'Gilead, Merck Clear Path to Market for Daily HIV Pills With New Late-Stage Data'

 

At the 2026 Conference on Retroviruses and Opportunistic Infections, Gilead and Merck demonstrated that their respective daily oral HIV drugs can match current therapies in keeping the virus at bay.

As Gilead and Merck race to bring their respective daily HIV pills to the market, new Phase 3 data presented at a key medical conference earlier this week show that these oral drugs can keep virus levels suppressed over a long period of time.

At the 33rd Conference on Retroviruses and Opportunistic Infections (CROI 2026), Gilead unveiled updated data from the late-stage ARTISTRY-1 and ARTISTRY-2 studies, which investigated a daily single-tablet combination of its integrase strand transfer inhibitor bictegravir and the capsid blocker lenacapavir (BIC/LEN). Lenacapavir is also the active ingredient in the pharma’s recently approved twice-yearly pre-exposure prophylaxis shot Yeztugo.

In the respective trials, patients who achieved virological suppression after their baseline complex regimen or after Biktarvy treatment were assigned to either receive the daily BIC/LEN combo or stay on their current schedule. Results from ARTISTRY-1 showed that BIC/LEN was non-inferior to a multi-tablet regimen at sustaining virologic suppression after 48 weeks, according to a news release on Wednesday.

ARTISTRY-2 returned similar outcomes: After 48 weeks, 1.3% of patients on BIC/LEN had HIV RNA levels exceeding or equal to a predetermined suppression threshold, as opposed to 1% of comparators on Biktarvy.

These data, analysts at Truist Securities said in a Wednesday note, “reinforce the durability of the company’s HIV franchise.” With BIC/LEN and other earlier-stage HIV assets, “we believe [Gilead’s] long-standing dominance in HIV leadership a likely path to continue long-term growth.”

Gilead in December 2025 said the ARTISTRY program will form the basis of a regulatory submission for BIC/LEN. Truist expects that a market launch could happen in the back half of this year.

Also at CROI 2026 is Merck, which is developing a daily HIV pill combining its nucleoside analog islatravir with the non-nucleoside reverse transcriptase inhibitor doravirine (DOR/ISL). Phase 3 data presented Wednesday showed the drug was non-inferior to Gilead’s Biktarvy, with viral suppression rates of 91.8% for Merck’s pill and 90.6% for Gilead’s drug at 48 weeks.

DOR/ISL maintained high levels of viral suppression at 96 weeks, though Merck did not perform statistical testing at this time point.

The FDA is currently reviewing DOR/ISL with a target action date of April 28, the pharma said on Wednesday. Results presented at CROI, according to analysts at RBC Capital Markets, make approval “likely.”

Still, if approved, DOR/ISL will only be an “incremental positive” for Merck, the analysts said, adding that it will continue to be overshadowed in the HIV space by Gilead. “Biktarvy has become the dominant standard-of-care in treatment-naïve patients,” they explained, adding that Merck’s presence in the space is nevertheless “significantly smaller” than Gilead’s “and share capture requires steep pricing discounts or heavy investment.”

https://www.biospace.com/drug-development/gilead-merck-clear-path-to-market-for-daily-hiv-pills-with-new-late-stage-data