Dolutegravir and lamivudine vs other antiviral regimens in HIV-1 treatment-naïve patients: a systematic review and network meta-analysis.

OBJECTIVE:

Compare the efficacy and safety of the 2-drug antiretroviral therapy (ART) regimen dolutegravir + lamivudine (DTG+3TC) with traditional 3-drug regimens in treatment-naïve patients with HIV-1.

DESIGN:

Data from double-blind, randomized controlled trials (RCTs) of ≥48 weeks' duration in treatment-naïve patients with HIV-1 identified by systematic review were evaluated using a Bayesian network meta-analysis (NMA) methodology.

METHODS:

The primary outcome was virologic suppression (VS) at Week 48 for 3-drug regimens versus DTG+3TC (also analyzed in patient subgroup with baseline viral load (VL) > 100,000 RNA copies/mL). Secondary outcomes included CD4+ cell count change from baseline and safety (adverse events [AEs], serious AEs, and drug-related AEs) at Week 48.

RESULTS:

The network contains 14 unique regimens from 14 RCTs based on data from 10,043 patients. The proportional difference for viral suppression at 48 weeks for Dolutegravir + Lamivudine (DTG+3TC) versus the other 13 regimens included in the network ranged from -2.7% (-11.0%, 5.6%) vs DTG + tenofovir alafenamide (TAF)/FTC to 7.3% (0.6%, 13.8%) vs efavirenz + tenofovir disoproxil fumarate/emtricitabine (EFV+TDF/FTC). DTG+3TC was found to be significantly better than EFV+TDF/FTC and similar to all other regimens analysed in terms of viral suppression at 48 weeks. With regards to other outcomes (CD4, AE, SAE, DRAE) at 48 weeks, DTG+3TC was broadly similar to all regimens analysed.

CONCLUSIONS:

This NMA demonstrates similar efficacy and safety outcomes over 48 weeks with DTG+3TC compared with traditional 3-drug ART regimens.This is an open access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND), where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal. http://creativecommons.org/licenses/by-nc-nd/4.0.