Gilead’s Novel Capsid Inhibitor Treatment for HIV Gains First Approval from European Commission

On August 22, Gilead Sciences announced the European Commission (EC) granted a Marketing Authorization for their HIV treatment Sunlenca® (lenacapavir). Sunlenca is a capsid inhibitor blocking the replication of the HIV virus. The EC’s approval marks the first gained by Sunlenca from any regulatory agency.

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Capsid Inhibitors Prevent the Spread of the HIV Virus

Sunlenca belongs to a class of HIV drugs called capsid inhibitors. These drugs damage the shell that protects the genetic material within a virus needed for replication called a capsid. Once disrupted, the virus cannot replicate, leading to an overall reduction in HIV count within the body.

Currently, treatments for HIV include the use of antivirals. One such example is Ziagen, an antiviral that similarly lowers the amount of HIV in a patient’s blood. Rather than inhibit the capsid, this antiviral inhibits the reverse transcriptase, a part of the virus required to infect other cells. However, reverse transcription is only one stage out of the seven in an HIV virus’ life cycle.

Unlike most antivirals, Sunlenca works on multiple HIV virus life cycle stages. Furthermore, capsid inhibitor has no cross-resistance to any other drug classes. In addition, medical professionals administer Sunlenca via injection or oral tablet once every six months rather than in daily doses. 

Sunlenca demonstrated itself as a new treatment option for HIV patients whose virus no longer effectively responds to their current therapy in a phase ⅔ clinical trial. 

First Regulatory Approval Based off Clinical Trial Data

The CAPELLA phase ⅔ study evaluated the antiviral activity of Sunlenca. The seventy-two subjects of the double-blinded, placebo-controlled study included men and women with multi-class HIV-1 drug resistance in North America, Europe, and Asia.

The results, published in The New England Journal of Medicine in May, showed that the patients who received Sunlenca showed a more significant reduction in their virus count than those taking the placebo.

Due to the study’s results, the EC granted Marketing Authorization for Sunlenca in all twenty-seven of its member states, in addition to Norway, Iceland, and Liechtenstein.

On the EC’s approval, Daniel O’Day, Chairman and Chief Executive Officer at Gilead Sciences, said, “Lenacapavir is a unique and potent medicine with the potential for flexible dosing options. Following today’s approval, it will now be the only twice-yearly treatment for people who struggle with multi-drug resistant HIV.”

Capsid inhibitors are a novel drug type, with none currently approved by the United States Food and Drug Administration (FDA). However, in July, the FDA accepted Sunlenca for review in the New Drug Application (NDA). With the approval of the EC, the future for Sunlenca’s approval by other regulatory agencies appears to be bright. 

Author

Max Heirich