Efficacy and Safety of BIC/FTC/TAF as a Rapid Initiation of Antiretroviral Therapy Regimen in Elderly Chinese People with HIV/AIDS: A Retrospective Real-World Study from China

Efficacy and Safety of BIC/FTC/TAF as a Rapid Initiation of Antiretroviral Therapy Regimen in Elderly Chinese People with HIV/AIDS: A Retrospective Real-World Study from China | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article Efficacy and Safety of BIC/FTC/TAF as a Rapid Initiation of Antiretroviral Therapy Regimen in Elderly Chinese People with HIV/AIDS: A Retrospective Real-World Study from China Wei Zhang, Qi sui Li, ChangGang Deng, Min Liu, Jing Yuan This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-9292623/v1 This work is licensed under a CC BY 4.0 License Status: Under Review Version 1 posted 5 You are reading this latest preprint version Abstract Background Rapid ART has improved the prognosis of people with HIV/AIDS (PWH). However, real-world studies on the Chinese elderly population (≥ 50 years) were limited. This study aimed to evaluate the efficacy, safety, retention rate, and patient-reported outcomes (PROs) of BIC/FTC/TAF as a rapid ART initiation regimen in elderly Chinese PWH(≥ 50 years). Methods We retrospectively collected data on treatment-naive (TN) PWH aged ≥ 50 years who started BIC/FTC/TAF within 7 days of diagnosis. Virological suppression, immunological indices, renal function, lipid profiles, and safety outcomes were assessed at weeks 12, 24, 48, and 96. PROs, treatment adherence, and the retention rate at week 96 were also evaluated. Results A total of 111 elderly TN PWH were enrolled. Males accounted for 59.5% (66/111), and the mean baseline age was 60.4 ± 8.0 years,,Of these, 86.4% (96/111) presented late (CD4 + T cell count 500,000 copies/mL (high viral load), 63.0% (70/111) had comorbidities, and 57.6% (64/111) used comedications. Over 90% achieved virological suppression within 12 weeks, which was sustained through 96 weeks. These predominantly late-presenter elderly PWH showed rapid and significant CD4 + T cell count increases after ART, reaching a mean of 423.1 ± 203.8 cells/µL at week 96. Lipid levels fluctuated within the normal range post-ART. Renal parameters showed no significant changes from baseline. PROs improved after ART (P 97%). The retention rate at week 96 was 96.3% (105/109), excluding 2 deaths. Conclusions BIC/FTC/TAF as a rapid initiation regimen demonstrated high efficacy and safety in elderly Chinese PWH. It significantly improved immune function and PROs and achieved a high overall treatment retention rate. Treatment-naive HIV/AIDS patients Elderly Rapid initiation BIC/FTC/TAF Efficacy Safety Introduction The global promotion of antiretroviral therapy (ART) has transformed HIV infection from a fatal disease into a manageable chronic condition, significantly prolonging life expectancy among people with HIV/AIDS (PWH) [ 1 ]. However, elderly PWH (≥ 50 years) face unique challenges [ 2 , 3 ], including a high incidence of late diagnosis (CD4 + T cell count < 350 cells/µL), multiple comorbidities such as diabetes and cardiovascular and cerebrovascular diseases, and age-related physiological changes like reduced renal function, which may affect drug metabolism and tolerance. These factors complicate ART management, requiring a careful balance among efficacy, safety, and drug interactions. Rapid ART—defined as treatment initiation within 7 days of diagnosis—has been endorsed by international guidelines as a key strategy to reduce morbidity, mortality, and viral transmission [ 4 , 5 ]. Although integrase strand transfer inhibitor (INSTI)-based regimens have demonstrated superiority in achieving rapid virological suppression [ 6 , 7 ], real-world evidence of their efficacy and safety in the elderly population remains scarce, especially in regions with high rates of late diagnosis and limited resources, such as southwest China. China’s HIV epidemic is marked by a notable aging trend, with approximately 30% of newly diagnosed cases aged ≥ 50 years [ 8 , 9 ]. Late diagnosis (CD4 + T cell count 500,000 copies/mL) are common [ 10 ], increasing the risk of malignancies and poor immune reconstitution [ 11 , 12 ]. Current rapid ART guidelines recommend INSTI-based regimens such as bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) due to their high efficacy, good tolerability, and minimal drug interactions [ 13 , 14 ]. Most existing studies have focused on younger PWH in developed countries; data on BIC/FTC/TAF as a rapid cART regimen in elderly PWH from resource-limited settings in China are limited. This population may exhibit distinct immune responses and metabolic profiles compared to younger individuals. Additionally, in elderly patients with comorbidities, the long-term renal and lipid safety of tenofovir alafenamide (TAF) requires further evaluation, alongside careful management of comorbid conditions. This single-center, retrospective, real-world study aimed to evaluate the 96-week efficacy and safety of BIC/FTC/TAF as a rapid ART strategy in Chinese PWH aged ≥ 50 years. The focus was on virological suppression, immune recovery, renal and lipid safety, treatment sustainability, and patient-reported outcomes. By addressing the intersecting challenges of late diagnosis, polypharmacy, and aging-related physiological changes, our findings provide valuable evidence to optimize rapid ART strategies in this vulnerable population. Methods Ethical Approval The study protocol was approved by the Ethics Committee of Chongqing Public Health Medical Center (No. 2024-004-01-KY). As this was a retrospective study analyzing anonymized data, the institutional review board waived the requirement for written informed consent. Study Population and Design We retrospectively collected data on treatment-naive PWH aged ≥50 years who initiated ART within 7 days of HIV diagnosis at Chongqing Public Health Medical Center between January 1, 2022, and December 31, 2022, excluding pregnant women. Inclusion criteria followed the Chinese Guidelines for HIV/AIDS Diagnosis and Treatment (2024 Edition) [15]. Diagnosis required a positive HIV antibody screening test and confirmatory test. Virological suppression was defined as HIV RNA <50 copies/mL. Safety assessments included renal function and lipid profiles. Patient-reported outcomes (PROs), adherence, and 96-week regimen retention rate were also evaluated. Data Collection Baseline demographic and clinical data—including age, sex, marital status, infection route, BMI, CD4+ T cell count, HIV RNA viral load, comorbidities (e.g., type 2 diabetes, hypertension), concomitant medications, and baseline drug resistance—were extracted from electronic medical records and laboratory databases. Data were collected at ART initiation and follow-up visits at weeks 12, 24, 48, and 96 (±2 weeks). Variables included ART regimen, HIV RNA viral load, CD4+ T cell count, fasting lipid panel, creatinine, and other biochemical markers. Adverse events were recorded at each visit. Outcomes of Interest The primary objective was to evaluate the efficacy of ART initiated within 7 days in elderly treatment-naive PWH at weeks 12, 24, 48, and 96. Secondary objectives included assessing changes in CD4+ T cell count, retention of the initial ART regimen at week 96, PROs, and the safety profile of lipid metabolism and renal function at week 96. Statistical Analysis Statistical analyses were performed using SPSS 27.0. Categorical variables were presented as frequencies (percentages) and compared using χ² or Fisher’s exact tests. Normally distributed continuous variables were expressed as mean ± standard deviation and compared with independent samples t-tests. Non-normally distributed data were expressed as median (P25, P75) and compared using non-parametric tests. A p-value <0.05 was considered statistically significant. Results Baseline Characteristics Among 1,057 ART initiators in 2022, 586 (55.4%) were aged ≥50 years; 232 (39.6%) initiated ART within 7 days; and 111 PWH receiving BIC/FTC/TAF were enrolled. Males accounted for 59.5% (66/111), mean age was 60.4±8.0 years, and 96.4% acquired HIV via heterosexual transmission. Late presentation (CD4+ T cell count 500,000 copies/mL) in 39.7% (44/111), comorbidities in 63.0% (70/111), and comedications in 57.6% (64/111). Baseline drug resistance was detected in 11 cases: 1 protease inhibitor (PI), 2 INSTI (elvitegravir and raltegravir, low-level resistance), and 8 NNRTI，the detailed demographic and clinical characteristics of the study cohort are presented in Table 1. Table 1: Demographic and Clinical Characteristics BIC/FTC/TAF (n=111) Male (n，%) 66 (59.5) Age (years, x̅ ± s) 60.4±8.0 BMI 22.9±3.1 Marital Status Single 5(4.5) Married 90 (81.1) Divorced or widowed 16 (14.4) Mode of Transmission Male-to-Male Sexual Transmission 4 (3.6) Heterosexual Transmission 107（96.4) Blood Transfusion/Blood Products 0 CD4 counts, cells/mm3 ＜100 29（26.1） 100-199 32（28.8） 200-349 35（31.5） ≥350 15（13.6） HIV-RNA VL, copies/ml <100000 34（30.6） 100000- 500000 33（29.7） ＞500000 44（39.7） Comorbidities 1 condition 39(35.1) ≥2 conditions 31(27.9) Concomitant Medications 1 medication 27(24.3) ≥2 medications 37(33.3) Drug Resistance Testing Status Test