Gilead Reports Positive Results for Lenacapavir, Semiannual HIV Treatment

Highly anticipated data on Gilead’s novel twice yearly HIV treatment have been announced, suggesting that the therapy is effective in heavily pretreated patients who have stopped responding to other treatments. Early data from a second trial is also indicating that the treatment may yield benefits for patients who have not yet received treatment for HIV.

Presented at the International AIDS Society Conference in July, the results for lenacapavir have implications for the multidrug-resistant patients. The findings from the Phase 2/3 CAPELLA study showed that lenacapavir was able to suppress HIV in those patients with 81% of the 36 patients having an undetectable level of HIV six months after receiving the treatment.

“Despite the advances in treating HIV infection, there remains an unmet need for treatment options for people who struggle with multi-drug resistance,” said Jean-Michel Molina, M.D., professor of infectious diseases and head of the infectious diseases department at the Saint-Louis and Lariboisière Hospitals, in a prepared statement. “The CAPELLA results are exciting as they demonstrate that an undetectable viral load is achievable in a patient population that has typically had challenges with viral suppression over the course of their journey living with HIV.”

Lenacapavir is currently being evaluated by the FDA for approval in these patients, with the CAPELLA trial forming the basis of Gilead’s application. If approved, it will become the first approved HIV treatment that can be administered just twice a year. Once-daily pills have been the main form of HIV treatment. So far, just one extended-release, injectable treatment for HIV has been approved, ViiV Healthcare’s Cabenuva, a combination of cabotegravir and rilpivirine, which is injected once a month.

These newly released findings for lenacapavir, which were presented by Molina, are likely to strengthen Gilead’s application and perhaps usher in a new era of HIV. Lenacapavir is designed to interrupt various phases of the HIV replication. Many of the current HIV treatment inhibit just one phase of viral replication.

Upon enrollment in the CAPELLA trial, patients continued taking treatment they stopped responding to and were randomized to receive either oral lenacapavir or placebo for 14 days. Following those two weeks, patients entered the maintenance part of the study, receiving subcutaneous injections of lenacapavir every six months for a year in addition to an optimized background regimen.

The findings from these 36 patients showed that the treatment was also generally well tolerated among the patients, with no patients discontinuing treatment because of adverse events and no reported serious adverse events related to the treatment. The most common adverse events were mild injection-site reactions.

Data from a different phase 2 trial called CALIBRATE trial suggests that lenacapavir may also be eventually become a treatment option for patients with HIV who have yet to be treated, a much larger group than the patients who have stopped responding to the current batch of treatment. Results from CALIBRATE, which were also presented the International AIDS Society Conference, showed that a combination of lenacapavir, given orally and subcutaneously, and the oral emtricitabine-tenofovir alafenamide combination (which Gilead is selling as Descovy) resulted in 94% of the 157 patients achieving viral suppression by 28 weeks.

The CALIBRATE trial results also show that lenacapavir is well tolerated.