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Dolutegravir plus lamivudine vs dolutegravir plus tenofovir disoproxil fumarate and emtricitabine in antiretroviral-naive adults with HIV-1 infection (GEMINI-1 and GEMINI-2): Week 48 results from two multicentre, double-blind, randomised, non-inferiority, phase 3 trials

The Lancet Nov 18, 2018

Cahn P, et al. - Authors assessed the effectiveness and safety of a two-drug regimen compared with a three-drug region for the treatment of HIV-1 infection in antiretroviral therapy (ART)-naive adults. In ART-naive adults, the non-inferior efficacy and similar tolerability profile of dolutegravir plus lamivudine to a guideline-recommended three-drug regimen at 48 weeks supports its use as initial therapy for patients with HIV-1 infection.

Methods

  • Experts conducted two identically designed, multicentre, double-blind, randomised, non-inferiority, phase 3 trials: GEMINI-1 and GEMINI-2.
  • They conducted both the studies at 192 centres in 21 countries.
  • They included participants (≥18 years) with HIV-1 infection and a screening HIV-1 RNA of 5,00,000 copies per mL or less, and who were naive to ART.
  • Participants were randomly assigned (1:1) to receive a once-daily two-drug regimen of dolutegravir (50 mg) plus lamivudine (300 mg) or a once-daily three-drug regimen of dolutegravir (50 mg) plus tenofovir disoproxil fumarate (300 mg) and emtricitabine (200 mg).
  • An oral administration of both the regimen drugs was done.
  • Participants and investigators were masked to treatment assignment: dolutegravir was administered as single-entity tablets (similar to its commercial formulation, except with a different film colour), and lamivudine tablets and tenofovir disoproxil fumarate and emtricitabine tablets were over-encapsulated to visually match each other.
  • The proportion of participants with HIV-1 RNA of less than 50 copies per mL at week 48 in the intention-to-treat-exposed population, using the Snapshot algorithm and a non-inferiority margin of −10% was the primary endpoint.
  • They conducted safety analyses on the safety population.

Results

  • As per data, 1,441 participants across both studies were randomly assigned between July 18, 2016, and March 31, 2017 to receive either the two-drug regimen (n=719) or three-drug regimen (n=722).
  • Results demonstrated that at week 48 in the GEMINI-1 intention-to-treat-exposed population, 320 (90%) of 356 participants receiving the two-drug regimen and 332 (93%) of 358 receiving the three-drug regimen achieved plasma HIV-1 RNA of less than 50 copies per mL (adjusted treatment difference -2·6%, 95% CI -6·7 to 1·5); in GEMINI-2, 335 (93%) of 360 in the two-drug regimen and 337 (94%) of 359 in the three-drug regimen achieved HIV-1 RNA of less than 50 copies per mL (adjusted treatment difference -0·7%, 95% CI -4·3 to 2·9), showing non-inferiority at a -10% margin in both studies (pooled analysis: 655 [91%] of 716 in the two-drug regimen vs 669 [93%] of 717 in the three-drug regimen; adjusted treatment difference -1·7%, 95% CI -4·4 to 1·1).
  • Numerically, compared to the two-drug regimen, more drug-related adverse events occurred with the three-drug regimen (169 [24%] of 717vs 126 [18%] of 716); few participants discontinued because of adverse events (16 [2%] in the three-drug regimen and 15 [2%] in the two-drug regimen).
  • In the two-drug regimen group of GEMINI-2, 2 deaths were reported, but neither was considered to be related to the study medication.

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