Performed 43 (38.7) Drug Resistance Not Detected 32(28.8) Drug Resistance Detected 11（9.9） CD4+T cell count and Virologic Suppression Following BIC/FTC/TAF treatment, significant increases in CD4+ T cell count were observed in this elderly PWH cohort. CD4+ T cell counts at weeks 12, 24, 48, and 96 post-ART initiation are detailed in Table 2. Statistically significant improvements (p < 0.05) were noted at all time points compared to baseline. High rates of virologic suppression were achieved, reaching 90.2% (83/92) by week 12 and 99% (99/100) at week 96. Table 2: Virologic Outcomes and immunologic responses at Week12,week24,Week 48, week 96 Characteristics Baseline Week 12 Week24 Week 48 Week 96 CD4 (cells/µL) 201.5±135.1 （n=111） 308.6±166.4 （n=98） 325.5±147.3 （n=102） 367.8±155.1 （n=105） 423.1±203.8 (n=100) p-value a <0.001 <0.001 <0.001 <0.001 HIVRNA <50copies/ml (n，%) 0 90.2(83/92) 93.3(84/90) 96.9(96/98) 99.0(99/100) Safety Monitoring Renal function and lipid profiles at each follow-up time point post-ART initiation are summarized in Table 3, TC, LDL, and HDL levels increased compared to baseline but remained within normal ranges. No significant changes were observed in serum creatinine (SCr), uric acid (UA), eGFR, or triglycerides (TG) at any time point compared to baseline (p > 0.05). Table 3: Renal and Lipid Safety data at week 96 Table 3: The changes in renal safety and lipid profiles between baseline and follow-up data in treatment-naïve PWH Characteristics Baseline Week 12 Week24 Week 48 Week 96 SCr (umol/L) 62.9 (54.1,74.1) 69.8 (59.7,79.0) 71.6 (57.8,80.7) 69.7 (58.3,77.4) 72.1 (59.7,84.5) p -value a 0.070 0.058 0.054 0.052 UA (umol/L) 323.5 (274.8,77.8) 327.5 (265.8,422.0) 340.0 (277.3,399.3) 322.5 (267.5,385.5) 309.0 (262.5,381.0) p -value a 0.452 0.481 0.830 0.853 eGFR 99.0 (92.5,104.0) 93.0 (84.8,101.0) 93.0 (92.5,104.0) 94.5 (83.5,99.0) 91.0 (80.0,98.0) p -value a 0.060 0.061 0.070 0.052 TG (mmol/L) 1.61 (1.18,2.35) 1.69 （1.18,2.52） 1.58 (1.21,2.63) 2.05 (1.21,2.79) 1.92 (1.26,3.25) p -value a 0.985 0.955 0.280 0.087 TC (mmol/L) 4.15 (3.54,4.84) 4.80 （3.88,5.47） 4.77 （4.02,5.50） 4.73 （4.03,5.44） 4.67 （4.11,5.14） p -value a 0.001 ＜0.001 ＜0.001 0.004 HDL (mmol/L) 1.08 (0.88,1.32) 1.29 （1.14,1.48） 1.34 （1.12,1.51） 1.19 （1.06,1.45） 1.21 （1.07,1.39） p -value a <0.001 <0.001 0.002 0.002 LDL (mmol/L) 2.45 (2.06,2.85) 2.69 (2.28,3.19) 2.59 （2.24,3.10） 2.61 （2.36,3.05） 2.68 (2.23,3.07) p -value a 0.008 0.026 0.037 0.041 PRO Outcomes and Adherence Patient-reported outcomes (PROs) were assessed using the SF-36 Health Survey Scale. After 96 weeks of treatment, significant improvements (P < 0.05) were observed across all eight SF-36 domains (Table 4). Median self-reported adherence measured by the Visual Analogue Scale (VAS) was 100.0 (interquartile range [IQR]: 97.0–100.0) throughout the 96-week period. Among participants, 105 (94.6%) reported no missed doses, 4 (3.6%) missed doses on one day, and 2 (1.8%) missed doses on two days (Table 5). Table 4: Performance of SF-36 factors in 111 PWHs Characteristics Baseline Median (IQR) Week 96 Median (IQR) Z p-value General Health (GH) 42.0 (10.0,59.5) 77.0(62.0,97.0) -3.481 <0.001 Physical Functioning (PF） 57.0 (65.0,95.0) 100 (95.0,100) -2.541 0.011 Role-Physical (RP) 0(0,62.5) 100(25,100) -2.204 0.028 Bodily Pain (BP) 64.0(52.0,74.0) 100(100,100) -3.084 0.002 Vitality (VT) 25(12.5,60.0) 85.0(72.5,90.0) -3.503 <0.001 Social Functioning (SF) 44.0(22.0,78.0) 89.0(83.5,100.0) -2.931 0.003 Role-Emotional (RE) 0(0,0) 100.0(100.0,100.0) -3.721 <0.001 Mental Health (MH) 32.0(12.0,62.0) 84.0(70.0,94.0) -3.396 <0.001 Table 5: PWHs’ self-reported adherence level (n = 111) Self-Reported ART Adherence Level ART Adherence VAS score PLWH Median (IQR) 100.0(97.0,100.0) Forgotten days of medication Past week 96 ,n (%) 0day 105 (94.6%) 1day 4(3.6%) 2day 0(0) 3day 2(1.8%) Treatment Retention The overall treatment retention rate at week 96 was 94.6% (105/111). After excluding 2 deaths, the adjusted retention rate was 96.3% (105/109). By week 96, 11 PWH had switched their ART regimen. The retention rate for the initial regimen was 90.1% (100/111). Reasons for switching included: 6 patients transitioned to National Free Antiretroviral Treatment Program (NFATP) regimens due to financial constraints, 3 switched to 3TC/DTG because of drug-drug interactions (DDI) with tuberculosis medications, and 2 switched to ABC/3TC/DTG due to weight gain. Discussion In recent years, the aging of the AIDS population has drawn widespread global attention [16–17]. ART has prolonged the life expectancy of infected individuals and reduced mortality rates. Data from the Chinese Center for Disease Control and Prevention indicate that the proportion of PWH aged over 50 in China increased from 22% in 2011 to 44% in 2022. The number of newly diagnosed elderly PWH has risen, reflecting a prominent aging population and a heavy disease burden [18]. In this study, elderly PWH aged over 50 accounted for 55.4%. Selecting an appropriate treatment regimen for this population is critical for controlling the local HIV epidemic. However, only 39.8% of newly diagnosed elderly PWH initiated rapid ART (within 7 days), considerably lower than the 68.3% reported in a retrospective study in Taiwan, China [19]. This discrepancy may stem from several factors: insufficient HIV/AIDS awareness among the elderly leading to low acceptance of rapid ART initiation; studies have shown substantial gaps in elderly individuals’ knowledge of HIV transmission routes, treatment effects, and side effects, which may reduce willingness to start treatment promptly [20–22]. Additionally, economic burden [23–24] remains an important barrier despite availability of many free antiretroviral drugs, as related costs such as transportation and nutritional support may limit access, particularly in resource-limited areas. Social discrimination against HIV-infected individuals may cause elderly patients to delay treatment for fear of exclusion [25]. Furthermore, domestic health education on HIV infection among the elderly is insufficient [26], with poor basic knowledge and limited understanding of ART’s importance and benefits, resulting in reluctance or unawareness about rapid ART initiation after diagnosis. Our study found that 86.4% of elderly PWH initiating rapid ART had CD4+ T cell counts 500,000 copies/mL). Two PWH exhibited potential low-level resistance to elvitegravir and raltegravir. The BIC/FTC/TAF regimen achieved a high virological suppression rate, reaching 90.2% at 12 weeks and increasing to 99.0% at 96 weeks of follow-up. This regimen demonstrated robust virological suppression and immunological improvement, consistent with international studies [27–28], suggesting that rapid ART initiation can significantly improve prognosis even in elderly populations with late diagnosis and high viral load. Rapid ART effectively reduces immune system damage and lowers the risk of HIV-related and non-HIV-related comorbidities [29–30], thereby enhancing survival and quality of life for PWH. In this study, TC, LDL, and HDL levels increased compared to baseline after treatment but stabilized over time, consistent with previous reports [31–32]. Most PWH maintained lipid levels within the normal range during follow-up, possibly because some had elevated baseline lipids but a low proportion received treatment for hyperlipidemia. Clinicians may prioritize virological and immunological markers while overlooking metabolic management, such as lipid control. As a newer ART regimen, BIC/FTC/TAF has relatively minimal metabolic effects. However, integrase inhibitors may influence lipid metabolism and contribute to weight gain [33–34]. Therefore, regular lipid monitoring and appropriate lipid-lowering interventions are recommended to maintain metabolic health in PWH. ART discontinuation rates are generally high among elderly PWH, negatively impacting treatment success. In this study, patient-reported outcomes (PROs) improved significantly after treatment (P < 0.05), and treatment adherence was high (VAS ≥97%). This indicates that BIC/FTC/TAF not only achieved virological and immunological efficacy but also significantly improved quality of life and treatment satisfaction. High adherence, a key factor for ART success, may relate to the regimen’s good tolerability and low side-effect profile [35]. Overall, 96-week treatment retention was 94.6%, aligning with prior findings that BIC/FTC/TAF maintains high retention rates (99.2%) as a same-day rapid initiation regimen [36]. Among participants, 63.0% had comorbidities and 57.6% used concomitant medications. Despite this, BIC/FTC/TAF was well tolerated with a low incidence of adverse reactions, consistent with international data [37]. Its minimal drug-drug interactions (DDIs) [38–39] and unaffected viral suppression despite concomitant medications make it particularly advantageous in elderly patients with multiple comorbidities. In conclusion, BIC/FTC/TAF as a rapid initiation regimen demonstrated strong virological suppression in elderly Chinese PWH, with significant immune recovery, improved PROs, high adherence, and excellent treatment and regimen retention rates. This single-center retrospective study may be subject to selection bias, and its relatively small sample size could limit the generalizability of results. Future multi-center studies with larger cohorts are warranted. Declarations Author contribution statement Changgang Deng 、Qisui Li proposed the conceptualization. Jing Yuan wrote and edited the review.Wei Zhang、Min Liu wrote the original draft. Data availability Statement Other datasets used and analyzed in this study are available upon reasonable request from the corresponding author. Conflicts of interest None Funding Statement This work was supported by grants from the first batch of the Key Public Health Key Discipline Construction Project (Junior College), the Traditional Chinese Medicine Research Project of Chongqing Municipal Health Commission (2024WSJK147), and the Chongqing Center for Disease Control and Prevention Research Program. References Duong KNC, Schmutz HW, Ben-Umeh KC, et al. Real-world clinical and economic outcomes from rapid start antiretroviral therapy in HIV: systematic review and meta-analysis. AIDS . 