Gilead’s Single-Tablet HIV Regimen Meets Primary Endpoints

Gilead Sciences recently announced positive results from the phase 3 ARTISTRY-1 trial, which evaluated the effectiveness of an investigational single-tablet regimen combining bictegravir and lenacapavir for the treatment of HIV, according to a recent news release. The data will be filed with regulatory authorities to be presented at future scientific congresses, the release reads.

The tablet, which contains 75 mg of Bictegravir and 50 mg of lenacapavir (BIC/LEN), was statistically non-inferior to multi-tablet regimens, although specific data was not disclosed.

ARTISTRY-1 is a multicenter phase 2/3 trial in which patients were randomized 2:1 to receive the investigational BIC/LEN therapy or instructed to continue with their established management regimen. At baseline, patients were taking between 2 and 11 pills per day to manage their HIV and 40% were taking antiretrovirals more than once a day, the news release says.

Primary effectiveness was measured by the number of patients with HIV-1 RNA ≥50 copies/mL at Week 48, as well as the number of patients with a change in CD4 cell count, and the proportion of patients who reported treatment-emergent adverse events.

“Developing new effective, convenient regimens for those left behind by advances in medical research is necessary to close the unmet HIV treatment gap,” Chloe Orkin, MBE, clinical professor of Infection and Inequities at Queen Mary University of London, said in the news release. “These ARTISTRY-1 trial results demonstrate that a combination regimen of bictegravir and lenacapavir maintains viral suppression in people living with HIV who would otherwise have to take a complex multi-tablet regimen. The findings are significant for those people, many of whom have lived with HIV for decades and who have medical comorbidities of aging and thus take many other medications as well.”

Gilead is currently testing other formulations in ARTISTRY-2, specifically the safety and efficacy of switching from Biktarvy (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets) to the BIC/LEN tablet. Findings from ARTISTRY-2 will help determine whether BIC/LEN could offer an alternative single-tablet regimen option for patients who prefer fewer components or different dosing characteristics.

“People living with HIV who are on complex antiretroviral treatment regimens may experience pill burden, adherence challenges and difficulties with the long-term management of HIV,” Jared Baeten, M.D., Ph.D., senior vice president, Clinical Development, Virology Therapeutic Area Head at Gilead Sciences, said in the news release. ““Gilead developed the first single-tablet complete regimen for the treatment of HIV in 2006. Today, innovative single-tablet regimens are still needed to help suit people’s needs, modernizing treatment while helping to sustain viral suppression. By reducing the multi-tablet burden, we hope to improve health outcomes while expanding options.”

Bictegravir is an integrase strand transfer inhibitor, which targets HIV integrase, the enzyme that allows the virus to replicate and spread. It is used only in combination with other antiretrovirals. Lenacapavir has been approved as a form of preexposure prophylaxis (PrEP) to prevent the transmission of HIV, and as a treatment for drug-resistant HIV. Most recently, it was approved as a form of twice-yearly injectable PrEP, marketed as Yeztugo by Gilead.

Together, the two agents could represent a new chapter in simplifying daily HIV management—offering another path toward sustained viral suppression and improved quality of life for people living with HIV.