New data presented by Gilead Sciences, Inc. has highlighted the efficacy, safety, and patient tolerability of Sunlenca (lenacapavir), the first long-acting injectable HIV treatment administered twice yearly.

The data came from the Phase 2/3 CAPELLA trial, including patient-reported outcomes (PRO), demonstrating lenacapavir’s potential in transforming HIV clinical care. The findings were unveiled at the 12th International AIDS Society (IAS) Conference on HIV Science (IAS 2023) held in Brisbane, Australia from July 23-26.

In the CAPELLA trial, participants used five validated instruments to measure health-related quality of life components, including physical and mental health. At week 52, 64 out of 72 participants reported favorable scores consistently, reflecting values close to those of the general U.S. population.

Separately, analyses from the CAPELLA and Phase 2 CALIBRATE trials showed that weekly oral lenacapavir, combined with an optimized background regimen (OBR), led to high rates of virologic suppression and efficacious concentrations of lenacapavir in the blood when the subcutaneous administration of lenacapavir was interrupted.

Vice President of HIV Clinical Development at Gilead Sciences, Dr Jared Baeten, said the PRO data offer insight into the tolerability of lenacapavir and how it fits into patients’ lives. The study collected data from five instruments assessing quality of life, revealing lenacapavir’s potential to be an effective HIV regimen without compromising health-related quality of life.

Further analysis from the CAPELLA and CALIBRATE trials provided insights on lenacapavir’s potential to maintain high rates of efficacy, virologic suppression, and tolerability, when combined with an OBR after missed doses. Also, the data showed that when supplemented with a weekly oral bridging dose, lenacapavir may provide concentrations high enough to bridge a missed dose of the twice-yearly subcutaneous injection.

Professor of Infectious Diseases at Université Paris Cité, Jean-Michel Molina, recognized the potential for lenacapavir’s oral therapy in maintaining virologic suppression between planned or missed injection dosing visits in clinical practice.

Currently, Gilead Sciences is developing twice-yearly lenacapavir as a foundation for future HIV therapies, offering long-acting oral and injectable options with various dosing frequencies. However, its use for HIV prevention remains investigational and unapproved by any regulatory authority.

Sunlenca in forms of 300 mg tablets and 463.5 mg/1.5 mL injections is a long-lasting HIV capsid inhibitor approved for treating HIV infection in the US. This first-of-its-kind treatment, used alongside other antiretroviral therapies, is indicated specifically for individuals with HIV resistant to multiple drugs and who have a history of extensive treatment.

Uniquely, Sunlenca requires only twice-yearly administration, making it a standout in HIV treatment options. Sunlenca tablets are sanctioned for oral loading at the onset of treatment, coinciding with or preceding the first long-acting lenacapavir injection, based on the chosen initiation method.

Nonetheless, the usage of Sunlenca, either alone or combined with other therapies, lacks approval from any regulatory authority beyond Australia, Canada, the European Union, Israel, Switzerland, the United Arab Emirates, the UK, and the US.

  Dr Jared Baeten, Gilead Sciences, HIV, HIV Treatment, Jean-Michel Molina, lenacapavir, USA