ViiV Healthcare Strengthens Evidence for Long-Acting HIV Therapies with Positive Cabenuva and Apretude Data at AIDS 2026

ViiV Healthcare has reported new clinical and real-world findings supporting its long-acting injectable HIV portfolio at the 26th International AIDS Conference (AIDS 2026) in Rio de Janeiro, Brazil. The data expand evidence for Cabenuva (cabotegravir plus rilpivirine) in HIV treatment and Apretude (long-acting cabotegravir) for HIV pre-exposure prophylaxis (PrEP), while introducing baseline results from EXTEND 4M, an investigational program evaluating a three-times-yearly cabotegravir formulation for HIV prevention.

Long-Acting HIV Therapies Continue to Build Clinical Evidence

Long-acting injectable antiretroviral therapies offer an alternative to daily oral treatment by reducing dosing frequency while maintaining viral suppression or HIV prevention. Cabenuva combines the integrase strand transfer inhibitor (INSTI) cabotegravir with the non-nucleoside reverse transcriptase inhibitor (NNRTI) rilpivirine as a complete maintenance regimen for virologically suppressed people living with HIV. Apretude contains long-acting cabotegravir for HIV prevention in individuals at substantial risk of infection.

Improving adherence remains a major challenge in HIV care, particularly among adolescents and populations requiring long-term preventive therapy. Long-acting regimens may address these barriers by reducing pill burden and supporting sustained engagement in care.

LATA and OPERA Studies Support Long-Term HIV Treatment

Updated Week 96 results from the Phase III LATA study (NCT05154747) demonstrated that every-two-month Cabenuva was superior to daily oral dolutegravir/tenofovir disoproxil fumarate/lamivudine in 476 virologically suppressed adolescents aged 12 to 19 years across Kenya, South Africa, Uganda, and Zimbabwe.

Confirmed viral rebound occurred in 0.9% of adolescents receiving Cabenuva compared with 6.4% receiving daily oral therapy. Additionally, 94% of participants reported that injectable treatment was easier to take than daily oral medication, highlighting the potential benefits of long-acting therapy in younger populations where adherence often remains difficult.

Complementing these findings, real-world data from the US OPERA cohort involving nearly 6,800 virologically suppressed adults showed comparable long-term viral suppression between Cabenuva and daily bictegravir/emtricitabine/tenofovir alafenamide (Biktarvy) therapy. Confirmed virologic failure remained low in both groups, occurring in 1% of Cabenuva recipients and 2% of patients receiving daily oral therapy.

Injection Experience and Adherence Favor Long-Acting Cabotegravir

Six-month follow-up data from the Phase I CLARITY study showed a more favorable injection experience with intramuscular long-acting cabotegravir than subcutaneous lenacapavir following a single dose.

Approximately 70% of participants rated cabotegravir injections as “very acceptable” or “totally acceptable,” compared with 37% for lenacapavir. Persistent injection-site nodules were reported by 20% of cabotegravir recipients versus 90% of those receiving lenacapavir. No severe injection-site reactions were reported with cabotegravir, whereas severe nodules occurred in one-fifth of affected lenacapavir recipients. Healthcare professionals also reported fewer administration challenges with cabotegravir.

Additional real-world studies strengthened the prevention evidence. The CAPTIVATE study found that 97% of previous oral PrEP users preferred Apretude over daily oral PrEP, while the PrEPFACTS analysis of 2,913 individuals showed high adherence, with 89% maintaining PrEP coverage for at least 90% of the observation period.

Executive Perspective

Jean van Wyk, Chief Medical Officer at ViiV Healthcare, said the AIDS 2026 presentations demonstrate the breadth of evidence supporting long-acting injectable HIV therapies across clinical trials and routine practice. He noted that real-world OPERA data complement clinical trial findings by showing sustained virologic suppression outside controlled study settings, providing a stronger foundation for future long-acting innovations.

Future Development

ViiV Healthcare also presented baseline data from the Phase IIb EXTEND 4M registrational study (NCT06741397) evaluating an investigational intramuscular cabotegravir formulation administered three times per year for HIV prevention. The study enrolled 229 participants across 27 US sites and will evaluate pharmacokinetics, safety, and tolerability. Future congress presentations are expected as the program progresses, potentially expanding long-acting HIV prevention options while reducing the number of clinic visits required annually.

What This Means for Patients

The findings suggest that long-acting injectable HIV medicines can reduce the burden of daily pills while maintaining effective HIV treatment and prevention. Cabenuva showed durable viral suppression and was easier for many adolescents to use than daily therapy. For HIV prevention, most participants preferred Apretude over oral PrEP and maintained high adherence. An investigational three-times-yearly cabotegravir formulation could further simplify HIV prevention if future studies confirm its safety and effectiveness.

Reference

Cabenuva demonstrates superiority to daily oral therapy in adolescents living with HIV, as ViiV Healthcare highlights new long-acting injectable data at AIDS 2026 | GSK