P-348. Real-world efficacy, safety and persistence of dolutegravir/lamivudine vs. bictegravir/emtricitabine/tenofovir alafenamide among virologically suppressed adults with HIV-results from the 96-week observational extension phase of the DYAD study

TL;DR

A 96-week study found that switching to dolutegravir/lamivudine for HIV treatment was as effective as continuing bictegravir/emtricitabine/tenofovir alafenamide, with similar persistence but more side effects.

Contribution

The study provides real-world 96-week data on the efficacy and safety of switching to DTG/3TC in virologically suppressed HIV patients.

Findings

At week 96, 2% of DTG/3TC and 1% of B/F/TAF participants had HIV-1 RNA ≥50 copies/mL.

Drug-related adverse events were higher with DTG/3TC (28%) compared to B/F/TAF (5%).

Persistence on therapy was similar between the two groups at week 96.

Abstract

DYAD demonstrated noninferior efficacy of switching to dolutegravir/lamivudine (DTG/3TC) vs. continuing bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) among virologically suppressed adults through Week (W) 48. Here, we present real-world efficacy, safety and persistence from the 96-week observational extension phase.

DYAD (NCT04585737) was an open-label clinical trial that randomized adults with HIV-1 RNA<50 copies/mL and no prior virologic failure (2:1) to switch to DTG/3TC vs. continue B/F/TAF. Primary endpoint was the proportion with HIV-1 RNA≥50 copies/mL at W48. At study exit, consent was obtained from participants to collect and report virologic efficacy, safety and persistence on therapy from medical records through W96 and W144.

Among 222 enrolled, DYAD randomized 149 to switch to DTG/3TC and 73 to continue B/F/TAF, 134 on DTG/3TC and 65 on B/F/TAF completed W48. At study exit, 124 on DTG/3TC and 63 on B/F/TAF consented to participate in the observational extension phase. At W96, 3 (2%) on DTG/3TC and 1 (1%) on B/F/TAF had HIV-1 RNA≥50 c/mL (adjusted treatment difference 0.6%, 95% confidence interval [-4.6%, 5.5%]). HIV-1 RNA< 50 copies/mL was observed in 99 (66%) on DTG/3TC and 52 (71%) on B/F/TAF (adjusted treatment difference -4.8%, 95% confidence interval [-17.0%, 8.5%]). Through W96, 13 on DTG/3TC and 6 on B/F/TAF met confirmed virologic failure criteria, resistance was observed in 2 on DTG/3TC and 1 on B/F/TAF. At W96, 112 (75%) persisted on DTG/3TC and 59 (80%) persisted on B/F/TAF. The most common reason for DTG/3TC discontinuation was adverse events (AEs) in 11/37, whereas B/F/TAF discontinuation was most commonly due to consent withdrawal in 5/14. Drug-related AEs occurred in 42 (28%) on DTG/3TC and 4 (5%) on B/F/TAF through W96. No significant differences in mean change from baseline in creatinine, lipid parameters, weight, and BMI were observed between treatment groups at W96.

In the 96-week DYAD observational extension phase, there was no significant difference in virologic efficacy among those switching to DTG/3TC vs. continuing B/F/TAF and no new cases of resistance between W48-96. Persistence was similar between treatment arms, however drug-related AEs and discontinuations due to AEs were higher with DTG/3TC.

Charlotte-Paige M. Rolle, MD, MPH, Gilead Sciences: Grant/Research Support|Gilead Sciences: Honoraria|MSD: Grant/Research Support|ViiV Healthcare: Advisor/Consultant|ViiV Healthcare: Grant/Research Support|ViiV Healthcare: Honoraria Federico Hinestrosa, MD, Gilead Sciences: Honoraria|MSD: Honoraria

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