New HIV drug approved in Europe.

On June 23, 2022, an innovative HIV drug called Sunlenca (lenacapavir) manufactured by the American company Gilead was approved in Europe. The drug has been approved under a centralized procedure in all 27 EU member states, including Norway, Iceland and Liechtenstein.

The regulators made their decision based on a phase II/III study called CAPELLA. In the trial, 83 % of patients treated with lenacapavir in addition to an optimized background regimen achieved an undetectable viral load (<50 copies/mL) at week 52. Phase III trials are currently underway to use the agent as pre-exposure prophylaxis, as well as phase II trials to test the drug in people who have never received HIV therapy before.

Sunlenca is a capsid inhibitor indicated for the treatment of multidrug-resistant HIV infection in adults. The advantage of the drug is not only its high efficiency, but also the frequency of administration: in clinical trials, Sunlenca was administered to participants only 2 times a year in combination with other antiretroviral drugs. The data obtained indicated high rates of virological suppression in people with HIV who had previously received therapy.

Lenacapavir also showed good tolerability and did not cause serious adverse events. The most commonly observed adverse events were reactions at the injection site.

The drug is manufactured in two dosage forms – tablets and solution for injection. According to the instructions for use, treatment begins with taking a tablet form, then patients switch to injections.

Interestingly, in the US, the Food and Drug Administration (FDA) rejected Gilead’s new drug application (NDA) for lenacapavir due to manufacturing problems, namely the formation of glass particles from the interaction of Sunlenca and borosilicate vials for the drug. The application was resubmitted in July 2022 and is currently under review by the regulator.

It is worth noting that Sunlenca is not the first injectable drug for the treatment of HIV infection, designed to reduce the frequency of administration. In 2021, FDA approved an injectable HIV treatment called Cabenuva from ViiV Healthcare. The drug, consisting of the active substances cabotegravir and rilpivirine, must be administered every month to suppress the virus. It has been proven that injection and tablet methods of treating HIV are equally effective.