2025;39(3):241-252. doi:10.1097/QAD.0000000000004046. 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Real-world effectiveness and safety of BIC/FTC/TAF in comparison with other regimens in people with HIV starting therapy with AIDS-defining conditions. Results from the CORIS Cohort: The ACTUAS II Study. Clin Infect Dis . Published online March 27, 2025. doi:10.1093/cid/ciaf162. Yuan J, Deng C, Li Q, et al. Human immunodeficiency virus/acquired immune deficiency syndrome antiretroviral therapy initiated on the same day in treatment-naïve people with human immunodeficiency virus: A comparative study of efficacy and regimen. Chin Med J (Engl) . 2024;137(22):2720-2725. doi:10.1097/CM9.0000000000003330. Torralba M, Rodríguez G, González Gasca FJ, et al. Bictegravir/Emtricitabine/Tenofovir Alafenamide in a Multicentre Cohort: Real-Life Experience From Spain. Ann Pharmacother . 2024;58(2):140-147. doi:10.1177/10600280231168852. Schafer JJ, Pandit NS, Cha A, et al. Incidence and Severity of Drug Interactions Before and After Switching Antiretroviral Therapy to Bictegravir/Emtricitabine/Tenofovir Alafenamide in Treatment-Experienced Patients. Open Forum Infect Dis. 2020;8(1):ofaa625. Published 2020 Dec 18. doi:10.1093/ofid/ofaa625. De Clercq E, Zhang Z, Huang J, Zhang M, Li G. Biktarvy for the treatment of HIV infection: Progress and prospects. Biochem Pharmacol. 2023;217:115862. doi:10.1016/j.bcp.2023.115862. Additional Declarations No competing interests reported. Cite Share Download PDF Status: Under Review Version 1 posted Reviewers invited by journal 07 May, 2026 Editor invited by journal 27 Apr, 2026 Editor assigned by journal 07 Apr, 2026 Submission checks completed at journal 07 Apr, 2026 First submitted to journal 01 Apr, 2026 You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. 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Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-9292623","acceptedTermsAndConditions":true,"allowDirectSubmit":false,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":638041021,"identity":"2c160921-f819-46c0-bfe2-4cb597d2e8fe","order_by":0,"name":"Wei Zhang","email":"","orcid":"","institution":"Chongqing Public Health Medical Center","correspondingAuthor":false,"prefix":"","firstName":"Wei","middleName":"","lastName":"Zhang","suffix":""},{"id":638041022,"identity":"a5471ea5-0e0e-429e-94ec-dc428fc9a2bb","order_by":1,"name":"Qi sui Li","email":"","orcid":"","institution":"Chongqing Public Health Medical Center","correspondingAuthor":false,"prefix":"","firstName":"Qi","middleName":"sui","lastName":"Li","suffix":""},{"id":638041023,"identity":"5d13d7ed-cc39-49d8-9df8-716cede50146","order_by":2,"name":"ChangGang Deng","email":"","orcid":"","institution":"Chongqing Public Health Medical Center","correspondingAuthor":false,"prefix":"","firstName":"ChangGang","middleName":"","lastName":"Deng","suffix":""},{"id":638041025,"identity":"3e43ecfe-053c-4075-8280-c9583323b532","order_by":3,"name":"Min Liu","email":"","orcid":"","institution":"Chongqing Public Health Medical Center","correspondingAuthor":false,"prefix":"","firstName":"Min","middleName":"","lastName":"Liu","suffix":""},{"id":638041027,"identity":"7b3346c2-9f83-4f8d-a04d-ff1f39a47fc3","order_by":4,"name":"Jing Yuan","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAAA8klEQVRIiWNgGAWjYLACCQMQyXwASFgwMPAwMH4gUgtbAgNDggRIC7MEkXbxGMC0sHHgU2dwI/nZA4uCO3b97TkfH/P+kJDj5znAxvAxB5+WNHMDCYNnyTPOvN1szJMgYSzZ28DGOHMbPi0JZhISBoeTDSRyt0kDtSRuOM/AxsyLV0v6N6iWnGfEaskB22IH1MIG0XK2gY0bnxbJM2/KQFoSJM48Mzackwb0S8/BZkl8fuE7nr5NWuLPYXv+9uSHD97Y2ABDLPngh494tCgcYADHXGIDQwJMjLEBt3ogkAdKg9KHPQNCyygYBaNgFIwCVAAAzT5N5VVAbkgAAAAASUVORK5CYII=","orcid":"","institution":"Chongqing Public Health Medical Center","correspondingAuthor":true,"prefix":"","firstName":"Jing","middleName":"","lastName":"Yuan","suffix":""}],"badges":[],"createdAt":"2026-04-01 13:38:16","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-9292623/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-9292623/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":109335493,"identity":"3a790ac9-efb7-47fb-82de-7a2659326a20","added_by":"auto","created_at":"2026-05-15 16:59:36","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":285872,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-9292623/v1/826cf6ac-d57d-4fb5-be3d-51f810c4a1f3.pdf"}],"financialInterests":"No competing interests reported.","formattedTitle":"Efficacy and Safety of BIC/FTC/TAF as a Rapid Initiation of Antiretroviral Therapy Regimen in Elderly Chinese People with HIV/AIDS: A Retrospective Real-World Study from China","fulltext":[{"header":"Introduction","content":"\u003cp\u003eThe global promotion of antiretroviral therapy (ART) has transformed HIV infection from a fatal disease into a manageable chronic condition, significantly prolonging life expectancy among people with HIV/AIDS (PWH) [\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e]. However, elderly PWH (\u0026ge;\u0026thinsp;50 years) face unique challenges [\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e, \u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e], including a high incidence of late diagnosis (CD4\u0026thinsp;+\u0026thinsp;T cell count\u0026thinsp;\u0026lt;\u0026thinsp;350 cells/\u0026micro;L), multiple comorbidities such as diabetes and cardiovascular and cerebrovascular diseases, and age-related physiological changes like reduced renal function, which may affect drug metabolism and tolerance. These factors complicate ART management, requiring a careful balance among efficacy, safety, and drug interactions. Rapid ART\u0026mdash;defined as treatment initiation within 7 days of diagnosis\u0026mdash;has been endorsed by international guidelines as a key strategy to reduce morbidity, mortality, and viral transmission [\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e, \u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e]. Although integrase strand transfer inhibitor (INSTI)-based regimens have demonstrated superiority in achieving rapid virological suppression [\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e, \u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e], real-world evidence of their efficacy and safety in the elderly population remains scarce, especially in regions with high rates of late diagnosis and limited resources, such as southwest China.\u003c/p\u003e \u003cp\u003eChina\u0026rsquo;s HIV epidemic is marked by a notable aging trend, with approximately 30% of newly diagnosed cases aged\u0026thinsp;\u0026ge;\u0026thinsp;50 years [\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e, \u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e]. Late diagnosis (CD4\u0026thinsp;+\u0026thinsp;T cell count\u0026thinsp;\u0026lt;\u0026thinsp;350 cells/\u0026micro;L) and high baseline viral load (HIV RNA\u0026thinsp;\u0026gt;\u0026thinsp;500,000 copies/mL) are common [\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e], increasing the risk of malignancies and poor immune reconstitution [\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e, \u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e]. Current rapid ART guidelines recommend INSTI-based regimens such as bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) due to their high efficacy, good tolerability, and minimal drug interactions [\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e, \u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e]. Most existing studies have focused on younger PWH in developed countries; data on BIC/FTC/TAF as a rapid cART regimen in elderly PWH from resource-limited settings in China are limited. This population may exhibit distinct immune responses and metabolic profiles compared to younger individuals. Additionally, in elderly patients with comorbidities, the long-term renal and lipid safety of tenofovir alafenamide (TAF) requires further evaluation, alongside careful management of comorbid conditions.