ViiV Healthcare’s EMBRACE Study: Ultra-Long-Acting HIV Treatment Shows Promise
march 12, 2025
San Francisco, CA – ViiV Healthcare, a global specialist HIV company majority owned by GSK, with Pfizer and Shionogi as shareholders, unveiled encouraging findings from its EMBRACE phase IIb study at the Conference on Retroviruses and Opportunistic Infections (CROI 2025) in San Francisco, U.S. The EMBRACE study demonstrates the potential of a novel, ultra-long-acting HIV treatment regimen. The research centered on N6LS (VH3810109 or VH109), a broadly neutralizing antibody (bNAb), administered every four months in conjunction with monthly cabotegravir long-acting (CAB LA).
The EMBRACE study indicates that this combination effectively maintained undetectable viral load in adults living with HIV who were already stable on their existing treatment. Study participants reported the regimen was well-tolerated, marking a significant advancement in the pursuit of more convenient and less frequent HIV treatment options. This growth could revolutionize how HIV is managed, offering a more discreet and manageable approach to maintaining health.
Key Findings from the EMBRACE Study
The six-month primary endpoint data from the EMBRACE study revealed compelling results. Specifically, 96% of participants receiving VH109 at a dosage of 60mg/kg intravenously (IV) and 88% receiving VH109 at 3000mg subcutaneously (SC) with rHuPH20 maintained HIV-1 RNA levels below 50 copies/mL. This was comparable to 96% in the standard-of-care group, highlighting the non-inferiority of the new regimen.VH109 was administered every four months in both arms, combined with monthly CAB LA.
while the overall efficacy was high, confirmed virologic failure was observed in two participants from each VH109 group. Further analysis revealed that 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. These findings suggest that while the N6LS and CAB LA combination is highly effective for most individuals, ongoing monitoring and further research are crucial to understand and address the instances of virologic failure.
Tolerability and Adverse Events
The tolerability of VH109 was generally favorable. However, infusion site reactions were more prevalent with subcutaneous (SC) administration, occurring in 14% of participants compared to none with intravenous (IV) administration. Adverse events specifically related to the study medication were reported in 64% of the IV group and 65% of the SC group. Notably, 16% of participants in the SC group experienced grade 3-4 adverse events, specifically erythema (redness of the skin). No participants in the IV group experienced a grade 3-4 adverse event.
These observations underscore the importance of considering the route of administration when developing long-acting injectable HIV treatments, as it can considerably impact the patient experience and tolerability. the choice between intravenous and subcutaneous administration can considerably influence patient comfort and adherence to the treatment regimen.
Future Directions: EMBRACE Part Two
Building on the promising results observed in the initial trial, ViiV Healthcare is moving forward with a second phase of the EMBRACE study. This next phase will evaluate a six-month IV formulation of VH109 in combination with CAB LA. this extended dosing interval represents a significant advancement, potentially reducing the frequency of injections to just twice a year.
According to Kimberly Smith, M.D., MPH, Head of research Development at ViiV Healthcare, the company is committed to building on the positive patient and physician experience we have with cabenuva and pioneering the next generation of long-acting treatment options.
She added,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.
About Cabenuva
Cabenuva (cabotegravir rilpivirine) is currently indicated as a complete regimen for the treatment of HIV-1 infection in adults and adolescents 12 years and older, weighing at least 35kg, to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA < 50 copies/mL) on a stable antiretroviral regimen with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine.
The complete regimen combines cabotegravir, an integrase strand transfer inhibitor (INSTI) developed by viiv Healthcare, with rilpivirine, a non-nucleoside reverse transcriptase inhibitor (NNRTI) developed by Janssen Sciences Ireland Unlimited Company. INSTIs inhibit HIV replication by preventing the viral DNA from integrating into the genetic material of human immune cells (T-cells), a crucial step in the HIV replication cycle. Rilpivirine, on the other hand, interferes with an enzyme called reverse transcriptase, preventing the virus from multiplying.
ViiV Healthcare: A Commitment to Innovation
ViiV Healthcare, established in November 2009 by GSK and Pfizer, with Shionogi becoming a shareholder in October 2012, is dedicated to delivering advances in treatment and care for people living with HIV and for those who could benefit from HIV prevention. The company’s mission is to take a deeper and broader interest in HIV and AIDS than any company has done before, adopting a new approach to deliver effective and innovative medicines for HIV treatment and prevention, while also supporting communities affected by HIV.
Conclusion
The positive results from ViiV Healthcare’s EMBRACE study represent a significant advancement in the ongoing effort to develop more convenient and effective HIV treatment options. The combination of N6LS and cabotegravir long-acting holds promise for reducing the frequency of injections, improving patient adherence, and ultimately enhancing the quality of life for individuals living with HIV. As the EMBRACE part two trial progresses, the potential for a six-month injectable regimen brings the prospect of ultra-long-acting HIV treatment closer to reality.
Ultra-Long-Acting HIV Treatment: A revolutionary Leap Forward?
“The EMBRACE study results suggest we’re on the verge of a paradigm shift in HIV management, moving from daily pills to perhaps just two injections a year. This isn’t just about convenience; it’s about fundamentally changing the lives of millions.”
Interviewer (World-Today-news.com): Dr. Anya Sharma, a leading infectious disease specialist, welcome to World-Today-News.com. The recent EMBRACE study results regarding ViiV Healthcare’s ultra-long-acting HIV treatment are generating significant excitement. Can you explain, for our readers, what makes this growth so groundbreaking?
