ViiV HEALTHCARE SHOWS MORE THAN 99% EFFECTIVENESS IN REAL-WORLD STUDIES FOR APRETUDE (CABOTEGRAVIR LONG-ACTING), THE ONLY APPROVED LONG-ACTING HIV PREP, IN DATA PRESENTED AT IDWEEK 2024

London, 16 October 2024 – ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer and Shionogi as shareholders, today announced the presentation of new real-world evidence and implementation data showing the effectiveness, adherence, and quality-of-life improvement of Apretude (cabotegravir long-acting (CAB LA)) for HIV pre-exposure prophylaxis (PrEP). The data will be presented at IDWeek 2024, being held in Los Angeles, California from 16 – 19 October.

Findings from two real-world evidence studies (from OPERA and Trio Health cohorts) showed more than 99% effectiveness of CAB LA for PrEP in nearly 1,300 individuals. In the PILLAR implementation study, reductions were shown in stigma and anxiety among the 200 individuals using the long-acting injectable PrEP option.

Harmony P. Garges, M.D., MPH, Chief Medical Officer at ViiV Healthcare, said: “The findings presented at IDWeek 2024 continue to support the strong and sustained effectiveness of Apretude for people in real life, outside the controlled environment of a clinical trial. The results of the studies from OPERA and Trio cohorts add to the growing body of evidence generated over the last three years, showing CAB LA for PrEP is a highly effective option for HIV prevention. We believe long-acting options have the potential to be transformative in increasing uptake among a broad range of people that could benefit from PrEP and are critical to ending the HIV epidemic.”

Trio Health cohort shows CAB LA for PrEP’s effectiveness in the real world with zero cases of HIV acquisition during follow-up1

New data from the Trio Health cohort shows the real-world use of CAB LA for PrEP in preventing HIV acquisition and adherence, among 474 individuals in the U.S.. The analysis identified a diverse population of cis- and transgender male and female individuals initiating CAB LA for PrEP from electronic health records between December 2021 through January 2024.

Findings from the cohort showed that there were zero HIV diagnoses identified during follow-up among participants taking CAB LA for PrEP. Eighty-three percent persisted on CAB LA for PrEP injections at the time of analysis, and injections were also administered on time for most of the initiators. Of the 396 participants with continuation injections, 33% experienced delays with a median of one delayed injection and median delay of 12 days [IQR: 3-29]. Adherence to CAB LA for PrEP was high, with only 3% of participants experiencing a missed injection.

OPERA study highlights high adherence and effectiveness of CAB LA for PrEP2

Real-world findings from the OPERA study provide insights into injection timing, adherence, and effectiveness among individuals using CAB LA for PrEP in the U.S.. The OPERA study reported findings from a large, diverse U.S. cohort, which included 764 individuals using CAB LA for PrEP, 29% of whom are Black and 29% Hispanic.

CAB LA for PrEP was effective in 99.7% of individuals (762 of 764 were not diagnosed with HIV during the follow-up period). There were two cases of HIV (0.3%) observed among the CAB LA for PrEP initiators. These cases could not be directly linked to the regimen due to its discontinuation in one case and inconsistent testing in the other case.

Eighty-five percent of individuals taking CAB LA for PrEP had complete initiation of the regimen (i.e. completed their first two initiation injections 60 or less days apart from each other). Sixty-nine percent of these complete initiators received all of their continuation injections on time. While some injection delays were observed among those with complete initiation, most were short, with a median delay of three days from the target date. 

PILLAR implementation study shows CAB LA for PrEP may help address key PrEP challenges of stigma and anxiety3

New findings from the PILLAR trial explore the experiences of more than 200 men who have sex with men (MSM) and transgender men (TGM) who initiated CAB LA for PrEP after previous experience with daily oral PrEP. PILLAR is a phase 4 implementation trial assessing the integration of CAB LA for PrEP across 17 U.S. clinics among a diverse population of MSM and TGM, 23% of whom are Black and 39% Hispanic/Latino.

