Dolutegravir approved in Europe

On 21 January 2014, ViiV Healthcare announced that the European Commission has approved dolutegravir for use in combination with other antiretroviral medicinal drugs for the treatment of HIV positive adults and adolescents above 12 years of age.

Approval was based on results from four Phase 3 adult studies in treatment-naïve and treatment-experienced patients, including people with resistance to other integrase inhibitors. The submission supporting today’s approval included data from four pivotal Phase III clinical trials in which 2,557 adults received treatment with dolutegravir or a comparator. The submission also included data from a fifth study in children aged 12 years and older5.

The efficacy of dolutegravir – as a ‘third agent’ – was statistically superior to its comparator in two pivotal Phase III studies1,2 and non-inferior in a third comparator study. In clinical trials, Tivicay had low rates of discontinuation due to adverse events (1-3%) in both treatment-naive and treatment-experienced patients.

The safety profile is based on pooled data from Phase IIb and Phase III clinical studies in 980 previously untreated patients, 357 previously treated patients unexposed to integrase inhibitors and 234 patients with prior treatment failure that included an integrase inhibitor (including integrase class resistance). The most commonly seen treatment emergent adverse reactions were nausea (15%), diarrhoea (16%) and headache (14%). The most severe adverse reaction, seen in an individual patient, was a hypersensitivity reaction that included rash and severe liver effects.

The recommended dose of dolutegravir for most patients is one 50 mg tablet once daily. For patients with documented or clinically suspected resistance to the integrase class, or when co-administered with certain medicines, the recommended dose of dolutegravir is 50 mg twice daily.

Please refer to the full European Summary of Product Characteristics for full prescribing information, including contraindications, special warnings and precautions for use. [2]