ViiV announced three different long-acting HIV treatment and PREP news pieces this week
As the Conference for Retroviral and Opportunistic Infections (CROI) came to a close, so did the press embargoes and ViiV had a lot of news to share. See them below.
ViiV Healthcare showcases leadership in long-acting injectables innovation at CROI 2025 with data on third-generation integrase inhibitor (INSTI) and highly potent capsid inhibitor against HIV-1
ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer and Shionogi as shareholders, announced positive findings from two phase IIa proof-of-concept studies of investigational antiretroviral therapies VH4524184 (VH184) and VH4011499 (VH499). These findings, presented at the Conference on Retroviruses and Opportunistic Infections (CROI 2025) in San Francisco, support the continued development of these two compounds as distinct options for a new generation of long-acting injectables for HIV, with the potential for extended dosing intervals.
Kimberly Smith, M.D., MPH, Head of Research & Development at ViiV Healthcare said:
It’s clear long-acting injectable medicines deliver on unmet patient need and will play a critical role in achieving our ambition of ending HIV and AIDS. Our pipeline with INSTIs at the core showcases our continued leadership in long-acting injectable innovation. Data shows that the potency and tolerability of our third-generation INSTI and our capsid inhibitor will make them a major part in the development of our next generation of long-acting injectable therapies.
VH184 demonstrated high antiviral potency
This study aimed to explore the antiviral activity and safety of three doses of VH184 (10mg, 50mg and 300mg taken once every three days) by assessing the maximum change in plasma HIV-1 RNA levels during a 10-day monotherapy period in 22 adults who had not previously received antiretroviral therapy. People who participated in the study had HIV-1 RNA levels of at least 3000 copies/mL.
VH184, a third-generation INSTI, demonstrated potency at all doses leading to a marked drop in the HIV-1 viral load. After 10 days of monotherapy, the average decreases were -1.17, -2.15, and -2.31 log10 copies/mL for the 10mg, 50mg, and 300mg doses, respectively. The maximum viral load decline (-2.69 log10) was observed in the 300mg dose. Additionally, no drug resistance mutations were observed at the end of the study. All side effects were mild to moderate, and no serious side effects or participant discontinuations occurred.
Long-acting formulations of VH184 in adults without HIV are being evaluated in an ongoing phase 1 study (NCT06310551). The findings of this trial support further development of VH184 as a potential long-acting injectable antiretroviral.
Higher VH499 dose correlated with greater decline in viral load.
This study evaluated the compound’s antiviral effect, safety, and tolerability by assessing the maximum change in plasma HIV-1 RNA levels from baseline through day 11 in 23 adults who had not previously received antiretroviral therapy. People who participated in the study also had HIV-1 RNA levels of at least 3000 copies/mL.
The trial of VH499, an investigational capsid inhibitor, showed that all oral doses (25mg, 100mg, and 250mg) led to a decrease in HIV-1 viral load ranging from -2.2 log10 copies/mL in the 250mg arm, to -1.8 log10 copies/mL in the 25mg and 100mg arms. VH499 was well tolerated with all adverse events being mild to moderate in severity. There were no adverse events leading to withdrawal and no serious adverse events were reported. On day 11, one individual on the 25mg dose developed a single mutation associated with reduced susceptibility to capsid inhibitors.
In a previous phase I clinical trial of adults without HIV-1, VH499 was well tolerated, and showed no induction or inhibition of CYP3A4.3 Long-acting formulations of VH499 in adults without HIV are being evaluated in ongoing phase 1 studies (NCT06012136; NCT06724640).
These findings, in combination with the potent antiviral activity in this phase IIa study, support further development of VH499 as a potential long-acting antiretroviral for HIV treatment.
For more information, read the original press release.
ViiV Healthcare announces new implementation study data showing zero cases on HIV with appretude, the only long-acting injectable approved for HIV PREP
ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer and Shionogi as shareholders, announced new data from two implementation studies showing zero cases of HIV acquisition for Apretude, the only long-acting injectable approved for HIV prevention. Real-world data were also presented for Cabenuva, the only approved, complete long-acting injectable treatment regimen, showing its effectiveness in the three years since it has been available.
