genetic barrier and reduced pill burden. Its inclusion in China’s National Reimbursement Drug List in 2021 has made it accessible through resident medical insurance, leading to an increasing number of HAART-experienced patients transitioning to this regimen. This study aims to elucidate the reasons for this transition and evaluate the safety, efficacy, and side effects of switching to TAF/FTC/BIC in real-world settings.
The study was conducted as a retrospective cohort analysis at Beijing Ditan Hospital, Capital Medical University, from September 2021 to August 2022. A total of 1684 HIV-infected patients with previous HAART experience who switched to TAF/FTC/BIC were included. The median age of the participants was 37.8 years, and the average duration of HAART was 5.6 years. Baseline CD4 cell counts averaged 666.79 cells/µL, and 6.89% of patients had an HIV viral load (VL) above the target not detected (TND) threshold.
The most common reason for switching to TAF/FTC/BIC was regimen simplification (58.79%), followed by osteoporosis or osteopenia (22.27%), liver dysfunction (13.72%), inability to adhere to TAF/FTC/EVG/c with food restrictions (12.77%), virological failure (6.89%), renal dysfunction (5.34%), central nervous system side effects (2.79%), and dyslipidemia (1.78%). These reasons were not mutually exclusive, indicating that multiple factors often influenced the decision to switch regimens.
In terms of efficacy, the study found that TAF/FTC/BIC demonstrated potent antiretroviral effects. Among the 116 patients with a baseline VL above TND, the VL was suppressed below the detection threshold after 12 months of switching. This highlights the high genetic barrier of TAF/FTC/BIC, which facilitates rapid and effective virological suppression.
The safety profile of TAF/FTC/BIC was also evaluated, particularly its impact on lipid panels, bone mineral density, and hepatic and renal functions. Among patients receiving NNRTI-containing regimens at baseline, significant increases in serum triglyceride (TG), total cholesterol (TC), and low-density lipoprotein (LDL) levels were observed one year after switching to TAF/FTC/BIC, while high-density lipoprotein (HDL) levels decreased. This suggests that TAF/FTC/BIC may worsen serum lipid panels and increase cardiovascular risk in this subgroup.
Conversely, among patients receiving boosted protease inhibitor-containing regimens, such as lopinavir/ritonavir (LPV/r) or TAF/FTC/EVG/c, the lipid panel showed a decreasing trend one year after switching to TAF/FTC/BIC. Specifically, serum TC levels decreased, and HDL levels increased significantly, while TG and LDL levels also exhibited a trend of reductions. This indicates that switching from booster-containing regimens to TAF/FTC/BIC may have a favorable impact on lipid profiles.
Bone mineral density was evaluated using dual-energy X-ray absorptiometry (DXA) scans of the lumbar spine and hips. Although the absolute BMD value did not significantly improve, there was a trend of improvement in spine BMD one year after transitioning to TAF/FTC/BIC. This is consistent with previous studies that have shown TAF-containing regimens to be associated with less BMD loss compared to tenofovir disoproxil fumarate (TDF)-containing regimens.
Hepatic and renal functions were also assessed, and the results indicated that TAF/FTC/BIC improved alanine transaminase (ALT), aspartate transaminase (AST), estimated glomerular filtration rate (eGFR), and serum creatinine levels. This suggests that TAF/FTC/BIC has a protective effect on liver and kidney function, making it a viable option for patients with hepatic or renal dysfunction.
In conclusion, the transition to TAF/FTC/BIC demonstrated good treatment potency and safety in real-world settings. The primary motivation for switching was regimen simplification, followed by concerns related to bone health, liver dysfunction, and other side effects. TAF/FTC/BIC effectively suppressed HIV viral load and showed a favorable impact on bone mineral density and hepatic and renal functions. However, it may worsen serum lipid panels in patients switching from NNRTI-containing regimens, necessitating periodic screening for cardiovascular risk factors. Overall, this study provides valuable clinical evidence supporting the stable conversion to TAF/FTC/BIC for HAART-experienced patients in China.
doi.org/10.1097/CM9.0000000000002939
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