# Dolutegravir/Lamivudine Is Noninferior to Continuing Dolutegravir- and Non-Dolutegravir-Based Triple-Drug Antiretroviral Therapy in Virologically Suppressed People With Human Immunodeficiency Virus: DUALING Prospective Nationwide Matched Cohort Study

## TL;DR

A study in the Netherlands found that switching HIV patients to dolutegravir/lamivudine is as effective as staying on more complex drug regimens.

## Contribution

This study provides real-world evidence supporting the use of dolutegravir/lamivudine as a simplified HIV treatment.

## Key findings

- Dolutegravir/lamivudine was noninferior to triple-drug regimens in preventing treatment failure after one year.
- Treatment failure rates were comparable between the groups, with no genotypic resistance detected.
- Switching to dolutegravir/lamivudine was associated with weight gain, especially when tenofovir was discontinued.

## Abstract

Confirming the efficacy of dolutegravir/lamivudine in clinical practice solidifies recommendations on its use.

Prospective cohort study (DUALING) in 24 human immunodeficiency virus (HIV) treatment centers in the Netherlands. HIV RNA–suppressed cases were on triple-drug antiretroviral regimens without prior virological failure or resistance and started dolutegravir/lamivudine. Cases were 1:2 matched to controls on triple-drug antiretroviral regimens by the use of dolutegravir-based regimens, age, sex, transmission route, CD4+ T-cell nadir, and HIV RNA zenith. The primary endpoint was the treatment failure rate in cases versus controls at 1 year by intention-to-treat and on-treatment analyses with 5% noninferiority margin.

The 2040 participants were 680 cases and 1380 controls. Treatment failure in the 390 dolutegravir-based cases versus controls occurred in 8.72% and 12.50% (difference: −3.78% [95% confidence interval {CI}, −7.49% to .08%]) by intention-to-treat and 1.39% and 0.80% (difference: 0.59% [95% CI, –.80% to 1.98%]) by on-treatment analyses. The treatment failure risk in 290 non-dolutegravir-based cases was also noninferior to controls. Antiretroviral regimen modifications unrelated to virological failure explained the higher treatment failure rate by intention-to-treat. A shorter time on triple-drug antiretroviral therapy and being of non-Western origin was associated with treatment failure. Treatment failure, defined as 2 consecutive HIV RNA >50 copies/mL, occurred in 4 cases and 5 controls but without genotypic resistance detected. Viral blips occured comparable in cases and controls but cases gained more weight, especially when tenofovir-based regimens were discontinued.

In routine care, dolutegravir/lamivudine was noninferior to continuing triple-drug antiretroviral regimens after 1 year, supporting the use of dolutegravir/lamivudine in clinical practice.

NCT04707326.

DUALING is a nationwide study in the Netherlands that provides robust empirical evidence from routine clinical care that virologically suppressed people with HIV-1 on triple-drug antiretroviral regimens can safely switch to dolutegravir/lamivudine.