{
  "abstract": "Background Long-term real-world data on bictegravir/tenofovir alafenamide/emtricitabine (BIC/TAF/FTC) remain limited. Within the BICTEL cohort, this single-tablet regimen has demonstrated sustained virological effectiveness, favourable safety, and encouraging improvements in immune markers over extended follow-up. Although overall renal function remained largely stable after switching, without progressive deterioration beyond week 48, aggregate analyses identified a modest decline in estimated glomerular filtration rate (eGFR) over time. The clinical relevance and determinants of this decline remain unclear. We therefore aimed to identify predictors of clinically significant renal deterioration at week 144 (w144).Methods We conducted a retrospective interim analysis within the BICTEL cohort including people living with HIV (PLWH) who switched to BIC/FTC/TAF and had available eGFR measurements at baseline and w144. Clinically significant renal decline was defined a priori as a ≥10% reduction in eGFR from baseline to w144. Independent predictors of renal decline were assessed using multivariable penalized logistic regression, using Firth method and adjusting for age, baseline eGFR, hypertension, diabetes, and pre-switch backbone (TDF-based vs non-TDF-based regimens). Odds ratios (OR) with 95% confidence intervals (CI) and corresponding p-values were reported.Results Among 125 patients with available renal follow-up at week 144, 31.2% experienced a ≥10% decline in eGFR. Baseline characteristics are summarized in table 1A. In penalized multivariable logistic regression analysis, diabetes (OR 5.7; 95% CI 1.6–20.5; p=0.007) and prior TDF exposure (OR 5.2; 95% CI 1.0–26.3; p=0.048) were independently associated with clinically significant renal decline. Baseline eGFR, age, and hypertension were not significantly associated. Full results are reported in table 1B.Conclusions Within the BICTEL cohort, clinically significant renal decline at 144 weeks after switching to BIC/FTC/TAF was not uniformly distributed but concentrated in patients with underlying diabetes and prior TDF exposure. These associations persisted after penalized regression, suggesting that metabolic vulnerability and legacy TDF exposure may contribute to long-term renal trajectories. Although subgroup sizes were limited, these findings refine previous aggregate observations and underscore the importance of pre-switch history and comorbidity burden when interpreting long-term renal outcomes in real-world settings. Overall renal stability at the population level supports the favorable renal safety profile of BIC/FTC/TAF, while a risk-stratified approach to long-term monitoring may be warranted. Larger studies are needed to confirm these associations and further clarify the interaction between metabolic vulnerability and prior antiretroviral exposure.The project has been partially supported by a Gilead Sciences Medical grant.Abstract P32 Table 1A,B",
  "authors": [
    {
      "affiliations": [
        "Department of Public Health and Infectious Diseases, Sapienza University of Rome, Rome, Italy"
      ],
      "name": "L Bortolani"
    },
    {
      "affiliations": [
        "Department of Public Health and Infectious Diseases, Sapienza University of Rome, Rome, Italy"
      ],
      "name": "R Donà"
    },
    {
      "affiliations": [
        "Department of Public Health and Infectious Diseases, Sapienza University of Rome, Rome, Italy"
      ],
      "name": "A Lazzaro"
    },
    {
      "affiliations": [
        "Department of Public Health and Infectious Diseases, Sapienza University of Rome, Rome, Italy"
      ],
      "name": "F Alessi"
    },
    {
      "affiliations": [
        "Department of Public Health and Infectious Diseases, Sapienza University of Rome, Rome, Italy"
      ],
      "name": "M Ridolfi"
    },
    {
      "affiliations": [
        "Department of Public Health and Infectious Diseases, Sapienza University of Rome, Rome, Italy"
      ],
      "name": "E Altavilla"
    },
    {
      "affiliations": [
        "Department of Public Health and Infectious Diseases, Sapienza University of Rome, Rome, Italy"
      ],
      "name": "C Carafa"
    },
    {
      "affiliations": [
        "Department of Public Health and Infectious Diseases, Sapienza University of Rome, Rome, Italy"
      ],
      "name": "S Figliomeni"
    },
    {
      "affiliations": [
        "Department of Public Health and Infectious Diseases, Sapienza University of Rome, Rome, Italy"
      ],
      "name": "G Ceccarelli"
    },
    {
      "affiliations": [
        "Department of Public Health and Infectious Diseases, Sapienza University of Rome, Rome, Italy"
      ],
      "name": "CM Mastroianni"
    },
    {
      "affiliations": [
        "Department of Public Health and Infectious Diseases, Sapienza University of Rome, Rome, Italy"
      ],
      "name": "G d’Ettorre"
    }
  ],
  "title": "P32 Long-term renal outcomes after switch to bictegravir: determinants of clinically significant decline at week 144 in the BICTEL cohort",
  "uid": "baba17ed-837b-5f6c-b781-45d727521a1f"
}