Trial Shows Limited Resistance to Sunlenca in Patients with HIV

Resistance to Sunlenca (lenacapavir) occurred in a minority of patients and only among those with inadequate adherence to their background regimen. These results are from two-year data in the ongoing phase 2/3 CAPELLA trial evaluating Sunlenca in treating adult patients with multi-drug resistant HIV. They were recently presented at the 19th European AIDS Conference.

Developed by Gilead Sciences, Sunlenca is part of a new class of drugs called capsid inhibitors, which block the HIV-1 virus’ protein shell (the capsid) and interfer with the virus' lifecycle. In December 2022, the FDA approved Sunlenca, a twice-yearly treatment for patients whose HIV is not adequately controlled by their current treatment regimen. It has a list price of $42,250.

Jared Baeten, M.D., Ph.D.

“The next wave of innovation in HIV includes long-acting options that are aiming to help address the differentiated needs and preferences of the diverse range of individuals and communities affected by the epidemic,” Jared Baeten, M.D., Ph.D., vice president, HIV Clinical Development at Gilead Sciences, said in a press release. “These unmet needs fueled our research teams at Gilead to develop Sunlenca, an innovative treatment option that helps respond to the unmet needs of adults with limited therapy choices.”

Despite advances in antiretroviral therapy, there is a need treatment option for patients who are heavily treatment experienced and are unable to maintain virologic suppression due to resistance.

In the CAPELLA trial, investigators enrolled 72 participants with advanced HIV. Of the 27 patients who met the resistance analysis criteria, 14 developed resistance to Sunlenca; all patients either had inadequate adherence to their background treatment or had a background treatment that lacked fully active antiretrovirals. Of the 14 patients, 7 were able suppress the virus when adherence to background therapy was established.

In an additional survey conducted with 25 study professionals and coordinators, the majority of respondents believed Sunlenca would be easy to integrate into real-world clinical practice. They indicated that Sunlenca has the potential to improve clinical outcomes and health-related quality of life for heavily treatment-experienced adults.

Gilead Sciences also presented real-world data evaluating Bicktarvy (bictegravir/emtricitabine/tenofovir alafenamide). Three-year data from ongoing BICSTaR study found to be highly effective for patients after three years of follow-up, with 97% of treatment-naïve and 97% of treatment-experienced patients about to have the virus suppressed. Additionally, there were no reports of treatment-emergent resistance.

The BICSTaR study also assessed mental health outcomes. Rates of mental health conditions are higher among people with HIV compared with the general population. Mental health issues can increase the risk of negative health outcomes. Self-reported symptoms associated with depression, anxiety, or insomnia remained stable over the course of treatment with Biktarvy. Drug-related adverse events of depression, anxiety, or insomnia were reported in 6% of patients, which led to discontinuation of the study drug in four people.

"Real-world evidence and observational studies can help bridge the gap between clinical trials and clinical practice, providing valuable insights into the characteristics of individuals with HIV in specific regions or communities, particularly those historically underrepresented in HIV clinical research,” Fernando Bognar, M.D., vice president of Global Medical Affairs for HIV at Gilead Sciences, said in a press release.