GSK’s ViiV said its two-drug HIV regimen Dovato was just as effective as Gilead’s three-drug combo Biktarvy in what it says is the largest head-to-head trial of the blockbuster oral drugs.
Dovato and Biktarvy are two of the leading HIV treatments on the market. Dovato generated $2.4 billion (£1.8 billion) in sales last year, while Biktarvy, which was approved first, brought in $11.8 billion.
In the 553-person open-label trial, Dovato proved non-inferior to Biktarvy at maintaining viral suppression, according to data set to be presented at the International AIDS Conference in Munich. However, ViiV executives also touted less weight gain as a key secondary endpoint.
Some patients gain weight on HIV medications, including integrase inhibitors like the ones included in Dovato and Biktarvy. At 48 weeks, fewer patients on Dovato saw a greater than 5% weight gain compared to those on Biktarvy, ViiV said.
Harmony Garges“Weight gain is a very hot topic in the field of HIV,” ViiV chief medical officer Harmony Garges told Endpoints News ahead of the readout. “As our therapies have gotten better and better from a potency perspective, and generally have gotten more tolerable, we’ve really now been focused on some of these important secondary endpoints.”
The study, dubbed PASO DOBLE, followed HIV patients who had been taking other treatments before switching to either Dovato or Biktarvy. While the study was conducted entirely in Spain, Garges said “there’s nothing in the population that would make us think this shouldn’t translate to every other country in the world.”
At week 48, 20% of Dovato patients experienced greater than 5% weight gain, compared to nearly 30% of Biktarvy patients, ViiV reported. The company noted that weight differences in the Dovato arm didn’t differ based on previous treatments, while the proportion of Biktarvy patients who experienced greater than 5% weight gain was higher in some subgroups who switched from certain treatments.
The study was funded by ViiV and conducted with SEIMC-GeSIDA, a research foundation for HIV and other infectious diseases in Madrid that was launched by the Spanish Society of Clinical Microbiology and Infectious Diseases.
GSK has long marketed Dovato as an effective option containing fewer medicines. It combines the HIV drugs dolutegravir and lamivudine, while Biktarvy contains bictegravir, emtricitabine and tenofovir alafenamide fumarate.
“We believe we can streamline people’s therapy. Two drugs are adequate,” Garges said. “In no field of medicine do people want to take a therapy that’s not needed.”