One year into treatment with an every-6-month dose of the investigational drug lenacapavir (LEN, Gilead Sciences) in a dual-treatment combination, 88% of treatment-naive people living with HIV had undetectable viral loads.
The findings, presented at the Conference on Retroviruses and Opportunistic Infections (CROI) 2022 Annual Meeting, also showed the drug was well tolerated, with 2 of 182 people developing drug-resistant mutations to lenacapavir and one person developing a nodule at the injection site.
Laura Waters, MD, consulting physician in HIV and sexual health at Central and Northwest London NHS Trust, who was not involved in the trial, called the findings "hugely exciting," especially given its unique mode of administration. Right now it's formulated as a subcutaneous injection, not an intramuscular injection like cabotegravir and rilpivirine (Cabenuva, ViiV Healthcare).
"Clearly it's incredibly exciting to have the option for a subcutaneous drug that could be given at home every 6 months," Waters told Medscape Medical News. With phase 3 trials and long-term follow-up still to come, she said she's looking forward to how the treatment evolves.
The Study to Evaluate the Safety and Efficacy of Lenacapavir in Combination With Other Antiretroviral Agents in People Living With HIV (CALIBRATE) is a phase 2, four-arm, open-label, active-control study.