\u003c/p\u003e \u003cp\u003eThis single-center, retrospective, real-world study aimed to evaluate the 96-week efficacy and safety of BIC/FTC/TAF as a rapid ART strategy in Chinese PWH aged\u0026thinsp;\u0026ge;\u0026thinsp;50 years. The focus was on virological suppression, immune recovery, renal and lipid safety, treatment sustainability, and patient-reported outcomes. By addressing the intersecting challenges of late diagnosis, polypharmacy, and aging-related physiological changes, our findings provide valuable evidence to optimize rapid ART strategies in this vulnerable population.\u003c/p\u003e"},{"header":"Methods","content":"\u003cp\u003e\u003cstrong\u003eEthical Approval\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe study protocol was approved by the Ethics Committee of Chongqing Public Health Medical Center (No. 2024-004-01-KY). As this was a retrospective study analyzing anonymized data, the institutional review board waived the requirement for written informed consent.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eStudy Population and Design\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eWe retrospectively collected data on treatment-naive PWH aged \u0026ge;50 years who initiated ART within 7 days of HIV diagnosis at Chongqing Public Health Medical Center between January 1, 2022, and December 31, 2022, excluding pregnant women. Inclusion criteria followed the Chinese Guidelines for HIV/AIDS Diagnosis and Treatment (2024 Edition) [15]. Diagnosis required a positive HIV antibody screening test and confirmatory test. Virological suppression was defined as HIV RNA \u0026lt;50 copies/mL. Safety assessments included renal function and lipid profiles. Patient-reported outcomes (PROs), adherence, and 96-week regimen retention rate were also evaluated.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eData Collection\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eBaseline demographic and clinical data\u0026mdash;including age, sex, marital status, infection route, BMI, CD4+ T cell count, HIV RNA viral load, comorbidities (e.g., type 2 diabetes, hypertension), concomitant medications, and baseline drug resistance\u0026mdash;were extracted from electronic medical records and laboratory databases. Data were collected at ART initiation and follow-up visits at weeks 12, 24, 48, and 96 (\u0026plusmn;2 weeks). Variables included ART regimen, HIV RNA viral load, CD4+ T cell count, fasting lipid panel, creatinine, and other biochemical markers. Adverse events were recorded at each visit.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eOutcomes of Interest\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe primary objective was to evaluate the efficacy of ART initiated within 7 days in elderly treatment-naive PWH at weeks 12, 24, 48, and 96. Secondary objectives included assessing changes in CD4+ T cell count, retention of the initial ART regimen at week 96, PROs, and the safety profile of lipid metabolism and renal function at week 96.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eStatistical Analysis\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eStatistical analyses were performed using SPSS 27.0. Categorical variables were presented as frequencies (percentages) and compared using \u0026chi;\u0026sup2; or Fisher\u0026rsquo;s exact tests. Normally distributed continuous variables were expressed as mean \u0026plusmn; standard deviation and compared with independent samples t-tests. Non-normally distributed data were expressed as median (P25, P75) and compared using non-parametric tests. A p-value \u0026lt;0.05 was considered statistically significant.\u003c/p\u003e"},{"header":"Results","content":"\u003cp\u003e\u003cstrong\u003eBaseline Characteristics\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eAmong 1,057 ART initiators in 2022, 586 (55.4%) were aged \u0026ge;50 years; 232 (39.6%) initiated ART within 7 days; and 111 PWH receiving BIC/FTC/TAF were enrolled. Males accounted for 59.5% (66/111), mean age was 60.4\u0026plusmn;8.0 years, and 96.4% acquired HIV via heterosexual transmission. Late presentation (CD4+ T cell count \u0026lt;350 cells/\u0026mu;L) occurred in 86.4% (96/111), high viral load (HIV RNA \u0026gt;500,000 copies/mL) in 39.7% (44/111), comorbidities in 63.0% (70/111), and comedications in 57.6% (64/111). Baseline drug resistance was detected in 11 cases: 1 protease inhibitor (PI), 2 INSTI (elvitegravir and raltegravir, low-level resistance), and 8 NNRTI，the detailed demographic and clinical characteristics of the study cohort are presented in Table 1.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eTable 1: Demographic and Clinical Characteristics\u003c/strong\u003e\u003c/p\u003e\n\u003ctable border=\"1\" cellspacing=\"0\" cellpadding=\"0\" width=\"464\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 231px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 233px;\"\u003e\n \u003cp\u003eBIC/FTC/TAF (n=111)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 231px;\"\u003e\n \u003cp\u003eMale (n，%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 233px;\"\u003e\n \u003cp\u003e66 (59.5)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 231px;\"\u003e\n \u003cp\u003eAge (years, x̅\u0026nbsp;\u0026plusmn;\u0026nbsp;s)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 233px;\"\u003e\n \u003cp\u003e60.4\u0026plusmn;8.0\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 231px;\"\u003e\n \u003cp\u003eBMI\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 233px;\"\u003e\n \u003cp\u003e22.9\u0026plusmn;3.1\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 231px;\"\u003e\n \u003cp\u003eMarital Status\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 233px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 231px;\"\u003e\n \u003cp\u003eSingle\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 233px;\"\u003e\n \u003cp\u003e5(4.5)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 231px;\"\u003e\n \u003cp\u003eMarried\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 233px;\"\u003e\n \u003cp\u003e90 (81.1)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 231px;\"\u003e\n \u003cp\u003eDivorced or widowed\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 233px;\"\u003e\n \u003cp\u003e16 (14.4)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 231px;\"\u003e\n \u003cp\u003eMode of Transmission\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 233px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 231px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003eMale-to-Male Sexual Transmission\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 233px;\"\u003e\n \u003cp\u003e4 (3.6)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 231px;\"\u003e\n \u003cp\u003eHeterosexual Transmission\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 233px;\"\u003e\n \u003cp\u003e107（96.4)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 231px;\"\u003e\n \u003cp\u003eBlood Transfusion/Blood Products\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 233px;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 231px;\"\u003e\n \u003cp\u003eCD4 counts, cells/mm3\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 233px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 231px;\"\u003e\n \u003cp\u003e＜100\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 233px;\"\u003e\n \u003cp\u003e29（26.1）\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 231px;\"\u003e\n \u003cp\u003e100-199\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 233px;\"\u003e\n \u003cp\u003e32（28.8）\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 231px;\"\u003e\n \u003cp\u003e200-349\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 233px;\"\u003e\n \u003cp\u003e35（31.5）\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 231px;\"\u003e\n \u003cp\u003e\u0026ge;350\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 233px;\"\u003e\n \u003cp\u003e15（13.6）\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 231px;\"\u003e\n \u003cp\u003eHIV-RNA VL, copies/ml\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 233px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 231px;\"\u003e\n \u003cp\u003e\u0026lt;100000\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 233px;\"\u003e\n \u003cp\u003e34（30.6）\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 231px;\"\u003e\n \u003cp\u003e100000-\u003c/p\u003e\n \u003cp\u003e500000\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 233px;\"\u003e\n \u003cp\u003e33（29.7）\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 231px;\"\u003e\n \u003cp\u003e＞500000\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 233px;\"\u003e\n \u003cp\u003e44（39.7）\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 231px;\"\u003e\n \u003cp\u003eComorbidities\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 233px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 231px;\"\u003e\n \u003cp\u003e1 condition\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 233px;\"\u003e\n \u003cp\u003e39(35.1)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 231px;\"\u003e\n \u003cp\u003e\u0026ge;2 conditions\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 233px;\"\u003e\n \u003cp\u003e31(27.9)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 231px;\"\u003e\n \u003cp\u003eConcomitant Medications\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 233px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 