ViiV Healthcare today announced that the European Commission has approved Tivicay™ (dolutegravir), an integrase inhibitor, for use in combination with other anti-retroviral medicinal products for the treatment of HIV infected adults and adolescents above 12 years of age.
The Tivicay clinical development programme was comprehensive in its breadth, including people living with HIV who were new to treatment (naive), as well as those who had already been treated with other HIV medicines (experienced) and those who were infected with a virus that had developed resistance to previously available 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 Tivicay or a comparator. The submission also included data from a fifth study in children aged 12 years and older.
"Today's approval of Tivicay is an important advance, opening the door to new treatment combinations for people living with HIV in Europe. Tivicay's clinical development programme was only possible through partnerships with the people living with HIV and healthcare professionals who participated in it, and we aim to move forward together with them based on an absolute commitment to the HIV/AIDS global response," said Dr Dominique Limet, Chief Executive Officer, ViiV Healthcare.
Today's approval of Tivicay is the European regulatory authorisation to market the medicine in each member state of the European Union. Tivicay will become available in each country as pricing and reimbursement processes are completed, with availability in some of the first countries anticipated in the immediate future.
The efficacy of Tivicay – as a 'third agent' – was statistically superior to its comparator in two pivotal Phase III studies 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.
"HIV treatment is not a question of 'one-size fits all' – especially now that treatment is something that patients will live with for many years," said Dr John Pottage, Chief Medical Officer, ViiV Healthcare. "We continue to find measurable clinical differences among the treatments now available for use in combination therapy to combat HIV. Using the clinical data for Tivicay, doctors and people living with HIV can fully consider the effectiveness against the virus and the side effect profile that Tivicay may bring."
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.
Tivicay inhibits an enzyme used by the HIV virus during its replication cycle, known as integrase. By binding to the site where integrase acts, it blocks the "strand transfer" step of the HIV replication process – stopping the viral DNA from forming a new virus. The recommended dose of Tivicay 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 Tivicay 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.