In the largest study of its kind, GSK’s two-drug regimen Dovato demonstrated non-inferior efficacy compared to Gilead Sciences’ three-drug regimen Biktarvy for the treatment of HIV-1.
GSK is challenging Gilead Sciences in the HIV treatment market. The pharma pitted its rival Dovato therapy against Gilead’s Biktarvy in a Phase IV study, sharing results at the AIDS 2024 congress in Munich this week. The trial showed Dovato is just as effective with one bonus—significantly less weight gain.
ViiV Healthcare, GSK’s HIV unit, conducted a 48-week study dubbed PASO DOBLE of Dovato’s two-drug regimen against Gilead’s Biktarvy three-drug regimen. In patients with HIV-1 who are virologically suppressed, Dovato showed non-inferior efficacy compared to patients switched to Biktarvy. Both maintained suppression based on viral RNA with a 1.4% difference in Biktarvy’s favor—well within the FDA’s margin for non-inferiority.
The trial was the largest head-to-head study of its kind, according to GSK. Out of the 553 participants, one Biktarvy patient and zero Dovato patients had a confirmed virological failure.
The average weight gain for trial participants on the Dovato regimen was “significantly lower” than those on Biktarvy over the ocurse of the year, ViiV Healthcare CMO Harmony Garges said in a statement. The proportion of patients with weight gain greater than 5% was close to 30% in the Biktarvy arm versus 20% in the Dovato arm.
“This is a meaningful outcome, as treatment-related weight gain is an important topic for many people living with HIV,” Garges said, adding Viiv Healthcare wants to bring therapies to the patient community that are not only effective but address the specific needs beyond viral suppression.
Biktarvy is far and away Gilead’s best-selling drug. The drug accounted for 44% of total product sales in 2023 at $11.8 billion for the full year. By contrast, GSKs Dovato brought in $2.3 billion last year. The FDA expanded to include adolescents in April 2024. GSK has forecasted growth up to $8.5 billion in sales by 2026.
In addition to Dovato, GSK’s HIV franchise includes a once-monthly injectable HIV treatment Cabenuva. Adherence to an HIV treatment regimen is crucial for patients because poor adherence allows the virus to multiply and destroy the immune system. The once-a-month and every other month dosing is intended to help alleviate some of the burden of treatment and to address the problem.
Despite effective treatments, HIV remains a major global public health challenge. An estimated 40 million people worldwide were living with HIV at the end of 2023, of whom over nine million weren’t getting any life-saving treatment, according to a new report from the United Nations.
Correction (July 23): This story was updated to reflect the April FDA approval was an expansion to include adolescents, not the initial approval. BioSpace apologizes for the error.
