The WHO recommended yesterday dual therapy (2DR) Dolutegravir/Lamivudine (DTG/3TC) in countries with limited resources. But do we have solid data to support this strategy?
The Anrs Mie Moderato test is the first study to assess, in West and Central Africa, the non-inferiority of maintenance dual therapy (DTG/3TC or Atazanavir boosted [ATV/r] + 3TC) compared to tritherapy (3DR, Tenofovir/3TC/Efavirenz, Tle, or Tenofovir/3TC/Doltégravir, TLD) in people living with HIV-1.
Between November 2020 and February 2023, 480 patients were included in 3 countries (Burkina Faso, Cameroon and Côte d’Ivoire). All were under antiretroviral treatment (TLE or TLD) for at least 2 years, without a history of virological failure or hepatitis B, with a CD4+ rate greater than 200/mm³ to inclusion. The main objective was the maintenance of a charge virale The plasma viral load is the number of viral particles contained in a sample of blood or other container (saliva, LCR, sperm, etc.). For HIV, the viral load is used as a marker in order to follow the progression of the disease and measure the effectiveness of treatments. The level of viral load, but even more the CD4 rate, participate in the antiretroviral treatment decision. Undetectable to S96 (<50 copies/ml), according to the FDA Snapshot method.
The patients were distributed randomly: 160 in each of the 2 2DR arms and 160 in the 3DR arm: 149 in the Tle arm and 11 in the TLD arm. The median age was 50 years, with a median duration of treatment of 9 years and a CD4+ median rate of 768/mm³.
In S96, the virological success rates intention to treat was 95 % in the 2DR arm and 98 % in the 3DR arm, confirming the non-inferiority of 2DR. Ten 2DR patients and 4 under 3DR presented a virological failure. The evolution of the CD4+ rate was comparable between the groups.
The side effects were similar (12 % vs 9 %). A death linked to a tetanus has been reported in the DTG/3TC arm. Also note, a significantly greater weight gain in the 2DR arms: +3.7 kg in the DTG/3TC arm, +2.6 kg in the ATV/R arm, against +0.6 kg in the Tle arm. No notable change was observed on the other metabolic parameters (lipids, DFGE, etc.).
Going to a 2DR proved to be virologically not lower than 3DR to S96 in this test carried out in West and Central Africa, with good clinical and organic tolerance. These results reinforce the WHO recent recommendations and encourage this maintenance strategy in the countries of the South.
According to Fadiga F et al. Abstr. 5282, updated
This article was previously published in the E-Journal of the Infectiologist’s letter on the occasion of the IAS 2025. We reproduce it here with their kind authorization.