ViiV Healthcare presented significant advances in its HIV treatment and prevention portfolio at the Conference on Retroviruses and Opportunistic Infections (CROI 2025) held March 9-12 in San Francisco. The presentations highlighted real-world effectiveness data for approved long-acting injectables and promising results from pipeline candidates that could expand treatment options.
Long-Acting PrEP Shows Zero HIV Acquisitions in Real-World Implementation
The PILLAR implementation study, which assessed strategies for delivering cabotegravir long-acting (CAB LA) for pre-exposure prophylaxis (PrEP) across 17 U.S. sites, reported zero HIV acquisitions at the 12-month mark. The study demonstrated high persistence with the injectable PrEP regimen, supporting Apretude's effectiveness in real-world settings.
"These results are extremely encouraging as we work to expand access to long-acting prevention options," said Dr. T. Khan, lead investigator of the PILLAR study. "Zero HIV acquisitions at 12 months reinforces the potential public health impact of injectable PrEP when implemented effectively."
Additional data from the ImPrEP CAB Brazil implementation study showed enhanced PrEP coverage among young key populations when given the choice between CAB LA or oral PrEP. The study highlighted the importance of offering multiple prevention options to increase uptake among vulnerable groups.
Sustained Effectiveness of Long-Acting HIV Treatment
Long-term follow-up data from multiple studies confirmed the durability of Cabenuva (cabotegravir + rilpivirine long-acting) as a complete treatment regimen for people living with HIV.
The OPERA cohort study presented two-year effectiveness data showing sustained viral suppression in individuals receiving CAB+RPV LA. A separate analysis from the same cohort specifically examined clinical outcomes in women receiving the long-acting treatment, addressing an important demographic often underrepresented in clinical trials.
The CARES study provided critical insights on the efficacy, safety, and tolerability of CAB+RPV LA in people living with HIV in sub-Saharan Africa through 96 weeks of treatment. These findings are particularly significant as they demonstrate the regimen's effectiveness in a region with the highest HIV burden globally.
"The long-term data across diverse populations reinforces the role of long-acting injectables as a valuable option in our treatment arsenal," said Dr. C. Kityo, who presented the CARES study results. "Sustained viral suppression through 96 weeks in African populations is an important milestone for expanding treatment options in resource-limited settings."
Promising Pipeline Developments
A late-breaking phase IIb study (EMBRACE) presented efficacy and safety findings for VH3810109 (VH109), an investigational broadly neutralizing antibody (bNAb). The study evaluated the bNAb in combination with cabotegravir LA in virologically suppressed adults, showing promising results that could lead to new long-acting treatment options.
Two proof-of-concept studies highlighted ViiV Healthcare's continued innovation in developing next-generation long-acting antiretrovirals:
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VH4524184 (VH184), an investigational third-generation integrase strand transfer inhibitor (INSTI) with potential for long-acting dosing, demonstrated a favorable exposure-response relationship to HIV-1 at multiple doses.
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VH4011499 (VH499), a highly potent investigational capsid inhibitor, showed promising antiviral effects, pharmacokinetics, safety, and tolerability profiles that support its further development as a potential component of future long-acting treatment regimens.
Expanding Treatment Options with Two-Drug Regimens
The PASO-DOBLE week 48 subgroup analysis, the largest head-to-head randomized clinical trial comparing dolutegravir/lamivudine (DTG/3TC) versus bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF), presented efficacy and clinically meaningful weight change data across different subgroups, including sex at birth, age groups, ethnicity, and prior antiretroviral therapy experience.
"The comprehensive data presented at CROI 2025 demonstrates our commitment to advancing HIV care through innovation in both treatment and prevention," said Dr. Harmony P. Garges, Chief Medical Officer at ViiV Healthcare. "From the real-world effectiveness of our approved long-acting options to the promising pipeline candidates, we're working to provide more choices that can help address the diverse needs of people affected by HIV."
Addressing Diverse Population Needs
Several studies specifically addressed the needs of key populations, including women, adolescents, and people in resource-limited settings:
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Data on the acceptability of long-acting cabotegravir among pregnant and lactating people in South Africa provided insights into expanding PrEP options for this vulnerable population.
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The AFINAty study presented interim week 48 results in South African youth living with HIV on long-acting injectable therapy, addressing the critical need for effective treatment options for young people.
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A study examining the safety and pharmacokinetics of long-acting cabotegravir and rilpivirine in children between 20-40kg highlighted efforts to expand treatment options for pediatric populations.
The breadth of data presented at CROI 2025 underscores ViiV Healthcare's comprehensive approach to addressing the HIV epidemic through innovations in both treatment and prevention, with particular attention to the needs of diverse populations globally.
About ViiV Healthcare's Long-Acting HIV Portfolio
Apretude (cabotegravir LA) is indicated for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection in adults and adolescents weighing at least 35 kg who are at risk of HIV acquisition. It is administered as an intramuscular injection every two months after initial dosing.
Cabenuva (cabotegravir + rilpivirine) is a complete long-acting regimen for the treatment of HIV-1 infection in adults and adolescents who are virologically suppressed. The treatment combines an integrase strand transfer inhibitor (cabotegravir) with a non-nucleoside reverse transcriptase inhibitor (rilpivirine) and is administered as an intramuscular injection monthly or every two months, depending on the approved dosing schedule in different regions.
ViiV Healthcare, established in 2009 by GSK and Pfizer with Shionogi joining in 2012, is dedicated to delivering advances in HIV treatment and prevention, as well as supporting communities affected by HIV.
