ViiV Healthcare Presents Promising Advances in Long-Acting HIV Treatment and Prevention
New data presented at the upcoming Conference on Retroviruses and Opportunistic Infections (CROI) in Denver, Colorado, demonstrate significant progress in the development of ultra-long-acting HIV therapies. ViiV Healthcare, a global specialist HIV company majority owned by GSK, with Pfizer and Shionogi as shareholders, is showcasing research that could dramatically alter the landscape of HIV treatment and prevention, potentially extending dosing intervals and improving patient convenience.
A key focus of the presentations is VH184, described as the first third-generation integrase inhibitor. Early data from an ongoing first-in-human phase I study will be presented, offering insights into its potential for ultra-long-acting regimens. Researchers will also analyze its resistance profile compared to bictegravir, an existing integrase inhibitor.
Beyond VH184, ViiV Healthcare is also reporting on lotivibart (N6LS), an investigational broadly neutralizing antibody. Twelve-month data from a study combining lotivibart with long-acting cabotegravir will be presented, evaluating the feasibility of even longer dosing intervals. Additional research will explore dosing and ultra-long-acting feasibility of the injectable HIV-1 capsid inhibitor, VH499.
Expanding Prevention Options with Cabotegravir
The company is also investigating ways to extend the interval for HIV prevention using cabotegravir. A phase I study, CAB ULA 012, is exploring dosing options to support administration every four months, potentially broadening prevention choices.
Real-World Evidence for Existing Therapies
ViiV Healthcare is also presenting updated data on its established long-acting injectable treatment, Cabenuva (cabotegravir + rilpivirine LA), and the two-drug regimen Dovato (dolutegravir/lamivudine). Late-breaking results from the phase IIIb VOLITION study will provide an update on outcomes among adults switching to Cabenuva after achieving viral suppression on Dovato. Analyses from the OPERA cohort will report virologic outcomes based on body mass index and provide four-year follow-up data for individuals initiating Cabenuva.
Further research focuses on optimizing the use of Cabenuva and Apretude (cabotegravir LA for PrEP). An updated analysis from the phase I CLARITY study will detail the acceptability, visibility, and size of injection-site reactions following single doses of lenacapavir, and cabotegravir. Data from the OPERA cohort will outline the effectiveness of Apretude over three years, as well as its coverage compared to oral PrEP in routine care. Specific data will also be presented on the effectiveness and acceptance of Apretude among Black women, a population disproportionately affected by HIV.
Strengthening Evidence for Dolutegravir-Based Treatment
Research also supports the continued use of dolutegravir-based treatments. The first efficacy meta-analysis comparing Dovato to three-drug regimens in individuals with high viral loads and/or low CD4 counts will be presented. Several analyses from the PASO DOBLE trial will provide insights into the metabolic impact of Dovato, including its effects on steatotic liver disease and adipose tissue. The SUNGURA study will present safety and efficacy data in older adults switching to Dovato.
Advancing Pediatric Treatment
ViiV Healthcare is also focused on improving treatment options for children. Data from studies IMPAACT 2017 (MOCHA) and IMPAACT 2036 (CRAYON) will illustrate the use of Cabenuva in younger age groups. Findings from Southern Africa will describe viral suppression in children aged five years and under on dolutegravir, highlighting its role in pediatric treatment. The PENTA 21 study will explore the effectiveness of a simplified oral regimen of dolutegravir/lamivudine compared to a three-drug regimen in treating children.
Jean van Wyk, MBChB, MFPM, Chief Medical Officer at ViiV Healthcare, emphasized the company’s commitment to developing long-acting therapies, stating, “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.”
Apretude is currently approved for HIV-1 pre-exposure prophylaxis (PrEP) in adults and adolescents weighing at least 35 kg who are at high risk of HIV infection. Vocabria, in combination with rilpivirine, is approved for the treatment of HIV-1 infection in virologically suppressed adults and adolescents. Cabenuva is a complete regimen for treating HIV-1 infection in virologically suppressed adults and adolescents.
ViiV Healthcare is a global specialist HIV company established in 2009 by GSK and Pfizer, with Shionogi becoming a shareholder in 2012. The company’s mission is to advance treatment and care for people living with and at risk of HIV.