Dr. Sharma: Thank you for having me. The EMBRACE study’s findings are indeed revolutionary because they showcase the potential of a truly transformative treatment approach for HIV. For decades, the standard of care involved daily medication, leading to challenges with adherence and long-term management. This new approach, using a combination of a broadly neutralizing antibody (bNAb) like VH109 and cabotegravir long-acting (CAB LA), offers the possibility of dramatically reducing the frequency of injections, potentially to just twice a year. This simplified regimen has the potential to greatly improve patient adherence, simplify treatment complexities, and ultimately improve health outcomes for people living with HIV.
Interviewer: The study highlighted two governance routes: intravenous (IV) and subcutaneous (SC). what are the key differences, and which method seems more promising for widespread adoption?
Dr. sharma: the choice between IV and SC administration for VH109 is crucial, impacting both efficacy and tolerability. While the IV administration showed slightly fewer adverse events, especially concerning grade 3-4 adverse events like erythema, the SC route offers greater convenience for patients. The higher rates of injection site reactions with SC administration are a consideration, which might require adjusting injection techniques or developing improved formulations to mitigate these side effects. Ultimately, the most promising method will be steadfast by a balance of efficacy, tolerability, and practicality for real-world implementation. Patient preference will play a significant role. We need further research and, possibly, improved formulations to achieve optimal results with both routes of administration within the context of long-term use in a real-world clinical setting.
Interviewer: The study mentioned instances of virologic failure. How significant is this finding, and what are the implications for future research?
Dr.Sharma: The observation of virologic failure in a small percentage of participants—although a small proportion—underscores the importance of ongoing monitoring and further research, especially long-term clinical trials evaluating the complete regimen. While initial results are highly encouraging, it’s crucial to thoroughly investigate the reasons for these failures.Potential factors include individual variations in immune responses or developing antibody resistance, and the development of a new viral strain. The development of any new strain or resistance related to the HIV virus is of ongoing concern for long-term treatment outcomes. Further analysis and longer-term follow-up are necessary before wider implementation. This points to the need for continued surveillance and the potential development of strategies to prevent or manage these occurrences, perhaps through adjusted dosages or the addition of other drugs to the regimen.
Interviewer: The EMBRACE study is moving into a second phase, focusing on a six-monthly IV formulation.What are the potential benefits of this extended dosing interval?
Dr. Sharma: Extending the dosing interval to six months, as proposed in EMBRACE part two, represents a major leap forward. Such an ultra-long-acting HIV treatment regimen offers unparalleled convenience,potentially transforming the patient experience. Reducing injections to just twice yearly coudl significantly improve medication adherence among individuals living with HIV. While this extended six-monthly treatment is only currently in the trial phase, should it prove successful, it would simplify the already cumbersome process that is often associated with keeping HIV managed and will help lessen the burden on patients, healthcare providers, and healthcare systems. The potential benefits are profound, potentially leading to increased retention within the treatment cycle, improved quality of life, and broader access to effective HIV treatment.
Interviewer: How does this new treatment relate to the existing HIV treatment regimens, such as Cabenuva?
Dr. Sharma: Cabenuva currently represents a significant improvement over daily oral regimens. But the EMBRACE regimen aims to take this convenience a step further, greatly reducing the frequency of injections compared to existing long-acting options. The findings of the EMBRACE study signify a progression, aiming to simplify the treatment approach even more and provide a potentially easier-to-manage method of controlling the virus. It represents the cutting edge of research into long-acting injectable HIV therapies, building upon the foundation established by Cabenuva and aiming for the ultimate goal of a highly effective and less frequent treatment regimen. This is a step towards a future where HIV is managed with minimal impact on daily life, fundamentally changing the way this condition is viewed and approached.
Interviewer: What is the anticipated impact of this ultra-long-acting treatment on global HIV management?
Dr. Sharma: The potential is enormous. Improved adherence due to less frequent injections could lead to substantially lower rates of viral rebound and transmission. This could have a significant impact on public health and potentially contribute to the global effort towards HIV eradication. The simplicity of the regimen might also improve access to treatment, notably in resource-limited settings, which could make a considerable difference in the lives of those who have difficulty adhering to daily or monthly regimens. The findings show a great deal of promise, which is incredibly inspiring for the health care field as a whole. It simplifies the process for health care provider’s as well allowing for a greater efficiency in care.
Interviewer: What are some of the key takeaways from this interview that readers should keep in mind?
Dr. Sharma:
The EMBRACE study presents highly encouraging results for a potentially revolutionary ultra-long-acting HIV treatment.
The choice between IV and SC injection routes requires further consideration regarding efficacy and tolerability.
Ongoing monitoring and further research are essential to fully understand and address instances of virologic failure.
A six-monthly injection regimen, if proven successful in the ongoing EMBRACE part two study, represents a significant advancement.
* This research highlights the ongoing commitment to developing safer, simpler, and more convenient HIV management strategies.
Thank you for this opportunity to discuss such promising developments in HIV treatment. I encourage people living with HIV to discuss these options with their healthcare providers.
Interviewer: Thank you, Dr. Sharma. This has been an incredibly insightful discussion. We urge our readers to share their thoughts and questions in the comments section below.