Source – Gilead
Gilead Sciences presented new data at the 12th International AIDS Society (IAS) Conference on HIV Science (IAS 2023) in Brisbane, Australia. The data highlighted the effectiveness, safety, and tolerability of lenacapavir, a groundbreaking long-acting injectable HIV treatment, which is administered twice-yearly. This medication has shown promising results in the Phase II/III CAPELLA trial, including positive patient-reported outcomes (PRO).
The findings emphasize lenacapavir’s role as a patient-centric therapy option, with the potential to transform HIV clinical care in the future. Participants in the CAPELLA trial reported favorable scores in their health-related quality of life, including physical and mental health, which remained consistent over time. These scores were similar to those observed in the general US population.
āUnderstanding potential real-world use of novel HIV options is essential to helping ensure they have the greatest potential impact. The patient-reported outcome data presented at IAS 2023 provide deep insight into the tolerability of lenacapavir, and the oral bridging data helps demonstrate how twice-yearly lenacapavir can fit into peopleās lives. As we continue development of lenacapavir-based options with the goal to optimize HIV treatment, peopleās experience and insights are at the center.ā
– Jared Baeten, MD, PhD, Vice President, HIV Clinical Development, Gilead Sciences
Notably, the combination of weekly oral lenacapavir with an optimized background regimen (OBR) resulted in high rates of virologic suppression in both CAPELLA and the Phase II CALIBRATE trial. Moreover, lenacapavir’s concentrations in the blood remained efficacious when the subcutaneous administration was interrupted.
For heavily treatment-experienced individuals with HIV, maintaining a good quality of life can be challenging due to symptoms affecting mobility, self-care, mental health, and physical pain, potentially impacting their adherence to treatment. However, lenacapavir plus OBR demonstrated the ability to maintain an effective HIV treatment without compromising the patients’ health-related quality of life.
Additional analyses from the CAPELLA and CALIBRATE trials revealed that lenacapavir, when paired with an OBR, can maintain high rates of virologic suppression and tolerability even after missed doses of subcutaneous lenacapavir. To address this, participants received a weekly oral bridging (OB) dose, which contributed to virologic suppression. The majority of participants showed a high level of adherence to the OB dose.
In the CAPELLA trial, almost all participants who were virologically suppressed at Weeks 10, 20, and 30 while on OB remained suppressed. Similarly, in the CALIBRATE trial, all participants maintained virologic suppression at these time points. However, it is worth noting that one participant in CAPELLA, who missed two non-consecutive oral lenacapavir doses during OB, did not maintain virologic suppression.
The data also revealed that the mean plasma concentrations of lenacapavir remained at effective levels during the Week 30 OB period. This indicates that a weekly oral dose of 300 mg lenacapavir, in combination with the OBR, could potentially bridge a missed dose of the twice-yearly subcutaneous injection.
It’s important to highlight that the use of lenacapavir for oral bridging has not been approved by any regulatory authority. Nonetheless, these findings suggest that lenacapavir holds significant promise in providing an effective and well-tolerated HIV treatment option, improving the lives of people living with HIV.
