A Randomized Controlled Trial Evaluating Virologic and Renal Outcomes After Switching from TDF+FTC or 3TC+EFV to...

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.

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.

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 5.15 mL/ min/1.73 m² (95% CI: -12.06 to 22.35; p = 0.532) for cystatin C and 4.01 mL/min/1.73 m² (95% CI: -3.58 to 11.59; p = 0.277) for creatinine. All participants maintained virological suppression. No significant differences were observed in BMI, LDL, or CD4 counts.

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.

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