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Abstract

Introduction

Tenofovir disoproxil fumarate (TDF)/lamivudine (3TC)/dolutegravir (DTG) (TLD) is the preferred first-line therapy for all people living with HIV (PWH) per WHO 2019 and Thai HIV guidelines. This has prompted switches from TDF+FTC or 3TC+EFV to TLD in Thailand.

Methods

We conducted a randomized trial among virologically suppressed PWH aged ≥18 years on TDF+FTC or 3TC+EFV who were switched to either TLD or DTG+3TC. The primary outcome was the change in estimated glomerular filtration rate (eGFR) calculated by cystatin C at 24 weeks.

Results

Sixteen participants (eight per group), 69% male with a mean age of 41 years and a median duration of HIV diagnosis of 7.1 years, were enrolled. A greater, though not statistically significant, decline in eGFR was observed in the TLD group. The mean differences were 5.15mL/ min/1.73m2 (95% CI: -12.06 to 22.35; p=0.532) for cystatin C and 4.01mL/min/1.73m2 (95% CI: -3.58 to 11.59; =0.277) for creatinine. All participants maintained virological suppression. No significant differences were observed in BMI, LDL, or CD4 counts.

Discussion

Although not statistically significant, TLD was associated with a trend toward greater eGFR decline. This finding warrants attention, particularly in patients at risk for renal dysfunction.

Conclusion

Dual therapy with DTG+3TC may be a preferable switch option over TLD for virologically suppressed PWH with renal safety concerns.

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2025-09-29
2025-12-05

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A Randomized Controlled Trial Evaluating Virologic and Renal Outcomes After Switching from TDF+FTC or 3TC+EFV to TDF/3TC/DTG (TLD) Versus DTG+3TC in Virologically Suppressed Thai PWH – A Pilot Study
Bentham Science Publishers ; https://doi.org/10.2174/011570162X384022250910065252
/content/journals/chr/10.2174/011570162X384022250910065252
/content/journals/chr/10.2174/011570162X384022250910065252
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  • Article Type:     Research Article
Keywords: switching regimen ; eGFR ; dolutegravir + lamivudine ; Dual antiretroviral therapy ; PWH ; cystatin C

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