Dolutegravir, an integrase inibitor, to prevent HIV spread in patients

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The European Commission granted a marketing authorization valid throughout the European Union for Dolutegravir on 16 January 2014. Tivicay, the commercial name, is an antiviral medicine approved to treat adults and adolescents from 12 years of age who are infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS). It inhibits HIV integrase by binding to the integrase active site and blocking the strand transfer step of retroviral Deoxyribonucleic acid (DNA) integration which is essential for the HIV replication cycle. Tivicay does not cure HIV infection or AIDS, but it may delay the damage to the immune system and the development of infections and diseases associated with AIDS. The benefit with Dolutegravir are analyzed in four main studies. The efficacy was demonstrated in adult patients with and without resistance to the integrase inhibitors class (documented or clinically suspected) and in adolescents without resistance to the integrase inhibitors class. The most common side effects for Tivicay are diarrhea (16%), nausea (15%) and headache (14%). The main measure of effectiveness in all the studies was the response rate, which was the proportion of patients with a reduction of the levels of virus (viral load) in the blood to fewer than 50 copies of HIV-1 RNA per ml. Tivicay is available as tablets (50 mg).

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