Dolutegravir was approved in January 2014 for use in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV) infection in adults and adolescents over the age of 12 years. The IQWiG has completed an early benefit assessment pursuant on AMNOG,  on whether the new drug offers an additional benefit against the appropriate comparator therapy.

The manufacturer's dossier provides an evidence of a significant added value in adults without pre-treatment as well as an indication of a small additional benefit in treatment-experienced adults with INI-demand (i.e. where an integrase inhibitor, INI, should be part of the therapy). These patients have fewer side effects with the new drug than the respective comparison therapy.

For more details, go to: https://www.iqwig.de/de/presse/pressemitteilungen/pressemitteilungen/dolutegravir_bei_hiv_1_infektion_zusatznutzen_bei_erwachsenen_patienten.6114.html?&et_cid=4&et_lid=%208 [German]