TROGARZO

• Key points  

Favourable opinion for reimbursement in the treatment of adults infected with multidrug-resistant HIV-1 infection for whom it is otherwise not possible to construct a suppressive antiviral regimen.  

• What therapeutic improvement? 

Therapeutic improvement in the care pathway for patients with multidrug-resistant HIV-1 infection and for whom currently available antiretroviral therapies (ARVs) are unable to achieve viral suppression.   

• Role in the care pathway? 

The management of HIV infection is well standardised and is the subject of national and international guidelines. Combination therapies with at least 3 highly active agents are recommended for first-line treatment, including 2 NRTIs + a third agent (1 PI, 1 NNRTI or 1 INI). 

In patients with established virologic failure, the choice of the new treatment should ideally be discussed at a multidisciplinary review meeting, including clinicians, a virologist and a pharmacologist. The opinion of a team experienced in the management of these patients is essential in situations where the treatment options appear to be limited. Except in specific cases, treatment interruptions should be avoided. The optimal treatment regimen consists of three active agents, based on treatment history and cumulative genotype. ARVs that can be considered to be active are those belonging to a class not yet used or belonging to a class already used but for which the current or cumulative resistance genotype(s) suggest(s) that the ARV in question is active. 

Introduction of a new therapy including just one active medicinal product is not recommended since this would lead to rapid selection of new resistance mutations. Following a change of antiretroviral therapy due to virologic failure, early control (after one month) of viral load and the safety of the new treatment is required.  

Role of the medicinal product in the care pathway 

TROGARZO (ibalizumab) is a last therapeutic option, in combination with other appropriate antiretrovirals, for the treatment of patients with multidrug-resistant HIV-1 infection and for whom currently available antiretroviral therapies are unable to achieve viral suppression.  

• Special recommendations 

Given the product characteristics and the complexity of management of patients in a multi-drug failure situation, the Committee recommends restricting the prescription of TROGARZO to physicians experienced in the management of patients with multidrug-resistant HIV-1 infection and following discussion at a multidisciplinary review meeting.