Preoperative Rapid Suppression of Viral Load by Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Regimen in Human Immunodeficiency Virus-Positive Fracture Patients Significantly Reduces Postoperative Complications
Human immunodeficiency virus (HIV) remains a significant public health challenge in China, with an estimated 1.25 million people living with HIV (PLWH) and over 135,000 new cases diagnosed in 2018. Among this population, HIV-positive patients who suffer fractures face particularly high rates of postoperative complications. Additionally, healthcare workers are often exposed to occupational risks during the perioperative period, leading to reluctance among surgeons to operate on these patients. To address these concerns, this study explores the efficacy of rapidly suppressing viral load (VL) preoperatively using antiretroviral therapy (ART) to reduce complications and enhance surgical safety.
The study focuses on comparing two ART regimens: a single-tablet regimen (STR) containing elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide (E/C/F/TAF) and a multiple-tablet regimen (MTR) consisting of tenofovir disoproxil fumarate, lamivudine, and efavirenz (TDF/3TC/EFV). The E/C/F/TAF regimen is a newer treatment option known for its rapid and reliable VL suppression, while TDF/3TC/EFV is a more widely available and commonly used regimen in China. The study aims to evaluate the impact of these regimens on VL suppression, immune function restoration, and postoperative outcomes in HIV-positive fracture patients.
The study was conducted at Beijing Ditan Hospital, Capital Medical University, from January 2011 to August 2019. A total of 120 HIV-positive patients with closed fractures were enrolled and divided into three groups: the E/C/F/TAF regimen group (n = 40), the TDF/3TC/EFV regimen group (n = 40), and an untreated control group (n = 40). The median age of the patients was 35 years, ranging from 20 to 53 years. All patients underwent open reduction and internal fixation for their fractures. The study was approved by the hospital’s ethics committee, and informed consent was obtained from all participants.
Viral load and CD4+ T-cell counts were measured at diagnosis and after 7 and 10 days of treatment. Statistical analyses were performed using SPSS version 24.0. Continuous variables with non-normal distribution were expressed as median (Q1, Q3) and analyzed using the Kruskal-Wallis H test followed by the Nemenyi test. Categorical variables were presented as numbers (%) and compared using Fisher’s exact test or the Chi-squared test, as appropriate. A P-value of less than 0.05 was considered statistically significant.
The results demonstrated that the E/C/F/TAF regimen achieved more rapid VL suppression compared to the TDF/3TC/EFV regimen. After 7 days of treatment, the median VL in the E/C/F/TAF group was 4.86 log10 copies/ml (interquartile range [IQR]: 4.48–5.01), significantly lower than the 5.31 log10 copies/ml (IQR: 5.03–5.61) observed in the TDF/3TC/EFV group (P = 0.017). By day 10, the E/C/F/TAF group further reduced the VL to 3.58 log10 copies/ml (IQR: 3.16–3.79), compared to 4.05 log10 copies/ml (IQR: 3.55–4.37) in the TDF/3TC/EFV group (P = 0.038).
In terms of immune function restoration, the E/C/F/TAF regimen also outperformed the TDF/3TC/EFV regimen. After 7 days of treatment, the median CD4+ T-cell count in the E/C/F/TAF group was 505.6 cells/mm3 (IQR: 385.3–698.0), higher than the 453.2 cells/mm3 (IQR: 319.2–700.3) in the TDF/3TC/EFV group (P = 0.021). By day 10, the CD4+ T-cell count in the E/C/F/TAF group increased to 551.2 cells/mm3 (IQR: 374.2–710.6), compared to 483.3 cells/mm3 (IQR: 337.6–698.2) in the TDF/3TC/EFV group (P = 0.046).
Postoperative complications, including surgical site infection, delayed union and nonunion of fractures, thrombosis, pulmonary infection, and renal failure, were monitored for 12 months. The E/C/F/TAF regimen group experienced significantly fewer complications (3/40, 7.5%) compared to the TDF/3TC/EFV regimen group (7/40, 17.5%) (P = 0.031). The untreated control group had the highest complication rate (9/40, 22.5%).
The study highlights the superiority of the E/C/F/TAF regimen in rapidly suppressing VL and improving immune function in HIV-positive fracture patients. This regimen not only reduces the risk of postoperative complications but also enhances the safety of surgical interventions for both patients and healthcare workers. While the TDF/3TC/EFV regimen also demonstrated VL suppression, its effects were less pronounced and slower compared to the E/C/F/TAF regimen.
In conclusion, the findings underscore the importance of preoperative VL suppression in HIV-positive fracture patients. The E/C/F/TAF regimen offers a more effective and rapid approach to achieving this goal, thereby reducing postoperative complications and improving overall outcomes. This study provides valuable insights for clinicians managing HIV-positive patients requiring surgical interventions, emphasizing the need for timely and effective ART to optimize surgical safety and patient recovery.
doi.org/10.1097/CM9.0000000000001185
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