 |
|
|
| |
CABENUVA DEMONSTRATES SUPERIORITY TO DAILY ORAL THERAPY IN ADOLESCENTS LIVING WITH HIV, AS ViiV HEALTHCARE HIGHLIGHTS NEW LONG-ACTING INJECTABLE DATA AT AIDS 2026
|
| |
| |
Download the PDF here
Superiority data from LATA, together with OPERA findings, add to the clinical and real-world evidence base for long-acting injectable Cabenuva
Six-month follow-up CLARITY data further reinforce a more favourable injection experience with long-acting cabotegravir compared with lenacapavir after a single dose; additional studies showcase high real-world adherence and a preference for Apretude among previous oral PrEP users
EXTEND 4M explores a new investigational intramuscular cabotegravir formulation dosed three times a year for HIV prevention, as part of broader long-acting pipeline data
London, 29 July 2026 – ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Shionogi as a shareholder, today announced data to be presented this week at the 26th International AIDS Conference (AIDS 2026) in Rio de Janeiro, Brazil. Multiple studies span long-term outcomes, real-world use, injection experience, adherence and future long-acting options for HIV treatment and prevention.
Jean van Wyk, MBChB, MFPM, Chief Medical Officer at ViiV Healthcare, said: "The data presented at AIDS 2026 underscore the depth and breadth of evidence ViiV Healthcare has generated for long-acting injectables across HIV treatment and prevention. With OPERA, real-world evidence from nearly 6,800 adults in routine care shows Cabenuva maintained high and comparable virologic suppression to daily oral therapy, helping us better understand how it performs outside clinical trials and supports people over time. Together with clinical and patient-reported data, this evidence provides a trusted foundation for the next generation of innovation, shaped by people affected by HIV and designed to deliver impact at scale."
Superiority data from LATA, together with OPERA findings, add to the clinical and real-world evidence base for cabotegravir + rilpivirine (CAB+RPV LA) in long-acting HIV treatment.
Week 96 results from the LATA trial, led by University College London, showed CAB+RPV LA dosed every two months was superior to daily oral dolutegravir/tenofovir disoproxil fumarate/lamivudine (DTG/TDF/3TC) in 476 virologically suppressed adolescents aged 12 to 19 years living with HIV in Kenya, South Africa, Uganda and Zimbabwe.1
Confirmed viral rebound occurred in 0.9% (n=2/235) of adolescents receiving CAB+RPV LA versus 6.4% (n=15/241) receiving daily oral therapy.
94% (n=215/228) reported that long-acting injections were much easier to take than daily oral therapy.
The findings contribute to evidence in an adolescent population, where adherence and retention in care can be challenging.
New real-world data from the US-based OPERA cohort showed CAB+RPV LA dosed every two months maintained virologic suppression comparable to daily oral bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) in nearly 6,800 virologically suppressed adults living with HIV.2
89% (n=3,655/4,095) of individuals receiving CAB+RPV LA and 83% (n=2,239/2,699) receiving BIC/FTC/TAF had viral load <50 copies/mL, at a median follow-up of 15 months and 22 months, respectively.
Confirmed virologic failure risk was low and comparable in both groups, occurring in 1% (n=46) of individuals receiving CAB+RPV LA and 2% (n=46) receiving BIC/FTC/TAF.
Six-month follow-up data from CLARITY reinforce a more favourable injection experience with long-acting cabotegravir (CAB LA) versus lenacapavir (LEN) after a single dose; additional studies showcase high real-world adherence and a preference for CAB LA for PrEP among previous oral PrEP users.
The phase I CLARITY study compared participant experience after a single intramuscular dose of CAB LA and a single subcutaneous dose of LEN in 63 participants without HIV-1. Building on earlier Day 22 findings published in Advances in Therapy, follow-up data show injection site reactions (ISRs) were less visible with CAB LA compared with LEN through six-months.3,4
70% (n=42/60) rated the CAB LA injection experience as "very acceptable" or "totally acceptable," compared with 37% (n=22/60) for LEN LA.
No healthcare professionals reported challenges with administration and patient management with CAB LA, whereas 3/4 had difficulty with LEN LA administration and 2/4 had difficulty managing participants on LEN LA.
Additional late-breaking participant-reported outcomes from an Injection-Site Reaction Assessment (ISRA) analysis at six months following dosing, showed CAB LA was associated with shorter lasting and less bothersome ISRs, with lower interference with daily activities.5
90% (n=54/60) of LEN participants continuing to report nodules after six-months, compared to only 20% with CAB LA (n=12).
No severe CAB-associated ISRs were reported, while 11/54 (20%) of LEN LA-associated nodules were reported as severe.
At Day 90, 92% of participants receiving CAB LA (n=56/61) reported they were not bothered by ISRs, compared with 58% receiving LEN LA (n=36/62).
No participants receiving CAB LA reported being "quite a lot" or "very much bothered" by ISRs, compared with 12% (n=7/60) receiving LEN LA.
These findings highlight the importance of ISRs in the injection experience in including patient-provider consideration that visible, persistent or bothersome ISRs may affect people's daily lives.
CAPTIVATE found strong preference for CAB LA for PrEP among people with prior oral PrEP experience and positive provider experiences delivering CAB LA for PrEP in US clinical practice.6,7 The study included 241 PrEP users and 36 healthcare providers across 18 US sites.
Among participants with prior PrEP / oral PrEP experience, 97% (n=185/190) preferred CAB LA for PrEP, compared to daily oral PrEP (2%).
Nearly all participants reported feeling protected from HIV (99%; n=239/241) and less worried about acquiring HIV (99%; n=238), as well as feeling more in control of their life (91%; n=219) because they use CAB LA for PrEP.
Among healthcare providers, 89% (n=16/18) reported a positive overall opinion of administering CAB LA for PrEP in their practice. Prescribers cited benefits of regular injection visits, including assurance of adherence (89%), more frequent STI testing (72%) and opportunities to address other health needs (61%)
These findings support CAB LA for PrEP as a preferred option for those who value control and engagement with their broader care, as well as convenience.
PrEPFACTS showed that people using CAB LA for PrEP had high adherence to their dosing schedule, in a large US real-world analysis of 2,913 people.8
Overall adherence was high, with a median proportion of days covered (PDC) of 1.00 (IQR: 0.96-1.00), indicating high coverage during measured follow-up.
89% (n=2,588) were covered by PrEP for at least 90% of the measured period.
Most continuation injections were given within recommended timeframes, including 85% (n= 9,798/11,476) within 67 days and 96% (n=11,009/11,476) within 90 days.
These findings add to real-world evidence that people can maintain adherence with CAB LA for PrEP, an important factor for maintaining protection.
EXTEND 4M baseline data describe diverse enrolment in the first study of a new investigational intramuscular cabotegravir formulation dosed three times a year for HIV prevention, representative of those who could benefit from PrEP in the real-world.
Baseline data from the phase IIb EXTEND 4M registrational study include 229 participants aged 16 years and older enrolled across 27 US sites in regions with significant HIV transmission among subpopulations disproportionately affected by HIV.9
Participants include 45% assigned female sex at birth, 32% Black or African American participants and 37% Hispanic/Latine participants.
28% of participants had previous oral PrEP use.
The study will assess pharmacokinetics, safety and tolerability, designed to support a potential HIV prevention option that could reduce clinic visits while maintaining regular screening and care. Data is expected to be presented at a future medical congress.
--
|
| |
|
|
|
|
|
