TIVICAY (dolutégravir sodique) (VIH pédiatrique)

Key points

Favourable opinion for reimbursement in the indication extension for the treatment of children of at least 4 weeks of age or older and weighing at least 3 kg infected with HIV-1 without resistance to the integrase class.

Unfavourable opinion for reimbursement by public funding in view of the available alternatives in children of at least 4 weeks of age or older and weighing at least 3 kg infected with HIV-1 with resistance to the integrase class, in the absence of data enabling determination of a dosing regimen in these situations.

Favourable opinion for reimbursement of the new form of TIVICAY (dolutegravir) 5 mg dispersible tablets in adults and children of at least 6 years of age or older in the same conditions as the forms already included on the list.

What therapeutic improvement?

Therapeutic improvement in the management of children from 4 weeks to less than 6 years of age and weighing at least 3 kg infected with HIV-1 without resistance to the integrase class.

Role in the care pathway?

Treatment combinations with at least three highly active agents are recommended as first-line therapy. They include two nucleoside reverse transcriptase inhibitors (NRTI) + a third agent (protease inhibitor [PI], non-nucleoside reverse 1 transcriptase inhibitor [NNRTI] or integrase inhibitor [INI]).

The first-line treatment in children with no prior therapy increasingly favours INI or PI treatment boosted with 2 NRTIs as the preferred treatment regimens from 2 weeks of age.

Role of the medicinal product in the care pathway

Considering:

• data available in adults and limited data in children,
• the high immuno-virologic activity of dolutegravir and its high genetic barrier to resistance, as well as,
• its favourable safety profile and practicality of use (dosing without requirements in terms of food),

the Committee considers that TIVICAY (dolutegravir) is a first or second-line treatment option, as an alternative to PIs in children (from 4 weeks to less than 6 years of age and weighing at least 3 kg) infected with HIV-1 without resistance to the integrase class. It should be administered in combination with other antiretroviral medicines. Its use should be guided by genotype resistance testing. In addition and in accordance with the risks identified in the RMP, monitoring of psychiatric disorders in children is necessary.

In the event of resistance to the integrase class, the data is insufficient to determine a dosing regimen for use of dolutegravir in the paediatric population (see SPC). TIVICAY (dolutegravir) therefore has no role in this situation in children and adolescents.

Special recommendations

The Committee highlights the fact that the use of dolutegravir from the first month of life is a significant advance in the optimal treatment of HIV infection. It regrets that the majority of antiretrovirals are reserved for children from 6 years of age or from 2 years of age in some cases, whereas currently HIV infection in children is the consequence of transmission during pregnancy and antiretroviral therapy should be discussed from birth.