ViiV Healthcare will present new data from its long-acting and ultra long-acting HIV treatment and prevention portfolio at the Conference on Retroviruses and Opportunistic Infections (CROI 2026), including first-in-human results for its third-generation integrase inhibitor VH184 and early findings for capsid inhibitor VH499.

The company said the data reflect progress in its strategy to extend dosing intervals beyond currently available long-acting regimens, with several assets targeting administration every four months or longer.

Among the headline presentations are Phase 1 data for injectable long-acting formulations of VH184, described by the company as the first third-generation integrase strand transfer inhibitor (INSTI). An additional analysis will assess its in vitro resistance profile compared with bictegravir. Early data will also be presented for VH499, an investigational HIV-1 capsid inhibitor, including analyses intended to inform ultra long-acting dosing feasibility.

Jean van Wyk, chief medical officer at ViiV Healthcare, said: “We are making major advances towards new ultra long-acting regimens that build on ViiV’s legacy of integrase inhibitors, including pipeline assets such as VH184 that have the potential to extend dosing intervals to four months or longer – beyond what is available today for HIV treatment. Listening to the needs of the HIV community shapes our research and development, and the breadth of clinical and real-world data we are presenting at CROI 2026 reflects our commitment to delivering long-acting therapies that people impacted by HIV need and want.”

The programme also includes updated 12-month data from the Phase 2b EMBRACE study evaluating investigational broadly neutralising antibody lotivibart (N6LS) administered every four months in combination with monthly long-acting cabotegravir. The study is assessing maintenance of HIV suppression and long-term safety.

For prevention, Phase 1 data from the CAB ULA 012 study will explore dose selection of ultra long-acting cabotegravir for pre-exposure prophylaxis (PrEP), supporting potential four-month dosing intervals.

ViiV will also present new analyses for its approved long-acting injectable regimen Cabenuva (cabotegravir + rilpivirine LA), including late-breaking Phase 3b VOLITION results in adults who switched after achieving virologic suppression on Dovato (dolutegravir/lamivudine). Real-world data from the OPERA cohort will examine virologic outcomes by body mass index and long-term outcomes up to four years.

In prevention, updated OPERA analyses will report on three-year effectiveness data for Apretude (cabotegravir long-acting for PrEP), including coverage compared with oral PrEP in routine care. Additional real-world data will focus on Black women, a population disproportionately affected by HIV.

Beyond long-acting agents, ViiV will present a meta-analysis comparing dolutegravir/lamivudine with dolutegravir-based three-drug regimens in ART-naïve individuals with high viral load or low CD4 counts. Results from the PASO DOBLE trial will provide 96-week data on metabolic outcomes, including steatotic liver disease and adipose tissue changes.

Paediatric data will also feature prominently, including 96-week results from IMPAACT 2017 (MOCHA) in adolescents receiving long-acting cabotegravir plus rilpivirine, and early safety and pharmacokinetic data in children under 20 kg from IMPAACT 2036 (CRAYON). Additional findings will examine dolutegravir-based regimens in children aged five years or younger in Southern Africa.

The breadth of presentations underscores ViiV’s continued focus on long-acting innovation in HIV, with an emphasis on reducing dosing frequency, maintaining viral suppression and expanding options across diverse populations. As competition in long-acting HIV treatment intensifies, data from CROI 2026 will help clarify the clinical profile and feasibility of next-generation ultra long-acting regimens.