Cabotegravir/Rilpivirine

LONDON, UK I March 12, 2025 I ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer and Shionogi as shareholders, today announced positive findings from the company’s EMBRACE phase IIb study. 1 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. About Cabenuva (cabotegravir + rilpivirine) Cabenuva is indicated as a complete regimen for the treatment of HIV-1 infection in adults and adolescents 12 years and older and weighing at least 35kg to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA <50 c/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 the integrase strand transfer inhibitor (INSTI) cabotegravir, developed by ViiV Healthcare, with rilpivirine, a non-nucleoside reverse transcriptase inhibitor (NNRTI) developed by Janssen Sciences Ireland Unlimited Company. Rilpivirine tablets are approved in the U.S. and when used with cabotegravir is indicated for short-term treatment of HIV-1 infection in adults and adolescents 12 years and older and weighing at least 35kg who are virologically suppressed (HIV-1 RNA less than 50 copies/mL) on a stable regimen with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine. INSTIs inhibit HIV replication by preventing the viral DNA from integrating into the genetic material of human immune cells (T-cells). This step is essential in the HIV replication cycle and is also responsible for establishing chronic disease. Rilpivirine is an NNRTI that works by interfering with an enzyme called reverse transcriptase, which stops the virus from multiplying. Please consult the full Prescribing Information . Trademarks are owned by or licensed to the ViiV Healthcare group of companies. About ViiV Healthcare ViiV Healthcare is a global specialist HIV company established in November 2009 by GSK (LSE: GSK) and Pfizer (NYSE: PFE) dedicated to delivering advances in treatment and care for people living with HIV and for people who could benefit from HIV prevention. Shionogi became a ViiV shareholder in October 2012. The company’s aims are to take a deeper and broader interest in HIV and AIDS than any company has done before and take a new approach to deliver effective and innovative medicines for HIV treatment and prevention, as well as support communities affected by HIV. For more information on the company, its management, portfolio, pipeline, and commitment, please visit viivhealthcare.com. About GSK GSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together. Find out more at gsk.com. References 1 Taiwo, B et al. VH3810109 (N6LS) Efficacy and Safety in Adults Who Are Virologically Suppressed: The EMBRACE Study. Presented at the Conference on Retroviruses and Opportunistic Infections (CROI 2025), 9-12 March, San Francisco, CA SOURCE: ViiH Healthcare

ViiV Healthcare, GSK's HIV-focused subsidiary, is pushing forward with a new long-acting treatment for patients with HIV. After positive results from a mid-stage study, the company says it will advance development of a six-month intravenous (IV) version of its experimental antibody-based therapy, N6LS (VH109), in combination with its long-acting HIV drug cabotegravir.The Phase IIb EMBRACE trial, presented Wednesday at the Conference on Retroviruses and Opportunistic Infections (CROI), showed that N6LS, given every four months along with monthly cabotegravir injections, successfully kept the virus under control in adults already stable on treatment.Primary endpoint data showed that after six months of treatment, 96% of patients given the IV formulation of N6LS maintained HIV-1 RNA levels below 50 copies/mL — exactly matching the success rate of current standard treatments. When given as a subcutaneous (SC) injection, 88% of patients maintained HIV-1 RNA levels below 50 copies/mL. Confirmed virologic failure was observed in two participants from each N6LS group.Meanwhile, the IV option stood out as better tolerated, with no infusion site reactions — unlike the SC group, where 14% of participants reported issues."We are building on the positive patient and physician experience we have with Cabenuva (cabotegravir/rilpivirine) and pioneering the next generation of long-acting treatment options," said Kimberly Smith, head of R&D at ViiV. Cabenuva was first approved by the FDA in 2021, with the product’s label updated the following year to include dosing every two months in virologically suppressed adults."We're looking forward to continuing the development of VH109 as a component of our future ultra long-acting regimens," Smith added.The N6LS presentation was part of a broader showcase of ViiV's long-acting portfolio at CROI, where the company also presented positive findings from two Phase IIa proof-of-concept trials. These additional studies evaluated VH184, a third-generation integrase inhibitor, and VH499, a capsid inhibitor.Specifically, ViiV said VH184 led to a "marked drop" in HIV-1 viral load across all tested doses — 10 mg, 50 mg, and 300 mg taken once every three days — during a 10-day monotherapy period, with the highest average viral load decline being -2.31 log10 copies/mL in the highest dose group. Similarly, VH499 showed decreases in HIV-1 viral load ranging from -1.8 to -2.2 log10 copies/mL across its dosing arms — 25 mg, 100 mg, and 250 mg — with the highest dose producing the greatest reduction.