The six-month findings from the PILLAR trial showed that individuals taking CAB LA for PrEP reported lower rates of PrEP stigma and anxiety compared to their prior oral PrEP experience, and that the long-acting injectable was feasible, acceptable, and convenient for their life. When recounting their oral PrEP experience at the initiation of the trial, 15% of participants had worried about privacy while taking oral PrEP, 24% felt they had to hide their oral PrEP from others, and 29% expressed worry about stigma from taking oral PrEP. After initiating CAB LA for PrEP and completing surveys at month six of the trial, <1% of participants reported concerns about privacy and only 1% expressed worry about stigma while taking CAB LA for PrEP. Participants who completed interviews noted CAB LA for PrEP reduced the stress and fear of missing a PrEP dose, while offering confidence of protection from HIV.

While 45% of participants reported injection site reactions (ISRs), 86% of participants returned to daily activities the same day and few reported being bothered by injection pain (8%). These individuals who had been initially bothered by injection pain reported that pain decreased over subsequent injections.

CAB LA for PrEP demonstrated high levels of acceptability among users, with mean acceptability scores increasing from 4.4 at baseline (SD: 0.69) to 4.6 at six months (SD: 0.61), with interviewees noting that CAB LA for PrEP was convenient for their life. This positive experience was supported by flexible clinic scheduling, transportation assistance, and the use of virtual appointments, all of which were identified as valuable facilitators of adherence.

These studies demonstrate ViiV Healthcare's commitment to generating robust real-world evidence for CAB LA for PrEP, furthering the study of its implementation, and advancing the understanding of its impact on diverse communities who can benefit from HIV prevention. Further research will continue to explore the long-term benefits of CAB LA for PrEP and optimise its use.

About Apretude (Cabotegravir LA for PrEP)

Apretude is a medicine used for preventing sexually transmitted HIV-1 infection (pre-exposure prophylaxis or PrEP) in adults and adolescents weighing at least 35 kg who are at high risk of being infected. It should be used in combination with safer sex practices, such as using condoms. Apretude contains the active substance cabotegravir.

Please find additional safety information here.

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 are at risk of acquiring HIV. 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.

Cautionary statement regarding forward-looking statements

GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described under Item 3.D “Risk factors” in GSK’s Annual Report on Form 20-F for 2023, and GSK’s Q2 Results for 2024.

Registered in England & Wales:

GSK plc                                ViiV Healthcare Limited
No. 3888792                        No. 06876960

Registered Office:

79 New Oxford Street        ViiV Healthcare Limited
London                                 GSK Medicines Research Centre
WC1A 1DG                            Gunnels Wood Road, Stevenage
                                               United Kingdom
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References

1. M Ramgopal, et al. Real-world use of cabotegravir long-acting for pre-exposure prophylaxis: Data from Trio Health cohort. Presented at the Infectious Disease society of America (IDSA) IDWeek™ 2024, 16-19 October, Los Angeles, CA.
2. R Hsu, et al. Cabotegravir Long-Acting for Pre-Exposure Prophylaxis (PrEP): Real World Data on On-Time Dosing, HIV Testing and HIV Acquisition from the OPERA Cohort. Presented at the Infectious Disease society of America (IDSA) IDWeek™ 2024. October 2024.
3. H. Holder, et al. Patient Experiences at Month 6 after Initiation of Cabotegravir Long-Acting (CAB LA) for PrEP in the First Male Gender Concordant Implementation Science Trial (PILLAR) in the US. Presented at the Infectious Disease society of America (IDSA) IDWeek™ 2024. October 2024.

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Media contacts

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OR call +44 7823 523 755

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Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in the package leaflet. You can also report side effects directly via the GSK Reporting Tool link https://gsk.public.reportum.com/. By reporting side effects, you can help provide more information on the safety of this medicine.

If you are from outside the UK, you can report adverse events to GSK/ ViiV by selecting your region and market, here.

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Source: https://viivhealthcare.com/hiv-news-and-media/news/press-releases/2024/october/real-world-studies-for-apretude/

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