Further analysis shows that 300 mg lenacapvir tablets plus an optimized background regimen can effectively reconcile a missed dose of lenacapavir injection in patients with HIV.
Lenacapavir (Sunlenca) shows long-term favorable outcomes for patients with HIV who are heavily treatment-experienced, according to patient-reported outcomes (PRO) collected through 52 weeks from the phase 2/3 CAPELLA trial and presented at the 12th International AIDS Society (IAS) Conference on HIV Science, July 23-26, Brisbane, Australia.
“Understanding potential real-world use of novel HIV options is essential to helping ensure they have the greatest potential impact,” said Jared Baeten, MD, PhD, vice president, HIV Clinical Development, Gilead Sciences, in a press release.
Heavy treatment can negatively impact health-related quality of life (QoL), which may worsen treatment adherence. However, lenacapavir did not significantly compromise QoL at 52 weeks, based on scores from 5 QoL assessments: the EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) index, EQ-5D-5L visual analogue scale (VAS), Short Form-36 (SF-36), HIV Symptom Index (HIV-SI), and Numeric Pain Rating Scale (NPRS).
In the phase 2/3 CAPELLA trial, investigators conducted additional analysis on weekly oral lenacapavir (300 mg tablets) plus optimized background regimen (OBR; or other antiretroviral) for patients who missed a lenacapavir injection. The results of the additional analysis show that once weekly lenacapvir plus OBR was tolerable and led to high rates of virologic suppression at weeks 10, 20, and 30, among 98%, 97%, and 100% of participants, respectively.
This bridging dose also maintains high rates of efficacious concentrations of lenacapavir in the blood and based on 30 weeks of data, 300 mg of lenacapavir with OBR can reconcile a missed dose of lenacapvir injection, although this indication is not yet approved by a regulatory authority.
“Results from this analysis provide support for the future potential use of oral therapy with lenacapavir as a treatment strategy to maintain virologic suppression in patients between planned or otherwise missed injection dosing visits in clinical practice,” said Jean-Michel Molina, MD, Université Paris Cité, professor of Infectious Diseases and head of the Infectious Diseases Department at the Saint-Louis and Lariboisière Hospitals, in the press release.
Lenacapavir is an HIV capsid inhibitor that is combined with other antiretroviral(s) for patients with multi-drug resistant HIV who have been heavily treated. It is a twice-yearly and multi-stage treatment that consists of lenacapavir 463.5 mg/1.5 mL injection with oral loading of lenacapavir 300 mg tablets before (or during) the first injection. The most common adverse events (AEs) are injection site reactions and nausea.
According to investigators, this treatment could be a foundational HIV therapy regimen as a single agent to prevent HIV or combined with other antiretroviral agents to treat HIV. Injectable lenacapvavir for HIV prevention is under investigation by researchers.
“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 people’s lives,” Baeten said in the press release.
Twice-Yearly Lenacapavir Demonstrates Sustained Impact on Health-Related Quality of Life in People With HIV. Gilead. News Release. July 24, 2023. Accessed on July 26, 2023. https://www.gilead.com/news-and-press/press-room/press-releases/2023/7/twice-yearly-lenacapavir-demonstrates-sustained-impact-on-health-related-quality-of-life-in-people-with-hiv