ViiV Healthcare's Dovato matches Biktarvy efficacy with less weight gain

ViiV Healthcare announced 96-week clinical trial results showing its HIV treatment Dovato demonstrated equivalent effectiveness to Gilead Sciences' Biktarvy while causing significantly less weight gain in patients.

The PASO DOBLE study, conducted across 30 sites in Spain, enrolled 553 virologically suppressed HIV-1 patients who switched from their previous treatments to either Dovato (277 patients) or Biktarvy (276 patients). The trial met its primary endpoint, with Dovato showing non-inferior efficacy in maintaining viral suppression compared to Biktarvy over the two-year period.

Patients taking Dovato experienced a mean adjusted weight gain of 0.84 kg compared to 2.35 kg for those on Biktarvy, representing a statistically significant difference of 1.52 kg. Additionally, 20.1% of Dovato patients experienced greater than 5% weight increase versus 34.8% of Biktarvy patients.

The study found drug-related adverse events occurred in 7.6% of Dovato patients compared to 13.4% of Biktarvy patients. Three patients in the Biktarvy group experienced protocol-defined virological failure through 96 weeks, while no Dovato patients experienced such failure. No resistance was observed in cases of virological failure.

ViiV Healthcare is majority owned by GSK (LSE: GSK), with Pfizer (NYSE: PFE) and Shionogi as shareholders. The results were presented at the European AIDS Clinical Society annual congress in Paris.

The findings come from what the company describes as the largest head-to-head randomized clinical trial comparing the two HIV medications. Dovato is a two-drug regimen while Biktarvy contains three active components.

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