Gilead Sciences’ HIV drug designed for twice-yearly dosing is now available approved for use in Europe, providing a new treatment option for patients whose virus no longer responds to currently available therapies.
The European Commission’s approval, announced Monday, covers the use of the drug lenacapavir in combination with other antiretroviral drugs in adults with HIV. The drug, which patients start with an oral dose before switching to the long-acting injection, will be marketed under the brand name Sunlenca.
Although there is no cure for HIV/AIDS, antiretroviral therapy can keep the virus under control and give the immune system a chance to recover. Antiviral drugs work by affecting part of the virus’ life cycle, preventing viral replication. While most antiviral drugs target a single stage of the life cycle, Foster City, Calif.-based Gilead designed Sunlenca to block HIV at multiple stages. The company also said its new HIV drug has no known cross-resistance with other classes of drugs currently available to treat HIV. This means it can be used in combination with other HIV medicines.
The European Commission based its decision on the results of a placebo-controlled phase 2/3 study involving 72 patients whose HIV had become resistant to multiple therapies. The results showed that 83 percent of study participants who received the experimental Gilead drug in addition to other therapies achieved an undetectable viral load at week 52, meeting the study’s primary objective. Gilead also reported that patients treated with the drug showed an increase in levels of CD4 cells, a type of immune cell whose numbers are used to measure the health of the immune system in HIV patients. The most commonly reported side effects are nausea and injection site reactions. The results of the survey were published in May in the New England Journal of Medicine.
For years, the standard antiviral treatment for HIV consisted of daily pills. Last year, FDA approval by ViiV Healthcare’s Cabenuva gave patients the option of a once-monthly treatment administered as an injection. This decision covers patients with no history of failure of other treatments and no known or suspected resistance to the two main antiviral components of the drug. Gilead’s new HIV drug provides an option for those whose virus has developed drug resistance.
“Lenacapavir is a unique and powerful drug with the potential for flexible dosing options,” Gilead Chairman and CEO Daniel O’Day said in a prepared statement. “After today’s approval, it will now be the only twice-yearly treatment for people fighting multidrug-resistant HIV.”
The European regulatory approval is Sunlenca’s first. The drug ran into hurdles at the FDA; in March, the US agency rejected Gilead’s application for the drug due to a manufacturing problem. The regulator had questions about the drug’s compatibility with the glass used in the vials. Gilead resubmitted its application in June. A regulatory decision is now expected by December 27. Gilead said additional regulatory filings and decisions are expected later this year.
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