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Randomized Controlled Trial
. 2024 Jun 1;96(2):156-160.
doi: 10.1097/QAI.0000000000003395. Epub 2024 Mar 1.

Durable Efficacy of Switching From a 3- or 4-Drug Tenofovir Alafenamide-Based Regimen to the 2-Drug Regimen Dolutegravir/Lamivudine in the TANGO Study Through Week 196

Stéphane De Wit  1 , Fabrice Bonnet  2 , Olayemi Osiyemi  3 , Fiona Bisshop  4 , Julian Olalla  5 , Jean-Pierre Routy  6 , Christoph Wyen  7 , Riya Moodley  8 , Keith Pappa  9 , Ruolan Wang  9 , James Oyee  10 , Parminder Saggu  10 , Emilio Letang  11 , Brian Wynne  9 , Bryn Jones  8 , Kimberly Y Smith  9 , Mounir Ait-Khaled  8
Affiliations
Randomized Controlled Trial

Durable Efficacy of Switching From a 3- or 4-Drug Tenofovir Alafenamide-Based Regimen to the 2-Drug Regimen Dolutegravir/Lamivudine in the TANGO Study Through Week 196

Stéphane De Wit et al. J Acquir Immune Defic Syndr. .

Abstract

Background: Switching to the 2-drug regimen dolutegravir/lamivudine demonstrated durable non-inferior efficacy vs continuing 3- or 4-drug tenofovir alafenamide-based regimens for maintaining virologic suppression in people with HIV-1 through Week 144 in TANGO.

Setting: 134 centers, 10 countries.

Methods: Adults with HIV-1 RNA <50 copies/mL for >6 months and no history of virologic failure were randomized to switch from stable tenofovir alafenamide-based regimens to dolutegravir/lamivudine on Day 1 (early-switch group) for 196 weeks. Those randomized to continue tenofovir alafenamide-based regimens on Day 1 who maintained virologic suppression at Week 144 switched to dolutegravir/lamivudine at Week 148 (late-switch group). Efficacy, safety, and tolerability (including weight and biomarker changes) of dolutegravir/lamivudine in early-switch and late-switch groups were assessed through Week 196.

Results: Overall, 369 participants switched to dolutegravir/lamivudine on Day 1 (early-switch) and 298 switched at Week 148 (late-switch). In the early-switch group, 83% (306/369) maintained virologic suppression through Year 4, and 3% (11/369) reported new adverse events between Weeks 144 and 196. The late-switch group at Week 196 and early-switch group at Week 48 had comparable proportions with virologic suppression (93% each) and similar safety profiles. No late-switch participants and 1 early-switch participant met confirmed virologic withdrawal criteria through Week 196, with no resistance-associated mutations observed. Treatment continued to be well tolerated long-term.

Conclusion: Switching from tenofovir alafenamide-based regimens to dolutegravir/lamivudine showed durable efficacy, high barrier to resistance, and good tolerability through 4 years. These results support dolutegravir/lamivudine as a robust treatment for maintaining virologic suppression.

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Conflict of interest statement

Conflicts of Interest and Source of Funding: SDW has received funding from ViiV Healthcare paid to his institution. FBonnet has served as a consultant, invited speaker, and/or received grants from Gilead and ViiV Healthcare. OO has served as a consultant for Gilead and ViiV Healthcare and received honoraria from ViiV Healthcare. FBisshop has participated in advisory boards for Gilead. JOlalla has served as a consultant, invited speaker, and/or received grants from Gilead, GSK, Janssen, Merck, and ViiV Healthcare. J-PR has served as a consultant, invited speaker, and/or received grants from AbbVie, Gilead, GSK, Merck, and ViiV Healthcare. CW has no conflicts to disclose. RM, KP, RW, JOyee, EL, BW, BJ, KYS, and MA-K are employees of ViiV Healthcare or GSK and own stock in GSK. PS is a complimentary worker on behalf of GSK. This study was funded by ViiV Healthcare.

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