- 2-drug therapy with dolutegravir plus lamivudine shows noninferior efficacy vs 3-drug dolutegravir plus tenofovir disoproxil fumarate and emtricitabine in adults with HIV-1 who have not initiated antiretroviral therapy (ART).
- Results from GEMINI-1 and GEMINI-2 suggest similar tolerability of 2-drug regimen, also.
Why this matters
- Accompanying editorial says results suggest 2-drug regimens could become reliable drug-sparing options and pose a “high genetic barrier” at least for 48 weeks.
- 96-week results are forthcoming.
- GEMINI-1, intention-to-treat-exposed population, plasma HIV-1 RNA
- 90% with 2-drug regimen.
- 93% with 3-drug regimen.
- Adjusted treatment difference: −2.6% (95% CI, −6.7% to 1.5%).
- GEMINIs are identical randomized, placebo-controlled, double-blind phase 3 trials; 192 centers, 21 countries.
- Participants ≥18 years, HIV-1 infection, HIV-1 RNA ≤500,000 copies/mL, no prior ART; 719 in 2-drug group; 722 in 3-drug.
- Primary endpoint: proportion with
- Funding: ViiV Healthcare.
- Little low-resource country representation.
- Largely young men