Dolutegravir/Lamivudine Efficacy and Safety Outcomes in People With HIV-1 With or Without Historical Resistance Results at Screening: 48-Week Pooled Analysis.

Background

Drug resistance testing aids in appropriate antiretroviral therapy selection to improve treatment success but may not be readily available. We evaluated the impact of switching to dolutegravir/lamivudine (DTG/3TC) using pooled data from the TANGO and SALSA trials in adults who were virologically suppressed with or without historical resistance results at screening.

Methods

Adults who were virologically suppressed (HIV-1 RNA <50 copies/mL for >6 months) with no prior virologic failure were randomized to switch to DTG/3TC (TANGO, n = 369; SALSA, n = 246) or continue their current antiretroviral regimen (CAR; TANGO, n = 372; SALSA, n = 247). Week 48 HIV-1 RNA ≥50 and <50 copies/mL (Snapshot algorithm, Food and Drug Administration; intention-to-treat exposed), CD4+ cell count, and safety were analyzed by availability of historical resistance results.

Results

Overall, 294 of 615 (48%) participants in the DTG/3TC group and 277 of 619 (45%) participants in the CAR group had no historical resistance results at screening. At week 48, proportions with Snapshot HIV-1 RNA ≥50 copies/mL were low (≤1.1%) and similar across treatment groups and by historical resistance results availability. High proportions (91%-95%) maintained virologic suppression through week 48, regardless of results availability. Across both subgroups of results availability, greater increases in CD4+ cell count from baseline to week 48 occurred with DTG/3TC vs CAR. No participants taking DTG/3TC had confirmed virologic withdrawal, regardless of historical resistance results availability. One participant undergoing CAR without historical resistance results had confirmed virologic withdrawal; no resistance was detected. Overall, DTG/3TC was well tolerated; few adverse events led to withdrawal.

Conclusions

Findings support DTG/3TC as a robust switch option for adults who are virologically suppressed with HIV-1 and no prior virologic failure, regardless of historical resistance results availability.

Clinical trial registration

TANGO: NCT03446573, https://clinicaltrials.gov/study/NCT03446573. SALSA: NCT04021290, https://clinicaltrials.gov/study/NCT04021290.

Informations de copyright

© The Author(s) 2024. Published by Oxford University Press on behalf of Infectious Diseases Society of America.

Déclaration de conflit d'intérêts

Potential conflicts of interest. S. S. has received honoraria from PPD/GSK for participation in the TANGO study and has received grants and/or personal fees for consultancy, lectures, and congress support from AbbVie, Cepheid, Gilead, Janssen, Merck Sharp and Dohme, Theratechnologies, and ViiV Healthcare. P. C. has received consulting fees from Gilead, Merck, and ViiV Healthcare and has participated in data safety monitoring/advisory boards for Gilead, Janssen, Merck, Moderna, and ViiV Healthcare. J. P. has received grants, personal fees, and nonfinancial support from Gilead, Janssen-Cilag, and ViiV Healthcare. F. B. has participated in advisory boards for Gilead and is the president of AusPATH. S. H. has participated in advisory boards for Gilead, Merck, and ViiV Healthcare; her institution has received support from Merck and ViiV Healthcare. P. R. has received support for speaking/advisory activities from Gilead and ViiV Healthcare. B. R. W., C. Y. M., R. G., R. W., B. J., M. A.-K., M. K., and C. O. are employees of ViiV Healthcare or GSK and may own stock in GSK. All other authors report no potential conflicts.