Gilead pads case for top-seller Biktarvy in HIV, hepatitis B co-infection

Gilead Sciences' triple-threat Biktarvy is already a standout in the HIV treatment space—and it’s the company's top seller, to boot. Now, Gilead is trumpeting data that could pave the way to millions of additional patients worldwide.

Biktarvy, comprising bictegravir 50-mg, emtricitabine 200-mg and tenofovir alafenamide 25-mg tablets, showed potential suppression of HIV and hepatitis B (HBV) co-infection on par with an alternative HIV regimen, Gilead said in a presentation of interim data from the phase 3 ALLIANCE trial. Gilead rolled out the results at the 24th International AIDS Conference.

The late-stage ALLIANCE study pitted Biktarvy against dolutegravir 50-mg plus emtricitabine 200-mg with tenofovir disoproxil fumarate 300-mg (DTG+F/TDF) in patients co-infected with HIV and HBV who were just starting treatment. Interim results found both antiretroviral regimens were efficacious, Gilead said in a release.

At the trial’s 48-week mark, however, Biktarvy boasted superior HBV DNA suppression, the company noted. Over that same time span, patients who started treatment on either Biktarvy or DTG+F/TDF had “similarly high” rates of HIV suppression, the company said.

Safety panned out similarly between Biktarvy and the control antiretroviral regimen, though incidences of certain side effects were slightly higher in patients on Gilead’s med. Common side effects included upper respiratory tract infection, fever, elevated liver enzymes and cold.

The ALLIANCE trial is slated to continue through 96 weeks to weigh longer-term safety and efficacy of Gilead’s med.

The “landmark clinical trial” could help open the door to treatment for “[e]merging HIV epidemics in areas of high HBV rates such as Asia,” Anchalee Avihingsanon, M.D., Ph.D., a senior researcher at the Thai Red Cross AIDS Research Center in Thailand, said in a statement. Avihingsanon trumpeted the inclusiveness of Gilead’s study, which enrolled and treated participants from 11 different geographies, 88% of whom were of Asian descent, “driving the availability of data from within those communities most impacted.”

For its part, Gilead branded HIV/HBV co-infection a “major global public health threat,” which can increase the risk of complications and death “beyond either infection alone.” The company estimates HBV affects around 8% of people with HIV globally, with co-infection rates reaching as high as 25% in places like Asia where both viruses are endemic.

Between 33.9 million and 43.8 million people were living with HIV worldwide at the end of 2021, according to the World Health Organization. Going by Gilead’s estimate that some 8% of the global population infected with HIV could suffer from an HBV infection, too, a co-infection treatment opportunity could unlock some 3 million patients around the globe.

Biktarvy is currently lining Gilead’s pockets as the company’s top-selling drug. For the first three months of 2022, Biktarvy pulled down sales of $2.15 billion worldwide. Of that sum, Biktarvy generated around $1.7 billion in the U.S. For comparison, the drug generated global sales of $1.8 billion over the same stretch in 2021.

Gilead is set to report second-quarter results Tuesday.