EU approves Juluca for human immunodeficiency virus type 1.- ViiV Healthcare.

ViiV Healthcare announced that the European Commission has granted marketing authorisation for Juluca (dolutegravir 50mg/rilpivirine 25mg) for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable antiretroviral regimen for at least six months with no history of virological failure and no known or suspected resistance to any non-nucleoside reverse transcriptase inhibitor or integrase inhibitor.

Data from the SWORD studies, presented at the Conference for Retroviruses and Opportunistic Infections (CROI) 2017 and later published in The Lancet, showed that the dolutegravir and rilpivirine regimen is non-inferior to traditional three and four drug regimens in maintaining virologic suppression (HIV-1 RNA less than 50 copies/mL) through 48 weeks in adults who are infected with HIV-1, in both pooled and individual analyses of the SWORD-1 and SWORD-2 studies (dolutegravir+rilpivirine 486/513 [95%] current antiretroviral regimen 485/511 [95%], [adjusted difference -0.2% (95% confidence interval: -3.0%, 2.5%), pooled analysis]). The most commonly reported (more than 5%) adverse events in the dolutegravir+rilpivirine arm were nasopharyngitis, headache, diarrhoea and upper respiratory tract infection. Participating adults had stable plasma HIV-1 RNA (viral load <50 copies/mL) for 6 months or longer at screening, with no resistance-associated major integrase inhibitor, protease inhibitor, nucleoside and non-nucleoside reverse transcriptase inhibitor mutations.