Virological, Immunological, and Renal Outcomes after Fixed-Dose Tenofovir Disoproxil Fumarate–Lamivudine–Dolutegravir (TLD) among People Living with HIV at Phu Kradueng Hospital, Loei Province, Thailand: A Retrospective Cohort Study

Abstract

The fixed-dose combination of tenofovir disoproxil fumarate, lamivudine and dolutegravir (TLD) is the preferred first-line regimen in the Thai national guidelines, but real-world outcome data from Phu Kradueng Hospital were lacking.

          To describe virological, immunological and renal outcomes among people living with HIV receiving TLD.

          This retrospective single-arm before–after cohort study included adults who received TLD continuously for at least 3 months with adherence ≥95% at Phu Kradueng Hospital (1 October 2022–30 September 2025). Data were extracted from HOSxP and NAPPLUS. The primary outcome was the proportion with viral load (VL) <50 copies/mL before and after TLD (exact McNemar test). Secondary outcomes were changes in CD4 count and in serum creatinine (SCr) and eGFR (CKD-EPI 2021), analysed with the Wilcoxon signed-rank test, with 95% confidence intervals and sensitivity analyses.

          175 patients analysed (157 switched from other regimens; 18 initiated ART with TLD), mean age was 43.5±11.9 years and 52.0% were male. Among switched patients with paired VL results (n=150), VL <50 copies/mL was 92.7% before and 94.0% after TLD (McNemar p=0.79); 95.7% (133/139) of those suppressed at baseline remained suppressed. At the latest test, 94.0% (158/168; 95% CI 89.4–96.7) of tested patients had VL <50 copies/mL. Post-treatment CD4 was available for only 84 of 175 patients, and re-testing depended on baseline CD4, so CD4 findings are exploratory (median 330 to 557 cells/mm³ among 83 paired patients). In the renal analysis (n=91 with a verifiable pre-treatment baseline), median SCr rose from 0.70 to 0.94 mg/dL and eGFR fell from 110.9 to 88.9 mL/min/1.73 m² (median change −18.8; p<0.001). An eGFR decline ≥25% occurred in 34.1% and new eGFR <60 in 2 patients (2.2%). No factor was associated with the magnitude of decline, and results were consistent across sensitivity analyses.

          High viral suppression was maintained after TLD in a predominantly already-suppressed population; the CD4 increase cannot be attributed to TLD. The consistent rise in SCr and fall in eGFR is compatible with the known effect of dolutegravir on tubular creatinine secretion but cannot be separated from tenofovir toxicity with these data. Baseline renal values should be recorded and follow-up performed according to guidelines, with further evaluation for patients with large eGFR declines.