Bictegravir/Emtricitabine/Tenofovir Alafenamide Fumarate

iStock, cagkansayin 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. FDA Gilead Wins Historic Approval for Twice-Yearly HIV Drug Lenacapavir, to be marketed as Yeztugo, could “redefine the PReP market,” according to analysts. June 18, 2025 · 2 min read · Dan Samorodnitsky 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.”

Gilead is looking to target unmet needs in HIV and present a new, unique treatment option with a single-tablet combination of its bictegravir and lenacapavir. In 2006, Gilead Sciences and Bristol Myers Squibb left a permanent mark on the HIV treatment paradigm by fusing together three antiretrovirals and creating the first once-daily single tablet HIV regimen. Now 20 years later, Gilead is combining two of its powerhouse HIV drugs to create another single-tablet option that the company believes can fill in some treatment gaps by replacing more complex regimens. The investigational combo pill pairs bictegravir, one of the three ingredients in Gilead's leading HIV treatment Biktarvy, with its novel capsid inhibitor lenacapivir. The latter drug was recently launched as a long-acting pre-exposure prophylaxis (PrEP) drug called Yeztugo, but it first hit the market as Sunlenca, a treatment option for those living with multidrug-resistant HIV.  Together in one tablet, currently dubbed BIC/LEN, Gilead figures that the proposed combo could present a new tailored option for those currently taking complex multi-tablet regimens or those looking to switch from other drugs such as Biktarvy. The company painted a picture of the combo’s prowess in different populations of people living with HIV with virologic suppression through its pair of Artistry clinical trials, results from which were presented this week at the 33rd Conference on Retroviruses and Opportunistic Infections (CROI) in Denver. The detailed data build on previously announced top-line results that left Gilead plotting regulatory filings late last year. Gilead’s Artistry trial program was designed to include a broad range of people living with HIV who could benefit from the BIC/LEN combo, the company’s SVP of clinical development and head of virology, Jared Baeten, M.D., Ph.D., told Fierce Pharma in a recent interview. Both studies assessed the percentage of participants with HIV-1 RNA levels ≥50 copies/mL, a standard indicator of detectable HIV, as their primary endpoint.Artistry-1 included patients currently managing their HIV with complex multi-tablet regimens due to a variety of factors, such as acquired drug resistance, tolerance issues or drug interactions, to name a few. The phase 2/3 study was conducted across a diverse population of 557 people who were taking between 2 and 11 pills a day at baseline to manage their HIV.  At week 48, BIC/LEN proved noninferior to the complex regimens in maintaining patients' virologic suppression (or low levels of HIV), with 0.8% of participants who switched to the investigational treatment having HIV-1 RNA levels ≥50 copies/mL compared with 1.1% of those who stayed on a complex antiretroviral regimen. To put it another way, 96% of participants had low levels of HIV on the BIC/LEN combo compared to 93.5% who were on complex regimens, according to the study. Switching to the BIC/LEN combo was also linked to an improvement from baseline in fasting lipid levels and, importantly, an increase in patient-reported treatment satisfaction. This was demonstrated by a mean boost of 7 points on the HIV Treatment Satisfaction Questionnaire (HIVTSQ).A 96-week follow-up showed that trial participants who joined the extension period still maintained virologic suppression, researchers found. Detailed Artistry-1 results were also published in The Lancet on Feb. 25.Artistry-1 enrolled patients of various ages and with a range of HIV treatment durations. The median age was 60 years old and the median treatment duration was 28 years.The older population in particular may be especially prone to drug resistance or other intolerance based on decades of experience with early, “less robust therapies of the past,” Baeten explained. “This is a medicine, really, that is addressing some of the challenges of aging with HIV,” Baeten said of BIC/LEN.  The subset of the HIV population covered in the Artistry-1 enrollment criteria represents about 5% of people living with HIV in the U.S., but as Baeten points out, some who are already stable on a single-tablet regimen could also be interested in a different option, meaning the combo could be “beneficial beyond that 5%,” he said.  This is where Artistry-2 comes in. That trial included 574 people with HIV and stacked the combo against Biktarvy, a common standard of care that Gilead notes is recommended in global treatment guidelines. Through week 48, the proposed combo treatment again proved non-inferior to the standard of care Biktarvy in maintaining virologic suppression among those who switched. In this study, 1.3% of those who switched to the BIC/LEN combo had HIV-1 RNA levels ≥50 copies/mL, compared to 1% on solo Biktarvy.Biktarvy’s proven efficacy and safety has long served as an “internal bar” for Gilead when developing new treatments, Baeten said, making the randomized double-blind comparison study of Biktarvy versus BIC/LEN a “high challenge to ourselves.” “With efficacy shown to be comparable to a guideline-recommended therapy, we look forward to the prospect of having another meaningful treatment option for adults with HIV who are virologically suppressed,” trial investigator Eric Meissner, M.D., Ph.D., said in Gilead’s recent release.   Next-generation HIV portfolio  Biktarvy has long been a standout in Gilead's HIV portfolio, but as the med approaches its patent cliff in the next decade, the company is looking to lenacapivir as its next foundational therapy. The novel med forms the bedrock of Gilead’s current HIV pipeline, as the company looks to offer “the right suite of options” for HIV treatment and prevention across medication formulation and dosing timelines, Baeten said. “We are several important steps into this next generation of Gilead‘s HIV portfolio, but we've got a vision that extends well into the next decade,” he added.  The company is planning seven new HIV launches over the next seven years and is studying lenacapivir in various combinations, such as with Merck’s investigational islatravir and with broadly neutralizing antibodies. Gilead doesn’t report specific Sunlenca sales, but Yeztugo generated $150 million in 2025 after its mid-year launch. Upon BIC/LEN's top-line readouts late last year, Citi analyst Geoffrey Meacham, Ph.D., previously wrote that the novel combo “targets a key unmet need within the HIV market” and could allow Gilead to expand its reach in HIV without "cannibalizing its flagship product.” "Overall the positive results across both ARTISTRY (1&2) trials will allow Gilead to provide a simplified 2-drug regimen and provide an alternative for the specific market segments that prefer fewer medications,” Meacham wrote at the time, predicting a 2027 launch and 2030 sales of $630 million.