A 2-drug regimen with dolutegravir-lamivudine is efficient and safe

  • Daniela Ovadia — Agenzia Zoe
  • Medical News
Access to the full content of this site is available only to registered healthcare professionals. Access to the full content of this site is available only to registered healthcare professionals.



  • The meta-analysis supports the paradigm shift from 3-drug antiretroviral therapy (ART) regimens to a 2-drug regimen in treatment-naive patients with HIV-1.
  • The analysis shows that a 2-drug regimen with dolutegravir and lamivudine (DTG+3TC) was similar to traditional 3-drug regimens in terms of virologic suppression, change in CD4+ cell count from baseline and safety at week 48.
  • Results were also confirmed in the subgroup of difficult-to-treat patients with high baseline viral load (>100,000 RNA copies/ml).

Combination ART traditionally comprises a 3-drug regimen, two nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs) and a non-NRTI core agent. Since ART agents are associated with long-term risk, a 2-drug regimen based on DTG and 3TC is actually recommended by guidelines. Indeed, this regimen was found to have favourable efficacy and safety in treatment-naive patients with HIV-1 in two single-arm, pilot studies. Further, two large phase III randomised controlled trials demonstrated noninferiority of DTG+3TC relative to DTG+tenofovir disoproxyl fumarate/emtricitabine (TDF/FTC).

In order to compare the efficacy and safety of DTG+3TC regimen with traditional 3-drug regimens, authors performed a network meta-analysis, including 14 double-blind randomised controlled trials (10,043 patients).

The analysis of efficacy (the primary outcome) showed that DTG+3TC was better than efavirenz+TDF/FTC (mean difference: -7.3% [95% CrI: -13.8, -0.8]), and similar to all other 3-drug regimens investigated in term of virologic suppression at week 48.

Results were consistent in the subgroup of patients with baseline viral load over 100,000 RNA copies/ml. With only two exceptions, for which subgroup data were not available, the proportion of patients achieving virologic suppression at week 48 with DTG+3TC was relative to virologic suppression seen with 3-drug regimens, in the overall population.

Further, in the overall population, DTG+3TC induced similar increases in CD4+ cell count between baseline and week 48 compared with all 3-drug regimens investigated, except for DTG+tenofovir alafenamide/FTC.

With regard to safety (the secondary outcome that included adverse events, serious adverse events and drug-related adverse events at 48 weeks), DTG+3TC was broadly similar to all regimens analysed, with few exceptions.

This study demonstrates comparable efficacy and safety outcomes over 48 weeks with the 2-drug regimen DTG+3TC compared with traditional 3-drug antiretroviral therapy regimens and supports its use in treatment-naive patients with HIV-1. In addition, 2-drug regimens can improve patient adherence and reduce costs.

Limitations: Not all studies reported all of the efficacy and safety outcomes or subgroup data.