The US Food and Drug Administration (FDA) has approved ViiV Healthcare’s Juluca, the first complete treatment regimen containing only two drugs to treat certain adults with human immunodeficiency virus type 1 (HIV-1).
The first 2-drug regimen (2DR) Juluca consists of dolutegravir at 50mg, an integrase strand transfer inhibitor and rilpivirine at 25mg, a non-nucleoside reverse transcriptase inhibitor.
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ViiV Healthcare CEO Deborah Waterhouse said: “The FDA approval of Juluca marks an important milestone in our commitment to deliver innovative advances in HIV care by providing new treatment options that challenge the traditional approach to care.
“This is the start of a new era in HIV treatment. We are delighted to be able to provide the first 2-drug regimen to physicians and people living with HIV in the US, to support the reduction of long-term ART exposure as they receive lifelong treatment for their chronic condition.”
The approval by FDA is based primarily upon data from SWORD-12 and SWORD-2,2 clinical trials.
These two pivotal phase III trials showed that Juluca achieved non-inferior viral suppression (HIV-1 RNA less than 50 copies per mL) at 48 weeks compared with a three or four-drug regimen in both pooled and individual analyses of the SWORD-1 and SWORD-2 studies.
Juluca, a fixed-dose tablet containing the two previously approved drugs dolutegravir and rilpivirine to treat adults with HIV-1 infections, will help lessen the lifetime burden of treatment for people living with HIV.
