Conference Presentation

Gilead's twice-yearly HIV regimen reaches Week 104 data at AIDS 2026

The Phase 2 lenacapavir-antibody combination that hit 96% suppression at Week 26 now reports two-year follow-up as Gilead moves the regimen into Phase 3.

Gilead Sciences will present Week 104 outcomes from its Phase 2 study of twice-yearly lenacapavir combined with the broadly neutralizing antibodies teropavimab and zinlirvimab in an oral session at AIDS 2026 in Rio de Janeiro, running July 26-31.

By AppliedXLJuly 21, 2026Trial NCT05729568

Executive Summary

Gilead will present two-year follow-up data from a Phase 2 trial of its twice-yearly, injection-based lenacapavir-antibody combination for HIV treatment, extending a regimen that already posted a positive primary result and has since advanced into Phase 3.
Durability at two years would reinforce the case for a regimen dosed roughly twice a year instead of daily, a design choice aimed squarely at the adherence problem that limits current oral antiretroviral therapy.
Lenacapavir already anchors an approved long-acting HIV prevention franchise, and this combination sits inside a field where capsid inhibition remains a narrow mechanism class even as long-acting HIV treatment overall grows crowded with integrase- and reverse-transcriptase-targeted rivals.
The trial's enrollment settled at target and its Active, not recruiting status simply reflects a Phase 2 study that finished enrolling and moved to follow-up, not a sign of distress.

The presentation

Gilead Sciences, Inc. said it will present new HIV data at the 26th International AIDS Conference, running July 26-31 in Rio de Janeiro, including Week 104 outcomes from NCT05729568, a Phase 2 open-label study of lenacapavir combined with the broadly neutralizing antibodies teropavimab (GS-5423) and zinlirvimab (GS-2872). The trial tests whether virologically suppressed adults with HIV-1 can switch from daily oral antiretroviral therapy to an injectable and infused regimen dosed roughly every six months. Jared Baeten, Gilead's senior vice president of clinical development for virology, said the AIDS 2026 program reflects the company's "ongoing commitment to advancing HIV prevention, treatment and cure research". Gilead+1

Probability of Success

Endpoint Met75%

Completes79%

Clinical Significance19%

Regulatory93%

What already read out

The trial's registered primary endpoint measured the percentage of participants with HIV-1 RNA at or above 50 copies per mL at Week 26, using the FDA-defined snapshot algorithm. At that Week 26 readout, 1.9% of participants on the combination and 0% on the oral stable baseline regimen met that threshold, and the trial's primary result summary reported 96% virologic suppression in both the combination arm (51 of 53 participants) and the oral-therapy arm (26 of 27 participants), with treatment-emergent adverse events in 68% of the combination group versus 63% of the comparator group. The FDA granted Breakthrough Therapy Designation to the combination in January 2025 on the strength of that data. The Week 104 presentation extends that already-disclosed result rather than introducing a first readout. NCT05729568

Competitive position

Lenacapavir's capsid-inhibitor mechanism has few direct peers: the closest comparator sharing both target and modality is Gilead's own Phase 3 lenacapavir program in HIV pre-exposure prophylaxis, alongside Merck's older Phase 2 vicriviroc, another HIV-1 capsid-targeted small molecule. The broader long-acting HIV-1 treatment field is more populated, spanning ViiV Healthcare's cabotegravir-based regimens and ongoing Phase 3 programs from Merck and others targeting integrase or reverse transcriptase instead of capsid protein. Within HIV-1 capsid inhibition specifically, activity is concentrated almost entirely inside Gilead's own pipeline, with Gilead's next-generation capsid candidate GS-3242 now in Phase 2/3 testing. Given a field where suppression rates on modern combination oral therapy already exceed 95%, the bar this regimen has to clear is not a first demonstration of antiviral activity but durable suppression maintained across less frequent dosing without new safety signals.

Trial mechanics

The 83-patient study enrolled at its final target after an early adjustment cut the anticipated enrollment from 125 to 75 participants in mid-2023, before settling at 83 when the trial moved to Active, not recruiting status in January 2024. The registered primary completion date shifted three times, ultimately landing on July 2, 2024, changes tied to enrollment finalizing on schedule rather than delay. Gilead has already used interim readouts from this trial at CROI 2025 (Week 26 primary results), EACS 2025 (Week 52 durability), and CROI 2026 (patient-reported outcomes) to build the case that supported its move into Phase 3 development. NCT05729568

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