ViiV Healthcare Presents Ultra Long-Acting HIV Treatment and Prevention Data at CROI 2026 in Denver

At the 33rd Conference on Retroviruses and Opportunistic Infections (CROI) in Denver, Colorado, ViiV Healthcare is presenting new data that could help redefine long-acting HIV treatment and prevention. From first-in-human results for a third-generation integrase inhibitor to extended dosing strategies for prevention, the company is signaling a strong push toward ultralong-acting innovation.

Jean van Wyk, MBChB, MFPM, chief medical officer at ViiV Healthcare, spoke about the significance of this year’s data and being presented at CROI, as noted in a press release.

“We are making major advances towards new ultralong-acting regimens that build on ViiV’s legacy of integrase inhibitors,” van Wyk said. “Pipeline assets such as VH184 that have the potential to extend dosing intervals to 4 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.”

One of the most closely watched presentations involves VH184, described as the first third-generation integrase strand transfer inhibitor. First-in-human phase I data evaluating injectable long-acting formulations will offer insight into their pharmacokinetics and potential durability. Separate analyses will examine its resistance profile compared to bictegravir, a key benchmark in the current treatment landscape.

Beyond integrase inhibitors, ViiV is also presenting early data on VH499, an investigational injectable HIV-1 capsid inhibitor. Interim analyses are expected to inform dosing strategies that could support ultralong-acting regimens. Meanwhile, 12-month results from the phase IIb EMBRACE study are evaluating lotivibart, an investigational broadly neutralizing antibody administered every 4 months, in combination with monthly long-acting cabotegravir for HIV treatment.

Established long-acting therapies also feature prominently. New findings from the phase IIIb VOLITION study will provide Month 11 outcomes in ART-naïve adults who switched to long-acting cabotegravir plus rilpivirine after achieving virologic suppression on once-daily dolutegravir and lamivudine. Additional real-world data from the OPERA cohort examine virologic outcomes by body mass index and long-term outcomes over 4 years in individuals initiating therapy with viral loads at or above 50 copies per milliliter compared to those below that threshold.

In prevention, updated analyses from the phase I CAB ULA 012 study explore cabotegravir ULA formulations designed for administration every 4 months. Additional OPERA data highlight the 3-year effectiveness of long-acting cabotegravir for pre-exposure prophylaxis and compare coverage with oral PrEP in routine care settings. Data on the real-world effectiveness over 12 months for Black women, who are still disproportionately impacted by HIV, will also be shared.

The company is also strengthening evidence for dolutegravir-based regimens across diverse populations. A new meta-analysis compares dolutegravir and lamivudine to 3-drug dolutegravir regimens in treatment-naïve individuals with high baseline viral load or low CD4 counts. Results from the PASO DOBLE trial at 96 weeks will examine metabolic outcomes, including steatotic liver disease and adipose tissue changes. Additional data from the SUNGURA study focus on older adults aged 60 years and above.

Pediatric research is another priority. Week 96 data from IMPAACT 2017 and new safety and pharmacokinetic data from IMPAACT 2036 evaluate long-acting strategies in “younger age groups.” Additional findings explore viral suppression in children aged 5 years and younger receiving dolutegravir-based regimens.