231px;\"\u003e\n \u003cp\u003e1 medication\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 233px;\"\u003e\n \u003cp\u003e27(24.3)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 231px;\"\u003e\n \u003cp\u003e\u0026ge;2 medications\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 233px;\"\u003e\n \u003cp\u003e37(33.3)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 231px;\"\u003e\n \u003cp\u003eDrug Resistance Testing Status\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 233px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 231px;\"\u003e\n \u003cp\u003eTest \u0026nbsp;Performed\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 233px;\"\u003e\n \u003cp\u003e43 (38.7)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 231px;\"\u003e\n \u003cp\u003eDrug Resistance Not Detected\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 233px;\"\u003e\n \u003cp\u003e32(28.8)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 231px;\"\u003e\n \u003cp\u003eDrug Resistance Detected\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 233px;\"\u003e\n \u003cp\u003e11（9.9）\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003e\u003cstrong\u003eCD4+T cell count and Virologic Suppression\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eFollowing BIC/FTC/TAF treatment, significant increases in CD4+ T cell count were observed in this elderly PWH cohort. CD4+ T cell counts at weeks 12, 24, 48, and 96 post-ART initiation are detailed in Table 2. Statistically significant improvements (p \u0026lt; 0.05) were noted at all time points compared to baseline. High rates of virologic suppression were achieved, reaching 90.2% (83/92) by week 12 and 99% (99/100) at week 96.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eTable 2: Virologic Outcomes and immunologic responses at Week12,week24,Week 48, week 96\u003c/strong\u003e\u003c/p\u003e\n\u003ctable border=\"1\" cellspacing=\"0\" cellpadding=\"0\" width=\"587\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 129px;\"\u003e\n \u003cp\u003eCharacteristics\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 93px;\"\u003e\n \u003cp\u003eBaseline\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 91px;\"\u003e\n \u003cp\u003eWeek 12\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 94px;\"\u003e\n \u003cp\u003eWeek24\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 93px;\"\u003e\n \u003cp\u003eWeek 48\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 87px;\"\u003e\n \u003cp\u003eWeek 96\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 129px;\"\u003e\n \u003cp\u003eCD4\u003c/p\u003e\n \u003cp\u003e(cells/\u0026micro;L)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 93px;\"\u003e\n \u003cp\u003e201.5\u0026plusmn;135.1\u003c/p\u003e\n \u003cp\u003e（n=111）\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 91px;\"\u003e\n \u003cp\u003e308.6\u0026plusmn;166.4\u003c/p\u003e\n \u003cp\u003e（n=98）\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 94px;\"\u003e\n \u003cp\u003e325.5\u0026plusmn;147.3\u003c/p\u003e\n \u003cp\u003e（n=102）\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 93px;\"\u003e\n \u003cp\u003e367.8\u0026plusmn;155.1\u003c/p\u003e\n \u003cp\u003e（n=105）\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 87px;\"\u003e\n \u003cp\u003e423.1\u0026plusmn;203.8\u003c/p\u003e\n \u003cp\u003e(n=100)\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 129px;\"\u003e\n \u003cp\u003ep-value a\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 93px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 91px;\"\u003e\n \u003cp\u003e\u0026lt;0.001\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 94px;\"\u003e\n \u003cp\u003e\u0026lt;0.001\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 93px;\"\u003e\n \u003cp\u003e\u0026lt;0.001\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 87px;\"\u003e\n \u003cp\u003e\u0026lt;0.001\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 129px;\"\u003e\n \u003cp\u003eHIVRNA\u003c/p\u003e\n \u003cp\u003e\u0026lt;50copies/ml (n，%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 93px;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 91px;\"\u003e\n \u003cp\u003e90.2(83/92)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 94px;\"\u003e\n \u003cp\u003e93.3(84/90)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 93px;\"\u003e\n \u003cp\u003e96.9(96/98)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 87px;\"\u003e\n \u003cp\u003e99.0(99/100)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003e\u003cstrong\u003eSafety Monitoring\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eRenal function and lipid profiles at each follow-up time point post-ART initiation are summarized in Table 3,\u003c/p\u003e\n\u003cp\u003eTC, LDL, and HDL levels increased compared to baseline but remained within normal ranges. No significant changes were observed in serum creatinine (SCr), uric acid (UA), eGFR, or triglycerides (TG) at any time point compared to baseline (p \u0026gt; 0.05).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eTable 3: Renal and Lipid Safety data at week 96\u003c/strong\u003e\u003c/p\u003e\n\u003ctable border=\"0\" cellspacing=\"0\" cellpadding=\"0\" width=\"633\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd colspan=\"6\" valign=\"top\" style=\"width: 633px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eTable 3: The changes in renal safety and lipid profiles between baseline and follow-up data in treatment-na\u0026iuml;ve PWH\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 89px;\"\u003e\n \u003cp\u003e\u0026nbsp;Characteristics\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 110px;\"\u003e\n \u003cp\u003eBaseline\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 93px;\"\u003e\n \u003cp\u003eWeek 12\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003eWeek24\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 107px;\"\u003e\n \u003cp\u003eWeek 48\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 119px;\"\u003e\n \u003cp\u003eWeek 96\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 89px;\"\u003e\n \u003cp\u003e\u003cem\u003eSCr\u003c/em\u003e\u003c/p\u003e\n \u003cp\u003e(umol/L)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 110px;\"\u003e\n \u003cp\u003e62.9\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e(54.1,74.1)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 93px;\"\u003e\n \u003cp\u003e69.8\u003c/p\u003e\n \u003cp\u003e(59.7,79.0)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e71.6\u003c/p\u003e\n \u003cp\u003e(57.8,80.7)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 107px;\"\u003e\n \u003cp\u003e69.7\u003c/p\u003e\n \u003cp\u003e(58.3,77.4)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 119px;\"\u003e\n \u003cp\u003e72.1\u003c/p\u003e\n \u003cp\u003e(59.7,84.5)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 89px;\"\u003e\n \u003cp\u003e\u003cem\u003ep\u003c/em\u003e-value \u003csup\u003ea\u003c/sup\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 110px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 93px;\"\u003e\n \u003cp\u003e0.070\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e0.058\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 107px;\"\u003e\n \u003cp\u003e0.054\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 119px;\"\u003e\n \u003cp\u003e0.052\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 89px;\"\u003e\n \u003cp\u003e\u003cem\u003eUA\u003c/em\u003e\u003c/p\u003e\n \u003cp\u003e(umol/L)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 110px;\"\u003e\n \u003cp\u003e323.5\u003c/p\u003e\n \u003cp\u003e(274.8,77.8)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 93px;\"\u003e\n \u003cp\u003e327.5\u003c/p\u003e\n \u003cp\u003e(265.8,422.0)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e340.0\u003c/p\u003e\n \u003cp\u003e(277.3,399.3)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 107px;\"\u003e\n \u003cp\u003e322.5\u003c/p\u003e\n \u003cp\u003e(267.5,385.5)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 119px;\"\u003e\n \u003cp\u003e309.0\u003c/p\u003e\n \u003cp\u003e(262.5,381.0)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 89px;\"\u003e\n \u003cp\u003e\u003cem\u003ep\u003c/em\u003e-value \u003csup\u003ea\u003c/sup\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 110px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 93px;\"\u003e\n \u003cp\u003e0.452\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e0.481\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 107px;\"\u003e\n \u003cp\u003e0.830\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 119px;\"\u003e\n \u003cp\u003e0.853\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 89px;\"\u003e\n \u003cp\u003e\u003cem\u003eeGFR\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 110px;\"\u003e\n \u003cp\u003e99.0\u003c/p\u003e\n \u003cp\u003e(92.5,104.0)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 93px;\"\u003e\n \u003cp\u003e93.0\u003c/p\u003e\n \u003cp\u003e(84.8,101.0)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e93.0\u003c/p\u003e\n \u003cp\u003e(92.5,104.0)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 107px;\"\u003e\n \u003cp\u003e94.5\u003c/p\u003e\n \u003cp\u003e(83.5,99.0)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 119px;\"\u003e\n \u003cp\u003e91.0\u003c/p\u003e\n \u003cp\u003e(80.0,98.0)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 89px;\"\u003e\n \u003cp\u003e\u003cem\u003ep\u003c/em\u003e-value \u003csup\u003ea\u003c/sup\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 110px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 93px;\"\u003e\n \u003cp\u003e0.060\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e0.061\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 107px;\"\u003e\n \u003cp\u003e0.070\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 119px;\"\u003e\n \u003cp\u003e0.052\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 89px;\"\u003e\n \u003cp\u003e\u003cem\u003eTG\u003c/em\u003e\u003c/p\u003e\n \u003cp\u003e\u003cem\u003e(mmol/L)\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 110px;\"\u003e\n \u003cp\u003e1.61\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e(1.18,2.35)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 93px;\"\u003e\n \u003cp\u003e1.69\u003c/p\u003e\n \u003cp\u003e（1.18,2.52）\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e1.58\u003c/p\u003e\n \u003cp\u003e(1.21,2.63)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 107px;\"\u003e\n \u003cp\u003e2.05\u003c/p\u003e\n \u003cp\u003e(1.21,2.79)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 119px;\"\u003e\n \u003cp\u003e1.92\u003c/p\u003e\n \u003cp\u003e(1.26,3.25)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 89px;\"\u003e\n \u003cp\u003e\u003cem\u003ep\u003c/em\u003e-value \u003csup\u003ea\u003c/sup\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 110px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 93px;\"\u003e\n \u003cp\u003e0.985\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e0.955\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 107px;\"\u003e\n \u003cp\u003e0.280\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 119px;\"\u003e\n \u003cp\u003e0.087\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 89px;\"\u003e\n \u003cp\u003eTC\u003c/p\u003e\n \u003cp\u003e(mmol/L)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 110px;\"\u003e\n \u003cp\u003e4.15\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e(3.54,4.84)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 93px;\"\u003e\n \u003cp\u003e4.80\u003c/p\u003e\n \u003cp\u003e（3.88,5.47）\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e4.77\u003c/p\u003e\n \u003cp\u003e（4.02,5.50）\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 107px;\"\u003e\n \u003cp\u003e4.73\u003c/p\u003e\n \u003cp\u003e（4.03,5.44）\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 119px;\"\u003e\n \u003cp\u003e4.67\u003c/p\u003e\n \u003cp\u003e（4.11,5.14）\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 89px;\"\u003e\n \u003cp\u003e\u003cem\u003ep\u003c/em\u003e-value \u003csup\u003ea\u003c/sup\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 110px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 93px;\"\u003e\n \u003cp\u003e0.001\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e＜0.001\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 107px;\"\u003e\n \u003cp\u003e＜0.001\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 119px;\"\u003e\n \u003cp\u003e0.004\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 89px;\"\u003e\n \u003cp\u003eHDL\u003c/p\u003e\n \u003cp\u003e(mmol/L)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 110px;\"\u003e\n \u003cp\u003e1.08\u003c/p\u003e\n \u003cp\u003e(0.88,1.32)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 93px;\"\u003e\n \u003cp\u003e1.29\u003c/p\u003e\n \u003cp\u003e（1.14,1.48）\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e1.34\u003c/p\u003e\n \u003cp\u003e（1.12,1.51）\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 107px;\"\u003e\n \u003cp\u003e1.19\u003c/p\u003e\n \u003cp\u003e（1.06,1.45）\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 119px;\"\u003e\n \u003cp\u003e1.21\u003c/p\u003e\n \u003cp\u003e（1.07,1.39）\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 89px;\"\u003e\n \u003cp\u003e\u003cem\u003ep\u003c/em\u003e-value \u003csup\u003ea\u003c/sup\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 110px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 93px;\"\u003e\n \u003cp\u003e\u0026lt;0.001\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e\u0026lt;0.001\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 107px;\"\u003e\n \u003cp\u003e0.002\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 119px;\"\u003e\n \u003cp\u003e0.002\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 89px;\"\u003e\n \u003cp\u003eLDL\u003c/p\u003e\n \u003cp\u003e(mmol/L)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 110px;\"\u003e\n \u003cp\u003e2.45\u003c/p\u003e\n \u003cp\u003e(2.06,2.85)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 93px;\"\u003e\n \u003cp\u003e2.69\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;(2.28,3.19)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e2.59\u003c/p\u003e\n \u003cp\u003e（2.24,3.10）\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 107px;\"\u003e\n \u003cp\u003e2.61\u003c/p\u003e\n \u003cp\u003e（2.36,3.05）\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 119px;\"\u003e\n \u003cp\u003e2.68\u003c/p\u003e\n \u003cp\u003e(2.23,3.07)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 89px;\"\u003e\n \u003cp\u003e\u003cem\u003ep\u003c/em\u003e-value \u003csup\u003ea\u003c/sup\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 110px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 93px;\"\u003e\n \u003cp\u003e0.008\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e0.026\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 107px;\"\u003e\n \u003cp\u003e0.037\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 119px;\"\u003e\n \u003cp\u003e0.041\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003e\u003cstrong\u003ePRO Outcomes and Adherence\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003ePatient-reported outcomes (PROs) were assessed using the SF-36 Health Survey Scale. After 96 weeks of treatment, significant improvements (P \u0026lt; 0.05) were observed across all eight SF-36 domains (Table 4). Median self-reported adherence measured by the Visual Analogue Scale (VAS) was 100.0 (interquartile range [IQR]: 97.0\u0026ndash;100.0) throughout the 96-week period. Among participants, 105 (94.6%) reported no missed doses, 4 (3.6%) missed doses on one day, and 2 (1.8%) missed doses on two days (Table 5).\u003c/p\u003e\n\u003ctable border=\"0\" cellspacing=\"0\" cellpadding=\"0\" width=\"493\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd colspan=\"5\" valign=\"top\" style=\"width: 493px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eTable 4: Performance of SF-36 factors in 111 PWHs\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 147px;\"\u003e\n \u003cp\u003e\u0026nbsp;Characteristics\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 103px;\"\u003e\n \u003cp\u003eBaseline\u003c/p\u003e\n \u003cp\u003eMedian (IQR)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 108px;\"\u003e\n \u003cp\u003eWeek 96\u003c/p\u003e\n \u003cp\u003eMedian (IQR)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 75px;\"\u003e\n \u003cp\u003eZ\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 60px;\"\u003e\n \u003cp\u003ep-value\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 147px;\"\u003e\n \u003cp\u003eGeneral Health (GH)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 103px;\"\u003e\n \u003cp\u003e42.0 (10.0,59.5)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 108px;\"\u003e\n \u003cp\u003e77.0(62.0,97.0)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 75px;\"\u003e\n \u003cp\u003e-3.481\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 60px;\"\u003e\n \u003cp\u003e\u0026lt;0.001\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 147px;\"\u003e\n \u003cp\u003ePhysical Functioning (PF）\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 103px;\"\u003e\n \u003cp\u003e57.0 (65.0,95.0)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 108px;\"\u003e\n \u003cp\u003e100 (95.0,100)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 75px;\"\u003e\n \u003cp\u003e-2.541\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 60px;\"\u003e\n \u003cp\u003e0.011\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 147px;\"\u003e\n \u003cp\u003eRole-Physical (RP)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 103px;\"\u003e\n \u003cp\u003e0(0,62.5)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 108px;\"\u003e\n \u003cp\u003e100(25,100)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 75px;\"\u003e\n \u003cp\u003e-2.204\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 60px;\"\u003e\n \u003cp\u003e0.028\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 147px;\"\u003e\n \u003cp\u003eBodily Pain (BP)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 103px;\"\u003e\n \u003cp\u003e64.0(52.0,74.0)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 108px;\"\u003e\n \u003cp\u003e100(100,100)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 