These data were presented at the Conference on Retroviruses and Opportunistic Infections (CROI 2025), in San Francisco, U.S.
Harmony P. Garges, M.D. MPH., Chief Medical Officer at ViiV Healthcare, said:
As the leaders in long-acting injectables for HIV, we’re committed to collecting data to understand the effectiveness of these first-in-class medicines in real-world settings. Our ongoing, real-world and implementation studies for Apretude show effectiveness of HIV prevention of more than 99% in nearly 4,000 people; and we have real-world experience in more than 15,000 people receiving Cabenuva for HIV treatment showing continued high effectiveness up to two years. Our data at CROI 2025 reinforce that, across a broad range of settings and populations, our long-acting injectables provide a highly effective option for both HIV treatment and prevention, that remove the need for daily pills.
Ricky Hsu, M.D., Department of Medicine, NYU Grossman School of Medicine and Medical Director, AHF Healthcare Center, said:
While randomised clinical trials are the gold standard for testing the safety and efficacy of medicines, real-world evidence can provide a fuller understanding of the safety and effectiveness of a therapy over time. Since ViiV Healthcare’s introduction of long-acting injectables, generating these valuable insights is more important than ever to help providers decide who could benefit from particular medicines and better understand how they address the everyday needs of people impacted by HIV.
Highlights from ViiV Healthcare and partner real-world and implementation studies for long-acting injectables Apretude (prevention) and Cabenuva (treatment):
PILLAR 12-month clinical results: zero HIV acquisition and high persistence with CAB LA for PrEP
New 12-month findings from the PILLAR study explore effectiveness, diagnostic testing, persistence (time that an individual continued to receive injections), safety and tolerability of CAB LA in 201 participants. PILLAR is a phase IV implementation trial assessing the integration of CAB LA for PrEP across 17 clinics in the U.S. among a diverse population of men who have sex with men and transgender men, 26% of whom were Black and 38% Hispanic/Latino.
No cases of HIV acquisition were observed through 12 months. Persistence on CAB LA was high, at 85% (n=171/201) at six months and 72% (n=142/196) at 12 months; excluding five participants who completed the study post-data cutoff. Five participants missed an injection and received either oral CAB or alternative PrEP.
Adverse events (AEs) related to CAB LA were uncommon, with injection site pain the most frequently reported (3%, n=6). Five percent of participants (n=11) had AEs leading to discontinuation, most commonly due to injection site pain.
These implementation study data - obtained from a diverse population - support CAB LA as an effective PrEP option associated with high persistence.
ImPrEP CAB Brazil implementation study data shows significantly improved PrEP coverage and protection with CAB LA
The ImPrEP CAB Brazil study (The Choice Cohort) assessed PrEP coverage and HIV incidence among 1,447 participants who were given the choice of CAB LA or oral PrEP (TDF/FTC) for HIV prevention. The Choice Cohort included PrEP-naïve, cisgender men who have sex with men, non-binary and trans people aged 18 to 30. As a comparison group, the study assessed 2,263 people of a similar demographic, initiating oral PrEP through the Brazilian public health system during the same period.
The results show that offering CAB LA injections significantly improved PrEP coverage and HIV prevention for young key populations, reinforcing the role of CAB LA in addressing adherence challenges some people face with oral PrEP.
Eighty-three percent of the 1,447 participants who were free to choose either CAB LA or oral PrEP chose CAB LA (1,200 participants) and there were zero HIV acquisitions reported over 798.4 person-years in The Choice Cohort. There were eight HIV acquisitions over 408.52 person-years reported in the comparison group (incidence rate 1.96 [95% CI 0.98-3.92] per 100 person-years).
The proportion of individuals covered by PrEP during follow-up was highest in the CAB LA group (96.2%, 221,273/ 229,951 days), followed by the oral PrEP group within The Choice Cohort (64.1%, 32,272/ 50,310 days) and lowest in the comparison group (47.4%, 191,765/ 404,781 days).
