Doravirine ART Regimen Shows Less Weight Gain vs. Dolutegravir

A doravirine-anchored antiretroviral therapy (ART) regimen demonstrated comparable efficacy to a dolutegravir-based approach while resulting in significantly less weight gain among patients initiating ART for HIV. This finding emerged from an open-label randomized trial that enrolled treatment-naive individuals.

The trial, which enrolled 1,100 participants, compared two different ART regimens. The primary endpoint was the proportion of participants with HIV-1 RNA levels below 50 copies/mL at week 48. Both regimens achieved high rates of viral suppression, with the doravirine group showing 85% viral suppression and the dolutegravir group showing 86% viral suppression. This indicates non-inferiority between the two treatment strategies in terms of virological control.

However, a key secondary endpoint revealed a notable difference: weight change from baseline to week 48. Patients receiving the doravirine-based regimen experienced an average weight gain of 1.1 kg, whereas those on the dolutegravir-based regimen gained an average of 4.1 kg. This difference of 3.0 kg was statistically significant (p < 0.001), highlighting doravirine's potential advantage in mitigating treatment-associated weight gain.

Further analysis of weight changes showed that 34% of participants on the dolutegravir regimen gained 5% or more of their baseline body weight, compared to only 15% of those on the doravirine regimen. This observation is particularly relevant given the increasing recognition of weight gain as a significant side effect of certain ART medications, which can contribute to metabolic complications such as dyslipidemia, hypertension, and diabetes. The study's findings suggest that doravirine may offer a more favorable metabolic profile for initiating HIV treatment, especially for individuals concerned about or predisposed to weight gain.

The study, presented at the 12th International AIDS Society (IAS) Conference on HIV Science, also reported on other safety and tolerability aspects. Both regimens were generally well-tolerated, with similar rates of treatment-related adverse events. However, the differential impact on weight gain could influence long-term adherence and overall patient well-being. Clinicians may consider these findings when selecting an initial ART regimen for treatment-naive HIV patients, balancing the need for potent viral suppression with the management of potential metabolic side effects.