75px;\"\u003e\n \u003cp\u003e-3.084\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 60px;\"\u003e\n \u003cp\u003e0.002\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 147px;\"\u003e\n \u003cp\u003eVitality (VT)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 103px;\"\u003e\n \u003cp\u003e25(12.5,60.0)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 108px;\"\u003e\n \u003cp\u003e85.0(72.5,90.0)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 75px;\"\u003e\n \u003cp\u003e-3.503\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 60px;\"\u003e\n \u003cp\u003e\u0026lt;0.001\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 147px;\"\u003e\n \u003cp\u003eSocial Functioning (SF)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 103px;\"\u003e\n \u003cp\u003e44.0(22.0,78.0)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 108px;\"\u003e\n \u003cp\u003e89.0(83.5,100.0)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 75px;\"\u003e\n \u003cp\u003e-2.931\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 60px;\"\u003e\n \u003cp\u003e0.003\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 147px;\"\u003e\n \u003cp\u003eRole-Emotional (RE)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 103px;\"\u003e\n \u003cp\u003e0(0,0)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 108px;\"\u003e\n \u003cp\u003e100.0(100.0,100.0)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 75px;\"\u003e\n \u003cp\u003e-3.721\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 60px;\"\u003e\n \u003cp\u003e\u0026lt;0.001\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 147px;\"\u003e\n \u003cp\u003eMental Health (MH)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 103px;\"\u003e\n \u003cp\u003e32.0(12.0,62.0)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 108px;\"\u003e\n \u003cp\u003e84.0(70.0,94.0)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 75px;\"\u003e\n \u003cp\u003e-3.396\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 60px;\"\u003e\n \u003cp\u003e\u0026lt;0.001\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003ctable border=\"0\" cellspacing=\"0\" cellpadding=\"0\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd colspan=\"2\" valign=\"top\" style=\"width: 492px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eTable 5: PWHs\u0026rsquo; self-reported adherence level (n = 111)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd colspan=\"2\" valign=\"top\" style=\"width: 492px;\"\u003e\n \u003cp\u003eSelf-Reported ART Adherence Level\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 251px;\"\u003e\n \u003cp\u003eART Adherence VAS score\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 241px;\"\u003e\n \u003cp\u003ePLWH\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 251px;\"\u003e\n \u003cp\u003eMedian (IQR)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 241px;\"\u003e\n \u003cp\u003e100.0(97.0,100.0)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 251px;\"\u003e\n \u003cp\u003eForgotten days of medication\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 241px;\"\u003e\n \u003cp\u003ePast week 96 ,n (%) \u0026nbsp; \u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 251px;\"\u003e\n \u003cp\u003e0day\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 241px;\"\u003e\n \u003cp\u003e105 (94.6%)\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 251px;\"\u003e\n \u003cp\u003e1day\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 241px;\"\u003e\n \u003cp\u003e4(3.6%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 251px;\"\u003e\n \u003cp\u003e2day\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 241px;\"\u003e\n \u003cp\u003e0(0)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 251px;\"\u003e\n \u003cp\u003e3day\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 241px;\"\u003e\n \u003cp\u003e2(1.8%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003e\u003cstrong\u003eTreatment Retention\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe overall treatment retention rate at week 96 was 94.6% (105/111). After excluding 2 deaths, the adjusted retention rate was 96.3% (105/109). By week 96, 11 PWH had switched their ART regimen. The retention rate for the initial regimen was 90.1% (100/111). Reasons for switching included: 6 patients transitioned to National Free Antiretroviral Treatment Program (NFATP) regimens due to financial constraints, 3 switched to 3TC/DTG because of drug-drug interactions (DDI) with tuberculosis medications, and 2 switched to ABC/3TC/DTG due to weight gain.\u003c/p\u003e"},{"header":"Discussion","content":"\u003cp\u003eIn recent years, the aging of the AIDS population has drawn widespread global attention [16–17]. ART has prolonged the life expectancy of infected individuals and reduced mortality rates. Data from the Chinese Center for Disease Control and Prevention indicate that the proportion of PWH aged over 50 in China increased from 22% in 2011 to 44% in 2022. The number of newly diagnosed elderly PWH has risen, reflecting a prominent aging population and a heavy disease burden [18]. In this study, elderly PWH aged over 50 accounted for 55.4%. Selecting an appropriate treatment regimen for this population is critical for controlling the local HIV epidemic. However, only 39.8% of newly diagnosed elderly PWH initiated rapid ART (within 7 days), considerably lower than the 68.3% reported in a retrospective study in Taiwan, China [19]. This discrepancy may stem from several factors: insufficient HIV/AIDS awareness among the elderly leading to low acceptance of rapid ART initiation; studies have shown substantial gaps in elderly individuals’ knowledge of HIV transmission routes, treatment effects, and side effects, which may reduce willingness to start treatment promptly [20–22]. Additionally, economic burden [23–24] remains an important barrier despite availability of many free antiretroviral drugs, as related costs such as transportation and nutritional support may limit access, particularly in resource-limited areas. Social discrimination against HIV-infected individuals may cause elderly patients to delay treatment for fear of exclusion [25]. Furthermore, domestic health education on HIV infection among the elderly is insufficient [26], with poor basic knowledge and limited understanding of ART’s importance and benefits, resulting in reluctance or unawareness about rapid ART initiation after diagnosis.\u003c/p\u003e\n\u003cp\u003eOur study found that 86.4% of elderly PWH initiating rapid ART had CD4+ T cell counts \u0026lt;350 cells/μL at diagnosis, indicating late presentation, and 39.7% had high viral loads (\u0026gt;500,000 copies/mL). Two PWH exhibited potential low-level resistance to elvitegravir and raltegravir. The BIC/FTC/TAF regimen achieved a high virological suppression rate, reaching 90.2% at 12 weeks and increasing to 99.0% at 96 weeks of follow-up. This regimen demonstrated robust virological suppression and immunological improvement, consistent with international studies [27–28], suggesting that rapid ART initiation can significantly improve prognosis even in elderly populations with late diagnosis and high viral load. Rapid ART effectively reduces immune system damage and lowers the risk of HIV-related and non-HIV-related comorbidities [29–30], thereby enhancing survival and quality of life for PWH.\u003c/p\u003e\n\u003cp\u003eIn this study, TC, LDL, and HDL levels increased compared to baseline after treatment but stabilized over time, consistent with previous reports [31–32]. Most PWH maintained lipid levels within the normal range during follow-up, possibly because some had elevated baseline lipids but a low proportion received treatment for hyperlipidemia. Clinicians may prioritize virological and immunological markers while overlooking metabolic management, such as lipid control. As a newer ART regimen, BIC/FTC/TAF has relatively minimal metabolic effects. However, integrase inhibitors may influence lipid metabolism and contribute to weight gain [33–34]. Therefore, regular lipid monitoring and appropriate lipid-lowering interventions are recommended to maintain metabolic health in PWH.\u003c/p\u003e\n\u003cp\u003eART discontinuation rates are generally high among elderly PWH, negatively impacting treatment success. In this study, patient-reported outcomes (PROs) improved significantly after treatment (P \u0026lt; 0.05), and treatment adherence was high (VAS ≥97%). This indicates that BIC/FTC/TAF not only achieved virological and immunological efficacy but also significantly improved quality of life and treatment satisfaction. High adherence, a key factor for ART success, may relate to the regimen’s good tolerability and low side-effect profile [35]. Overall, 96-week treatment retention was 94.6%, aligning with prior findings that BIC/FTC/TAF maintains high retention rates (99.2%) as a same-day rapid initiation regimen [36].\u003c/p\u003e\n\u003cp\u003eAmong participants, 63.0% had comorbidities and 57.6% used concomitant medications. Despite this, BIC/FTC/TAF was well tolerated with a low incidence of adverse reactions, consistent with international data [37]. Its minimal drug-drug interactions (DDIs) [38–39] and unaffected viral suppression despite concomitant medications make it particularly advantageous in elderly patients with multiple comorbidities.