The study is sponsored by the Evandro Chagas National Institute of Infectious Diseases at the Oswaldo Cruz Foundation, Brazil, and funded by Unitaid.
Real-world data from OPERA show high effectiveness of CAB + RPV LA in broad populations
The first of two OPERA analyses looked at long-term effectiveness in diverse virologically suppressed individuals on CAB+RPV LA - 42% of whom are Black and 30% Hispanic - through two years.
In this large (n=2,485) U.S. cohort of individuals who switched to CAB + RPV LA, with a median follow-up time of 11 months (IQR: 6-18), 95% maintained virological suppression (<50c/ml at last Viral Load (VL)) and 1% (n=21) experienced confirmed virologic failure (CVF) after a median of seven months. Outcomes were consistent over time through 24 months and across BMI categories (<30 kg/m2, ≥30 kg/m2).
In a second analysis among a diverse group of 381 virologically suppressed women with HIV, with a median follow-up time of 12 months (IQR:7-19), 94% maintained suppression at their last viral load and CVF was ≤1.3% (n≤5).
High rates of viral suppression observed in Trio Health cohort
The Trio Health cohort followed 928 virologically suppressed individuals initiating CAB + RPV LA in real-world settings in the U.S. The median (IQR) follow-up time after the first injection was 12 months (5-19) and 89% of injections (6176/6934) were administered without delay (<7 days after the target dosing date). Ninety-five percent of individuals on CAB+RPV LA maintained viral suppression (last VL <50 c/mL) and 1.6% (n=15) experienced CVF.
These studies add to the real-world evidence supporting CAB+RPV LA’s high effectiveness in a broad range of populations.
For more information including professional indication and important safety information, read the original press release.
ViiV Healthcare's investigational broadly neutralising antibody - N6LS - successfully maintains viral suppression in long-acting treatment of HIV
ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer and Shionogi as shareholders, announced positive findings from the company’s EMBRACE phase IIb study. The study found that N6LS (VH3810109 or VH109), given every four months in combination with monthly cabotegravir long-acting (CAB LA), successfully kept viral levels suppressed in adults living with HIV who were already stable on treatment. It was also well tolerated by participants.
These results were presented today at the Conference on Retroviruses and Opportunistic Infections (CROI 2025) in San Francisco, U.S.
Kimberly Smith, M.D., MPH, Head of Research & Development at ViiV Healthcare, said:
As leaders in long-acting injectable innovation, we are building on the positive patient and physician experience we have with Cabenuva and pioneering the next generation of long-acting treatment options. The EMBRACE study demonstrated that VH109, a CD4-binding broadly neutralising antibody, administered every four months with cabotegravir, achieved high efficacy and was well tolerated through six months. We’re looking forward to continuing the development of VH109 as a component of our future ultra long-acting regimens.
Results from the EMBRACE study at the six-month primary endpoint showed that 96% of participants receiving VH109 60mg/kg intravenously (IV) and 88% receiving VH109 3000mg subcutaneously (SC) with rHuPH20 maintained HIV-1 RNA levels below 50 copies/mL, compared to 96% in the standard-of-care group. VH109 was administered in both arms every four months, combined with monthly CAB LA. Confirmed virologic failure was observed in two participants from each VH109 group.
Overall, 4% of the IV group and 6% of the SC group had HIV-1 RNA levels of 50 copies/mL or higher, compared to none in the standard-of-care group when measured at month six.
VH109 was generally well tolerated, though infusion site reactions were more frequent with SC administration, occurring in 14% compared to none with IV administration. Adverse events specific to the use of study medication were reported in 64% of the IV group and 65% of the SC group, with 16% of participants in the SC group experiencing grade 3-4 adverse events (erythema). No participants in the IV group experienced a grade 3-4 adverse event.
Based on the favourable results seen in the trial, ViiV Healthcare will be progressing a six-month IV formulation of VH109 in combination with CAB LA for further evaluation in an EMBRACE part two trial.
For more information, read the original press release.
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