\u003c/p\u003e\n\u003cp\u003eIn conclusion, BIC/FTC/TAF as a rapid initiation regimen demonstrated strong virological suppression in elderly Chinese PWH, with significant immune recovery, improved PROs, high adherence, and excellent treatment and regimen retention rates.\u003c/p\u003e\n\u003cp\u003eThis single-center retrospective study may be subject to selection bias, and its relatively small sample size could limit the generalizability of results. Future multi-center studies with larger cohorts are warranted.\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eAuthor contribution statement\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eChanggang Deng 、Qisui Li proposed the conceptualization. Jing Yuan wrote and edited the review.Wei Zhang、Min Liu wrote the original draft.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eData availability Statement\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eOther datasets used and analyzed in this study are available upon reasonable request from the corresponding author.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConflicts of interest\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eNone\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFunding Statement\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis work was supported by grants from the first batch of the Key Public Health Key Discipline Construction Project (Junior College), the Traditional Chinese Medicine Research Project of Chongqing Municipal Health Commission (2024WSJK147), and the Chongqing Center for Disease Control and Prevention Research Program.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\n\u003cli\u003eDuong KNC, Schmutz HW, Ben-Umeh KC, et al. 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Effectiveness, safety, and patient-reported outcomes of treatment with bictegravir/emtricitabine/tenofovir alafenamide fixed dose combination in people living with HIV in Argentina: the BICTARG cohort. \u003cem\u003eRev Esp Quimioter\u003c/em\u003e. 2025;38(1):40-47. doi:10.37201/req/080.2024.\u003c/li\u003e\n\u003cli\u003eWang J, Xiao N, Zhu Z, et al. Comparing acute versus AIDS ART initiation on HIV-1 integration sites and clonal expansion. \u003cem\u003eSignal Transduct Target Ther\u003c/em\u003e. 2025;10(1):23. Published 2025 Jan 10. doi:10.1038/s41392-024-02113-7.\u003c/li\u003e\n\u003cli\u003eMichienzi SM, Barrios M, Badowski ME. Evidence Regarding Rapid Initiation of Antiretroviral Therapy in Patients Living with HIV. \u003cem\u003eCurr Infect Dis Rep\u003c/em\u003e. 2021;23(5):7. doi:10.1007/s11908-021-00750-5.\u003c/li\u003e\n\u003cli\u003eWang X, Liu A, Li Z, et al. 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Results from the CORIS Cohort: The ACTUAS II Study. \u003cem\u003eClin Infect Dis\u003c/em\u003e. Published online March 27, 2025. doi:10.1093/cid/ciaf162.\u003c/li\u003e\n\u003cli\u003eYuan J, Deng C, Li Q, et al. Human immunodeficiency virus/acquired immune deficiency syndrome antiretroviral therapy initiated on the same day in treatment-na\u0026iuml;ve people with human immunodeficiency virus: A comparative study of efficacy and regimen. \u003cem\u003eChin Med J (Engl)\u003c/em\u003e. 2024;137(22):2720-2725. doi:10.1097/CM9.0000000000003330.\u003c/li\u003e\n\u003cli\u003eTorralba M, Rodr\u0026iacute;guez G, Gonz\u0026aacute;lez Gasca FJ, et al. Bictegravir/Emtricitabine/Tenofovir Alafenamide in a Multicentre Cohort: Real-Life Experience From Spain. \u003cem\u003eAnn Pharmacother\u003c/em\u003e. 2024;58(2):140-147. doi:10.1177/10600280231168852.\u003c/li\u003e\n\u003cli\u003eSchafer JJ, Pandit NS, Cha A, et al. 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Biochem Pharmacol. 2023;217:115862. doi:10.1016/j.bcp.2023.115862. \u003c/li\u003e\n\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":false,"highlight":"","institution":"","isAcceptedByJournal":false,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"bmc-infectious-diseases","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"infd","sideBox":"Learn more about [BMC Infectious Diseases](http://bmcinfectdis.biomedcentral.com/)","snPcode":"","submissionUrl":"https://www.editorialmanager.com/infd","title":"BMC Infectious Diseases","twitterHandle":"#bmcinfectdis","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"em","reportingPortfolio":"BMC Series","inReviewEnabled":true,"inReviewRevisionsEnabled":true},"keywords":"Treatment-naive HIV/AIDS patients, Elderly, Rapid initiation, BIC/FTC/TAF, Efficacy, Safety","lastPublishedDoi":"10.21203/rs.3.rs-9292623/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-9292623/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003ch2\u003eBackground\u003c/h2\u003e \u003cp\u003eRapid ART has improved the prognosis of people with HIV/AIDS (PWH). However, real-world studies on the Chinese elderly population (\u0026ge;\u0026thinsp;50 years) were limited. This study aimed to evaluate the efficacy, safety, retention rate, and patient-reported outcomes (PROs) of BIC/FTC/TAF as a rapid ART initiation regimen in elderly Chinese PWH(\u0026ge;\u0026thinsp;50 years).\u003c/p\u003e\u003ch2\u003eMethods\u003c/h2\u003e \u003cp\u003eWe retrospectively collected data on treatment-naive (TN) PWH aged\u0026thinsp;\u0026ge;\u0026thinsp;50 years who started BIC/FTC/TAF within 7 days of diagnosis. Virological suppression, immunological indices, renal function, lipid profiles, and safety outcomes were assessed at weeks 12, 24, 48, and 96. PROs, treatment adherence, and the retention rate at week 96 were also evaluated.\u003c/p\u003e\u003ch2\u003eResults\u003c/h2\u003e \u003cp\u003eA total of 111 elderly TN PWH were enrolled. Males accounted for 59.5% (66/111), and the mean baseline age was 60.4\u0026thinsp;\u0026plusmn;\u0026thinsp;8.0 years,,Of these, 86.4% (96/111) presented late (CD4\u0026thinsp;+\u0026thinsp;T cell count\u0026thinsp;\u0026lt;\u0026thinsp;350 cells/\u0026micro;L), 39.7% (44/111) had HIV RNA\u0026thinsp;\u0026gt;\u0026thinsp;500,000 copies/mL (high viral load), 63.0% (70/111) had comorbidities, and 57.6% (64/111) used comedications. Over 90% achieved virological suppression within 12 weeks, which was sustained through 96 weeks. These predominantly late-presenter elderly PWH showed rapid and significant CD4\u0026thinsp;+\u0026thinsp;T cell count increases after ART, reaching a mean of 423.1\u0026thinsp;\u0026plusmn;\u0026thinsp;203.8 cells/\u0026micro;L at week 96. Lipid levels fluctuated within the normal range post-ART. Renal parameters showed no significant changes from baseline. PROs improved after ART (P\u0026thinsp;\u0026lt;\u0026thinsp;0.05), and treatment adherence was high (VAS\u0026thinsp;\u0026gt;\u0026thinsp;97%). The retention rate at week 96 was 96.3% (105/109), excluding 2 deaths.\u003c/p\u003e\u003ch2\u003eConclusions\u003c/h2\u003e \u003cp\u003eBIC/FTC/TAF as a rapid initiation regimen demonstrated high efficacy and safety in elderly Chinese PWH. It significantly improved immune function and PROs and achieved a high overall treatment retention rate.\u003c/p\u003e","manuscriptTitle":"Efficacy and Safety of BIC/FTC/TAF as a Rapid Initiation of Antiretroviral Therapy Regimen in Elderly Chinese People with HIV/AIDS: A Retrospective Real-World Study from China","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2026-05-15 16:59:19","doi":"10.21203/rs.3.rs-9292623/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"reviewersInvited","content":"","date":"2026-05-07T04:59:20+00:00","index":"","fulltext":""},{"type":"editorInvited","content":"","date":"2026-04-27T16:30:29+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2026-04-07T09:26:18+00:00","index":"","fulltext":""},{"type":"checksComplete","content":"","date":"2026-04-07T09:25:49+00:00","index":"","fulltext":""},{"type":"submitted","content":"BMC Infectious Diseases","date":"2026-04-01T13:21:42+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"bmc-infectious-diseases","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"infd","sideBox":"Learn more about [BMC Infectious Diseases](http://bmcinfectdis.biomedcentral.com/)","snPcode":"","submissionUrl":"https://www.editorialmanager.com/infd","title":"BMC Infectious Diseases","twitterHandle":"#bmcinfectdis","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"em","reportingPortfolio":"BMC Series","inReviewEnabled":true,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"5f9357a7-2045-4da9-8ebb-15bc7da9f67b","owner":[],"postedDate":"May 15th, 2026","published":true,"recentEditorialEvents":[{"type":"reviewersInvited","content":"5","date":"2026-05-07T04:59:20+00:00","index":"","fulltext":""}],"rejectedJournal":[],"revision":"","amendment":"","status":"under-review","subjectAreas":[],"tags":[],"updatedAt":"2026-05-15T16:59:19+00:00","versionOfRecord":[],"versionCreatedAt":"2026-05-15 16:59:19","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-9292623","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-9292623","identity":"rs-9292623","version":["v1"]},"buildId":"XKTyCvWXoU3ODBz1xrDgd","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}